LAS VEGAS—Medical professionals must be rigorous in evaluating the sources of the compounded medications that they prescribe for intrathecal delivery, said Joshua P. Prager, MD, MS, at the 16th Annual Meeting of the North American Neuromodulation Society. Ideally, prescribers should visit the facilities that compound the medications so that they can evaluate their operations. Dr. Prager, Director of the Center for Rehabilitation of Pain Syndromes at the University of California, Los Angeles, made his remarks in a lecture directed at physicians, surgeons, anesthesiologists, pain specialists, neurologists, and any physician who prescribes or uses compounded medications.
During a facility visit, a clinician should ask representatives of the compounding pharmacy for information about its background. For example, the prescriber should ask how many years of experience the facility or team has in sterile compounding, said Dr. Prager. In addition, the sterile compounding pharmacy should be asked whether it has been accredited by an acknowledged compounding association, such as the Pharmacy Compounding Accreditation Board.
A physician also should ask the compounding pharmacy about its policies and practices. Company representatives should explain, for example, whether the facility has an employee training and evaluation program in compliance with the United States Pharmacopeia (USP) and the relevant board of pharmacy.
Employees who produce sterile drugs must wear masks, hats, gloves, and gowns to protect the product from contamination. Medical professionals should ask the compounding pharmacy what its policies and procedures are for hand washing, gowning, and gloving, said Dr. Prager.
Prescribers also should ask whether the facility includes adequate space for compounding sterile medications. A compounding pharmacy typically has a wide, open room with high-pressure laminar airflow that pushes air and potential particulates out. “It’s a sealed room, and if there’s any leaking, it’s going out, not coming in,” said Dr. Prager.
Contained sterile preparation areas should be dedicated strictly to that task and separated from the rest of the facility. Clinicians should ask company representatives to describe the site’s policies and procedures for sterile compounding of medication, said Dr. Prager.
To ensure that the compounding pharmacy follows USP guidelines for sterile preparation, physicians should ask about the air quality classification of the site’s hoods and laminar airflow workbenches. A representative should explain what the classifications mean and state how often the sterile preparation room is recertified.
The compounding pharmacy also should describe how it performs environmental monitoring, said Dr. Prager. Prescribers should ask whether the facility tests for air microbial bioburden and how often it tests for particulates in the air. The frequency at which the site performs surface and fingertip microbial testing, and the equipment vendor that the site uses for this testing, also should be discussed.
Medical professionals also should learn about the facility’s disinfection program, including the frequency of and procedure for disinfecting the sterile environment. The facility should explain how it performs end product testing, “which is really the final common pathway for problems,” said Dr. Prager. If the site performs sterility tests, the clinician should ask whether it conducts quantitative analysis. Representatives should describe the facility’s procedures for endotoxin testing and fungal testing, as well as the equipment used for these tests.
Physicians should request at least five references from the facility—primarily clinicians who purchase its drugs, said Dr. Prager. Physicians can and should call the references and ask about their experiences with the compounding pharmacy.
Intrathecal pumps that deliver compounded medications have a 7% failure rate over a five-year period, while pumps that deliver branded drugs have a 3% failure rate over the same timeframe, said Dr. Prager, citing the Implantable Systems Performance Registry. Although concern about how compounded medications affect intrathecal pumps is valid, the difference between the two failure rates is complicated, and further analysis is necessary before definitive inferences can be made, he said. “There’s a low event rate, with complex data, and it makes it extremely difficult to analyze.”
In the future, prescribers must learn whether compounded medications play a role in fouling intrathecal pumps, said Dr. Prager. If compounded drugs do foul pumps, clinicians should learn which drugs have this effect and at what concentrations. “Apparently, Demerol has had a history of fouling pumps, but there may be others,” said Dr. Prager. “We have to better understand this going forward.”
—Erik Greb