The Opioid Epidemic: A Perfect Storm

The Opioid Epidemic: A Perfect Storm

I recently was asked to take part in a series of expert workshops supporting FDA’s efforts to reduce the growing epidemic of opioid abuse, dependence and overdose in the United States. The first workshop, focused on packaging innovations, sought to gather input from a multi-disciplinary team to identify key intervention points; examine data needs and guiding design principles for the development of packaging, storage and disposal solutions; and contemplate the intricacies of integrating such solutions into the current healthcare marketplace. With representatives from academia, manufacturing, patient and provider groups, payor organizations, and government – the conversation was rich yet circular. What became clear to me throughout the day was that this issue, with its layers upon layers of complexity, truly was the perfect storm of public health crises.

Unraveling the problem will require a thorough understanding of the intricacies of human behavior – especially those related to addiction. Starting with the patient who fills the prescription, unintentional non-adherence, driven by forgetfulness, health illiteracy or simple misunderstanding, makes this problem in certain limited ways no different than the general “medication adherence crisis” that has been recognized and studied. Non-adherence has been proven to cost the US healthcare system hundreds of billions of dollars annually and to lead to immeasurable and preventable negative health outcomes. For the last decade, we’ve been trying to figure the whole “why don’t people take their medication as directed” problem out – and to address it - to no avail. What we’ve learned is that the reasons people don’t take their medications correctly are as individual as the people themselves and thus, so are the solutions.

To this conundrum, we now add on the problems associated with the nature of these particular drugs themselves.  Opioids further confound the problem of non-adherence (which we have not been able to solve) in unbounded ways. Opioid’s psychoactive effects and the propensity for dependence development converts unintentional non-adherence to intentional non-adherence (although one could argue about the meaning of intentional activity in addictive behavior).  What I mean to say is that we are no longer dealing with patients forgetting or failing to understand – but rather - seeking. Intentional activity is a whole new ball game and one for which virtually none of the innovations designed to address forgetfulness and literacy will help. Combine that with provider prescribing practices and rules around pharmacy and hospital reimbursement, and you’ve added fuel to the fire. Whether on the part of the patient or a third party (through diversion or sharing), intentional non-adherence draws into the conversation topics associated with access limitation, SUD diagnosis and treatment, traceability, and criminality, among others. Furthermore, the problem has created cultural issues of stigma and shame which force open discussion and self needs identification underground.

-          And then there’s the money. Both legally and illegally, it’s a profitable industry - and I’ll leave it at that for purposes of this discussion.

-          And what about patients living in chronic pain? It was obvious in the room that the concept of limiting access struck fear in the hearts of those advocating for the rights of those living in chronic pain.

-          And what about our love of privacy? We Americans delude ourselves into thinking that we have some - and we are recalcitrant in giving any up - regardless of whether actual or perceived.

-          And what about the gateway issues? If limiting access to opioids will drive current misusers to illicit drugs – how does that help?

For every proposed solution, another convoluted problem rose its ugly head. At the end of the day, only a precious few bright lines were left on the drawing board.  First, the criticality of having all stakeholders engaged, connected and aligned in the development and deployment of potential solutions was obvious. Second, given the mind-blowing statistics around the speed and the pervasiveness of the epidemic we’d better get used to the fact that our current rules of play need to be off the table and we’d better get moving.  In the war against the opioid epidemic, perhaps Patton would be right in opining that a good plan violently executed right now is far better than a perfect plan executed next week.

Regenerative Medicine in the Trump Era

Presentation - Ed Allera, Esq. and Barbara Binzk Blumenfeld, Ph.D., M.A., Esq.