The need to attribute blame — whether towards people, industries, systems, or, even oneself — appears to be a fundamental human tendency.
When we started planning this month’s cover story on opioids, blame was the first topic that surfaced. Both myself and our Senior Editor, Meagan (who authored the article, read it here), had differing opinions on how the country found itself in this opioid crisis. Ultimately, we agreed that the only way to productively cover the topic as a manufacturing-based publication was to move beyond the blame and discuss the possible solutions being explored by industry and regulators.
Dismissing blame entirely, however, is unwise — how can we solve a problem without determining what went wrong? Isn’t that the premise behind industry Corrective and Preventative Action programs? Without undergoing a root cause analysis (RCA) to identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed. And in a RCA, it’s important to consider all possible causes.
But the CAPA process does not end after the root cause is determined. An important step in CAPA compliance involves implementation. After the investigation is closed and the potential root causes are identified, the CAPA needs to be implemented in order to affect actual change.
In terms of the opioid crisis, the battle has shifted from the doctor’s office to the streets as illegal painkillers become the prime source of overdose — meaning the current struggle is less about pharma companies pushing pain prescriptions and more about combating illegal imports. While easing up on the blame game doesn’t make the pharma industry less culpable, it may be freeing up time and resources that can be directed towards solutions.
Drugmakers such as Purdue Pharma (arguably the main character in the pharma-fueled opioid narrative) are now promoting the use of prescription monitoring programs, offering abuse-deterrent formulations and have promised to stop sales forces from touting the benefits of opioids to doctors. The FDA has recently began taking new steps to tighten controls around narcotics as well come up with a plan to fast-track approvals for new treatments for addiction and non-opioid analgesics. Industry associations have accelerated research toward non-addictive pain medications and new treatments for addiction, as well as raised funds for programs for addiction treatment and to help families impacted by opioids.
As pharma’s legal responsibilities surrounding opioids continue to play out in the courtrooms and the media, it’s promising to see that further work is being done in the field towards finding and implementing corrective actions. Focusing all our attention on attributing blame leaves us with little energy left to focus on solutions. And it’s these solutions that ultimately will help us do better as an industry...and, on a larger scale, as a country.
