The Human Medicines (Amendment) Regulations 2019, which came into force on 9 February 2019, includes provisions that allow pharmacies to dispense an alternative under a ‘serious shortage protocol’ where there is or may be a serious shortage of particular prescription-only medicines. This means that, when the protocol is implemented, pharmacists can substitute a different strength, quantity or pharmaceutical form of a prescription-only medicine, or a different prescription-only medicine or a generic equivalent, according to the protocol rather than the prescription, and without going back to the prescriber.

An explanatory note was published by the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency. In the note, the agency said that the new powers for pharmacists ‘do not relate to withdrawal from the European Union (EU)’. However, if the withdrawal affects medicines supplies, a ‘serious shortage protocol’ could be used in those circumstances. However, on 17 January 2019, England’s Chief Pharmaceutical Officer Keith Ridge said in a letter to National Health Service pharmacy leaders, that the ‘serious shortage protocols’ form part of ‘Government’s contingency preparations for a ‘no deal’ EU exit’.

Although the regulations came into force on 9 February 2019, pharmacies will have to wait for UK Ministers to publish a ‘serious shortage protocol’. This, according to the explanatory note, will only happen ‘when they consider that a medicine is or may become in serious shortage’.

A standard template for the protocols will be developed and any necessary protocols would be issued and kept centrally. Any alternative quantity, strength, pharmaceutical form or medicine which is to be supplied would also be agreed centrally and would be based on the views of senior clinical advisors.

A survey carried out by the All-Party Pharmacy Group in 2016 found that 56% of pharmacists and 37% of doctors were ‘almost certain’ to be out of stock of a medicine or prescribe a medicine once a day over the last six months. The UK’s Department of Health, however, responded that the ‘vast majority’ of prescriptions in the country are not subject to supply problems [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. UK’s DoH says most medicines do not experience shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 22]. Available from: www.gabionline.net/Pharma-News/UK-s-DoH-says-most-medicines-do-not-experience-shortages

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