Emergency supply without prescription
The emergency supply of prescription-only medicines during a pandemic is enabled by the
Human Medicines Regulations 2012. However, this does not extend to Schedule 2, 3 and
Part 1 Schedule 4 substances. We propose to legislate to allow registered pharmacies to
supply these drugs without a prescription, where the patient has been receiving them as
part of on-going treatment. To do this, patients must lawfully be able to possess those
drugs and we propose to amend the 2001 Regulations to enable them to do so.
Safeguards ？ emergency supply without prescription
The capacity for supply by pharmacists without prescription would:
？ 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.
Mechanism for bringing the arrangements into place
The arrangements would be made operational through specific routes in England, Wales
and Scotland. In England, this would be through NHSE-I commissioning routes and signoff
by a Senior Civil Servant on behalf of DHSC Ministers. The measures would require
consultation with Welsh and Scottish Ministers when they are affected. Any arrangements
would be:
？ limited to a defined time period (a maximum of three months, which can be
extended for further periods of not more than three months); and
？ limited to a defined geographical area (potentially, limited only to defined GP
practices and pharmacy services or, if required, nationwide);
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 (SSPS)
SSPs manage the shortage for individual drugs. They enable communi 

 community pharmacists, in
the event of a serious shortage of a prescribed item, to supply in accordance with the
Protocol rather than against a prescription, without going back to the prescriber. SSPs are
currently not available for use for Schedule 2, 3 and Part 1 Schedule 4 substances. There
is a significant risk of supply shortages, given the impact of Covid-19 on the supply chain.
We therefore propose to allow SSPs to apply to these substances in anticipation of
possible shortages.
Safeguards ？ SSPs for controlled drugs
SSPs are only introduced with the involvement of clinicians (doctors and
pharmacists). Additionally, as appropriate, there will be consultation with relevant patient
groups, the devolved administrations, NHS England and Improvement, relevant
manufacturers and relevant pharmacy organisations including Pharmaceutical Services
Negotiating Committee (PSNC).
The following controls and safeguards would apply as part of introducing this measure:
？ 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 criteria 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 provide 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 scope of SSPs. In
England, we will seek in discussions with the Pharmaceutical Services Negotiating
Committee to trigger automatic notifications in such cases