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Update on new legislation relating to controlled drugs during the COVID-19 pandemic

Three temporary emergency measures have been introduced by the UK Government into legislation (The Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020)

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. This includes patients requiring opioid medicines for palliative care, severe pain management, or taking regular opioid substitution therapy. This would help the pharmacy sector to continue to deliver the care and services needed to protect some of the most vulnerable members of society.

There has been confusion about the introduction and use of these emergency, temporary measures, including in media reporting. Please share with your colleagues the key points below, which help explain more about these new measures and how they might be used in the future:

  • The Government is clear that these measures will not come into use with immediate effect.
  • The amendments are enabling and would only be used in limited circumstances following an announcement by the Secretary of State and under conditions specified by the health service in the area(s) to which the announcement applies.
  • The announcement will include:
    • The measure(s) being made active
    • The duration period, including the start date
    • The area to which the measure applies (this could be limited to a region, or an area covered by a Board)
  • These measures will only be used if demand pressures and workforce illness during the pandemic means that local health services are at imminent risk of failing to fulfil their duties. Each request for the use of emergency measures will be assessed on a case-by-case basis. The emergency measures will only last for the duration of the emergency. 
  • Before engaging one or more of the measures, clear guidance for healthcare professionals will be in place, and the precise scope and duration of the measures clearly defined.
  • The emergency measures, if enacted, will end as soon as possible after the measure ceases to be necessary. 
  • 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). 

The new measures were developed following the advice of the Advisory Council of the Misuse of Drugs (ACMD).

The measures are:

1. Emergency supply of controlled drugs at the request of a patient during a pandemic which extends the Human Medicines Regulations and Misuse of Drugs Regulations which allows a pharmacist working in a registered pharmacy, to supply prescription only medicines (POMs) at the request of a patient in an emergency. This emergency supply has now been extended to include Schedule 2, 3 and 4 (Part I) controlled drugs.

2. Supply of controlled drugs under a Serious Shortage Protocol during a pandemic

This would only be used as a last resort and in exceptional circumstances; it extends the range of medicines which can be supplied under an SSP to Schedules 2, 3 and 4 (Part I) controlled drugs. The SSPs will be highly specific and limited in scope, so that pharmacists can be reassured that they are ensuring patient safety under clear instruction.  

3. Enabling pharmacists to vary the frequency of dispensing an instalment prescription for controlled drugs during a pandemic

This is a temporary change to the Human Medicines Regulations and Misuse of Drugs Regulations which will allow pharmacists to vary the frequency of the dispensing of controlled drug instalments. However, it is important to note that: Pharmacists will only be able to vary the frequency of instalments on instalment prescriptions if they have first consulted with the prescriber (or an appointed representative of the prescriber).

The RPS has produced factsheets providing more detailed guidance for pharmacy teams about the use of these emergency measures if they are activated; the factsheets are available on the RPS website. In addition, health services in each nation will develop and issue guidance on the implementation of the measures; the Government will work collaboratively with the Devolved Administrations to ensure that health service guidance is aligned across Great Britain.

Reuse of medicines in a care home or hospice

The Department of Health and Social Care and NHS England has separately published guidance on the reuse of medicines (including controlled drugs) in a care home or hospice. Read the Coronavirus (COVID-19): reuse of medicines in a care home or hospice guidance.

Work is ongoing in Scotland and Wales to develop guidance on the reuse of medicines in care homes and hospices for each country. We will add links to these documents once they are available.