Ernest P. Gates Jr., RPh, FASCP, FIACP, FACA

Ernest P. Gates Jr. is the president of Gates Healthcare Associates (www.gatesconsult.com), a Massachusetts-based pharmaceutical and healthcare consulting firm.

Compounding pharmacists too often suffer from the “woe is me” affliction. They feel victimized by the acts of a rogue few, pushed down by the heavy thumb of regulation and often forgotten by other sectors of the health profession. Yet, they are vital to so many patients who depend on them for medications that are not commercially available.

It has been a long road. The New England Compounding Center (NECC) tragedy--where a company that was willfully ignoring proper compounding procedures prepared and distributed toxic injectable medications that killed 64 and injured 753--became a black mark for our profession.
	
	In its wake, there were criminal investigations into enterprises that compounded pain creams for veterans and others and that charged tens of thousands of dollars for products that cost a fraction of that.
	
	The NECC tragedy led to increased regulation and oversight–a good thing but challenging, nonetheless, for independent compounding pharmacies–and the pain cream scandal led health plans and Pharmacy Benefit Managers (PBMs) to reduce or eliminate coverage of compounded medications.
	
	For the profession, it must close this chapter and invest all of its energy in building a reinvigorated compounding pharmacy industry. It is high time for compounding pharmacists to lift their heads, throw their shoulders back and become leaders, rather than overburdened professionals continually reacting to circumstances around them.
	
	Here are four steps the profession and those in it can take to do just that.

 – Compounding pharmacists must embrace accreditation and view it as something that is mandatory and not elective, because it is so very beneficial over the long run to the practice. Now, it is true that regulators and payors are generally not yet requiring it. From the perspective of industry credibility, however, it is important to embark on the accreditation journey. For one thing, the ACHC (PCAB), URAC or other accreditation seals will give the public confidence in what you do. Even more important, though, is the transformation that your pharmacy will go through in order to become accredited. By its very nature, accreditation requires you to take a hard look at your practice, to hone your procedures and tighten your processes and that, in and of itself, improves the quality of the medications that you prepare and dispense. We must now tell patients nationwide that, when purchasing a compounded medication, to look for an accreditation seal.

 – Roughly one year from now, pharmacies will be required to comply with USP 800, the new United States Pharmacopeia chapter that deals specifically with workplace safety. For some pharmacies, this means gutting and replacing their labs, for others it means upgrading their equipment. To advance the profession, it is important for compounding pharmacies to not just squeak by, barely meeting the threshold. Use this requirement to really retool and ensure you are operating at the state-of-the-art. As a profession, let’s come out of this requirement in overwhelming compliance.

 – Compounders have very special skills. You spend the time with patients that physicians and chain pharmacies cannot. You are the savior when the patient needs a highly specialized regimen and nothing off-the-shelf exists. Let the community and the nation see what you do. Make sure that your lab is visible to the public. If people see medications being compounded through large picture windows right before their eyes, it gives them confidence in the product. At the same time, practice within the scope and capabilities of your training and facilities.

 – Compounders must engage with the broader professional community as a means of staying current in their practice and also to increase the profession’s standing and clout. The easiest and most effective way to do this is to join a professional association that represents and advocates for the compounding community.


	It’s important for compounding pharmacists to be really good at what they do and to be a resource for their communities, but at the same time to understand and internalize their limits. Accidents can happen when any professional exceeds their scope of practice and such episodes keep the profession down.
	
	The steps outlined above, which will restore the profession’s credibility, will not be easy for compounders to follow nor will they be inexpensive. It is the difficult changes that are always most impactful.
	
	The vast majority of compounding pharmacists are excellent practitioners who physicians and patients rely upon. The profession should not be judged by a minute percentage of bad actors.
	
	It is time for our profession to shine at what we do best, to broadly adopt best practices and to do not just what is expected of us, but what is not.

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Four steps that compounding pharmacists must take to restore their credibility.

Author | Ernest P. Gates Jr., RPh, FASCP, FIACP, FACA

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