Can we fix it?
Yes, we can - if we're willing to join our voices, effort, and resources in confronting, for starters, three significant challenges.
Take your reputation, for one thing.
When I say "your," I don't mean you as an individual. No, I mean the reputation of your profession, of compounding as a whole in the aftermath of nationwide media attention on serial scandals and tragedies in which patients died or were harmed not because of insufficient regulation but because of improper enforcement. And I'm talking about the practically weekly reporting in the media of new fraudulent billing schemes involving compounding - and compounders fined or going to jail.
None of those reflect very well on you, even though you weren't remotely involved in any of them. Likely, you're heartbroken that patients may have been harmed by others in your profession.
But here's the thing: To the public, your reputation is only as good as the most recent headline about a compounding pharmacy. And Congress and the FDA take their regulatory cues from public opinion.
So when regulatory enforcement goes wrong, the knee-jerk reaction always is to think we need stronger regulation, not proper enforcement of current regulation. And when the media reports a scandal-a-week involving compounders and pain creams and billing fraud, it begins to look like compounders are all con men or unregulated snake oil salesmen.
Again: You didn't cause the loss of life or the bilking of taxpayers, but your credibility is being judged in large part by those events.
We've got to do something about that.
Helping media and policy makers see (and feel) the actual value of your work in serving patients will be a start. Strengthening IACP's Code of Ethics as the gold standard for compounding professionalism - turning membership in IACP and adherence to and enforcement of that code into a sort of Good Housekeeping Seal of Approval - is worthy of discussion. In any case, we can't continue to allow the horror stories and frauds to define your value. We've got to tell a better story - the real story. I'll be focused on working with IACP leaders to do that.
Next, take the regulatory overreach your profession is confronting.
It's a direct result of the credibility and safety issues that have resulted from the news-making tragedies and fraud mentioned above. As you might expect, it's awfully difficult to credibly suggest we maintain the regulatory status quo when the media and consumers are pounding on Congress and the FDA to do something.
In that environment, unfair as it is, we cannot afford to be seen as the "hell, no!" lobby. Yes, we must preserve the appropriate role of state boards of pharmacy as the primary, front-line regulators of compounding, but we also understand that the FDA plays an important role when it comes to outsourcing facilities and larger 503As distributing interstate. Beyond that, compromises are likely to be called for - some needle-threading to get to solutions that allow you to continue to serve your patients and run a successful business but that also give policymakers confidence that consumers are protected. I'm not talking about rolling over in the face of regulatory over-reach. But we must begin to promote solutions we can live with without being seen as obstructive. The sooner we can get past the head-butting with FDA, the sooner we can focus on advancing and restoring the reputation of your profession.
Lastly, take the splintered voice - voices - of compounders nationwide.
We're speaking, but not with one voice. We're communicating, but it's not particularly coordinated. The result - at least to the ears of policymakers - is a profession that seems to be all over the map and not quite unified in what it thinks and wants.
In that environment, the entity uniquely positioned to enunciate a single voice for the compounding profession - IACP - must re-emerge as a leader of the profession, must corral all those voices into a unified voice and re-assert itself on behalf of its members and constituents.
To accomplish that, IACP must be strengthened, both in its membership and financially. We must enunciate a new vision that attracts compounders and corporate partners and compounding educators to the organization. Strategically, we've got to refocus on a few things we can do exceptionally well and jettison the idea that we have to be all things to all people. We must become the one organization to which you can't afford not to belong.
If we can do that, we can attract the movers and shapers in compounding pharmacy and elevate the profession.
So: Lots to do. It's time to get strap on our toolbelts, don the safety helmets, and get to work.
Can we fix it?
Yes, we can. Working together, I'm confident we can.
