Our fake friends: falsified medicines
Medicines are designed to mend, yet online commerce allows for nightmare to become reality, as the ominous presence of falsified medicines is proving that one wrong click of the mouse can be fatal.
Not to be confused with counterfeit medicines which enjoy a parallel notoriety by not complying with EU legislation on industrial and intellectual property rights, falsified medicines are arguably more menacing, disguising themselves as authorised pharmaceutical products. Performing the role of authenticity so well, falsified medicines conceal their toxic ingredients and incorrect dosages from the consumer, enabling them to burrow their way into the legal market.
As the number of falsified medicines on the market proliferates, and they boast ever-increasing sophistication, EU patients are, in turn, placed at greater risk. Trust in the legal supply chain is suffering severely as a result, and the European Union and World Health Organisation are poised on high alert, demonstrating, through the construction of a comprehensive and international strategy, their sensitivity to the threat, and their awareness that action from Pharma packaging manufacturers is essential.
A Directive with a deadline
The Falsified Medicines Directive was approved by the EU in February 2011, and was established as law in 2013. Deadlines are now looming, and companies manufacturing, selling, and dispensing medicines and pharmaceutical packaging within the EU are required to meet track and trace regulations, introduced in the Directive, by 9th February 2019.
The Directive has been designed to implement rigour and control, yet the move towards uncompromising regulation of pharma packaging manufacturers comes not without its challenges; the data to be reported on is no small task, and the flexibility granted to each EU Member State applying the requirements might well prove to be a double-edged sword.
Safety features ensure security
Unique identifiers are the first step towards meticulous control, as the Falsified Medicines Directive calls for a sequence of numeric or alphanumeric characters to be printed on each medicinal pack using packaging decoration techniques. Each 2D barcode should be entirely unique, and the risk of the serial number being guessed by falsifiers will be minimised to lower than one in ten thousand through random generation. Whilst multi-pack products that cannot be sold separately should be marked with a unique identifier on the outside of the bundle packaging, legislation underscores the importance of labelling each and every single pack when individual sale is permitted.
From the 9th February 2019 onwards, the authenticity of a medicinal product will be ensured by community pharmacists with just a scan of the barcode. If authentic, the unique identifier will be recognised by the national database, enabling the decommission of the unique identifier and supply of the medicine. If flagged as inactive, decommission and supply will be preventable.
According to the Falsified Medicines Directive, packaging manufacturers should take note that every medicinal pack should also sport an anti-tampering device, a safety feature facilitating easy verification of whether the packaging has been meddled with by a falsifier. A common logo has also been designed for legal online retailers to display clearly on each website page, encouraging consumers to place their trust in the legal supply chain and packaging manufacturers once again.
The Directive stresses the value of penalties, highlighting their effectiveness in dissuading medicinal falsification. Proportionate penalties should be enforced, and their efficacy measured by data assessment, a process which will necessitate cooperation and communication of all EU Member States. Pharma packaging manufacturers should expect to be watched with an eagle eye in the future.
Control of the chain
The expanse of the medicinal supply chain is enormous, and it is crucial to remember that in order to maintain meticulous control, legislation should address not only wholesale distributors and manufacturers of both medicines and pharma packaging, but also brokers involved in sale and purchase, regardless of whether they physically handle the medicinal products or not. Importation is also an area necessitating careful attention, and written confirmation of required manufacturing practice is essential from authorities of the exporting nation. Medicine packs received from another EU country must first be decommissioned and then re-packaged with new unique serial codes and anti-tampering devices, demanding further action from packaging companies.
The call for clarity
Changes brought about by the Falsified Medicines Directive can seem clouded by complexity, and, for some pharmaceutical packaging companies, clarification is key. It is important to know that the new regulations apply only to medicinal products intended for human use, and not to products used in the veterinary world. In a parallel manner, radiopharmaceuticals too will not be affected. Product batches intended solely for clinical trials are also exempt from safety features outlined in the Directive, and pharmaceutical companies enquiring about cost may be disappointed to hear that they will not receive financial support in the acquisition of necessary safety features.
As 9th February approaches fast round the corner, pharmaceutical packaging companies feel the pressure to ensure that they are prepared to comply. Ultimately, however, despite complexities, the majority of pharmacists are in agreement that the 9th represents better and safer times to come.