Packaging materials have an impact in regulatory compliance, patient safety and drug efficacy
Pharmaceutical companies all share a common goal in bringing drug products to the market that offer new therapeutic options to patients with better health outcomes and lower overall treatment costs. Beyond safety and efficacy, healthcare systems across the globe are looking to derive a higher value from medications for specific populations to maximize healthcare resources while also providing optimal patient outcomes. In support of these goals, a growing number of pharma companies are turning to packaging innovations to meet more stringent requirements from regulators and payors.
More holistic approaches to packaging designs and selection are now being taken. Drug products are being presented in sophisticated drug delivery systems. There are a growing number of package presentations that address all aspects critical for outcomes – functionality, reliability and usability. They are meeting and exceeding user expectations by creating positive user responses under real world conditions. Given its growing popularity for versatility and a wide range of applications, thermoformable blister packs have seen strong growth as of late, due to its compelling design features.
The pharmaceutical industry is under more regulatory scrutiny than ever before, with a responsibility throughout the manufacturing process to ensure that drugs are within specification limits at the time of the release and over the course of the product lifetime. As such, drug manufacturers have had to cope with a range of regulatory standards that differ between regions and vary from country to country, when it comes to their packaging solutions.
In Europe, pharmaceutical producers must meet new standards governing tamper evidence, while regulatory bodies in the U.S. have enacted strict guidelines for child-resistant capabilities. Worldwide standards cover issues including track-and-trace down to the individual pack level through the mandate of 2D barcodes and other technology upgrades.  As pharma companies navigate these standards and regulations, it’s important they consult with their package supplier to be vigilant of the shifting regulatory landscape.
Greater demand for customization
Still the vast majority of medicines are taken orally by tablets or capsules, which are either packed in blister packs or fed into plastic bottles. Regardless of the packaging material, there is growing recognition of the need to provide tailored, individualized packaging solutions designed to guarantee the effectiveness of medicines in a wide range of applications.
Heightened consumer demand and a growing focus on customization at the patient level has forced small batches and shorter lead times for pharmaceutical manufacturers – which has ultimately led to a shift toward packaging goods much closer to the point of sale in order to ensure more efficient distribution.
With these changes, quality management remains top-of-mind for packaging suppliers. There is an increased emphasis on specialized medicine that is adjustable to small patient populations that requires different drug potencies and delivery mechanisms. This also holds true for packaging solutions which need to be adaptable for meeting patients’ dosing regiments most effectively. Blister packaging plays an important role here because it can be made customizable down to the individual patient, controlling dosage and optimizing accessibility for older portions of the population, while still delivering drugs safely.
Another major trend impacting the industry generally and packaging in particular is digital mass serialization that works to combat counterfeiting schemes. This technique involves adding machine-readable codes containing a serial number to individual packs of medication.
Unlike all other methods for verifying drugs, this enables product authentication at the point of dispense (POD) and provides the ultimate barrier between potentially harmful drugs and the patient. But serialization goes beyond traceability to enable authentication of drugs at any stage of the supply chain. It improves safety for end users by expediting recalls in the event of a drug problem.
Individual blister packs can be easily coded with overt or covert security features like visible holograms of company logos or letter and number combinations that can instantly identify the medication as original.
Drug recalls due to packaging
Over the past year, medication recalls spiked due to failures in packaging that have presented significant life-threatening risks to patients. From blood pressure pills to birth control, unsafe packaging has played a major role in user safety, forcing manufacturers to revisit their packaging partners and processes.
So how can packaging solutions begin to remedy this growing issue? Thanks to their ability to meet a variety of industry needs and requirements, thermoformable blister packs are versatile for a wide range of drug applications.
Manufactured from a selection of polymer-based substrates, including polyvinyl chloride (PVC), polythene terephthalate (PET), cyclo-olefinic copolymers (COC) and polypropylene (PP), blister packs are manufactured in different ways depending on pack performance requirements. Further, laminates made with polychlorotrifluoroethylene (PCTFE) offer several benefits including an enhanced moisture barrier, which helps ensure a drug’s chemical stability and efficacy during both storage and transportation. The use of such materials ensures that drugs deliver effective treatment to patients without putting their safety at risk.
Based on studies conducted by Honeywell, thermoformed blister packs have demonstrated significant benefits over next best alternatives such as plastic containers and Alu/Alu blisters in the areas of medication error prevention via see-through functionality, ease of dosage extraction and portability.  Last but not least, the visual evidence of medication taken strongly supports patient adherence to therapies and enables real world evidence of treatment outcomes.
About the author
Kori Anderson is General Manager, Healthcare Packaging, at Honeywell.