Controlled drugs - Scotland

Summary

Under the Misuse of Drugs Act (1971) and the Misuse of Drugs Regulations (2001), GPs have a responsibility for controlled drugs (CDs) within their practice. This factsheet highlights what you should be aware of when carrying, storing and recording controlled drugs.

Accountable Officers

The Health Act (2006) gave power of entry and inspection to the police, who can now enter practices and inspect CD registers. An accountable officer, appointed by the health board, has the right to visit a practice unannounced to review the storage and records relating to their use. This may be a primary care medical director, clinical governance lead or health authority pharmacist.

Storage

The Misuse of Drugs (Safe Custody) Regulations (1973) state that all schedule 2 (eg, opiates) and some schedule 3 (eg, temazepam) drugs should be stored in a cabinet or safe, locked with a key. The cabinet should be made of metal and fixed to the wall or floor. A designated person at the practice should be nominated as responsible for the CDs and appoint key holders. The keys should be kept in a safe place and no unauthorised members of staff should have access to the keys, eg, a locum. For home visits doctors should carry CDs in a lockable bag.

Controlled drugs register

Any practice storing CDs should have a CD register. This can take the form of a bound book or an electronic form. These must be kept for at least two years.

A separate book must be held for each premises, eg, one for a main practice and a separate one for a branch surgery. If the CD register is electronic, it should be auditable and be able to be printed, displaying the information detailed below on each page.

In the book a separate sheet must be used for each strength and form of that drug. On the page relating to that drug you must record:

• the date the supply was obtained
• the name and address from whom it was obtained (eg, wholesaler, pharmacy)
• the quantity of ampoules obtained.

In addition, it is best practice to ensure accuracy and veracity of the entries, to record:

• running balances of each drug
• the prescriber’s identification number and/or the professional registration number of the prescriber (where known), and also the name and professional registration number of the healthcare professional supplying the CD.

Stock checks

The practice should undertake regular stock checks, ideally by two members of staff who are healthcare professionals. Both should then initial the entry if a book is used.

If a discrepancy arises, this should be investigated and then a record made in the CD register correcting the discrepancy in the balance. Keep a record of the action taken when the discrepancy occurs. If you cannot resolve the discrepancy you should inform the accountable officer.

Doctor’s bag

All healthcare professionals in legal possession of CDs have a professional duty of care to take all reasonable steps to maintain safe custody of that CD at all times. If a GP wishes to carry CDs in his/her bag, the following should take place:

• A staff member should witness the GP stocking the bag from the practice CD stock and record an entry in the CD register.
• The CDs should be stored in a locked receptacle, which can only be opened by the person to whom the regulation applies. A digital combination lock is a convenient solution. Bags containing CDs should not be left in a vehicle overnight, or for long periods of time.
• Each doctor must keep a CD register for the CDs carried in their bags. The GP is responsible for the receipt and supply of CDs from their own bags.
• Details of the administration of a CD to a patient should be recorded in the doctor’s CD register.
• If a CD in the bag has expired, the doctor should return the CD to the practice stock, to await future destruction. A record of this transaction should be recorded in both registers.

Tramadol

Tramadol is now classed as a CD. Note the requirements for interval of supply, amount per supply plus daily dose to be included if prescribing by instalments. Prescriptions are only valid for 28 days. Good practice recommendation is no more than 30 days’ supply per prescription. There is no need to store in the CD cupboard and there are no requirements to record in the CD register.

PGDs: tramadol cannot be included on any PGDs.

Destruction: tramadol, like all Schedule 2-4 CDs, should be denatured by use of a CD destruction kit before disposal in pharmaceutical waste.

Top ten tips for handling controlled drugs

1. Ensure that CDs are kept in a metal lockable cupboard or safe.
2. Maintain a CD register – either a bound book or electronic register.
3. It is best practice to maintain a running balance of stock in the practice CD register.
4. Ensure that entries are recorded on the correct page of the practice CDs register, ie, a separate page for each drug.
5. Wherever possible, two members of staff (at least one clinical) should check all stock received or removed; both individuals should initial the entry in the CD registers. You may wish to carry this out monthly as part of your standard operating routine.
6. Ensure that all doctors have individual registers for CDs carried in their bags.
7. Develop a practice system for checking expiry dates for drugs carried in the doctors’ bags. Consider creating a log of all drugs carried in the bags, including expiry dates, onto a computer spreadsheet. This should be regularly checked and managed by a designated member of staff.
8. Ensure CDs that have expired are destroyed by an authorised person.
9. Develop standard operating procedures for the management of CDs in accordance with the guidance below.
10. Contact MPS if you have any queries relating to the management of CDs within your practice.

Further information

• Safer Management of CD (CDs): Private CD prescriptions and changes to NHS Prescriptions – www.sehd.scot.nhs.uk
• Safer Management of CD: A. Changes to record keeping requirements; B. Destruction of CD: new role for accountable officers – www.sehd.scot.nhs.uk
• Safer Management of CD – Guidance on Strengthened Governance Arrangements – www.sehd.scot.nhs.uk
• Safer Management of CD: Standard Operating Procedures – www.sehd.scot.nhs.uk
• Doctor’s bag – Contents – www.patient.co.uk/doctor/The-Doctor’s-Bag-Contents.htm
• UK National Prescribing Centre, A Guide to Good Practice in the use of CD in Primary Care, Third edition, December (2009) – www.npc.nhs.uk/controlled_drugs