Blister Packaging for Certain Immediate Release Opioid Analgesics for Treatment of Acute Pain – Docket No. FDA-2019-N-1845 as it relates to opioid packaging, and recently passed Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients (SUPPORT) Act, passed in late 2018.
Now the goal of the legislation and its inclusion of unit dose packaging is to address the ongoing opioid crisis in the USA and one of the key culprits — an oversupply of unused drugs in American medicine cabinets. HCPC supports the concept that more accurate prescribing and dispensing practices can go a long way toward reducing excess supply and the potential for extra doses finding their way into the wrong hands. Properly sized unit dose packaging can be a wonderful tool in this path, aside from the myriad of other benefits it can provide.
FDA’s request for comment on the incorporation of unit dose packaging for immediate release opioids included several areas of concern. The impact on patients, prescribers, pharmacy and the manufacturers were the broad categories. FDA recognizes that such a change and mandate on a packaging form could cause unintended consequences that affect other stakeholders and it is appropriate that all potential parties should be considered.
From the HCPC’s perspective, the missing party in this is the children and the thousands upon thousands of annual ER visits, accidental poisonings and hospitalizations resulting from easy access to these drugs in the home. The CDC cites that the average annual ER visits by children under 6 due to opioid analgesic exposure between 2010 and 2013 was 4,661.1 We pointed this out in our response and clarified our position that unit dose packaging provides significant benefits to curbing the opioid crisis, including the tantamount issue of improved CR. In particular, F-1 CR/SF packaging can provide better visibility to doses in the package, which can aid in adherence monitoring (accidental overdose being a key concern), and better visibility to pilfered doses which a vial cannot address. These are just a few benefits of unit dose blisters.
What struck the HCPC as we read through responses from other commenting organizations was the total lack of understanding of what unit dose packaging is and what it can provide. Seemingly high-profile professional organizations demonstrated in their comments a lack of understanding for the package form. These are organizations that work in and around pharmaceuticals, so it is unsettling that there is such a gap in understanding about this packaging form and what it really looks like in the market today.
Another thing that stands out in the responses is the tunnel vision other stakeholders in the industry exhibit. It is certainly understandable that each organization would look to protect their “constituents” and prevent potential impact, but we all should have enough sense to consider the bigger picture.
What seems to be lacking in many of the responses we reviewed was the basic understanding that the current system has gone off the rails. It is beyond broken and there are literally tens of thousands of dead bodies and hundreds of thousands of victims of this runaway segment of the pharmaceutical supply chain. So when we read that some organizations think that the status quo can and should be maintained because changing will be difficult, we are left scratching our heads. What don’t these organizations understand? How can anyone look at what the opioids have delivered to the U.S. market and not understand that every effort should be undertaken to try to stop the bleeding? Nothing should be sacred, every change considered and if there are costs to be born and processes to be changed, then that is what we need to do to protect and save lives.
1 Lovegrove M, et al., Pediatrics 2015;136(4):e821-9