Safe and secure handling of medicines manual

Contents

1 Introduction

In the trust the principles which govern the management of medicines must be applied to all the activities in which medicines or their administrative and legal control is concerned.

The key principles are:

• compliance with current legislation
• adherence to guidance issued by the Health Departments for England, Wales, Scotland and Northern Ireland and other national guidance, for example, National Prescribing Centre (NPC) Guide, Medicines and Healthcare products Regulatory Agency (MHRA) alerts
• management of the risks to patients and staff arising from the use of medicines

These principles will be applied to the management and physical handling processes involved in the initiation of treatment, prescribing, procurement, production, acquisition, storage, distribution, dispensing, preparation, administration to patients and the safe handling and disposal of any residual medicinal product.

Medicines management focuses on optimizing the use of medicines and is defined in the audit commission’s report “A Spoonful of Sugar” as “encompassing the entire way that medicines are selected, procured, delivered, prescribed, administered and reviewed to optimize the contribution that medicines make to produce informed and desired outcomes of care”.

Aspects of medicines management run throughout the trust, across all localities and service areas, and comprehensive medicines’ management is crucial to the achievement of the trust strategic and operation objective. Medicines management involves patients, carers, and all pharmacy services within the trust.

2 Purpose

The Department of Health requires that NHS Trusts establish and maintain an effective system to ensure that medicines are handled in a safe and secure manner.

The purpose of this policy is that it overarches the safe and secure handling of medicines manual including all the standards contained therein. It sets out the arrangements for managing the risks associated with medicines in all care environments; and, to enhance standards of professional practice in the safe prescribing, dispensing and administration of medicines by:

• providing a procedural framework supporting the safe and secure use of medicines across all trust activities. This framework is to be used to support the development of ward, department, and base point specific standard operating procedures
• ensuring that the handling and storage of medicines within the trust meets legal requirements
• creating a robust audit trail that will be monitored in line with the trust audit programme
• defining the roles and limitations of staff working within the trust in relation to medicines
• detailing the lines of responsibility for the investigation of medicines related incidents

Additionally, the aims of this policy are to ensure that:

• all patients receiving treatment and requiring medication do so in the correct and proper manner
• all precautions have been taken to ensure that the proper procedures have been followed in providing that treatment
• proper procedures have been followed such that all medicines have been stored and transported to ensure that their integrity has been maintained and to minimize risks to staff, patients, and the public

The result of using this policy (in conjunction with any other appropriate local policies) should be that the right patient receives:

• the correct medication
• in the correct dosage
• by the correct route
• at the right time
• for the right duration however, medicines management should not be viewed as a mechanistic task, which becomes routine, as it requires thought and the exercise of professional judgment with each practitioner being accountable for their actions and omissions

3 Scope

This policy applies to those members of staff that are directly employed by the trust and for whom the trust has legal responsibility who are involved with the use of medicines. For those staff covered by a letter of authority or honorary contract or work experience this policy is also applicable whilst undertaking duties on behalf of the trust or whilst working on trust premises and forms part of their arrangements with our organisation.

As part of good employment practice, agency workers are also required to abide by the trusts policies and procedures, as appropriate, to ensure their health, safety, and welfare.

All staff contracted to work within the trust who are involved with the use of medicines must familiarise themselves with the correct procedures contained within this policy. Those in charge of wards, units and clinics are responsible for ensuring that their staff, (especially new and locum staff), follow procedures in this policy, which may differ from procedures used elsewhere. The policy will be available at all inpatient and outpatient sites on the trust’s website.

If situations occur that may require staff to go outside of policy, then the chief pharmacist must be contacted who will decide whether the course of action is appropriate, and whether they can continue, or it needs further agreement. Following this the chief pharmacist will then consult with the team manager and head of professional service for agreement and document the decision, this will then be taken to medicines management for ratification.

3.1 Medicines which fall within this policy

Medicines, whether for internal or external use, will be regarded, for the purpose of the policy, as comprising the following categories.

• Controlled drugs controlled under the provisions of the misuse of Drugs Act (1971), with stringent requirement for supply, storage, and administration.
• All other medicines and medicinal products prepared for administration to patients, and which are controlled by the Medicines Act (1968). This also includes many diagnostic agents, x-ray contrast agents and medical gases. Whilst less stringent regulations apply than in the case of controlled drugs, they must be treated with equal care.
• All complementary medicines, for example, aromatherapy, herbal or homeopathic remedies. These products are used for therapeutic purposes and require the same safeguards as other medicines.
• Other pharmaceutical preparations such as disinfectants, reagents and other preparations are not used directly to treat patients. However, the use of these products must still be subject to agreed and approved procedures. Full attention must also be given to the requirements of current Control of Substances Hazardous to Health (COSHH) Regulations.
• It is important to understand that procedures listed in this document apply to all medicines used in the trust. These include topical lotions, applications, injectable fluids, medicated dressings, dietary products, and complementary medicines.
• Standard operating procedures (SOPs) must be followed, new SOP’s must be developed in conjunction with the Medicines Management team.

4 Responsibilities, accountabilities and duties

The duties and responsibilities for medicines procedures that may be held by various grades of practitioners are shown below. However, all grades of practitioners must:

• be aware of the tasks they may or may not perform
• identify their training needs making their manager aware of any training deficit
• maintain a personal record of all competency-based assessments
• report near-misses, clinical incidents and serious incidents regarding their prescribing, dispensing, storage, and administration of medicines

4.1 The board of directors (including medical director)

The board of directors through the executive medical director and the chief pharmacist is responsible for medicines management within the trust.

4.2 Quality Committee

The Quality Committee is responsible for:

• establishing, auditing, and maintaining effective processes for medicines management
• to receive audit results and ensure action plans are appropriate and robust in relation to the audit results
• receiving, debating, and acting on as appropriate the annual report of the accountable officer for controlled drugs

4.3 Clinical policy review and approval group

The clinical policy review and approval group (CPRAG) is responsible for receiving, discussing, and ratifying proposed medicines related policies and suggested amendments to existing policies.

4.4 The Medicines Management Committee

The Medicines Management Committee (MMC) is responsible for:

• developing effective medicines management policies which supports compliance with medicines legislation and good professional practice in prescribing, supplying, administering, and monitoring of medicines
• ratifying and registering all unlicensed medicinal products supplied or administered through the trust
• promoting safe medication practice by the systematic review of medication errors
• recommending to clinical policy review and approval group all documentation associated with the prescribing and administration of medicines
• recommending to the clinical policy review and approval group protocols which enable non-medical practitioners to supply and administer medicines
• audit medicines policies and procedures and the administration of medicines as part of the annual clinical audit program

4.5 Chief pharmacist (accountable officer for controlled drugs and medication safety officer)

The chief pharmacist is responsible and accountable to the trust board for:

• pharmacy services
• medicines management throughout the trust, ensuring timely reporting against the monitoring requirements of this policy
• ensuring processes are in place supporting the appropriate acquisition, storage, usage, and disposal of medicines across the trust
• providing a monthly report from the Medicines Management Committee to the clinical governance group
• providing an annual report to the clinical governance group in their capacity as accountable officer for controlled drugs
• providing an annual report to the trust board from the controlled drug local intelligence network (LIN)
• providing a monthly report on medication related errors to the Medicines Management Committee
• signatory to trust patient group directions
• providing advice on the medicines management element of the trusts clinical audit programme

4.6 Trust pharmacists

Trust medicines are supplied through either service level agreements with acute hospitals within the localities or via a contract with local pharmacies.

Trust employed pharmacists are responsible for supporting the best use of medicines throughout the trust including:

• the safe, effective, and economical use of medicines
• appropriate storage of medicines in clinical area
• supporting the trust’s clinical audit programme in relation to medicines management
• appropriate investigation of medicines related incidents
• support staff training in relation to medicines management
• monitor prescription cards in line with the 10 point plan

4.7 Pharmacy technician

These staff offer a service trust-wide but are based within the Doncaster locality and will inspect the stocks of medicines held on the wards or in departments at any time to ensure the medicines are in date and stored or disposed of under the proper legal and environmental conditions. Provide assurance to the trust regarding medication storage and security.

Under agreement administer medication in line with trust policy and competency.

4.8 Prescribing responsibilities of all staff, practitioners with prescribing, ordering, storing, and administering of medicines responsibilities

4.8.1 Staff definitions

Throughout the policy, certain specialist titles describe healthcare staff that have defined responsibilities regarding the management of medicines. In general, only staff with contracts (including honorary contracts) of employment to work within the trust are assessed as having any involvement with medicines. All nurses or practitioners who are either new or unsure about certain practices should administer in pairs, one of which should be competent in the given task.

4.8.2 Independent prescribers

Independent prescribers may include medics, dentists, nurses, pharmacists or physiotherapists. Independent prescribers are responsible for prescribing medicines for patients. They, and any other authorized prescribers, must comply with current legislation, national guidance and the safe and secure handling of medicines policy, when performing these duties.

Except clozapine, which can only be initiated by a consultant psychiatrist, who in turn must be registered with Zaponex treatment access system (ZTAS). All qualified doctors may prescribe licensed medication on inpatient charts, leave prescriptions to take out (TTOs) and outpatient prescriptions.

Off-licence prescribing must be consultant-led, unless supported by the trust formulary or national or local guidance such as the National Institute for Health and Care Excellence (NICE) and should be recorded in the patient’s clinical record.

4.8.3 Independent prescribing

Non-medical prescribers must not prescribe unlicensed medicines. However, medication which is licensed, but outside its licensed indications may be in exceptional circumstances prescribed by an independent nonmedical prescriber, if such use is justified by current best practice (for example, national NHS guidance or local trust guidance). Prescribing medicines outside the terms of the product licence must accept professional, clinical, and legal responsibility for that prescribing. This prescribing must be carried out within their professional competence.

4.8.4 Supplementary prescribing

Supplementary prescribing with the agreement of patients enables nurses, pharmacists, and allied health professionals (AHP) previously identified, to make adjustments to medication based on agreed clinical management plans, thus facilitating a more flexible approach to care delivery and the development of new professional roles.

The Department of Health (2004) defines supplementary prescribing as:

“A voluntary partnership between an independent prescriber (a doctor or dentist) and a supplementary prescriber to implement an agreed patient specific clinical management plan (CMP) with the patient’s agreement.”

4.8.5 Non-medical prescribers

Non-medical prescribers (NMPs) are nurses, pharmacists, or certain allied health professionals who have satisfactorily completed the supplementary and independent prescribing course. They should only prescribe within their agreed area of expertise and competence, please refer to the trust’s non-medical prescribing policy.

4.8.6 Prescribers responsibility

It is the responsibility of any authorised prescriber to:

• ensure the intent in regard to the pharmacological management plan is clear
• write the prescription legibly and correctly
• include all relevant details of the patient on the prescription
• prescribe medication in accordance with the standards in the safe and secure handling of medicines policy
• check the patient’s medical record prior to writing any new prescription
• follow local and national prescribing standards
• pay particular attention to the accuracy of complex drug calculations
• discuss the proposed treatment plan with the patient and their carer or relatives (subject to the patient’s agreement) and record a summary of this discussion in the patient’s records stating clearly:
  • what medication is to be prescribed?
  • the aims of the treatment plan
  • how long the medication should be taken for?
  • what alternative treatment plans have been discussed?
  • review date and monitoring

4.8.7 Informed prescribing

The trust appreciates that face to face assessment, by the prescriber, of a patient prior to any prescribing decision is the ideal situation. However, the reality is that in many instances this is simply not possible or in the patient’s best interest, most notably in out of hours situations, community teams where patient assessment may be by another health care professional (HCP) or occasions where a patient receives a repeat prescription from us as part of their ongoing care.

In such instances the trust supports national and professional guidance which requires prescribers to work within their competencies and assure themselves of the patient’s health and their need for the medication prior to prescribing. This assurance may be informed by:

• phone conversation with the patient or their carer
• the patient’s clinical notes or care plan
• referral letters from other health care professionals
• adequate feedback from other health care professionals who have assessed the patient
• other sources that are considered reliable

When making such prescribing decisions, due regard should be given to the prescriber’s experience, the seriousness of the patient’s clinical condition and specific drug considerations such as potency, monitoring requirements and abuse potential.

The prescriber is responsible for any prescription they sign, including repeat prescriptions for medicines initiated by colleagues; therefore, prescribers must make sure that any prescription that is signed is safe and appropriate.

4.8.8 Appointed practitioner in charge or responsible person (service manager or ward manager)

This is the senior practitioner appointed to take charge of a ward or department, for example, ward manager or team leader. In the event that the person in charge is not from a professional nursing background appropriate to take on the duties and responsibilities within this policy (for example, community team leader with a social work background), another senior member of the nursing team will undertake the role of appointed practitioner in charge with respect to controlled drugs and may take the role of appointed practitioner in relation to all medicines’ management issues.

This appointed practitioner or staff member has ultimate responsibility for:

• ensuring that this policy and other associated procedures in relation to medicines administration are being followed correctly
• the safekeeping of medicines on the ward, department or base point and will ensure their safe and appropriate storage at all times
• ensuring that procedures are relevant to their area of practice, are consistent with the standards of this policy and that all staff have read and signed procedures appropriate to their role
• ensuring that the staff performing physical security checks and stock reconciliation is appropriately rotated to ensure secure delegation is maintained
• arranging for an appropriate investigation to take place if there are any exceptions or discrepancies
• ensuring that unwanted medicines are disposed of in appropriate pharmaceutical waste bin prior to collection
• ensuring that all controlled stationery on the ward, department or base point is held securely, where a department is closed for any reason for up to 7 days the responsible person will ensure that all medicines are stored in cupboards as specified in section 5.6
• signing for receipt of any medicines delivered to the ward or department, this process will involve checking the received stock against requisition, and patients own medication against the prescription, as well as ensuring security of storage through transit has been maintained
• ensuring that access to medicines is restricted, by control of keys to the medicine cupboards and refrigerators, or other alternative approved storage areas, this responsibility remains with the responsible person even if they decide to delegate this duty
• checking stock levels at least once every six months when a ward or department is not served by a pharmacy top-up service
• ensuring that a running balance of controlled drugs is recorded after each transaction and recorded under the last entry for each medicine in the controlled drug register
• administration of medicines. This duty may be delegated to another practitioner, but the appointed practitioner or responsible person in charge must exercise supervision as necessary and be satisfied that the staff member to whom they have delegated the task has received relevant training
• if a situation arises where medication, which has been prescribed has not been written in accordance with the standards in this policy, the practitioner may still administer the medication provided they are satisfied the prescription is legible and safe, and that any delay in administration would be detrimental to the patient. The prescriber must be contacted immediately and informed of the deficiencies with the prescription being re-written correctly within 24 hours

4.8.9 Assigned practitioner in charge

This is the senior practitioner on duty (for example, team manager) who in the absence of the appointed practitioner in charge or responsible person has been rostered as the professional in charge for that shift. Whilst in charge this person is responsible for all the duties as set out in the above section.

4.8.10 Non-registered healthcare staff

These are clinical support workers, trainee and assistant practitioners, healthcare workers, support workers and nursing assistants who assist in medication duties. These staff must have the relevant training or trust approved training, allowing them to undertake certain functions with respect to assisting with medicines administration, or administering medication in agreed circumstances, such as community homes and other community settings. Prior to administering medication, the staff must be deemed competent by the lead clinician to carry out the task, and where appropriate receive approved training.

The following situations are suitable for support staff to administer or aid in the administration, provided the task has been delegated to them as an individual authorised for that level of administration.

They must administer medication in line with trust policy following appropriate training and assessment of competence. For example, this may include:

• administration of oral medication, such as in a community home or supported living
• the application or insertion of creams, ointments or drops
• nursing a child who is using a nebulizer
• the supervision of a dependent patient to ensure their medicines are taken effectively
• simple eye care
• simple dressings
• suitably trained health care assistants may administer insulin

The individual authorised to administer medicines retains the responsibility to ensure that a medicine has been administered correctly; and that responsibility cannot be delegated. In line with this the individual authorised to administer will identify the correct medicine and correct patient to whom the medicine is to be administered.

Practitioners in training must be given every opportunity to become proficient in medicines related activities under appropriate supervision. The supervising practitioner always has responsibility for such medicine procedures.

4.8.11 Bank or agency nursing staff

Before administering medication, agency or bank staff should have received appropriate guidance on local practices, this includes the use of the electronic prescribing system. Regular bank or agency registered nursing staff confident in trust practices may administer medicines with approval of the appointed practitioner in charge. It is the responsibility of the registered nurse to report any issues regarding their competence.

4.8.12 Staff who administer medication

The individual authorised to administer medicines will be responsible for:

• ensuring they have an understanding of the use, action, usual dose, side effects and handling hazards of the medicine(s) being administered
• ensuring they are certain of the identity of the patient to whom the medicine is to be administered before initiating any administration activity
• retaining the responsibility to ensure that a medicine has been administered correctly; this cannot be delegated. However, in certain circumstances support staff may aid in the administration of medicines. In these circumstances the administrator will ensure that the support staff has sufficient training and information to aid the administration of the medicines safely
• they have received appropriate training to administer medication, especially when given parenterally or via enteral feeding tubes

4.8.13 Supplying pharmacist (community or hospital)

Supplying pharmacists are responsible for ensuring they comply with the service level agreement.

5 Standards

5.1 Standards for the prescribing of medicines including clinical trials

5.1.1 Aim

The aim of this document is to set down the standards for prescribing of medicines including clinical trials within the trust.

5.1.2 Responsibilities

This document should be read in conjunction with electronic prescribing and medicines administration (EPMA) standard operating procedures (SOPs) listed under inpatient standard operating procedures (staff access only).

Prior to prescribing any medication the prescriber should have checked that the medicines reconciliation has been completed and that an allergy status is present and up to date, please see standard 13, medicines reconciliation and allergy status.

5.1.3 Patient involvement

Patients have beliefs, attitudes and life experience which will influence their medicine taking behaviours, taking these into account and prescribing with that knowledge may have a positive effect on concordance.

Concordance refers to a consultation and negotiation process between a health care professional and a patient, which has an ethos of a shared approach to decision-making. Within this context it is the process of prescribing and medicine taking based on partnership, and the following three essential elements define the process:

5.1.3.1 Patient has enough knowledge to participate as partners

To aid this, patients must be provided with information which is:

• tailored
• clear
• accurate
• accessible
• sufficiently detailed
• choice and medication information leaflets

5.1.3.2 Prescriber consultation involves patient as partners in decision-making

To achieve this, patients must be:

• invited to talk about their concerns and expectations
• have their treatment regimens fully explained

5.1.3.3 Patients are supported in taking their medication

This will be achieved by giving patients:

• ample opportunity to discuss their medication
• the effective sharing of information between all professionals involved in the patients care
• involving the patient in all reviews of their treatment regimes

5.1.4 Sources of information to patients

Information to patients is available in the following ways:

• from practitioners involved in their care and treatment
• from the information leaflets which are contained within the medication packs or from the electronic medicines compendium (EMC)
• from the trust pharmacy department
• through one-to-one sessions with the specialist pharmacists employed within the trust
• from the pharmacy information leaflets
• Mind and other independent organisations also offer information to patients around treatment and medication
• long term outpatients will receive a complete set of patient information leaflets every three months
• via the trust choice and medication

5.1.5 Prescribing principles

• The patient’s clinical record should always be checked before a new prescription is written.
• Prescribers should have access to a pharmacist who is able to provide advice on the drug treatment plan.
• Prescribers should follow local trust and national prescribing standards, following their professional bodies guidance:
  • prescribing and managing medicines and devices resource:
    • General Medical Council
    • Royal College of Physicians
    • Nursing and Midwifery Council
• Prescriptions should always carry specific patient directions and never be issued with the stand-alone instruction “as directed”.
• Particular attention should be paid to checking the accuracy of complex drug calculations.
• The proposed treatment plan and the discussions with the patient or their representative regarding:
  • what the medication is
  • what the aims of treatment are
  • how long it should be taken
  • potential side effects
  • alternatives and
  • what to do if stopping it as well as
  • how the response to drug therapy is to be monitored should be clearly documented in the patient’s clinical notes.
• Patients should be provided with information on their treatment.
• Prescribers should be trained and assessed as competent before being required to prescribe.
• Where available electronic prescribing systems should be used.
• Actual and potential prescribing errors should be recorded using the trust IR1 system, and reviewed regularly to raise awareness of risk, and to improve practice.

Electronic prescribing and medicines administration training on SystmOne is considered as “essential to role” for prescribers and inpatient staff who administer medication to ensure that:

• They have received the prescribing or transcribing or meds administration (as appropriate) as part of their induction training prior to using SystmOne
• Exceptionally where the need is urgent, for example, urgent start for employed staff or agency staff that their use is through the Temporary Access Card (TAC) available on the ward. Employed staff are to then complete the training at the first available opportunity.

5.1.6 How medicines are managed on handover between care settings

Changes to medication must be documented in any correspondence between areas, for example, discharge letter, clinic letter, transfer letter.

This should include details and rationale of:

• medication stopped
• medication started, including review timescales
• any medication monitoring required and who is responsible
• allergies and sensitivities

When patients are received from any care setting medicines reconciliation must be completed where there is prescribing responsibility for the receiving team.

5.1.7 Prescription documentation

Medicines may only be prescribed on trust authorised stationery.

• Authorised inpatient paper drug chart.
• Electronic prescribing system administration (EPMA) drug chart.
• Leave or discharge prescription sheet.
• Outpatient prescriptions.
• Relevant FP10 documents.
• In community settings the prescription may come from the local acute trust or general practitioner and be followed with an instruction to administer, for example, syringe driver or non-syringe driver.
• Depot card.
• Medicine administration record (MAR), community homes generated by the supplying pharmacy.

These maybe paper or electronic, currently prescriptions requesting supply must be paper, but for instructions to administer they may be paper or electronic.

Where paper copies are in use, only one should be available at any time, previous copies must be scanned and uploaded to the clinical record.

5.1.7.1 Where handwritten paperwork is being used

• Write clearly.
• Use capitals for the drug name, this is to be expressed as the recommended international non-proprietary name (rINN) unless:
  • it is a combination product for which no recommended international non-proprietary name exists
  • it is a modified release preparation where brand substitution could potentially lead to symptomatic change
• Use black ballpoint pen when writing on paper charts (prescribing in pencil is illegal), pharmacists may use a green ballpoint pen on drug cards to ensure points of clarification or validation are clearly attributable to them.
• When making comments on the electronic prescribing system charts this will be made in the notes section.
• Write figures clearly.
• If a decimal point is used, ensure it is clearly visible (exaggerate if necessary), do not use a comma.

5.1.7.2 Date and sign

• Use your full signature or smart card verification.
• Specify bleep number if appropriate.
• Print name (in capitals).
• It is illegal to use a photocopied, doctor’s signature.

5.1.7.3 Patients details

Any prescription must contain:

• patient’s name (including aliases, or known by)
• date of birth (age)
• ward clinic name, or patient’s address
• consultant
• patient’s hospital number and, or NHS number (where available, exceptions may include crisis or home visits for example)
• known allergies and sensitivities to medicines

5.1.7.4 Additional requirements in community practice or discharge or to take out prescriptions

Prescriptions issued must indicate a quantity to be supplied which should be for a period not exceeding 28 days and no less than 14 days for discharge medication unless:

• treatment is being stabilised
• the medicine is presented in a pack of more than 28 days and splitting the pack is unreasonable
• patients are going on holiday when, exceptionally, up to 3 months’ supply can be made to ensure continuity of treatment
• for patients receiving regular medication from community teams, such as Access team or assertive outreach, may use a repeat prescription using the outpatient prescription form from Lloyds for a period of up to six collections of 28 days each. A record should be made on the trust approved form or electronic clinical record when a new prescription is issued and required
• patients who are under substance misuse services may receive FP10 MDA or FP10SS prescriptions, which allow for instalment dispensing

5.1.7.5 Function of the prescription chart

• To direct the administration of the medicine to the patient.
• To provide a permanent record of the patients treatment with medicines.
• To indicate the patient’s allergies and sensitivity to medicines.
• To facilitate the provision of the correct medicine through pharmacy
• To assist compliance with the requirements of the Mental Health Act 1983 (amended by the Mental Health Act 2007).
• For patients currently detained under the act, a placeholder should be included in the prescription chart documenting where a copy of the original can be found, for example, in communications and attachments.
• Clarification notes.

5.1.7.6 Initiation of treatment

Only suitably authorised independent and supplementary prescribers have the authority to prescribe medicines for patients under the care of the trust.

Practitioners must not administer medicines that have not been authorised by an authorised prescriber. This authorisation must be in writing, in the form of a signed prescription (for community teams administering medication a letter of authorisation), in advance of the administration of the medicine.

Foundation year 1’s may only authorise prescriptions within the trust, such as inpatient medication charts, and may not write FP10 prescriptions or similar.

Staff may also administer medication from a patient group directive, patient specific direction, or agreed emergency medication.

5.1.7.7 Transcribing

This is to support the continuation of administration of medication, not the supply of new medication.

Registered professionals may transcribe medication from one “direction to supply or administer” to another form of “direction to supply or administer”. This is a two-person procedure and includes:

• registered nurses
• pharmacists
• pharmacy technicians

The process must use one of the following sources in combination with the medicines reconciliation, to highlight discrepancies and ensure a complete and appropriate list is prescribed:

• a prescription (FP10) signed by a general practitioner (GP), independent prescriber (for example, community matron) or non-medical prescriber (for example, specialist nurse)
• GP current medication list (signed)
• discharging treatment sheet or discharge letter from hospital accident and emergency; medical assessment unit (MAU); clinical decision unit (CDU) (signed, including electronic signature). This medication to be validated by patients own GP at the earliest opportunity
• accident and emergency notes, where new medication has been prescribed and signed by a doctor
• “Dear Sister” letter from out of hours team; or a signed letter from the GP or community matron, typed and signed, detailing reason for admission and list of current and any new medications
• clinical record entry by the clinician responsible for prescribing medication for the patient, providing it is clear and current
• patient’s labelled medication all sources must have a signature, hand or electronic, to authorise the medications, and a prescribers name so it can be traced back if necessary

5.1.7.8 Completing the prescription (see inpatient standard operating procedures)

Date, to be written as “DD/MM/YY”.

This indicates the date the treatment or dose change commences which may or may not coincide with the date of admission.

Name and form of the medicine.

The approved or generic name of the medicine must be written clearly in capital letters. Drug names are not to be abbreviated under any circumstances.

A medicine may have numerous brand names but only one approved name. If the medicine is a combination of two or more medicines (with no approved name) or has unique release properties or bioavailability, then the brand name will be accepted.

5.1.7.9 Dosage frequency

All medications should have a frequency stated, see standard 4. When required, pro re nata (PRN) medication for details on PRN.

• For “regular medicines” the prescribing times should be in accordance with regular medicine rounds wherever possible.
• For antibiotics the prescribing times should be in accordance with regular medicine rounds wherever possible, and equally spaced to promote effective treatment.
• Depot injections must be prescribed with the time interval expressed using the term “every” (for example, every 3 weeks rather than 3 weekly, which can be misinterpreted. This can be abbreviated as 3/52). The date that the first depot injection is to be given must also be clearly stated.
• Be aware of drugs which are given at weekly intervals. For drugs given less frequently than once daily (for example, methotrexate, fentanyl patches, alendronate), use crosses on the prescription chart to indicate the days when the drug should not be given.
• Medicines that are intended to be given once only must be prescribed in the “once only” section of the prescription sheet.
• For any medication where the dose varies at different times of the day, it must be written up as two separate prescriptions.

5.1.7.10 Prescribing signature

Each prescription item must be validated by the full signature of a registered medical practitioner or authorised prescriber, or through smart card verification. The signature must be legible or the printed name of the prescriber must be written next to the signature. See policy for healthcare record keeping policy.

5.1.7.11 Letters of instruction or prescriptions for community nursing staff to administer against

Community nursing staff may receive requests to administer medication to patients in their own home, such as antibiotics, insulin and enteral medication.

These must include the same details along with any additional information on diluents or flushes or locks or rates of infusion where indicated

These forms will normally be sent to community nursing services via the single point of access (SPA).

5.1.7.12 Changing the dose, frequency or route

Any changes to the prescription in terms of dose time or route require a new prescription to be generated.

5.1.7.13 Length of treatment

Any prescription (excluding controlled drugs) is valid for a maximum period of six months. A prescription for controlled drugs is only valid for 28 days. Where a course is indicated a review or stop date must be included.

5.1.7.14 Cancellation of treatment

The drug name and all prescribing details must remain legible, as the chart is a legal record; sign and date the “stop” box on the chart when using paper records.

When using the electronic prescribing system, a note should be made of the reason for cancellation. When the “stop date” box is used in anticipation of the treatment cancellation date, this indicates that at midnight on the date specified the prescription must be discontinued, and no further doses are to be administered.

Cancellation of areas of the medicine administration record by the Prescriber, or by a designated practitioner or pharmacist, is another permitted method of indicating when the medicine should be administered and when it should be omitted.

For example, “XXXX_XXXX_XXXX”.

Amendments to prescriptions are not permitted. Changes to doses or frequency require cancellation of the old dose and a new entry written for the new dose.

5.1.8 Range of medicines which can be prescribed

Prescribing should be within the relevant district formulary.
Any newly introduced psychotropic medicines onto the market may only be prescribed in the trust after submission for consideration and approval by the Medicines Management Committee (MMC). Any medicines provisionally approved will be subject to a probationary period, after which time final approval will be considered.

In exceptional circumstances, if an urgent request for a new medication is thought to be necessary, then a request can be made to the chair of the Medicines Management Committee for approval.

Wherever possible, trust doctors must not prescribe or recommend medicines that are not approved for use by general practitioners.

5.1.9 Contact with pharmaceutical industry representative

The trust Medicines Management Committee has decided that trust staff will not be permitted to meet with representatives or agents of the pharmaceutical industry on trust premises or during normal working hours.

This decision has been made as the Medicines Management Committee does not consider such meetings to be an appropriate use of trust resources. The Medicines Management Committee believes that it is important that trust staff should focus their NHS time on clinical and patient focused activities as well as planning and management activities designed to serve the trust’s immediate and long-term goals. The Medicines Management Committee do not consider that meeting with sales representatives of the pharmaceutical industry service is in the interest of patients, clinicians or the trust.

It is recognised that there may be research opportunities or other collaborative arrangements where interaction with the pharmaceutical industry can be mutually beneficial to the NHS, but this should be organized in a planned way through the appropriate Research Governance procedures. Also, the Medicines Management Committee recognises that there may be opportunities for other planned collaborative work with the pharmaceutical industry that specifically serves the trust’s educational, training or other goals. Such specific and planned projects should be cleared with Medicines Management Committee on a case by case basis and the representatives of the pharmaceutical industry have strict codes (The Association of the British Pharmaceutical Industry Code of Practice) by which they must abide. In line with this code they should:

• not enter any patient areas
• never have access to patient’s clinical records
• never directly promote their products to patients or carers

Individual educational and continuous professional development (CPD) activities should continue to be discussed and arranged through the usual channels of appraisal, supervision ad job planning.

5.1.10 Valproate (in women and girls of child bearing potential)

All women or girls of child bearing potential where valproate is either being prescribed or being considered must comply with the prevent guidance and an annual declaration form should be completed. Medicines and Healthcare products Regulatory Agency Valproate guidance.

5.1.11 Prescribing homeopathic or herbal remedies

• Homeopathic and herbal medicines are subject to the licensing provisions of the Medicines Act (1968) although those on the market when the act became operative (which means most of those now available), received product licences without any evaluation of their efficacy, safety or quality.
• There are some patients who will be on homeopathic and, or herbal medicines and will wish to continue receiving these whilst on the inpatient wards.
• Such a request should be discussed with the responsible prescriber who must consider the appropriateness of the therapy to both the condition of the patient and co-existing treatments.
• If it is agreed that any homeopathic and herbal medicines can continue then these will be listed on the prescription card.
• In the event that the patient is requesting homeopathic or herbal remedies that they have not already been taking prior to admission the authorised prescriber must discuss the request with the patient and only list it on the prescription card if they feel they are competent to do so.

5.1.12 Above British National Formulary maximum prescribing limits (combined maximum)

• All prescriptions for psychotropic medications (including combinations) should usually be within British National Formulary (BNF) limits, apart from cross titrations.
• Any prescribing antipsychotics above British National Formulary maximum must be discussed in the multi-disciplinary team meeting (ideally two professionals involved in the patients care). The decision to prescribe must be done by a consultant.
• The rationale for the decision to prescribe above British National Formulary maximum limits and the monitoring requirements must be documented in the clinical records using the relevant form.
• Patients on high dose antipsychotics must be readily identifiable to the team.

Prescribing above the British National Formulary maximum limits is an unlicensed form of prescribing and it is therefore the consultant’s responsibility to ensure General Medical Council (GMC) and specialist colleges’ guidance is followed and treatment plan well documented.

5.1.13 Prescribing rights for non-prescribers on the electronic prescribing system

The range of personnel and scope of activity or product will be agreed by medicines management and agreed through the trust governance process. To allow full use of the clinical system, some groupings may need additional smart card rights which impinge on prescribing rights on the system.

Activity will be reviewed and monitored against the agreed restrictions.

For example:

• dieticians, dietary supplements, including water
• pharmacists, to allow minor amendments to the drug chart

5.1.14 Prescriptions for hospital staff and their families

Medical staff and non-medical prescribers should not prescribe for themselves or their family in line with current General Medical Council (GMC) recommendations.

FP10 (HP) prescription forms should never be used by medical staff or non-medical prescribers to prescribe for themselves or their families. These are only for use by registered outpatients to take to outside pharmacies when the hospital pharmacy is closed.

5.1.15 Staff self-administration of medicines

On no account must any member of staff take for themselves or give to another person medicines that has not been prescribed for them.

Hospital medicine supplies are for the use of trust patients only in response to a prescription from a doctor or other authorised prescriber.

Staff who require treatment for minor ailments must be referred to the occupational health department or purchase medicines from a local pharmacy.

5.1.16 Patient group direction

Whilst it is necessary that all medicines administered by a practitioner are given on the authority of an authorised prescriber, in some area certain medicines can be initiated by practitioners in accordance with a patient group direction (PGD).

The patient group directions must comply with National Institute for Health and Care Excellence guidance.

It is the responsibility of the senior registered nurse of each ward, department or area to ensure that if medicines are administered without a written prescription then a valid and current patient group direction is available to guide practitioners in their area and that the person administering the medicine has received training and is competent in working within a patient group direction. A list of all practitioners signed off for each patient group direction must be sent to pharmacy, to be kept with the original document.

Copies of approved patient group directions must be available in each area and must reflect accurately practice in that area.

A patient group direction cannot be introduced without authorisation from Medicines Management Committee. Staff should refer to the prescribing and medicines management section of the clinical polices on the trust intranet for details of existing patient group directions.

Approved patient group directions will be signed by the chief pharmacist, medical director and director of nursing.

All original patient group directions will be stored by the pharmacy department, along with a copy of the list of those authorised to use them.

5.1.17 Monitoring of medication

Monitoring must be in line with the trust formulary guidance and or the information within the summary of product characteristics (SPC) which can be found on the Electronic Medicines Compendium.

5.1.18 Off license and unlicensed medication guidance and clinical trails

5.1.18.1 Use of unlicensed medicines

In the UK no medicine can be marketed for human use without a product licence (PL) granted by the Licensing Authority (Department of Health). The product licence specifies the indications for which a product may be used and also the dose, and route of administration and so on. Licensing arrangements are determined by the Medicines Act (1968) and implemented through the Medicines and Healthcare products Regulatory Agency (MHRA). Under the Consumer Protection Act of (1987) the manufacturer of a drug, which has a UK product licence is liable for damages if the product is defective.

Unlicensed medicines fall into 5 broad categories:

• products derived from licensed medicines and prepared by the NHS or commercial unit with a “specials” manufacturing licence or prepared in a hospital pharmacy department under a Medicines Act exemption, for example, the manufacture of a suspension from tablets or capsules or special low-dose formulations for children
• products, whose licence has been abandoned, suspended, revoked or not renewed
• Products for which a licence has yet to be granted, but which are available and licensed outside the UK
• medicines used outside the terms of their product licence, for example, for an unlicensed indication, via an unlicensed route, or at an unlicensed dosage, this is often referred to as off label prescribing
• unlicensed medicines undergoing clinical trials

Prescribers have a duty in common law to take reasonable care and to act in a way consistent with the practice of a responsible body of their peers of similar professional standing. In using an unlicensed medicine the prescriber must act responsibly and with reasonable care and skill. Not to meet these standards lays the prescriber open to claims of negligence liability.

The responsibility for use of unlicensed medicines lies with the prescriber. Mechanisms must be in place to ensure that a prescriber knows when a medicine prescribed or supplied is unlicensed and that he or she is aware of his or her responsibilities.

Most common drugs have product licences; however, there are two circumstances where a prescriber may wish to use an unlicensed drug:

• a product awaiting a UK product licence
• a product that has been withdrawn from UK market

5.1.18.2 Trust procedure for the prescribing of unlicensed medication

Unlicensed medicinal products are only to be used when no pharmaceutically equivalent licensed product or suitable alternative licensed product is available for use at the time the patient requires it.

Prescribers who carry overall clinical responsibility for patients may use unlicensed medicines in the course of their practice. However by their nature the effects of an unlicensed medicine may be less well known than a licensed product. Health care professionals are reminded of their duty always to act in the best interest of their patient. In the case of an unlicensed medicine this may mean refusing to administer an unlicensed medicine where they have grounds to believe it may be unsafe.

When prescribing two or more medicinal products together for the purpose of administering them to meet the needs of a particular patient this product becomes unlicensed. This is now legally allowed providing that controlled drugs are not included. However, Medicines and Healthcare products Regulatory Agency (MHRA) have issued a statement that nonmedical prescribers are unlikely to be prosecuted for the purposes of palliation even though this product is not legal.

Should any prescriber within the trust wish to prescribe an “unlicensed drug” they must firstly make an initial application to the chair of the Medicines Management Committee. If it is felt therapeutically justified then the proposal should be taken to the trust’s medical director, director of nursing and chief executive for approval.

Authorised pharmacy staff will advise the prescriber (and, or the assigned practitioner in charge) of the unlicensed nature of the medicines. Where such unlicensed use is not common practice, or is deemed to constitute a significant risk, this must be recorded in the patient’s clinical record by the trust prescriber or pharmacist.

Prescribers must consider carefully the use of unlicensed medicines and only use this form of therapy when the benefits outweigh the risks.

Prescribers must obtain consent to treatment and inform the patient of the medicines licence status. The patient must also be informed that the effects of an unlicensed product will be less well understood than those of a licensed product.

Prescribers must inform their medical colleagues (especially general practitioners) of the medicine’s licence status prior to any transfer of the patient.

5.1.18.3 Definition of off-label medicines

The summary of product characteristics (SPC) lists: indications, dose ranges, methods of administration and age restrictions as granted by the marketing authorisation for each medicine licensed for use within the UK. Any use not in accordance with the summary of product characteristics is considered “off-label”, or an unlicensed use. This policy also applies to products used outside their product licence “off label use”, or herbal or homeopathic products. Off label prescribing should only be carried out by senior prescribers within their area of competence and should be supported either by trust or national guidance.

5.1.19 Clinical trails including pharmaceutical products

• Anyone considering conducting a clinical trial must refer to the Medicines and Healthcare products Regulatory Agency (MHRA) guidelines Description of the Medicines for Human Use (Clinical Trials) Regulations (2004).
• Any clinical trial within the trust can only be undertaken after careful consideration and approval from the Medicines Management Committee.
• If the trial is sponsored by a pharmaceutical company it must comply with the guidelines on compensation issued by the Association of the British Pharmaceutical Industry (ABPI).
• Any patient who is to be involved in the trial must give informed consent in line with the Mental Capacity Act (2005).
• Supplies of the drug will be issued by pharmacy as agreed in the trial protocol.
• Pharmacy will supervise the use of the medicine in the trial.

5.1.20 New medicine related documents

All new and updated polices, guidelines, protocols patients group directions (PGDs) and patient specific directions (PSDs) relating to medicines must go through the Medicines Management Committee and on to the clinical policy review and approval group for approval, unless exempted by the chief pharmacist such as guidance and Public Health England documents.

5.2 Standards for the administration of medicines within the trust

5.2.1 Aim

The aim of this document is to set down the standards for the administration of medicines within the trust; this should be read in conjunction with inpatient standard operating procedures (staff access only).

5.2.2 Medicines and the law

• The Human Medicines Regulations (2012) controls the manufacture, distribution and importation of medicine and requires that medicines available only on prescription must be given as instructed by the authorised prescriber (a doctor, a dentist or a nurse or pharmacist or occupational health practitioner prescriber). Changing the dose or giving prescribed medicines to a different person without the authorised prescriber’s permission is against the law.
• While the law states who can prescribe medicines it allows anyone to administer them provided they follow the authorised prescriber’s instructions.
• Non-registered practitioners may only administer medicines after receiving appropriate training and assessment at local level in accordance with local guidance.
• An epinephrine (adrenaline) injection, Glucagon, Naloxone, Aspirin, Glyceryl Trinitrate may be legally administered without a prescription for the purpose of saving life in an emergency (Section 19 of the Human Medicines regulations). This is in line with the Resuscitation Council guidance, however; it remains a prescription only medicine until such time as it needs to be administered.
• The administering of a medicine authorised for a patient will occur by one of three ways:
  • by an individual authorised to administer medicines
  • by the prescriber
  • by the patient or carer who meets agreed self-administration criteria
• Where the authority to administer is of questionable legibility, incomplete, or ambiguous to the person authorised to administer, the medicine will be withheld until the instruction has been checked with the prescriber or a new authority issued. Guidance on omitted doses must be followed as to when to contact the prescriber.

A single person administration system is in place except the following instances:

• calculation of complex dose, for example, doses expressed by weight or surface area. This is for the calculation only. It should be done prior to the first dose, and any subsequent changes of treatment. The details of the calculations can be recorded in to the patient’s treatment goals for future reference
• administration to children under 16 years of age without parental consent, assessed not to be Fraser competent
• administration of controlled drugs. In exceptional circumstances, such as lone workers in special schools, it may be necessary to administer controlled drugs such as Midazolam Buccal without witnesses. In these situations the medication is the patient’s own and not stock
• intrathecal injections, hospice
• except emergency medication in the circumstances as stated above medicines can only be administered in line with a valid prescription issued by an authorised prescriber:
  • the prescription must be legible, signed, dated, and written in black ink or on an approved electronic prescribing system. The name of the drug, dose, form, route and maximum frequency, in hours, of administration should be stated
  • any illegible or ambiguous prescriptions must be brought to the attention of the prescriber, and clarified
• for any patients who are subject to Mental Health Act consent to treatment rules, under the mental health act, staff must check that the appropriate consent form is in place and that the treatment to be administered is recorded on the form prior to any medication being administered
• where possible patients should only have one prescription chart in use at any given time. Where this is not possible all current prescription charts for the patient are to be marked with the total number of charts in use
• the relevant allergy section on the prescription chart must always be completed. If the patient states none ‘none known’ is to be recorded

5.2.3 Who has the authority to administer medication?

• Medical staff, registered nurses, and student nurses (under the supervision of a registered nurse), nurse associates, trainee nurse associates (under supervision), pharmacy technicians, health care assistants, who have undergone trust approved training and are deemed competent.
• Student nurses will be given every opportunity to become proficient in the administration of drugs under the supervision of a registered nurse. The registered nurse who supervises the student remains accountable for the correct administration of the drug. Both the registered nurse and student are to sign the prescription chart.
• In community settings a non-registered member of staff may prompt a patient to take their medication or supervise them removing medicine from labelled containers which have the patients name on, or a compliance aid. Under no circumstances are untrained staff to select the medicines on the patient’s behalf.
• Health care assistants, who have undertaken trust approved training may administer medication to patients, unsupervised, in agreed circumstances, and must follow the same rules as qualified staff. Area’s where this has been agreed are community homes and supported living. Other areas wishing to utilise this must discuss this with their service managers and the chief pharmacist.
• Non-registered staff that are to be involved in the handling of patients medicines must undergo appropriate competency training.

5.2.4 Patient self-administration of medication

5.2.4.1 Inpatient services general self medication scheme

Patients in the inpatient services may only undertake routine self-administration of their medicines where a ward has in place a specific local procedure approved by the trust chief pharmacist, and medical director.

Where these are used there must be a regular assessment of compliance, this should be recorded in the patient’s record.

The benefits of such an approach include:

• helping patients achieve or maintain a great degree of independence during their stay
• identifying compliance issues prior to discharge
• improving service user’s knowledge of prescribed medicines
• promoting drug administration at the most appropriate time
• reducing wastage of primary care derived medication
• preventing medicine hoarding and consequent inappropriate resumption of discontinued treatment
• minimising delay at discharge

Procedures can be found on the trust website:

• self-administration of medication within open and locked rehabilitation and recovery inpatient services
• management of medicines on hazel, hawthorn and magnolia wards procedure

5.2.5 Specific medicinal products

Where patients are prescribed Glyceryl Trinitrate (GTN) tablets and sprays for the relief of angina pain, or inhalers of beta (β) adreno-receptor agonist as bronchodilators, it is appropriate to allow the patient immediate access to the medicines when they are required.

An individual authorised to administer medicines may assess a patient as suitable for this type of self-administration provided the following conditions are met:

• the patient understand what their medicines are for and the how to take them correctly
• that the self-administration of such medicines has been considered as part of the patient’s multi-disciplinary risk assessment, and the consultant in charge of their care is in agreement
• suitable safe keeping arrangements are available to prevent misuse by others. In this case this does not necessarily mean in a locked cupboard
• the medicines are labelled with the patients name and instructions for use
• a record of the dose and frequency of self-administered medicine is made on the inpatient drug administration chart

5.2.6 Community service

Within community services it is a patients’ right to self-administer their own medicines if willing and able to do so. However, some patients have difficulty managing their medicines safely and sometimes trust staff are the only people to see these patients who can therefore highlight the need for help.

5.2.6.1 Patients in the community who are unable to self-administer medication

• Trust staff that are caring for or managing patients who are self-administering medication should be aware of factors which can affect a patient’s ability to self-medicate.
• Self-administration from dispensed containers may not be possible for some patients and in such cases the advice of a community pharmacist or the patient’s GP must be sought. The most appropriate form of help can then be identified.
• If a patient requires a compliance aid such as monitored dose container, this must be dispensed, labelled and sealed by a pharmacy If there is a delay in allocating a pharmacist to fill a compliance aid, staff must inform the patient that trust staff are unable to fill compliance aids due to the risk of error. This information must be clearly documented in the patient’s clinical record if the patient lacks capacity, then Best Interests guidance must be followed.

However, there may be occasions when to support the patient to take their required medication is vital and it is not possible to have the pharmacy fill compliance aids. This is the case with tuberculosis (TB) medication which is prescribed and dispensed at the hospital. Therefore, community pharmacy will not undertake this task. The trust colleagues within the Tuberculosis team may need to support the patient and their family to build confidence with this task. If, in exceptional circumstances, when there is no family member who can support the patient with this, the tuberculosis nurse needs to dispense their tuberculosis treatment medications into a weekly compliance aid (provided by the tuberculosis team and contains only the tuberculosis medications) this will be undertaken by 2 persons (one of whom must be a qualified nurse) and for the shortest possible period of time. The qualified nurse will record in the electronic patient record the rationale, who filled the container and who checked with them for accuracy.

5.2.7 Principles of administration

• The individual authorised to administer medicines will be responsible for ensuring they have an understanding of the use, action, usual dose, side effects and handling hazards of the medicines being administered.
• This person will ensure they are certain of the identity of the service user to whom the medicine is to be administered before initiating any administration activity, in line with the trust policy on patient identification.
• The individual authorised to administer medicines will check that the authorisation for administration is within this policy.
• Medication may only be administered against an authorised prescription chart in inpatient settings. The only exceptions to this are drugs covered by section 19 of the Human Medicines Regulations (2012) for emergency use, medications authorised via verbal orders, and those covered by a patient group direction.
• For routes of administration other than oral then the process as described in the Royal Marsden manual (staff access only).

Electronic prescribing system training on SystmOne is considered as “essential to role” for prescribers and inpatient staff who administer medication to ensure that:

• they have received the prescribing or transcribing or meds administration (as appropriate) as part of their induction training prior to using SystmOne
• exceptionally where the need is urgent, for example, urgent start for employed staff or agency staff that their use is through the temporary access card (TAC) available on the ward. Employed staff are to then complete the training at the first available opportunity

5.2.8 Action prior to administering medication

Prior to administering any medication the staff member must observe the following principles.

• Be able to confirm the identity of the patient:
  • within an inpatient setting this will be confirming that the name and hospital number expressed on the authorisation for administration corresponds with that on the patients’ identity bracelet or photographic identification (ID), and wherever possible, verbally confirming this detail with the patient themselves
  • within a community based setting, or where an inpatient is wearing an identity bracelet or there is no photographic identification, this will be verbally confirming the name, address and date of birth expressed on the authorisation for administration with the patient, or where appropriate, the patient’s carer
• Check the consent status of the patient and if the patient is subject to consent to treatment guidelines under the Mental Health Act.
• Check that the medicine has not already been administered.
• Check that the drug to be administered has not past its expiry date.
• Give the correct drug, check the label on the drug against the prescription.
• Give the correct dose, if unfamiliar with the drug or dosage, verify before administration.
• Give the drug in the right form, check whether tablets or liquid.
• For oral liquid medication in non-standard doses, for example, not multiples of 5ml, approved oral syringes must be used.
• Give the drug at the correct time, it is important to give medication as it is prescribed in order to maintain therapeutic levels of treatment.
• Check that the drug is administered by the route specified, and that the formulation used is appropriate to that route. Administration by enteral feeding tube is covered by the enteral tube feeding adults policy.
• At no time are any medicines to be left unattended by the administering staff member.
• Where more than one medicine is specified for administration, they will consider whether any of the medicines may dangerously interact with each other.

5.2.9 Consent to treatment

This must be in line with the trust consent to care and treatment policy.

Wherever possible the proposed medication should be discussed with the patient in a way which gives them the opportunity to openly ask questions and express their agreement with the treatment.

Consent within the context of this policy is the voluntary and continuing permission of the patient to receive a particular medication.

However, for a patient to give valid consent or not, they must have capacity. Therefore, the authorised prescriber must first undertake an assessment of the patient’s capacity if they have any concerns, in line with trust policy.

This consent is based on the patient having been provided with:

• adequate knowledge of the purpose, nature, and likely effects of the treatment
• information as to any commonly known risks associated with the treatment
• details as to the likelihood of the treatment succeeding
• information about any alternative treatments which are available

Any agreement to proceed with treatment which is given under unfair or undue pressure is not consent (Mental Capacity Act Code of Practice 2005).

It is the duty of everyone proposing to give treatment to use reasonable care and skill, not only in giving information prior to seeking a patients consent, but also in meeting the continuing obligation to provide the patient with adequate information.

All discussions relating to consent to treatment are to be recorded in the patient’s clinical records. The appropriate Mental Health Act (MHA) consent to treatment forms should be completed, if applicable.

Information given to the patient by a pharmacist or other practitioner about the treatment is provided in addition to that given by the prescriber, not as an alternative.

5.2.10 Treatment of patient who lack the capacity to consent

Where there any concerns about the patients’ ability to consent an assessment of capacity should be undertaken.

Where an assessment of capacity has been undertaken evidence that the person lacks capacity must be documented on the appropriate Mental Capacity Act (MCA) 1 questionnaire in the patient’s clinical record.

If the person lacks capacity a best interests decision under the Mental Capacity Act (MCA) (2005) should be made if treatment cannot be given under the Mental Health Act.

Decisions taken on behalf of a person who may lack capacity to make a particular decision for themselves must comply with the requirements of the Mental Capacity Act (2005) and the supporting code of practice in that:

“An act done or decision made under this act for or on behalf of a person who lacks capacity must be done, or made in his or her best interest” (Mental Capacity Act 2005, Code of Practice, page 66).

The trust Mental Capacity Act (2005) policy must be followed.

Any decision regarding medication given in a person’s best interests should be recorded on Mental Capacity Act (MCA) 2 questionnaire in the patients clinical record.

5.2.11 Treatment of patient detained under the Mental Health Act (1983) amended by the Mental Health Act (2007)

The Mental Health Act (1983) amended by the Mental Health Act (MHA) (2007) provides the prescriber with a 3-month period in which to develop a treatment program to meet the patient’s needs (for patients detained under a section of the act which legislates for consent to treatment provision). However, even though the act allows for treatment to be administered without the consent of the patient the prescriber should still adhere to the same principles of seeking consent as described above.

Note, the 3-month period starts from when treatment or medication is first prescribed.

For treatment after this 3-month period the responsible clinician will receive notification from the Mental Health Act administrator within their locality that the patient’s consent to treatment needs to be reviewed and on receipt of this notification the responsible clinician must:

• seek the patient’s consent for the treatment to continue beyond the 3-month period
• record the discussion in the clinical notes including an assessment of the patient’s ability to consent
• if the patient consents to continued treatment, complete a form T2
• if the patient refuses consent or is deemed unable to provide a reliable consent, the responsible clinician must request a second opinion doctor (SOAD) visit from the Mental Health Act commission
• if the second opinion doctor agrees with the responsible clinician that treatment is necessary and should be given, the second opinion doctor will complete a form T3. The responsible clinician must fill in a form SN62 (in questionnaires on SystmOne) to cover the period until the second opinion doctor completes the T3
• a placeholder must be prescribed on the drug chart, and a copy of the document should be available for staff to be able to read

Note, no treatment is to be administered to any patient detained under the Mental Health Act without a check being made that there is a valid T2 or T3 in place.

For further details staff should refer to the Mental Health Act Code of Practice.

5.2.12 Checking administration

It is good practice that, wherever possible, all medicines are prepared and administered in the presence of another practitioner. If this is not possible for any reason a single registered nurse may carry out administration, but not for the following:

• schedule 2 controlled drugs (staff are to refer to the trust controlled drugs (with the exception of trust physical health community services) procedure)
• prior to administration, the calculation of complex doses, including weight related doses, the administration itself may be done by a single practitioner
• rapid tranquillisation policy and guidelines (pharmacological management of violence)

The purpose of the second person is as a check of the correct administration of the drug (for example, right patient, right drug, right dose, right route and dose, and form), and that the appropriate paperwork is completed.

Where the second person is a qualified professional they should also review the clinical appropriateness of the dose (this will exclude nurse assistants and pharmacy technicians for example).

It is the administering nurse’s responsibility to observe the patient taking any oral medication.

The following may be appropriate for counter-signatories or witnesses:

• registered nurses
• doctors
• pharmacists
• pharmacy technicians (directly employed by the trust)
• appropriately trained healthcare professional
• nurse associates
• student nurses including trainee nurse associates under supervision by someone other than the first signatory
• nurse assistants, health care assistants or clinical support workers

5.2.13 Complex calculations

These checks, such as for syringe drivers may take place away from the place of administration, such as the district nurse community base. These should only be done by staff competent to work out such calculations.

5.2.14 Controlled drugs

Following the administration of the medicine the staff member must sign the prescription chart or medicines administration record (MAR) sheet or make an appropriate entry on an electronic patient record system such as SystmOne. This signature signifies that the patient has taken or been administered the medication. Students administering medication should have their signature countersigned by the supervising practitioner. This should be done once the medication has been administered.

If any medication is not administered, the code must be recorded on the approved administration card or prescription chart using one of the trust’s recognised codes found on the drug chart and or electronic system, an entry made in the clinical records, and the prescriber informed where appropriate. Please see the omitted medication guidance (staff access only).

Electronic charts, when the administering person does not have access to the SystmOne:

• the chart should be printed prior to the member of staff coming on duty, the person administering will sign the paper chart
• at the earliest opportunity a person with administration rights will record on the chart that there is a signature on the paper record, with a note to say administered by, for example, agency staff. The paper record should then be scanned into the patient record. The trust can assure the person completing the electronic record that they are only confirming that they have seen the paper record, this is to maintain the administration record on the electronic chart

5.2.15 Failure to record the administration or omission of a medication constitutes a medication incident and must be reported

If a patient is absent from the ward, or has missed a dose for some other reason, the delayed dose can be administered at a later time provided the prescriber has confirmed that it is appropriate to do so. If this is the case the actual time of administration is to be recorded on both the prescription chart, and in the patient’s clinical records.

Any patient who is classified “nil by mouth” for any reason is to be given all their prescribed medication unless specifically advised otherwise by medical staff.

5.2.16 When a patient who does not receive the medication prescribed (omitted doses)

Inpatients and community patients should have a plan in place as to what to do in the event of them missing the medication for whatever reason; this should be based on the nature of the medication and the potential risks. The trust guidance on omitted doses (staff access only) must be followed. It should include when to contact the prescriber and any remedial action required.

5.2.17 Covert administration of medicines

Covert medication refers to medication that is hidden in food or beverages. The covert administration of medication is the practice of hiding medication in food or beverages so that it will be undetected by the person receiving the medication. Pills may be crushed or medication in liquid form may be used, if it is safe to do so. This practice exclusively applies to patients who lack capacity to consent to the treatment. It is intended to ensure that patients refusing treatment as a result of their illness will have access to effective medical treatment.

As a general principle, by disguising medication in food or drink, the patient is being led to believe that they are not receiving medication, when in fact they are. This is not acceptable as the patient has not consented to its administration. However if the patient lacks capacity and the medication is deemed essential covert administration of medication can be given providing it is in the person’s best interests, after a best interests meeting has taken place and a covert medication plan is in place, see below for details.

The decision and plan will be detailed in the patients care plan and case notes or SystmOne.

5.2.17.1 Process for the administration of covert medication

Legal authority to treat: if the Mental Health Act is not applicable the Mental Capacity Act (2005) policy should be followed to assess the patient’s capacity to make decisions about their medication. If the person is deemed to have capacity then covert medication cannot be given.

If the person is assessed to lack capacity then a decision should be made in the persons best interests. The courts have said the best interests decision should be made via a best interests meeting involving all interested parties. This includes family, carers, attorneys and advocates as well as professionals.

• Covert medication care plan, the method of giving the medication covertly is generated in partnership with a pharmacist. The pharmacy should be contacted to generate a care plan documenting the agreed method, along with any necessary dosage changes (appendix D, see safe and secure handling of medicines manual homepage to access).
• Administration, each dose of medication is offered normally, if refused it may then be administered covertly.
• Documentation, use of covert medication, and how it is given, should be documented explicitly on the prescription chart.
• Safety, systems are in place for safe, optimal practice with a clear audit trail of events, including evidenced reviews.
• Review, review by the ward manager and ward multidisciplinary team, on a planned and regular basis.
• Supervision, nursing staff giving covert medication have ongoing training or clinical supervision.

The pharmacy service (staff access only) offers support to all inpatient areas, giving advice on management with covert medication.

5.2.18 Use of patient’s own medicines

The trust has a duty of care to ensure that any patients own medicines used while they are under the trust inpatient care are both safe and fit for purpose. The trust acknowledges that medicines brought in are the patient’s property and staff require the permission of the patient to dispose of their medicines.

Medicines brought into hospital by a patient can be administered to them during their stay until new supplies can be obtained from pharmacy. These medicines must be assessed by pharmacy as being suitable for use, for example:

• the medicine can be easily identified from the backing on the strip pack or markings on the tablet or capsule
• the medicine has not expired and appears to be in a good condition
• the medicine is prescribed by an authorised prescriber and is on the inpatient medicine card
• the patient does not object to their own supply being used

Patient’s own medication is not to be used if:

• there are any doubts about the identity or quality of the medicines
• the patient objects, and has capacity, however if they lack capacity and the medication is deemed essential, then a best interests decision must be made in line with trust policy

Note, medicines brought into hospital by one patient must never be used for any other patient.

5.2.19 Monitoring arrangements

5.2.19.1 Recorded electronic prescribing of medicines administration training of inpatient staff administering medicines

• How: inpatient audit.
• Who by: pharmacy.
• Reported to: Medicines Management Committee.
• Frequency: annually.

5.2.19.2 Recording of administered doses against inpatient drug card

• How: inpatient audit.
• Who by: pharmacy.
• Reported to: Medicines Management Committee.
• Frequency: annually.

5.2.19.3 Adherence to covert administration guidance

• How: inpatient audit.
• Who by: pharmacy.
• Reported to: Medicines Management Committee.
• Frequency: annually.

5.3 Standards for administering, ordering or storage and prescribing of specific medications

5.3.1 Aim

The aim of this document is to set down the standards for administering of specific medications within the trust.

5.3.2 Scope

This document covers medications where specific guidance exists, such as Medicines and Healthcare Products Regulatory Agency (MHRA) guidance. It applies to all areas where these medications are used.

5.3.3 General

This document must be read in conjunction with standard 2 administration of medicines within the safe and secure handling of medicines manual.

The Royal Marsden procedures (staff access only) should be used for guidance on procedures of how to administer medication.

5.3.4 Parenteral (injectable) medicines

Guidance on specific parenteral medication can be found in the Medusa injectable medicines guide (staff access only), along with The Royal Marsden procedures (staff access only).

All staff administering Injectable medications must have:

• up-to-date anaphylaxis training, along with access to adrenaline
• be competent in administering medication through this route
• have access to all the necessary equipment needed to administer the medication
• knowledge of the medication being administered

Staff administering parenteral medication must have completed approved training and be judged competent by a competent practitioner, being signed off by their line manager prior to reconstitution and administration of an injection.

When administering intravenous (IV) antibiotics in the community the first dose must have been administered in hospital prior to transfer into the community.

The standards outlined in standard 2 administration of medicines must be followed, along with standard 1 prescribing of medicines including clinical trials. Along with standard information the prescription must also include:

• use of any diluent
• use of any flushes (the relevant patient group direction (PGD) can be used, either heparin sodium to line lock a vascular access device administration (PGD) or sodium chloride 0.9% injection as a flush administration dependent upon the clinical scenario)
• rate of infusion, if not a bolus injection

5.3.4.1 Community services including the hospice

For medicines administered via syringe driver or palliative care, staff should follow the syringe driver administration of drugs via the CME medical T34 syringe driver procedure.

For all other injections technical information and risk assessments can be found at Medusa injectable medicines guide (staff access only).

• Under medicines legislation, except in very restricted circumstances, mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine. The person undertaking this preparation, unless an exemption applies, must hold a manufacturer’s licence.
• Regulation 20 of the Human Medicines Regulations (2012) exempts nurse and pharmacist independent prescribers as well as supplementary prescribers from these restrictions (the manufacturing restrictions do not apply to doctors and dentists, regulation 3 refers.). It allows these prescribers to mix medicines themselves or direct others to mix. Directions must be in writing
• The list of acceptable combinations can be found on Health Improvement Scotland.

5.3.4.2 Administration of intravenous antibiotics to children in the community

5.3.4.2.1 Eligibility criteria

• All referrals for intravenous (IV) medication administration in the community must be discussed with the Community Children’s Nursing (CCN) team before planned discharge. Acceptance may be dependent upon available capacity within community resources; however, wherever possible referrals will be prioritised.
• The child or young person or their carer or guardian must consent to treatment being continued in the home environment.
• Referrals must be correctly completed on the appropriate Community Children’s Nursing team referral form:
  • the Community Children’s Nursing team reserves the right to decline a referral until the correct information is provided or if the suitability of the home environment compromises the safe administration of the prescribed medication. Referrals will not be accepted on a Friday afternoon for medication on a Monday
• The child’s or young person’s health condition must be stable.
• A treatment review or completion date has been set and documented by the responsible prescriber.
• The child or young person must have received the first dose of any medication in a hospital setting prior to discharge.
• The child or young person must have patent IV access and secure, clean, transparent, adherent dressing applied (UK DH, 2007).
• The child or young person must be discharged with the required medication and drug chart or authorisation sheet for Community Children’s Nursing team staff to administer the required medication in the community.
• All medication, including diluents and flushes, needed to complete the course of prescribed treatment will be prescribed and provided by the referring source. Along with enough consumables for the first week of treatment in the community (except a sharps bin). Flushes can be used by employing the patient group directive (PGD) where appropriate.
• The time of administration and completion of the required medication dose must be within the operational hours of the service (Monday to Friday, 9am to 5pm). Outside these times these will be agreed with the Community Children’s Nursing. During a weekend the child will need to attend the children’s observation unit at Doncaster Royal infirmary and the Community Children’s Nursing team will arrange this.
• The IV medication requested must be clinically suitable for the safe administration outside a hospital setting, for example, consideration of the risk of adverse effects and specific monitoring requirements.
• The requested medication must be on the trust formulary (unless specifically requested by microbiology). Consultation with the team leader or nurse consultant for the Community Children’s Nursing team must be undertaken if the medication is outside this list and is clinically indicated.
• A clean area within the home will be available for the safe preparation of medication and that a home assessment will be conducted by the Community Children’s Nursing team at the first home visit. Should a suitable area not be available at the time of the home visit the family must be made aware that the Community Children’s Nursing will not be able to administer the medication and the child will be required to return to the ward.

5.3.4.2.2 Exclusion criteria

• Eligibility criteria cannot be met.
• Safeguarding concerns.
• The risk assessment completed at the first home visit highlights areas of concern.
• There is a known allergy or risk of allergy to the medication or device. History of previous allergic reactions to medication being prescribed or similar group of medicine.
• Administration of antibiotics via intramuscular injection.
• Administration of blood or cytotoxic medication.
• Treatment regimens exceeding once or twice daily doses will only be considered in exceptional circumstances depending on the child’s condition and service capacity, for example, middle day doses where child is still required to attend hospital for early morning or late evening doses.

5.3.4.3 Nursing or medical responsibilities

The child and family must be discharged with all the medication and equipment for one week. If the Community Children’s Nursing team are not informed within enough time to co-ordinate visits or the treatment sheet and, or referral form is not completed appropriately the child will return to the ward for the dose until these are correct.

The Community Children’s Nursing or registered children’s nurse administering medications will have completed the trust approved training and be deemed competent to administer intravenous (IV). Access to injectable medicines guidance will be available at all times via Medusa (staff access only).

The community children’s nurse or registered children’s nurse administering the IV medication will ensure they have the knowledge and understanding of the medication to be administered prior to the home visit. The nurse must confirm the indication for use and that there are clear instructions for use, including any monitoring.

After a referral to the team has been accepted the community children’s nurse will calculate the medication dose, the infusion rate and check recommendations within the current British National Formulary (BNF). The adrenaline dose will be calculated and documented within the clinical record and checked by a second registered nurse.

The community children’s nurse or registered children’s nurse administering the IV medication will ensure the prescription is:

• not for a substance to which the patient is known to be allergic or otherwise unable to tolerate
• based, whenever possible, on the patient’s or the patient’s parent or carers’ informed consent and awareness of the purpose of the treatment
• clearly written, typed or computer-generated and indelible
• specifies the substance to be administered, using its generic name and its stated form, together with the strength, dosage, timing, frequency of administration, start and finish dates, route of administration, flushes, and diluents as necessary and final infusion volume
• is signed and dated by the authorised prescriber (Nursing and Midwifery Council (NMC) 2010)
• that the dose is appropriate for the child or young person’s age, weight and condition
• when a calculation of the dose needs to be undertaken to either prepare or administer the medication, these should be done and checked with another qualified nurse
• following assessment of the clinical risks this will be facilitated with a two-person visit for the initial visit and should there be no further changes a one-person visit thereafter, where the dose requires complex calculating or there has been a change or is a small dose, for example, 3.3mls, then there will be a two registered nurse visit each time

5.3.4.4 Prescribing

Prior to any administration the nurse must ensure they have a valid prescription or authorization to administer along with all the necessary equipment and medication, which must be in original containers, and stored in accordance with the summary of product characteristics (SPC).

5.3.5 Clozapine

Any patients who are prescribed clozapine will be monitored through the clozapine clinics, which are within each of the trust’s localities. For further details staff should refer to the trust clozapine clinic protocols, or contact their clozapine local clinic.

Key points:

• it is very important that compliance is assured due to the strict requirements for re-titration if it is missed for more than 48 hours
• follow the initiation and re-titration guidance in the clozapine clinic protocols
• regularly assess side effects using the clozapine side effect questionnaire on the clinical record

5.3.6 Administration of rapid tranquillisation

The trust’s rapid tranquillisation policy provides guidance on the use of rapid tranquillisation and clinical staff employed in areas where rapid tranquillisation may be used should be familiar with its contents.

They should be aware of when it should be used, and the importance of monitoring.

For further details staff should refer to the rapid tranquillisation policy.

5.3.6.1 Flumazenil

The trust has taken the decision, on advice provided by the Medicines Management Committee and the Resuscitation Committee, not to carry Flumazenil, the antidote to benzodiazepine overdose. This is due to the requirement for it to be given by an intravenous route, and only by specialists, for example, Anaesthetists. Therefore, the use of the grab bag and ringing for an ambulance must be used. The risk assessment that under-pinned this decision will be reviewed annually.

5.3.7 Lithium

The prescribing of Lithium to patients will be in line with the trust Lithium monitoring via nurse led clinic policy, and staff should refer to this for further details on treatment and monitoring, including National Patient Safety Agency (NPSA) guidance.

Key points:

• regular monitoring of levels and physiological markers
• prescribing by specific brand rather than generically
• shared care where in use

5.3.8 Oral anticoagulants

The prescribing of oral anticoagulants should be in line with the local district formulary.

5.3.9 Cytotoxic or cytostatic chemotherapy or medication

• An increasing number of patients will be receiving chemotherapy in the community, as the provision of care is moved from secondary care to primary care.
• Practitioners administering these drugs parenterally must be deemed to be competent to do so. The Royal Marsden should be followed or the specific directions from the originating prescriber should be sought. They should have a written prescription clearly stating:
  • the drug name
  • dose rate (if appropriate)
  • frequency and timing
  • route of administration
  • where appropriate, a review date of the treatment
  • this should be signed and dated by a prescriber
• An assessment should be made of the suitability of the patient’s home environment including phone access in case of emergency or anaphylaxis.
• Administering oral cytotoxic or cytostatic medication in inpatient settings:
  • these are identified on the medication chart with the words cytotoxic or cytostatic, which is automatically inserted by SystmOne
  • pregnant women should not physically administer these medications, staff should be double gloved. The medication form must not be altered, for example, crushing, prior to administration. If the patient spits out any medication this must be disposed of in the cytotoxic purple lidded bin, ideally without touching it directly
• Cytotoxic waste must be disposed of in a cytotoxic waste bin or other receptacle, which should be supplied by the hospital at the same time as the supply of the drug. For further information please refer to the trust’s waste policy, and the poster which is in treatment rooms by the disposal bins

5.3.10 Antimicrobials

Authorised prescribers should follow the local integrated care board (ICB) policy for the prescribing of antimicrobials.

As a minimum when prescribing antimicrobials staff must ensure:

• clinical indication and duration complies with local guidance
• antimicrobials for suspected urinary tract infections should not be prescribed based purely on a urine dipstick
• clearly documented in the clinical record and should comply with community guidance in locality for drug selection, dose, and duration of treatment
• swab or culture (if indicated). Sample taken prior to initiation or in response to empirical 1st line failure as per guideline, and evidence of review of results
•  a review of continued appropriateness should be completed within 48 to 72 hours by the treating team, ideally a review can be added to the chart on SystmOne, to remind staff
• mark clearly duration or review date or stop date and indication on the drug chart

5.3.11 Naloxone ampoules 400mcg

Naloxone injection is an antidote to opiate-induced respiratory depression and should be available in all clinical locations where opioids, such as diamorphine or morphine injections are stored or administered, in line with NHS Commissioning Board Special Health Authority guidance.

5.3.11.1 Ward and department

All areas where morphine or diamorphine ampoules are stock items, they must also have naloxone 400mcg ampoules as a stock item.

Naloxone is covered by section 19 of the Human Medicines Regulations covering the emergency use of drugs, and as such can be administered without a prescription; dosing guidance found with the medication must be adhered to.

5.3.11.2 Community

Naloxone ampoules will be a stock item at base points and available for use by community nurses when dealing with patients using diamorphine or morphine injections.

Naloxone prefilled syringes may be made available via the substance misuse clinics where agreed, in line with national guidance, identified staff may supply this medication in line with local guidance widening the availability of naloxone.

5.3.12 Administration of medication via a percutaneous endoscopic gastrostomy tube

• Patients with percutaneous endoscopic gastrostomy (PEG) tubes may receive medication via this route. The tube should be flushed before and after administration of medication with tap water, inpatients who are immunocompromised then recently boiled water should be used.
• Medication should never be mixed with the feed. A chemical or physical reaction may occur, which may adversely affect the drug, food, or both. Guidance should be sought from the prescriber and acute trust, alternatively the use of NEWT guidelines can be used.
• Medication should be prescribed in liquid form to prevent tube blockage. If a drug is not available in liquid form, advice must be sought from a pharmacist or medical practitioner whether it can be crushed and flushed down the tube

For details see enteral tube feeding adults policy.

5.3.13 Medical gases

The Medical Gases Committee has overall responsibility for reviewing guidance on the use of and training requirements for medical gases

Additional guidance can be found on the resuscitation and clinical skills (staff access only), please scroll down to the “clinicalskills.net” section.

With respect to the safe storage of medical gases the following precautions must be observed:

• oxygen is mainly available in cylinder form; however, it is also available in piped form in some areas, staff must be aware:
  • the source of oxygen in their area of work
  • how to use the equipment
  • how and when to order further supplies
  • need for servicing
• the number of cylinders held as stock in any department should be kept to a minimum
• cylinders must be firmly secured at all times to prevent them falling over
• they should be stored under cover, preferably inside and not subjected to extremes of heat
• naked lights must not be allowed within the immediate vicinity of a cylinder
• no oil or grease should be applied to the cylinder or tap connector
• allow for segregation of full and empty cylinders and permit separation of different gases within the store
• have warning notices posted prohibiting smoking and naked lights within the vicinity of the store
• allow for a strict rotation of full cylinders to enable the cylinders with the oldest filling date to be used first
• the storage should be designed to prevent unauthorised access and to protect cylinders from theft
• excessive force or any tools must not be used to open or close a cylinder valve
• cylinders with damaged valves and defective equipment must be labelled appropriately and withdrawn from use
• estates must inform the emergency services of the location and contents of the medical gas cylinder store
• contact suppliers for more specialist advice where necessary The arrangements for the maintenance and repair of medical devices (which includes flow meters and oxygen regulators) within the trust localities are as below

5.3.13.1 Doncaster

A combination of in-house and service level agreements with the Doncaster and Bassetlaw Hospitals NHS Foundation Trust.

5.3.13.2 Rotherham

A combination of in-house and service level agreements with the Rotherham NHS Foundation Trust.

5.3.13.3 Scunthorpe

Medical physics at Scunthorpe General Hospital, North Lincolnshire, and Goole NHS Foundation Trust.

5.3.13.4 Oxygen administration

• Patients should be correctly assessed for the use of oxygen. A risk assessment must be included in relation to safety and recorded in the clinical records. Medical grade oxygen is regarded as a drug and may only be prescribed by a doctor or appropriately qualified practitioner. The prescription should include the type of appliance to be used, the appropriate percentage of oxygen, the flow rate, and the duration of administration.
• Patients and carers must be educated in the safe use of oxygen in relation to smoking and hygiene of tubing and mask. Concentration of oxygen and duration of administration should be the minimum required for efficacy, and patients and carers should be educated in its safe usage.
• Safety guidelines must be adhered to, and appropriate warning notices displayed on vehicles in which oxygen cylinders are transported.

5.3.14 Flammable liquids

Flammable liquids are issued from pharmacy and labelled “flammable” Control of Substances Hazardous to Health (COSHH) data sheets must be available for all flammable liquids kept on the premises. The data sheets must be kept in a central point available to all staff.

To reduce the risk of combustion or explosion:

• keep stock levels to a minimum
• avoid spillage
• keep bottle closed
• replace the screw cap immediately after use
• keep well away from naked flame or electrical apparatus
• do not store in a refrigerator
• tore all flammable liquids in a locked metal cupboard that displays an appropriate hazard notice

5.3.14.1 Alcohol gel

It should be noted that as alcohol gel is also a highly flammable substance the precautions as stated above must be followed.
If nursing staff need to store alcohol gel in their car it must not be stored anywhere where it would be subject to direct sunlight. Alcohol gel must therefore be stored in nursing bags, pockets and, or in the boot of the car, when not being used.

5.3.14.2 Emollients

These contain paraffin and can be highly flammable; Medicines and Healthcare products Regulatory Agency drug safety alerts must be followed.

5.3.15 Dressings

• Doncaster community nursing staff will provide dressings in line with the wound care formulary Doncaster.
• On wards non medicated dressings should routinely be ordered either from the local dressing store in Doncaster or through Regional Supplies.

5.3.16 Insulin

• All regular and single insulin (bolus) doses are measured and administered using an insulin syringe or commercial insulin pen device appropriate to the insulin. Intravenous syringes must never be used for insulin administration.
• The term “units” is used in all contexts. Abbreviations, such as “U” or “IU”, are never used.
• When community nursing staff are requested to administer insulin, they must have either a prescription or letter of instruction including the brand, dose, and time of each dose. Prior to administration they must assure themselves that the insulin is in date and has been stored appropriately, and that it has not already been given at a duplicate visit.
• All clinical areas and community staff treating patients with insulin have adequate supplies of insulin syringes and subcutaneous needles, which staff can obtain at all times.
• All healthcare staff involved in prescribing, administering, or monitoring insulin must undertake the online training safe use of insulin, available on electronic staff record (ESR). For those senior healthcare assistants and nurses who work within the trust’s physical health community nursing service they must also undertake the six steps to insulin safety training (staff will need to register first, it takes about 45 minutes). Evidence of completion should be shared with the staff member’s line manager.

5.3.17 Adrenaline

Adrenaline can be administered without a prescription when used in an emergency situation, as listed in schedule 19 of the Medicines Act (2012), staff must be competent to administer adrenaline, in line with life support training.

5.3.17.1 Inpatient

Must have Adrenaline accessible in the event of anaphylaxis occurring.

5.3.17.2 Clinics

Where injectable medicines are being administered, for example, depot clinics or vaccine clinics adrenaline must be available.

5.3.17.3 Community visits

Staff administering long-acting injections (depots) must carry adrenaline with them for the first two injections, and it is advised they carry it routinely.

Community nurses administering injections, such as antibiotics must carry adrenaline with them.

Adrenaline shock packs are available from the trust pharmacy.

5.4 Standards for when required (PRN) medication

5.4.1 Aim

The aim of this document is to set down the standards for prescribing when required medication, pro re nata (PRN).

5.4.2 Definition

PRN (pro re nata) medication is medication that has been identified as being needed to be occasionally administered in particular circumstances on an as and when basis.

5.4.3 Prescription

A clear need must be identified for the need of when required (PRN) medication, rather than it might be needed. The review or initiation should be carried out during the patient review. If it is out of hours and a normal team medic is unavailable, then consideration of the once only section of the drug card should be strongly considered.

An unambiguous indication must be stated, for example, for pain, for rapid tranquillisation, if patient refuses regular oral medication:

• clear dosage instructions must be stated
• what dosage, for example, 1mg, one puff
• suggested maximum frequency based on clinical need, ideally in hours, for example maximum every 4 hours
• maximum total dose per 24 hours
• if a dosage range is written it must be clear when to use different doses

The 24-hour period is a rolling 24 hours, not midnight to midnight. The exception to this may include the use of hypnotics which would be administered just prior to retiring to bed, which will vary from day to day.

If there is a need to prescribe the same drug by two different routes, this must be written as two separate prescriptions. Consider using the electronic prescribing medicines administration (EPMA) grouping functionality to link these together.

If two drugs or variable doses are being used for a similar indication, ensure it is clear for the person administering to know when to use them, for example, first or second line.

If the requirement is it is to be used a certain number of times before active review, consider crossing out any additional slots on the administration record. It must be reviewed at least every seven days. When no longer needed the medication should be discontinued to reduce the chances of misadministration.

Take into account any regular medication the patient is taking, this should also be indicated in the total maximum 24 hourly dosage where appropriate.

Guidance should be given if PRN medication may be given just before a regular dose of the medication, for example, Lorazepam.
Where there is either a T2, T3, or S62 in place this must reflect PRN medication as well.

If the use of medication is going to take the total dose of that medication or class of medication above British National Formulary (BNF) limits, then this must only be written or recorded after discussion with the patient’s consultant or their deputy and this must be clearly documented within the patient’s records. If the high dose medication involves antipsychotics the high dose antipsychotics protocol must be implemented, and this must be clearly recorded.

A clear treatment plan should be included in the clinical record, including a maximum period before review. This should include what alternatives should be considered prior to the decision to administer, in order to deliver person centred care, including unintended consequences, such as increased falls risk.

5.4.4 Administration

The use of PRN medication must be care planned.

Consider the use of medication and the most appropriate way of dealing with the issue, for example, for agitation has talking or distraction been considered:

• is the prescription clear and unambiguous?
• what regular medication has the patient already received?
• when was the PRN last given, how much have they already been given in the last 24 hours?
• is it in line with any consent to treatment documentation?

Explain the purpose and likely effects of the medication to the patient, and to report any problems to the nurse. Due consideration should be taken of capacity issues, where patients are unable to understand the nature of the PRN medications.

The decision to administer PRN medication lies with the professional view of practitioner following an assessment of both the patient and situation. Any decision to or not administer should be documented. This applies in both community and inpatient settings.

5.4.4.1 Recording

The administration must be recorded on the drug chart at the point of administration and then there should be an entry in the record of why it was given and what the outcome was. This may be done one by one basis, for example, the use of Lorazepam for agitation or behavioural control. In these instances, there should be a corresponding entry on the administration record on the medication chart. Alternatively in areas such as the hospice where the prn medication is used as a part of the regular treatment plan a single entry in the tabbed journal covering that shift, where they are discussed daily.

5.4.5 Standards for leave of discharge

When a patient is going on leave the PRN medication should be reviewed. If it is decided that it should continue, then the to take out (TTO) should reflect how many doses the pharmacy should issue. In most cases PRN medication will no longer be required, and the inpatient card amended accordingly.
A clear description should be given to the patient on how to use it.

Where appropriate instructions for carers or relatives should be provided, ideally in a written format.

Guidance should be included in the discharge letter on how it should be reviewed, and by whom.

5.5 Standards for ordering and receiving of medication

5.5.1 Aim

The aim of this document is to set down the standards for ordering and receiving medication.

5.5.2 Responsibilities, accountabilities and duties

Are in line with the overarching policy, unless otherwise stated within this policy. Medications may be ordered by:

• authorised pharmacy staff
• nursing staff
• ward based technicians
• clinic managers
• prescribers

5.5.3 Ward or clinic stock

• All wards have a list of stock medicines agreed between the ward, pharmacy, and the supplying pharmacy.
• Community clinics stock list will be determined by the clinic manager dependent on the patient cohort.
• Frequency of review should be informed by any changes in patient grouping or practice. This should be done as a minimum annually.
• Pharmacy or ward technician staff are responsible for a weekly top-up of stock medicines to agreed levels there should be a minimum of 10 days medication available.
• Ward nursing staff may have to order some medications if usage has changed between technician top-ups.
• Ordering must be done on the non-stock pad (form WZT696).
• There must be only a single order book in use at any one time.
• Orders must:
  • have ward or clinic name and date and contact phone number
  • have full drug name, strength, and quantity details
  • be signed by an authorised member for staff
• Orders are to be signed scanned and emailed to the supplying pharmacy and the original copy must be sent using a secure pouch or medicines box.
• Delivery of stock orders is between Monday to Friday for those orders placed by 1pm the previous day.
• Urgent stock items within hours check other onsite units and arrange transfer (see below).
• If unsuccessful use to take out (TTO) ordering specifically for patient (see below). All stock items will be delivered in either a sealed box or satchel. There should be a tamper evident closure.

5.5.4 Receipt of medication

• All stock orders will arrive with a delivery note.
• The stock should be checked off against the delivery note by an authorised member of staff.
• Where stock is known to be missing by the supplying pharmacy there will be an “owing slip”. Staff should attach the owing slip to the delivery note for later reconciliation.
• Any owing, missing or inappropriate stock should be brought to the attention of the team manager or senior clinical staff on shift to identify relevant actions.
• Missing or inappropriate stock must be brought to the attention of the supplying pharmacy for rectification.
• Stock should be stored in the appropriate locked drug cupboard ensuring all stock is rotated so that stock with the shortest expiry date is available for first use.
• The relevant stock medicines reconciliation forms should be updated to reflect new stock levels.

5.5.5 Named patient medication

• Patient specific medicines refers to instances where a medication will be dispensed and labelled specifically for a particular patient. Examples of these are:
  • medication for patients going on leave
  • to take out (TTO)
  • urgently required medicines or those where the delay in receiving “stock delivery” would lead to a gap or undue delay in medication which would be detrimental to patient care
  • community clinics, in agreement with the chief pharmacist the clinics may use to take out (TTO) pads or appropriate FP10’s
• The default process for generating prescriptions for patient specific medicines for inpatients is to generate them using SystmOne to take out (TTO) functionality: these should be printed and then signed by the prescriber.
• In exceptional circumstances and for community clinics, for example, when the electronic record is unavailable and delay in ordering would lead to an unnecessary delay in getting the medications. For example, delayed start to antibiotics or discharge) manual “to take out pads” (form WZT697) may be used. It should be documented for community patients what medication is being supplied by the trust and which by the patient’s GP:
  • there must be only a single manual to take out pad in use at any one time
  • manual ordering of patient specific medications must be done on the trust to take out pad by an authorised member of staff and contain the following information:
    • patient identifier (name, date of birth (DOB) and address, NHS number)
    • drug strength, dose form, dosage details and quantity (maximum of 28 days as appropriate clinically or for the level of patient risk)
    • rationale for quantity should be part of the discharge care plan
    • the prescriber’s name
  • patient specific requests must be signed and dated by an authorised prescriber following printing
  • the signed copy of all manually written to take out’s must be scanned and entered into the relevant clinical record and a note made in the record of the need to manually prescribe
• FP10’s, they should routinely be electronically generated and sent to the Pharmacy using electronic prescription service (EPS) functionality of SystmOne, where not possible then they may be written by hand or computer generated. Where handwritten then a corresponding entry must be made in the clinical record.
• For the initial ordering of an unlicensed medicines (products that do not have a product licence in the UK, this is not when medicines are being used outside their licensed indications), the trust pharmacy must be informed before ordering.

Completed forms are to be signed, scanned, and emailed to the local pharmacy provider; the original must be sent using a secured pouch or drug box.

• Copies of the order (either computer generated to take out (TTO) copy or yellow carbon copy if manually generated) must be placed in the pharmacy folder for checking upon delivery.
• Clozapine ordering:
  • all clozapine ordering is done as named patient orders.
  • existing clozapine patients will come onto the ward with their supply and Lloyds Pharmacy will continue to supply against the original prescription unless there is a dose change, or the original prescription expires.
  • the ward will need to let their Lloyds Pharmacy supplier know when the patient has been admitted and discharged.
  • new clozapine patients or prescriptions are done on the to take out form with the prescription length being determined by dose titration or stability of monitoring.
  • if a patient arrives out of area on a different brand of clozapine, for example, Clozaril then the clozapine clinic must be informed to allow transfer to the agreed brand. The patient’s existing stock can be used until then as long as it is deemed to have been stored properly, is correctly labelled, and they still have a valid blood test
• NOMAD or other monitored dosage systems required for to take out (TTO), this must be clearly indicated on the to take out and arranged well in advance of discharge:
  • where a new NOMAD is considered clinically appropriate, prior to discharge an identified pharmacy must be contacted to ensure continuity of supply. They will need to be contacted for agreement
  • where deemed appropriate patients can be referred to the discharge medicines service to facilitate a check and review in the community

5.5.5.1 Receipt of named patient medication

• Patient specific medicines will be delivered in a clear plastic bag, in either a sealed box or satchel. There should be a tamper evident closure.
• The patient specific medicines should be checked off against the delivery note by an authorised member of staff.
• Patient specific medicines should be stored in the appropriate locked drug cupboard awaiting check by qualified staff.
• The relevant reconciliation forms should be updated to reflect new stock levels.
• Authorised qualified staff should check:
  • all dispensed medicines are accurate against the prescription chart
  • the quantities are appropriate for delivery of original dispensed packs only
  • patient information leaflets are available
• Any patient named controlled drugs (CDs) must:
  • be entered into the back of the controlled drug register by a qualified member of staff and a witness, use a separate page for each patient and drug
  • stored in the controlled drug cupboard

5.5.6 Controlled drugs

• Staff should refer to the trust’s full inpatient standard operating procedure (SOP) for controlled drugs (CD) (staff access only).
• All controlled drugs are to be ordered in one of two ways depending on if they are stock or named patient. There is a trust wide list agreed with Lloyds of controlled drugs which can be ordered as stock. All other controlled drugs need to be ordered as named patient. A list of these stock controlled drugs may be found on the wards, and pharmacy can be contacted if needed.
• Stock, to be ordered on a ward controlled drug order book (WOP100). This requires:
  • full drug name, strength, and quantity details. Quantity must be in words and figures for stock use
  • signature and date, entered by a doctor
• Completed requisition book must be sent in the box to the ward’s wholesaling Lloyds Pharmacy
• To take out (TTO) or leave medication or urgent, to be ordered as per patient specific medicines. Details as per patient specific medicines above plus:
  • quantity in words and figures
  • signature and date, entered by a prescriber
• Methadone for opioid dependence is not ordered as part of a “to take out” (TTO). Patient should be referred to the appropriate substance misuse service before being discharged.
• Completed to take out forms must be sent in the box to the ward’s local Lloyds Pharmacy.

5.5.6.1 Receipt of controlled drugs

• All stock controlled drug items will be delivered in either a sealed box or satchel. There should be a tamper evident closure. This will be separate to other stock.
• Stock will need to be checked against the controlled drug requisition book and the delivery note.
• The delivery note must be signed and given to the driver as proof of delivery for the pharmacy.
• Stock should be stored in the controlled drug cupboard ensuring all stock is rotated so that stock with the shortest expiry date is available for first use.
• The controlled drug register should be completed by a qualified member of staff and a witness, ensuring the total balance is correct.
• Any discrepancies should be reported to the clinic or ward manager and the trust controlled drug accountable officer (via the pharmacy department).

5.5.7 Transferring medication between wards

• All transfer of medicines onto the ward and out of the ward must be recorded along with the name of staff involved and the receiving ward in the transfer book on both the source and receiving the ward.
• In exceptional circumstances stock may be transferred between wards and community teams in the following circumstances:
  • out of hours or urgently required items
  • transferring specific medication, for example, clozapine, named patient medication following the transfer of a patient
• There must be only a single transfer book in use at any one time
• The Transfer of Medicines book (DP3628) must be completed on all occasions and must contain:
  • a record of medicines transferred onto the ward AND medicines transferred off the ward
  • the names of both wards involved
  • the date, drug details and quantity
  • a signature from a qualified nurse
• Controlled drugs must not be transferred. Wards should individually dose from another ward while awaiting stock to arrive.

5.5.8 Out of hours

Stock items are available Monday to Friday, refer to contact sheet for relevant hours and cut off times.

Outside of normal hours staff should consider:

• local trust wards for non-controlled drugs stock transfer first, then refer to contact sheet for relevant local pharmacy supplier hours and order via to take out (TTO) paperwork and processes. No delivery service is available, so request will need to be collected
• urgent requests up to 11pm can be handled by the local pharmacy provider, see ward-based procedures for specific location details
• urgent requests after 11pm will be handled through Lloyd’s wholesaler (AAH), see contact sheet for details, this attracts a £300 callout fee

5.5 Standards for the storage of medication

5.5.1 Aim

The aim of this document is to set down the standards for the storage of medication.

5.5.2 Storage of medicines on wards and community teams

• The appointed practitioner and team manager in charge is responsible at all times for the safekeeping of all medicines on their ward or department
• The design and location of all ward or department medicine storage cupboards must be approved by authorised pharmacy staff and regularly monitored, this should be at a minimum on a quarterly basis by pharmacy staff.
• Controlled drugs (CD) schedule 2 and 3 must be stored in a separate designated controlled drug cupboard and recorded in the controlled drug register, the cupboard must be approved by the chief pharmacist.
• All internal and external medicines, disinfectants and re-agents must be stored in locked cupboards, trolleys attached to a wall or other secure cabinets, all reserved solely for medicinal products. The only exceptions to this requirement are medicines for clinical emergencies, intravenous fluids, flammable fluids, medical gasses, sterile topical fluids, nutritional products, and some bulky medicated dressings which, because of their bulk, are stored in a clean area (as agreed between the appointed practitioner in charge and an authorised member of the pharmacy staff).
• Oxygen storage should be in line with trust guidance (is there a link)
• The medicines trolley or computer on wheels (COW) that contain medication may only be removed from its fixings during medicine rounds.
• The nurse in charge of the medicines round should be clearly identifiable and must never leave the drugs trolley unattended at any time. The nurse and administration technician must not be disturbed during the medicine rounds unless there is a dire emergency. In such an emergency the trolley must be locked.
• Internal medicines must be stored separately from other medicines. Under no circumstances must medicines be transferred from one container to another, nor must they be taken out of their container and left loose.
• Patients own medication must be stored separately from stock medications for example, individual K-Bins where these are in use.
• Patients who self-medicate must have access to an approved secure locker and draw to store their medication.
• All medicines in transit must be in a sealed tamper evident container
• Where cold storage of medicines is necessary a lockable, temperature controlled and monitored medicines fridge must be made available, which must be reserved solely for the purpose, other items such as food or samples must not be kept in these.

Where the ward or department holds a supply of medicines for use in a medical emergency this will be held in a tamper evident container. This container need not be kept in a locked cupboard but will be located in an area that is most likely to have a constant staff presence that is not obvious to the public, generally in the treatment room.
On some ward areas (and subject to risk assessment) to enable timely treatment the following medicines can be exempted from locked storage:

• Glyceryl trinitrate (GTN) tablets and spray for the treatment of angina pain (subject to a risk assessment, detailed below)
• inhalers of beta (β) adreno-receptor agonist as bronchodilators (subject to a risk assessment, detailed below)
• Nicotine replacement therapy supplied under a patient group direction (subject to a risk assessment, detailed below)
• Glucagon for the management of hypoglycaemia
• Naloxone for the management of opioid overdose
• Adrenaline for the management of anaphylaxis

Subject to a risk assessment an individual authorised to administer medicines may assess a patient on an inpatient area as suitable to have control of and take this medicine themselves provided the following conditions are met:

• the patient understands what their medicines are for and the how to take them correctly
• suitable safe keeping arrangements are available to prevent misuse by others
• the medicines are labelled with the patient’s name and instructions for use
• a record of the dose and frequency of administration is made on the inpatient drug administration chart

5.6.3 Expiry dates

• All stock must be checked regularly, and the expiry date highlighted when that date is approaching.
• Eye drops must be marked with the date opened and expiry date and disposed of once its expiry has been reached (check individual product for details).
• Insulin must be marked when either a vial or pen has been started, and disposed of, if not already used up, after 28 days.
• Liquids, the date of opening must be marked on the bottle, and it should be disposed of within 3 months or as marked on the container.

5.6.4 Agile working (community)

When agile working any medication stored on trust premises must be in a trust approved area for example, clinic room in line with the above standards. If on the occasional instance where medication is taken home it must be stored securely in line with the storage requirements of that medication, in no circumstances must medications requiring fridge storage (2C to 8C) be stored in a staff members home.

When transporting medication in their car it must be in a secure container, kept out of sight, see transporting medication section. Medicines requiring cold storage must be stored in a trust approved cool box (see transport section).

5.6.5 Temperature monitoring, overview

The trust have implemented a centralised temperature monitoring system in place of staff taking manual temperature readings; the new system takes a temperature reading every 7 and a half minutes.

5.6.5.1 Alarm notifications

Should a fridge or room exceed the set temperature parameters the system will send an alarm notification directly to the team. How a team receives an alarm notification has been discussed and arranged with each team individually therefore please speak to your manager to find out the arrangements for your team.

Generally, if a team has a monitored group email address with its own inbox the team will receive an email notification first. If the notification is not responded to after 30 minutes the team will receive a text to speech phone call to the team’s phone number. If the team does not have a group email address, they will only receive a text to speech.

5.6.5.2 Resolving a notification

Upon receiving the alarm notification staff are to go to the fridge or room to try to resolve the issue, such as close the fridge door or turn on the air conditioning. Some troubleshooting solutions can be found below

5.6.5.2.1 Fridge

• Has the fridge been accidently unplugged or turned off?
• Power cut or generator test.

Fridge door left opened:

• fridge door been opened for long periods of time due to stock take or delivery
• fridge over full air not being allowed to circulate
• fridge not having been reset after last recording was taken
• build-up of ice or water check the back of the fridge behind shelving may need defrosting
• seal around door damaged

5.6.5.2.2 Room

• Turn off any lights that are available to be switched off.
• Open any available windows.
• Check if air con has been switched off if fitted.
• Close any blinds.
• Check if any radiators that are in close proximity are on and if so switch off or down (speak to estates if unsure).
• If there is a fridge in the room consider moving it to a different location, if possible.

Once the issue has been resolved the staff member must log onto the real time system using their team’s username and password to resolve the alarm. A step-by-step guide can be found below.

1. Log onto the real time system.
2. Click on “monitoring” located on the menu on the left-hand side.
3. The click on “notifications”.
4. Here you will see any alarms which have been unacknowledged, those which are acknowledged have been resolved. Find the unacknowledged alarm which related to your fridge or room then click edit.
5. In the first drop-down box select the most appropriate action taken to resolve the temperature excursion.
6. Enter a comment to advise what has taken place to resolve the alarm then enter your name and your phone number.
7. Press save.

If the staff member cannot resolve the issue they must contact pharmacy services for further advice; however, if the fridge is broken then the fridge must be reported to estates via Backtraq (staff access only).

Alarm notifications must be responded to on the same day, if the notification occurs outside of working hours, then the notification must be responded to on the next working day.

Staff are to log onto the real time system once a week to check their fridge and, or room temperatures are okay and running within temperature. Each team has access to their own team username and pass

5.6.6 Medicines storage room ambient temperature monitoring

Unless stated otherwise in product literature and on labels the majority of medicinal products, that do not require refrigeration, can be stored under conditions of controlled room temperature without compromise to their stability and recommended shelf life. These products are usually labelled “do not store above 25C”.

The room temperature is monitored via the centralised temperature monitoring system.

If the temperature reaches above 26C for more than 7 days, contact pharmacy services for medicines advice in regard to opened liquids. At this temperature and for a short duration tablets, powders and capsules should be stable.

Request a visit from the pharmacy team to review the options available to mitigate against this problem if this is likely to be a long term problem.

In the event of a break in monitoring for a prolonged period, the maximum and minimum must be checked via the centralised temperature monitoring system and pharmacy contacted if this is out of range.

Complete an incident form in regard to the temperature of the area, and the medicines affected.

The pharmacy team can advise on any changes of expiry due to excessive temperature

5.6.7 Drugs fridges

• Medicines that require refrigeration should be stored in an approved medicines fridge, which must be used solely for the storage of medicines requiring refrigeration.
• The fridge must be connected to the electricity supply in such a manner that does not allow accidental disconnection, for example, attached by a spur to the mains electricity supply or with a cover over the switch.
• Medicines must never be stored in the kitchen fridge.
• The medicines fridge temperature should be within 2C to 8C.
• Pharmacy team or estates must be contacted if there is a problem (area specific).

5.6.8 Siting of cupboards or trolleys

Cupboards and trolleys must be sited where most convenient for staff, whilst also allowing adequate space and permitting surveillance to afford maximum security against unauthorised entry. Medicine cupboards will generally not be sited where they may be subjected to higher than average humidity or temperature. Re-agent cabinets, were used, must be sited in area where testing is carried out.

5.6.9 Controlled drugs cupboards

No ward or department must store controlled drug unless there is an appointed practitioner in charge responsible for their storage and use. Controlled drug cupboards must be reserved solely for the storage of controlled drug and be secured to the wall.

These cupboards may be separate from others or inside other locked medicines cupboards used to store internal medicines. Keys should be kept with the other drugs keys, although some wards may keep them in a locked key safe.

See standard operating procedures (SOP) for location specific guidance.

5.6.10 Community services (patients own medication)

In the community services, the storage of patient’s own medication in their own home, (including controlled drugs) remains the service user’s responsibility, except new beginnings where storage is maintained on patient’s behalf. However, where appropriate, professionals should advise on good storage practice, and be mindful of the patient’s circumstances when delivering medication.

Patient’s medication no longer needed in the community. In the first instance they should be encouraged to take it to their local pharmacy for disposal, if it is brought back to base it should be recorded, and disposed of in approved pharmaceutical waste containers

5.6.11 Custody and safe keeping of medicine

5.6.11.1 Keys for medicine cupboards, medicine trolleys and drug fridges

• Keys for the external medicine cupboard, internal medicine cupboard, medicine trolley, medicine refrigerator must be kept together on one key ring reserved solely for these keys. The keys must be clearly identified.
• The keys must be kept on the person of a ward or team manager, in the event of no designated practitioner being on duty in a ward or unit; the keys must be handed to a designated practitioner on a ward or unit in the near vicinity. This information must be made known to the staff on both wards. Where medicines administration is by pharmacy technicians, then they may hold the keys to allow them access.
• In a community setting the keys may be held by non-nursing staff, as long as they are authorised by the team leader.
• The key must never leave the ward or unit or be left unattended. The designated practitioner should carry them at all times. The only exception being when the designated person is covering for more than one area.
• No other person should have access to the medicine cupboards except in the presence of the key holders, except authorised pharmacy staff for the purpose of stock control.
• At community team bases where a number of designated practitioners may require access to the medicine cupboards at different times a secure system must be agreed between the assigned practitioner in charge and the locality pharmacist.
• Keys must not be handed over to medical staff or other non-key holders
• Lost keys must be reported immediately to the ward and department manager. In the event that the keys cannot be found, all locks must be changed immediately.
• Spare keys may be kept, with agreement in a neighbouring ward, normally in the controlled drug cupboard, clearly labelled and accessible only by qualified staff.

5.6.11.2 Keys to the controlled drugs cupboard

• The controlled drug cupboard key must be kept on the person of the assigned practitioner in charge or designated practitioner nominated by them.
• Responsibility remains with the assigned practitioner in charge.
• No practitioner can have access to the controlled drug cupboard except with the agreement of the practitioner in charge, officially holding the key. The key must not be handed over to medical staff.
• Authorised pharmacy staff may have access to the controlled drug cupboard key for the purpose of performing statutory checks.
• In the event of the person in charge being inappropriately qualified, the key must be handed to an assigned practitioner in charge of a ward or department in the near vicinity. The information must be made known to staff in both the ward and department and to the manager in charge of that section.

5.6.11.3 Re-agent cupboard keys

The key to the re-agent cupboard will be kept separately and, in a place, designated by the appointed practitioner in charge.

5.6.12 Containers for storage of medicines

Pharmacy does not re-use plastic or glass bottles. When empty, plastic bottles may be disposed of in the normal rubbish bags. Oral, non-toxic liquids may be returned to pharmacy. Empty glass bottles may be disposed of in the usual way. Child resistant containers (CRCs) are used routinely on discharge items. If a member of the ward staff feels that child resistant container’s would be difficult for the patient to open they should contact the supplying pharmacy to discuss suitable alternatives.

5.7 Standards for the transport of medication

5.7.1 Aim

The aim of this document is to set down the standards for the transport of medication.

5.7.2 Transport within wards and departments

Medicines may only be transported by trust staff authorised staff or contractors of supplying trusts. No medicines are to be left unattended at any time during transportation.

5.7.3 Transport of medicines between health services premises

Medicines accompanying a patient who is being transferred to another hospital or unit may be transported with the patient in the ambulance, taxi, or other form of transport. It is important that the medicines are packaged securely and labelled with the final destination. The medication is the responsibility of the accompanying staff during this time.

5.7.4 Transportation of medicines from the supplying pharmacy

• All medicines will be transported in locked tamper evident containers.
• On arrival at the ward or department they will be left in a secure designated area or room.
• Delivery vans carrying medicines must not be externally distinguished from other health service vans.
• Delivery vans must not carry any unauthorised passengers.
• Delivery vans are to be locked when unoccupied.
• Once delivered to the ward or department the responsibility for the security of the medicines rest with the practitioner in charge, or nominated deputy who will unpack the contents, check them against the delivery note, and store them appropriately.

5.7.5 Transportation by taxi

Taxis should not routinely be used for the transportation of medicines; however, if an emergency arises and there is no alternative staff should:

• use a hospital contract taxi
• check the driver’s identification
• make sure the medication is in a tamper evident container
• contact the address to which the medication is to be delivered to let them know what time the taxi left with the medication and request that they confirm receipt either by phone or email

5.7.6 Transport of medicines to patients at home

• Discharge or leave medicines may be transported home by the patient or their carer.
• Patients who leave the hospital or unit before all their medicines have been dispensed should be instructed to return later to collect them.
• The transport of medicines to a patient’s home at other times must be authorised by the practitioner in charge of the ward or department.

5.7.7 Transport of patients medicines by community staff

Medicines may be carried by community staff in relation to their role. This will include medication:

• required for emergency treatment.
• to be administered via a patient group directive (PGD)
• to be administered against a prescription, for example, a “to take out” (TTO)
• a letter of authorisation, or similar

Where staff are going to a patient’s home to administer the medication, such as a long-acting injection, they must have the authorisation to administer along with them, such as the electronic depot card. Community nurses may carry stock drugs, needed to carry out their jobs, such as dressings, adrenaline, and medication for PGD’s.

The security of medicines issued to community based or visiting staff will be the responsibility of the individual authorised to administer or prescriber to whom they are issued.

Upon delivery all medicines will be stored away from public access and in a locked container. Except when carried by the individual authorised to administer or a prescriber the container will be kept locked and out of sight at all times, for example, in the boot of their car.

Staff who are not registered nurses may deliver medication to a patient for self-administration.

Staff delivering medication to a patient’s home should record this in the clinical record, ideally getting the patient to sign for it.

In the unusual event staff remove medication from the patient’s home; this must be signed for by the patient and a record made in their clinical record.

Where getting a patient’s signature is impractical, a contemporaneous record in the notes noting their agreement.

In the event that the patient is not at home to receive the medication it is to be returned to the medicine cabinet in the team base. Under no circumstances are staff to post the medication through the patient’s letterbox. Where agile working occurs in exceptional circumstances the medication may be kept by the practitioner. The practitioner is responsible for its security at home, and it must under no circumstances be left in the car. Refrigerated items must be returned to their team’s base.

Staff must always endeavour to return to their team’s base at the end of their working day to return any unused medication; however, in exceptional cases medication may be taken home, to allow for agile working. This does not include medication such as to take out’s from a ward, in these situations it must be agreed by the team manager, and the medicine must be stored securely at home out of the reach of children and others, ideally in a locked case such as a briefcase.

Items requiring refrigeration, for example, vaccines, must be carried in a Trust approved cool box and stored in a temperature monitored location when at the team’s base. The temperature to be monitored during transport and recorded.

In situations where there is excessive temperature (26C and above), then the pharmacy team should be contacted for advice around shortening shelf lives.

5.8 Standards for disposal of medication that is no longer required including ward closures

5.8.1 Aim

The aim of this document is to set down the standards for disposal of medication that is no longer required including ward closures.

5.8.2 Disposal of non-controlled drugs

Any medicines, which are no longer required by the ward or department, are to be disposed of in the pharmaceutical waste bin, provided for the purpose.

5.8.2.1 Cytotoxic or cytostatic drugs

These must be disposed of in the purple lidded pharmaceutical waste bin. A list of these drugs can be found in the treatment rooms. This can be found on the medicines management intranet page. They are also identified by SystmOne on the medication chart.

5.8.3 Disposal of controlled drugs (CD)

5.8.3.1 Stock

• Controlled drugs must not be returned by wards or departments.
• Where they are no longer required, they must be removed by authorised pharmacy staff. Upon removal of the controlled drug, the authorised member of the pharmacy staff will enter the appropriate stock balance and sign the controlled drug register. The transaction must be witnessed by a designated practitioner who will also sign the register. The drugs must remain securely stored in the controlled drug cupboard prior to their removal.
• Patients own, inpatients: where they have been held by the ward and are no longer required the same guidance as stock must be followed along with an entry in the clinical record.
• Patients own community:
  • for community services the destruction of controlled drugs and unknown substances by pharmacy services staff SOP must be followed, and the form completed
  • in the first instance the patient or carer should be advised to take the medication to their supplying pharmacy
  • staff with written permission, removal of patents own drugs form (staff access only), take the medication to the supplying pharmacy, this should be fully documented, and consent sought
  • medication can be brought back to the trust, pharmacy department for disposal. In this case permission must be gained and documented in the clinical record. This should only be done during working hours, please note that this should be the exception and, we do not have facilities for the destruction of controlled drugs

5.8.3.2 Care homes

• Where community nurses are supporting the care of a patient in a care home, for example, maintaining a syringe driver and the patient dies, the following process must be followed:
  • all medications are to remain at the care home for 7 days
  • where staff have been administering the medication, for example, syringe driver set up, a final balance should be checked and recorded in the patients S1 record
  • if the care home is a residential home, then the home makes arrangements for them to be collected by or taken to their pharmacy for destruction

If the care home is a nursing home, it is the responsibility of the home to destroy and dispose of them.

5.8.4 Disposal of patients own medication

5.8.4.1 Inpatients

Any medication brought into hospital by a patient is their property and as such cannot be destroyed without their permission. In the event that the patient agrees to the destruction of the medication it is to be placed in the pharmaceutical waste bin. All medicines should be recorded in the destruction of medication book which is held by wards.

If the patient or carer refuses to agree to the disposal of the medicines, this can either:

• be recorded in the patient’s clinical records and held in a sealed bag in a separate section of the medicine’s cupboard from all other stock until they can be returned to the patient on discharge
• or if the patient insists be returned home, however, the patient and or their carer or relative must be advised that as the treatment regime will be reviewed whilst the patient is on the ward, it is likely that the supplied discharge medication will be different, and this poses a real risk that the wrong medication may be taken in future

Where patients lack capacity, this should be documented, and a best interest decision made.

If there are safety concerns in relation to the medication being returned home, then the nurse in charge is to consult with the consultant in charge of the patient’s care. The consultant then may make a decision to refuse to return the medicines and have them destroyed. For the safe disposal of any medicines staff should refer to the guidelines issued by their supplying pharmacy.

5.8.4.2 Community

Where excess medication is identified it is recommended that the patient or carer is advised to dispose of the medication at their local pharmacy.

In the rare case where the practitioner believes this will not occur and that this poses a significant risk then they should contact their manager for guidance and document any conversations in the clinical record. Staff should take into account capacity and risk, ultimately the medication belongs to the patient. Where this may indicate poor compliance, the prescriber or patients GP should be contacted, with a view to altering the repeat prescription.

5.8.5 Ward closures

5.8.5.1 Temporary or routine ward or department closures

Where a ward or department is closed for any reason for up to 7 days the responsible person will ensure that all medicines are appropriately stored in cupboards as agreed by the chief pharmacist.

The individual in charge at the time of such a closure will be responsible for ensuring the medication keys are stored in a secure place which has been agreed as suitable between the responsible person and the trust lead pharmacist.

Wherever possible, the doors to the ward or department will be kept locked during the period of closure.

5.8.5.2 Permanent closure of a ward or department for longer than 7 days

The management team will be responsible for notifying the trust chief pharmacist of the permanent closure.

The trust chief pharmacist will then be responsible for arranging the return and credit of disposal (as appropriate) of all medicines stocked on the ward or department. Relevant registers will be stored as per trust records management policy.

5.8.6 Removal of and disposal of unknown substances

Unknown substance may be illicit in nature and in accordance with its duties under the Misuse of Drugs Act. The trust does not knowingly permit the use of or dealing in illicit substances on its premises. In the event that staff become aware of someone on the premises having an unknown substance on them, they should follow the guidance as detailed below.

5.8.6.1 Action if a visitor is in possession of an unknown substance

• If any visitors are seen to be in possession of a suspected illicit substance, they will be asked to leave the premises.
• If any visitor is seen or suspected to have passed illicit substances to a patient or other visitor, they will be asked to leave. The nurse in charge of the ward will then consult with the modern matron about the need to report the matter to the police, and bar any further visits by the person concerned (please refer to the trust’s drug misuse on trust premises policy).

5.8.6.2 Action if a patient is in possession of an unknown substance

• In the event that it is a patient who is suspected to have illicit substances on them the nurse in charge of the ward will discuss their suspicions with them and ask that they voluntarily hand over the substance for destruction.
• If the person refuses then a discussion with the manager must occur, and a decision on whether to involve security or the police made.

This discussion must be held in the company of another staff member and this staff member must witness the actions of the nurse in charge once the substance has been handed over. Pharmacy should then be contacted who will destroy the substance in line with the destruction of controlled drugs and unknown substances by pharmacy services staff procedure.

5.9 Standards for leave and discharge medication

5.9.1 Aim

The aim of this document is to set down the standards for leave and discharge medication.

5.9.2 Responsibilities

Prescribers are responsible for ensuring that any to take out (TTO) are written in a timely manner and the nurse in charge of the ward is responsible for these being received by the pharmacy in sufficient time for the medicines to be dispensed and returned to the ward.

Ideally, this should be 24 hours prior to any period of leave or the discharge of a patient so that the medication will be available when the patient is ready to leave. Requests for monitored dosage systems may take up to 48 hours to be turned around.

These prescriptions can be authorised in one of three ways:

• an instruction, written in ink, signed, and dated by a prescriber, on a trust prescription form
• a computerised prescription held on a trust approved computerised prescribing system, entered by a prescriber, and validated by password controlled electronic signature, and then signed in ink, this should then be scanned in and emailed to the pharmacy, and the original sent to the supplying pharmacy
• a patient group direction (PGD), approved by the trust

The trust Inpatient standard operating procedures or patient group direction must be followed when writing these prescriptions:

• all when required (PRN) prescriptions must be reviewed prior to prescriptions being generated to assess for continued need. Where this is required, the quantity needed must be stated, and a review period should be included in the discharge paperwork
• patients who are being discharged will usually receive a minimum of 14 days’ supply of medication from pharmacy. This should allow sufficient time for the discharge letter to reach the general practitioner (GP). If for clinical reasons fewer days are supplied, for example, risk of overdose the GP must be informed
• a patient information leaflet must be supplied with each medicine

Note, registered nurses must not dispense drugs for patients to take home from ward stock.

All to take out’s (TTOs) coming into a ward or department shall be received by a designated practitioner, or authorised person who must:

• check them against the medicine card, leave card or to take out form to confirm that all details are correct, for example, name, medicine, dose, and directions
• lock them in the medicines cupboard immediately
• where they contain controlled drugs (CD), these must be recorded in the back of the controlled drug register and stored in the controlled drug cupboard until given the patient or carer
• report any discrepancies to the supplying pharmacy immediately

It is extremely important that the patient receives adequate information about their medicines prior to discharge.

The patient should know the purpose of the medicine; how to take it, how long it is to be taken for, and what side effects they may experience. This is the responsibility of the designated practitioner (named nurse or deputy), who may choose to involve authorised pharmacy staff in this process. It is the responsibility of the designated practitioner who discharges the patient from the hospital to confirm with the patient that they have received adequate information. Any information communicated verbally must be backed up and supported by an appropriate leaflet.

A record should be made in the clinical record of what has been given along with any additional information, such as any storage requirements or medication guide.

5.9.3 Controlled drugs to take out’s

Controlled drugs should be ordered in the same way as to take out’s (TTOs) and must conform to the legal requirements and be written in full, which has been personally completed by a prescriber in accordance with legal requirements:

• patient’s name, address, and unit number
• the drug name (controlled drug band name where appropriate), dose and directions
• the form (tablets, liquid)
• the total quantity to be dispensed in words and figures.
• signed and dated by the prescriber, the original printed and signed prescription must be sent to pharmacy for dispensing

5.9.4 Medication on transfer between trust wards

When patients are transferred between ward, the receiving ward must be contacted to ascertain any medication that will need to be transferred with them.

• Named patient medication, including fridge items, and medication carried by the patient, for example, inhalers.
• Stock (original boxes only) if the receiving ward does not carry it.
• Controlled drugs:
  • named patient can be transferred
  • stock cannot be transferred, consider creating a “to take out” (TTO) if transfer planned

All medication should be put in the medication transfer book, named patient controlled drugs need to be signed out of the register in line with the controlled drugs (with the exception of trust physical health community services) procedure.

5.10 Standards for medicines related incidents

5.10.1 Aim

The aim of this document is to set down the standards for medicines related incidents.

The purpose of the policy is to engender a safe approach to the supply, storage, use and administration of medicines.

5.10.2 Definition of a medication incident or error

A medication error is a preventable incident associated with the user of medicines, which may lead to patient harm. Such incidents may be related to any of the steps of the medicines process of the medication user, the following is a list of common, but not exhaustive examples.

5.10.3 Types of medication errors

5.10.3.1 Prescribing errors

• Omission of regularly prescribed medication.
• Drug or dose selection.
• Route or time of administration.
• Illegible or incomplete prescriptions.

5.10.3.2 Dispensing errors (supply)

• Wrong drug.
• Wrong dose.
• Wrong quantity.
• Wrong formulation.
• Unavailability of dose for administration at scheduled time.
• Dispensing out of date drug.
• Dispensing an incorrectly formulated drug.
• Absence of patient information leaflets in to take out (TTO) medications.

5.10.3.3 Administration errors

• Administering the drug to the wrong patient.
• Administering the wrong drug.
• Administering the wrong dose.
• Administering the drug at the wrong rate.
• Administering via the wrong route.
• Administering the drug at the wrong time.
• Non-justifiable omission of the dose.
• Administering an out of date drug.
• Administering an incorrectly formulated drug.

5.10.4 Patient care when an error occurs

5.10.4.1 Patient counselling

Failure to counsel a patient on the accurate use of their medicines.

5.10.4.2 Patient monitoring

Failure to monitor the appropriate patient parameters, to ensure the safe and effective use of a drug.

Dispensing errors, for example, errors in the supply of a medication to the ward or department should also be reported directly to the relevant pharmacy.

Errors are often made under pressure of work, or by failure to follow policies. It is essential that an atmosphere of openness prevail so that staff who realise any mistakes feel able to report them to avoid any detrimental effects on patients.

5.10.5 Action to take if an error occurs

The staff member who discovers the error must:

• maintain the patients safety
• inform the appropriate prescriber and seek advice on any action required
• review the patient’s care plan in light of any advice given
• report the error to the service manager or modern matron
• the relevant prescriber’s line manager (or on call cover) is responsible for dealing with prescribing errors concerning the patient. Errors must be discussed with the manager with the knowledge of the prescriber. The manager should discuss significant prescribing errors with the prescriber and the clinical pharmacist. Supporting statements will be required from the staff concerned. The EDMET tool (staff access only) should be used to help review the error and can be used as a record to review both prescribing and administration errors
• in the event of administration errors either as a result of a prescribing or administration error, the patient should be informed and offered reassurance. In the event that the patient has a condition which impairs their cognitive or intellectual functions, the doctor in charge of their care will be consulted so that a decision can be made about informing them and, or their relatives or carers of the error
• report the error using the trust’s electronic reporting system (IR1) giving details of the incident, immediate action taken, and any factors which may have contributed to the error
• if it is a dispensing error the trust chief pharmacist or nominated deputy will investigate and supporting statements will be required from all staff concerned in the event that the patient, relative or carer are dissatisfied with the outcome of the incident and the trust’s listening and responding to concerns and complaints policy will be followed

5.10.6 How the organisation learns from medication incidents

All medication incidents and near misses will be subject to review by the trust’s Pharmacy team. Themes and lessons learned from serious incidents (SIs) will be reviewed in the Medicines Management Committee (MMC) and will inform the medicines management training and policy review.

Each month all medicines related incidents are reviewed by the pharmacy team and the trusts’ medication safety officer (MSO), and a synopsis presented to the Medicines Management Committee. These are then presented to the care group governance meetings for further dissemination. All patient safety incidents will be shared with the trusts Patient Safety Response Framework (PSIRF) team to ensure that there is learning shared from all incidents.

5.10.7 Investigation of drug discrepancy or loss occurring in the hospital or community

It is acknowledged that in the community setting prescribed drugs are owned by the patient; however the following will apply throughout the trust.

Any knowledge or suspicion of drug loss or discrepancy of drugs, for which the staff member is responsible for administering and recording the balance of, must be reported immediately to the responsible person, and pharmacy team and their line manager. Discretion must apply in all instances.

Where an incident is due to suspected theft or burglary by a person external to the trust, staff will refer to the security manager and the police must be informed.

In all cases an incident form should be completed as per trust incident management policy.

The Pharmacy team will liaise with the relevant manager and investigate accordingly.

5.11 Standards for the management of controlled stationary related to medicines

5.11.1 Aim

The aim of this document is to set down the standards for the management of controlled stationary related to medicine.

5.11.2 Definition

The following documents are considered controlled stationary:

• inpatient drug charts
• discharge or leave forms
• community drug charts, including depot cards
• controlled order and record books
• invoices
• inpatient stock or nonstock order pads
• FP10 (NHS prescription) or FP10NC (NHS prescription, non-computerised) or FP10SS (NHS prescription, single sheet) and F10MDA (medication dispensing authority) forms

Documentation should be kept securely, so only limited authorised staff have access.

Where more than one pad or book exists it should be clear which is in current use. Only one pad or book should be in use at a time

The responsible person will ensure that all controlled stationery on the ward, department or base point is held securely.

Any loss or theft of any item of controlled stationery will be reported to the responsible person for the ward or department and their line manager, and to the trust chief pharmacist at the earliest opportunity. An incident form (IR1) must be completed.

5.11.3 Retention of documents

The healthcare record keeping policy must be adhered to.

5.11.4 Prescription pads

Prescribers seeing patients in the community will have access to a supply of FP10s (NHS prescriptions) which are written by prescribers employed by the trust but dispensed by a community pharmacy rather than hospital pharmacies.

Controlled stationery in relation to prescribing includes blank FP10NC (NHS prescription, non-computerised), FP10MDA (medication dispensing authority) and FP10SS (NHS prescription, single sheet) prescriptions, prescription stamps and prescription order forms.

Ordering of blank prescriptions can only be undertaken by authorised personnel and must be ordered from the appropriate supplier.

• They are classed as controlled stationary.
• Must be signed for when ordered by administrative staff.
• Prescription numbers must be recorded, see section 8 for computer generated prescriptions.
• Locked away securely with restricted access.
• A record of receipt must be maintained.
• When issued to individual prescribers they must be signed for and a record kept including the prescription numbers.
• Prescribers should keep them in a manner so that they are secure when not in use, and should only carry sufficient that would be required at any point in time.
• Prescriptions must be visible in the patients record. If this is a handwritten prescription, a record of all team prescriptions issued must be maintained on the FP10 tracker and in the patients record. The prescription can be scanned onto the patient record.
• In substance misuse services where prescription printing software is in use, access to these systems must be secure.
• Where prescriptions are spoilt, they must be marked void, a record made before being securely shredded.
• This is a two-person process.

5.11.5 Issuing FP10 prescriptions

Prescriptions once generated may be issued in one of the following ways:

• directly to the patient or representative
• recorded delivery to the patient’s address
• by staff to the community pharmacy
• collection by the pharmacy staff
• sent electronically using SystmOne by electronic transfer of prescription protocol

In all situations staff must be satisfied of the authorisation of any carrier and identification must be sought. A record of all prescriptions issued from a team prescription pad must be maintained on the FP10 tracker and in the patient record.

5.11.6 Prescribers leaving the trust or moving departments

When a prescriber moves jobs, they should return any existing prescription pads they have to the administrative staff. A cease to prescribe form must be completed, this can be found within the non-medical prescribing policy.

5.11.7 Computer generated FP10’s (paper versions)

• Ensure that the prescriptions are stored securely. They must not be stored in a printer overnight and must be returned to the secure location.
• When loading the printer with the prescriptions make a note of the serial number of the first prescription.
• When removing the unused prescriptions make a record of the serial number of the next prescription.

5.11.8 Lost prescription pads

In the event of a lost or stolen prescription or prescription pad all prescribers should:

• inform their line manager the same day
• complete an incident form (IR1)
• inform the chief pharmacist or medical director who will alert all pharmacies and liaise with the police and the prescribing pricing authority providing information including serial numbers
• the prescriber will be advised to write all prescriptions in red ink for the next 2 months

If the loss occurs out of hours contact the out of hours on call director and implement the following procedure:

• notify the police
• staff would then follow the in hours process on the first routine working day, this action should be completed by the manager to whom this has been reported to

5.11.9 Standard operating procedure for FP10’s (prescriptions)

All areas should have a specific standard operating procedure for managing these prescriptions, which will contain the details on how these standards will be carried out. Please refer to the following links depending on the area of work.

5.12 Standards for medicines safety

5.12.1 Aim

The aim of this document is to set down the standards medicines safety.

5.12.2 Medicines safety

The Medicines and Healthcare Products Regulatory Agency (MHRA) issue a regular drug safety alert monthly electronic bulletin bringing information and clinical advice about the safe use of medicines. These Alerts are reviewed by the Medicines Management Committee (MMC) and appropriate recommendation made; they are then circulated to all prescribers for information. It is intended for all healthcare professionals who work in the UK, doctors, pharmacists, nurses, dentists, allied health professionals, and coroners. The Medicines and Healthcare products Regulatory Agency is the government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

All staff (including self-employed staff contracted to work within trust provided services) should follow best practice detailed in Medicines and Healthcare products Regulatory Agency alerts and reports.

CAS alerts are assessed by pharmacy for relevance and circulated to the relevant teams for action; this is reported on by regular audit.

5.12.3 Adverse drug reactions

Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Prescribers, pharmacist and nurses are urged to help by reporting adverse reactions to the Medicines and Healthcare Products Regulatory Agency (MHRA) on pre-paid yellow forms, which are available in the British National Formulary (BNF) or on the British National Formulary.

The British National Formulary also provides further detail on the type of medicines and type of reactions, which should be reported (staff can also refer to appendix E of the safe and secure handling of medicines manual for further details). If the reporter of the adverse effect is not the lead clinician, they must be made aware of the problem and the clinical record updated accordingly.

5.12.4 Medicine defect reporting

Medicines may be considered defective for two principal reasons:

• physical defects caused by damage or contamination noted by an individual handling the medicine at any point in the medicines trail
• efficacy defects caused by reactions that in the judgment of a professional caring for the patients concerned indicate an unexpected response

Within the trust the following procedure applies when a defect is found or is suspected in any medicine:

• inform the supplying pharmacy who will advise on all reporting, recording and investigating on the defect
• retain any remaining product and any associated products or equipment (for example, administration sets, infusion devices and so on.) and clearly mark it “Defective: not for use”
• notify the chief pharmacist who is responsible for formally reporting all defective medicines to the authorities, the manufacturer concerned, and other wards and departments as necessary. In addition to this the chief pharmacist is also responsible for:
  • the retention of suspected defective medicines for analysis, return or impounding
  • recall to the pharmacy department of all potentially defective medicines
  • the dissemination of information relating to potentially defective medicines within the trust
• complete an electronic IR1 report, recording details of the product and defect
• if the product has been administered to a patient, inform the doctor responsible for them and record the defects in the patient’s clinical record
• report the incident to the appointed practitioner in charge

Suspected defective medicinal products are notifiable by doctors and pharmacists to:

The Adverse Incident Centre

The Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
2 or 2G Market Towers
1 Nine Elms Lane
London SW8 5NQ

5.12.5 Drug alerts, recalls and safety notices

The Medicines Health Care Regulatory Authority (MHRA) is responsible for informing trusts and primary care providers of product defects, which may have implications on a wider, sometimes national, scale. Such notification will then be circulated to trust units by their supplying pharmacy.

All such notifications received must be immediately brought to the attention of the assigned practitioner in charge, or member of healthcare staff in charge of the unit.

The staff member in charge must follow the instructions received regarding the identification and withdrawal of the defective product and bring any withdrawn medicines to the attention of the ward or unit pharmacist or other authorised pharmacy staff.

A record of the action taken must be made in the ward or unit 24-hour report.

5.13 Medicines reconciliation and allergy status

5.13.1 Introduction

Please see the inpatient standard operating procedures (staff access only) for how to record a medicines reconciliation and an allergy status within a clinical record.

This guidance forms part of the safe and secure handling of medicines manual.

In 2015, the National Institute for Health and Care Excellence (NICE) published guidance NG5 medicines optimisation that states when patients move between care settings, and the receiving team have prescribing or administration roles, then a medicines reconciliation should occur.

Medicines reconciliation will help ensure that all intended medication is given, all unintended medication is avoided, and the information transferred is accurate and contemporaneous.

5.13.2 Aim of the medicines reconciliation process

• To obtain and verify an accurate medication history for all patients on admission to a service.
• To maintain a contemporaneous record of current medicines and the reasons for addition, discontinuation, or alteration of the patient’s medicines during the inpatient stay.
• To provide accurate information of current medicines prescribed, including any changes, upon transfer of care for example, to the GP (general practitioner) upon discharge.
• Definition of medicines reconciliation.
• The National Prescribing Centre defines medicines reconciliation as:
  • collecting information on medication history (prior to admission) using the most recent and accurate sources of information to create a full and current list of medicines, for example, GP repeat prescribing record supplemented by information from the patient and carer
  • checking or verifying this list against the current inpatient prescription and summary care record and administration record in the hospital, ensuring any discrepancies are accounted for and actioned appropriately
  • communicating through appropriate documentation, any changes, omissions, and discrepancies.
• In the community the reconciliation process should also indicate clearly who is responsible for prescribing the medication.

5.13.3 Summary of roles and responsibilities

5.13.3.1 Role of the prescriber (to include medical staff and non-medical prescribers)

• To take a full, accurate medication history at the point of assessment on admission to the ward or team.
• To communicate with the patient or carer with regard to their usual medicines to ensure there are no discrepancies between the information obtained from the information sources and the patient or carer.
• To establish an allergy status and record this on the medication chart and on the alert sheet in the medical notes as documented in the overarching safe and secure handling of medicines manual.
• Only prescribe once the medication history is complete and accurate as to the persons current medication, doing so without this information is potentially hazardous.
• To complete and document the medication history with the information obtained.
• To document the reasons for any alteration in dose or frequency or for discontinuation of medication on admission on the medication history.
• To maintain an accurate, contemporaneous record for the addition, discontinuation and alteration of any medicines during the patient’s inpatient stay.
• To document any changes, discontinuations and additions of medicines on the patient’s discharge summary sheet.

5.13.3.2 Role of the pharmacist

• To verify that the medicines reconciliation process has been undertaken by the prescriber as soon as possible after the patient’s admission to hospital.
• To ensure the medication history appears complete and clinically coherent.
• To ensure the medication written on the current inpatient prescription and administration record matches that of the medication history, where appropriate.
• To ensure any discrepancies are documented appropriately in the patients record.
• To clarify any undocumented discrepancies with the prescriber.
• To verify the current medication chart, and highlight any discrepancies to the prescriber, and ward staff.
• To confirm and document allergy status, where appropriate.
• Where recorded allergies are thought to be inaccurate as request to mark in error should be made outlining the rationale.

5.13.3.3 Role of the ward based pharmacy technician

• To facilitate the medicines reconciliation process by establishing a medication history using appropriate resources in collaboration with a pharmacist.
• To record any additional information obtained on the treatment sheet.
• To inform the pharmacist, or prescriber where appropriate, of any discrepancies detected.
• To confirm and document allergy status, where appropriate.

5.13.3.4 Role of the nursing staff

• To highlight to a member of the medical or pharmacy team if they recognise any discrepancies between the inpatient prescription and administration record or and the patient’s regular medication.
• To ensure any information obtained is documented in the patient record.
• To ensure allergy status has been confirmed and documented in the allergy section of SystmOne prior to the administration of any medicines (unless in an emergency situation).
• To ensure any medicines prescribed are appropriate, after considering any allergy statuses.

5.13.3.5 Role of community team members (key worker)

• To take a full, accurate medication history at the point of assessment on admission to the team, for the patients under their care.
• To highlight to a member of the medical or pharmacy team if they recognise any discrepancies between what the record shows and what the patient is actually taking.
• To ensure any information obtained is documented in the clinical record.
• To ensure allergy status has been confirmed and documented in the clinical record, prior to medication being administered.
• To ensure any medicines prescribed are appropriate, after considering any allergy statuses.

5.13.4 The medicines reconciliation process

5.13.4.1 Sources of information

• Obtaining a full, accurate medication history requires access to one or more of the following sources:
  • referral letter from primary care
  • repeat prescription sheet from the patient
  • electronic medication record from the GP practice
  • GP surgery
  • community pharmacy
  • nursing home medication administration record (MAR sheet), care home and residential home
  • patient’s relative and carer
  • transfer from another unit or hospital
  • recent hospital discharge letter and prescription chart
  • patient’s own drugs
  • patient
• In addition to using the sources listed above to identify prescribed medicines, the patient, relative or carer should be questioned in regard to over the counter medicines and alternative therapies they may be taking.
• It is important to establish if there are any discrepancies between the information obtained independently to the patient and the information that the patient delivers. Ideally, more than one information source should be used to obtain an accurate medication history.

5.13.4.2 Recording the medication history

This must be recorded on the appropriate section on SystmOne, please see the medicines reconciliation procedures (staff access only).

5.13.4.3 Recording the medication history on admission

Complete the medication history with:

• date of admission
• source of information using appropriate codes
• full name of the medicine and the formulation, for example, tablet, capsule, modified release preparation
• dose, frequency, and route
• sign and date the entry
• if any of the patient’s current medication is to be discontinued or altered on admission (for example, if the reason for admission is medication related), this should be documented with the reason for discontinuation or alteration and the entry signed and dated
• who is responsible for prescribing the medication?

5.13.4.4 Recording the medication changes during a patient episode

All medicines that are discontinued or altered during the course of the patient’s episode should have the reason for this recorded in the clinical record.

5.13.4.5 Communicating medication changes at discharge or transfer

All significant changes to the medication that has occurred during a period of care, this includes outpatients settings, including medicines stopped on admission, must be recorded on the discharge summary, including allergy and sensitivity status, with reasons for those changes.

A discussion about sending a copy of the discharge letter, to the patient’s community pharmacy, should be had with the patient.

5.13.4.6 Frequency of review

This should occur on admission to teams and wards, and in the case of community teams this should be updated each time medication is changed, and at least annually at the point of their annual review. Community patients should be reviewed on admission to services, and ideally annually.

5.13.5 Allergy status

The prescriber retains the principal responsibility for ascertaining allergy status of any patient for whom they prescribe. However, it is the responsibility of every person involved in the medication process, prescribing, dispensing or administration, to take every practical step to establish the allergy status of the patient. The only exception to this is in an emergency situation where this information is unobtainable and the risk of not treating the patient outweighs the risk of having the information needed to make a fully informed decision. It must be recognised that prescribing and administering medicines without establishing allergy status is potentially hazardous.

5.13.5.1 Assessment

Take a history and undertake a clinical examination, using the guideline to help ascertain likelihood of it being an allergy. Please see appendix F of the safe and secure handling of medicines manual.

Documenting and sharing of information with other healthcare professionals.

5.13.5.2 Record in their notes, and drug chart as

• Drug allergy and hypersensitivity.
• None Known Drug Allergy (NKDA).
• Unable to ascertain (must be documented as soon as information is available).

5.13.5.3 If an allergy has been documented include (where information is available)

• Drug name (generic and brand if known).
• Signs, symptoms, and severity.
• Date when it occurred.

5.13.5.4 New allergies identified whilst under our care.

• Drug name, generic and brand, strength, and formulation.
• A description of the reaction.
• Indication of the drug.
• Date and time of reaction.
• Number of doses or days prior to reaction.
• Route of administration.
• Which drug and classes of drugs to avoid in the future.

5.13.5.5 Maintaining and sharing drug allergy information

• Ensure drug allergy and hypersensitivity is documented separately from adverse drug reactions so it is clearly visible.
• Included in all GP referral and hospital discharge letters.
• Ensure medicines reconciliation is carried out in line with National Institute for Health and Care Excellence guidance.

5.13.5.6 Providing information and support to patients

• Discuss the persons suspected allergy with them and provide structured written information and record who gave this and when.
• Ensure the person is aware of what drugs or classes of drugs they need to avoid in the future and advise them to check with the pharmacist before taking over the counter medication.
• Advise them to carry this information with them, and to share this information whenever they visit a health care professional.

5.13.5.7 Non-specialist management and referral to specialist services

• Consider stopping the suspected drug and advise avoiding in the future.
• Treat symptoms of the acute reaction; send people with a severe reaction to hospital.
• Document details as above.
• Provide person with information.

5.13.5.8 Refer to a specialist drug allergy service if they have

• A suspected anaphylactic reaction.
• A severe non-immediate cutaneous reaction, for example, Stevens-Johnson Syndrome.
• This should be via primary care and be communicated in any discharge letter.

5.14 Self-administration of medication on inpatient wards

5.14.1 Introduction

This standard recognises that inpatients require opportunities to acquire greater levels of autonomy and independence within which the self-administration of prescribed medicine is an important aspect of the care process.

The preferred method of medication administration should reflect the ultimate medication system when they are discharged, if this is a monitored dosage system (MDS) filled by a pharmacist, and if possible, this system of medication administration should be introduced to the service user at the earliest opportunity.

It is essential that wherever the patient is encouraged to self-administer medicines the management of such approach will be in keeping with the following principles:

• the environment is to have secure individualised storage facilities in place for each patient
• an emphasis on support, facilitation and concordance should be the primary feature of self-medication approaches. Whilst the patient may accept a personal challenge for growth and skills development these can neither be expected nor demanded
• independence requires education; the pathway to self-administration requires knowledge and understanding of mental illness and the medicines used in treatment. In order to acquire a safe and competent attitude towards medicines the patient will have to understand and value their use from a personal perspective
• competence in self-administration will be measurable by the patient’s capacity to demonstrate knowledge and understanding of, and commitment to, the need to safely manage medicines whilst also carrying out the requirements of the prescription
• individualised care must be recognised for all patients, not all patients will be successful in self-medicating and this fact may well determine the level of support that continues to be necessary following discharge from the service
• this support, which may become necessary, can be “bought in” as part of their package of care at the point of discharge for the patient if necessary

5.14.2 Aim

This standard is intended to set the standards for patients who self-administer medication on inpatient units.

5.14.3 Responsibilities, accountabilities and duties

In line the responsibilities laid out in the overarching safe and secure handling of medicines manual.

Additionally clinical staff working on the ward:

• ensure that there is a continuous supply of the patient’s medication (including any pro re nata (PRN) or when required medication)
• report any non-compliance with the contents of this standard

5.14.4 Procedure

5.14.4.1 The environment

Safe and secure individualised storage facilities for medication are made available for those patients who are deemed to be capable of self-medicating. There are individual medication cabinets located in the treatment room for staff to utilise when patients commence self-medication.

5.14.4.2 Supplying and storage of the medication

Medication should be supplied in an appropriate format consistent with the patient’s ability to self-administer medication for example, in original boxes and bottles or a monitored dosage system (MDS) clozapine prescription are also made up by the pharmacy supplier and not included in the monitored dosage system. If the clozapine is to be transferred into a Dosette type container, this should be done by the patient under the supervision of staff, and documented. Monitored dosage systems cannot be opened or amended to do this, prior to actual administration. (Staff should refer to the clozapine clinic standard operating procedures (SOPs) within the clozapine protocols for further guidance)

The pharmacy supplier requires at least 24 hours’ notice to make additions or changes to the monitored dosage system.

The only time that medication may not be supplied in monitored dosage system format by the pharmacy supplier is when a medicine is known to react with other medications if not kept separate in its foil wrapper.

For those patients who are working towards self-medication their medication is to be kept in the treatment room. Staff will then support, supervise and educate the individual patient to administer their own medication.

The storage and administration arrangements for the following items of prescription medications will be decided on an individual basis following consultation with the service user and documented in the individual care plan.

• Topical preparations.
• Eye, nose and ear preparations.
• Suppositories.
• Inhalers.
• Other preparations that aren’t given orally.

All medication will be held in the treatment room until it is required for use. It is the responsibility of clinical staff to ensure that there is a continuous supply of the patient’s medication, including any pro re nata (PRN) medication.

5.14.4.3 Assessing patient ability to self-medicate safely

For any patient to self-medicate safely it is important that staff undertake the following:

• when it is felt that a patient is eligible or safe to self-administer medication, it is to be discussed in the patient’s multidisciplinary team (MDT) meeting at the first opportunity
• an assessment of the patient’s capacity to self-medicate safely (this is to be recorded on a Mental Capacity Act 1 (MCA1) form). It is important that they understand the treatment, likely effects, benefits, and side effects. Staff are to refer to the trust’s Mental Capacity Act policy
• where there are concerns about a person’s ability to make decisions about self-medication an assessment of their capacity should be undertaken this should be recorded on the patients record on the Mental Capacity Act 1 (MCA1) questionnaire. It is important that they understand the purpose and nature of the treatment, likely effects, benefits, and side effects. Staff are to refer to the trust’s Mental Capacity Act policy
• if the person lacks capacity to make these decisions, then medication should be administered by staff

5.14.4.4 Supporting patients to self-administer medication

For safety reasons all patients who are to self-administer their medication will be observed and supported by a member of the nursing team for at least the first week.

Following this the level of support required by individual patients will be routinely reviewed at their MDT review.

The level of support provided will be based on a current risk assessment of the patient. A plan of care will be formulated to ensure the appropriate amount of support is in place.

Each member of the nursing team is to be made aware of the level of support and, or amount of prompting each individual patient requires in regard to the self-administration of medication as recorded in their care plan. Discussions and education around what medication the patient is prescribed. Assess their understanding of medications (Mental Capacity Act 1 (MCA1) and 2 (MCA2)). Patients should not be excluded if on Mental Health Act paperwork. Considerations should be taken in regard to changes in capacity and the ability to self-administer safely, as part of this assessment their ability to understand and comply with the regime should be assessed. To be discussed at MDT to decide if patient is appropriate and safe with medication administration. Prescriber to order medication for self-administration either in TTO (to take out) or nomad dependent on patient choice or identified need. Risk assessment completed.

To ensure the safe self-administration of medication as a minimum the following details must be included in the care plan:

5.14.4.5 Stage 1

• Named nurse to complete individualised care plan with patient.
• Patient to attend clinic room at prescribed medication time and to self administer medication under direct supervision.
• The length of this stage will be dependent on patient understanding and ability to self-medicate.
• Discussion with the responsible clinician (RC) and Clinical team and appropriate risk assessed to progress to next stage.
• At this stage the use of stock medication should be considered to limit the number of TTO’s being generated.
• Doses should be recorded as self-administered on the drug chart as per electronic prescribing medicines administration (EPMA) procedures.

5.14.4.6 Stage 2

Named nurse to complete individualised care plan with patient covering the following:

• patient attends clinic room each morning to collect a full day’s medication. Staff to ensure drug chart is updated accordingly to reflect a day’s supply of medication has been given
• staff to ensure the patient understands the need for safe storage of medications. A risk assessment is to be completed to reflect same
• staff to perform random checks on those patients who self-medicate to ensure compliance with taking prescribed medication, and storage. If any concerns are highlighted then please refer back to previous stage or cease the self-administration care plan dependent on highlighted concerns. This is to be reviewed within an MDT at the earliest opportunity
• a record should be made of the checks in the patient record
• discussion with RC and clinical team and appropriate risk assessed to progress to next stage

5.14.4.7 Stage 3

Named nurse to complete individualised care plan with patient covering the following:

• patient will attend the clinic room in the morning to collect 7 days of medication
• staff to ensure drug chart is updated with the documented 7 days self-administration accordingly
• staff to ensure patients understand the need for safe storage of medications. Risk assessment to reflect same
• staff to perform random checks on patients who self-medicate to ensure compliance with taking prescribed medication and storage as per stage 2
• this should be as a minimum weekly, and must be marked on the medication chart accordingly
• any concerns highlighted to refer back to previous stage or cease self-administration care plan dependent on highlighted concerns. This to be reviewed within an MDT at the earliest opportunity

5.14.4.8 Information to patients

Prior to any patient being prescribed medication whether they are self-medicating or not, it is important that both they, and if appropriate their carers, have a full discussion with the prescribing clinician about the risks, purpose and nature, and benefits of the proposed treatment. This discussion should also include:

• expected benefits of the treatment
• common side effects
• available alternative treatments
• risks and consequences of not having the treatment

Patients will also be given the above information in writing.

For patients whose first language is not English arrangements will be made for the presence of an interpreter. Staff should refer to the trust’s interpreters policy.

A medication guide can be given to the patient outlining what they are on, and when it should be taken. Pharmacy services can be contacted to generate one of these.

5.15 Covert medication guidance for inpatient services

5.15.1 Introduction

Covert medication is where medicines are administered in a disguised format without the knowledge or consent of the person receiving them, for example in food or in a drink.

Covert administration is only likely to be necessary or appropriate where:

• a person actively refuses their medicine
• that person is assessed not to have the capacity to understand the consequences of their refusal. Such capacity is determined by the Mental Capacity Act (2005)
• the medicine is deemed essential to the person’s health and wellbeing

Covert administration must be the least restrictive option after trying all other options.

5.15.2 Aim

This standard is intended to set the standards for the administration of medication covertly for inpatients.

5.15.3 Responsibilities, accountabilities and duties

In line the responsibilities laid out in the overarching safe and secure handling of medicines manual.

Additionally clinical staff working on the ward report any non-compliance with the contents of this standard.

5.15.4 Legal framework and national guidance

The prescribing and administration of covert medications are subject to a legal framework and relevant professional guidance and standards. The relevant legislation on covert medication administration in England and Wales are the:

• Mental Capacity Act (2005)
• Mental Health Act (1983)

The Mental Health Act (MHA) gives authority to provide treatment of both the causes and the manifestations of mental disorder to a patient detained under its powers without their consent. Treatment powers under the MHA are limited to treating a patient’s mental health. Where the patient has capacity to make decisions about their treatment, it is never appropriate to give medicines covertly to treat any patient’s physical health where they are refusing. Where a patient lacks capacity or refuses then a second opinion appointed doctor (SOAD) view should be sought.

For patients not detained under the MHA covert medication can be given to those who lack capacity to consent under the Mental Capacity Act 2005 (MCA) under certain circumstances. The administration of covert medication is only likely to be necessary or appropriate where:

• a person actively refuses their medicine
• that person is judged not to have the capacity to understand the consequences of their refusal
• the medicine is deemed essential to the person’s health and wellbeing

The covert administration of medication is the practice of hiding medication in food or beverages so that it will be undetected by the person receiving the medication. Pills may be crushed or medication in liquid form may be used, if it is safe to do so.

This practice exclusively applies to patients who lack capacity to consent to the treatment. It is intended to ensure that patients refusing treatment as a result of their illness will have access to effective medical treatment this is to ensure the patient’s treatment is delivered in the least restrictive manner (for example, orally, rather than through restraint and intramuscular injection).

Medication administered covertly should only be given in exceptional circumstance as a last resort; after all reasonable efforts have been made to give the medication in the normal manner.

In the case of AG v BMBC and Anor, district Judge Bellamy stated:

‘If a person lacks capacity and is unable to understand the risks to their health if they do not take their prescribed medication and the person is refusing to take the medication then it should only be administered covertly in exceptional circumstances.

5.15.5 Evidencing legal authority to treat a person who lacks capacity

Once a decision has been made to covertly administer medicine, nursing staff should ensure that an assessment of capacity to consent to the medication is undertaken and recorded on Mental Capacity Act 1 (MCA1) on the patient’s electronic record.

If it is determined that the person lacks capacity to consent then nursing staff should arrange a best interests meeting should be held, with all interested parties. It is essential that family and cares are consulted in relation to their views as to what is in the persons best interests and where there is no family to consult an independent mental capacity advocate (IMCA) is appointed.

The outcome of the meeting and the decision made should be recorded on the Mental Capacity Act 2 (MCA2) form. If there is any objection by interested parties to the decision to give medication covertly then the trust should consider taking the matter to the court of protection as a matter of urgency. Staff should contact the Mental Capacity Act lead for further advice.

If is determined that it is in the patient’s best interests to be given the medication covertly, then consideration needs to be given whether it is safe to do so. Medication administered in this way can alter their therapeutic properties and effects, and they could become unsuitable or ineffective. Staff should take advice from a healthcare professional to make sure medicines are safe and effective before it is considered whether it can be given to the patient and a covert medication care plan completed (see safe and secure handling of medicines manual).

5.15.6 Covert medication care plan

The covert medication care plan should include the type of medication review by the prescriber, advice to staff on how the medication can be given safely, and a plan to regularly review the need for continued covert administration of medicines, see below the factors to consider:

• actions taken to give medicines in the normal manner
• how medicines will be administered covertly
• if we alter the form, for example, crushing and so on, then it becomes an off label (for example, unlicensed) use of the drug, which must be an explicit decision by the consultant
• specialist input to show suitability of the method chosen, for example crushed or mixed with certain food or drinks
• whether the medicine is unpalatable
• adverse effects (actual or perceived)
• swallowing difficulties
• lack of understanding about what the medicine is for
• lack of understanding of the consequences of refusing to take a medicine
• ethical, religious or personal beliefs about treatment
• what to do if the person refuses food or drinks
• agreed method added to the notes on the medication chart on SystmOne

As part of the planning staff should also:

• consider guidance from pharmacy regarding the appropriateness of appropriate dose formats or vehicles in which to put them for that specific patient
• that the movement to covert meds should involve only those drugs that are deemed to be essential rather than the entire regime
• that the manner in which the drug may be given needs to be explicitly stated on the drug card (this can be done in the notes section for the drug entry)

Medicines administered under covert conditions must be administered in line with extant trust guidance in the safe and secure handling of medicines manual with particular attention to ensure that the covert dose is not left unattended or taken by someone other than the intended patient. Medicines administration records should clearly record which medicines are administered covertly and when. This is particularly important for people with fluctuating capacity.

At time of discharge medications should be assessed by the prescriber and pharmacist as GP can switch the drugs from tablet to liquid and dose must be altered. It can be for any reason to avoid unable use of medication or availability of the drug.

5.15.7 Exceptional circumstances

If the situation is urgent, it is acceptable for a less formal discussion to occur between staff, the prescriber and family or advocate and an urgent decision made. However, a formal best interests meeting should be arranged as soon as possible afterwards.

5.15.8 Lasting powers of attorney

Lasting powers of attorney (LPAs) can be drawn up or appointed by the patient, while he or she has mental capacity to appoint someone, to act on their behalf if they are no longer able to make decisions. If the person has a registered lasting power of attorney for health and welfare then the attorney can consent to the person having the medication but if the person is refusing, a best interest’s meeting will still need to be held.

An objection to covert medication by the lasting powers of attorney for health and welfare must be followed. However, if it becomes apparent that the lasting powers of attorney is not acting in the patient’s best interests, the concern should be referred to the office of public guardian to investigate and if necessary referred to by the court of protection.

5.15.9 Objection from other parties

In “An NHS Trust versus XB and Ors (2020)” (EWCOP 71), Theis J has further emphasised the thin legal ice for professionals seeking to administer medication covertly, especially where someone is objecting.

If there is any objection to the best interests decision to administer the medication covertly, then staff should seek advice from the Mental Capacity Act lead about whether an application needs to be made to the court of protection for approval of the covert medication care plan.

Staff should not delay in seeking advice when necessary.

5.15.10 Covert medication and deprivation of liberty safeguards

Judge Bellamy, in the AB case, confirmed that covert medication should involve consideration of the least restrictive option of the person’s rights and freedom of action. He advised that where a person is subject to a deprivation of liberty authorisation a review of the authorisation should be triggered by covert medication or any change in their administration regime.

5.15.11 Flowchart process for administration of covert administration of medicines

Health practitioners should ensure that the following process for covert administration of medicines is followed in line with the Safe and Secure Handling of Medicines Manual and the Mental Capacity Act (2005) policy.

1. Patient refusing medication or medicine which is deemed essential to their health and wellbeing.
2. Establish the reasons why the patient is refusing particular medication. Consult the prescriber for advice on the various alternative preparations that can be tried.
3. If a patient is refusing medications for a mental disorder, and the person is not detained under the Mental Health Act (MHA) the relevant Mental Health team needs to be consulted:
   • person lacks capacity to refuse medication and person detained under Mental Health Act, medication can be given covertly
   • person has capacity to refuse medication and not detained under the Mental Health Act, medication cannot be given
4. If the person is not subject to the Mental Health Act undertake an assessment of their mental capacity regarding their ability to make decisions about their medication, record on Mental Capacity Act 1 (MCA1).
5. Person lacks capacity to refuse medication and the medication cannot be given under the Mental Health Act.
6. Arrange a Mental Capacity Act best interest meeting of all the relevant the health professionals, the healthcare professional responsible for prescribing the medicines, the involved pharmacist, and any interested parties such as family, friends or any appointed attorneys or advocate. The aim of the BI meeting is to agree whether administering medicines without the patient knowing (covertly) is in the patient’s nest interest. Record on Mental Capacity Act 2 (MCA2).
7. Decision made that it is in the person’s best interests to be given medication covertly under the Mental Capacity Act and there is no objection from any interested party:
   • covert medication care plan completed, review data set, undertake regular reviews
   • where there is an objection to the medication being given covertly by any interested party the trust should consider taking matter to the court of protection
8. Decision made it is in not in the person’s best interest to be given medication covertly, medication should not be given.
9. Attorney or deputy for health and welfare objects to the decision to give covert medication, medication cannot be given without an order from the court of protection.

6 Standing operating procedure

Please see the pharmacy’s procedure page on the staff intranet (staff access only) for standard operating procedures:

• inpatient standard operating procedures
  • medicines reconciliation
  • medicines prescription
  • medicines ordering
  • medicines receiving and storage
  • medicines administration
  • medicines disposal
  • network unavailable
• controlled drug standard operating procedures:
  • controlled drug prescribing aspire drug and alcohol service Doncaster care group
  • controlled drugs (trust care groups community services (physical health))
  • controlled drugs (with the exception of trust physical health community services) procedure
  • controlled drugs St John’s hospice
  • destruction of controlled drugs:
• destruction of controlled drugs and unknown substances by pharmacy services staff
  • community inpatient services:
  • management of medicines on Hazel, Hawthorn and Magnolia wards and Evergreen day services
• adult community mental health:
  • management of medicines on trust adult mental health community services
  • community team drug chart, short, exemplar
  • community team drug chart, short
  • community team drug chart, long
  • stock medicines reconciliation form
  • stock medicines reconciliation form, exemplar
  • record of removal of medicines from a community patient
  • record of removal of medicines from a community patient, exemplar
  • patient medicines reconciliation form
• guideline for the administration of adrenaline for the emergency management of anaphylaxis
• omitted doses:
  • omitted medication guidance
• minor ailments:
  • guidelines for the supply and administration of medicines for minor ailments by registered nurses within Doncaster Deaf Trust
  • guidelines for the supply and administration of medicines for minor ailments by registered nurses within inpatient services
• local working Instructions:
  • the safe administration of Dalteparin (Fragmin), Tinzaparin (Innohep) and Enoxaparin (Clexane) in the community
  • standard operating procedure for the emergency supply of clozapine to an acute hospital by the Mental Health Hospital Liaison team
• guidelines:
  • guidance on missed doses of depots long-acting injections
  • licensed injection sites for depot antipsychotics
  • guidelines for the management of QTc prolongation in adults prescribed antipsychotics

7 Training implications

The training needs analysis for this policy can be found in the training needs analysis which is part of the trust’s mandatory and statutory training policy.

8 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, “not just clinically but in terms of dignity and respect”.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

No issues have been identified in relation to this policy.

8.2 Mental Capacity Act (2005)

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals’ capacity to participate in the decision-making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the rights of individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act 2005 (section 1).

9 Links to any other associated documents

• Listening and responding to concerns and complaints policy (formally complaints handling policy)
• Drug misuse on trust premises policy
• Section 62 procedure for clinical staff
• Healthcare record keeping policy
• Incident management policy
• Non-medical prescribing policy
• Patient group directions, a list of authorised patient group directions can be found on the trust’s website under clinical policies or prescribing and medicines management
• Patient identification policy
• Patient specific directions, a list of authorised patient specific directions can be found under clinical policies or prescribing and medicines management
• Rapid tranquillisation policy and guidelines (pharmacological management of violence)
• Risk management framework
• Safe and secure handling of medicines in trust day care facilities (mental health services and learning disability day services) procedure

10 References

• Audit Commission Report (2001) A Spoonful of Sugar, Medicines Management in NHS Hospitals.
• British Medical Association, Royal Pharmaceutical Society of Great Britain (most recent edition) British National Formulary.
• Care Quality Commission (2010) Essential standards of quality and safety.
• Consumer Protection Act of (1987).
• Control of Substances Hazardous to Health Regulations (2002). Crown Report (1998).
• Department of Health (1999) Review of Prescribing, Supply and Administration of Medicines.
• Department of Health (2004) Mechanisms for Nurse and Pharmacist Prescribing and Supply of Medicines.
• Department of Health (2007) Safer Management of Controlled Drugs: A Guide to Good Practice in Secondary Care.
• Department of Health (2015) Code of Practice Mental Health Act 1983.
• Department of Health (2015) Reference Guide to the Mental Health Act 1983.
• General Medical Council (2013) Good Practice in managing medicines and devices.
• Manchester Mental Health and Social Care Trust (2008) Medicines Policy 4th Edition.
• Medicines for Human Use (Clinical Trials) Regulations (2004).
• Mental Capacity Act (2005).
• Misuse of Drugs Regulations (2001).
• National Institute for Health and Clinical Excellence (2013) MPG 2 Patient Group directions.
• National Institute for Health and Clinical Excellence (2014) CG183 Allergy.
• National Institute for Health and Clinical Excellence (2015) NG15 Antimicrobial Stewardship.
• National Institute for Health and Clinical Excellence (2015) NG5 Medicines Optimisation.
• National Patient Safety Agency (2007) Promoting Safer Use of Injectable Medicines.
• Nursing and Midwifery Council (2008) Mental Health Act Manual Eleventh Edition.
• Nursing and Midwifery Council (2015) Standards of Proficiency for Nurse and Midwife Prescribers.
• Nursing and Midwifery Council (2015) The Code: standards of conduct, performance and ethics for Nurses and Midwives.
• Nursing and Midwifery Council 2015 Standards for Medicines Management.
• Royal College of Psychiatrists (2007) Use of Licensed Medicines for Unlicensed applications in Psychiatric Practice.
• Royal Pharmaceutical Society of Great Britain (2008) Medicines Ethics and Practice, A Guide for Pharmacists and Pharmacy Technicians.
• The Association of the British Pharmaceutical Industry Code of Practice (2006).
• The Duthie Report (1988).
• The Human Medicines Regulations (2012).
• The Medicines Act (1968).
• The Misuse of Drugs Act (1971).
• The Royal Marsden NHS Foundation Trust (2004) Clinical Nursing Procedures 6th Edition.
• The Stationery Office (2007) Mental Capacity Act (2005) Code of Practice.
• Waddell L. and Taylor M. A new self-rating scale for detecting atypical or second-generation antipsychotic side effects, Psychopharmacol 2008.

11 Appendices

11.1 Appendix A Accepted Abbreviations that may be used when prescribing

The following abbreviations may be used when describing medication route of administration or strength.

With respect to tablet and capsule release characteristics only the following abbreviations may be used with in the trust:

11.1.1 Combination products

For oral medications containing more than one drug, write the approved name followed by the strength of each component, then the number of dose units, for example, co-amilofruse 5/40 i od.

11.1.2 Dose

The dose must be expressed in metric units. Quantities of less than 1 gram must be written as milligrams. Decimal points should not be used, for example 500mg not 0.5g to avoid confusion. Whenever a decimal point is necessary, the prescriber and the practitioner administering the drug must exercise great care. The terms microgram and nanogram must not be abbreviated but must be printed in full and used for quantities less than one milligram. Liquid preparations should show the dose in milligrams or micrograms or the strength of the preparation and the dose in millilitres.

In regard to the prescribing of insulin this must always be prescribed as units, and in line with the NPSA alert on insulin it must not be prescribed using the abbreviations U or IU.

11.1.3 Dosage forms

Only the following abbreviations are acceptable within the trust:

Microgram and nanogram must be written in full

11.1.4 Route of an administration

This must be stated for all prescriptions and only the following abbreviations are acceptable:

All other routes of administration must be written out in full.

11.1.5 Directions

No other abbreviations are permitted when documenting medications.

11.2 Appendix B High dose antipsychotic form

Refer to appendix A: high dose antipsychotic form (staff access only).

11.3 Appendix C Combined fridge room temperature monitoring chart

Refer to appendix C: combined fridge room temperature monitoring chart (staff access only).

11.4 Appendix D Covert medication administration care plan

Refer to appendix D: Covert medication administration care plan (staff access only).

11.5 Appendix E Adverse drug reporting

11.5.1 Adverse drug reaction reporting and yellow card scheme

The yellow card scheme for spontaneous reporting of suspected adverse drug reactions (ADRs) was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. Adverse Drug Reactions should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) by completing a yellow card.

11.5.1.1 Who can report?

Until recently adverse drug reaction reporting using the yellow card scheme was only available to healthcare professionals such as doctors, pharmacists, coroners and nurses. In October 2005 the yellow card scheme was opened up to service users and their carers.

11.5.1.2 What should be reported?

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use that is suspected to be related to the drug.

For intensively monitored medicines identified by an upside down triangle (▼) report all suspected reactions.

For established drugs and herbal remedies report all serious adverse reactions in adults, report all serious and minor reactions in children (under 18).

Serious reactions include those that are:

• fatal
• life threatening
• disabling
• incapacitating
• result in or prolonged hospitalisation
• and or are medically significant
• congenital abnormalities

If in doubt about the seriousness of a reaction please report it.

11.5.1.3 Areas of special interest

Although all adverse reactions with medicines are monitored there are a number of areas of particular interest, as listed below:

• children
• the elderly
• delayed drug effects
• congenital abnormalities
• herbal remedies: it is important to monitor all herbal products to ensure their safety

It would be helpful to report the ingredients, source or supplier.

11.5.1.4 Where to find a yellow card

A paper version of the yellow card is included in:

• British National Formulary
• Nurse Prescriber Formulary
• Monthly Index of Medical Specialties (MIMS)

Alternatively download a copy from the Medicines and Healthcare products Regulatory Agency website.

11.5.1.5 Service user details

Provide one of the following:

• service user’s initials
• age
• sex
• weight if known
• local identifier

Do not identify the service user by date of birth or name of patient. In order to help identify the service user in any future correspondence also include their initials and a local identification number, which will identify them in the case of any future correspondence. This does not breach any confidentiality agreements between the health care professional and the service user.

11.5.1.6 Copy of yellow card in patients notes

It is vital that a copy of the yellow card report is included in the service users clinical record. It is also recommended that a copy be sent to the GP for future

11.5.1.7 Drug alerts

Medicines and Healthcare Products Regulatory Agency (MHRA) Drug Alerts are cascaded directly to the trust pharmacists and they are responsible for ensuring that the advised action is taken, which may necessitate the removal of the affected pharmaceuticals from pharmacy stock.

11.6 Appendix F Allergy assessment

When assessing a potential allergy the following tool should be used: National Institute for Health and Care Excellence clinical guideline 183 (CG183).

11.6.1 Signs and allergic patterns of suspected drug allergy with timing of onset after exposure to drug

When assessing a person presenting with possible drug allergy, take a history and undertake a clinical examination, use the following when deciding whether to suspect drug allergy:

11.6.1.1 Immediate, rapidly evolving reactions

• Anaphylaxis: a severe multi-system reaction usually with erythema, urticaria or angioedema in combination with hypotension and bronchospasm.
• Urticaria or angioedema without systemic features.
• Exacerbation of asthma, for example with non-steroidal anti-inflammatory drugs (NSAIDs).

Onset usually under 1 hour, previous exposure not always confirmed.

11.6.1.2 Non-immediate reactions without systemic involvement

• Widespread red macules or papules (exanthem-like).
• Fixed drug eruption (localised inflamed skin).

Onset usually on day 6 to 10 of first drug exposure (reaction to first exposure may be more prolonged), or day 1 to 3 of second exposure.

11.6.1.3 Non-immediate reactions with systemic involvement

• Widespread red macules, papules or erythroderma with systemic involvement. For example, drug reaction with eosinophilia and systemic symptoms (DRESS) or drug hypersensitivity syndrome (DHS), characterised by fever, lymphadenopathy, liver dysfunction and platelets below the laboratory limits. Onset usually 2 to 6 weeks after first drug exposure, or 24 to 48 hours after second exposure. Note, this list describes common and important presenting features of drug allergy, but other presentations are also recognised.
• Toxic epidermal necrolysis or Stevens Johnson syndrome, characterised by mucosal or cutaneous erosions, vesicles, blistering or epidermal detachment, and red purpuric macules or erythema multiforme. Painful rash and fever are often early signs. Onset usually 7 to 14 days after first drug exposure, or 24 to 48 hours after second exposure.
• Acute generalised exanthematous pustulosis: widespread pustules, usually with a fever and neutrophilia. Onset 3 to 5 days after first drug exposure.
• Common disorders caused, rarely, by drug allergy (time of onset variable):
  • eczema
  • hepatitis
  • photosensitivity
  • vasculitis

Be aware that the person’s reaction is more likely to be caused by drug allergy if:

• the reaction occurred while the person was being treated with the drug
• the drug is known to cause that type of reaction
• the person has had a similar reaction to that drug or class of drug in a previous exposure

Be aware that the person’s reaction is less likely to be caused by drug allergy if:

• • there is a possible non-drug cause for the person’s symptoms, for example, they have had similar symptoms when not taking the drug
  • the person has gastrointestinal symptoms only

Note, this list describes common and important presenting features of drug allergy, but other presentations are also recognised.

11.6.2 Serum tryptase

After a suspected drug-related anaphylactic reaction, take blood samples for mast cell tryptase in line with recommendations in anaphylaxis (National Institute for Health and Care Excellence clinical guideline 134).

Record in the person’s notes and on the pathology request form, the exact timing of both blood samples taken for mast cell tryptase after onset of suspected anaphylaxis.

Ensure that tryptase sampling tubes are included in emergency anaphylaxis kits.

11.6.3 Serum Immunoglobulin E (IgE)

Do not use blood testing for specific Immunoglobulin E (IgE) for diagnosing drug allergy in a non-specialist setting.

The full guideline can be viewed at the National Institute for Health and Care Excellence guidelines.

---

Document control

• Version: 2.1.
• Approved by: director of corporate assurance (COVID-19 emergency measures).
• Date approved: 4 July 2023.
• Name of originator or author: chief pharmacist.
• Name of responsible committee or individual: executive medical director.
• Unique reference number: 547.
• Date issued: 11 August 2025.
• Review date: 31 August 2026.

Page last reviewed: December 10, 2025
Next review due: December 10, 2026

Problem with this page?

Please tell us about any problems you have found with this web page.

Report a problem