Hospital pharmacies across the US are well aware of the scrutiny with which regulatory and accreditation bodies examine pharmacy practices, but some may be surprised by the results of a recent DHHS Office of Inspector General (OIG) study titled, Medicare’s Oversight of Compounded Pharmaceuticals Used in Hospitals.* The study (report released this past January) reviewed the practices of five entities—CMS and the four organizations that accredit hospitals for participation in Medicare: The Joint Commission, The American Osteopathic Association, Det Norske Veritas Healthcare, and The Center for Improvement in Healthcare Quality.
In summary, the study found that while these oversight entities address most of the recommended compound sterile preparation (CSP)-related practices, at least some of the time, only one oversight entity always reviews hospital contracts with standalone compounding pharmacies. The report went on to indicate that oversight entities may lack the human capital required to thoroughly review a hospital’s preparation and use of CSPs; surveyors may receive only limited training specific to compounding, and most oversight entities do not routinely include pharmacists on hospital surveys. Regardless, most oversight entities are considering changes to how they oversee hospitals’ preparation and use of CSPs.
As a logical continuance of this report, hospital pharmacies can expect their oversight entities to bring an increased focus to reviewing contracts with standalone compounding pharmacies and assessing whether the hospital evaluates compliance with the contracts. According to the OIG report, such reviews could include whether the terms of the contracts address CSP recall procedures, proper storage of CSPs while in transit, and quality assurance related to CSP sterility and potency, among other aspects.
Given this notice, pharmacy directors should prepare for more detailed examinations of contract oversight, and PP&P feels this is a perfect time for readers to peruse and consider the results of our own annual survey of health system pharmacists—The State of Pharmacy Compounding. In addition to addressing numerous other challenges facing pharmacy compounding practices, be sure to review the detailed section on regulatory inspections. As the old saying goes, if you seek peace, prepare for war.
With best regards,
R. Mitchell Halvorsen
Reference*For the OIG report, visit https://oig.hhs.gov/oei/reports/oei-01-13-00400.pdf.