The controlled drug legislation allows ministers in Great Britain and the Department of Health in Northern Ireland to invoke flexibilities for the supply of controlled drugs during a pandemic. These measures are not currently enabled and would only be applied in limited circumstances, following an announcement by the Secretary of State.
In this article we’ve provided some further information about how the emergency measures might be used if they were introduced at any point.
Under what circumstances could the emergency measures be introduced?
Potentially, the new measures could be introduced 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.
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.
How would the emergency measures be introduced?
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.
Any such announcement would 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)
How would the emergency measures work in practice?
Before engaging one or more of the measures, clear guidance for healthcare professionals would be in place, and the precise scope and duration of the measures clearly defined.
How long would the emergency measures last for?
The emergency measures, if enacted, would end as soon as possible after the measure ceases to be necessary.
The maximum period for which a measure would apply is three months (which may be extended for another three months if the Secretary of State determines it is necessary).
What measures are included in the emergency legislation?
The measures are:
1. Emergency supply of controlled drugs at the request of a patient during a pandemic
This 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).
Find out more
The RPS has produced factsheets providing more detailed guidance for pharmacy teams about the use of these emergency measures if they are activated.
In addition, health services in each nation will develop and issue guidance on the implementation of the measures; the UK Government will work collaboratively with the devolved administrations to ensure that health service guidance is aligned across Great Britain.