Controlled Drug Regulations
Controlled Drug Regulations
|The Misuse of Drugs
Regulations 2001 (16(2))
|Dispensing Controlled Drugs|
|Monitoring and inspection
|Patient drug record cards|
|Record keeping requirements|
Pharmacy contractors must have appropriate arrangements in place for securing the safe destruction and disposal of CDs. All CDs in Schedule 2 and those CDs in Schedule 3 that are subject to safe custody requirements should be placed into waste containers only after the controlled drug has been rendered irretrievable (i.e. by denaturing). Where practicable pharmacists should use CD denaturing kits in order to denature CDs, these can be obtained from some PCOs, waste contractors and the NPA. Where this is not possible other methods of denaturing may be used for example adsorbing onto cat litter, provided that there are no risks to human health or the environment. Detailed guidance on the disposal of unwanted medicines can be found in the waste section of this website.
Patient returned CDs: Pharmacies can accept CDs returned by patients from their own homes and from care homes providing personal care for safe destruction and onward disposal. Pharmacies in England and Wales are not able to accept waste medicines, including CDs, from care homes which provide nursing care. Pharmacists must make a record of patient returned Schedule 2 CDs, and their destruction, and to ensure another member of staff, preferably a pharmacist or pharmacy technician if available, witness the destruction. There is currently no requirement for the destruction of patient returned CDs to be destroyed by an authorised witness. The record of the destruction should be made somewhere other than the CD register.
Date expired pharmacy stock: It is a legal requirement for pharmacy contractors to have stocks of obsolete, expired and unwanted Schedule 1 and 2 CDs destroyed in the presence of an authorised witness.
An amendment to the Misuse of Drugs Regulations 2001 which came into force on the 16th August 2007 allows Accountable Officers to authorise people or groups of people to witness the destruction of controlled drugs to render them irretrievable. Previously the witnessing of destruction of controlled drugs was undertaken by the police chemist inspection officers, the Royal Pharmaceutical Society inspectors, and the Home Office inspectors.
Any person authorised to witness destruction of controlled drugs by the accountable officer should have the appropriate training and will be accountable for this directly to the accountable officer.
A record of the date of destruction, quantity of product destroyed and a signature of the witness should be entered into the CDR. The disposal of date-expired medicines in Schedules 3,4 and 5 does not need to be witnessed or recorded.
Monitoring and Inspection Arrangements (back to top)
New arrangements were introduced in January 2007 for monitoring the management, usage and other aspects of controlled drugs in England. These arrangements do not yet apply in Wales.
Every healthcare organisation (e.g. NHS England Area Team) must have an appointed ‘Accountable Officer’ with a duty to oversee the management and use of controlled drugs. The accountable officers appointed by Area Teams have a range of responsibilities including ensuring that pharmacies have adequate and up-to-date standard operating procedures (SOPs) in relation to the use of CDs, have appropriate arrangements in place for securing the safe destruction and disposal of CDs and systems in place to alert the Accountable Officer of complaints or concerns involving the management and use of CDs.
As part of the new arrangements, the RPSGB now ask pharmacy contractors to make a declaration in relation to the management and use of CDs at each of their premises. This forms part of the annual premises retention fee cycle.
SOPs: Pharmacy contractors are required under their terms of service to have SOPs for dispensing and repeat dispensing. The regulations now also require SOPs relating to the management and use of controlled drugs to cover the following points:
- Ordering and receipt of CDs;
- Assigning responsibilities;
- Where the Controlled Drugs are stored
- Who has access to the CDs
- Who should be alerted if complications arise
- Security in relation to the storage and transportation of CDs as required by the Misuse of Drugs regulations
- Disposal and destruction of CDs
- Record keeping, including maintaining relevant CDRs under the Misuse of Drugs legislation and maintaining a record of the CDs specified in Schedule 2 to the Misuse of Drugs Regulations 2001 that have been returned by patients
Monitoring and Supporting Staff Handling CDs: Pharmacy contractors need to have in place arrangements for monitoring and auditing the management and use of CDs by pharmacists and staff. The arrangements are required to include:
- Recording any concerns raised in relation to the management and use of CDs by the relevant individual;
- Assessing and investigating any concerns raised regarding the management and use of CDs by the relevant individual; and
- Determine if there are any concerns in relation to the management and use of CDs by a relevant individual which the pharmacy contractor considers should be shared with a responsible body e.g. RPSGB
Pharmacy contractor must also ensure that pharmacists and staff handling CDs receive from time to time, appropriate training to carry out their responsibilities in the management and use of CDs.
Recording concerns: Pharmacy contractors should record concerns expressed about incidents that involved or may have involved improper management or use of CDs by a pharmacist or member of staff. The record should include the following:
- The date on which the concern is made known;
- The dates on which the matters giving rise to the concern;
- Details regarding the nature of the concern;
- Details of the pharmacist or staff involved;
- Details of the person or body raising the concern;
- Details of any action taken;
- An assessment of whether information should be disclosed to a responsible body; and
- If disclosure to a responsible body takes place, details of the disclosure and the responsible body to which the disclosure was made
An Accountable officer and police officers would have the power to enter and inspect pharmacy premises if concerns were being investigated.
Patient Drug Record Cards (back to top)
Pilots are being undertaken in which patients are handed drug record cards with all dispensed injectable schedule 2 controlled drugs. These cards are used by the patient or their nurse to record each administration event, and to carry out an audit of stock remaining if any at the end of a course of treatment.
Until the trials are complete, the precise processes will not be decided, but a common feature of all the pilots is that the dispensing pharmacist prepares the drug record card. We expect these changes to happen at some time in the future and further guidance will be provided.
Record Keeping Requirements (back to top)
Running Balances: As a matter of good practice pharmacists who supply CDs should maintain a running balance of stock in their Controlled Drug Register (CDRs). This is expected to become a mandatory requirement once electronic registers are in common use. Further guidance on the maintenance of a running balance in the CDR is available on the RPS Website.
Controlled Drug Registers: From 1st February 2008 the requirement to maintain a Controlled Drug Register (CDR) in its prescribed form as was set out in schedule 6 of the 2001 regulations was removed and replaced with a requirement for specific headings/fields in the CDR. The regulations now also require that additional information should be recorded in the CDR in relation to the identity of the person collecting a schedule 2 CD supplied on prescription.
The regulations allow the following information to be recorded in the CDR, under the following specific headings, when CDs are obtained:
- Date supply obtained
- Name and address from whom obtained (e.g. wholesaler, pharmacy)
- Quantity obtained
When CDs are supplied, the regulations require information to be recorded in the CDR, under the following specifc headings:
- Date supplied
- Name and address of person or firm supplied
- Details of authority to possess-prescriber or license holder details
- Quantity supplied
- Whether the person who collected the drug was the patient, the patient’s representative or a healthcare professional acting on behalf of the patient;
- If the person who collected the drug was a healthcare professional acting on behalf of the patient, that person’s name and address;
- If the person who collected the drug was the patient or the patient’s representative, whether evidence of identity was requested of that person (yes/no);And whether evidence of identity was provided by the person collecting the drug (yes/no).
Further guidance on the changes to record keeping requirements for controlled drugs can be found on the Department of Health website.
Electronic Controlled Drug Registers: Pharmacists are allowed legally to keep CDRs electronically if they wish to do so providing they comply with the legislation. The Regulations require that every computerised entry must be attributable and capable of being audited. The computerised register must be accessible from the premises to which it relates and persons authorised by the Secretary of State (e.g., the Society’s inspectors) are able to request that a copy of the register, in its computerised or other specified form, be sent to them.
Pharmacists are advised that CD registers may only be held in a computerised form if safeguards are incorporated into the software to ensure all of the following:
- The author of each entry is identifiable
- Entries cannot be altered at a later date
- A log of all data entered is kept and can be recalled for audit purposes
Access control systems should be in place to minimise the risk of unauthorised or unnecessary access to the data and adequate backups must be made. Pharmacists are also advised that arrangements must be made so that inspectors can examine computerised records during a visit with minimum disruption to the dispensing process. A number of pharmacy system suppliers have now integrated electronic registers into their dispensing systems.