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In our update for 2018, we report on the recent focus on the increase in opioid prescribing across the UK, the way forward following the Gosport report, our continuing concerns regarding lower schedule controlled drugs and the introduction of legislation for cannabis based medicinal products. We share the key issues raised by NHS England controlled drug accountable officers and their unaccounted-for losses of controlled drugs by NHS England area. We also provide some examples of the issues raised and followed up through the local area networks.
As in previous years, we provide data on overall prescribing trends for controlled drugs in 2018, which were broadly similar to 2017. This year, we show the prescribing picture for opioids in Schedules 2 to 5 prescribed in combination with benzodiazepines, pregabalin or gabapentin across CCG areas of England, based on primary care prescription data.
The report and updates from our stakeholders can be found at:
http://www.cqc.org.uk/publications/major-report/safer-management-controlled-drugs
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The Department of Health and Social Care (DHSC) and the 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, with the aim to publish the review report by 31 March 2020.
In consideration of the widespread support to maintain the current regulatory provisions, DHSC and SG have agreed to seek to remove the statutory expiry date (sunset clause) of 31 March 2020 from the Regulations. This is with the intention to address uncertainty for stakeholders of the Regulations, and would result in the regulatory provisions, as currently drafted, being maintained until further legislative action is taken. This approach is subject to Ministerial agreement in both countries. DHSC and SG will progress associated work as quickly as possible, and an update will be provided in due course. |
Cannabis-based products for medicinal use
The law changed on 1 November 2018 to allow specialist doctors on the General Medical Council’s Specialist Register to prescribe unlicensed cannabis-based products for medicinal use, where clinically appropriate, in the best interest of patients and where the clinical need cannot be met by existing licensed medicines.
DHSC has taken several steps to implement this policy and provide support for clinicians:
- Interim clinical guidance has been published by The Royal College of Physicians (RCP), the British Paediatric Neurology Association (BPNA) and the Association of British Neurologists (ABN) to support doctors looking to prescribe cannabis-based products.
- The Department has commissioned National Institute for Health and Care Excellence (NICE) to produce guidelines on the clinical use of cannabis-based products for medicinal use. We expect NICE to consult on draft guidelines between 23 July 2019 - 20 August 2019, with a view to publishing final guidelines by October 2019. NICE’s guidelines will supersede the advice provided by the RCP, BPNA and ABN. Further information at: https://www.nice.org.uk/guidance/indevelopment/gid-ng10124
- NHS England has commissioned Health Education England who in conjunction with Birmingham University are developing an e-learning pack on cannabis and cannabis-based products for medicinal use, which all healthcare professionals across all UK nations will be able to easily access online. It is expected that this will be available shortly.
- To improve the evidence base, the National Institute for Health Research (NIHR) are supporting the industry to take action to produce evidence in a form that will support decisions about public funding. The NIHR has issued two calls for research proposals on medicinal cannabis and we are aware of several proposals being developed. They are now further considering how best to encourage further good quality research proposals in response to the calls across the range of indications for which the Chief Medical Officer identified early promise. Further information at: https://www.nihr.ac.uk/funding-and-support/themed-calls/cannabis-based-products.htm
- After meeting with patients and families, the Health Secretary has asked NHS England to undertake a rapid process review to address any system barriers to clinically appropriate prescribing. This review is under way and the Government will carefully consider any further action we might take to improve access in light of the review.
- The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on Cannabidiol (CBD) products in Appendix 10 of its guidance note 8 “A guide to what is a medicinal product” which deals with the regulations, CBD products for non-medical purposes and Compliance with other regulatory frameworks. It has also published detailed guidance on the supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials’.
Pregabalin and gabapentin
From 1 April 2019, two statutory instruments came into effect. As a result, pregabalin and gabapentin have been controlled as class C drugs under paragraph 1 (b) of Part 3 of Schedule 2 to the Misuse of Drugs Act 1971. They are also listed as Schedule 3 drugs to the Misuse of Drugs Regulations 2001. The two drugs are also being listed into schedule 1 to the Misuse of Drugs (Safe Custody) Regulations 1973 (“the 1973 Regulations”), which means that they are exempted from the safe custody requirements.
Therapeutic radiographers independent prescribing
On 19 December 2018 the Home Office Minister responded to accept the ACMDs recommendation that the Misuse of Drugs Regulations 2001 will be amended to allow therapeutic radiographers to independently prescribe 6 controlled drugs (tramadol, lorazepam, diazepam, morphine, oxycodone and codeine). Work is now underway on amending the regulations and it is expected that changes will come into force by the end of the year.
Safe custody regulations
Plans to hold a full consultation to the modernising of the Misuse of Drugs (Safe Custody) Regulations 1973 remain on hold. The Home Office is keeping this situation under review.
Home Office controlled drugs licence ‘renewal’
Members of the policy sub-group thought it might be helpful to share the following information for those organisations due or undergoing renewal of their Home Office controlled drugs licence:
Renewal process
Renewal applications must be made in good time and at least 6 to 8 weeks before the expiry of existing licences. This should be sooner if the organisation has been advised in their licence letter that they will be subject to a compliance visit the following year.
Where an existing licensee has submitted a timely controlled drugs licence application i.e. prior to the expiry of the existing licence and on the same basis as the current licence then under the Home Office policy, the organisation can continue with their day-to-day business under the conditions of their existing licence until consideration of their replacement licence application has been completed.
In situations where an organisation is having difficulty with a supplier due to the processing of their ‘renewal’ licence application, on request, the Home Office Drugs Licensing Team can provide an email to confirm this policy so that the organisation can continue with their day-to-day operations. However, in accordance with General Data Protection Regulation (GDPR) provisions, this can only be done where consent has been given by the organisation to the Drugs Licensing Team that they can disclose this information directly to the named supplier. This means that a separate email would be needed with consent for each different supplier that an organisation uses.
How licensees can help with their application?
There are often common reason why a controlled drugs licence cannot be progressed:
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Protracted Disclosure and Barring Service (DBS) process
- The Home Office cannot process an application until they are in receipt of an enhanced DBS clearance
- (via Security Watchdog) for all persons named on the application form. It is therefore important to remember to take documents for validation and encourage your organisation to use the ‘update’ service.
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Incomplete application or documents
- The Home Office cannot allocate cases for a decision or take a decision on an application until they have all the information needed.
- This includes:
- Ensure contact details of all parties are provided to ensure receipt of system emails;
- Use the upload function for documents on the application, or ‘reply to’ system emails so it goes to your case;
- Where the licence includes a Schedule 1 controlled drug, it is important for the prescriber to be available for the HO visit
- Think through any issues with the supply chain
- Include consent to share information with third parties, as applicable
Further information can be found in the application guidance: https://www.gov.uk/government/publications/domestic-licensing-application-guidance
There are further considerations for Health & Justice settings as follows:
NHS England Health and Justice commissioners have been made aware of the destruction of CD stock (Schedules 2-5) when a new provider has taken on provision of healthcare services at prisons or other custodial secure environments. To avoid this waste and the operational issues that arise from it, the Home Office Drugs and Firearms Licensing team and NHS England have collaborated to agree a mechanism by which this waste can be avoided whilst acting within controlled drug licencing regulations.
To enable a ‘one off’ supply of residual stock where there is a contract transition between providers, a Home Office controlled drug licence to ‘possess and supply’ must be in place to enable the lawful ‘supply’ to take place. Where an amendment is required to the licence to include ‘supply’, every effort should be made to submit a formal application as far in advance as possible. An application to make an amendment to a licence attracts a current fee of £326. However, where this is not possible, for example, due to limited time in the contract handover a ‘change in service provider’ proforma can be submitted, in these limited and genuinely exceptional circumstances, requesting an exceptional and one-off licence variation. This provision is at the discretion of the HO Drugs and Firearms Licensing unit and where an application could reasonably have been submitted much earlier, an exceptional request to consider under this process may be rejected. The one-off licence variation will attract a current fee of £45 and only once this has been paid will the licence be amended accordingly. All completed proformas must be sent to DFLU.dom@homeoffice.gov.uk
Once the licence has been amended for the exiting Health and justice provider, arrangements will need to be made with the incoming Health and justice provider to transfer the stock between the organisations as part of the contract handover. This requires two people from each provider (for example a senior staff member and a witness) who will confirm the quantity of stock for each controlled drug transferred and complete controlled drug register entries in the controlled drug registers for both providers.
Medicines and healthcare products regulatory agency (MHRA) YELLOW CARD “YouTube” guides
MHRA has launched new videos that provide guidance to assist patients with completing a YELLOW CARD report of a suspected side effect of a medicine or possible problem with a medical device. The videos have been published on the YELLOW CARD website and can be found here and on MHRA’s YouTube channel:
MHRA is also promoting the videos through the following social media channels:
MHRA would be grateful if you could help to raise awareness of these videos amongst your own networks and online communities, using the links provided in this message, to encourage the reporting of suspected side effects of medicines or possible problem with medical devices.
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Opioid Expert Working Group meets at MHRA
An Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) has been established to begin the review of the benefits and risks of opioid medicines, including dependence and addiction- https://www.gov.uk/government/news/opioid-expert-working-group-meets-at-mhra
In April, Health Secretary Matt Hancock announced that all opioid medications will now carry a clear warning on their label, stating that they can cause addiction and that they contain opioids.”
Misuse of propofol by healthcare professionals
Alfentanil in palliative care
The sub-group has been made aware of the potential diversion and misuse of propofol by healthcare professionals leading to harm and suicide, however, it is not clear whether the suicides/deaths were intentional or unintentional. Information published in the USA and Australia claim that the abuse of propofol often starts from the inability to sleep (41%) or from anxiety (17%) with those individuals abusing propofol often dying within 4 months. Further information can be found at: https://www.aaahp.org.au/resources/Documents/pdf/Propofol%20Essay.pdf
While we recognise that profofol is not a controlled drug, it is a medicine that can cause significant harm if misused. We do ask that you be vigilant, and should you have any concerns in relation to a change of behaviour by your colleagues to discuss those concerns locally with your managers who are better able to help and support to the individual.
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Alfentanil in palliative care
There have been two recent incidents of patient harm following conversion from alfentanil to other opioids. Both were on alfentanil due to renal impairment (RI). RI alters the clearance of the parent compound and affects accumulation of its metabolites. Elimination of opioids may be prolonged.
Alfentanil is one of the opioids which exhibits the safest pharmacological/pharmacokinetic profile in RI. Whilst there is limited evidence for the use in RI, it can be used cautiously but the risk of an unfamiliar opioid should be considered. Dose titration of alfentanil should be supervised by a specialist familiar with its use as it is a highly potent opioid ( 30x stronger than oral morphine) Monitoring for signs of toxicity is require)
It is therefore important not to change alfentanil to another opioid without specialist advice. When undertaking any opioid conversion, it is advisable to get another prescriber to check for you.
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Approximate 24-hour dose equivalent
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Oral Morphine
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SC Morphine
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SC Diamorphine
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Oral Oxycodone
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SC Oxycodone
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SC Alfentanil
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30mg
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15mg
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10mg
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15mg
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7.5mg
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1mg
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SC = subcutaneous
Diamorphine assisted treatment
Some services are now providing diamorphine assisted treatment whereby nurses administer diamorphine to patients, for example in GP Practices.
This requires some specific governance arrangements to be put in place as diamorphine will need to be held as stock in sufficient quantities, the in-house administration may make it more difficult for NHSE CDAOs to monitor prescribing and also places a greater demand on diamorphine supplies which already experience regular shortages.
There is currently little evidence available to support diamorphine assisted treatment for addiction. However, the ‘Drug misuse and dependence: UK guidelines on clinical management ‘guideline, (the ‘Orange guide’) sets out when this may be appropriate.
Diamorphine assisted treatment - dangers of over-prescribing of opioids for chronic pain
NHS England has shared a new film aiming to highlight the dangers of over-prescribing of opioids for chronic pain and shows how a patient changed their life with other alternatives treatments.
Opioids are often prescribed for patients to deal with long term pain and recent studies have challenged the appropriateness of the levels of prescribing. There is little evidence to show that they are helpful for long term pain. The video tells the story of a patient who had a hernia operation 25 years ago and due to an infection, ended up suffering chronic pain. For many years, the patient had been taking large doses of opioids which presented numerous side effects and they still suffered from continued chronic pain.
The film shows how long-term use of high-dose opioid prescribing had a devastating impact on quality of life and how non-drug therapy has been life changing. Through alternative therapies such as mindfulness and meditation, the patient has been able to deal with their pain without the reliance on opioids to manage. The film aims to encourage and inspire patients with chronic pain to seek alternatives to prescription opioids to help deal with their condition.
The video was played in the House of Lords on Tuesday 25 June before an all-party parliamentary group on chronic pain. The group aims to raise awareness of chronic pain and to provide a forum for discussion and debate on issues relating to prevention, treatment and management of chronic pain.
To view the film follow the web-link: https://www.youtube.com/watch?v=BnJHJ9ZlJjY&feature=youtu.be
Prescription security
we would like to make practices aware of incidents involving the theft of blank prescription forms and the subsequent use of these forms to try to fraudulently obtain controlled drug medication from community pharmacies. The high standard of some of these forgeries has resulted in supplies being made. The thefts of these blank prescription forms have usually taken place from printers in unlocked rooms. We would like to remind surgeries that blank prescriptions should be removed from rooms when they are not being used.
Please note that NHS Counter Fraud Authority published guidance in March 2018 “Management and control of Prescription forms” and the CQC has published guidance in the form of a tips and myth buster factsheet “Nigel's surgery 23: Security of blank prescription forms”. Both guidance documents suggest that “it is not advisable to leave the forms in printer trays when not in use or overnight.
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Mix-ups of oxycodone and oramorph®
There have been reports of administration errors involving liquid morphine and liquid oxycodone preparations. These incidents have involved one drug being administered when the other is intended. Upon investigation, we understand that brands of oxycodone are often mistaken for brands of morphine (especially oxynorm® when oramorph® is prescribed), and vice versa. Continued care is needed when administering these medicines.
Post-dated prescriptions – a case study
Post-dated prescriptions were held at a community pharmacy for the patient's representatives to collect when due. A collection was made at the end of January and again in February. The pharmacy received a call at the end of February asking for the patient’s medication to be ready for collection the following morning as the patient was unwell. The pharmacist contacted the surgery to check that all prescription items prescribed for the patient were still needed. The surgery called the pharmacist back to inform them that the patient had died in January. The pharmacy had another month of post-dated prescriptions waiting for collection and informed the surgery that 2 collections of medication had been made by the family since the patient's death. In situations described above it is important to check with the prescriber whether the post-dated prescriptions are still needed before dispensing
Learnings from a domestic homicide review - a case study
The remains of a woman from the Bolton area were found concealed in the boiler cupboard of the home she had shared with her partner. She was reported missing having been last seen alive over 2 years ago. However, given the passing of time, it was not possible to prosecute her partner due to the difficulty in determining how she died.
The review highlighted the failure of agencies in contact with the female at the time to share concerns. This failure contributed to the delay in discovering her body. The pharmacy did not share their concerns about her clinical deterioration while her partner continued to be supported by the subsistence misuse service who made no enquiries about his partner.
Of relevance, at the point she disappeared, there was an absence of communication between the pharmacy which supervised her methadone prescription, her substance misuse service and her GP. Had better links been in place and a more proactive approach taken, the outcome may have been very different.
Further information on Domestic Homicide Reviews (DHRs) is available of the government’s website: https://www.gov.uk/government/collections/domestic-homicide-review
Pregabalin and gabapentin:
Cannabis based products for medicinal use (CBPMs) Guidance
Home Office:
- Drug Licensing Factsheet- Cannabis, CBD and other cannabinoids
- The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018
MHRA:
- The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials
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NHS England:
- Cannabis-based products for medicinal use
NHS England and Department of Health and Social Care (DHSC):
- Supplementary information on cannabis-based products for medicinal use
NICE:
- Guidance expected by October 2019.
Relevant organisation links
CQC is the health and social care services regulator with responsibilities for oversight of safe arrangements for controlled drugs across England. Website
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 The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. Website
NICE The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. Website
- Controlled drugs: safe use and management guideline (NG46) published in April 2016
NHS Counter Fraud Authority (NHSCFA) The NHS Counter Fraud Authority (NHSCFA) is a special health authority charged with identifying, investigating and preventing fraud and other economic crime within the NHS and the wider health group. Website
- Management and control of prescription forms: A guide for prescribers and health organisations
Opioids Aware
- A resource for patients and healthcare professionals to support prescribing of opioid medicines for pain
- Briefing Statement to Health Professionals on the Management of opioid Medications
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