Controlled Drugs National Group 

Sub-Group Newsletter – April 2021. Issue number 11Joint Sub-

Introduction The whole health and social care system is continuing to adapt to new situations and challenges posed by the coronavirus (COVID-19) pandemic. In our last newsletter we continued to showcase some of the many initiatives local health and care organisations have introduced to cope with the demands posed by these challenging times, but recognise that providers may follow different approaches according to their local needs.

Who is your local NHS England and NHS Improvement  Controlled Drugs Accountable Officer (CDAO)?

We would like to take this opportunity to provide a reminder of your local NHS England CDAO’s contact details. Regional Lead Controlled Drugs Accountable Officers (CDAOs) are responsible for all aspects of Controlled Drugs management in their area.

CDAOs strongly advocate a ‘Just Culture’ in which health and care staff are supported to be open about mistakes to allow valuable lessons to be learnt so the same errors can be prevented from being repeated. CDAOs can support people to investigate, to reflect, to learn and to take action to prevent a recurrence.

This is not only for healthcare workers, but extends to people working in the social care sector, too. Controlled drugs related incidents that happen in social care settings (including theft or loss) should be reported to your local NHS England CDAO, who can provide the appropriate advice and support.

The CD reporting tool can be found here, and can be used by both those working in health and social care: https://www.cdreporting.co.uk/

Care Quality Commission

Earlier in the year we published two consultation documents – one on our new strategy and the other on flexible and responsive regulation. Whilst these consultations are now closed, and we are currently analysing the responses, further detail about both of these can be found below.

CQC’s formal consultation on our draft strategy. Our draft strategy is the product of over 10,000 interactions with stakeholders and sets a bold ambition for the organisation over the next five years. The pandemic has forced health and social care to think differently, and we are no exception. For CQC, it has accelerated the need for us to change. Our draft strategy has been developed to enable more effective regulation for the future and support services to keep people safe. We need to make changes to the way we regulate so that it’s more relevant, working with health and care services to find solutions to problems and improve outcomes for everyone. We also want to be more flexible to help us manage risk and uncertainty. Our strategy is built on four themes that together determine the changes we want to make. For more information, the link to our draft strategy can be found on our website here.

Consultation on flexible and responsive regulation Following on from the consultation on our new strategy, we proposed some specific changes that will enable us to deal with ongoing challenges from the pandemic and move us towards our ambition to be a more dynamic, proportionate and flexible regulator. Our inspection reports and ratings give a view of quality that’s vital for the public, service providers and stakeholders. In this consultation we proposed some changes to allow us to assess and rate services more flexibly, so we can update our ratings more often in a more responsive and proportionate way. The changes will make ratings easier to understand for everyone. In the consultation document, we also set out how we’ll engage with all our stakeholders in the future when we make changes to the way we regulate. Further information can be found here:

Patient Safety

Preventing harm from misuse of morphine sulfate oral solution

The following article has been shared with us by the  NHSE&I South West CDAO team, to share learning and highlight the risk of harm associated with inappropriate use of morphine sulfate oral solution.

Controlled Drugs Accountable Officers and other stakeholders continue to be concerned about the harms (both accidental and deliberate) that arise from the misuse of morphine sulfate oral solution, which continues to be implicated in cases involving deaths of both adults and children.

The most common such medicine is morphine sulfate 10mg/5ml oral solution, which is listed as a schedule 5 controlled drug in the Misuse of Drugs Regulations (and listed as a Class A drug in the Misuse of Drugs Act).

Morphine sulfate 10mg/5ml oral solution contains 200mg of morphine in a 100ml bottle, which is the smallest pack size. This is a sufficient quantity of drug to cause severe harm if used inappropriately. The fact that it is a liquid formulation means that a large amount of morphine can be ingested very quickly, and therefore like most other liquid opioid formulations it is a high-risk medicine. We frequently hear of incidents involving overdoses of morphine that occur with this medicine - both accidental, and deliberate.

As morphine sulfate 10mg/5ml oral solution is a schedule 5 controlled drug, there is no regulatory requirement for an explicit dose to be stated on the prescription that would be transcribed across to a dispensing label. For the purposes of safety, prescribing of liquid opioids should include clear directions, as stated in NICE guideline NG46. Unclear dosage instructions on morphine sulfate solution prescriptions have caused deaths before, and continue to do so.

There is significant under-reporting of incidents with this medicine to CDAOs. Please bear in mind that as this is a controlled drug, it should be reported as a controlled drug incident.

Colleagues in many parts of the country are now seeking to reduce the inappropriate use of this medicine. This is being achieved through general prescribing guidance, but also individual patient review, as follows:

• Review the indication – is an opioid appropriate?
• If so, is morphine the most appropriate drug?
• If so, is an immediate formulation appropriate?
• If so, is a liquid necessary?
• If so, is the prescribed dose appropriate, are the prescriber’s directions clear, and are they understood by the patient?
• If so, do the quantities being supplied correspond with the dose and frequency?
• How will you prevent supplies occurring in response to inappropriately frequent requests?
  Is the quantity being supplied on each occasion a safe amount for the patient to have in their home?
• Will it be stored safely and out of reach and sight of children, pets, and vulnerable adults?

Stock discrepancy and unaccounted for losses with liquid preparations of controlled drugs

Inaccurate counting and poor record keeping of controlled drugs can reduce staff time for patient facing activities. Learning from practice has been shared with us for wider sharing in this newsletter.

Ideas to improve accuracy of counting and record-keeping
Ensure that a SOP is in place for stock checks and recording of all controlled drugs entered into the CD register including:

• A visual inspection of liquid balances
• periodic volume checks and
• balance confirmation on completion of a bottle as per NICE Guidance – Controlled Drugs: Safe use and management (NG46), as a minimum.

For balance checks of liquids, consider implementing the following:

• Do not decant liquids to check balances: you lose some each time
• Use a calibrated bottle (see Fig 1) to aid visual inspection and accurate measurement
• Medication doses to be administered must be drawn up using an oral syringe

Periodic checking and recording

Organisations need to consider the most appropriate frequencies for both checking and recording stock. NICE Guidance NG46 states:

“the frequency of stock checks, which should be based on the frequency of use and
controlled drug-related incidents, and risk assessment; for most organisations stock
checks should be at least once a week, but they may be carried out more or less often
depending on the circumstances.”

Fig 1 below– calibrated bottles to aid balance checks (courtesy of Claire House Hospice, Wirral)

Over the Counter Codeine 

With escalated scrutiny of opioid usage in the USA in response to trends of increasing addiction, overdose and opioid-related deaths, effort is required to prevent such issues reaching a similar level in the UK. To support the wider agenda of opioid stewardship, Boots UK has introduced a Patient Safety Card (attached) to prompt early interventions and appropriate ‘nudge behaviours’ in patients requesting opioid-containing medication over the counter. Following successful pilot work, the Patient Safety Card has been introduced in all Boots pharmacies as a conversational tool to help reinforce key advisory points pertaining to safe and appropriate use, to raise awareness of the potential risks from long-term opioid use and to disrupt patient behaviour patterns indicative of opioid abuse at the earliest opportunity. Recognising that conversations with patients about opioid misuse or abuse may sometimes be challenging, the Patient Safety Card helps pharmacy professionals to engage in dialogue with patients and, if appropriate, effect a compassionate approach to their signposting to suitable sources of support with any issues associated with opioid misuse.

Boots UK - Patient Safety - Codeine card (Mar 2021).pdf

Members of the sub-group would like to thank Jose Moss and Boots for their contribution.

Vigilance 

GP practice clinical systems and misuse of controlled medicines

The following article has been shared with us by a regional NHSE&I CDAO team, to share learning in relation to reducing the risks of misuse of GP practice systems to illegally acquire controlled medicines

NHS England & NHS Improvement are currently stakeholders in a fraud investigation into the activity of a practice manager who registered themselves with their practice as a temporary resident, and then used a locum GP’s log-in to the practice clinical system to issue controlled drugs prescriptions for themselves. Some of these prescriptions were printed on paper FP10 forms and signed by the practice manager themselves. Others were sent via EPS using the locum’s smartcard.

The individual concerned was able to abuse their position of trust in this way in a number of GP practices for some time before the behaviour was detected. 

Learning shared by some of the GP practices concerned is copied below, and could be helpful when considering policies and process to reduce the risk of an event such as this recurring.

Some of the learning points include:

1. Remind all staff of the support available to them if they are in difficulty, for example struggling with problems such as addiction.
2. Always refer members of staff who ask for prescriptions to their own GP.
3. Periodically check that no members of the practice’s own staff are registered with the practice without the knowledge of the partners.
4. If members of the practice’s own staff are intentionally registered with the practice, periodically check who prints the prescriptions, who signs them, and that the prescribing gives no cause for concern.
5. Regularly review clinical system user accounts and disable accounts that are no longer required. Remove any inappropriate permissions to generate prescriptions.
6. Disable locum log-ons that are not being used, and lock away locum smartcards.
7. Set up smartcards for new members of staff as a priority to minimise the use of locum smartcards
8. Identify unusual activity such as staff logging in to the system out of hours to issue prescriptions.
9. Insist on appropriate references when employing new members of staff; when employing senior staff who have been employed by medical practices before, references should be obtained from GP partners of previous practices.
10. If you are a dispensing practice, regularly audit and reconcile stocks in the most appropriate way for your practice. It is worth considering that in some cases weak opioids such as codeine, benzodiazepines, and morphine sulfate oral solution are widely misused and diverted. Do the amounts you are obtaining from suppliers correspond with what is being supplied to patients?

If you have any concerns about a member of staff in relation to this article or have any queries about this article please e-mail your NHSE&I CDAO (contact details of your local NHSE&I CDAO can be found on our published CDAO Register, and at the top of this article).

Prescribing and Monitoring

Updated prescribing guidance from the General Medical Council (GMC)

The GMC has updated its prescribing guidance –Good practice in prescribing and managing medicines and devices. The guidance will help provide support to doctors who are seeing patients more frequently by remote and virtual consultations. Updates to the guidance includes advice for doctors not to prescribe controlled drugs unless they have access to patient records, except in emergencies, as well as advice on information sharing with other health professionals.

The updated guidance can be found here.

The International Association for the Study of Pain (IASP) position statement on the use of cannabinoids to treat pain.

The International Association for the Study of Pain (IASP) works to support research, education, clinical treatment, and better patient outcomes for all pain conditions with the goal of improving pain relief worldwide.

Over the past two and a half years IASP’s Task Force on Cannabis and Cannabinoid Analgesia has completed a comprehensive review of research on the use of cannabinoids to treat pain. A position statement released in March 2021 finds that there is a lack of sufficient evidence to endorse the general use of cannabinoids for the treatment of pain.

The IASP states: “Reviews of preclinical research and clinical safety and efficacy of cannabis and cannabinoids for pain relief have identified important research gaps. Due to the lack of high-quality clinical evidence, the International Association for the Study of Pain (IASP) does not currently endorse general use of cannabis and cannabinoids for pain relief. International Association for the Study of Pain recognizes the pressing need for preclinical and clinical studies to fill the research gap, and for education on this topic.”

Further information can be found in IASP’s journal, PAIN. There are a series of 13 linked scientific articles that review all of the relevant laboratory and clinical research on this topic. These articles form the body of evidence that informed IASP’s position.

National Institute of Health and Care Excellence (NICE) guideline on Chronic Pain

On 07 April 2021, NICE published a new guideline: Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain.

The guideline is for healthcare professionals, commissioners, providers of services and people with chronic primary pain and chronic secondary pain, their families and carers.

This guideline should be used alongside NICE guidelines for other chronic pain conditions.

It contains guidance on both pharmacological and non-pharmacological management of chronic primary pain, as well as key recommendations for future research. The full guideline can be found here, as can the visual summary on how to use the guideline.

Planning access to end of life care medicines

The Specialist Pharmacy Service have published guidance on Planning access to end of life care medicines out-of-hospital during a pandemic. The four good practice points were drawn up together with help from resources and colleagues from Care Quality Commission (CQC), Royal College of Nursing (RCN), Queen’s Nursing Institute (QNI), and Controlled Drug Accountable Officers (CDAOs). The practice points are intended to be supportive to organisations and health and care systems that need to set up systems to access end of life care (EoLC) medicines in a pandemic in a way that works best in their localities.

Faculty of pain medicine guidance

The faculty of pain medicines has recently published new best practice guidance on surgery and the use of opioids. This guidance is centred around two key aims collaboration amongst all healthcare professionals involved in perioperative care with a view to both patient centred care and good opioid stewardship; and the appropriate use of opioids so that they are used when they are needed but stopped when no longer required. The guidance sets out some helpful detailed recommendations for healthcare professionals involved in pre-, peri- and post-operative patient care.

Research: New study of Anticipatory Prescribing local policies and guidance

The following article has been shared with us by a research team, who would like to raise awareness of their ongoing study.

Professor Stephen Barclay and colleagues in Cambridge University are undertaking a UK-wide study of End of Life Care prescribing. The COVID-19 pandemic has created many challenges for End of Life Care in the community. In order to support colleagues across the UK to adapt to the changes needed during these difficult times, Professor Barclay’s team are undertaking a UK-wide study of policies and guidance concerning:

1. Anticipatory Prescribing and syringe drivers
2. End of Life medicines repurposing in care homes
3. Family carer administration of End of Life Care drugs

If you are happy to share your local community policies and guidance, please contact:

Megha Majumder, PhD student mm2426@medschl.cam.ac.uk
Professor Stephen Barclay sigb2@medschl.cam.ac.uk

Professor Barclay’s team have also recently published a paper in the BMJ Supportive & Palliative Care about the risks and benefits of anticipatory syringe pumps which can be found on the link below:

20210414 Anticipatory syringe.pdf

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
CQC CD Annual Reports
CQC Controlled Drug Accountable Officer Register
Other CD National Sub-Group Newsletters

General Pharmaceutical Council (GPhC)

The GPhC have published a suite of guidance covering coronavirus (COVID-19) pandemic issues which can be found on their website here. 

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 may want to sign up to MHRA alerts via the MHRA Central Alerting System, here.

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 NHSE Primary Care Bulletin can be found here and other useful links include:

1. Remote prescribing guidance for health and justice sites
2. NHS England Speciality Guide: Clinical guide for the management of palliative care in hospital during the coronavirus pandemic

National Institute for Health Protection (previously Public Health England (PHE)

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)

The Department of Health and Social Care (DHSC)

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.

Home Office

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)

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 suite of guidance covering coronavirus (COVID-19) pandemic issues which can be found on their website here.