While we wait for the FDA to compile and review the responses to its request for comments on Fixed Quantity Unit of Use Blisters Packaging, Docket No. FDA-2019-N-1845 in response to the SUPPORT Act of 2018, we want to take the safer packaging of opioids conversation a bit further.
One of the key points HCPC drove in our docket response was that child safety seems to have taken a back seat in the packaging discussion. Granted, the main issues to be tackled are adult opioid abuse and the oversupply caused by over-prescribing. We applaud the efforts to reduce excess supply in the home, a large source of misused product. We agree reduced quantities of opioids for initial acute care will reduce the opportunity for abuse and development of dependence. Use of unit dose blister will automatically improve the safety of these drugs in the home, but why wasn’t improved child safety another focal point of the legislation? More importantly, why wasn’t more effective child-resistance (CR) for opioids discussed before, given the historic data on accidental exposure?