RPS guidance issued on new CD regulations for pandemic supply

RPS guidance issued on new CD regulations for pandemic supply

May 7, 2020

Three changes to the Misuse of Drugs Regulations 2001 (MDRs) came into force last week, which provide Ministers with emergency powers for the supply of controlled drugs (CDs). The purpose of the changes is to ensure community pharmacies can continue to supply patients with essential medicines at critical times during a pandemic, such as the COVID-19 outbreak. The regulations are enabling so may be used only if ‘activated’ or ‘switched on’ by Ministers and apply in very limited circumstances.

Today, the Royal Pharmaceutical Society (RPS) issued guidance for pharmacists on the legislation and associated professional practice considerations. The guidance was developed in consultation with the pharmacy sector including PSNC.

The three changes to the MDRs set out in the Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020 are:

1. Emergency supply of a CD without a prescription – at the request of a patient, medicines of Schedule 2, 3 and (Part 1) Schedule 4 to the MDRs may be supplied without a prescription, in accordance with the directions of a pharmacist, where:

  1. as a consequence of a current or anticipated disease that is a pandemic and a serious risk or potentially a serious risk to human health there has been an announcement by the Secretary of State (SoS) in respect of such CDs, to assist the management of that risk (the new MDRs have to be ‘activated’ or ‘switched on’);
  2. supply is part of NHS services (for example, an Enhanced Service) and the contractor complies with those NHS arrangements;
  3. the NHS arrangements are within the scope of the SoS’s announcement with regard to
    1. the area,
    2. particular circumstances (for example, a GP practice closure), and
    3. period in question (up to 3 months at a time, this can be amended, withdrawn, or extended);
  4. supply is from a retail pharmacy business (e.g. the contractor’s NHS pharmacy);
  5. the supervising pharmacist is satisfied that the patient has been receiving the medicine as part of ongoing treatment from a relevant prescriber and the dose is appropriate for the patient (linked to requirements in Reg 266 of the HMRs, see below);
  6. as with NHS services generally, the supervising pharmacist must also exercise appropriate professional judgement in accordance with accepted standards in the profession (in this case, the RPS guidance).

The new MDRs complement and extend existing legislation which allows the supply of POMs (and schedule 5 and 4 (part II) CDS) without a prescription during a pandemic (Reg 226 of the Human Medicines Regulations (HMRs)). So far as PSNC is aware, Reg 226 has been used only once for NHS supplies, early during the outbreak, following the closure of a GP practice. Patients of the practice who required essential medicines could not obtain prescriptions in a timely manner. So, an Enhanced Service was commissioned quickly by NHSE&I, with the involvement of DHSC and PSNC (DHSC amended the Directions for Enhanced Services accordingly). This enabled specified pharmacies in the local area to provide POMs to patients of the GP practice for 2 weeks or so – provided that the supervising pharmacist was satisfied that (i) the patient had been treated with the POM on a previous occasion by an appropriate prescriber and (ii) the dose was/remained appropriate for the patient (Reg 226 requirements), and the requirements of the Enhanced Service were satisfied. The Enhanced Service also provided the means for contractor reimbursement and remuneration.

2. Emergency supply of a CD against a Serious Shortage Protocol (SSP) – this provision is essentially the same as that for supply of a CD without a prescription. It enables medicines of Schedule 2, 3 and (Part 1) Schedule 4 to the MDRs to be supplied under SSPs, if there is a serious shortage of the medicine and the requirements for SSP supply are satisfied (reg 226A of the HMRs). Thus, requirements (a) to (d) and (f) above apply and more requirements relating to SSPs – please see the PSNC briefing on SSPs which also describes the relevant Terms of Service for SSP supplies and requirements for reimbursement and remuneration.

3. Emergency change to a CD instalment direction with the agreement of the prescriber – this provision allows pharmacists without prescribing rights to change the frequency of instalments on instalment prescriptions for medicines of schedule 2 and 3 of the MDRs, without the need for a new prescription from the prescriber. The changed intervals are treated as the intervals of the prescriber. Any changes MUST be agreed in advance with the prescriber or, if the prescriber is unavailable, a person specified by the prescriber who is a part of the same team responsible for treating that patient. The requirements (a) to (d) and (f) above apply.

For any queries, please contact Gordon Hockey, PSNC’s Director of Operations and Support.

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