The Institute for Safe Medication Practices surveyed hospital pharmacists and other practitioners about issues including who should be responsible for ensuring the safety of high-risk compounded sterile preparations.
A survey carried out by the Institute for Safe Medication Practices in November and December 2012 addressed a range of issues regarding the preparation, oversight, and use of high-risk compounded sterile preparations (CSPs). The survey
yielded responses from 412 hospital practitioners, primarily pharmacists but also including pharmacy technicians, nurses, and physicians. In the wake of the recent fungal meningitis outbreak caused by contaminated steroids, there is a great deal of concern over how to ensure compliance with sterility standards in pharmacies.
High-risk CSPs were defined as preparations in which non-sterile ingredients or devices play a role in preparation, necessitating sterilization before use. More than 1 in 10 respondents reported that contamination of CSPs had occurred in their facility in the last year, although there was some disparity in this regard between pharmacist respondents (11%) and pharmacy technicians (29%). Just 50% of pharmacists and 38% of technicians expressed confidence that contamination had not occurred in their facility in the last year. In addition, almost 74% of all respondents said that contamination could occur in their facility.
When high-risk CSPs were compounded in hospital pharmacies, 70% of respondents said that the pharmacy itself should be responsible for monitoring compliance with USP <797> sterility standards, 70% assigned responsibility to the accrediting agencies, 48% to prescribers, and 61% to the pharmacy and therapeutics (P&T) committee. When high-risk CSPs were compounded in external pharmacies, 74% assigned responsibility for monitoring compliance to accrediting agencies, 48% assigned responsibility to prescribers, and many noted that state boards of pharmacy should play a role as well.
Overall, 67% of respondents believed that pharmacists should disclose the source of high-risk CSPs to prescribers (75% if they were prepared by an external compounding pharmacy and 60% if they were prepared by the hospital pharmacy), while 23% did not see a need for disclosure, and 10% were undecided. Those in favor of disclosure most often argued it was important that prescribers understand the CSP was high-risk, especially in cases where they might not be aware of this. Those opposed to disclosure argued that the pharmacy is responsible for the safety of high-risk CSPs and that prescribers should be able to trust it.
Regarding disclosure of the source of high-risk CSPs to patients, 59% of respondents thought this was warranted when the medication was prepared by an external compounding pharmacy and 48% when it was prepared by the hospital pharmacy. Those in favor of disclosure to patients tended to cite the patient’s right to be informed of risks associated with their care, especially if a high-risk CSP has not been approved by the FDA. Those opposed to disclosure argued that patients would not be able to evaluate the safety of high-risk CSPs and balance their risks and benefits.
In addition, 81% of respondents said state boards of pharmacy should require technicians who perform sterile compounding to be certified or licensed after demonstrating proficiency in sterile compounding. Comments from many respondents expressed concern with pharmacist training in sterile compounding as well, noting that it is lacking in pharmacy schools.