Standard Operating Procedures (SOPs)

References

1. National Institute for Health and Care Excellence (NICE) British National Formulary (BNF) ‘Controlled drugs and drug dependence: Regulations and classification’ Last Accessed January 2022.
2. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.
3. Pharmaceutical Services Negotiating Committee (PSNC) Controlled Drug regulations Last Accessed January 2022.

Before you read the next section – what do you think you know about CDs schedules?

Controlled drug schedules

The designations in brackets are the legal classifications used in the Alphabetical List of Medicines for Human Use in the Medicines Ethics and Practice Guide (MEP).¹ The full list of drugs included in the schedules can be found in the Appendix

References

1. The Medicines Ethics and Practice Guide (MEP) (Access is for members of the Royal Pharmaceutical Society only) Last Accessed January 2022.
2. National Institute for Health and Care Excellence (NICE) British National Formulary (BNF) ‘Controlled drugs and drug dependence: Regulations and classification’ Last Accessed January 2022.

Safe storage of CDs

• The Regulations state that CDs in Schedules 1, 2 and 3, must be kept in safe custody.¹
• Quinalbarbitone (Schedule 2) is exempt from the safe custody requirements¹ (although we recommend that it is stored securely as reminder that it still needs to meet the additional prescription requirements, and its records need to be kept regarding receipt and supply).
• Safe custody requirements apply to Schedule 3 drugs except for:¹
  • 5,5 disubstituted barbituric acid
  • Gabapentin
  • Mazindol
  • Meprobamate
  • Midazolam
  • Pentazocine
  • Phentermine
  • Pregabalin
  • Tramadol hydrochloride
  • Any stereoisomeric form or salts of the above

What is “safe custody”?

Typically, a locked and secured cupboard or cabinet used solely for the purpose of storing CDs. There are detailed specifications which CDs cupboards must meet in order to satisfy the Misuse of Drugs (Safe Custody) Regulations 1973.²

The CDs cupboard must be kept locked when not in use and access must be limited to those with specific authority e.g., pharmacist, or locum GPs and experienced dispensers.²

References

1. National Institute for Health and Care Excellence (NICE) British National Formulary (BNF) ‘Controlled drugs and drug dependence: Regulations and classification’ Last Accessed January 2022.
2. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.

Ordering CDs from a wholesaler

• Pharmacists do not need to issue a signed order when purchasing Schedule 2 or 3 CDs from a pharmaceutical wholesaler.¹
• Any organisation that holds stocks of CDs should keep those levels to a minimum whilst holding sufficient stock to meet patients’ needs. Reviewing CDs usage over the previous 2 years can help to ensure current stock holding is appropriate. Requisitions and invoices for CDs should ideally be kept for longer than the mandatory 2 years as cases often come to court at a much later date, by which time any evidence would have been destroyed.¹
• When receiving a supply of CD, it is the responsibility of the pharmacist to ensure that the correct items have been delivered and that all appropriate entries are made in the Controlled Drug Register (CDR) on the day or following day of receipt. The task of completing the CDR can be delegated, but the doctor or pharmacist is ultimately accountable.¹
• Anyone who receives CDs from the wholesaler other than the accountable doctor or pharmacist should be authorised to do so in writing, in advance, and should sign the supplier’s delivery note at the point of receipt.¹
• Where CDs are transferred between pharmacies, the pharmacist requesting the supply should provide a requisition as described above (FP10CDF) and the supplier should submit the original to the Prescription Pricing Division (PPD). Both pharmacists must ensure that the correct entries are made in their respective CDRs within 24 hours.¹

Reference

1. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.

Before you read the next section - When receiving CDs, which three pieces of information do you think must be recorded in the Controlled Drugs Register (CDR)?

A. Date the supply was received

B. Name and address from the wholesaler it was received

C. Whether proof of identity was requested of you (yes or no)

D. Quantity

E. The name of the delivery driver

Controlled Drugs Registers (CDRs)

The following rules must be followed:

• Records for Schedule 2 CDs must be kept in a CDs register. This is not a legal requirement for Schedule 3, 4 or 5 CDs.¹
• Be bound (not loose-leaved) or a computerised system which is in accordance with best practice guidance.²
• A separate register or separate part of the register must be kept for each class of drug and a separate page shall be used for each strength and form of drug.²
• The name of the drug, its strength and form must be written at the top of the page.²
• Entries must be in chronological sequence so must be made in the order in which they happen.²
• Entries must be made on the day of the transaction or on the next day (within 24 hours).²
• No cancellation, obliteration or alteration may be made; any errors should be marked neatly e.g., with an asterisk* and amendments or corrections must be put in as a footnote and signed and dated.²
• Entries must be in ink or otherwise indelible or shall be in computerised form.²
• Electronic registers need to identify the person making each entry and must prevent entries being altered at a later date.¹
• The CDR must be kept at the practice and must be kept for a minimum of 2 years after the date of the last entry, once completed.¹

References

1. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.
2. Care Quality Commission ‘GP mythbuster 28: Management of controlled drugs’, Last Updated 28 April 2021 Last Accessed January 2022.

Records of the supply and collection of CDs

It is essential to record the supply and collection of CDs

A lot of information relating to the supply of CDs must be recorded in the CDR, including information about who has collected drugs ordered on a requisition or prescription.¹

• The details required as a minimum are:¹
  • When CDs are obtained
    • Date of supply obtained
    • Name and address from whom obtained (e.g., wholesaler, pharmacy)
    • Quantity obtained
  • When CDs are supplied
    • Date supplied
    • Name and address of person or firm supplied
    • Quantity
    • Person collecting the Schedule 2 Controlled Drug (this could be the patient/patient’s representative/healthcare professional; if it is a healthcare professional their name and address)
    • Details of authority to possess, in other words, the prescriber or licence holder’s details
    • Whether proof of identity of person collecting was requested (yes or no)
    • Whether proof of identity of person collecting was provided (yes or no)
• Note: Entries relating to the supply of CDs should not be made until the supply has taken place. Frequently the item will be dispensed on a different day to the date of supply.¹

It is good practice that wherever possible, two members of staff should check all stock received or removed, and both individuals should initial the entry in the CDR, where the format of the register allows this.¹

Reference

1. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.

Prescribing CDs

• Pharmacist independent prescribers are able to prescribe any controlled drug listed in schedules 2-5 for any medical condition within their competence, except diamorphine, cocaine and dipipanone for the treatment of addiction (pharmacist independent prescribers are able to prescribe other controlled drugs for the treatment of addiction).¹
• Pharmacist independent prescribers can requisition controlled drugs and are authorised to supply or administer the drugs they are able to prescribe. The existing authorities for pharmacists to possess, supply and offer to supply schedule 2-5 controlled drugs remain.¹
• Following a change in legislation in 2015, schedule 2 and 3 CDs prescriptions can be sent electronically via the Electronic Prescription Service (EPS) or handwritten.²
• It is good practice to limit prescription to provide sufficient supply for a patient for 30 days. There are some circumstances where this can be extended i.e., clinical indication and where the risk / benefit ratio has been assessed as acceptable – the prescriber should be prepared to justify the decision if later challenged.²
  • The decision for extending the supply beyond 30 days should be recorded in the patient’s record.²

References

1. Gov.uk ‘Nurse and pharmacist independent prescribing changes announced’ 23 April 2012 Last Accessed January 2022.
2. Care Quality Commission ‘GP mythbuster 28: Management of controlled drugs’, Last Updated 28 April 2021 Last Accessed January 2022.

Example of a prescription form for schedule 2 and 3 CDs

This form contains fictitious patient information for illustrative purposes only.

What has gone wrong?

This form contains fictitious patient information for illustrative purposes only. Review the below form and click ‘next’ to see what has gone wrong.

Did you spot the errors?

This form contains fictitious patient information for illustrative purposes only.

Dispensing prescriptions for CDs

• Pharmacists dispensing CDs to substance misusers should liaise with the prescriber regarding collection/non-collection of the CDs by these clients.¹
• As with all dispensed medicinal products (except unlicensed medicines), it is a legal requirement to provide a manufacturer’s patient information leaflet when medicines are dispensed.¹
• In addition, as part of a risk management strategy, other than in exceptional circumstances, the prescriber of CDs should ideally not dispense, transport and administer the medication prescribed, in other words, at least one other suitably trained person should be involved in the process.¹

Reference

1. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.

Administrating CDs

• Supervised consumption is not a legal requirement under the 2001 Regulations. Nevertheless, when supervised consumption is directed on the prescription, the Department of Health recommends that any deviation from the prescriber’s intended method of supply should be documented and the justification for this recorded.¹
• Patients who require supervision of consumption should be conducted by a pharmacist, or a member of staff who has undergone appropriate Primary Care Trust (PCT) approved training. This should ideally be carried out in a quiet area of the pharmacy. This area should not normally be the dispensary, or involve taking the patient through the dispensary.²
• The pharmacist should separate the dispensing process from the supervised consumption process. Patients should be invited to check the label, but the pharmacist should retain the bottle and destroy the label.²
• Where more than one day’s supply is dispensed the pharmacist should ensure that the patient can measure the dose.²
  • Note: If the prescriber doesn’t add the words ‘Dispense daily doses in separate containers and in advance’ the pharmacist will not be reimbursed for prescribing in individual containers.²

References

1. National Institute for Health and Care Excellence (NICE) British National Formulary (BNF) ‘Controlled drugs and drug dependence: Regulations and classification’ Last Accessed January 2022.
2. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.

Checking dispensed prescriptions

• Robust checking protocols should be in place and staff involved in checking should have consistently demonstrated their competence before being allowed to check dispensed items. In each case, the checker must check the prescription is legal and complete, and then use the prescription to check:
• The Dispensing Label¹
  • name of the patient
  • name and address of the supplying pharmacy
  • date of dispensing
  • name of the medicine
  • directions for use of the medicine
  • precautions relating to the use of the medicine
  • ‘Keep out of the sight and reach of children’
• The Dispensed Item¹
  • Drug name, strength, form, quantity, expiry date, PIL and sundry items.
  • Where possible, when dispensing CDs, the quantity/volume and strength should be verified by a second person.
• Private prescriptions¹
  • Private prescriptions for CDs in Schedules 2 and 3 must be on specific forms (FP10PCDs in England, PPCDs in Scotland, W10PCDs in Wales).
  • Prescriptions must include the prescriber’s identification number (NHS prescriber code in Scotland). This is not the same as the professional registration number.
  • The original prescription forms must be sent to the relevant NHS Agency, as is the case for the standardised CDs requisitions.

Reference

1. Dispensing Doctors Association (DDA) Dispensing Guidance, Eighth Edition, Published 2019 Last Accessed January 2022.

Destruction of CDs

Pharmacy contractors must have appropriate arrangements in place for securing the safe destruction and disposal of Controlled Drugs. These will either be CDs that have passed their expiry date, or drugs which have been dispensed for a patient and have now been returned for safe destruction.¹

Storage of items awaiting destruction²

• Drugs which would normally require safe custody, continue to do so whilst awaiting destruction. This affects both stock and patient returns. It is therefore extremely important that the items are clearly marked and kept as separate as possible from the stock of CDs to prevent them being selected and dispensed by accident.

Obsolete, expired and unwanted stock of CDs

• The destruction of Schedule 1 and 2 CDs must be witnessed by a person authorised by the Secretary of State. There are a number of different people who can act as witnesses for the destruction of stock, including police officers who are CDs liaison officers.³
• The destruction of stocks of Schedule 3 and 4 CDs does not need to be witnessed by an authorised person.³
• Expired Schedule 5 preparations can be destroyed without an authorised witness.³
• Stock waiting to be destroyed must be included in the running balance in the CDR until it is destroyed. The destruction must be appropriately noted in the register and the authorised witness should sign the entry.¹

References

1. Pharmaceutical Services Negotiating Committee (PSNC) Controlled Drug regulations Last Accessed January 2022.
2. NHS England ‘NHS England BGSW Area Team Controlled Drug Management: Standard Operating Procedures’, Published October 2014.
3. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009.

Destruction of patient returned medicines

References

1. The National Prescribing Centre ‘A guide to good practice in the management of CDs in primary care in England’, Third Edition, Published December 2009 2. NHS England ‘NHS England BGSW Area Team Controlled Drug Management: Standard Operating Procedures’, Published October 2014 Last Accessed January 2022.
2. NICE Guideline ‘Controlled drugs: safe use and management’ Published 12 April 2016 https://www.nice.org.uk/guidance/ng46/resources/controlled-drugs-safe-use-and-management-pdf-1837456188613 Last Accessed January 2022.

Destruction of CDs

• All CDs in Schedules 2, 3 and 4 (Part I) must be denatured so that the drug is irretrievable before being placed into waste containers.¹
• Wherever possible it is best to use commercially available denaturing kits.¹
• The table below gives detailed information on the way in which different formulations should be denatured.²

References

1. Pharmaceutical Services Negotiating Committee (PSNC) Controlled Drug regulations Last Accessed January 2022.
2. NHS England ‘NHS England BGSW Area Team Controlled Drug Management: Standard Operating Procedures’, Published October 2014 Last Accessed January 2022.

Useful links

• The Medicines Ethics and Practice Guide (MEP) – detailed information on the management of CDs in pharmacy, much of which applies to dispensing practices. In addition to stating the requirements specified in the Regulations it also contains useful summary tables
• The National Prescribing Centre – a guide to good practice in the management of CDs in primary care in England
• Example of a Controlled Drug Self-assessment and Declaration form
• List of most common CDs – a list of the most commonly encountered drugs currently controlled under the misuse of drugs legislation showing their respective classifications under both the Misuse of Drugs Act 1971 (MDA) and the Misuse of Drugs Regulations 2001 (MDR)

You have now completed the training slides.