February 20, 2013
Survey Looks at Hospital Pharmacy Compounding Practices After Meningitis Outbreak
Horsham, PA—With the outbreak last year of fungal meningitis linked to contaminated steroid injections from a compounding pharmacy, compounding practices and policies are coming under more scrutiny.
The Institute for Safe Medication Practices (ISMP) recently surveyed 412 pharmacists and pharmacy technicians on how hospitals are responding to the challenge. The survey focused primarily on management of high-risk compounded sterile products (CSP), defined as those where nonsterile ingredients or a nonsterile device is involved in the preparation and terminal sterilization is required before use, not just a simple mixture of sterile ingredients.
One controversial issue addressed in the survey was disclosure to both prescribers and patients.
Some two-thirds of the respondents (67%) said that prescribers should be informed of the source of the high-risk CSPs, especially if prepared by an external compounding pharmacy (75%) instead of in-house at the hospital pharmacy (60%).
On the other hand, most (54%) of respondents did not think prescribers need to disclose the source of high-risk CSPs to patients, although they indicated that was more necessary when an external compounding pharmacy was involved (59%). Only 48% of respondents said that patient disclosure was necessary when the compound was prepared at the hospital pharmacy. Even fewer, 45%, said they thought that written, informed consent should be required before drug administration.
As for monitoring compliance with USP sterile compounding guidelines,
that should fall to the pharmacy (72%) and accrediting agencies (80%), according to survey respondents. In fact, 79% said the purchasing hospital pharmacy had the responsibility for making sure an external compounding pharmacy had the ability and safeguards in place to prepare high-risk CSPs for hospital use.
The survey also showed overwhelming support for requiring that technicians who work in sterile compounding be certified or licensed by state pharmacy boards after successful demonstration of proficiencies, with 81% of respondents agreeing.
Responses to the question of whether contamination had occurred at their facility varied by who was answering, however.
While overall 13% of respondents reported contamination of high-risk CSPs at their facility in the past year, technicians (29%) were far more likely to report contamination than pharmacists (11%). Differences also were seen in reporting based on pharmacy position: 16% of frontline staff, but only 11% of managers and 6% of directors reported contamination issues.
Asked if they were confident that contamination had not occurred with their facility’s CSPs, only 50% of staff pharmacists and 38% of pharmacy technicians said they were.
The survey was published in the January 24, 2013 issue of the ISMP Medication Safety Alert! newsletter.
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