The safer management of controlled drugs: Controlled Drugs National Group activity report 2020

Page last updated: 12 May 2022

Department of Health and Social Care

The Department of Health and Social Care (DHSC) continued to work collaboratively in 2020 on the shared controlled drugs agenda, including with NHS England, the Care Quality Commission, the Home Office, the General Pharmaceutical Council and the National Institute for Health and Care Excellence.

Controlled Drugs (Supervision of Management and Use) Regulations 2013

DHSC and the Scottish Government conducted a post-implementation review of the 2013 regulations to consider their appropriateness and effectiveness, and to assess whether the regulatory measures remain fit for purpose. This review has now been completed and the Department published The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020 on 19 March 2020. Given the strong support for maintaining the regulations and the need to provide certainty for the health system and employers, this instrument amends the 2013 regulations to remove the statutory expiry date to enable them to remain in force.

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 cannabis-based products for medicinal use. Since then, the level of prescribing has been low and largely restricted to the private sector. This is expected given the limited evidence base for the clinical and cost effectiveness of these products.

The latest guidelines from the National Institute for Health and Care Excellence (NICE) shows a clear need for more evidence to support routine prescribing and funding decisions for unlicensed cannabis-based products on the NHS. The Department is working hard with the health system, industry and researchers to improve the knowledge base and implement the recommendations of NHS England’s review into the Barriers to accessing cannabis-based products for medicinal use on NHS prescription. Progress against the recommendations includes:

Patient registry

NHS England is working to establish a national registry for patients prescribed cannabis-based products for medicinal use, covering both NHS and private patients to maximise the use of the data in future research and analyses. This is being piloted and NHS England is finalising the requirement to complete the patient registry (covering both licensed and unlicensed products) as part of the NHS Standard Contract Schedule 6 from 1 April 2021. As such, it will be mandated by NHS England and NHS Improvement for commissioners to use for all contracts for healthcare services other than primary care contracts. In due course, the patient registry will be extended across the UK.

Clinical trials for cannabis-based medicinal products

The Department is working closely with NHS England and NHS Improvement and the National Institute of Health Research to establish clinical trials to help further develop the evidence base to support further commissioning decisions, and has also called on the pharmaceutical industry to contribute to developing the evidence base for their products.

Work has continued during the COVID-19 pandemic to agree the trial design, although at a slower pace than originally intended. Negotiations are underway with a preferred manufacturer to supply products for the trials and product stability data will be needed beforehand. Once commercial discussions are complete, clinicians and patient groups will be updated.

See: Department of Health and Social Care (GOV.UK)

Department of Health Northern Ireland

Two amendments to the Misuse of Drugs Regulations (Northern Ireland) 2002 came into operation during the reporting year. The first was to ease pressures on the health service during the pandemic. This provided flexibility, in an emergency, to relax certain restrictions relating to the possession and supply of controlled drugs by pharmacists in retail pharmacy businesses that provide HSC (NHS) services. The second amendment provided for a specified cannabis-based medicine to be placed in Schedule 5 of the Regulations.

Under the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 (as amended), the Department sends out an annual self-assessment/declaration form to community pharmacies. A new form has been developed using an online platform called Citizen Space to replace the existing form. Previously, pharmacies were asked to complete the form and retain it in their controlled drug register for when the pharmacy inspector visits. This revised format has two key benefits: firstly, during the current emergency period when routine pharmacy inspections are not happening, the Department can still receive assurances that controlled drugs are being managed safely and any concerns can be shared with the Department in a timely way. Secondly, in the long term, the new online form will enable the Department to receive a speedier response.

The Medicines Regulatory Group undertakes authorised witness training relating to the destruction of controlled drugs. Historically, this training was face-to-face, but during the pandemic period, training was carried out remotely online. The online training was very successful and was an efficient use of time for both the trainers and participants, particularly during such a busy period.

See: Department of Health Northern Ireland

General Medical Council

In November 2019, the General Medical Council (GMC) launched a call for evidence on remote consultations and prescribing. This helped to inform an updated version of its guidance, Good practice in prescribing and managing medicines and devices, published in February 2021. Key changes include new advice that doctors must not prescribe controlled drugs without access to relevant information from patient records. Exceptions include where there is no other person available with access to records to prescribe without unsafe delay and there’s a need to avoid serious harm or deterioration in health; or to enable continuity of treatment where a patient is unexpectedly without access to medication for a limited period.

The GMC also used feedback from a patient roundtable, held in 2019, to help shape and inform safety tips for patients accessing healthcare online. The tips were co-produced with CQC, the General Pharmaceutical Council and other regulators, and launched in March 2020.

The GMC takes action to deal with concerns involving individual doctors, and shares intelligence with other UK healthcare organisations to ensure appropriate steps are taken to protect the public.

See: General Medical Council

General Pharmaceutical Council

The General Pharmaceutical Council (GPhC) stopped routine pharmacy inspections during the first part of the pandemic. Instead the focus was on providing support to registered pharmacies to help them manage the pressures and challenges. GPhC inspectors identified numerous examples of notable practice in the way pharmacies were dealing with the pandemic, and these were published on the knowledge hub of the GPhC inspection website. Some pharmacy inspection visits were resumed at times when the lockdown restrictions were relaxed, prioritising those that had previously not met all the standards.

Throughout the pandemic, GPhC continued to carry out intelligence-led inspections in response to information that suggested pharmacies were not operating safely. GPhC used statutory enforcement powers to take action against a number of pharmacies where serious risks to patient safety were identified. GPhC worked collaboratively with the MHRA to identify areas of risk in relation to supplies of codeine linctus and imposed conditions to prevent some pharmacies from supplying this, and other medicines that are liable to misuse, when they identified that the medicines were being sold without effective control.

See: General Pharmaceutical Council

Health and Care Professions Council (HCPC)

The Health and Care Professions Council (HCPC) has produced new web content for registrants on the use of controlled drugs.

The COVID-19 advice hub sets out how HCPC expects registrants to meet its standards during the pandemic, including an advice page on medical rights .

Newly revised pages on meeting standards include advice for registrants with medical rights.

HCPC responded to NHS England’s consultations on proposed amendments to the list of controlled drugs that physiotherapists and podiatrists can independently prescribe across the UK. Read the response to the consultation.

See: Health and Care Professions Council

Home Office - Drug Licensing and Compliance

Pandemic Emergency Supply Regulations

The Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020 amend the Misuse of Drugs Regulations 2001 and came into force on 30 April 2020. If brought into effect by the Health Secretary, the measures in the 2020 regulations would:

allow registered pharmacies to supply certain substances without a prescription, where the patient has been receiving them as part of ongoing treatment
allow the supply of substances under a Serious Shortage Protocol to enable ongoing treatment with alternative products where prescribed items are unavailable or are in short supply nationally
allow pharmacists without prescribing rights to change the frequency of instalments on instalment prescriptions without the immediate need for a new prescription.

The amendments are only intended to be used in limited circumstances where demand or workforce pressures during a pandemic meant that local health services were at imminent risk of failing to fulfil their duties, or if there is a national shortage of a specified controlled drug.

There will be no changes to practice until an announcement is made by a Secretary of State. The supply of medicines is the policy responsibility of the Department of Health and Social Care (DHSC) and the NHS and it would therefore be the Secretary of State for Health and Social Care who will decide when to use these powers and make the announcement setting out the conditions of supply.

Although the measure enabling the supply of medicines without a prescription, for example, may be applied across the whole of Great Britain, or the whole of England, Wales or Scotland, it could also be implemented in a relatively small geographical area, for example, a specific town or the area from which a GP practice that has been forced to close has accepted patients onto its patient list. The geographic scope will be determined by the extent of need. An announcement that affects all or any area of Scotland or Wales would be made following consultation with Scottish or Welsh Ministers.

Gamma-hydroxybutyric acid (GHB) and related compounds (GHBRS)

The Advisory Council on the Misuse of Drugs (ACMD) provided advice on GHBRS on 20 November 2020. The report makes extensive recommendations:

GHBRS be scheduled as Class B drugs under the Misuse of Drugs Act 1971
gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD) be placed under Schedule 1 of the of the Misuse of Drugs Regulations 2001
recommendations on improved data, toxicology, prevention, treatment, and training staff in health and social care.

The Home Office is considering the report in discussion with DHSC, Public Health England and other partners and agencies, and will provide a joint ACMD response shortly.

Novel benzodiazepines

On 29 April 2020, the ACMD recommended that three novel benzodiazepines: flualprazolam, flunitrazolam and norfludiazepam be controlled under Class C of the Misuse of Drugs Act 1971 owing to their risk of harm and prevalence in the UK. They also recommended placing them under Schedule 1 to the Misuse of Drugs Regulations 2001, as they currently have no known medicinal use in the UK. See the full report and the Government’s response published on 8 September 2020.

The draft affirmative order to control the three benzodiazepines under Class C of the Misuse of Drugs Act 1971 was laid on 25 March 2021. A draft negative order to schedule the drugs as Schedule 1 drugs will follow in due course, subject to Parliamentary procedure.

Fentanyl and fentanyl analogues

The ACMD’s report on fentanyl was published on 3 January 2020. It made wide-ranging recommendations, and the Home Office worked with other government departments and agencies and consulted the devolved administrations in developing its response.

The Government's response accepted the recommendations in principle, committing to respond further on some points.

Synthetic Cannabinoid Receptor Agonists (SCRAs)

The ACMD provided advice on SCRAs on 28 October 2020. The report makes wide-ranging recommendations on data collection, toxicology (including sharing information and developing capacity), surveillance, and outreach to identify and refer users to treatment services. The Home Office alongside DHSC, other relevant agencies, and the Devolved Administrations, will provide a formal response.

Cannabis-based products for medicinal use

The ACMD provided advice on 27 November 2020 on CBPMs and aims to provide a response to the recommendations by April 2021.

Cannabidiol (CBD)

The Government asked ACMD for advice on potential amendments to the 2001 Regulations to prescribe a permitted trace percentage in consumer (non-medicinal) CBD products.

In 2020, the Home office’s Drug Licensing team:

further reduced waiting times for licensees across the unit
reacted to the emerging pandemic situation during mid-March and put mechanisms in place to secure timely decisions on ‘clinically imperative’ applications, critical to the nation’s pandemic response
pivoted overnight on 24 March to a system for remote working and issuing e-licences to enable continuity of supply of all UK medicine requirements
issued 2,452 domestic controlled drug domestic licences, including 145 compliance visits
conducted compliance visits to the maximum extent possible; visits stopped completely from 25 March to 3 October, after which they resumed on a limited basis strictly risk-assessed basis, focusing on clinically critical applications
considered 101 ‘Theft and Loss’ reports and served 13 administrative licensee contraventions
issued 22,160 import-export licences, approximately 95% of these for controlled drugs.

See: Home Office (GOV.UK)

Human Fertilisation and Embryology Authority

The Human Fertilisation and Embryology Authority (HFEA) publishes and maintains a register of accountable officers for centres in England that are not registered with CQC.

Management of medicines remains one of the top four areas of non-compliant practice within the fertility sector. In February 2020, the fertility sector was provided with a reference table detailing statutory, regulatory and best practice guidance to improve practice in this area and there are plans to update medicines management guidance in the Code of Practice in 2021.

See: Human Fertilisation and Embryology Authority

Medicines and Healthcare Products Regulatory Agency

Diversion of controlled drugs/prescription-only medicines inquiry

The Medicines and Healthcare products Regulatory Agency (MHRA) has continued the investigation into the large-scale diversion of specific class C controlled drugs or prescription-only (POM) medicines. These include diazepam, zopiclone and zolpidem from the authorised UK supply chain to an illegal market. Evidence has shown that they were being sold either online or distributed through the black market and cases of historic diversion have been identified and investigated.

Indications are that this activity has significantly reduced the demand for benzodiazepines and non-benzodiazepines from manufacturers and large wholesale dealers, but the market for unauthorised generic versions, predominantly from India, has become stimulated. There is no legal restriction on pharmacists purchasing unlimited quantities of these medicines, but dispensing is restricted to a prescription being submitted and, if licensed by both the Home Office and the MHRA, they can be distributed wholesale within the UK and abroad. Several cases investigated and prosecuted as part of the enquiry have reached court stages:

two pharmacists have pleaded guilty to charges of selling controlled drugs from registered pharmacy premises and were due to be sentenced in June 2021.
Sarfraz Hussain, a pharmacist was sentenced to 28 months imprisonment for supply of class C drugs with a street value of between £854k and £1.4 million. He has been suspended by GPhC.
In March 2021 Balkeet Singh KHAIRA, a pharmacist, was sentenced to 12 months imprisonment having pleaded guilty to unlawful supply of class C drugs from his pharmacy (29,105 packs).
A trial is due to start in August 2021 involving three pharmacists charged with diverting substantial quantities of class C drugs from the legal supply chain. Two of the pharmacists have pleaded guilty, the third is to stand trial.

UK departure from the EU

UK medicines legislation allows medicines of all categories (including prescription-only medicines (POMs)) to be sold online provided existing legal requirements are met. This is a contributory factor in the remote prescribing services offered through some pharmacy websites. Patients are offered an online consultation where a doctor conducts the consultation by telephone, video call or an online questionnaire, and may decide to provide a prescription. The online consultation and prescribing are not MHRA’s remit – the General Medical Council and CQC lead, but the four regulators involved (CQC, GPhC, GMC and MHRA) have been collaborating to address safety concerns raised by online-only healthcare services, map the regulatory landscape and, importantly, identify gaps. Many of the companies are registered in other EEA Member States and this sits outside the regulatory remit of UK authorities.

UK departure from the EU has had an impact on EEA prescriptions. See the updated guidance on the Government’s website.

Human Medicines regulations have been amended to reflect that the UK recognises prescriptions from a maintained list (currently all EEA countries). Prescriptions issued in the UK are not recognised in the EEA.

There is an exception – the Republic of Ireland has amended legislation to enable prescriptions to still be recognised and dispensed in Ireland after the end of the transition period when written by registered medical practitioners, registered dentists and registered nurse prescribers, including midwife prescribers, in the United Kingdom.

Although most measures introduced by the EU Falsified Medicines Directive will remain in place, requirements were disapplied on 1 January 2021 for:

online sales of medicines (Common Logo scheme)
barcoding or unique serial number on POMs for scanning in or out of supply chain

The Medicines and Medical Devices Act 2021 gives powers for the UK to introduce replacement schemes to combat falsified medicines. MHRA is considering what systems would best suit the UK environment and market, and will consult with stakeholders.

MHRA is working with GPhC and other stakeholders in relation to status and abuse of codeine linctus, and assisted the GMC with the updated guidelines for remote consultation and prescribing.

See: Medicines and Healthcare Products Regulatory Agency

Ministry of Defence

The challenges of the coronavirus pandemic have added an extra complexity in 2020, with external assurance visits postponed and unexpected Unit closures causing issues for some areas. In April, to accommodate the significant increase in activity, a temporary relaxation in routine quarterly controlled drug reporting was introduced, in line with NHSE recommendations. However, usual reporting activity was resumed from quarter 3, and despite the challenges faced, all areas have reported successes and/or implemented improvements this year.

MoD did not identify any major concerns regarding the safe management and use of controlled drugs. The number of incidents reported, while generally low, is increasing year on year. This is welcomed as it reflects an increased awareness, understanding and engagement in governance processes. To further mitigate the risk of under-reporting, Responsible Officers have committed to more collaborative working initiatives between the medical and logistical chains.

There was also a thorough review of the controlled drugs policy, with the final policy and updated reporting templates introduced from February 2021.

See: Ministry of Defence (GOV.UK)

National Institute for Health and Care Excellence (NICE)

The NICE guideline on controlled drugs: safe use and management (NG46), published in April 2016, is due for review in 2021. NICE guideline on Safe prescribing and withdrawal management is scheduled to publish in April 2022. The NICE guideline on Chronic pain: assessment and management was published in April 2021.

See: National Institute for Health and Care Excellence

National Police Chiefs’ Council

The new National Police Chiefs Council (NPCC) lead, Assistant Chief Constable O’Doherty (Thames Valley Police), contacted Chief Officers about the role of controlled drug liaison officers (CDLOs). Most police forces throughout England have CDLOs, but some areas such as central and southern England have gaps. Most forces have a named contact and some forces are now carrying out reviews into the role. This year’s CDLO course (run by Greater Manchester Police) has 24 officers/staff attending, which is encouraging.

Areas of concern are similar to previous years. They include thefts by healthcare professionals, from care establishments, especially wastage from the theatre setting and from drug stock rooms (lower schedules of controlled drugs such as benzodiazepines, codeine products and sleeping pills). There has also been an increase in the theft/diversion of codeine linctus and promethazine from retail pharmacies, with several ongoing investigations involving the MHRA, GPhC and the police.

CDLOs are attending local intelligence network meetings and report good outcomes where they work closely with the NHS England and NHS Improvement CDAO teams.

The Association of Police Controlled Drug Liaison Officers (APCDLO) continues to hold an annual Best Practice Event.

See: National Police Chiefs’ Council

NHS England and NHS Improvement

NHS England has a statutory duty to provide assurance on the safe use of controlled drugs across the health system, including private providers locally. NHS England and NHS Improvement-appointed controlled drugs accountable officers (local lead CDAOs) are operationally responsible for discharging the function. The duties of a local lead CDAO are set out in the regulations and include operating Local Intelligence Network (LIN) where concerns about systems and/or individuals can be raised and where information is shared across Responsible and Designated Bodies. This statutory function is aligned with pharmacy and medicines optimisation, patient and professional safety, surveillance and resolution. There are close links to:

primary care contracting
revalidation
patient safety
quality surveillance
medicines management
wider system issues.

Since the 2019 annual controlled drug report was published, NHS England and NHS Improvement continues to discharge its functions under the Controlled Drugs (Supervision of Management and Use) Regulations 2013 (as amended).

Coronavirus (COVID-19). Work continues with partners and stakeholders to support health and social care systems to provide safe and effective care to people during the pressures and challenges of the pandemic. There is a risk-based and proportionate approach to this work to continue the safe management and use of controlled drugs

Local intelligence networks. Face-to-face LIN meetings were suspended due to pandemic restrictions. All LINs have and continue to meet virtually, which was a successful approach.

Online prescribing and supplies of controlled drugs. During the pandemic there was a significant increase in the use of online consultation and prescribing services. There is still a concern in relation to medicines at risk of misuse or dependence, such as opioid-based medicines, which can result in greater risk of harm, including death. Coroners in England and Wales have issued a number of ‘Reports to Prevent Future Deaths’ where the prescribing and supply of controlled drugs online or remotely has been the primary matter of concern.

In addition, some of the procedures introduced by delivery services during the pandemic, such as no longer requiring or obtaining signatures on delivery, have added an additional risk where medicines, including controlled drugs, may be diverted or not delivered to the correct recipient when they are supplied through a delivery service.

The NHS remains focused on its response to the pandemic, including the vaccination programme and recovery plan. The CDAO function continues to support the NHS with this, providing rapid assistance and advice on maintaining patient care while ensuring the safe management and [clinical] use of controlled drugs in challenging circumstances. As we emerge from the pandemic, processes will be reviewed to ensure any relevant learning and innovation from this challenging episode is captured.

See: NHS England and NHS Improvement

NHS England Health and Justice

During 2020, the focus for medicines and pharmacy services has been on providing strategic support for medicines continuity during the COVID pandemic, including controlled drugs. Resources to support this have been published on NHS COVID webpages. These include:

Guidance on medicines continuity in health and justice commissioned services: This includes specific advice about controlled drugs and an appendix about handling continuity of Buvidal injection for detainees released from prisons in Wales.
Information to support remote prescribing within the legislation
Supporting information about how released detainees can access medicines during the COVID pandemic.

Health and Justice leads have supported the development of the Regional Medicines Optimisation Committee Buvidal guidance. This was delayed due to COVID but the final guidance will be published early in 2021/22. This will support providers in health and justice and community services to introduce injectable buprenorphine into their formularies and care pathways.

See: NHS England Health and Justice

Nursing and Midwifery Council (NMC)

In January 2020, the NMC introduced new standards of proficiency for midwives. These set an evidence-based benchmark for the profession, creating a foundation for future midwives to receive a first-class education and reflect the transforming landscape in which midwives work. 2020 was very much about supporting registrants during the COVID pandemic and helping to influence healthcare during this time.

The Government’s emergency legislation allowed temporarily registering of nursing and midwifery professionals who wanted to support the response to the COVID-19 pandemic.

NMC introduced emergency education standards to allow more flexibility in programme delivery, and specifically to allow students to undertake extended placements without the requirement for supernumerary status to support the health and social care workforce.

In 2020, NMC received 341 referrals relating to prescribing errors and medicines management. These included:

14 prescribing errors
37 thefts of medicines
66 breaches of controlled drugs procedures

Of these referrals, it was found there was a case to answer or sanction decision for:

5 prescribing errors
16 thefts of medicines
36 breaches of controlled drug procedures

NMC is seeing an increasing trend in cosmetic-related referrals received, and trends in the types of allegations made. A significant number are referred by the public, and a substantial number of complaints come from Save Face, a national register of accredited practitioners who provide non-surgical cosmetic treatments, which suggests concerns around registrants’ abilities in this industry.

See: Nursing and Midwifery Council

Public Health England

Public Health England (PHE) was involved in several activities related to controlled drugs in 2020.

The impact of COVID-19

PHE's advice to services on responding to the COVID-19 pandemic helped to reduce the use of supervised consumption of opioid substitution therapy (OST) and the frequency of instalment collections, if these were based on individual risk assessments. Despite this caution, there have been a handful of reported incidents in which patients took home quantities of OST that they then overdosed on or sold to others. In-treatment deaths and hospital admissions for methadone poisoning also increased during the pandemic and PHE is considering, with service providers, the impact of the pandemic on: changes in service practice, service users’ mental health, and COVID-19 infection.

Drug-related deaths and medicines

Illicit drugs continue to be by far the biggest contributor to rising numbers of deaths from drug misuse. However, there are several deaths from controlled and prescribed drugs, especially opioids. PHE’s review of the evidence on medicines that can lead to dependence and withdrawal, some of which are controlled drugs, was published in September 2019 and programmes of work by NHS England and others to reduce inappropriate prescribing continue.

Diamorphine licensing and prescribing

PHE continues to provide clinical advice to the Home Office on applications from suitably competent doctors in England for licences to prescribe diamorphine in the treatment of addiction. Despite delays caused by COVID-19, PHE continued to develop guidance on supervised diamorphine treatment for opioid misuse and dependence (often called heroin assisted treatment or HAT). The guidance was published in March 2021.

See: Public Health England (GOV.UK)

Royal College of Veterinary Surgeons

In response to the COVID-19 pandemic, the Royal College of Veterinary Surgeons (RCVS) Council agreed a temporary departure from its Codes of Professional Conduct to allow prescribing of prescription-only veterinary medicines (POM-Vs) remotely without first having physically seen the animal. This temporary guidance has been drafted and continues to be reviewed considering the changing government guidance as each of the four nations ease lockdown restrictions.

The RCVS Practice Standards Scheme suspended assessments during the first lockdown in March 2020. In October 2020 it started virtual assessments concentrating on medicines aspects. Practices due for assessment upload their controlled drug standard operating procedures and copies of their last two months’ controlled drug registers for Schedule 2 controlled drugs, which are checked in advance by the Assessors. On the day, a member of the practice team takes a mobile camera around, directed by the Assessor who looks the security and contents of the controlled drug cabinet. This is working very well.

The other issue during COVID had been denaturing of Schedule 2 controlled drugs in the presence of a Veterinary Medicines Directorate (VMD Inspector, a Practice Standards Scheme (PSS) Assessor or an independent vet. This has been very difficult for practices, with VMD and PSS mostly not doing face-to-face visits and independent vets reluctant to enter a different practice because of biosecure bubbles. RCVS have asked both VMD and the Home Office for a solution to this as many practices have large stocks of Schedule 2 controlled drugs awaiting destruction, which is a risk for team members and a security risk.

See: Royal College of Veterinary Surgeons

Scottish Government, Healthcare Improvement Scotland and the Scottish CDAO Network

The Scottish Government Medicines and Pharmacy Division has been engaged in implementing The Misuse of Drugs (Co) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020, to support continuity of supply of controlled drugs during a pandemic. To implement the statutory instrument in Scotland, a Direction and operational guidance is required, and work is underway to develop these. Scottish Government will communicate to key stakeholders once the guidance has been finalised.

The Scottish Controlled Drugs Accountable Officer (CDAO) Network has been actively involved in various short-life working groups, including the guidance on re-provisioning medicines in care homes in a pandemic situation. Care homes were the basis for much of the work in 2020. Arrangements were put in place for quick access to medicines for people at the end of their life in care homes across Scotland. This meant liaising with GPhC on how care homes could meet the regulations for supply and storage of controlled drugs for patients who were rapidly deteriorating with end of life COVID symptoms. Joint working with Health Improvement Scotland and the Area Drug and Therapeutic Committee Collaborative also contributed to the national Palliative Care Toolkit for treatment of COVID-19.

The Network’s Working Group is updating the Primary Care Guide to the Management of Controlled Drugs – Scotland, and the CDAON FAQs and controlled drugs Induction Handbook will also be updated this year. The following resources have also been updated:

Controlled drug self-assessment questionnaire (SAQ) general practice (dispensing)
Controlled drug self-assessment questionnaire (SAQ) general practice (non-dispensing)
Controlled drug requisitions from ships, offshore installations and master of foreign ships in British waters
Information booklet for administrative staff in general practice.

Healthcare Improvement Scotland (HIS) continues with its statutory functions in relation to the governance of controlled drugs as well as the regulation and inspection of independent healthcare services that prescribe controlled drugs. Recent work has focused on strengthening monitoring and inspecting organisations involved in the supply of cannabinoid products. HIS has been working with NHS England to address gaps in data capture and reporting in relation to dispensing controlled drug prescriptions in Scotland that were generated in another part of the UK.

HIS has also been engaged with National Services Scotland and the CDAO Network to improve data capture for private stock ordering of controlled drugs in Scotland to inform assurance. Linkages with Police Scotland for controlled drug-related matters have also been strengthened by representation on CDAO Network groups. Work continues with LINs to ensure sharing of intelligence across Scotland. HIS is working with the Scottish Government to explore how the diversion and supply of illicit medicines work should link with the work of CDAO Networks in Scotland as well as reviewing exiting arrangements for governance of controlled drugs and addressing any gaps.

See: Healthcare Improvement Scotland

UK Anti-doping

In November 2020, the Protect Your Sport Campaign was launched to encourage more people to come forward and share their concerns about doping in sport. On average, UK Anti-doping (UKAD) receives over 1,200 reports a year, but this number has been significantly affected by the halt of competitive sport considering the COVID-19 pandemic. Intelligence plays a vital role in the work of UKAD, and led to 30% of all published Anti-Doping Rule Violations (ADRVs) in 2020.

In line with its Strategic Plan priorities, UKAD has also been exploring with partners what other options are available to enhance the effectiveness of investigations.

UKAD has been working with Europol on an investigation into the distribution of anabolic steroids throughout Europe and further afield. Europol want to identify manufacturing and distribution hubs within Europe, and UKAD will be working to secure details of intended parcel recipients and to identify any links to sport that could lead to action being taken against individuals under the Anti-Doping Rules. UKAD will attempt to ensure that the relevant police force(s) take steps to develop and take action on this intelligence wherever possible. UKAD is on the National Police Chief Council National Drugs Working Group, which discusses emerging threats and opportunities to work collectively in reducing harm from drugs.

See: UK Anti-doping

Veterinary Medicines Directorate

Routine inspections of veterinary practice premises were put on hold in March 2020 during the first lockdown but resumed in August until the second national lockdown. Since then some remote inspections have taken place. In 2020, the Veterinary Medicines Directorate (VMD) inspected 219 veterinary practice premises as a mixture of on-site and remote inspections, a reduction in previous years.

The VMD’s inspectors regularly advise veterinary surgeons on how to comply with the Misuse of Drugs Regulations 2001, particularly regarding safe storage, record-keeping, disposal and requisition orders. Inspectors provide reports after an inspection that point out non-compliance and give advice and guidance on the measures required to correct them.

VMD inspectors will also often have to carry out witnessed disposal of out of date controlled drugs during inspections. They are also asked to witness disposal as a special visit (not related to an inspection) but VMD is encouraging vets to use independent vets as much as possible.

See: Veterinary Medicines Directorate (GOV.UK)

Wales Controlled Drugs Local Intelligence Network

Controlled Drug Local Intelligence Network (CDLIN) meetings across Wales were suspended at the beginning of the COVID-19 pandemic, and used an IT-based virtual meeting format later in the year to reinstate their meetings as the pandemic pressures eased.

Collaboration with colleagues in England enabled the Welsh standard operating procedure for repurposing end of life medicines to be adopted. Further adaptations were made to ensure patients were able to receive palliative controlled drugs promptly, and the Just in Time Emergency Medicines Pack service to address out-of-hours difficulties was established. This operates through six end of life pharmacy hubs with a distribution network set up to centralise procurement, ensuring 100% geographical coverage of Wales.

Welsh Ambulance Services NHS Trust (WAST) worked very closely and quickly with clinical leads from pharmacy, palliative care, and primary care, to develop a vehicle-based Just in Case Medication (JIC) box. This enables paramedics to administer end of life treatment to patients through a verbal order without escalation to hospital.

There have been different approaches to managing controlled drugs in the temporary Nightingale hospitals, but all responsibility has been under the governance of the secondary care pharmacists in the Health Boards.

Substance misuse services ensured all patients have been individually risk assessed and their treatment plan adjusted to minimise risk. However, the level of risk accepted has, anecdotally, varied across Wales. Welsh Government encouraged the conversion to using buvidal, a prolonged release injection allowing for weekly or monthly treatment of dependency, where appropriate.

Activity during 2020

The CDLINs have reported activity relating to:

lessons learned after the first wave of the pandemic
a new community system/process to ensure quick access to controlled drugs for patients at the ed of their life
a newsletter focusing on the harm caused by prescribed medicines when abused or diverted
a new controlled drug incident report form and a generic email address to simplify incident reports
outcomes from incident investigations that are now used to strengthen governance arrangements across the Health Board
strengthened relationships with Counter Fraud, Police, the military and other partner organisations through improved communication and collaboration
updated information sharing agreements
work with the local MOD to ensure formulary adherence, after identifying prescriptions for non-formulary controlled drugs
annual visits by controlled drug pharmacists to independent hospitals and hospices carried out by telephone rather than face-to-face
authorised witness activity re-instated after initial suspension early in the pandemic, with training sessions delivered by a number of Health Boards, both virtually and latterly face to face sessions with small numbers of attendees.

Welsh Ambulance Service NHS Trust

Recognition of the value of the ‘just in case’ drugs in pre-hospital care has meant that the trust will work with partners to make the just in case boxes a permanent feature to manage patients at the end of life. The trust will also develop appropriate patient group directions, to support a more robust mechanism, for paramedics to administer these drugs.

Rollout of the new Abloy controlled drug security system providing digital key access to controlled drugs in ambulances across Wales was completed during 2020. This gives the trust the ability to monitor safe access activity and to know which key was used and at what time to access any of the vehicle-based controlled drug safes.