New advancements in the field of pharma packaging are revolutionising the healthcare industry, setting the stage for a more efficient and sustainable future.

Throughout CPHI Barcelona, Pieter Vercruysse, VP Customer Success & Supply Chain at Tjoapack, has been looking at the innovations shaping the future of healthcare packaging. In this final blog of the series, Pieter explores the advances that are making pharmaceutical products more secure and safer for patients.

Pharma packaging plays a critical role in ensuring the safety and efficacy of medications. Some of the key safety issues companies have been focusing on include:

• Drug counterfeiting: This poses a significant threat to the pharmaceutical industry, risking patient safety and undermining the integrity of the global supply chain. With counterfeit drug seizures in 2021 increasing 101% on the previous year^[1] pharmaceutical companies face a pressing need for robust solutions to combat counterfeit drugs.
• Tampering: This can encompass the opening of packaging to change the product within it for a substandard alternative, or the changing of labels or serial numbers to falsify the chain of custody of a medication. The total number of such substandard and falsified medicines circulating in low- and middle-income countries is estimated to be 13.6% overall^[2], and as high as 19.1% for antimalarials^[3]. Patients risk not receiving life-saving medication and if they become ill from counterfeit therapies falsely marketed under a respected brand name, the company could find their reputation at serious risk.
• Stability in transport and storage: The advent of biologics — with their unique sensitivity to environmental factors — has increased demand for temperature-controlled transit to ensure that the product remains stable until it reaches the patient. As a result, the global pharmaceutical cold-chain logistics market is estimated to grow by $11.6 billion from 2022 to 2027, with a compound annual growth rate of 9.51% during the forecast period^[4]. Any temperature excursions experienced by such products could shorten their shelf life, resulting in them being unviable or even dangerous by the time they reach patients. With this in mind, steps need to be taken to minimise the risk of temperature anomalies.

Advances in packaging to solve issues

The advent of new technologies is providing the industry with the opportunity to tackle these safety issues, achieving higher levels of security and quality control:

• Smart labels to enhance serialisation: Serialisation has been a comprehensive means of ensuring the authenticity and traceability of pharmaceuticals throughout the supply chain, from the factory to the patient, for over a decade. Legal frameworks are in place in key markets, such as the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA), which is due to have phase II changes come into force later in 2023.

Compliance with these regulations — in particular the ability to assign and track unique identifiers for each product unit throughout the supply chain — presents challenges for the pharmaceutical industry. For instance, how can companies harmonise and integrate their data with those of their suppliers to support the traceability of each product unit? How can they ensure collaboration with supply chain partners, as well as maintain time and cost efficiency?

Innovations in product packaging are providing the solution to these conundrums. Smart labels containing radio-frequency identification (RFID) or near-field communication (NFC) technology can now be added to pharmaceutical product packaging. These can carry more information than traditional labels, supporting the latest serialisation regulatory requirements. Moreover, they are easier to scan during transport as they don’t need to be near the reader. Supporting efforts to harmonise data systems across the pharmaceutical supply chain, smart labels have the potential to reconcile serialisation compliance requirements with efficiency in the future.

• Tamper-evident seals: As of 9 February 2019, most prescription medicines and some over-the-counter medicines supplied in the EU are required to have an anti-tampering device on their outer packaging in addition to a unique identifier^[5].

These devices can be anything from blister packs — as is the case for oral solid dose medicines — as well as perforated caps on liquid products or foil stickers across secondary packaging closures to demonstrate they have not been opened. Packaging experts keep coming up with new ideas to eliminate the possibility of such devices being altered without the change visible to patients while making them more efficient to install during packaging.

The choice of the device will depend on the nature of the product. Close collaboration between pharmaceutical companies and their packaging partners will be vital to ensure that anti-tampering devices continue to meet the needs of the industry into the future, reconciling security with manufacturing efficiency.

• Temperature-sensitive packaging: Advances such as smart labels can support pharmaceutical companies in monitoring the temperature and conditions experienced by each product unit in real time as it is transported through the supply chain.

These labels can contain processor cores that allow them to monitor the temperature in the immediate vicinity of the product unit and send the data to nearby receivers to be fed to a central database. As a result, they enable companies and their logistics providers to identify any units that have experienced a temperature excursion so they can be disposed of safely. The system can even provide data to support companies and their partners in understanding the root cause of an excursion so it can be prevented from happening in the future.

Partnerships are key to harnessing innovation

These are just a few examples of how advances in pharmaceutical packaging are supporting companies in not only complying with stringent regulations but also going above and beyond, all while streamlining manufacturing processes.

However, collaboration with contract packaging organisations (CPO) will be key if pharmaceutical companies wish to harness the full benefits of these innovations to make the pharmaceutical supply chain safer and more efficient for patients. Contact us to talk to our experts to find out more: solutions@tjoapack.com

^[1] https://www.psi-inc.org/incident-trends

^[2] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2696509

^[3] https://www.who.int/features/factfiles/malaria/en/

^[4] https://finance.yahoo.com/news/cold-chain-logistics-market-pharmaceuticals-000000427.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuYmluZy5jb20v&guce_referrer_sig=AQAAABd5r7eFYK18j2mLTqHauVEuJnXI2v2V7vVOsGj5-R3meyJdpWmiu8uZY8aGoxAAo_15asm6rNlZ5TQD7QTNUuzF99B2qFC0cb7wAEAMGZQ54_GdogwZqBib5m4Y7QbVxd9lxLgkq_V2QeU8TSJcoL704-lnppSdRaDA0D-XSq_u

^[5] https://www.ema.europa.eu/en/news/new-safety-features-medicines-sold-eu