Regulatory requirements for serialization have been a significant driver in the pharmaceutical and healthcare industries. Serialization facilitates regulation compliance, helps ensure product safety, and prevents counterfeit goods from flowing through the supply chain. 2024 will be a historic year for sterilization and packaging as the Drug Supply Chain Security Act (DCSA) deadline is now November 2024. Serialization practices are now expanding across other aspects of health to help address areas such as medication adherence, animal health, sustainability and agriculture which will also come into focus.
Final DSCSA Compliance Deadline
The most important event of the year for the serialization and packaging industry will be the Drug Supply Chain Security Act (DSCSA) compliance deadline in November. As dictated by this federal regulation, all organizations in the pharmaceutical supply chain will need to serialize products at the unit level and have systems in place to receive, store up to six years, and transmit serialized data to downstream trading partners in an electronic and interoperable format.
The DSCSA federal regulation was adopted in 2013 to create a system to quickly verify the authenticity of prescription drugs, enhance the drug recall processes, and improve the detection and interception of illegitimate products in the supply chain. The pharma industry has developed specifications and procedures to establish effective drug safety and serialization procedures in collaboration with the FDA, the GS1 Organization and the Healthcare Distribution Alliance (HDA). Pharma for the most part has implemented these methodologies. Pharma manufacturers and the industry’s contract packagers have developed and implemented serialization technologies that meet the intent and standards of the DSCSA. The November 2024 DSCSA deadline is the culmination of years of work to ensure the security and integrity of the pharmaceutics supply chain.
Medication Adherence Continues to Vex Healthcare
Poor medication adherence poses significant challenges to the healthcare community. Non-adherence leads to adverse patient outcomes, including increased healthcare costs, decreased health conditions, and quality of life. For patients with chronic conditions such as diabetes or high blood pressure the repercussions can be severe, even life-threatening.
As a result, several drug manufacturers are now transitioning the packaging of their medications from bottles to calendarized blister packs. This packaging is a ground-breaking solution that radically changes how medications are packaged, shipped, and dispensed.
A blister-sealed tamper-evident medication pack is paired with a recyclable paperboard where calendarized day codes are printed to remind individuals to take their medication, improving medication adherence and lift. This packaging method requires patients to push sealed tablets or capsules through the foil to access the drug. Medication adherence packaging heightens the patient’s awareness about their own compliance and leads to better informed, knowledge-based decision-making during engagement opportunities with their providers, pharmacists, and other stakeholders.
Consumers Concerned About Sustainability
Growing concerns over climate change and environmental issues have led consumers to demand sustainable packaging. Social pressures are forcing brand manufacturers to make hard choices regarding their packaging. Companies now feel the necessity to utilize eco-friendly materials and the most efficient packaging designs to reduce waste and environmental impact.
In 2019, an estimated 4.38 billion retail prescriptions were filled throughout the United States. 80% of those prescriptions were filled in translucent, amber-colored medicine bottles, which are classified as #5 recyclable. However, most curbside recycling programs do not accept these bottles because of their small size. Another reason organizations are turning to medication adherence packaging is to support sustainability initiatives. Compared to dispensing medication in a standard 90 cc bottle, medication adherence blister packaging reduces plastic by 53%. And compared to the commonly used bulk bottles, which require counting pills that are placed in amber vials at pharmacies, the reduction of plastic can easily be over 75%.
Elevated Focus on Pet Health
Pet ownership is on the rise. The shift to remote work and flexible schedules due to the pandemic has helped accelerate the increase in pet ownership. People found that when they were at home, they desired companionship and they had more flexibility to care for pets. And the positive impact of pets on mental health also helped increase pet adoptions.
All these new pets have driven the pet prescription market, which was estimated at $12M in 2022. This market is expected to keep growing as these pets age. Unfortunately, like many expanding markets, it attracts bad actors looking to profit from pet owners. These malicious people are counterfeiting pet medicines and selling them to unsuspecting individuals.
Serialization mandated by DSCSA and requires all human medications to be tracked and traced from manufacturer to dispenser, is now being considered to address animal safety. Serialization allows for tracking and tracing all pet medications from production to consumption. This process ensures the authenticity and quality of medications, significantly reducing the risk of counterfeit or substandard products that could harm animals. Veterinarians and pet owners can verify the medications’ origin and flow through the supply chain. Serialization integrated into the pet care ecosystem can enhance transparency, accountability and overall health outcomes for pets.
Food Traceability Comes into View
Serialization and traceability are also expanding into agriculture. Today, people are very conscious of what they eat. They are concerned about where their food comes from, how it was made, and its impact on the environment. Using serialization, companies can easily and quickly identify when, where, and by who, their products were produced, which suppliers were involved and where products were delivered.
Regulations such as the FDA’s Food Traceability Final Rule are being enacted to protect the food supply chain. According to the FDA, in the case of a foodborne illness outbreak or contamination event, efficient product tracing helps government agencies and those who produce and sell food to rapidly find the source of the product and where contamination may have occurred.
The benefits of serialization in packaging across health are enormous, and 2024 looks to be the year that many sectors expand their embrace of this innovative technology.
