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Pharma packaging firms: take note

Pharma packaging firms: take note

Pharmaceutical companies must comply with EU
legislation combating 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.

Falsified medicines have been subject of worry since 1500 BC, when Queen Hatshepsut of Egypt sent hunters out to bring back genuine medicinal plants as the pharmaceutical market was inundated with fakes.

The pharmaceutical packaging industry has been tarnished with disrepute as falsified medicines have swarmed the supply chain, and the World Health Organisation attributes one million deaths annually to counterfeit drugs.

Substandard products have a particular notoriety in destitute nations where diseases are rife, and scientists commissioned by WHO estimate that falsified medicines might be responsible for a further 116,000 annual deaths from malaria. 2013 saw 44 children in Paraguay suffer in quick succession following consumption of a particular cough-medicine. Investigators traced the falsified product back to an import from India, and, whilst Paraguayan doctors were able to find an antidote before tragedy struck, cases such as this have sparked a surge in media attention, and pharmaceutical packaging companies have, without doubt, felt the impact.

Reasons are Rife

Falsified medicines cast a shadow on the pharmaceutical packaging world, and reasons for the exponential growth in sales of such products are numerous. Arbitrage is particularly prevalent in the EU, and, whilst perfectly legal, exploitation of price differences between markets and repackaging products for resale complicates regulation of the supply chain, rendering falsification of medicines more difficult to detect. Cost pressures are too felt by the individual, and families may have no choice but to resort to street market or internet purchases, where medicines supplied by unlicensed traders are more likely to be cheaper.

Nations suffering from political unrest or disaster are particularly vulnerable to the proliferation of falsified medicines, as trade and vigilance of border control is disrupted. Human error is often to blame, and failure by health care workers to report pharmaceutical packaging irregularities such as fictitious addresses and spelling errors in the warning ‘Keep out of rech of children’ (sic) in Guinea-Bissau, 2013 serves as one shocking example.

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.

DIN EN ISO 8317 and DIN EN 14375 standards establish stipulations for child-resistant packaging within the EU, yet tamper-proof seals remain lacking, and the Falsified Medicines Directive pledges to make a change. The standardisation of security features envisages a future in which the unauthorised opening of a pack is noticed with ease, minimising the entry of falsified medicines into the legal supply chain. Whilst alteration or damage to packaging following first opening should be starkly obvious and irreversible, authorities stress how imperative it is that all prescribed information printed onto the pharmaceutical pack remains legible following the breaking of the tamper-evident seal.

Pressure to meet packaging requirements by February 2019 has launched existing techniques into the spotlight, and standards praise the effectiveness of certain security features in particular. Fiber-tear seals present a satisfying solution, as considerable adhesive strength leaves visible damage once the seal has been peeled back, whilst void films instead reveal a warning message to users. The use of glue dots means that tearing the packaging is unavoidable upon opening, and seals with a zipper perforation are equally effective.

Technology takes down tampering

The Falsified Medicines Directive calls for technological innovation, and pharmaceutical packaging companies are rising to the challenge. Schreiner MediPharm’s innovative BitSecure received global attention at Pharmapack 2018, impressing key players within the pharmaceutical field with its remarkable app technology. Utilising systematic algorithms throughout the analysis process, the BitSecure app boasts indisputable reliability, and, necessitating only a simple scan of the BitSecure pattern and individual serial number printed onto the pharmaceutical packaging in order to verify authentication, the technology has been marketed as attractively user-friendly. The random generation of a high-resolution pattern measuring only a few millimetres across means that any attempt at forgery verges on impossible, and Schreiner is confident that the intuition of its BitSecure app will be increasingly recognised by customers as the Directive deadline approaches

Consumer Physics’ SCiO technology is similarly avant-garde, functioning as an infrared spectrometer scanner. The start-up serves up a cost-effective solution which allows anyone from customs officials to aid workers in poverty-stricken nations to distinguish between fake and genuine medicinal products in cases where tamper-evident seals on packaging may not be so reliable. Optaglio epitomises technological excellence in the packaging world with its research on high resolution e-beam lithography security holograms, having delivered over one billion holograms to organisations in the last 25 years. Optaglio’s holographic foils are transferred to pharmaceutical packaging using the hot-stamping decoration method, and the company’s microholograms are recognised globally for their sophistication, as complicated mathematical algorithms uphold them as resistant to imitation by

Power of
penalties

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.

Coordinated by INTERPOL, the annual Operation Pangea is most rigorous in its crack-down on falsified medicines, targeting illegal pharmaceutical websites, removing advertisements for illicit online platforms, and launching investigations into potentially dangerous medicines and devices, which culminate in a significant number of arrests. 2017 saw a record 123 nations participating in the operation, and the disruption of criminal networks resulted in the seizure of a shocking 25 million packs. Awareness raised through the campaign exerts pressure upon pharmaceutical packaging companies to conform with regulations by February, and threat of arrest otherwise means that packaging firms are likely to respond.

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.

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  • Multimedia
  • English
  • Modified 03 Jun 2019
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