Welcome to the Summer edition of the Controlled Drug (CD) Sub-Group newsletter. In this edition we launch the 2019 CD Annual Update and continue our focus on the continued safe management and use of CDs during the coronavirus (COVID-19) pandemic.
Summary of contents:
- Introduction
- Care Quality Commission
- Department of Health and Social Care
- Home Office
- NHS England and NHS Improvement
- Medicines at end of life stories and articles
- Further information and links
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Further information on the work and membership of the CD National Group and its sub-groups can be found on our internet page here.
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Introduction
The whole health and social care system are continuing to adapt to new situations and challenges posed by the coronavirus (COVID-19) pandemic period. In our last newsletter we shared information from Government departments, professional and regulatory bodies to provide clarity regarding managing controlled drugs during the initial outbreak period. In this edition we share links to the publication of our 2019 CD annual update and stakeholder report. We also showcase some of the many initiatives local health and care organisations have introduced to cope with the demands posed by these challenging times.
Care Quality Commission (CQC)
Today, 21 July 2020, we published our CD annual update in which we share our findings on the continued safe use and management of CDs through our national oversight role. We make 3 recommendations to continue to strengthen existing arrangements.
Our findings are important for:
- all controlled drugs accountable officers (CDAOs) in England and their support teams
- organisations that handle controlled drugs
- health and care professionals with an interest or remit in controlled drugs
- commissioners of healthcare services
- professional healthcare and regulatory bodies.
The data we use in this annual update relates to the calendar year 2019, but we also include relevant information for the first half of 2020 and covers the period during the COVID-19 outbreak. In this update, we look at key issues and areas of interest:
- opioid medicines
- Gosport Independent Panel report
- Cannabis-based medicinal products
- issues relating to the coronavirus (COVID-19) pandemic.
You can find a link to the annual update and stakeholder report on our website here.
CQC's regulatory approach
Throughout the coronavirus pandemic period our regulatory role has not changed, and we continue to ensure that health and social care services provide people with safe, effective, compassionate, high-quality care. At the start of the pandemic we moved quickly to support providers to keep people safe, including pausing routine inspections and redeploying some of our staff to frontline services. During this period, we continued to only carry out focused inspections in response to immediate risks and concerns about safety and have continued to monitor services and engage with providers to identify where extra support is needed. From September we will focus on services where we have evidence that people may be at risk or that care needs to be improved. This will not mean a return to our pre COVID-19 inspection programme. This may mean a move away from frequency-based inspections and using more information we hold about not only individual providers, but also about local systems to understand where there are barriers to good care.
Innovation and inspiration: examples
We recognise the enormity of challenges faced by health and care providers in responding to coronavirus (COVID-19). At very short notice, services developed new procedures and ways of working. They looked at how they work with others and how people they care for can stay in touch with family and friends of how providers are responding to coronavirus (COVID-19). Examples of innovation and inspiration can be found on our website here.
During these exceptional times we continue to respond to the many queries we are receiving around access, delegation of tasks, stock and re-using named patient medicines, this includes the safe management and use of controlled drugs. To address the more common questions we are being asked, we have published guidance on Coronavirus (COVID-19): medicines information for adult social care providers and some general information on hot hubs in Nigel's surgery 97: Responding to coronavirus (COVID-19). In our last CD Sub-Group newsletter, published in April, we signposted our readers to guidance from Government departments, professional and regulatory bodies and have provided some further guidance below. We will regularly update these resources to reflect the rapidly changing situation, so it is important to keep checking this guidance for the latest updates..
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Department of Health and Social Care (DHSC)
Coronavirus (COVID-19): reuse of medicines in a care home or hospice - GOV.UK
Standard operating procedure on how to run a safe and effective medicines reuse scheme in a care home or hospice during the coronavirus outbreak. The guidance is available here.
COVID-19: guidance for commissioners and providers of services for people who use drugs or alcohol
The DHSC and Public Health England (PHE) published guidance in May 2020 giving COVID-19 advice for commissioners and service providers involved in assisting people who are dependent on drugs or alcohol or both. The guidance is available here.
Home Office
The Home Office have made changes to the Misuse of Drugs Regulations 2001: The Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020 that give government ministers (Department of Health and Social Care (DHSC)) emergency powers for the supply of CDs in specific circumstances during a pandemic, such as the current COVID-19 outbreak.
The regulations are enabling so may be used only if 'activated' by ministers and apply in very limited circumstances.
The three changes being made to regulations are:
- emergency supply of a CD without a prescription;
- emergency supply of a CD against a Serious Shortage Protocol (SSP);
- an emergency change to a CD instalment direction with the agreement of the prescriber
General Pharmaceutical Council (GPhC) have provided some information to clarify the arrangements which can be found here.
This means that there is no change in practice until the flexibilities introduced by the legislation are activated by an announcement from the DHSC. It is anticipated that these provisions will be used infrequently and would only be used if demand and workforce pressures during a pandemic meant that local health services were at imminent risk of failing to fulfil their duties.
Royal Pharmaceutical Society (RPS)
The RPS have published a suite of guidance on the contingency legislation for its members to enable the supply of controlled drugs to continue through the pandemic period.
Please note this guidance is available to members of the RPS or complete a sign-in request.
Epidyolex re-scheduling
Epidyolex, a cannabidiol based product, was licensed in November 2019 as an adjunctive treatment for treating seizures attributable to Lennox Gastaut and Dravet syndrome. Following assessment by the Advisory Council on the Misuse of Drugs it was moved from Schedule 2 to Schedule 5 of the Misuse of Drugs Regulations 2001 on 24 June 2020 because the psychoactive constituent, tetrahydrocannabinol (THC), is present only as an impurity meaning it has a low risk of abuse potential, dependency and diversion. Please see Circular 001/2020: Epidyolex scheduling, (SI) 2020 No. 559 for further information.
NHS England and NHS Improvement (NHSE&I)
During the initial COVID-19 response, the requirement for the submission of occurrence reports was stood down. All designated and non-designated bodies were required to only report incidents or concerns that were considered “extremely serious” or to have had a “catastrophic” outcome.
For the avoidance of doubt, NHSE&I considered this to mean serious patient harm or death and any theft or significant loss, especially where misappropriation by a healthcare professional.
As NHSE&I are now moving into the restoration and recovery phase, some regional controlled drugs accountable officer teams are returning to the more normal quarterly reporting cycles. Organisations required to submit these returns are advised to check what local arrangements are in place.
To comply with the COVID-19 restrictions, Controlled Drugs Local Intelligence Networks (CDLINs) were cancelled during the initial period. However, to ensure sharing of concerns and learning continue these meetings are now taking place virtually until it is safe to resume face to face meetings.
Health and Justice
Accessing medicines for detainees released during COVID-19
NHSE&I has published a guide to support probation and youth offending teams and other teams supporting people released from custody on accessing medicines and pharmacy services during the COVID-19 outbreak. The guide can be found here.
Medicines at end of life stories and articles
Staffordshire sustainability and transformation partnership (STP) Pharmacy End-of-Life (EOL) COVID Subgroup – Overview
Article provided by NHS Stafford & Surrounds CCG and University Hospitals of North Midlands
A subgroup was established under the COVID structure, reporting to the Strategic EOL Cell. Representation on the cell included:
- Lead pharmacists from CCG, local acute Trust (UHNM), community provider (MPFT)
- Local Pharmaceutical Committee representatives (North and South Staffordshire)
- GPs from primary care with specialist interest in EOL/palliative care
- Palliative Care Specialist Nurse – MPFT
- Palliative Care Consultant – UHNM
- Medicines Optimisation Nurse Consultant /Non-Medical Prescribing Lead – MPFT
The key activities undertaken and outcomes included:
- EOL prescribing guidance for COVID
Developed to support prescribing across the health economy and to address general symptom management in EOL and COVID specific management. Adapted from NICE guidance and National EOL Formulary. Included non-parental treatment options to mitigate potential issues with EOL drug availability and community capacity for drug administration.
- Electronic standard prescription and authorisation forms
Within EMIS clinical system (used by the majority of local practices) a template protocol was developed for both parental and non-parental EOL prescriptions. This was based on the prescribing guidance as above. An electronic authorisation form was developed and installed onto the clinical systems to enable efficient authorisation of drugs to be administered by community nursing teams. In addition a patient information leaflet was produced to support relatives or carers to administer non-parental drugs to patients when necessary.
- EOL medication supplies and availability
A Pharmacy Palliative Care Service was already operational locally to stock key EOL medications across the health economy. A review was undertaken on the drugs kept by these pharmacies to support the COVID EOL prescribing guidance – this added additional drugs and non-parental treatment options to the stock lists. Geographical spread of these pharmacies was also reviewed and additional pharmacies were added to the service. To monitor stock availability, community pharmacies were asked to submit a daily SitRep report through PharmOutcomes to report any out-of-stock issues. This was shared with the CCG Medicines Optimisation team and the local Palliative Care Co-ordination Centre to support with any queries.
- Hospital discharges from UHNM
UHNM implemented ‘grab bags’ of EOL medications (prepared under their MHRA Specials Licence) to be supplied to palliative patients on discharge from A&E across their Trust. This approach was developed following discussions with the LIN Controlled Drug Accountable officer and key clinicians. Ensured all necessary documentation and regulations were adhered to. The bags facilitated a quicker discharge for patients. Improvements were made to ensure an effective referral process from UHNM to the community palliative care team was in place.
- Deliveries from community pharmacy
Despite the nationally agreed Pharmacy Delivery Service, it was identified that there may be instances where palliative care patients required urgent delivery of medications therefore the LPC worked with Local Authorities, Fire and Rescue Service and the Blood Bike Service to establish a referral process for community pharmacies to access support where urgent deliveries were required.
Next steps/future planning
The group has been seen to be an excellent example of collaborative working during the COVID period and has implemented significant improvements to the EOL process.
Moving forward this group will continue to meet monthly to continue to monitor the EOL implications of COVID and also to develop longer-term improvements to the prescribing of EOL/palliative care across the local health economy. The aim of this is to provide a consistent framework for the management of anticipatory medication in Staffordshire, minimising hazards to patients and ensuring that staff involved in this process do so effectively and safely.
Administration of end-of-life drugs by family caregivers during covid-19 pandemic -BMJ
In their BMJ editorial, Ben Bowers, Kristian Pollock and Stephen Barclay identify some of the challenges involved and call for training and 24/7 support for family caregivers willing to administer drugs in end-of-life care. The editorial was published on 24 April 2020 and can be found here.
Further information and links
Care Quality Commission (CQC) CQC is the health and social care services regulator with responsibilities for oversight of safe arrangements for controlled drugs across England. Website
General Pharmaceutical Council (GPhC) The GPhC have published a suit of guidance covering coronavirus (COVID-19) pandemic issues which can be found on their website; (https://www.pharmacyregulation.org/contact-us/coronavirus-latest-updates
Medicines and Healthcare products Regulatory Agency (MHRA) The MHRA has a web-based cascade system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care. To keep up to date with any changes you might want to sign up to MHRA alerts via the MHRA Central Alerting System.
NHS England and NHS Improvement. For the latest advice for clinicians on the coronavirus can be found here. Also, NHSE&I has a dedicated COVID-19 community health service page here and their NHS E Primary Care Bulletin can be found here and other useful links include:
Public Health England (PHE) PHE are supporting the NHS and social care to respond quickly to the challenges of the coronavirus pandemic by bringing a suite of documents which can be found on their website: Coronavirus (COVID-19)
Royal College of Anaesthetists The Royal College of Anaesthetists and its partners, working with NHS England and NHS Improvement, have published important guidance covering:
- Anaesthesia: Guidance on potential changes to anaesthetic drug usage and administration during pandemic emergency pressures.
- Intensive Care Medicine: Guidance on adaptations to standard UK critical care medication prescribing and administration practices during pandemic emergency pressures.
- Frequently asked questions for patients.
Royal Pharmaceutical Society (RPS) The RPS published guidance on ethical, professional decision making in the coronavirus COVID-19 Pandemic which can be found on their website here
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. Further information is available here
The Helix Centre The Helix Centre are an interdisciplinary group of designers, technologists, clinicians and researchers. Using human-centred design to rapidly dissect problems, identify opportunities, and develop clinically-evaluated digital solutions. They have published an End-of-life Care Toolkit for Carers at Home which can be found here
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. Further information is available here
The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. They are supporting the NHS and social care to respond quickly to the challenges of the coronavirus pandemic by bring a suite of documents which can be found on their website here including: COVID-19 rapid guideline (updated): managing symptoms (including at the end of life) in the community (NG163)
The Specialist Pharmacy Service (SPS) The SPS have published a suit of guidance covering coronavirus (COVID-19) pandemic issues which can be found on their website: https://www.sps.nhs.uk/category/covid-19-coronavirus/
The World Health Organisation (WHO) The WHO’s guidance documents Coronavirus disease (COVID-19) Pandemic can be found on their website here
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