11.18.2017 | Victoria Lawman
Controlled Drug regulations PSNC Main site
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.
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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.
Separate Regulations which came into force in January 2009 govern the monitoring and inspection arrangements in Wales. New arrangements were introduced in January 2007 for monitoring the management, usage and other aspects of controlled drugs in England.
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Every healthcare organisation (e.g. 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. local NHS England team) must have an appointed ‘Accountable Officer’ with a duty to oversee the management and use of controlled drugs.
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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:
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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. 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.
RPS guidance confirms that additional relevant information can be added without breaking the law. These are the minimum fields of information that must be recorded.
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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. 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.
Community pharmacy contractors are reminded of the requirements to submit completed Medicines Use Review (MUR) and/or New Medicine Service (NMS).
Monitoring and Inspection Arrangements.
Legislative changes to prescription writing requirements for Temazepam (effective June 2015).
The arrangements are required to include:. 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.
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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.
An Accountable officer and police officers would have the power to enter and inspect pharmacy premises if concerns were being investigated.
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Related Resources NICE guidelines- “Controlled drugs: safe use and management” (April 2016).
It also aims to reduce the safety risks associated with CDs. In November 2013, NHS England published guidance on the supervision of management and use of CDs. It aims to improve working practices to comply with legislation and have robust governance arrangements. 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.
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.
Department of Health: Best Practice Guidance – Controlled Drugs (Supervision of Management and use) Regulations 2013 (February 2013).
Pharmacy contractors can make a bulk declaration for all of their premises if they own more than one. 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.
This year’s contract monitoring survey is available to community pharmacy contractors until Sunday 9th July. The short screening survey removes the need for all contractors to complete the full CPAF questionnaire.
NHS guidance: The Controlled Drugs (Supervision of Management and Use) Regulations 2013 (November 2013).
The 2001 regulations require the following information to be recorded in the CDR, under the following specific headings, when CDs are obtained :
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. 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.
Community pharmacy contractors are reminded of the requirement to submit completed Medicines Use Review (MUR) and/or New Medicine Service (NMS).
RPS guidance indicates that for Schedule 3 CDs it would be good practice to have another member of staff witness the denaturing. 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.
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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 record should include the following:. 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.
Community pharmacy contractors are reminded that they have less than three days to submit their completed CPAF screening questionnaire, which.
CPAF screening questionnaire NHS pharmacy contractors have now had nearly three weeks to complete the CPAF screening questionnaire. Pharmacy contractors should.
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:.
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). 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).
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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. 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. PSNC understand that a number of pharmacy system suppliers have now integrated electronic registers into their dispensing systems.
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.
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. 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. Detailed guidance on the disposal of unwanted medicines can be found in the waste section of this website. Pharmacy contractors must have appropriate arrangements in place for securing the safe destruction and disposal of Controlled Drugs (CD / CDs).
Reporting CD related incidents.
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. Patient returned CDs should be denatured in the presence of another member of staff, preferably a pharmacist or pharmacy technician if available. 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). RPS guidance confirms that the destruction of patient returned CDs, whether they require denaturing or not, does not require witnessing by an authorised person.
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Pharmacy teams should ensure that there are robust processes for reporting CD-related incidents.
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. 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.
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Home Office Consultation on scheduling of Tramadol and exemptions for Temazepam prescriptions (September 2013).
When CDs are supplied, the regulations require information to be recorded in the CDR, under the following specific headings:
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. 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.
Record Keeping Requirements. 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. This may include: reviewing arrangements regularly to reflect local and national learning carrying out risk assessments of incidents sharing learning. 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.
Further guidance on the details required in the SOPs for CDs can obtained from the RPS and templates for CD SOPs may be obtained from the NPA.Controlled drugs list pharmacy