We all reach moments of reflection. An incident or series of events that makes you take a breath, step back and evaluate what has gone by and what might be to come.
As a nation, we’ve had too many of these moments in the last few months: from needless loss of life due to an invisible enemy to widespread impact from an economy strangled by overzealous bureaucrats.
In the packaging world, we had our own moment of reflection recently but in a much quieter way. Recently, a man named John Bitner passed away. To many of the readers, maybe most, this name may not mean much; but to anyone who has been around the pharmaceutical packaging industry for more than 20 years, the name means quite a bit.
John worked for GD Searle, which became part of Pharmacia Upjohn, as well as for Watson Labs. He was always in packaging and always a hero for safer packaging. In John’s mind, patient safety, senior safety and child safety went hand in hand. He spent considerable time both on behalf of his company and the IoPP, promoting ideas for packaging improvements and, as well, had considerable interest in the testing protocol represented by PPPA. John’s efforts went above and beyond that required by any dedicated engineer serving his company or profession.
As for reflection on the part of HCPC, we look at and admire the decades of dedication John provided for safer pharmaceutical packaging. We also look at and admire the recent work of the CDC’s PROTECT committee in improving the safety of liquid medicine containers by implementing improved guidance on flow restrictors, which is to be adopted into a FDA guideline to decrease child accidental ingestions and overdose (Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products – Docket No. FDA-2020-D-0567). These efforts encourage our organization to continue the fight for improvements in child safety, particularly in light of recent tragedies involving solid dose pharmaceuticals and packaging failures.
In particular, we are referring to the tragic poisoning and death of Maisie Gillan in early 2019.
We wish this were an isolated incident, but it is not. Child poisonings from medications in the home are all too common. Quite often, the original packages were either not reclosed properly, left open all together, or the product was transferred to another container (pill reminder) for convenience. Sadly, all three scenarios have the potential for ending in disaster.
The HCPC firmly believes that the only path to decrease the likelihood that these tragedies will continue is the modification of the PPPA with a focus on product toxicity. It was an unfortunate omission from the original law, albeit somewhat understandable in the world of 1970, when the law passed.
The only mention of toxicity in the original law refers to the use of unit dose packaging and specifies that the determining factor for selecting the level of CR for unit dose is “the amount of a product that can cause harm,” obliquely referring to toxicity. How much of the product will cause harm?
The HCPC believes this standard should apply to all packaging, ensuring that essential, and oftentimes lifesaving, drugs that are toxic to children be in the safest packaging possible. The goal of the Poison Prevention Packaging Act was the safeguarding of children. Allowing toxic products that can kill or cause harm in a single dose (or even more) to be dispensed in bottles containing 30, 60 or 90 units is simply inviting disaster.
As I reflect on previous hard work to improve child safety, I recognize the challenge of convincing the pharmaceutical world to change for the sake of safety. I realize the journey will not be easy, but I have the comfort of knowing that John Bitner and others preceding the HCPC have fought and won to create change and improve safety. The HCPC will continue this mission to improve pharmaceutical safety through packaging, building on the success of those who traveled before us.