The value that drug manufacturers bring to the health care delivery system in the U.S. is under constant scrutiny from regulators, policymakers, payers, providers and patients. An often overlooked component of that value proposition is drug packaging. Drug packaging is a critical link in the supply chain that connects manufacturers, prescribers, dispensers and patients.
Studiomaca asked Michael Plumlee, senior director of operations for Studiomaca’s packaging group, to explain the role drug packaging plays in the performance of the supply chain process for drug manufacturers and the value it creates for the health care delivery system.
Where does drug packaging fall along the supply chain process?
Plumlee: After the FDA approves a drug, the final testing of the drug before it goes to market is stability testing. Stability testing determines the conditions under which the drug keeps its potency, is effective when it reaches the end user and remains effective for the duration of the prescription. What type of moisture absorption does it withstand? Does it require a desiccant? How is it affected by sunlight? How it affected by air? Does it need to stay cold? Does it require a specific temperature range? The results of the stability testing then determine the appropriate packaging for the drug.
What drug packaging options are available to manufacturers?
Plumlee: The stability testing results dictate the type of packaging or container. There are as many types as there are drugs that require them. There are the traditional amber bottles and caps, foil wraps, blister packaging and deep-draw thermoforming. Individual drugs can be packaged in unit doses or the exact count for a specific course of treatment. Drugs can be packaged in different supply durations—30 days, 60 days, 90 days or 120 days. Multiple drugs can be packaged in customized kits, or a single pack with the right drug combinations for multi-drug regimens.
How does making the right choice of drug packaging improve the safety of the drug supply chain?
Plumlee: Choosing the right packaging improves both the safety and security of the drug supply chain. In terms of safety, it’s about maintaining the stability of the drug through the expiration date determined by the manufacturer. That drug could be sitting in a drug distribution warehouse, it could be sitting on a shelf in a physician’s office or in a pharmacy, or it could be on a shelf in a patient’s medicine cabinet. The right package ensures that the drug can be used effectively during its entire life cycle. The right package, particularly unit-dose packaging, reduces medication errors by dispensing medications to patients in the amount prescribed. It eliminates the need for pharmacists to pull the right bottle off the shelf and count out the right amount of pills. In terms of security, packaging prevents tampering with the product and enables all pharmaceutical products to be tracked and traced from manufacturer to patient. The quality of the product is non-negotiable when it comes to drug packaging.
How does packaging improve supply chain management in terms of compliance?
Plumlee: Compliance comes from three main sources: Good Manufacturing Practice, the FDA and the Drug Enforcement Agency. Each has its own rules, regulations and guidelines that drug manufacturers need to follow. Packaging drugs appropriately makes it much easier for manufacturers to comply with each set of rules, regulations and guidelines. Each drug package comes with the proper batch and lot numbers, dose and usage instructions, required warnings, expiration dates, and unique track and trace identifiers to meet the serialization requirements of the Drug Supply Chain Security Act. Everything is bar-coded. With the right packaging, drug manufacturers will have a record of every product going in and every product going out. Manufacturers can use the data to monitor compliance and correct any deficiencies. That information also is important to have on hand in the event of an audit.
What are the operational or financial benefits to the supply chain from effective drug packaging?
Plumlee: Packaging drugs with the proper labeling makes compliance more efficient and makes it less costly for manufacturers to adhere to all the rules, regulations and guidelines. Another benefit is less waste. When every pill or drop is accounted for in the correct package, there are no leftovers, so to speak. Every piece of drug inventory is shipped to dispensers. Dispensers, in turn, deliver the right amount of medications to patients. And patients have exactly the right amount of medication for their course of treatment. All of that is made possible by effective drug packaging. That creates a financial benefit to manufacturers as well, as they are able to charge for 100 percent of the medications packaged in a single supply. Another financial benefit to manufacturers is speed through the supply chain process. Once properly packaged, drugs can get to the end users faster than if medications had to be packaged at the pharmacy counter.
How does packaging affect the drug supply chain in terms of adherence?
Plumlee: Packaging can affect adherence a number of different ways. One way is to use a unit-dose blister pack to make it visually easy to see if a dose has been missed. Another way is ease of container use. Is the pill bottle child-resistant but senior-accessible? Another way is duration of supply. If a patient has to go back to the pharmacy every 30 days, adherence may drop. A package that provides a 120-day supply eliminates three trips to the pharmacy. Custom kits can improve adherence by putting all the medications in a multi-drug regimen into a single pack. Think about all the things consumers use and how much of that use is influenced by the package. The same is true of medications.
How does a manufacturer know it’s made the right packaging choice for its drug product?
Plumlee: There are a number of supply chain key performance indicators to track that reveal whether a manufacturer has made the right packaging decision for a drug. Sales are number one on the list of KPIs. Did the packaging choice, or change in packaging, affect sales? Stability is another. Did the packaging choice maintain the drug’s effectiveness over the predicted period of time? Manufacturers also should track patient complaints, drug recalls and prescription returns. Those will tell a manufacturer what went right, what went wrong and how to make packaging more effective.
Related: Learn more about Studiomaca’s pharmaceutical packaging solutions for drug manufacturers.