Pandemic Treatment Protocols
Published on: 6th November 2020 | Updated on: 17th April 2024
On 9th November 2020, new Terms of Service requirements were introduced for pharmacy owners related to Pandemic Treatment Protocols (PTPs).
During a pandemic disease, or in anticipation of a pandemic, Ministers may give approval for pharmacies to supply a Prescription Only Medicine (POM) without a prescription, for the prevention or treatment of the disease, in accordance with section 247 of the Human Medicines Regulations 2012 (HMR).
The PTP is a protocol for pharmacies to make such supplies as part of the Essential Dispensing service.
Supply in accordance with a PTP
Subject to the requirements of the PTP, where the pharmacy owner receives, via a secure service approved by NHS England, an electronic message that amounts to an order for the supply of a medicine in accordance with a PTP; and the person who is entitled to be supplied with that medicine in accordance with that order, requests the medicine from the pharmacy, a pharmacy owner must supply the medicine to the person, or that person’s representative, with reasonable promptness.
Additional requirements of PTPs
Certain record keeping requirements apply and will be contained in the PTP/Ministers approval under section 247 of the HMR. This information is likely to be necessary for pharmacy owners to claim a fee and any reimbursement for a supply of a medicine in accordance with a PTP.
The arrangements for an assessment of a person’s need for the medicine (who assesses and how) will be specified in relation to each PTP and there may be other additional requirements contained in a PTP.
A supply of a medicine in accordance with a PTP, similar to a supply of a medicine in accordance with an NHS prescription, must be made, for example:
- with reasonable promptness and, if asked, an estimate, or, as appropriate, a revised estimate of the time when the medicine will be ready given;
- in a suitable container;
- generally, in the manufacturer’s pack where the PTP specifies a pack size of multiple of that is readily available; and
- have a dispensing label which must, in addition to the general requirements for dispensing labels, includes information to identify the medicine was dispensed under the specific PTP.
If the PTP does not include the quantity, strength or dosage, the responsible pharmacist, using professional skill, knowledge and care, may provide an appropriate strength and dosage of the medicine and, subject to certain conditions in the terms of service, the quantity of medicine which may not exceed five days.
The above is a summary of subparagraphs (5) to (10) and (15) of paragraph 8 of schedule 4, Terms of Service, of the NHS (Pharmaceutical and Local Pharmaceutical Regulations) 2013, which apply in full to a supply of a medicine in accordance with a PTP.
A pharmacy owner may refuse to make a supply in accordance with a PTP where:
- the pharmacist considers that the person or representative’s request is not genuine;
- providing the medicine is contrary to the pharmacist’s clinical judgement; or,
- where the person or anybody accompanying the person is violent or threatening to pharmacy staff or commits or threatens to commit a criminal offence.
A pharmacy owner must refuse to make a supply in accordance with a PTP, if not satisfied that the person or representative’s request is in accordance with the PTP.
Note: A PTP is likely to state specifically which POM may be supplied in accordance with the PTP.
A PTP may not be used for a supply of a Schedule 2, 3, or part 4(1) Controlled Drugs.
