Controlled Drug regulations
Controlled Drug regulations
|REF: The Misuse of Drugs
Regulations 2001 (16(2))
|Dispensing Controlled Drugs|
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Destruction of Patient Returned and Stock Controlled Drugs
Pharmacy contractors must have appropriate arrangements in place for securing the safe destruction and disposal of Controlled Drugs (CD / CDs). The Royal Pharmaceutical Society (RPS) has issued guidance that unwanted CDs returned from patients homes in Schedule 2, Schedule 3 and Schedule 4 (part 1) should be placed into waste containers only after the CD 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 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 for disposal under the NHS funded unwanted medicines service. The RPS guidance to Pharmacists is that patient returned schedule 2 CDs should be recorded and their subsequent destruction recorded (in a separate record to the CD register). Patient returned CDs should be denatured in the presence of another member of staff, preferably a pharmacist or pharmacy technician if available. RPS guidance confirms that the destruction of patient returned CDs, whether they require denaturing or not, does not require witnessing by an authorised person.
Date expired pharmacy stock: It is a legal requirement under the 2001 regulations for pharmacy contractors to have stocks of obsolete, expired and unwanted Schedule 1 and 2 CDs destroyed in the presence of an authorised witness. RPS guidance indicates that for Schedule 3 CDs it would be good practice to have another member of staff witness the denaturing.
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 (the authorised witness) 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, GPhC (formerly Royal Pharmaceutical Society) inspectors, and the Home Office inspectors. The authorised witness is a person who is not involved in the day-to-day handling of controlled drugs who has been appointed by the CDAO to oversee the management and governance of activities related to controlled drugs.
Multiples may be able to obtain authorisation from NHS England’s Lead Controlled Drugs Accountable Officer (CDAO), for specified persons to be the authorised witness to be present to confirm the destruction of CDs within the pharmacy business. The authority is not available to persons who would normally handle CDs in the course of their employment; but could be for example, regional managers. You may wish to contact your local NHS team to discuss with the CDAO.
Bodies corporate, partnerships and/or individuals operating fewer than 5 community pharmacies may not have suitably trained individuals designated as Authorised Witnesses. To facilitate the timely destruction of obsolete CDs, NHS England will designate sufficient, suitably trained, individuals and/or class of person as Authorised Witnesses. This may include NHS England employees and/or agents, representatives of the appropriate Local Pharmaceutical Committee and/or persons nominated as appropriate to undertake the role by a recognised trade association such as the National Pharmacy Association or Independent Pharmacy Federation.
An independent community pharmacy may also contract with an independent Authorised Witness to facilitate the witnessed destruction of obsolete CDs. Where an independent community pharmacy requests an Authorised Witness to witness the destruction of obsolete CDs from NHS England, NHS England will ensure that one is made available
Any person authorised to witness the destruction of CDs by the accountable officer should have the appropriate training and will be accountable for this directly to the CDAO.
CQC maintain a record of the details of healthcare organisations’ accountable officers in an online register, which is updated whenever CQC are notified of changes.
In November 2013, NHS England published guidance on the supervision of management and use of CDs. In April 2016, NICE published guidance on “Controlled drugs: safe use and management” which covers systems and processes for using and managing CDs safely in all NHS settings except care homes. It aims to improve working practices to comply with legislation and have robust governance arrangements. It also aims to reduce the safety risks associated with CDs.
NICE Guidance states that when destroying and disposing of pharmacy own stock CDs in Schedule 2 the following must be entered into the CD register:
- the name, strength and form of the controlled drug;
- the quantity;
- the date of destruction;
- the signature of the authorised person witnessing the destruction
There is no requirement in the 2001 regulations that the disposal of date-expired medicines in Schedules 3, 4 and 5 to be witnessed or recorded. Nevertheless, NICE guidance confirms that even if legislation does not require a witness to be present when destroying pharmacy own stock CDs to consider having a witness present.
Monitoring and Inspection Arrangements
New arrangements were introduced in January 2007 for monitoring the management, usage and other aspects of controlled drugs in England. Separate Regulations which came into force in January 2009 govern the monitoring and inspection arrangements in Wales.
Every healthcare organisation (e.g. local NHS England team) must have an appointed ‘Accountable Officer’ with a duty to oversee the management and use of controlled drugs. The accountable officers appointed by local NHS England team 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 GPhC 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. Pharmacy contractors can make a bulk declaration for all of their premises if they own more than one.
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
NB: Schedule 2 to the Misuse of Drugs Act 1971 deals with Class A, B and C “controlled drugs” which should not be confused with the 5 Schedules to the Misuse of Drugs Regulations – which pharmacy teams will be familiar with.
Gabapentin and Pregabalin. In October 2018, the Misuse of Drugs Act 1971 (Amendment) Order 2018 was laid before Parliament and will come into force on 1 April 2019. This change means that it will be illegal to possess pregabalin and gabapentin without a prescription and it will be against the law to supply or sell them to others. These drugs will become Schedule 3 CDs but not be subject to the safe custody requirements.
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. GPhC
Pharmacy contractors 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.
Reporting CD related incidents
Pharmacy teams should ensure that there are robust processes for reporting CD-related incidents.
NICE guidance indicates that when multiple systems are used for reporting controlled drug-related incidents (for example, local and national systems and occurrence reporting), consider developing a local process that coordinates these systems within the organisation. This may include: reviewing arrangements regularly to reflect local and national learning carrying out risk assessments of incidents sharing learning. It goes on to suggest that consideration be given to include in local processes for reporting controlled drug-related concerns or incidents: how to inform the controlled drugs accountable officer or nominated person reporting incidents in a timely way, ideally within 48 hours.
Record Keeping Requirements
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 (for members).
Controlled Drug Registers: A Controlled Drugs Register (CDR) must be used to record details of any Schedule 1 and Schedule 2 CDs received or supplied by a registered pharmacy. The 2001 regulations 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 2001 regulations require 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 specific 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).
These are the minimum fields of information that must be recorded. RPS guidance confirms that additional relevant information can be added without breaking the law.
Electronic Controlled Drug Registers: Pharmacists are allowed legally to keep CDRs electronically (as an alternative to having a bound-book CDs register) 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.
RPS guidance confirms 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. PSNC understand that a number of pharmacy system suppliers have now integrated electronic registers into their dispensing systems.
Requisitions for Schedule 2 and 3 CDs
On 1 January 2008, amendments to the Misuse of Drugs Regulations 2001 came into effect in respect of requisitions used for the supply of Schedule 1, 2 and 3 CDs for use in the community. A dedicated requisition form (FP10CDF) (the standard form) was introduced for the supply of Schedule 1, 2 and 3 CDs which should be used unless there were “exceptional circumstances” e.g. where an individual may have difficulty in obtaining the standard form, so a supply could be made in response to an order written on a non-standard form, providing all the legal requirements were met. These changes applied to the supply of Schedule 1, 2 and 3 CDs by authorised practitioners and others.
From 30 November 2015, amendments to the Misuse of Drugs Regulations 2001 introduced the mandatory use of the new FP10CDF CD Requisition Form (the mandatory form) for requisitioning all Schedule 2 and 3 CDs. The mandatory use will apply to England, Scotland and Wales; however, Scotland and Wales have their own approved CD requisition forms which professionals in those countries should continue to use.
Those who must provide a requisition form to be supplied a Schedule 1, 2 and 3 CD:
- a practitioner;
- the person in charge or acting person in charge of a hospital, organisation providing ambulance services or care home*;
- a person who is in charge of a laboratory;
- the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it;
- the master of a foreign ship in a port in Great Britain;
- the installation manager of an offshore installation;
- a supplementary prescriber;
- a nurse independent prescriber;
- a pharmacist independent prescriber;
- a person who holds a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State, or a person who is a registered paramedic.
*Note: exemptions from those who must provide a requisition form include those for use in a prison; or for use in a care home, which as its whole or main purpose provides palliative care for persons resident there who are suffering from a progressive disease in its final stages (e.g. a ‘hospice’).
According to the Misuse of Drugs Act 1971 – the primary piece of legislation to the Misuse of Drugs Regulations 2001 – the term “Practitioner” (except in the expression “veterinary practitioner”) means a doctor, dentist, veterinary practitioner or veterinary surgeon.
The mandatory form
In England, the new mandatory form FP10CDF has been developed to make sure all of the current legal requirements for ordering Schedule 2 and 3 CDs are met. Pharmacy contractors must ensure that requisitions for Schedule 2 and 3 CDs are obtained on the new mandatory form from 30 November 2015. NHS Prescription Services has indicated that requisitions not received on the new mandatory form cannot be processed. The new mandatory form can be obtained online from the NHS Prescription Services website. They can be downloaded, completed online, printed and signed in wet ink.
In Wales, a standard requisition form WP10CDF should be used when ordering a Schedule 2 or 3 CD. Pharmacy contractors in Wales can obtain form WP10CDF from the local Business Service Centre Stores.
Marking of requisitions
The regulations also require the supplier of the CD to mark on the requisition their name and address at the time the supply is made. A pharmacy stamp containing the name and address of the pharmacy could meet this requirement.
In England, the regulations require that the original completed and signed mandatory form (FP10CDF) for all Schedule 2 and 3 CDs be submitted to NHS Prescription Services using the submission document FP34PCD* which is available on the NHS Prescription Services website.
Community pharmacies require a private CD account number which should be used when submitting FP10CDF mandatory requisition forms, which is a different account to the NHS account number used by contractors to submit NHS prescriptions.In England, suppliers who need to submit requisition forms but who do not already have a private CD prescription F code must contact their local NHS England team.
In Wales, the regulations require that the original completed and signed requisition form WP10CDF be submitted to NHS Wales Shared Services Partnership (NWSSP) – Primary Care Services using the WP34C submission form. Please contact Community Pharmacy Wales (CPW) for further support.
Q. Must I provide the mandatory CD requisition form to wholesalers to be supplied a Schedule 1, 2 or 3 CD?
A. It is our understanding that registered pharmacy businesses are not required under the Misuse of Drugs Regulations to provide a requisition to their wholesaler in order to be supplied a Schedule 1, 2 or 3 CD.
Nonetheless, pharmacies are recommended to use the standard requisition form FP10CDF if obtaining Schedule 1, 2 and 3 CDs from another pharmacy so that an audit trail is kept.
Further guidance may be obtained from the Home Office or from the Royal Pharmaceutical Society (if a member of the Society).
Legislative changes to prescription writing requirements for Temazepam (effective June 2015)