There had already been concern about drug shortages in the UK due to Brexit; however, since the COVID-19 pandemic kicked off, there has been a lot of talk and worry about potential drug supply shortages to patients.
Some EU Member States have indicated that they are starting to see shortages of certain medicines used for patients with COVID-19 or are expecting such shortages to occur very soon. These include medicines such as anaesthetics, antibiotics and muscle relaxants, as well as medicines used off-label for COVID-19. The situation has been aggravated in the pandemic by many factors, such as factory lockdowns, border closures, export bans, lockdowns in third-world countries supplying medicines to the EU, increased demand and stockpiling by hospitals and citizens, as well as at the Member State level.
To help mitigate supply disruptions, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events is setting up, with the pharmaceutical industry, the i-SPOC system to fast-track interaction on shortages between industry and the EU Executive Steering Group. More information on this can be found here.
In the UK there is deep concern about the support of care homes and hospices. As the number of COVID-19 deaths in care homes and hospices has grown in the UK, there have been strong opinions that the UK government has “forgotten” such residents. However, there are some new national measures to draw your attention that are aimed at assisting drug supply in these settings during the pandemic.
National UK temporary emergency measures — assisting drug supply to care homes and hospices
As the number of COVID-19 deaths in care homes and hospices has grown in the UK, there have been strong opinions that the UK government has “forgotten” such residents. However, there are some new national measures to draw your attention that are aimed at assisting drug supply in these settings during the pandemic.
Novel Coronavirus (COVID-19) Standard Operating Procedure – Medicines Reuse Scheme
The Department of Health and Social Care and NHS England has published guidance on the reuse of medicines (including controlled drugs) in a care home or hospice (“The Reuse of Medicines Guidance”). The Reuse of Medicines Guidance is applicable in England and for use during the COVID-19 pandemic only and has been developed to support care home and hospice providers.
The National Institute for Health and Care Excellence (NICE) has issued good practice for managing medicines in care homes (NICE Guidance) that includes a recommendation that care home providers must ensure that medicines prescribed for a resident are not used by another resident. The Reuse of Medicines Guidance is designed to help providers manage situations where, during the COVID-19 pandemic, the best interest of patients means that it is not appropriate to follow this NICE recommendation.
Part 12 of the Human Medicines Regulations 2012 limits the supply of prescription-only medicines (POMs) to supply in accordance with a prescription of an authorized prescriber, subject to various exceptions.
Due to concerns about the pressure on the drug supply chain during the COVID-19 pandemic, the Department of Health and Social Care and NHS England and NHS Improvement are recommending a relaxation of previous recommendations to accommodate reuse of medicines, under very specific circumstances and only in a crisis situation as outlined in the Reuse of Medicines Guidance. It is recommended that medicines should only be reused in accordance with a medicines reuse scheme set out in a standard operating procedure.
Each care home or hospice must carry out a risk assessment on an individual medicine basis. The Reuse of Medicines Guidance states the key indicators that should inform the risk assessment and the subsequent decision. For example, no other stocks of the medicine are available in an appropriate timeframe, no suitable alternatives for an individual patient are available in a timely manner and the benefits of using a medicine that is no longer needed by the person for whom it was originally prescribed outweigh any risks for an individual patient receiving that unused medicine.
All medicines no longer needed by the person for whom they were originally prescribed and intended for reuse must be under the supervision of a registered healthcare professional (HCP), and appropriate records should be kept, including details of the HCP who performed the check on suitability for reuse. There are tables in the Reuse of Medicines Guidance that include prompts to assist the healthcare professional when assessing a medicine for reuse: Table 1: Criteria to be considered before the medicine can be reused; Table 2: Minimize risk of cross-contamination; Table 3: Ensuring permission is obtained and patients, families and/or carers are fully involved.
The Reuse of Medicines Guidance suggests that care homes and hospices proactively seek written permission from all patients for their medicines (if no longer needed) to be made available for other patients and/or they are to receive a reused medicine, provided they are deemed safe for reuse.
Once a decision has been made to reuse a medicine, the processes in the Reuse of Medicines Guidance should be followed. These processes are summarized in a flow chart in Section 4 of the Reuse of Medicines Guidance entitled the “Medicines reuse pathway.”
Once an HCP decides a medicine is suitable for reuse, does this potentially open the HCP or the care home to product liability claims by injured recipients of the reused medicine? Please note that medicine reuse schemes are already widely used within National Health Service hospitals.
Emergency Supply of Controlled Drugs During a Pandemic
The UK government has introduced three temporary emergency measures into legislation (The Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020) (The Amendment Regulations).
This instrument puts in place emergency measures to help secure access to controlled drugs within the healthcare system in a pandemic and where there is a serious risk to human health. This includes patients requiring opioid medicines for palliative care, severe pain management (both of which are very relevant to care homes and hospices) or taking regular opioid substitution therapy. There are three main points in The Amendment Regulations:
- The emergency supply of POM during a pandemic without a prescription is enabled by the Human Medicines Regulations 2012. However, this does not extend to all controlled drugs. The Amendment Regulations implement measures to enable registered pharmacies to supply Schedule 2 to Part 1 Schedule 4 controlled drugs without a prescription in a pandemic if the patient has been receiving them as part of ongoing treatment.
- The supply of a different strength, quantity or pharmaceutical form of a POM to that ordered by the prescriber, in accordance with a serious shortage protocol, is enabled by the Human Medicines Regulations 2012. However, this does not extend to all controlled drugs. The Amendment Regulations implement measures to enable registered pharmacies to supply Schedule 2 to Part 1 Schedule 4 controlled drugs in a pandemic in accordance with a serious shortage protocol.
- The Amendment Regulations also provide flexibility for pharmacists to vary the frequency of dispensing Schedule 2 and 3 controlled drugs from an instalment prescription in a pandemic, with the agreement of the prescriber or their appointed representative.
These new measures will not come into use now but may potentially be introduced at some point in a particular area if there were severe disruptions to the supply of repeat prescriptions of controlled drugs for patients. The maximum period for which a measure will apply is three months (which may be extended for another three months if the Secretary of State decides it is necessary).
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