Introduction
The whole health and social care system is adapting quickly to new situations and challenges day by day. Many Government departments, professional and regulatory bodies are continuously publishing information that helps to bring clarity regarding managing controlled drugs during this coronavirus (COVID-19) pandemic period. In this special edition we highlight some of those publications, but it inevitably isn’t an exhaustive list. In addition, health and care professionals will need to continue to keep up to date with all new guidance relevant to their area of work.
Care Quality Commission
We have made several important changes to the way we work during the coronavirus (COVID-19) outbreak, they include how we do our job, our support to providers that keeps people safe and how people communicate with us. Further information on these changes can be found on our website here.
During these exceptional times we have been busy responding 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. We will regularly update this resource to reflect the rapidly changing situation so it is important to keep checking this guidance for the latest updates.
Some more general information including information on hot hubs can be found in Nigel's surgery 97: Responding to coronavirus (COVID-19).
Home Office
On the 1st April the Home Secretary wrote to the chair of the ACMD regarding emergency legislation to ensure the continued supply of controlled drugs during the Covid-19 pandemic. A copy of the letter and further details can be found: here
NHS England and NHS Improvement
NHS England and NHS Improvement (NHSE&I) lead controlled drugs accountable officers have contacted their Controlled Drugs Local Intelligence Network (LINs) members in recent weeks setting out the new incident reporting arrangements for CDs and associated tasks during this coronavirus (COVID-19) pandemic period.
Interim arrangements include:
Occurrence reports (applicable to Designated Bodies only)
- NHSE&I are not requesting quarterly occurrence reports until further notice.
Reporting incidents and concerns (applicable to all)
- NHSE&I only require reporting of incidents or concerns that are considered extremely serious’ or have had a ‘catastrophic’ outcome and these must be made as soon as practicable. For the avoidance of doubt, these include serious patient harm or death and any theft or significant loss, especially where misappropriation by a healthcare professional.
- Suspected misappropriation by healthcare professionals currently is of particular concern. NHSE&I are receiving reports of CDs being accessed through work in order to cope, self-medicate or self-harm. Please do ensure your governance processes protect the health and wellbeing of your colleagues.
Local Intelligence Network(s) meetings (applicable to LIN members)
- Face to face LIN meetings have been suspended but will be reconvened as soon as it is safe to do so. The purpose of the LIN is to facilitate the frank and timely sharing of information between relevant parties to maintain patient safety and public protection. NHSE&I may convene a ‘virtual’ LIN meeting and, where necessary, Investigation Panel(s), to ensure this duty is met.
Applications for Personal Identification Numbers
- NHSE&I will continue to process applications by prescribers for Personal Identification Numbers (CD PINs) to facilitate the prescribing Schedule 2 and/or 3 controlled drugs in private practice. In the current environment this may take up to four weeks to process and may be administered by another region in some circumstances.
Authorised Persons to witness the destruction of obsolete Schedule 2 CDs
- In designated bodies you should continue to follow your organisation’s process.
- In primary care, applications received will be processed through the established route.
- Applications may take longer to process than normal.
- Pharmacy ‘multiples’ that have authorised persons within their establishment should continue to follow their established processes.
- NHSE&I may have put alternative arrangements in place that allow for timely destruction of CDs without the need for the attendance of an external witness in person.
- If you hear of any problems with returning medicines to community pharmacies please let your NHSE&I CDAO team know.
Patient safety and public protection remain critical functions If you amend your governance processes during this emergency to reduce the operational burden for your organisation or colleagues, please consider how you will maintain these critical functions. NHSE&I will keep their approach under review, including their own contingency processes, and will advise of changes.
Medicines re-use scheme On the 28th April NHSE&I published guidance a standard operating procedure on how to run a safe and effective medicines re-use scheme in a care home or hospice during the coronavirus outbreak. This standard operating procedure can be found here.
Further coronavirus guidance for clinicians and NHS managers is available on the NHS England and NHS Improvement website here
Medicines & Healthcare products Regulatory Agency
MHRA is responding to the challenges posed by the Covid-19 crisis. There is detailed information on their website. It is worth noting that there are no medicines licensed specifically for the treatment or prevention of COVID-19 and no self-testing kits approved for home use. Consequently, products offering to do so are not authorised and it is illegal to supply such products. Of interest, the two website links below:
In terms of responding to suspicious activity, MHRA have provided the follow updates as of 30 April 2020;
- 14 investigations ongoing in relation to unlicensed / unapproved COVID-19 medicines and medical devices
- Products seen include unlicensed anti-viral medication, surgical face masks and self-testing kits. These products have not undergone the appropriate regulatory checks and therefore do not meet UK regulatory standards
- Investigating 80 web domains, 3 domain names have been suspended and 6 social media accounts/posts have been closed down
- Monitoring suspicious domain names that could be selling or advertising products falsely claiming to prevent, detect, treat or cure COVID-19
- Working with the City of London Police, National Crime Agency, Nominet and global partners to tackle online crime
- Collaborating with City of London Police to introduce landing pages on websites selling suspicious medical products that warn visitors of criminal activity on that site
- Engaging in public messaging re dangers of buying medicines and devices online – promoting reporting through the Yellow Card Scheme
Police Force; Controlled Drugs Liaison Officers (CDLOs)
We have been made aware that during the past few weeks there have been telephone calls to pharmacies from persons claiming to be from the Police. Callers have been requesting information regarding stocks of medicines, storage, security measures and vulnerability. Whilst the Police and CDLOs have established several of the calls made were in fact genuine and with good intent, several others were in fact found to be false.
To combat these attempts to elicit vital information and to prevent crime, the Police have issued guidance setting out that if a police officer makes contact, they will give you their name, ID number and the police station in which they are based. It is important that you:
- Satisfy yourself as to the identity of the caller. Record the telephone number displayed, if not withheld.
- Ask the person for their full name, their ID number. Where are they based, do they have a landline as well as a mobile.
- Get them to define the nature of their call. What exactly do they want to know? Ask for a police incident number or reference number. Take control and direct the conversation.
- Do they know of or are they aware of the CDLO (Controlled Drug Liaison Officer) within their Force? Most pharmacies will have a contact number.
- Be mindful of the caller asking for quantities of stock held, opening times, number of staff, the location of the Controlled Drug cabinet or even the layout of the premises or even keyholder details.
- Are they asking about physical security measures, the alarm, CCTV? Deliveries from the wholesaler. This should raise your suspicions, or something is wrong.
- If you feel pressured and in order to give yourself more time ask them to ring back at a specific time. This will give you time to verify if they are genuine. You can seek verification from NHS England and NHS Improvement controlled drugs accountable officer or your local CDLO.
- Try to remain focussed and remember details, such as male/female caller, local accent or anything you think might be relevant.
- Before you have any incident or caller, perhaps ensure that you create a list of relevant contact numbers which are on display at a convenient spot perhaps in the dispensary, out of public sight. (This includes Police telephone numbers).
- Consider revisiting your standard operating procedures amend or alter them accordingly. Ensure staff are fully briefed and are conversant with them. Remember to keep your procedures up to date.
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Royal Pharmaceutical Society (RPS)
The RPS has convened a short-life working group with the purpose of developing national guidance around temporary pandemic flexibilities to enable the supply of controlled drugs. RPS guidance on ethical, professional decision making in the Covid-19 Pandemic https://www.rpharms.com/resources/pharmacy-guides/coronavirus-covid-19/coronavirus-information-for-pharmacists-and-teams/ethical-decision-making
Specialist Pharmacy Service (SPS)
On the 21st April, the SPS held a medicine use and safety webinar supporting community health service pharmacy teams in responding to coronavirus (COVID-19). The webinar was designed to provide information about key resources to support CHS pharmacy teams during the Coronavirus COVID-19 pandemic and offered participants a chance to question the experts and share experiences and learnings. The slide set used can be found on the SPS’s website: Supporting CHS pharmacy teams in responding to COVID-19
In addition, SPS have published guidance on minimising wastage of critical medicines during coronavirus (COVID-19). This guide provides advice to staff in pharmacy aseptic units and to staff in clinical areas, on how to safely provide a supply of injectable medicines to meet the increased demand whilst minimising wastage. This guide covers injectable medicines used in the treatment and supportive care of COVID-19 patients when UK-wide supply of these medicines is severely constrained and is valid only for the duration of the current COVID-19 emergency.
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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