Quality Control in Compounding Pharmacy—Time to Take a Proactive Approach With Your Patients
Quality control at compounding pharmacies continues to face close scrutiny, especially following the tragic deaths from contaminated pharmaceuticals dispensed by the New England Compounding Center. Patients are rightfully concerned and pharmacists face a dilemma: do nothing and hope business doesn’t suffer (if it hasn’t taken a hit already), or tackle it head on. However, federal and state oversight isn’t going to go away, so pharmacies have everything to gain by being proactive. Pharmacists should stay abreast of all news regarding compounding pharmacies (whether real or sensational) and not hesitate to discuss with patients the steps taken to ensure their safety and well being.
Sort the Ongoing News—What’s Real vs. Sensational
Most patients read the reports or hear the news. While you don’t need to set every incorrect fact straight or explain every adverse event, you should always be prepared to respond to concerns. Even though compounding pharmacies are under the microscope, this may bolster confidence: these organizations aren’t alone when it comes to tainted products being recalled. Between July 2015 and June 2016, the FDA recalled 44 products—eight of which involved compounded drugs, 16 came from other pharmaceutical manufacturers (including some of the big boys), and the rest were supplements.1
As if real events weren’t dramatic enough, headlines can add to the problem by alarming patients with innuendo. For example, consider this: “Unsafe Drugs Were Prescribed More Than One Hundred Million Times Before Being Recalled.” The implication sounds scary, until you consider the facts: In June 2016, the International Journal of Health Services published a study that quantified the number of exposures to drugs that were newly approved, then later withdrawn from the market due to safety concerns. The researchers found 17 drugs that were approved, then withdrawn. Before being pulled from the market, they were prescribed at 112 million physician office visits in the United States.2
So yes, medications were prescribed more than “one hundred million times,” but the headline implies a solid indictment of the industry, which isn’t supported by the details. The data was collected from a period of 18 years—17 drugs withdrawn over 18 years. The researchers did not associate exposures with adverse events, and without cause-and-effect, the headline implies a health risk that isn’t substantiated.
Failure to Comply with USP Standards
Many individuals probably don’t realize that the New England Compounding Center (NECC) doesn’t even begin to represent the industry. Sure, contamination can seep in even when best practices are followed. But that’s not what happened. Fourteen NECC personnel were indicted on 26 charges of second-degree murder, criminal contempt, racketeering, structuring and mail fraud. Beyond the obvious—murder and contempt—what does all of this mean? It means that multiple employees purposefully did not comply with state regulations, USP <797> and USP <71>, created false financial records, and mislabeled vials and purposefully misrepresented how the drugs could be used. Here are three quality standards they snubbed:3
- Failure to obtain patient-specific prescriptions. More specifically, they dispensed drugs without patient-specific prescriptions and had salespeople assure prescribers they could use the meds for anyone, then send NECC a list of patients that received the injections after the fact. The indictment further alleged that they avoided registering as a 503B facility by claiming they had prescriptions.
- Unlicensed personnel prepared sterile compounds.
- Failed to maintain a sterile cleanroom. NECC had a consistent pattern of microbial and mold contamination for 37 out of 38 weeks.
What Patients Should Know About Quality Standards
Pharmacists can take a few different approaches to informing patients about quality assurance in compounding pharmacies. The key is to keep information clear and understandable, and to avoid raising red flags by sounding defensive. If you approach it from the perspective of caring for patients, which is the overriding concern, you’ll come across as genuine. Here are a few ideas to get you started:
- Put up posters posing this question – “Have questions about the quality and safety of your medications?” Invite them to approach the pharmacist with questions and have a handout ready that gives a brief outline of USP standards, state regulations and succinct mention of the FDA’s oversight via the Drug Supply Chain and Security Act.
- Develop a more informative infographic to put up near the pharmacy that tells about quality standards and regulations followed by compounding pharmacies. Be sure to keep the terminology user friendly.
- Sponsor a seminar for professionals, patients and the community. Invite a quality assurance specialist to talk about regulations and standards designed to ensure safe pharmaceuticals. Topics could include monitoring the cleanroom environment, fingertip testing, air sampling, staff certification, sterility testing, state regulations and changes implemented under DSCSA. Since this is a third party, they can also freely discuss the fraud and negligence that led to the NECC tragedy.
- Encourage patients to tell you about drug quality concerns and let them know the FDA has an online reporting system they can use to report drug problems and adverse events.4
- Be transparent about your role. Patients need to know that you make sure your staff are properly trained and licensed, that all personnel are responsible for complying with quality and safety standards, and that you ensure all APIs used in your pharmacy were manufactured and distributed in accordance with cGMP and CFR at DEA and FDA registered facilities.
Transparency About Quality Control Promotes Patient Confidence
Most people have a hard time knowing what to say to comfort friends when tough topics come up. A similar challenge arises when pharmacists must continue to promote their services in the wake of unfortunate occurrences caused by unscrupulous and fraudulent peers. In both instances, the worst thing you can do is nothing. The responses required are different, but you must proactively put out the word that you diligently comply with numerous standards designed to ensure safe pharmaceuticals.
Pharmaceutica North America provides bulk APIs and prescription drug products that are produced under strict compliance with best practices and USP standards. Contact us today to talk about our mandate to ensure the safety, purity and stability of our pharmaceuticals and naturally derived ingredients.
- “Drug Recalls,” June 2016, http://www.fda.gov/drugs/drugsafety/DrugRecalls/ ↩
- “Unsafe Drugs Were Prescribed More Than One Hundred Million Times in the United States Before Being Recalled,” June 2016, http://pnhp.org/blog/2016/06/14/over-100-million-prescriptions-written-before-drug-safety-recalls/ ↩
- “New England Compounding Center Indictment,” March 2015, http://www.ncbi.nlm.nih.gov/pubmed/26685489 ↩
- “MedWatch: The FDA Safety Information and Adverse Event Reporting Program,” July 2016, http://www.fda.gov/Safety/MedWatch/default.htm ↩