Government ‘shortage protocols’ should enable pharmacists to switch between branded drugs, say pharmacy leaders

Pharmacy organisations, including the Royal Pharmaceutical Society, have broadly approved a proposed amendment to the Human Medicines Regulation 2012.

Pharmacist holding a box of medicine

Health legislation should be amended to allow pharmacists to switch between branded medicines in case of a medicines supply shortage, pharmacy leaders have said.

The Pharmaceutical Services Negotiating Committee (PSNC), the Company Chemists’ Association (CCA) and the Royal Pharmaceutical Society (RPS) have all broadly approved a proposed amendment to the Human Medicines Regulation 2012 which would allow pharmacists to dispense an alternative drug if the one prescribed to a given patient is in short supply.

The Department of Health and Social Care (DHSC) 
launched an urgent consultation with stakeholders on 7 December 2018 asking for their input into the use of “serious shortage protocols” (SSPs), which could see pharmacists respond to a shortage in one of four ways, including dispensing a reduced quantity, a therapeutic equivalent, a generic equivalent or an alternative dosage form.

However, the PSNC and CCA both called for assurance that substitutions could be made between branded medicines.

The PSNC said in its response that it was “not convinced that the current drafting permits the substitution of one branded or proprietary medicine for another, which may be vital”.

It continued: “It is also important that SSPs can be drafted to permit the substitution of a generic medicine against any branded medicine of the same active ingredient(s) — to ensure any local reliance on non-originator brands of medicines does not complicate the substitution of medicines/introduction of SSPs.”

The response from the CCA added: “We also believe that there should be provision made for substituting between branded medicines, as we can see occasions where this will be needed, such as switching between branded Salbutamol inhalers for patients with asthma.”

The RPS response also called for pharmacists to be given the option to make changes to the dosage of a patient’s drug where necessary.

The RPS’s consultation response said: “This could be necessary for example if a modified release form of a medicine were substituted for a standard release medicine or vice-versa which would require a dosage change in addition to quantity and dosage form change.”

The consultation closed on 12 December 2018, with the DHSC planning to put the amendment before Parliament in January 2019 as part of the ‘Human Medicines (FMD) (Amendment) Regulations 2019’.

Last updated
The Pharmaceutical Journal, December 2018;Online:DOI:10.1211/PJ.2018.20205920