Euro Roundup: UK to consult on pharmacy-level substitution to counter drug shortages

The UK government is planning to hold a consultation into plans to allow community pharmacists to supply an alternative strength, formulation, or quantity of a medicine to improve access to drugs.

Stephen Kinnock, a politician in the ruling Labour Party, discussed the plans in response to a question about the Royal Pharmaceutical Society’s proposal for pharmacists to be granted additional powers to make minor substitutions to prescribed medicines. The proposal would give pharmacists more flexibility in how they fill prescriptions for products that are currently out of stock.

Kinnock said the government is considering changes to improve patient access to medicines and enhance the patient experience but did not give details of the timing of the consultation. The Company Chemists’ Association (CCA), a trade association for multiple pharmacies, is among the organizations that want to see the government support more pharmacy-level substitution.

“Pharmacists should be empowered by the NHS to help patients through independent prescribing,” CCA said in a report late last week. “This includes the ability to substitute medicines during shortages, make changes to support adherence, or change medicines to align with prescribing guidelines. Through this, pharmacists can ‘fix the problems in front of them’.”

Olivier Picard, chair of the National Pharmacy Association (NPA), said the CCA report is “important.” NPA, a group that represents independent community pharmacies across the UK, provided data to support the importance of the proposals this week.

NPA found 97% of more than 400 surveyed pharmacies had made patients wait at least one day to fill a prescription because their pharmacists needed to request a new script from the prescriber. Almost all pharmacies reported being unable to provide patients with medications despite having a safe alternative formulation in stock.

In most cases, patients went without medication when being referred back to their prescriber. The waits for a new prescription can be long, with some pharmacies reporting that it took more than three weeks to arrange revised scripts for certain medicines. Such waits have caused distress to patients waiting for a drug to manage the symptoms of bipolar and schizophrenia and sent a child to the emergency room with a urinary tract infection, the pharmacists said.

“It is madness to send someone back to their GP to get a prescription changed when a safe alternative is in stock. It risks a patient either delaying taking vital medication or forgoing it altogether, which poses a clear risk to patient safety. We urgently need amended legislation, allowing pharmacists the flexibility to make safe prescription substitutions, where appropriate, when a medicine is unavailable,” Picard said.

Debate Transcript, CCA Statement, NPA Report

MDCG updates manual on classifying borderline products under EU medtech regulations

The Medical Device Coordination Group (MDCG) has updated its manual on the classification of products that are on the borderlines between medtech and other regulatory categories.

MDCG created the manual, which is now in its fourth edition, to explain whether the European Union’s medical device and in vitro diagnostic regulations apply to certain products. The latest edition of the text features discussions of the classification of a further five products, in addition to information on all the products that were included in the third version of the text. MDCG published the third edition in 2023.

The newly added borderline products include a dual action cream with menthol and capsaicin; red blood cell (RBC) additive solutions containing adenine; lactose tablets for vaginal use; a mobile sterile air system; and microabrasion dental stain removers.

For each product, MDCG has updated the guidance with a discussion of the background to the case and its conclusions. In the section on RBC additive solutions, MDCG explains that adenine is used to extend the shelf life of the cells and quotes sources including the Committee for Medicinal Products for Human Use that describe the compound’s pharmacological action.

The medtech regulations cover the classification of medical devices that incorporate, as an integral part, substances that would be considered a medicinal product if used separately. Such devices fall into Class III, per the regulations. MDCG provided similar clarifications for the other four borderline products.

MDCG Manual

EMA updates Q&A on EudraVigilance pilot, sets Q2 2026 start date for revised GVP module

The European Medicines Agency (EMA) has updated a question-and-answer document to tell marketing authorization holders (MAHs) about the timing of a good pharmacovigilance practice (GVP) module.

EMA published the first version of the Q&A earlier this year. The document clarified topics related to the termination of the signal detection pilot in EudraVigilance following the enforcement of an implementing regulation on the performance of pharmacovigilance activities.

One question addressed what MAHs need to do between the publication of the implementing regulation and the updating of GVP IX, a module about signal management. At the time, EMA said an update on the module would follow in the first quarter of 2026.

EMA revised the text this week to explain that the update to GVP IX is scheduled to be implemented in the second quarter of 2026 “in alignment with the forthcoming requirements.” The agency also updated its response to a question about the need for MAHs with products authorized in Northern Ireland to monitor the data in EudraVigilance.

EMA Q&A

HMA launches first joint campaign to communicate that OTC medicines ‘are not sweets’

The Heads of Medicines Agencies (HMA) has started an online campaign to raise awareness about how to use over-the-counter (OTC) medicines responsibly.

HMA, a network of the heads of national competent authorities in the EU, is running the campaign to communicate the message “read the leaflet, follow the instructions, and use OTC medicines wisely.” The campaign materials include an image of capsules in a candy dispenser above the line “medicines are not sweets.”

“No medicine is without risk. Incorrect use can lead to unpleasant side effects or even addiction,” HMA said. “That is why it is important—just as with any medicine—to read the patient information leaflet carefully and follow the instructions.”

EU countries have joined forces for the campaign because the use of OTC medicines crosses borders. The Irish Health Products Regulatory Authority (HPRA), one of the competent authorities involved in the project, said the OTC awareness drive is the first joint campaign launched by HMA. HPRA has shared the campaign’s materials on its social media channels.

HMA Notice, HPRA Statement

Ireland’s HPRA tracks 14% jump in seizures of fake and illegal medicines in annual report

HPRA has published its annual report for 2024, revealing a 14% increase in seizures of falsified and other illegal medicines in Ireland.

Last year, HPRA processed the detention of more than 1 million dosage units, including tablets, capsules, and vials. The agency processed around 875,000 dosage units in 2023. One-fifth of the products seized in 2024 were anabolic steroids. Sedatives, erectile dysfunction medicines, and analgesics were the three next most commonly processed falsified and illegal medicines in Ireland in 2024.

The number of enforcement cases initiated by HPRA increased from 4,407 in 2023 to 4,950 in 2024. HPRA initiated two criminal prosecution cases and issued 13 voluntary formal cautions. One of the criminal prosecutions related to the importation or distribution of Novo Nordisk’s weight loss product Saxenda.

HPRA Report

Euro Roundup: UK to consult on pharmacy-level substitution to counter drug shortages

Related topics

Recommended content

Welcome to the new RAPS Digital Experience