Controlled drugs (except St John’s Hospice and physical health community services) 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 colleagues working in RDaSH (except St John’s hospice and physical health community services) that in the course of their employment will prescribe, administer, or dispose of controlled drugs. The services covered in this procedure are:

mental health inpatient and community teams
New Beginnings community inpatient wards (Hawthorn, Hazel and Magnolia)
St John’s Hospice

The procedure is made up of a series of at a glance’ documents covering various areas of managing controlled drugs which are pertinent to the inpatient and community mental health services and Doncaster care group inpatients services (physical health). Where a service’s processes cannot conform to the trust level guidance advice must be sought from the trust pharmacy department.

This procedure covers:

schedules 1 and 2 controlled drugs: additionally, the schedule 3a controlled drugs Temazepam, Buprenorphine, are to be treated as schedule 2 controlled drugs
schedule 3b controlled drugs Gabapentin, Midazolam, Phenobarbital, Pregabalin, Tramadol is to be treated as a schedule 2 and 3a controlled drug in regard to ordering, prescribing, administration and destruction. No storage in the controlled drug cabinet and no record in the controlled drug register required
schedule 3 controlled drugs such as Barbiturates
schedule 4 controlled drugs benzodiazepines, Z hypnotics, androgenic and anabolic steroids are to be treated as a schedule 2, 3a and 3b controlled drugs in regard to being destroyed by pharmacy department (Two-person process)
strong Potassium Chloride Solution BP 15%, therefore, each of these is subject to trust regulations regarding ordering, storage, administration, recording and destruction of controlled drugs

While the legal requirements do not require secure storage schedule 3 controlled drugs or recording them within a controlled drug register. Current trust practice for schedule 3 controlled drugs within an inpatient setting is that they are secured in a controlled drug cupboard and their use in the controlled drug register.

3 Link to overarching policy

This standard operating procedure is overarched by and to be used in conjunction with the trust’s safe and secure handling of medicines manual.

4 Procedure

4.1 General

Controlled drugs 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 procedure is contained within a series of at a glance documents which form the attachments to this procedure.

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 controlled drugs 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 trust medicines optimisation group and clinical policies review and approval group. This column is not available for teams to amend
the right-hand column allows wards or teams to make points of clarification or additional requirements so that resulting document is bespoke and describes the processes in place in their team. Colleagues identified to be able to carry out particular tasks may be named individually or by role or colleagues (for example, qualified nursing colleagues)
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 colleagues 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 controlled drugs
all colleagues working in the team who handle medicines must sign off against those documents relevant to their role

This procedure should:

form part of the new colleagues induction into the service
form part of a competency assessment following a medicines error

4.2 Service or team managers

It is the service or team manager’s responsibility to:

review and ensure that the at a glance documents forming this procedure have been amended as described above to detail the service’s processes around medicines
ensure all colleagues who handle medicines within their service have read and signed the at a glance documents which are relevant to their role
maintain the procedure 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 documents should be archived (with signatures)
- a new at a glance document amended to detail the revised process and circulated to colleagues for information and sign off
ensure adequate stocks of order pads and other relevant paperwork are available to support continuous adherence to these procedures
processes are in place to ensure secure storage of medicines and appropriate monitoring of that storage (for example, central temperature monitoring system, controlled drug registers)
ensure colleagues have received and are up-to-date with controlled drugs and medicine management training as mandated by the trust
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 Colleagues

It is the responsibility of trust colleagues to:

read and sign off against all at a glance documents, as part of this procedure, which are relevant to their role
comply with the guidance as detailed within this procedure
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, colleagues 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 controlled drugs within the trust. This includes:

having safe systems in place for the management and use of controlled drugs
monitoring and auditing the management systems which are in place for controlled drugs
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 controlled drug medications covered in schedules 3 to 5 (for example, Benzodiazepines) instigating special recording and storage procedures for specific drugs

4.4.2 Appointed practitioner in charge of a ward or team

The appointed practitioner in charge of a ward, unit or team is responsible for:

the safe and appropriate management of controlled drugs in that area. The assigned practitioner in charge can delegate control of access (for example, key holding) to the controlled drug 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 colleagues working under their direction being aware of these procedures 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 join or leave the team

4.4.3 Authorised prescribers

Authorised prescribers are responsible for:

prescribing controlled drugs appropriately, responsibly and legally
correcting any problems with controlled drug prescriptions that prevent legal supply occurring

4.4.4 All other clinical colleagues

Any colleague who has concerns over possible misuse of medications on their ward should speak in the first place to the ward or unit manager or in their absence contact the accountable officer.

4.4.5 Counter-signatory

The following colleague groups may be a 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
student pharmacy technicians under supervision by a pharmacy colleague
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 controlled drugs (they will check the accuracy of the controlled drugs received, administered and reconciled, but are not responsible for checking the appropriateness of controlled drug prescriptions)

The above healthcare colleagues 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 controlled drug tasks, the scope of the tasks are:

receipt of controlled drugs
as a second person check of the correct administration of the controlled drug (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 controlled drugs
signing controlled drugs out of the controlled drug register at the point of discharge

Please refer to appendix B.

4.4.6 Controlled drug 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 controlled drug 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 controlled drugs or holds controlled drugs on behalf of service users must keep a record of all controlled drugs received, disposed, administered or supplied to service users in an appropriate controlled drug register.

This is a bound register suitable for the recording of all controlled drug transactions for a specific ward, unit or team.

Within the trust the only approved form of register is that printed by Her Majesty’s Stationery Office (HMSO) for the purpose.

The controlled drug registers are available from the regional distribution centre and must be ordered using the code “WOP105”.

The authorised prescriber in charge of the ward, unit or team is responsible for keeping the controlled drug register up-to-date, 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 controlled drugs by the ward, unit or team must be recorded in the controlled drug register. All removal of controlled drugs from the ward, by any means, must be recorded in the controlled drug register.

4.4.6.3 Community nursing service controlled drug record

This is the controlled drug stationary that community colleagues in trust physical health community services use.

4.4.6.4 Prescription forms (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 centre’s in secondary care are FP10MDA-SS.

4.4.6.5 Electronic prescription service
Electronic prescription service (EPS) is the process by which a prescription is transmitted to a patient’s named community pharmacy for dispensing.

4.4.6.6 Drug card or 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 Appendices

5.1 Appendix A at a glance controlled drugs requirements

Refer to appendix A: at a glance controlled drugs requirements (staff access only).

5.2 Appendix B ward controlled drugs signatory and counter-signatory samples

Refer to appendix A: ward controlled drugs signatory and counter-signatory samples (staff access only).

Document control

Version: 6.7.
Unique reference number: 138.
Approved by: Clinical effectiveness group.
Date approved: 13 May 2025.
Name of originator or author: Senior pharmacist on behalf of the trust medicines optimisation group.
Name of responsible individual: Trust medicines optimisation group.
Date issued: 24 June 2025.
Review date: 30- June 2028.
Target audience: All colleagues.
Description of change: General review with minor amendments.

Page last reviewed: June 24, 2025
Next review due: June 24, 2026

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