If you thought pharmacy was already over-regulated, think again

Sid Dajani, the RPS-elected representative on the Pharmaceutical Group of the European Union, warns of increased bureaucracy around new medical device legislation

The EU medical devices legislation currently covers a wide range of products, including many that are distributed through pharmacies. These include: asthma inhalers, first aid bandages, syringes, thermometers, rubber condoms, pregnancy related kits, insulin pens, blood glucose monitoring systems, tongue depressors, examination gloves. In addition, the legislation will cover products such as hip replacement implants, prostheses, x-ray equipment, and heart valves.

Developments linked with the approval of medical devices, such as the problems with breast implants in France and the Johnson and Johnson hip replacement, have urged the European Commission to undertake this reform. In order to modify the legislation, the Commission is meeting member state representatives and the relevant stakeholders to discuss the draft legislation before the proposal is published.

The draft proposal is interesting for us as pharmacists because it includes:

• Obligations for distributors (including pharmacies)
• A proposal to trace medicinal devices using FMD end-to-end technology.

At this point it’s interesting to note that if the obligations on distributors as described in the proposal applies equally to pharmacies the consequences will be dramatically burdensome. Therefore some obligations will be unworkable and others will require an adaptation to the communication practices within the supply chain.

For example, there are problems of compatibility between the traceability systems proposed for medical devices and the verification process envisaged in the Falsified Medicines Directive. This means we will be exposed to different systems of traceability for human medicines and medical devices, using different technologies and verification processes. Such a duality of systems supposes a waste of resources with an ultimate prejudicial impact for patients. We are also expected to ensure that manufacturers have complied with all their traceability obligations and there is a provision that will impose further two years of professional training for pharmacists manufacturing custom-made devices.

The PGEU has supported amendments and lobbied:

• To ensure that corrective actions undertaken by pharmacists are legally within the scope of our activities
• To solve the problems of compatibility between traceability systems used in the pharmacy
• To enhance the vigilance over medical devices
• Against the requirement for two years’ training to manufacture a custom-made device
• To exclude pharmacists and other distributors from the obligation to ensure that manufacturers have complied with their entire traceability obligations.

If you thought pharmacy was already over-regulated, think again. This new piece of legislation will affect us all and increase the flow of bureaucracy through pharmacies, compounded further by the FMD which is due to be published any time now (possibly before you read this) and expected to be rolled out in 2018. Watch this space!