Julie Price, Clinical Risk Programme Manager, investigates whether practices are handling controlled drugs safely
"Good morning Beryl,” said the burly police officer, reading the receptionist’s name badge as he leaned over the reception desk of Goodyear Medical Practice. “I have come to inspect your controlled drugs register to ensure that all is in order – may I speak to the practice manager or senior partner please?"
How would you feel if this happened at your practice? Would you be confident that you are complying with legislation? Following the repercussions of the Harold Shipman inquiry, the government has introduced tougher processes to ensure that controlled drugs (CDs) are managed safely.
"Practices should be particularly mindful of how they handle controlled drugs, as not following the correct protocols could have repercussions"
The Health Act (2006) has given power of entry and inspection to the police, who can now enter practices and inspect CD registers. To quote the inspector from JB Priestley’s famous play: “You see, Mr Birling, you can never escape your actions.” So practices should be particularly mindful of how they handle controlled drugs, as not following the correct protocols could have repercussions.
Are practices managing CDs safely?
During 2009 MPS Educational Services facilitated more than 130 CRSAs of general practices across the UK. Many practices had taken the decision not to hold controlled drugs within the practice, or carry them in the doctor’s bag, due in part to the legislation surrounding CDs.
These were mostly practices in urban areas, where an ambulance could respond to a call quickly.
However, a vast number of practices still took the decision to hold CDs. An analysis of the data from the CRSAs revealed that 31% of the practices visited had risks related to the secure storage of controlled drugs.
These risks included problems relating to:
- CD registers, eg, no running balance of stock recorded
- Security of controlled drugs, eg, not stored in a lockable cabinet in the practice
- Destruction of CDs, e.g. the practice destroying date expired CDs in the practice using cat litter
- Carrying CDs in the doctor’s bag, eg, although the drugs were accounted for in the practice controlled drugs register, there were no individual registers for CDs carried in the bags.
What are the rules and regulations surrounding CDs? Under the Misuse of Drugs Act (1971) and the Misuse of Drugs Regulations (2001), GPs have a responsibility for CDs within their practice.
Not only do the police have a right of access into the practice, but an accountable officer, appointed by the PCT, has the right to visit your practice unannounced to review the storage and records relating to their use. The accountable officer may be a primary care medical director, clinical governance lead or health authority pharmacist.
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 the whereabouts only known by the designated key holders. No unauthorised members of staff should have access to the keys, eg, locum nurse or doctor.
Controlled drugs register
Any practice storing CDs should have a controlled drugs 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.1
Full details of the requirements for computerised CDRs are set out in SR005/2864, available from the following weblink: www.opsi.gov.uk
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.
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 controlled drugs 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 controlled drugs register for the controlled drugs 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 (see below). A record of this transaction should be recorded in both registers. If there is no practice stock then the expired CD would need to be destroyed directly from the bag and witnessed by an authorised person. A record should be made.
Destruction of controlled drugs
Practice staff are not allowed to destroy date- expired or unwanted CDs from their stock without the destruction being witnessed by an authorised person, nominated by the accountable officer. This authorised person should:
- not be someone who is involved with the day-to-day management and use of the CDs.
- be trained to undertake this role and be subject to a professional code of ethics and/or subject to a Criminal Record Bureau (CRB) check.
- use the CD denaturing kit in destruction.2
When a CD has been destroyed, details of the destruction should be recorded in the CD register. This should include:
- the name of the drug
- strength and quantity
- the date it was destroyed
- the signature of the authorised person who witnessed the destruction and the professional destroying it (ie, two signatures).
If a patient returns a CD from their home it is best practice that the CD is destroyed in the presence of the authorised person. A record should be made of this action. Ideally you should ask the patient to return the drugs to the local pharmacy.
Top ten tips for handling controlled drugs
- Ensure that CDs are kept in a metal lockable cupboard or safe.
- Maintain a CD register – either a bound book or electronic register.
- It is best practice to maintain a running balance of stock in the practice controlled drug register.
- Ensure that entries are recorded on the correct page of the practice CDs register, ie, a separate page for each drug.
- 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.
- Ensure that all doctors have individual registers for controlled drugs carried in their bags.
- 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.
- Ensure controlled drugs that have expired are destroyed by an authorised person.
- Develop standard operating procedures for the management of controlled drugs in accordance with the guidance below.
- Contact MPS if you have any queries relating to the management of CDs within your practice.
Standard operating procedures
Practices should draw up a protocol for the management and handling of all CDs, including all the points discussed in the article, in accordance with DH guidance.3
So how are practices doing?
A report published in 2010 by the CQC said that progress has been made in implementing regulations in response to the Shipman Inquiry.4 It said that health and social care organisations are continuing to develop systems to manage controlled drugs more effectively, while sharing concerns and best practice locally and nationally. The report concludes that managing and monitoring systems for controlled drugs will require ongoing activity and vigilance to sustain the developments achieved in the past three years. To reiterate the Inspector’s quote, maybe it’s not such a bad thing that Mr Birling could not escape his actions.
Please call the MPS advisory helpline if you have any queries relating to the management of CDs.
- National Prescribing Centre, A Guide to Good Practice in the Management of Controlled Drugs in Primary Care England, Third Edition (2009) – www.npci.org.uk
- Royal Pharmaceutical Society, Guidance for Pharmacists on the Safe Destruction of Controlled Drugs England, Scotland and Wales (2007) – www.rpharms.com
- DH, Safer Management of Controlled Drugs: Guidance on Standard Operating Procedures (2007) – www.dh.gov.uk
- CQC, The Safer Management of Controlled Drugs, Annual report 2009 (August 2010) – www.cqc.org.uk
Last updated: October 2010
Please note: Medical Protection does not maintain this article and therefore the advice given may be incorrect or out of date, and may not constitute a definitive or complete statement of the legal, regulatory and/or clinical environment. MPS accepts no responsibility for the accuracy or completeness of the advice given, in particular where the legal, regulatory and/or clinical environment has changed. Articles are not intended to constitute advice in any specific situation, and if you are a member you should contact Medical Protection for tailored advice. All implied warranties and conditions are excluded, to the maximum extent permitted by law.