Government has passed a legislation with amendments to the Misuse of Drugs Regulations 2001 which will empower pharmacists to supply some controlled drugs without prescription under three emergency measures.
Pharmacists in England, Wales and Scotland will be allowed to supply Schedule 2, 3 and 4 (Part I) controlled drugs during the coronavirus pandemic if the Health Secretary deems it necessary and makes an announcement activating the measure(s).
The announcement will be made under conditions specified by local needs in areas to which the announcement applies and can only be used if local health services fail to fulfil their duties due to demand pressures and workforce illnesses during a pandemic.
Additionally, each request for the use of emergency measures will be assessed on a case-by-case basis and these temporary measures will only last for the duration of the emergency. The maximum period for which a measure will apply will be three months, but it can be extended for a further three months if the Health Secretary decides it is necessary.
What are the three temporary measures?
- Emergency supply of controlled drugs during a pandemic: This will allow a pharmacist working in a registered pharmacy to supply Schedule 2, 3 and 4 (Part I) controlled drugs at the request of a patient who has been receiving them as part of their treatment.
- Supply of controlled drugs under a Serious Shortage Protocol during a pandemic: To be used as a “last resort” and in exceptional circumstances, this 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.
- Enabling pharmacists to vary frequency of dispensing 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, done only after consulting with the prescriber or their appointed representative.
Guidance for pharmacists
Health services in England, Wales and Scotland will be issuing guidance on the implementation of the measures. The Royal Pharmaceutical Society is producing three factsheets providing more detailed and professional guidance for pharmacists about the use of these emergency measures.
Commenting on the new measures, RPS President Sandra Gidley said: “We welcome this legislation to maintain patient access to treatment when the usual means of prescribing and accessing it are unavailable. This will bring relief to patients needing ongoing treatment for palliative care or substance misuse therapy.
“The flexibilities the legislation empowers pharmacists to provide the right care for patients during the pandemic.
“Now the legislation has been published, we will shortly provide professional guidance for pharmacists who may need to supply controlled drugs under the new measures.”
How did it all begin?
In early April, Home Secretary Priti Patel proposed changes to the existing regulations to help secure access to controlled drugs during the Covid-19 pandemic.
She wrote a letter to the government’s drug policy advisers – the Advisory Council on the Misuse of Drugs (ACMD) – asking their opinion on the risks of lifting restrictions on certain controlled drugs.
The ACMD was broadly supportive of the proposed measure, but it warned: “Without adequate support and guidance for the healthcare professionals affected by the proposed legislative change, there is a risk that pharmacists struggling to follow best practices could inadvertently lead to an increase in drug misuse and diversion.
“This is a particular risk for patient groups requiring opioid pain medicines, eg for palliative care or for opioid substitution therapy (OST).
“Additionally, whilst it will be necessary for the government to publicly announce in an emergency that these measures are to apply, common knowledge of the applicability of this measure may increase the risk of the misuse and diversion of controlled drugs.
“For example, patients with substance misuse issues might attempt to place pressure on a pharmacist to dispense in accordance with this measure, or might visit a range of pharmacists in an attempt to locate and exploit weaknesses in any of their practices in order to be supplied with medicines against best practice.”
The Council supported applying supply shortage protocol (SSP) to certain controlled drugs – which would allow pharmacists to hand out alternatives – but recommended this was done as a “last resort.”
In her response on Monday (April 27), the Home Secretary confirmed that emergency measures would be introduced at an appropriate time “to help secure access to controlled drugs within the healthcare system in a pandemic and where there is a serious risk to human health.”
The legislation was “laid before parliament” on Wednesday.