EU Regulatory Roundup: Accord, Glaxo Issue FMD Alerts Over 2D Barcode Problems
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.Accord, Glaxo Issue Falsified Medicines Directive Alerts Over 2D Code Problems
Accord Healthcare and Glaxo Wellcome have shared alerts about issues related to compliance with the Falsified Medicines Directive. The alerts are tied to the information encoded on serialised 2D codes.
Glaxo’s situation, which the drugmaker reported to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), involves a decommissioned batch of Beconase aqueous nasal spray. When pharmacies scan serialized 2D codes on packs of the rhinitis drug, the status of the pack may show up as “destroyed.”
MHRA has told healthcare professionals and wholesalers to stop supplying Beconase packs from the affected batch immediately. While there is no risk to product quality, MHRA wants stakeholders with packs from the batch to quarantine all remaining stock and return it to the supplier.
The UK regulator shared details of the Beconase notice on the same day as it issued an alert about Accord’s diamorphine hydrochloride. As the 2D data matrix does not encode for the expiry date, the packs trigger error notices such as “invalid barcode, missing required data elements” when scanned. The error message will vary due to differences in end user systems.
MHRA is advising healthcare professionals that trigger one of the error messages when scanning packs from the affected batches to perform standard checks for falsified medicines. The products can be dispensed if they clear the checks. MHRA’s willingness to permit the continued use of the batches reflects the inadequate supplies of alternative products.
Glaxo Notice, More
EMA Grants Public Access to Suspected Veterinary Medicine Side Effect Reports
The European Medicines Agency (EMA) has begun publishing reports of suspected side effects linked to veterinary medicines. EMA is making reports on around 250 veterinary medicines available on the website it already uses to share details of suspected side effects related to human therapeutics.
Adrreports.eu began hosting adverse event reports for human medicines in 2012. Now, EMA has rolled out an extension to the site to share reports directly from the Eudravigilance Veterinary database of pharmacovigilance submissions. The website allows users to search by product name or active substance and filter the results by variables including species and breed.
“Making this information publicly available allows EMA’s stakeholders, including the general public, to access important data used by European regulatory authorities to review the safety of a veterinary medicine or active substance,” EMA wrote in a statement to disclose the news.
EMA has provided users with ways to visualize the data. For example, one tab displays the number of side effect reports per month as a table and column chart. The website currently features reports going back 12 months.
EMA Statement
Spain’s AEMPS Partners With Patient Groups for Antibiotic Education Initiative
The Spanish Agency of Medicines and Medical Devices (AEMPS) has enlisted three patient groups to support its effort to educate the public about antibiotic resistance. AEMPS will work with the groups to raise awareness of the dangers posed by antibiotic resistance and ways to stop it from arising.
Citing European Commission survey data, AEMPS noted that one in three people in Spain think they can take antibiotics to treat flu and the common cold. The same survey found 5% of people in Spain take antibiotics without a prescription. AEMPS has survey data that paint a similar picture from its own work, leading the regulator to identify a need for better education about antibiotics.
The education initiative will take place within the framework of Spain’s National Antibiotic Resistance Plan (PRAN), which began in 2014 in response to the commission’s call for member states to act to tackle the rise of multidrug-resistant bacteria.
PRAN already involves multiple government bodies and tens of external collaborators. AEMPS has added three patient groups to its list of collaborators for the education initiative. The collaborators will form a working group.
AEMPS Notice (Spanish)
EMA Holds Second Herbal Medicine Consultation Years After Starting Process
EMA has released another draft version of its public statement on herbal medicines containing the compound estragole for consultation. An earlier version of the draft went into development in 2013 and was released for consultation the following year.
The ongoing, multi-year process of finalizing the draft means EMA is yet to replace the statement on estragole from 2005. EMA identified the need to update that statement after seeing data that “raised concerns from a toxicological point of view.” Those concerns led EMA to reassess data on the safe human use of herbal medicines containing estragole.
In revising its first attempt at updating the statement, EMA has retained large sections of the original draft. However, the changes EMA has made are significant, with many of them affecting the section on its recommendations.
The original draft stated, “The acceptable daily dose is 0.5 mg/person/day.” That statement is absent from the revised draft. In its place, EMA has inserted a lengthy discussion of the data and factors that will shape the safe limit. The new section lacks a concrete conclusion.
“Taking all the published data on estragole together, a conclusive adequate fit-for-purpose assessment for estragole or rather estragole containing active ingredients in herbal medicinal products seems not to be possible at current time,” EMA wrote. The agency thinks questions about the quality of the available studies and other matters need answering before a position is reached.
In the absence of a defined limit, EMA is proposing to look to background exposure to estragole via food to guide decisions about the use of the compound in medicinal products. That approach led EMA to suggest exposure to estragole via medicinal products “should be kept as low as reasonably possible.”
EMA is accepting feedback on the draft until 15 May.
Draft Statement, Consultation Feedback
France’s ANSM Shares Good Practices for Removing Cells for Therapeutic Use
The French National Agency for Medicines and Health Products Safety (ANSM) has published good practices for removing human cells and tissues for therapeutic use.
In the 70-page document, ANSM sets out its position on all aspects of the process, from the quality management systems and physical infrastructure it expects organizations to have through to the hygiene practices that need to be followed. The document covers the removal of cells and tissues from living and dead people, although there are differences to the rules that apply in each case.
The rules will come into force in six months. However, ANSM is giving organizations affected by rules on taking samples in certain contexts up to three years to comply with the new requirements. ANSM expects sites that benefit from that flexibility to comply with less onerous rules during the transition period.
ANSM Guide (French)
Other News:
MHRA has reported that 93% of general practitioner healthcare facilities now have integrated yellow card reporting capabilities. Healthcare professionals can use the capabilities to report suspected adverse drug reactions via EMIS Web. MHRA thinks the system will make it easier for doctors to report adverse events and, in doing so, protect patient safety. MHRA Notice
MHRA has shared a case study detailing its role in Sanofi’s filing for approval of a flu vaccine targeted at people aged over 65 years. The agency granted a license to Sanofi in seven months, down from the usual 12 months, enabling the vaccine to come to market in time for the current flu season. MHRA Notice