Standards for the prescribing of medicines including clinical trials

1 Aim

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

2 Link to overarching policy

This document links to the overarching safe and secure handling of medicines manual.

3 Responsibilities

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

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.

4 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:

4.1 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 (opens in new window)

4.2 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

4.3 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 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) (opens in new window)
from the trust pharmacy department
through 1-to-1 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 website (choice and medication) (opens in new window)

6 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:
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.

EPMA 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.

7 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.

8 Prescription documentation

8.1. Medicines may only be prescribed on trust authorised stationery

Authorised inpatient paper drug chart.
Electronic prescribing system (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.

8.2 Where hand written 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 rINN 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 EPMA 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.

8.3 Date and sign

Use 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.

8.4 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

8.5 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 installment dispensing

8.6. 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.

8.7 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.

8.8 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 (A and E); 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
A and E 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 medication(s), and a prescribers name so it can be traced back if necessary

8.9. 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.

8.10 Dosage frequency

All medications should have a frequency stated, see standard 4. When required (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.

8.11 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.

8.12 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).

8.13 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.

8.14 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.

8.15 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 EPMA 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.

9 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 MMC for approval.

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

10 Contact with pharmaceutical industry representative

The trust MMC 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 MMC does not consider such meetings to be an appropriate use of trust resources. The MMC 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 MMC 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 MMC 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 MMC on a case by case basis and the representatives of the pharmaceutical industry have strict codes (ABPI 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.

11 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. MHRA Valproate guidance (opens in new window).

12 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 licenses 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.

13 Above British national formulary (BNF) maximum prescribing limits (combined maximum)

All prescriptions for psychotropic medications (including combinations) should usually be within BNF limits, apart from cross titrations.
Any prescribing antipsychotics above BNF 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 BNF 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 BNF maximum limits is an unlicensed form of prescribing and it is therefore the consultant’s responsibility to ensure GMC and specialist colleges’ guidance is followed and treatment plan well documented.

14 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

15 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.

16 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 authorized prescriber.

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

17 Patient group direction (PGD)

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

PGD’s must comply with NICE guidance (opens in new window).

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 PGD 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 PGD. A list of all practitioners signed off for each PGD must be sent to pharmacy, to be kept with the original document.

Copies of approved PGD’s must be available in each area and must reflect accurately practice in that area.

A PGD cannot be introduced without authorization 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 PGDs.

Approved PGDs will be signed by the chief pharmacist, medical director and director of nursing.

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

18 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 EMC website (opens in new window).

19 Off license and unlicensed medication guidance and clinical trails

19.1 Use of unlicensed medicines

In the UK no medicine can be marketed for human use without a product license (PL) granted by the Licensing Authority (Department of Health). The PL 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 license 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 license 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 o 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 o 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 licenses; however, there are two circumstances where a prescriber may wish to use an ‘unlicensed drug’:

a product awaiting a UK product license
a product that has been withdrawn from UK market

19.2 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, 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 MMC. 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 license 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.

19.3 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 SPC is considered “off-label”, or an unlicensed use. This policy also applies to products used outside their product license “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.

20 Clinical trails including pharmaceutical products

Anyone considering conducting a clinical trial must refer to the 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.

21 New medicine related documents

All new and updated polices, guidelines, protocols PGDs and PSDs relating to medicines must go through the MMC 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.

Document control

Version: 2.
Unique reference number: 548.
Approved by: Clinical policy review and approval group.
Date approved: 2 August 2022.
Name of originator or author: Senior pharmacist.
Name of responsible individual: Executive medical director.
Date issued: 17 August 2022.
Review date: August 2025.
Target audience: Trust wide.
Description of change: Addition of EPMA (electronic prescribing and medicines administration) training.

Page last reviewed: May 07, 2024
Next review due: May 07, 2025

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