Overview

Legislation & Guidance

• The legitimate clinical use of CDs is governed by the Misuse of Drugs Regulations 2001
• These divide CDs into five therapeutic 'schedules' according to the level of control they need with the higher the schedule indicating the need for the greatest control
• Schedule 2 includes diamorphine (heroin), morphine and pethidine. All schedule 2 CDs are subject to the full controlled drug requirements relating to prescriptions and safe custody and the need to keep registers
• Schedule 3 includes buprenorphine, diethylpropion, midazolam, pentazocine, phentermine, temazepam, and tramadol. They are subject to the special prescription requirements, and some are required to be stored in a CD cupboard (e.g. temazepam and buprenorphine but not tramadol). A register does not need to be kept.
• The legislation that sets out the storage requirements: Misuse of Drugs (Safe Custody) Regulations 1973
• However, as this legislation is now more than forty years old, the Home Office has also recently published guidance: Security guidance for all existing or prospective Home Office Controlled Drug Licensees and/or Precursor Chemical Licensees or Registrants

All healthcare professionals need to remember their responsibility to speak up on areas of concern that may negatively affect patient safety, including prescribing, administering, dispensing, supplying, and disposing of controlled drugs (CDs).

Nominated Lead for Controlled Drugs (CDAO)

Dr Sarah Hawxwell

sarah.hawxwell@nhs.net or Teams

Safety Alerts

There is a thread of safety alerts on the MHRA website: https://www.gov.uk/drug-safety-update

Stocks & Ordering

Prescribing & Administration

• CD prescribers should regularly review patients’ clinical needs before prescribing and consider the quantity prescribed, particularly when issuing repeat prescriptions
• Prescribers should also follow local and national guidelines on route, dose (including dose conversion), and formulation, recording their justification for any deviation
• Use a recognised opioid dose conversion guide when switching drugs and ensure total opioid load is considered
• Information should be provided to the patient and their carers to include expected length of treatment, how long the medicine will take to work, what it is for, how to use immediate-release and sustained-release formulations, and effect on driving
• Prescriptions for Schedules 2 and 3 CDs can be sent electronically via the Electronic Prescription Service (EPS) and signed with an Advanced Electronic Signature (AES). EPS is the preferred route, but they can also be handwritten
• If hand written, the prescription must be scanned onto EMIS, and recorded in Medications
• Prescribers are strongly advised to limit the quantity of Schedule 2, 3 and 4 CDs prescribed to amounts that meet the patient’s clinical need for up to 30 days’ supply
• In exceptional circumstances, where the prescriber considers more than 30 days is clinically indicated and would not pose an unacceptable risk to patient safety, a record of the reasons for deviating from the guidance should be made in the patient’s record and the prescriber should be able to justify the decision, if challenged
• Independent Prescribing Practitioners (IPPs) must only prescribe within their areas of competency. IPPs and Locum GPs are advised to contact the regular GP on site to discuss
• For Practice Pharmacists, these are important notes to consider when prescribing and issuing a CD repeat prescription:
• Frequency of review for further repeat prescriptions - Take the CD and the person's individual circumstances into account
• Potential risk for misuse
• Practice staff need to take steps to prevent issuing prescriptions once they are aware that the patient no longer needs the controlled drug. See 🔁Repeat Prescribing
• Prescription stationery for CDs, including printer paper, must be stored securely to prevent theft and misuse to fraudulently obtain controlled drugs. See CQC Guidance

Patient Returns

• Patient returns are not accepted, and the patient, or their family, should be advised to return them to the local pharmacy

Audits

• CDAOs are responsible for all aspects of controlled drugs management within their organisation
• A CDAO must:
• be a senior manager of their organisation
• not routinely supply or handle controlled drugs themselves as part of their duties as an employee or officer
• The CQC has set out a self-assessment tool to help Primary Care organisations undertake controlled drug audits

Escalation Procedures

• The first contact for Controlled Drugs is the nominated Lead, Dr Sarah Hawxwell
• The London CDAO expects that all incidents and concerns in primary care are reported through the CD Reporting website to ensure consistency in the information provided. Furthermore, it is mandatory that all reports about the safe use and management of controlled drugs are made using this facility
• To use the online reporting tool, you are required to visit Controlled Drug (CD) Reporting and register as a user
• If a concern needs an urgent response, the London CDAO should be contacted in addition to using CD Reporting

London CDAO

Sarah Dennison

england.londoncdaccountableoffice@nhs.net or 0207 932 3113

Cannabis-based Products for Medicinal Use (CBPMs)

CBPMs can only be lawfully initiated by a doctor on the GMC’s specialist register and only for specific unmet clinical needs, however we may be involved in shared-care agreements (See also 🤝Shared Care Agreements)

NICE has a guideline covering prescribing CBPMs