 Welcome to this autumn/winter edition of the newsletter of the Controlled Drugs (CD) National Group sub-groups.
The following articles have been specially chosen by members of the relevant sub-groups and we would welcome your feedback for future articles.
Summary of contents:
- News from the Policy Sub-Group
- News from the Patient Safety Sub-Group
- News from the Prescribing Sub-Group
- News from the Vigilance Safety Sub-Group
- Links to key organisations and relevant guidance
Further information on the work and membership of the CD National Group and its sub-groups can be found in our latest controlled drugs annual report https://www.cqc.org.uk/publications/major-report/safer-management-controlled-drugs
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News from the Policy Sub-Group
Medicinal Cannabis
Guidance - On 31st October, NHS England issued interim clinical guidance to clinicians on the prescribing of cannabis-based products for medicinal use. They followed up on this on 20th November with an addendum clarifying that whilst there is interim guidance for doctors on the GMC Specialist Register in relation to prescribing cannabis-based products for medicinal use in a limited number of conditions, this does not remove or replace the clinical discretion of the prescriber in accordance with their professional duties.
prescribers/cannabis-based-products-for-medicinal-use/
Information for patients and the public explaining what the changes mean is available on the NHS website: https://www.nhs.uk/conditions/medical-cannabis/
NICE is expected to produce guidance by October 2019. Development of this guidance can be followed here:
https://www.nice.org.uk/guidance/indevelopment/gid-ng10124
Supply - DHSC is working closely with MHRA and NHS England to establish routes of supply. NHS England have shared with procurement pharmacists a list of products that are available via UK distributors, along with details of product composition and GMP certification where known. This should provide pharmacies with a head start should prescriptions be presented.
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Pregabalin and gabapentin Re-Scheduling
The Home Office has announced that pregabalin and gabapentin are to be placed in schedule 3 as controlled drugs but without the need to store them in a CD cupboard. The law change will come into effect in April 2019. We will keep you update should we became aware of any updates but in the meantime you can find the Home Office consultation and response on their website: https://www.gov.uk/government/consultations/pregabalin-and-gabapentin-proposal-to-schedule-under-the-misuse-of-drugs-regulations-2001
The Controlled Drugs (Supervision of Management and Use) Regulations 2013 review
The Department of Health and Social Care (DHSC) and Scottish Government (SG) are continuing to work-up a report on the post implementation review of the Controlled Drugs (Supervision of Management and Use) Regulations 2013. This will be shared with key stakeholders when appropriate. DHSC and SG aims to publish the review report in early 2019 – with the primary recommendation being to maintain the current regulations and update these where necessary.
News from the Patient Safety Sub-Group
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Opioid patch: patient information sheet
Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children
Given the on-going issues with incorrect use of transdermal opioid patches, the patient safety Sub-Group have been working on a patient information sheet to provide patient friendly information on their application and use. A draft has been circulated to some patient focus groups for comments and contributions and we hope to share the final version soon. Meanwhile the MHRA have published their Drug Safety Update article on transdermal Fentanyl patches and an information sheet on their safe use and disposal.
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News from the Prescribing Sub-Group
Please ensure you submit private prescriptions for schedule 2 and 3 controlled drugs to the NHS in a timely way for analysis and monitoring purposes
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In England, prescribers can only order Schedule 2 or 3 CDs privately on pink private prescription form FP10PCD. This requirement does not extend to veterinary prescriptions.
Prescriber identification number All authorised private prescribers of Schedule 2 or 3 CDs have been allocated a six digit prescriber identification number (issued by the NHS) which must be stated on private form FP10PCD. Private prescriptions for Schedule 2 or 3 CDs should not be dispensed in community pharmacies if they do not contain this identifier. Private prescribers should be referred to their local NHS England Controlled Drugs Accountable Officer if they require a private prescriber identification number.
Submission The Misuse of Drugs Regulations 2001 were amended in 2006 to introduce a requirement for all private prescriptions for Schedule 2 and 3 CDs to be sent to the NHS for analysis and monitoring purposes.
Amendments to other medicines legislation were made to allow for the original private FP10PCD prescriptions to be sent to NHS Prescription Services – these came into effect on the 1st September 2007.
Pharmacy contractors in England are required to submit FP10PCD forms to NHS Prescription Services for audit purposes each month using a special 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 their FP10PCD which is a different account to the NHS account number used by contractors to submit NHS prescriptions. In England, suppliers who need to submit private prescription forms but who do not already have a private CD account number should contact their NHS England Controlled Drugs Accountable Officer.
Guidance Guidance on how forms should be submitted in England and Wales and can be found in the Drug Tariff.
Action Please check your private prescription file/folder and if it contains any FP10PCD then submit these as soon as possible.
Contact For further information please contact your NHS England Controlled Drugs Accountable Officer.
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News from the Vigilance Sub-Group
Personal Security
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We are aware of a number of recent incidents where pharmacy staff in community pharmacies have experienced aggressive and threatening behaviour towards them. We want to raise awareness that this has been happening and would urge staff to be vigilant about their personal safety and security and consider conducting a risk assessment of their premises, the accessibility / security of all medicines liable to misuse and opening hours in order to keep staff as safe as possible.
We have also been made aware of a recent incident where a former care home staff member used their old lanyard as a means of identification to collect controlled drugs from their local community pharmacy. The pharmacy, in good faith, handed over the full supply intended for the care home to this former worker. Please include collection of identification passes and badges in your HR processes for staff and volunteers leaving your organisation to prevent this happening.
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Links to relevant organisations and key guidance
CQC is the health and social care services regulator with responsibilities for oversight of safe arrangements for controlled drugs across England.
http://www.cqc.org.uk/guidance-providers/controlled-drugs/controlled-drugs-accountable-officers
http://www.cqc.org.uk/guidance-providers/controlled-drugs/controlled-drugs-national-group
The Department of Health and Social Care (DHSC) helps people to live better for longer. They lead, shape and fund health and care in England, making sure people have the support, care and treatment they need, with the compassion, respect and dignity they deserve. Website
The Home Office leads on immigration and passports, drugs policy, crime policy and counter-terrorism and works to ensure visible, responsive and accountable policing in the UK.Website
NHS England leads the National Health Service (NHS) in England. We set the priorities and direction of the NHS and encourage and inform the national debate to improve health and care. Website
MHRA report product defects to them using the Yellow Card scheme: https://yellowcard.mhra.gov.uk/defective-products/
Recent Press and media coverage of online prescribing;
The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care.
NICE guidance (NG46) on Controlled Drugs: Safe Management and Use
NHS Counter Fraud Authority (NHSCFA) updated their guidance on prescription form security in March 2018:
https://cfa.nhs.uk/fraud-prevention/fraud-guidance
Opioids Aware
A resource for patients and healthcare professionals to support prescribing of opioid medicines for pain
https://www.rcoa.ac.uk/faculty-of-pain-medicine/opioids-aware
- Briefing Statement to Health Professionals on the Management of opioid Medications
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