Between 2001 and 2013, compounding pharmacies across the United States were linked to at least 19 outbreaks, resulting in over 1,000 illnesses and 132 deaths. These incidents have raised concerns about the safety and regulation of these facilities. Although the FDA oversees the nation's 76 outsourcing facilities, states also play a crucial role by requiring these facilities to register with them if they ship drugs to residents. This dual regulatory system aims to ensure that the ingredients used in compounded drugs meet specifications and are free from contamination.
In response to a significant 2012 meningitis outbreak that sickened nearly 800 people and claimed over 100 lives, Congress passed the Drug Quality and Security Act (DQSA). This legislation mandates that all compounding pharmacies adhere to standards set by the US Pharmacopeia (USP), which outlines rigorous requirements for training, competency, environmental surveillance, and quality control. Despite these measures, there is still a patchwork of regulation and inconsistent enforcement, as highlighted by recent cases involving bad actors in the industry.
One such case involved Pharm D Solutions, a compounding pharmacy shut down in 2019 due to multiple violations of lab procedures and potential contamination issues. Despite these problems, the state of Texas continued to license the company for five years. The FDA documented these violations, but it was not until customers like Jeff Reeh were directly affected that more stringent actions were taken.
In 2018, Jeff Reeh received a letter from Pharm D Solutions advising him to stop using their amino acid injections due to sterility issues. By then, Reeh was already battling a severe infection caused by Mycobacterium chelonae-abscessus, a bacteria commonly found in dirt and soil. The infection posed such a threat that Reeh's doctor warned him:
"You can either keep your hearing, or you can keep your leg." – Jeff Reeh's doctor
Reeh underwent treatment with antibiotics and other drugs administered through a special catheter (PICC line) for 153 days. His experience underscores the critical need for comprehensive oversight and proactive measures to prevent such tragedies.
The FDA's "compounding risk alerts" have become less frequent since the NECC episode, but experts emphasize the importance of vigilance. Elizabeth Rebello, MD, notes,
"There is increased scrutiny on the process, which is why you see it happening less frequently," – Elizabeth Rebello, MD
However, she adds,
"Not that you'll ever reach zero, but the goal should always be to reach zero." – Elizabeth Rebello, MD
Michael Ganio, PharmD, MS, highlights the challenges in estimating the frequency and severity of compounding errors:
"It's a lot like medical errors, in general," – Michael Ganio, PharmD, MS
"They aren't always reported, and it's hard to estimate how frequently they happen or how severe they are." – Michael Ganio, PharmD, MS
He warns that punitive action against adverse event reporting could hinder progress:
"If the adverse event reporting results in punitive action, then the number of reports will drop, trust in the system is lost, and the ability to learn from errors and apply them is diminished," – Michael Ganio, PharmD, MS
Elizabeth Rebello further cautions against those who prioritize profit over safety:
"You have a lot of people out there that — they see dollar signs," – Elizabeth Rebello, MD
"A lot of them do get by with it for a long while, but eventually they'll get caught because they'll end up hurting someone." – Elizabeth Rebello, MD
Jeff Reeh's ordeal serves as a stark reminder of the importance of consumer vigilance. He urges others to take preventative measures:
"Ask hard questions. It's a lot easier to do your due diligence on the front end rather than suffer the catastrophe that I went through." – Jeff Reeh
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