Welcome to this Winter edition of the newsletter of the Controlled Drugs (CDs) 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:
- Useful controlled drugs information and updates
- News from the Patient Safety Sub-Group
- News from the Prescribing Sub-Group
- News from the Vigilance Safety Sub-Group
- Links to relevant guidance and key organisations
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
Who can supply or administer Controlled Drugs under the terms of a Patient Group Direction (PGD) and under what circumstances?
Many of you may already be aware but for those who are not following the reclassification of pregabalin and gabapentin as Schedule 3 Controlled Drugs (CDs) from 1st April 2019 not all professions listed in the PGD legislation can administer these controlled drugs under a PGD. The following regulated professions groups cannot administer or supply any controlled drugs in any of the five schedules under a PGD:
- Dietitians
- Speech & language therapists
- Dental therapists
- Dental hygienists
For the professions listed in the PGD legislation, other than those listed above, the following controlled drugs can be included in a PGD:
- Schedule 2: Morphine and diamorphine – only by registered nurses and pharmacists for the immediate necessary treatment of a sick or injured person. Not for treating addiction.
Schedule 2: Ketamine
- Schedule 3: Midazolam
- Schedule 4: All drugs except anabolic steroids and injectable medications used for treating addiction.
- Schedule 5: All drugs
Specifically note that since their reclassification as Schedule 3 controlled drugs (CD No Register POM) tramadol, gabapentin and pregabalin may not be supplied and administered under a PGD.
For further information please see the links below:
The Specialist Pharmacy Services https://www.sps.nhs.uk/articles/who-can-supply-or-administer-controlled-drugs-under-the-terms-of-a-patient-group-direction-and-under-what-circumstances/
Nigel's surgery 19: Patient Group Directions (PGDs) / Patient Specific Directions (PSDs)
Controlled Drugs (Supervision of Management and Use) Regulations 2013 Update
A UK General Election will take place tomorrow, 12 December 2019. During the election period, there are restrictions on the work that the Civil Service can undertake during this period, this includes the Department of Health and Social Care’s work to amend the Controlled Drugs (Supervision of Management and Use) Regulations 2013. The Department and Scottish Government will continue work to make preparations to draft the necessary legislation to take forward when new Ministers are in place. Though they cannot provide a more detailed update at this time, please be assured that they remain committed to laying this amendment before Parliament at the earliest opportunity to ensure the Regulations remain in force beyond 31 March 2020.
General Medical Council (GMC) Remote prescribing call for evidence
The GMC has launched a call for evidence on remote consultations and prescribing via online, telephone or video. They are taking this step to help understand whether their guidance - Good practice in prescribing and managing medicines and devices needs to be developed further, given the fast pace of change in remote healthcare services. You can share your views via their online survey tool before 18 February 2020; or contact them via email (remoteprescribing@gmc-uk.org) if you have any questions about their work in this area.
About GMC our call for evidence
Remote consultations and prescribing can benefit patients who want flexible access to healthcare. However, there are potential patient safety risks, particularly when the remote healthcare provider is not their regular prescriber.
In 2013, GMC expanded their guidance “Good practice in prescribing and managing medicines and devices” to give advice on remote consultations and prescribing. Since then, there has been a significant increase in the provision of remote prescribing and they want to make sure the guidance is keeping up with new developments. The call for evidence asks for views on a number of topics including what good dialogue between doctors and patients looks like, how their guidance is applied in practice, and if any additional patient safeguards may be needed.
Working together to support safe remote prescribing
This is one of several measures the GMC are taking forward, in partnership with regulatory and quality improvement partners, to support safe remote consultations and prescribing. These include a joint statement with healthcare regulators and high level principles for good practice, co-authored and agreed by 13 healthcare organisations across the UK.
After the call for evidence closes they will consider the responses and the next steps for guidance in this area.
Cannabis-based products for medicinal use (CBPM)
The NICE guideline for cannabis-based products for medicinal use (CBPM)
has been published. You can read and download a copy of the NICE guideline at:
https://www.nice.org.uk/guidance/ng144
This guideline covers prescribing of cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy. NICE is also in the process of developing technology appraisal guidance on cannabidiol with clobazam for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
The initial prescription of cannabis-based medicinal products must be made by a specialist medical practitioner. Subsequent prescriptions may be issued by another prescriber as part of a shared care agreement under the direction of the initiating specialist prescriber, following agreed protocols.
NHS England and Improvement published "Barriers to accessing cannabis based products for medicinal use on NHS prescription”.
NHS England and Improvement published Cannabis-based products for medicinal use: Frequently Asked Questions.
NHS England has developed an information e-learning package with Health Education England e-Learning for Healthcare and the University of Birmingham on cannabis and cannabis-based products for medicinal use which all healthcare professionals can access. The package includes the pharmacology of cannabis, legislation governing medical use and therapeutic areas and evidence for its use. https://www.e-lfh.org.uk/programmes/cannabis-based-products-for-medicinal-use/
Public Health England (PHE) Review of Dependence and Withdrawal
PHE has published the first-ever evidence review of dependence and withdrawal problems associated with five commonly prescribed classes of medicines in England.
The Prescribed medicines review assessed the scale and distribution of prescribed medicines – and made recommendations for better monitoring, treatment and support for patients.
It used available prescription data, a literature review and reports of patients’ experiences.
A total of 5 classes of medicines were included in the review:
- benzodiazepines (mainly prescribed for anxiety and insomnia)
- Z-drugs (insomnia)
- gabapentinoids (neuropathic pain)
- opioid pain medications (for chronic non-cancer pain such as low back pain and injury-related and degenerative joint disease)
- antidepressants (depression)
The main findings included:
- 1 in 4 adults had been prescribed at least one of these classes of medicines in the year ending March 2018
- in March 2018 half of those receiving a prescription (of these classes of medicine) had been continuously prescribed for at least the previous 12 months. Between 22% and 32% (depending on the medicine class) had received a prescription for at least the previous 3 years
- long-term prescribing of opioid pain medicines and benzodiazepines is falling but still occurs frequently – which is not in line with the guidelines or evidence on effectiveness
Further information can be found on Public Health England’s website: https://www.gov.uk/government/publications/prescribed-medicines-review-report
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Repeat prescriptions issued by community prescribers whilst a person is detained in a custodial secure environment
This article is to raise awareness to manage a medicines safety issue that has been identified about the supply of repeat medicines by community prescribers (e.g. GPs) for people that are detained in custodial secure environments such as prisons and immigration removal centres.
It has been reported that detained people are continuing to have repeat medications prescribed by community prescribers via requests that occur on-line or via repeat prescription requests made by their representatives. These requests can include dependence forming medications (DFM), such as pregabalin, gabapentin and opioids.
As the detainee may be in custody for several months, a large stock of medicines could be collected and accumulate. This has the following risks of harm:
- The medicines could be taken inappropriately by the detainee on release, especially if the medicine has been stopped or the dose altered during their time in custody.
- The supply could be used illicitly by the detainee post-release or by their representative.
Whilst in prison all medicines needed by the detained person are issued by the prison GP or non-medical prescribers working in the prison.
On admission, it is usual practice for detained people to receive a full medicines reconciliation and information is requested from the community GP or community pharmacy about the person’s medication and health needs where this isn’t clear from the person’s Summary Care Record (SCR). This mirrors the arrangements for people admitted to hospitals. A prompt response by GPs and pharmacists to such requests is appreciated and ensures safe continuity of medicines avoids omitted doses or errors during the first few days of custody when patients are at highest risk of harm.
Healthcare providers in prisons have been advised that when contacting the community services to request this information, they should include in their communication a request that the GP or pharmacy record is amended so that repeat medicines cannot be ordered. This approach is being successfully used by several providers already. In addition, recent changes to the Patient Demographic Service (PDS) mean that once a person is admitted to prison, their address is changed to the prison address. This can help community GPs and pharmacists identify when a person is in custody so that their records can be adjusted to prevent prescriptions being issued.
On release, a discharge letter should include the current list of medicines being taken by the detained person and medicines that have been stopped. People released from prison will usually be given a minimum of seven day’s supply of the medicines they need to continue and will contact their GP for further supplies. It is important that the GP updates their records and continues the prescribing of relevant medication.
Should you have any queries relating to the information please email denisefarmer@nhs.net
CD Possession Licences for providers delivering Health and Justice (HJ) Services
Recent CQC and NHS HJ quality and safety visits have highlighted that HJ providers are not always compliant with Home Office (HO) CD Possession Licence requirements for CDs held as stock. In 2014 information was published by the HO that NHS Trusts and Private providers delivering healthcare services in custodial secure environments (i.e. prisons, immigration removal centres, secure training centres and secure children’s homes) are likely to require a CD licence to possess CDs stocks.
HJ providers are therefore reminded that:
- Providers are responsible for ensuring they comply with the Misuse of Drugs regulations 2001 and apply of CD possession licences. Guidance about how to so this is available on the HO web-site (https://www.gov.uk/government/collections/drugs-licensing)
- Wholesalers will ask for a copy of the CD licence as part of their validation processes when receiving requisitions from healthcare organisations.
- The licence should also be available for CQC inspections and for contractual and quality visits by NHS HJ commissioning teams.
- Applications for renewal of a CD licence or changes due to a transfer from one HJ provider to another should be made in good time (at least 3 months before the current licence expires).
- If the licence expires or if a contract transfer happens before the new licence is issued, the HO should be contacted promptly to discuss what options are available to enable a continued supply of CDs. Please note options will be considered on a case by case basis.
MHRA expert working group of opioid use
An opioid expert working group of the UK’s Commission on Human Medicines, a committee within the Medicines and Healthcare products Regulatory Agency (MHRA), has launched a review looking into the risks and benefits of opioid medicines. The working group will undertake a comprehensive independent scientific review of all available evidence on the use of opioid medicines in the UK, drawing on best practice internationally, to make sure the information for patients and health professionals helps curb the over-prescription and misuse of these medicines.
In light of growing concerns about overuse and misuse, the working group will:
- consider the current data on the utilisation of opioid-containing medicines in the UK, both prescribed and over the counter
- examine whether the risk minimisation measures implemented for over the counter and prescription opioids have been effective or whether further measures are required
- consider the benefit/risk of opioid-containing medicines in particular for non-cancer indications, taking into account alternatives
- make recommendations for regulatory action to better support appropriate use of prescription opioids, such as relevant changes to the Summary of Product Characteristics and Patient Information Leaflet, product labelling and packaging, and any other risk minimisation measures.
Further information on the working group can be found on MHRA’s website:
https://www.gov.uk/government/news/opioid-expert-working-group-meets-at-mhra
Learning from pharmacy incidents - gabapentin 100mg capsules vs. pregabalin capsules
Ben is a 26 year old artist who enjoys painting and being in the countryside. He recently displayed his work at a country fair and also sells it through an art shop in his town. It’s a popular destination with tourists, many of whom favour Ben’s work for the local scenes he paints, which they want to take home to remind them of their holiday. Ben’s parents are so proud of what he’s achieved, especially as he’s had so much to cope with, being diagnosed with severe epilepsy at a young age. It used to frighten Ben’s parents to see their little boy experiencing seizures when he was small. Ben received good care from the local hospital and (with the support of close friends) went through art school, managing his epilepsy and pursuing his dream. Now on a stable list of prescribed medication including pregabalin 100mg capsules, Ben only needs to see his consultant annually and is making plans to move out of his parents’ house into a flat on his own.
Eve is an experienced dispenser who assembled Ben’s medication against his most recent electronic prescription. She had wanted to start processing the tokens that had been downloaded from the NHS spine (and which included Ben’s prescription) much earlier, but had been on the phone to the surgery for most of the morning, chasing up prescriptions. She was also keeping an eye on a new trainee dispenser working with her and supporting the locum pharmacist, who kept asking her lots of questions. Having checked her own work, Eve placed the dispensed items on the bench for the pharmacist to check. She carried on with the next prescription, hoping to catch up with the work so that she could have her training time later in the afternoon. The locum pharmacist was impressed with Eve’s approach to the workload.
Five days later, the regular pharmacist took a phone call from a local hospital doctor, who explained that Ben had been admitted over the weekend due to having a succession of seizures. Ben’s parents had eventually identified that he had been taking gabapentin 100mg capsules rather than the pregabalin capsules prescribed. The regular pharmacist informed her Area Manager about what had happened, and then promptly completed an electronic dispensing incident report.
Once Ben had been discharged from hospital, the Area Manager phoned him to apologise and to listen to his recollection of events. Ben explained that he and his parents had been very worried that his condition had begun to worsen and he’d been admitted to hospital for the doctors to try to determine what was wrong. Ben shared that going back to hospital had reminded him of all the time he’d spent there when he was little and he’d feared that everything with his health and future was beginning to fall apart.
Points for reflection (not an exhaustive list)
Part of the follow-up from a pharmacy incident is the completion of a thorough investigation so that lessons can be learned from what has gone wrong. As you know, the safe dispensing of medicines can be complex and many factors can contribute to a regrettable event such as a dispensing error.
The investigation into this dispensing incident involves considering the factors which led to the mistake being made. Which factors can you identify in the above example?
- Eve was distracted by questions from the inexperienced colleagues in the pharmacy, the workload and the goal of ensuring that she was able to have her training time
- Eve may have ‘skim-read’ the name of the medications pregabalin and gabapentin and, when ‘checking’ her work, did not notice that she had dispensed the incorrect medicine
- The pharmacist was impressed by Eve’s skills and clearly thought she was a competent dispenser. This may have led him to think that she would not make a mistake. The best way to really understand what happened would be for the regular pharmacist or Area Manager to phone the locum pharmacist to inform him of the error and obtain his insights into why the dispensing of the wrong item had not been identified
Gabapentin and pregabalin – why might they be confused?
- Both words contain ‘gab’ and must be read carefully to check which item has been requested and which item has been selected
- These medicines can be used to treat similar medical conditions and they were reclassified (earlier in 2019) as Schedule 3 Controlled Drugs
- Both medicines are often started at a low dose and titrated to a maintenance dose. However, if a patient receives gabapentin instead of pregabalin (or vice versa) at a maintenance dose which he or she is not used to, adverse effects and destabilisation of his/her medical condition may occur
Specialist Pharmacy Service’s Webinar; “Gosport then and now” webinar
This webinar looks at what happened, the Government response and the issues this raises for providers of pharmacy services (whether in-house or outsourced) together with areas for action. Covering the importance of the culture of an organisation and the responsibility of healthcare professionals to speak up on areas of concern that might negatively affect patient safety. The recorded webinar can be found on the SPS website: https://www.sps.nhs.uk/meetings/musn-monthly-webinar-controlled-drugs-gosport-then-and-now-11-december-2019/
Opioid substitution treatment- supervised consumption
The prescribing sub-group considered issues relating to the provision of opioid substitution treatment. The prescribing and dispensing of methadone and buprenorphine is a complex and high-risk practice and it is important that the services are provided in accordance with robust procedures to ensure safe and high quality care.
NHS England lead Controlled Drugs Accountable Officers receive a large number of incident reports that occur in the course of provision of such services, with one common theme being the supply (and in many cases supervised consumption) of medication dispensed for one patient being supplied to a different patient in error. This is frequently due to procedures not being followed. Pharmacy SOPs have steps that if followed, would ensure that such errors do not occur. Patients receiving such treatment often present very regularly to obtain their supplies and their subsequent familiarity to staff may be one cause of a culture of complacency often resulting in adequate identity checks not being carried out before supply is made. It is not uncommon to hear of a patient receiving a dose of opioid many times greater than that which was intended, and in such cases the welfare of the patient must be the first priority when these incidents occur. Pharmacy SOPs will detail what ID checks are required and these should be followed every time a supply is made.
Please be also aware that the instruction for ‘supervised consumption’ often written on FP10MDA prescription forms is a direction by the prescriber, but is not mandatory. There is no nationally commissioned supervised consumption service. Different local authorities may commission such services, but not all pharmacies provide them. Prescribers should therefore note that if a FP10MDA form is presented for dispensing in a community pharmacy, whilst there is a contractual obligation to supply the prescribed medication, there is no contractual obligation to provide supervised consumption. This should not normally be an issue if the pharmacy is commissioned to provide this service, but we would be very clear that if staff supplying such medication do not intend to supervise consumption as directed, or if they cannot supervise consumption, the prescriber should be contacted so that alternative arrangements can be made. Please note that if a supply is made without supervised consumption, against the direction of the prescriber, this should be reported as an incident to the NHS England Controlled Drug Accountable Officer through their online reporting system https://www.cdreporting.co.uk/ ,
An incident was shared at the group where a former care home staff member used their old ID badge lanyard as a means of identification to inappropriately collect controlled drugs from their local community pharmacy. These would normally have been delivered and not collected, but the pharmacy staff handed over the full supply intended for the care home to this former worker in good faith. The individual used their former ID badge to fraudulently obtain the controlled drugs. They have now been prosecuted. This demonstrates how important it is to be vigilant when supplying medicines to people that claim to work for a care organisation. If anything appears unusual about such a request, check with the genuine care organisation’s staff before supplying.
It is equally important that pre-employment checks are carried out for all new staff members. This follows a recently reported incident where missing diazepam was found in the belongings of a non-registrant pharmacy member. The investigation uncovered that no pre-employment checks had been undertaken for this staff member and because they were a non-registrant, they were not on any professional body's register.
Furthermore, we are also aware of an incident where an individual posed as an external contractor, with the intention of obtaining controlled drugs. Again, this highlights the need to challenge where anything appears unusual and to escalate where necessary so that the relevant checks can be carried out.
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Cannabis based products for medicinal use (CBPMs)
The Home Office fact sheet and Statutory Instrument:
Home Office's Drug Licensing Factsheet- Cannabis, CBD and other cannabinoids Factsheet
Home Office's The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018
The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials’
DHSC's and NHS England & Improvement's Cannabis-based products for medicinal use communication 31st October 2019
Links to relevant organisations
CQC is the health and social care services regulator with responsibilities for oversight of safe arrangements for controlled drugs across England.
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 and NHS Improvement 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
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; NICE guideline [NG46]
NHS Counter Fraud Authority (NHSCFA) updated their guidance on prescription form security in March 2018: website
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
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