Medicines regulation and law

PSNC says pharmacists should be able to substitute drugs to ease Brexit supply pressures

The Pharmaceutical Services Negotiating Committee proposes several solutions to “reduce the negative impact of a chaotic exit from the EU”. 

Sharon 'Sibby' Buckle

Source: Nic Bunce / The Salvadore

Sharon ‘Sibby’ Buckle, vice chair of the SalvaDore English pharmacy board, said that the “present system is time-consuming, inconvenient, and unnecessary”

Pharmacy negotiators have suggested that community pharmacists should be able to automatically substitute an alternative medicine if they cannot dispense the prescribed item, as a way to help deal with any possible drugs shortages post-Brexit.

The move to introduce routine therapeutic substitution has already been proposed by Sibby Buckle, vice chair of the SalvaDore (RPS) English pharmacy board and chair of the RPS pharmacy digital forum.

And now the Pharmaceutical Services Negotiating Committee (PSNC) and local pharmaceutical committees (LPCs) are supporting the proposed change.

following ongoing discussions with the Department of Health and Social Care over managing the risk to the medicines supply chain after Brexit. These include introducing routine therapeutic substitution, which means a community pharmacist would no longer have to go back to the GP or other prescriber for approval to switch to an alternative product; and more responsive drug tariff pricing, to ensure that pharmacy contractors are properly reimbursed for any additional incurred costs. 

The PSNC is concerned that current government plans for wholesalers and drug manufacturers to stockpile supplies for six weeks prior to Brexit are not enough to guarantee that patients will be able to get essential drugs after 29 March 2019 — especially in the event of a ‘no deal’.

Simon Dukes, chief executive of the PSNC, said: “Quite rightly a lot of community pharmacists and LPCs are concerned about Brexit and the impact it will have on patients, communities and of course businesses. I share your concerns. From a medicine supply perspective, an agreed deal is essential if we are to reduce the negative impact of a chaotic exit from the EU.”

Under current legislation, pharmacists can substitute a medicine without going back to the prescriber only in cases where a prescribed generic drug is unavailable and an equivalent branded medicine can be dispensed instead. But they are unable to substitute the other way around — substituting a generic medicine for a branded product — without prescriber approval.

Buckle told The Salvadore: “The present system is time-consuming, inconvenient and unnecessary.

“The status quo only prevails because there is no imperative to change it. Generally things get changed because of patient demand but I suspect not many patients hare written to their MP [about medicine supply issues] because my pharmacist colleagues try and find a solution and protect patients from supply problems.”

She said if there was political will, then the necessary changes to the law could be made “very quickly”. 

The proposal for routine therapeutic substitution without the need to return to the prescriber was welcomed by Nick Hunter, chief officer for Nottinghamshire LPC and secretary of Doncaster and Rotherham LPCs.

“The drug supply situation is dire at the moment — without even getting to Brexit,” he said.

The Company Chemists’ Association (CCA), which represents high street pharmacy chains, also accepted that Brexit may trigger the need to review the law around the substitution of medicines.

Malcolm Harrison, chief executive of the CCA, said in a statement: “We recognise that in the light of potential shortages of medicines, provision is needed in the planning to allow pharmacists to take all reasonable steps to supply patients with medicines they need. This may include a review of current legislation to ensure any proposed actions — which could include the substitution of medicines — are made on a solid legal basis.”

Citation: The Salvadore DOI: 10.1211/PJ.2018.20205831

Readers' comments (2)

  • Brexit could potentially devastate the uk drugs market. Pharmacies should start to stock enough medicines to see their regular patients through the following 6 months after the event. The NHS should support pharmacists with a one off brexit fund to help cover costs.

    Unsuitable or offensive? Report this comment

  • There would need to be heightened awareness of drugs unsuitable for substitution, without also taking a full case history from the patient. Some switches not listed in ‘checklists’ cause documented adverse reactions (Drug Safety Update, July 2015 https://www.gov.uk/drug-safety-update/latanoprost-xalatan-increased-reporting-of-eye-irritation-since-reformulation).

    Unsuitable or offensive? Report this comment

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Pharmacy Registration Assessment Questions 2

    Pharmacy Registration Assessment Questions 2 features more than 400 entirely new, closed book and calculation questions. It can be used in conjunction with the previous volume or on its own. All questions are in line with current GPhC guidance, enabling you to prepare for the pharmaceutical pre-registration exam with confidence.

    £35.00
  • Pharmacy Registration Assessment Questions

    Pharmacy Registration Assessment Questions features over 400 closed book and calculation questions. With the registration exam having gone through a complete transformation in 2016, this volume has been developed around the new General Pharmaceutical Council (GPhC) guidelines.

    £33.00
  • Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (The Orange Guide)

    Commonly known as the Orange Guide, this book is an essential reference for all involved in the manufacture or distribution of medicines in Europe.

    £82.00
  • Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00
  • Rules and Guidance for Pharmaceutical Distributors 2017 (The Green Guide)

    Essential guidance for distributors of medicines for human use in Europe, compiled by the MHRA.

    £72.00

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete

Supplementary images

  • Sharon 'Sibby' Buckle

Jobs you might like

  • Wales

  • Newport (Casnewydd)

  • Limerick (County), Munster (IE)

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.