Controlled drugs (St Johns hospice) procedure

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 (CDs).

2 Scope

The contents of this procedure apply to all clinical staff working in Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH) St John’s Hospice 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 St John’s hospice.

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 3a CDs temazepam, buprenorphine are to be treated as a schedule 2 CD
schedule 3b CDs gabapentin, midazolam, phenobarbital, pregabalin and tramadol are to be treated as a schedule 2 and 3a CD in regard 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 in regard 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.

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 (opens in new window) 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 (opens in new window) (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 manual.

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 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 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)

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.

For the purposes of witnessing CD tasks, the scope of the tasks are:

receipt of CDs
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
destruction of CDs

Receipt of CDs and routine stock balance checks will not require a witness counter signature.

Please refer to appendix B.

4.4.6 CD stationary

4.4.6.1 Controlled drug requisition book

This is a requisition book containing pre-printed pages, each suitable for the ordering of a single controlled drug preparation and the generation of a carbon copy.

The CD requisition books are available from the regional distribution centre (RDC) and must be ordered using the code WOP100.

4.4.6.2 Controlled drug register

Each ward, 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.

4.4.6.3 Community nursing service controlled drug record

This is the controlled drug stationary that community staff in RDaSH care groups community services (physical health)

4.4.6.4 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.

4.4.6.5 Drug card and medication chart

This is a drug prescription and administration record that must be used in the inpatient settings to record the administration of medication.

5 Review and version control

The at a glance documents that form the basis of this SOP will be formally reviewed every three years. Interim updates will be produced to reflect changes to the safe and secure handling of medicines policy 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 (except 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

Appendix A At a glance CDs requirements (staff access only) (opens in new window)

6.2 Appendix B Ward controlled drug signatory and counter signatory samples

Appendix B Ward controlled drug signatory and counter signatory samples (staff access only) (opens in new window)

Document control

Version: 3.1.
Unique reference number: 439.
Date ratified: 7 June 2022.
Ratified by: Clinical policies review and approval group.
Name of originator: Specialist pharmacist on behalf of the trust Medicines Management Committee.
Name of responsible individual: Medicines Management Committee.
Date issued: 15 June 2022.
Review date: January 2024.
Target audience: All staff.
Description of changes: Change of procedure.

Page last reviewed: November 14, 2024
Next review due: November 14, 2025

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