The Human Medicines (Amendment) Regulations 2019 order – which is scheduled to come into force next week (February 9) – includes provisions to allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol”, rather than the prescription, without contacting the GP, in the event of a national medicines shortage.

In its explanatory note published alongside the order, the Department of Health and Social Care (DH) stressed that “protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients”. It gave the examples of “epilepsy or treatments requiring biological products, where the medicines...need to be prescribed by brand for clinical reasons”.

“In these cases, patients would always be referred back to the prescriber for any decision about their treatment, before any therapeutic or generic equivalent is supplied,” the DH added.

Based on the DH’s guidance, National Pharmacy Association (NPA) director of pharmacy Leyla Hannbeck suggested other medicines that may not be covered by a “serious shortage protocol” could include “those with a narrow therapeutic index”, such as warfarin and methotrexate.

“Drugs that have to be brand-prescribed, or insulins with different strengths, may be difficult to substitute,” she told C+D last week (January 23).

It would also be “unsuitable” for pharmacists to dispense alternatives to “anti-rejection drugs used in transplant patients”, such as mycophenolate or ciclosporin, “certain modified-release preparations that are not interchangeable” and “controlled drugs, especially those in schedules 2, 3 and 4”, Ms Hannbeck said.

“Medicines where patient familiarity with a specific brand is important and instruction for use may vary between brands” may also be unsuitable for any DH protocol, she added.

“However, in the event of the complete unavailability of a medicine, the DH may choose to initiate a [protocol] for a medicine that would have previously been considered unsuitable, to ensure that affected patients are not left without medication,” she added.

While the sector awaits further details on how the protocols will work in practice, Ms Hannbeck said “it would be expected” that any patients receiving medicines under a protocol would be closely monitored.

The DH stressed earlier this month that “any protocol would be developed with and signed off centrally by clinicians” before it is implemented.