With the ever-changing legislation surrounding the management of controlled drugs, clinical risk manager Kate Taylor asks, is your practice is up-to-date?
The repercussions of the Harold Shipman inquiry saw the introduction of tougher measures to ensure the safe management of controlled drugs (CDs).The Health Act (2006) gave inspection power to the police, who can now enter practices and inspect CD registers.1
Practices must ensure that they are compliant with the newly revised CDs regulations, which came into force in April 2013.2
Last year MPS facilitated more than 150 Clinical Risk Self Assessments (CRSAs) of general practices across the UK.
Due to the complexity of the legislation, an increasing number of practices are choosing not to stock controlled drugs or carry them in the doctor’s bag. Notably these were mostly practices whereby a quick response could be received from emergency services.
However, of those practices who held CDs, an analysis of the data from the CRSAs revealed that 13% of practices visited had risks associated with the overall governance surrounding CDs.
These risks included:
CD registers – no running balance of stock
Insecure storage – not stored in a lockable cabinet
Incorrect destruction of CDs
Carrying CDs in the doctor’s bag without concise records.
So what are the rules and regulations surrounding CDs?
An accountable officer appointed by the NHS Commissioning Board has authority to visit your practice unannounced to review the storage and records of CDs.
The CQC also has responsibility to make sure that health and social care providers maintain a safe environment for the management of controlled drugs. It incorporates CD governance arrangements into its inspection model for primary care.3
The Misuse of Drugs Regulations (1973) state that all schedule 2 (eg, opiates) and some schedule 3 (eg, temazepam) drugs should be stored in a metal secure cabinet or safe fixed to the floor or wall.
A designated person should be responsible for the CDs and appoint key holders. The keys should be kept in a confidential location no unauthorised members should have access to it.
Controlled drugs register
Any practice storing CDs should have a controlled drugs register (eg, bound book or electronic form).These records must be kept for two years and a separate book must be held for branch surgeries. If the CD register is electronic it should be auditable, printer friendly and display the information details clearly.
In the book a separate sheet must be used for the strength and form of each drug. You must record:
The date the supply was obtained
The name and address from whom it was obtained, including the quantity of ampoules.
To ensure accuracy it is best practice to record:
Running balances of each drug
The prescribers identification number and/or the professional registration number of the prescriber (where known).
The practice should undertake regular stock checks, ideally by two healthcare professionals. Both should initial the entry if a book is used. Any discrepancies should be investigated and recorded in the CD register correcting the discrepancy in the balance.
Keep a record of the action taken when a discrepancy occurs. If you cannot resolve the discrepancy, inform the accountable officer.
All healthcare professionals in legal possession of CDs have a professional duty of care to take all reasonable steps in maintaining safe custody of CDs.
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 CD stock and record an entry in the CD register.
The CDs should be stored in a lockable 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 register for the CDs carried in their bags. The GP is responsible for those drugs.
Administration of a CD to a patient should be recorded in the doctor’s CD register.
If a CD has expired, the GP should return it to the practice stock awaiting destruction. This should be recorded in both registers. If there is no practice stock, then the expired CD needs to be destroyed directly from the bag and witnessed by an authorised person. A record should be made.
Destruction of CDs
Practice staff are not allowed to destroy 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 subjected to a professional code of ethics and/or a DSB check
Use the CD denaturing kit in destruction.
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 authorised 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 an authorised person, and a record should be made of this action. Ideally you should ask the patient to return the drugs to the local pharmacy.
Standard operating procedures
Practices should draw up a protocol for the management and handling of CDs. It should include all points discussed in this article and be in accordance with Department of Health guidance.4
So how are practices doing?
A recent CQC report states that practices have made significant progress in implementing regulations in response to the Shipman inquiry. General practice teams are now registered with the CQC and will have to provide evidence that they are compliant with all the essential standards of quality and safety.
This includes regulation 13, outcome 9b that relates to the management of CDs. Inspection teams will require practices to provide evidence of compliance; this could include inspection of CDs storage facilities, reviewing the CD register, and asking staff about the practice policy on the overall management of CDs.
The Health Act (2006)
NHS England, The Controlled Drugs (Supervision of Management and Use) Regulations (2013)
CQC, The Safer Management of Controlled Drugs, Annual report 2009 (August 2010) – www.cqc.org.uk
Department of Health, Safer Management of Controlled Drugs: Guidance on Standard Operating Procedures (2007) – www.dh.gov.uk
Are your controlled drugs procedures up-to-date? Could they be identified as a risk within your practice? Book a Clinical Risk Self Assessment with MPS to find out.
For more information visit our workshop pages or contact our dedicated team on 0113 241 0359, or by email at firstname.lastname@example.org.
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