Emergency supply of controlled drugs could be allowed

A letter has been sent from the UK Home Secretary to the Advisory Council on the Misuse of Drugs to advise on COVID-19 emergency measures to enable the supply of controlled drugs.

The letter from the Rt Hon Priti Patel MP, asks the Advisory Council on the Misuse of Drugs to advise on three potential measures that would enable the supply of medicines containing controlled substances in light of the COVID-19 outbreak.

The Home Secretary intends to put in place emergency measures to:

Legislate to allow registered pharmacies to supply substances in Schedule 2, 3 and Part 1 Schedule 4 to the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’) without a prescription, where the patient has been receiving them as part of on-going treatment.
Allow supply of Schedule 2, 3 and Part 1 Schedule 4 substances under a Serious Shortage Protocol. These allow on-going treatment with alternative products where prescribed items are unavailable or are in short supply; and
Allow pharmacists without prescribing rights to change the frequency of instalments on instalment prescriptions without the immediate need for a new prescription from a prescriber.

The Home Secretary has said that these measures help secure access to controlled drugs within the healthcare system in a pandemic and where there is a serious risk to human health.

She states in the letter that they have been designed to ensure patients continue to have access to medicines critical for on-going treatment, build resilience and help relieve pressure elsewhere in the health system.

She has said that there are risks of making these changes related to greater access to controlled drugs and risk of diversion or misuse which have been taken into account in developing the measures.

The request of the ACMD is to advise on the potential harms or risks relating to these three measures, and the balance of the harms and risks of not proceeding in the current exceptional circumstances.

Emergency supply without prescription

The Home Secretary is proposing to legislate to allow registered pharmacies to supply schedule 2, 3 and part 1 schedule 4 substances without a prescription, where the patient has been receiving them as part of on-going treatment.

The following safeguards have been suggested:

Apply only to patients who have been receiving the drug as part of on-going treatment.
Be subject to the pharmacist’s professional judgment – relying on their knowledge and experience of working with a range of patients, albeit this will be an additional responsibility that they will not have had to date – pharmacists would not be obliged to supply the drugs.
Remain subject to existing safeguards, including record-keeping and checking the identity of the patient or the person obtaining the medicines on their behalf.

The measures would apply in England, Wales and Scotland. The Department of Health in Northern Ireland has said that it supports the proposals and indicated that it will introduce similar measures to align with Great Britain.

Serious shortage protocols

Serious shortage protocols (SSPs) are currently not available for use for Schedule 2, 3 and Part 1 Schedule 4 substances. The Home Secretary has said that there is a significant risk of supply shortages, given the impact of COVID-19 on the supply chain. She, therefore, has proposed to allow SSPs to apply to these substances in anticipation of possible shortages.

The following safeguards have been suggested:

The measures would only apply to medicines in Schedule 2, 3 and Part 1 of Schedule 4. It would not affect Schedule 1 drugs.
Drugs would only be supplied in accordance with an SSP – one criterion of which is that there is a prescription from a prescriber.
Drugs would only be supplied through registered pharmacies – regulated by the General Pharmaceutical Council.
Pharmacists would only supply under an SSP at their professional discretion and in cases where they deem it reasonable and appropriate for the patient and would refer any complex cases back to a prescriber.
Where a controlled drug is supplied in accordance with an SSP, NHS terms of service provided that the pharmacist must notify the patient’s GP of the alternative SSP supply, but this will not automatically apply to substances in Schedule 2, 3 and Part 1 of Schedule 4 because they have previously been out of the scope of SSPs.

Frequency of instalments on instalment prescriptions

As part of efforts to free-up capacity and maintain the safe supply of medicines, the proposals seek to allow pharmacists to vary the frequency of supply from an instalment prescription, following the instructions of the prescriber or their appointed representative of the NHS service responsible for the original prescription (if available). For example, moving from “three times a week” to “once a week”. These instructions could be by phone or email but, if by phone, must be followed up by written confirmation. The total quantity supplied would remain as specified on the prescription.

The Home Secretary has said that these proposals will also minimise social contact within pharmacies, helping to protect front-line staff and patients by enabling reductions in the frequency of collections of medication.

The following safeguards have been suggested:

Pharmacists would be expected to use their professional judgement, relying on their knowledge and experience of working with a range of patients, albeit this will be an additional responsibility that they will not have had to date. Existing clinical guidance and best practice should be maintained as far as possible.

The measures would only apply to medicines in Schedule 2, 3 and Part 1 of Schedule 4. It would not affect Schedule 1 drugs.
Changes to intervals on an instalment prescription would be on the basis of an agreement with the prescriber. If the prescriber is unavailable, the pharmacist will have to use their professional judgement, but in England, we would expect the relevant NHS arrangements to provide that contact should be made with the prescriber’s agreed representative of the service responsible for the original prescription (if available).
Any change to the interval on an instalment prescription would be recorded by the pharmacy and prescriber.
Drugs would only be supplied through registered pharmacies – regulated by the General Pharmaceutical Council.

You can read the full letter from the Home secretary below.