New year, same problems.
Happy 2017, RxAdherence readers!
The HCPC had a busy 2016. Most notably we hosted our first IoPP Drug and Pharmaceutical Packaging Committee meeting which seemed to be a success for all. A great exchange of ideas, some wonderful input from FDA and an encouraging look to the future. If suppliers and pharma manufacturers can continue to cooperate on best practices, addressing the healthcare challenges being presented we could see real progress on improvements in pharmaceutical safety.
On the broader front there have been a lot of interesting conversations with groups searching for solutions to ongoing problems and packaging, for once, is being considered.
The topics include: Opioid abuse, child poisonings, supply chain security, anti-counterfeiting and of course, medication adherence.
Groups range from FDA to CDC to NCPIE and more.
It seems that as the challenges increase these groups are being pushed to look outside their neighborhood for solutions and packaging is coming into play more often.
For instance, conversations with CDC yielded not only their major push to address opioid abuse but also a rising concern about accidental child poisonings from these drugs and the medications designed to cure addiction (specifically buprenorphine naloxone). A move into unit dose blisters in recent years yielded a significant drop in emergency room visits for accidental child poisonings. From HCPC's perspective this is not news. We've been touting that blisters are inherently safer than bottles simply by reducing access to large quantities of product from a single container opening.
What is interesting is that these problems have a common solution in unit dose packaging. Add to that the potential to track these products using the serial number provided for supply chain security under the Drug Supply Chain Security Act and you get a double benefit. A safer package for children and the ability to track and identify the source of abuse. It would not be a stretch to suggest that all opioids and possibly even all C2's should be dispensed in unit dose packaging.
We can continue down this path with some of the new dispensing guidelines being pushed in certain states. Several states have been enacting laws restricting the number of doses dispensed for certain drugs to try to inhibit abuse. Dispensing a limited 3 day prescription in a bottle is not terribly efficient because of the time spent counting doses and keeping track of doses in pharmacy. The small, limited number of doses the CDC and now some statesrecommend packaged in a blisteris efficient, cost effective, more easily traceable and provides for greater safety during home use.
We are not alone in this thinking. The following excerpt is from a Journal of Pediatrics article.
"We believe that an engineered solution, such as providing all potent opioids and other 'one pill can kill' medications in a single dose, child-resistant packing, such as a blister pack or foil pouch, by default, is more likely to be effective than additional efforts at education," Lavonas and colleagues stated.
They also argued against reliance on child-proof caps, which, if inadequately closed, can permit a child to obtain and swallow numerous pills rapidly, as prescriptions are often given in 30-day supplies.1
What is wonderful from the HCPC perspective is that these organizations are finally looking at packaging as not merely a container but as a functional part of a drug delivery solution.
We are looking forward to 2017 and further developments in this space.
Best Personal Regards,
VP Operations and Business Development, Pester USA
Executive Director, Healthcare Compliance Packaging Council
Adjunct Professor, Rutgers, Pharmaceutical Packaging
1Lavonas E, et al "Root causes, clinical effects, and outcomes of unintentional exposures to buprenorphine by young children" J Pediatr 2013; DOI: 10.1016/j.jpeds.2013.06.058.)