In 2020 the Healthcare Compliance Packaging Council celebrates its 30th anniversary. In that time, HCPC has witnessed dramatic changes in the pharmaceutical market, and our mission has evolved to meet the changing landscape of the healthcare industry.
At the outset in 1990, there were several focal points for the blister packaging-based group. The country had recently weathered the Tylenol Poisoning (Tampering) scare of the early ‘80s. Blister packaging by nature resists tampering and counterfeiting.
Calendarized blister packs, such as birth control compacts introduced over 50 years ago, are designed to aid patients in managing their regimen. While numerous studies demonstrated positive package performance, the broadest use of blisters continued to be in clinical trials.
Another hurdle for the wider use of blisters was the differentiation between bottles and blisters in the Poison Prevention Packaging Act, whereby there is a toxicity distinction made for unit dose packaging burdening the manufacturer in determining what constitutes a harmful dose to a 25 lb. child. As most companies were reluctant to make this distinction, the F-1 rated child resistant blister was the only choice. In the ’90s this was an expensive package compared to bottles.
These hurdles led the organization to challenge CPSC to re-examine PPPA and whether this distinction was reasonable. Companies were driven from a package form with many benefits to the patient — including better child resistance through protecting individual doses.
Fast forward to the early 2000s: F-1 packaging had evolved with lower costs and automated production. Counterfeiting and diversion were big news. Unit dose packaging offered a solution by eliminating repackaging in the pharmacy and providing the manufacturers’ original package, reducing the opportunity for diverted or counterfeit product.
At the same time, poor medication adherence was gaining recognition for impacting health outcomes and costs to our country. A 1999 paper from the IoM titled “To Err is Human: Building a Safer Health System” exposed the depth of the problem. The USA was spending more on medications than any other country and not getting the benefit. Our national health performance was not even in the top 20 globally. Once again, compliance prompting packaging was in the discussion and referenced in the report as one of many solutions to this broad-based problem.
Unfortunately the industry spent the next several years trying to grapple with the complexity of supply chain security, as states began passing their own legislation trying to secure their own pharmaceutical distribution without federal guidance. This ended in 2013 when the federal government finally passed the Drug Supply Chain Security Act, which would take 10 years to fully implement.
HCPC was involved, testifying before the Congressional Committee that ultimately drafted the legislation, constantly promoting the idea the unit dose packaging offered the most secure vehicle to move products through the supply chain to the consumer.
Menacingly growing in the background was the Opioid Crisis. As this situation spiraled out of control, Congress and the FDA began looking for solutions and packaging was again part of the discussion. HCPC promoted the benefits of unit dose for reducing prescribed quantities, providing visibility to doses taken, helping prevent accidental overdose, giving visibility to pilferage in the home and providing a safer package for children and the product.
As we enter 2020 this fight takes one more step. In fall 2019 there was a tragedy in Rochester, New York, where a 9-month-old child got a hold of a misplaced methadone tablet and died hours later. HCPC sees this as a direct failure of current pharmaceutical dispensing and packaging methods.
It has been an interesting journey for the HCPC. Our mission has evolved to meet the changing needs and challenges of an increasingly complex pharmaceutical supply chain, but our overall goal hasn’t changed — drive better packaging for safer patients, safer children, safer products and a safer supply chain. Won’t you join us?
