November 23, 2012

Jim Richards: Recent events don't diminish professionalism of compounding pharmacists


— I am a compounding pharmacist.  

Three months ago, most Americans would have shrugged at that statement.

Today, those same Americans would have a different reaction, and quite possibly a negative one.

Compounding pharmacies are on the front pages because of the ongoing tragedy that is attributable to the actions of the New England Compounding Center (NECC), based in Massachusetts.

My colleagues and I are outraged and sickened by the alleged malfeasance at NECC. They called themselves a compounding pharmacy, but in actuality they were apparently careless manufacturers who needlessly and shamefully endangered the lives of their customers.

It is alleged by regulators that NECC somehow was able to skirt existing state and federal laws and operate its business by shortchanging quality. That is not what a compounding pharmacist does.

What is a compounding pharmacist?

We make drugs for people who can’t take conventional medications that are manufactured by big companies. We customize cancer medications, we produce specialized drugs for children with autism, we make intravenous solutions. We also can compound medications when a conventional medication is unavailable, something that is happening more often as of late.

We are your local pharmacist, and we make some of the drugs that many of you take to make your lives better. We are also located in hospitals and help customize medications for their patients.

Every pharmacist is trained to compound medicines. More than half of all local pharmacies provide compounding services, with more than 7,500 pharmacies in the United States that specialize in compounding. In addition, there are about 8,200 pharmacies associated with hospitals and other health institutions that engage in compounding.

In short, compounding pharmacists fill the needs of patients who have unique health needs that can’t be met by off-the-shelf, manufactured medications. These personalized medications, prescribed by licensed practitioners and prepared under strictly controlled conditions by specially trained compounding pharmacists, are the only way to better health for these individuals.

What we don’t do is manufacture big batches of drugs and then send them off at cut-rate prices across the country, which is what NECC is alleged to have done. We don’t know all the details about what NECC was up to and why they weren’t stopped before this tragedy happened, but we do know some facts.

We do know that NECC had been cited by the FDA and by Massachusetts State regulators.

We also know that neither the FDA nor Massachusetts state regulators followed up effectively on their warnings, because the misbehavior continued. We know that the NECC was careless with the safety of its patients. And we have now been told by officials that much of what they did was illegal.

What we need to do now is find out all the facts and find out what exactly happened with the NECC and with its regulators. We need a thorough and complete assessment of state and federal laws governing the practice of pharmacy. We also must be sure that laws and regulations are enforced.

Our profession is determined to work with regulators, government officials, boards and others to ensure that the bodies charged with enforcement (Food and Drug Administration, Drug Enforcement Agency and state boards of pharmacy) are able to do their jobs.

There have been calls for the FDA to take over regulation of pharmacies, but the FDA has always had the authority to visit and inspect any pharmacy at any time, on its own or in response to complaints. Regulators at the state level might be better positioned to enforce rules and inspect facilities than this federal agency and its very broad scope.

There are a couple of steps that can be taken immediately.

Professional standards issued by the United States Pharmacopeial Convention, a nonprofit organization that sets rules to identify the strength, quality and purity of medications, have not been adopted by every state. Every state should immediately adopt these USP standards.

All compounding pharmacists should work to become accredited by the Pharmacy Compounding Accreditation Board (PCAB). To be accredited by PCAB means that a pharmacy is operating at the highest possible level. We urge all of our colleagues to get accredited.

The meningitis outbreak is a national tragedy. Our profession stands ready to work with leaders from government to make sure that what happened at NECC never happens again.



 Dr. Jim Richards, a pharmacist, is owner of Corner Drugs in Chatsworth.