How safe are compounded drugs?

September 18, 2006

An incident that tied a compounded drug solution to three deaths and eight acute illnesses has captured the attention of both the media and the many pharmacists who regularly compound critical care drug products for hospital use.

Essentially making an example out of Mary Washington Hospital, Fredericksburg, Va., a recent article in USA Today highlighted the institution's ordeal last summer in which 11 cardiac surgery patients were injected with a contaminated cardioplegia solution and went on to develop serious bacterial infections that led to the life-threatening systemic inflammatory response syndrome (SIRS). Since then, the eight surviving patients have filed lawsuits against the hospital and its ancillary service.

"Compounding medications, a skill that has been passed down through apprenticeships of the past and taught in modern pharmacy schools, has been the responsibility of pharmacists for as long as the profession has existed," asserted Michael L. Gallagher, M.S., R.Ph., assistant director of pharmacy and clinical coordinator at Union Hospital in Union, N.J.

Some pharmacists think that the USA Today article is not disclosing anything new; rather it highlights an old issue that is somewhat inherent to compounding. "Journalists are just starting to expose these problems to the public because, unfortunately, a sufficient number of patients were harmed in a unique enough way to warrant notice and a story," acknowledged Sasich.

In the incident involving Mary Washington Hospital, the cardioplegia solutions came from Central Admixture Pharmacy Services (CAPS), which is typically hired by hospitals to compound a variety of frequently used hospital-based products such as oxytocin and dialysis solutions. These products, which are difficult to prepare, are used in critical care settings.

In general, the FDA regulates large compounding facilities such as CAPS. But it's up to the state inspectors to enforce the agency's rules and oversee most of the smaller pharmacy compounders. In a letter to the editor responding to the USA Today article, ASHP stated that "the onus should not fall solely on the hospital." ASHP went on to say that "the fact that CAPS is an FDA-registered facility suggests that a reexamination of the regulatory framework (including rigor and frequency of inspections) of commercially large-scale operations that compound sterile products for hospitals is in order."

How pharmacists feel about the regulation-or lack thereof-of compounding is another matter. "This is basically a shadow industry with little regulatory oversight because many compounded drugs technically fall under unapproved drugs and the FDA simply doesn't have the manpower to be everywhere at once," noted Sasich.

When contacted for a response, CAPS declined to comment on the regulations over its compounding facility.

The need for hospitals to have either in-house or outsourced compounding services is as basic as their need to have chemotherapy, total parenteral nutrition, and other common IV mixtures that don't come premixed. And, quite legitimately, R.Ph.s have been compounding these much-needed IV solutions for some time. "Sterile compounding is not new to pharmacy, but it is a skill that requires better methods, better techniques, and much greater oversight in order to produce safe and effective products," noted Gallagher. And "if pharmacists are to perform sterile compounding, hospitals and pharmacies must not balk at spending the required money to supply the pharmacy with the needed equipment."

"If compounding pharmacies such as CAPS are offering a sterile compounding service, their standards must meet, if not exceed, USP chapter 797 standards set back in 2004," Gallagher concluded.

THE AUTHOR is a clinical writer and hospital pharmacist in New Jersey.