Contents
1 Aim
This standard operating procedure (SOP’s) represents the practice for safe completion of ordering, prescribing, receiving, storing, administration and where necessary disposal of controlled drugs (CD).
2 Scope
The contents of this procedure apply to all clinical staff working in RDaSH physical health community services that in the course of their employment will order, prescribe, administer, or dispose of CDs.
The procedure is made up of a series of ‘at a glance’ documents covering various areas of managing CDs which are pertinent to in RDaSH physical health community services.
Where a service’s processes cannot conform to the trust level guidance advice must be sought from the trust pharmacy department.
This SOP covers:
- schedules 1 and 2 CDs:
- additionally, the schedule 3 CDs temazepam, buprenorphine are to be treated as a schedule 2 CD
- schedule 3b CDs gabapentin, midazolam, phenobarbital, pregabalin, tramadol is to be treated as a schedule 2 and 3a CD with regards to ordering, prescribing, administration and destruction. No storage in the CD cabinet required
- schedule 3 CDs such as barbiturates
- schedule 4 CDs benzodiazepines, Z hypnotics, androgenic and anabolic steroids are to be treated as a schedule 2, 3a and 3b CDs with regards to being destroyed by pharmacy department (two-person process if available)
- strong potassium chloride solution BP 15%
Therefore, each of these is subject to trust regulations regarding ordering, storage, administration, recording and destruction of CDs.
While the legal requirements for all schedule 3 CDs do not require secure storage or recording in a CD register, current RDaSH practice for inpatient settings for schedule 3 CDs is that they are secured in a CD cupboard and their use is recorded in the CD register. This is applicable where community teams are holding medication in the trust premises.
In named localities storage, administration, recording and destruction of CDs may be different, and they will follow their own locality agreed SOP (for example, Heatherwood school). Heatherwood school now manages all their own medicines, in rare occasions the nurses attending the school will administer or handle any CD.
3 Link to overarching policy
This SOP links to safe and secure handling of medicines manual.
4 Procedure
4.1 General
- CDs are legally defined by the Misuse of Drugs Act 1971 as drugs which are “dangerous or otherwise harmful” and have the potential for abuse or misuse. Due to the nature of these drugs their use is regulated through legislation such as the Misuse of Drugs Regulations 2001 (with associated amendments) and this legislation dictates how they are to be prescribed, ordered and stored.
- In addition to these legal requirements, the trust also requires certain additional safeguards to be in place which are not specified by law, and trust employees are expected to adhere to these requirements as set out in these procedures in addition to their legally defined responsibilities.
- The practical guidance proved by this SOP is contained within a series of ‘at a glance’ documents which form the attachments to this SOP. At the time of communication (version 2) there are four documents,
Additional documents may be produced as services develop, regulations change or to reflect changes in the safe and secure handling of medicines policy.
- Each document consists of guidance and a sign off form.
- the guidance section is drawn up into three columns:
- the left hand column identifies various tasks within the relevant CDs domain
- the middle column details the minimum expected steps to be taken when carrying out that aspect. It is this column which has been approved through the medicines management committee and clinical policies review and approval group. This column is not available for teams to amend
- the right-hand column allows or teams to make points of clarification or additional requirements so that the resulting document is bespoke and describes the processes in place in their team. Staff identified to be able to carry out particular tasks may be named individually or by role or staff group (for example, qualified nursing staff and so on.)
- where a service’s processes cannot conform to the Trust level guidance advice must be sought from the trust pharmacy department
- the guidance section is drawn up into three columns:
- The sign off form
- is for individual staff members to indicate that they have read and understood the document and indicates their intention to comply with the Trust and team processes as they apply to managing CDs
- all staff working in the team who handle medicines must sign off against those documents relevant to their role
This SOP should:
- form part of the new staff member’s induction into the service
- form part of a competency assessment following a medicines error
4.2 Service and team managers
It is the service or team manager’s responsibility to:
- review and ensure that the ‘at a glance’ documents forming this SOP have been amended as described above to detail the services processes around medicines
- ensure all staff members who handle medicines within their service have signed the ‘at a glance’ documents which are relevant to their role
- maintain the SOP to be accurate for the processes in place in the service. Where a process may have changed within the service
- the existing ‘at a glance’ document(s) should be archived (with signatures)
- a new ‘at a glance’ document amended to detail the revised process and circulated to staff for information and signoff
- ensure adequate stocks of order pads, drug cards and other relevant paperwork are available to support continuous adherence to these SOPs
- processes are in place to ensure secure storage of medicines and appropriate monitoring of that storage (for example, fridge and room temperatures, CD registers and so on.)
- ensure staff have received and are up to date with medicines training as mandated by the trust and appropriate to their role
- identify where services do not comply with the trust standards and either rectify the process or contact the trust pharmacy department for support
4.3 Staff members
It is the responsibility of trust staff to:
- read and sign off against all ‘at a glance’ documents, as part of this SOP, which are relevant to their role
- comply with the guidance as detailed within this SOP
- exhibit professional judgement to identify those exceptional instances where a departure from this guidance is required to ensure a patient’s safety. Where such an action has been taken, staff must annotate in the patient record the rationale for the departure and the action taken. It must be reported to the service or team manager
4.4 Responsibilities, accountabilities and duties
4.4.1 Accountable officer
The accountable officer for the trust is the chief pharmacist who is responsible for all aspects of the safe and secure handling of CDs within the trust. This includes:
- having safe systems in place for the management and use of CDs
- monitoring and auditing the management systems which are in place for CDs
- the chief pharmacist may instigate actions or investigations in the event of suspected misuse of any drug. These actions may be instigated trust wide or limited to defined areas as specified by the chief pharmacist or accountable officer
- in the event of suspicion of misuse of CD medications covered in schedules 3 to 5 (for example, benzodiazepines) instigating special recording and storage procedures for specific drugs
4.4.2 Appointed practitioner (AP) in charge of a team
The appointed practitioner in charge of a team is responsible for:
- the safe and appropriate management of CDs if stored in trust premises. The assigned practitioner in charge can delegate control of access (for example, key holding) to the CD cupboard to another authorised professional, such as a designated practitioner, however legal responsibility remains with the appointed practitioner in charge. A task may be delegated but the responsibility may not
- any staff working under their direction being aware of these SOPs and any amendments made by the trust
- providing the dispensing pharmacy and trust pharmacy department with a copy of all authorised signatures for the ward or unit and keeping the list up to date when staff leave or join the team
4.4.3 Authorised prescribers
Authorised prescribers are responsible for:
- prescribing CDs appropriately, responsibly, and legally
- correcting any problems with CD prescriptions that prevent legal supply occurring
4.4.4 All other clinical staff
Any member of staff who has concerns over any unaccounted for losses of controlled medications must report to their line manager and the trust pharmacy department and accountable officer
4.4.5 Counter signatory (CS)
The following staff groups may be counter signatory:
- registered nurses
- doctors
- pharmacists
- pharmacy technicians (directly employed by the trust)
- appropriately trained healthcare professional
- student nurses under supervision by a someone other than the first signatory
- nurse assistant, healthcare assistant or clinical support worker (nurse assistant, healthcare assistant or clinical support worker can be only a counter-signatory on the receipt, administration, and balance checks of CDs (they will check the accuracy of the CDs received, administered and reconciled, but are not responsible for checking the appropriateness of CD prescriptions))
- school staff (within the health bus setting the counter-signatory would be a staff member working on the bus)
- health bus staff (within the health bus setting the counter-signatory would be a staff member working on the bus)
The above members of healthcare staff are permitted to witness specific tasks that they are competent with and sign to confirm that the task has been performed accurately and correctly.
Relatives or carers are able to be considered for administration accuracy checks (please refer to SOP 3.0).
For the purposes of witnessing CD tasks, the scope of the tasks are:
- as a second person check (if available) of the correct administration of the CD (for example, right patient, right drug, right dose, right time, and dose form) and ensure an accurate entry is made in the register with regard to drug, dose, dose form, quantity and resultant balance
- stock balance checks prior to destruction of CDs (please refer to SOP 4.0)
- destruction of CDs
Receipt of CDs and routine stock balance checks will not require a witness counter signature.
4.4.6 CD stationary
4.4.6.1 CD register
Each unit or team that holds stocks of CDs or holds CDs on behalf of service users must keep a record of all CDs received, disposed, administered, or supplied to service users in an appropriate CD register.
This is a bound register suitable for the recording of all CD transactions for a specific ward, unit, or team.
Within the trust the only approved form of register is that printed by HMSO (Her Majesty’s stationery office) for the purpose.
The CD registers are available from the regional distribution centre (RDC) and must be ordered using the code WOP105.
The team leader or delegate in charge of the unit or team is responsible for keeping the CD register up to date and in good order and must ensure it is kept locked securely in a cabinet, cupboard or draw between episodes of recording.
All receipt, destruction, administration, or supply of CDs by the unit or team must be recorded in the CD register. All removal of CDs by any means, must be recorded in the CD register.
4.4.6.2 Doncaster physical health medication record
This is the CD Stationary that community staff in RDaSH physical health community services use (please refer appendix B)
4.4.6.3 FP10
This is an NHS prescription form that can be dispensed by a registered community pharmacy. Those used by general practitioners and Secondary care are termed FP10. Those used by specialist drug misuse centres in secondary care are FP10MDA-SS.
5 Review and version control
The ‘at a glance’ documents that form the basis of this SOP will be formally reviewed every two years by trust pharmacy department and with input from appropriate clinical services. Interim updates will be produced to reflect changes to the safe and secure handling of medicines manual and will be evident through version numbers.
The pharmacy department have responsibility for:
- the formal reviews and generation of new versions resulting from changes to the content of the ‘At a Glance’ documents (with the exception of the right-hand column, which will remain the responsibility of the service or team manager)
- dissemination to teams and intranet availability of the most current version of the SOP
6 Appendices
6.1 Appendix A ‘at a glance’ CDs requirements
6.2 Appendix B district nursing service CDs
6.3 Appendix C destruction of unknown substance health bus record sheet
Document control
- Version: 4.1.
- Unique reference number: 459.
- Date ratified: 6 September 2022.
- Ratified by: Clinical policies review and approval group.
- Name of originator: Specialist pharmacist.
- Name of responsible individual: Medicines management committee.
- Date issued: 19 February 2024.
- Review date: 31 December 2026.
- Target audience: All clinical staff working in RDaSH community non-mental health services.
- Description of changes: General review with minor amendments.
Page last reviewed: April 24, 2024
Next review due: April 24, 2025