For most of us, the most advanced feature we have encountered in our pharmaceutical packaging is the child safety lock cap. And while the safety cap is a necessary feature, there are many challenges that current packaging does not address. Current research and development efforts are looking at tackling some major issues affecting the pharmaceutical market.
Cold Chain Monitoring
First is tracking the location and monitoring the environmental conditions that the pharmaceuticals experience all the way from production to dispensing to a patient. Generally referred to as “cold chain monitoring”, location and tracking are crucial to understanding the quality of the medicines, vaccines and other sensitive products throughout the logistics chain. For example, variations in temperature and light exposure can affect the efficacy and safety of certain medications. Physical damage to packaging could introduce contaminants that also affect pharmaceutical quality. Track-and-trace capabilities would also be beneficial to help to tackle anti-tamper, authentication and pharmaceutical trafficking concerns.
A series of forces are converging to drive the necessity for these changes. First, changes in regulations are putting more responsibility on pharmaceutical manufacturers to keep track of their products. The Drug Supply Chain Safety Act (DSCSA) in the U.S. and the Falsified Medicines Directive (FMD) in the EU are chief examples of these new regulations. These regulations but an emphasis on digitization and serialization to ensure end-to-end traceability of the world’s pharmaceutical supply chain. DSCSA is expected to come into full effect by 2023 following a ten-year implementation plan.
Increasing Global Demand and Postponement Packaging
Secondly, the worldwide demand for pharmaceuticals continues to grow steadily, with a concentrated growth in emerging economies. As such, the demand for pharmaceutical packaging is expected to grow $78 billion (USD) is 2016 to $150 billion by 2026. Furthermore, large pharmaceutical companies are shifting to broader global production footprints, requiring more active traceability of products as they move around the globe.
A parallel industry trend is a rise in postponement packaging. That is to say, it is more desirable to delay market-specific packaging until there is actual demand verses packaging based on market predictions which might result in waste if the estimates are incorrect. Efforts to minimize repackaging and increase package reuse will have both positive financial and environmental impacts. Postponement packaging is gaining traction in European markets to help companies address a wide variety of regulations and languages that vary from country to country.
Combined, these changes are creating the need to be able to continuously track and monitor pharmaceutical products from production to warehousing to dispensing to the patient. Adding intelligence and communications capabilities to product packaging will go a long way to ensuring compliance with the new regulations as well as consumer demand for safe, cost-effective medications. Embedded sensors, barcodes, NFC communications, energy harvesting, and flexible circuitry will are key enabling electronics technologies to making this future possible.
Tracking Patient Compliance
Another use case that next-generation pharmaceutical packaging looks to address is drug adherence monitoring. It is estimated that failure to take medications on schedule or at the correct dosage costs the United States alone between $100 billion to $290 billion every year. The financial implications are due to the additional hospital stays and treatment costs from the resultant worsening medical conditions or incorrect/over medication. Smarter pharmaceutical packaging could provide alerts to patients to remind them to take their medications. Furthermore, messages could be sent to healthcare providers indicating if the patient is using their medications incorrectly.
Smart pharmaceutical packaging promises a safer, more efficient medicine supply chain. It also offers a direct benefit to consumers by reducing the potential for misuse of prescribed medications. The proliferation of inexpensive embedded electronics along with ubiquitous Internet access is key to changing how the world tracks and monitors the logistics lifecycle and usage of pharmaceuticals.
The Molex Advantage
Molex has expertise in several key enabling technologies to help manufacturers create the next generation of pharmaceutical sensors and smart packaging, such as printed electronics technology, low power wireless development and sensor integration. We are experienced in executing leading-edge custom, tailored sensor solutions from concept through development to production. Our adoption of quality management systems such as ISO 13485:2016 and ISO 9001:2015 offers our clients a level of certainty, quality and repeatability that is unmatched. Molex’s expertise in engineering and delivering client solutions gives us a unique perspective in the flexible sensor solution market.