From the January 24, 2013
ISMP would like to thank the 412 practitioners, mostly pharmacists, who responded to our survey on sterile compounding in November and December 2012. We conducted the survey to learn more about how hospitals are managing the preparation and/or purchase of high-risk compounded sterile preparations (CSPs). For the purpose of the survey, we defined high-risk CSPs as preparations where non-sterile ingredients or non-sterile devices are involved in the preparation, which requires terminal sterilization before use (not simple mixtures of sterile ingredients).
BackgroundIn response to the national outbreak of fungal meningitis from contaminated steroid injections dispensed from a compounding pharmacy, all eyes have been focused on ways to more effectively monitor compliance with USP Chapter <797> sterility standards in these pharmacies. The deadly outbreak also served as a wake-up call to all healthcare providers who compound sterile medications in any setting to examine their own compounding procedures and to assess the training provided to those who prepare CSPs. With our survey, we were interested in learning practitioners’ viewpoints on disclosing the source (supplier) of high-risk CSPs; responsibility for investigating, approving, and monitoring the safety, accuracy, and quality of high-risk CSPs; training of technicians who prepare high-risk CSPs; and awareness of contaminated CSPs within hospitals during the past year.Survey ResultsDisclosure to prescribers. Overall, about a quarter (23%) of respondents do not believe pharmacists need to disclose to prescribers thesource of high-risk CSPs. Another 10% were undecided, leaving two-thirds (67%) who believe disclosure to prescribers is warranted—more so when the high-risk CSP has been prepared by an external compounding pharmacy (75%) rather than the hospital pharmacy (60%). Those who thought disclosure to the prescriber was necessary cited numerous reasons, most often to ensure that the prescriber understood that the preparations were “high-risk,” drawing similarities to the caution when prescribing a known “high-alert” medication. In the face of a drug shortage or product unavailability, numerous respondents told us that prescribers are not always aware that the products prescribed require sterile compounding from non-sterile ingredients and may consider other options if they were aware of the risks. Comments from respondents who did not believe disclosure to prescribers was necessary predominantly suggest that the pharmacy is responsible for the dispensed high-risk CSP, and the prescriber should be able to trust the pharmacy and have confidence in the preparation. Some felt that required disclosure was akin to pharmacy “passing the buck” of responsibility on to the prescriber. Many said that a pharmacy and therapeutics (P&T) committee should be aware of the use of high-risk CSPs and approve them, but specific disclosure to individual prescribers was not warranted. Some also noted that, except in lifesaving circumstances, high-risk CSPs should not be used at all. If their use is required, several respondents said that disclosing the source of the high-risk CSP was not as important as disclosing that the preparation is a high-risk CSP.
Disclosure to patients. Overall, about half (54%) of respondents do not think prescribers need to disclose to patients the source of high-risk CSPs. Again, a fair number (16%) of respondents were undecided on the issue. More respondents felt that disclosure to patients was warranted when high-risk CSPs were prepared by an external compounding pharmacy (59%) than by the hospital pharmacy (48%). However, less than half (45%) of these respondents felt that written informed consent was required before drug administration. Most cited that documentation of the discussion in the patient’s record would suffice.In general, those who thought disclosure to prescribers was necessary were also more likely to believe that disclosure to patients was also required. Common reasons cited by this group included a patient’s right to be informed about the risks associated with their care, particularly the fact that a high-risk CSP is not approved by FDA. They felt the patient should have an opportunity to decline the treatment based on informed risk. Some respondents felt the reason the drug had to be compounded should also be disclosed, and others qualified their answer by saying that disclosure to the patient should only happen when an outside compounding pharmacy was used, and only if the prescriber has enough information to answer questions. Respondents who do not believe disclosure to patients is necessary generally felt that patients would not have the knowledge to assess the safety of high-risk CSPs from either source, and would not have an objective way to decide whether to refuse or accept treatment. Some respondents suggested that the disclosure should be just one part of an overall informed consent for procedures or treatments where the high-risk CSP would be used.
Responsibility to investigate, approve, and monitor. When respondents were asked which practitioners were responsible for investigating, approving, and/or monitoring the safety, accuracy, and quality of high-risk CSPs, their responses made it clear that oversight of sterile compounding, both within hospitals and in compounding pharmacies, is viewed as a multi-faceted endeavor (see Table 1 in the PDF version of the newsletter). For sterile compounding in hospital pharmacies, most respondents (76%) said that the pharmacy itself has primary responsibility toinvestigate the feasibility of preparing high-risk CSPs safely. They also ranked prescribers as having the least responsibility, yet 30% still felt prescribers played an important role in the investigation of compounding practices within the hospital pharmacy. More than half (57%) of the respondents also assigned responsibility to accrediting agencies for investigating the hospital pharmacy’s capability to follow USP <797> when preparing high-risk CSPs. Most respondents felt the pharmacy (70%) and P&T committee (78%) had primary responsibility for approving the preparation and use of high-risk CSPs. Only half of respondents (51%) thought prescribers had responsibility for approving the use of high-risk CSPs prepared by the hospital pharmacy. Numerous respondents commented that prescriber approval of high-risk CSPs represents a conflict of interest given that the prescriber typically requests their use. Most respondents felt that the pharmacy (72%) and accrediting agencies (70%) were responsible for monitoring internal pharmacy compliance with USP <797> when compounding high-risk CSPs. About half or more respondents felt prescribers (48%) and the P&T committee (61%) also shared this responsibility for monitoring sterility standards in the hospital pharmacy. For sterile compounding in external compounding pharmacies, respondents said responsibility for investigating the external pharmacy’s ability to prepare high-risk CSPs for the hospital still falls on the purchasing hospital pharmacy (79%), although respondents thought that accrediting agencies (66%) and the P&T committee (43%) should also bear some responsibility for investigation of external compounding pharmacy’s capabilities. Overall, responsibility for approval of using high-risk CSPs prepared by external compounding pharmacies also remained high in the purchasing pharmacy and with the P&T committee, according to 72% and 80% of respondents, respectively. Most respondents (74%) told us that accrediting agencies should be responsible for monitoring compliance to USP <797> in external compounding pharmacies, and numerous additional respondents commented that the state boards of pharmacy, which they did not consider an “accrediting agency,” are the appropriate agency for monitoring compounding pharmacies. Prescribers, particularly those in private practices where high-risk CSPs are in use, share responsibility for monitoring external compounding pharmacies, according to about half (48%) of the respondents.
Technician training. Eighty-one percent of respondents believe the state boards of pharmacy should require technicians who perform sterile compounding to be certified or licensed after successful demonstration of proficiencies in sterile compounding. Another 8% are undecided on the issue. No significant differences were seen when comparing responses from technicians with responses from pharmacists. It is worth noting that respondents’ comments often revealed concern not only with technician training but with pharmacist training in sterile compounding, which numerous respondents agreed is also lacking in the academic setting.
Contamination of CSPs. Overall, about 13% of respondents reported that contamination of CSPs had happened in their facility during the past year. However, significant differences were noted between the percent of pharmacists—11%—and the percent of pharmacy technicians—29%—who reported actual contamination of a CSP. Differences were also apparent among the percent of frontline staff (16%), managers (11%), and directors (6%) who reported contamination of a CSP in the past year. Only half (50%) of all staff pharmacists and 38% of pharmacy technicians were confident that contamination had not occurred. Close to three-quarters (74%) of all respondents agreed that contamination could happen in their facility, and a majority of those who did not agree pointed out that high-risk CSPs were not prepared in their hospital pharmacies.
Conclusion. Although the response rate to this survey was not as high as with other surveys conducted by ISMP, the 412 pharmacists, pharmacy technicians, nurses, physicians, and others who did respond made it abundantly clear that sterile compounding of high-risk preparations is an exceptionally complex issue riddled with deep frustration regarding the conditions that require or promote the practice, nagging doubts about both internal and external pharmacy staff training, concerns regarding sterility and quality of CSPs, uncertainty regarding a solution to the problem, and empathy for the victims of contaminated CSPs. Opinions on these difficult issues were both strong and diverse in many aspects. Whether for or against a particular practice associated with sterile compounding, differing groups of respondents provided short but compelling arguments, or expressed frustration regarding the lack of a clear-cut solution or the opposite—an obvious pathway that seems clear to some but not to all. The high number of “undecided” responses is a tell-tale sign of the struggle we are up against in dealing with this issue. While we have been unable to cover each and every respondent’s perspective in this overview of the survey results, we want to assure all respondents that we have read every comment and intend to use what we have learned to promote safe compounding practices both within hospitals and in compounding pharmacies across the US.
BackgroundIn response to the national outbreak of fungal meningitis from contaminated steroid injections dispensed from a compounding pharmacy, all eyes have been focused on ways to more effectively monitor compliance with USP Chapter <797> sterility standards in these pharmacies. The deadly outbreak also served as a wake-up call to all healthcare providers who compound sterile medications in any setting to examine their own compounding procedures and to assess the training provided to those who prepare CSPs. With our survey, we were interested in learning practitioners’ viewpoints on disclosing the source (supplier) of high-risk CSPs; responsibility for investigating, approving, and monitoring the safety, accuracy, and quality of high-risk CSPs; training of technicians who prepare high-risk CSPs; and awareness of contaminated CSPs within hospitals during the past year.Survey ResultsDisclosure to prescribers. Overall, about a quarter (23%) of respondents do not believe pharmacists need to disclose to prescribers thesource of high-risk CSPs. Another 10% were undecided, leaving two-thirds (67%) who believe disclosure to prescribers is warranted—more so when the high-risk CSP has been prepared by an external compounding pharmacy (75%) rather than the hospital pharmacy (60%). Those who thought disclosure to the prescriber was necessary cited numerous reasons, most often to ensure that the prescriber understood that the preparations were “high-risk,” drawing similarities to the caution when prescribing a known “high-alert” medication. In the face of a drug shortage or product unavailability, numerous respondents told us that prescribers are not always aware that the products prescribed require sterile compounding from non-sterile ingredients and may consider other options if they were aware of the risks. Comments from respondents who did not believe disclosure to prescribers was necessary predominantly suggest that the pharmacy is responsible for the dispensed high-risk CSP, and the prescriber should be able to trust the pharmacy and have confidence in the preparation. Some felt that required disclosure was akin to pharmacy “passing the buck” of responsibility on to the prescriber. Many said that a pharmacy and therapeutics (P&T) committee should be aware of the use of high-risk CSPs and approve them, but specific disclosure to individual prescribers was not warranted. Some also noted that, except in lifesaving circumstances, high-risk CSPs should not be used at all. If their use is required, several respondents said that disclosing the source of the high-risk CSP was not as important as disclosing that the preparation is a high-risk CSP.
Disclosure to patients. Overall, about half (54%) of respondents do not think prescribers need to disclose to patients the source of high-risk CSPs. Again, a fair number (16%) of respondents were undecided on the issue. More respondents felt that disclosure to patients was warranted when high-risk CSPs were prepared by an external compounding pharmacy (59%) than by the hospital pharmacy (48%). However, less than half (45%) of these respondents felt that written informed consent was required before drug administration. Most cited that documentation of the discussion in the patient’s record would suffice.In general, those who thought disclosure to prescribers was necessary were also more likely to believe that disclosure to patients was also required. Common reasons cited by this group included a patient’s right to be informed about the risks associated with their care, particularly the fact that a high-risk CSP is not approved by FDA. They felt the patient should have an opportunity to decline the treatment based on informed risk. Some respondents felt the reason the drug had to be compounded should also be disclosed, and others qualified their answer by saying that disclosure to the patient should only happen when an outside compounding pharmacy was used, and only if the prescriber has enough information to answer questions. Respondents who do not believe disclosure to patients is necessary generally felt that patients would not have the knowledge to assess the safety of high-risk CSPs from either source, and would not have an objective way to decide whether to refuse or accept treatment. Some respondents suggested that the disclosure should be just one part of an overall informed consent for procedures or treatments where the high-risk CSP would be used.
Responsibility to investigate, approve, and monitor. When respondents were asked which practitioners were responsible for investigating, approving, and/or monitoring the safety, accuracy, and quality of high-risk CSPs, their responses made it clear that oversight of sterile compounding, both within hospitals and in compounding pharmacies, is viewed as a multi-faceted endeavor (see Table 1 in the PDF version of the newsletter). For sterile compounding in hospital pharmacies, most respondents (76%) said that the pharmacy itself has primary responsibility toinvestigate the feasibility of preparing high-risk CSPs safely. They also ranked prescribers as having the least responsibility, yet 30% still felt prescribers played an important role in the investigation of compounding practices within the hospital pharmacy. More than half (57%) of the respondents also assigned responsibility to accrediting agencies for investigating the hospital pharmacy’s capability to follow USP <797> when preparing high-risk CSPs. Most respondents felt the pharmacy (70%) and P&T committee (78%) had primary responsibility for approving the preparation and use of high-risk CSPs. Only half of respondents (51%) thought prescribers had responsibility for approving the use of high-risk CSPs prepared by the hospital pharmacy. Numerous respondents commented that prescriber approval of high-risk CSPs represents a conflict of interest given that the prescriber typically requests their use. Most respondents felt that the pharmacy (72%) and accrediting agencies (70%) were responsible for monitoring internal pharmacy compliance with USP <797> when compounding high-risk CSPs. About half or more respondents felt prescribers (48%) and the P&T committee (61%) also shared this responsibility for monitoring sterility standards in the hospital pharmacy. For sterile compounding in external compounding pharmacies, respondents said responsibility for investigating the external pharmacy’s ability to prepare high-risk CSPs for the hospital still falls on the purchasing hospital pharmacy (79%), although respondents thought that accrediting agencies (66%) and the P&T committee (43%) should also bear some responsibility for investigation of external compounding pharmacy’s capabilities. Overall, responsibility for approval of using high-risk CSPs prepared by external compounding pharmacies also remained high in the purchasing pharmacy and with the P&T committee, according to 72% and 80% of respondents, respectively. Most respondents (74%) told us that accrediting agencies should be responsible for monitoring compliance to USP <797> in external compounding pharmacies, and numerous additional respondents commented that the state boards of pharmacy, which they did not consider an “accrediting agency,” are the appropriate agency for monitoring compounding pharmacies. Prescribers, particularly those in private practices where high-risk CSPs are in use, share responsibility for monitoring external compounding pharmacies, according to about half (48%) of the respondents.
Technician training. Eighty-one percent of respondents believe the state boards of pharmacy should require technicians who perform sterile compounding to be certified or licensed after successful demonstration of proficiencies in sterile compounding. Another 8% are undecided on the issue. No significant differences were seen when comparing responses from technicians with responses from pharmacists. It is worth noting that respondents’ comments often revealed concern not only with technician training but with pharmacist training in sterile compounding, which numerous respondents agreed is also lacking in the academic setting.
Contamination of CSPs. Overall, about 13% of respondents reported that contamination of CSPs had happened in their facility during the past year. However, significant differences were noted between the percent of pharmacists—11%—and the percent of pharmacy technicians—29%—who reported actual contamination of a CSP. Differences were also apparent among the percent of frontline staff (16%), managers (11%), and directors (6%) who reported contamination of a CSP in the past year. Only half (50%) of all staff pharmacists and 38% of pharmacy technicians were confident that contamination had not occurred. Close to three-quarters (74%) of all respondents agreed that contamination could happen in their facility, and a majority of those who did not agree pointed out that high-risk CSPs were not prepared in their hospital pharmacies.
Conclusion. Although the response rate to this survey was not as high as with other surveys conducted by ISMP, the 412 pharmacists, pharmacy technicians, nurses, physicians, and others who did respond made it abundantly clear that sterile compounding of high-risk preparations is an exceptionally complex issue riddled with deep frustration regarding the conditions that require or promote the practice, nagging doubts about both internal and external pharmacy staff training, concerns regarding sterility and quality of CSPs, uncertainty regarding a solution to the problem, and empathy for the victims of contaminated CSPs. Opinions on these difficult issues were both strong and diverse in many aspects. Whether for or against a particular practice associated with sterile compounding, differing groups of respondents provided short but compelling arguments, or expressed frustration regarding the lack of a clear-cut solution or the opposite—an obvious pathway that seems clear to some but not to all. The high number of “undecided” responses is a tell-tale sign of the struggle we are up against in dealing with this issue. While we have been unable to cover each and every respondent’s perspective in this overview of the survey results, we want to assure all respondents that we have read every comment and intend to use what we have learned to promote safe compounding practices both within hospitals and in compounding pharmacies across the US.
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1 comment:
Thank you for giving us insights and inspirations. This article is really helpful and informative. We would like to see more updates from you in the future.
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