The Proprietary Association of Great Britain (PAGB) has called for self-administered injectable medicines to be considered for pharmacy reclassification.
Speaking at a European conference in Brussels yesterday, October 7, PAGB CEO Michelle Riddalls appealed for changes in medicines legislation, “including the criteria that determine prescription-only medicine status”.
She said self-administered injectable medicines should be considered for pharmacy classification, “where supported by evidence” and approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
Read more: Make community pharmacy a ‘core self-care partner’, urges PAGB
“Healthcare has changed dramatically over the last few decades, but the legislation governing medicines classification has not kept pace,” Riddalls said.
“Self-administered injectable medicines are becoming increasingly common, yet under the current rules they cannot even be considered for reclassification in the UK, regardless of any evidence supporting their safe use.”
The PAGB are seeking a “more modern regulatory framework”, with current UK prescription criteria dating back to 1968.
“All types”
Riddalls told C+D the PAGB wants to see the opportunity for “all types of self-injectable medicines” to make reclassification applications, provided the company has the “appropriate benefit risk data to support a submission”.
She said potential candidates for reclassification could include epi-pens, GLP-1s and vitamin B12, but added that it is “important to be clear that this would not constitute an automatic or blanket change”.
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“The key issue is that, under the current legislation, such applications cannot be made as a matter of principle,” Riddalls said.
“This means that even where robust evidence exists to support the safe and effective use of a medicine through a pharmacy route, there is currently no mechanism for that evidence to be considered through a reclassification application”.
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It comes after the PAGB in June called for community pharmacy to be “recognised as a core self-care partner” under the government’s 10-year health plan.
And it follows the Department of Health and Social Care’s suggestion last February for more medicine reclassifications from POMs to “available in a pharmacy”.
