ASHP Guidelines on Compounding Sterile Preparations

Kienle, Patricia C.; McElhiney, Linda F; Kastango, Eric S; Murdaugh, Lee B; Mccollum, Daryl; Power, Luci A.

doi:10.2146/sp140001

Cited by 78 publications

(29 citation statements)

References 26 publications

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“…Most notably, the pharmacy clean room contained a sink that was located close to both hoods and next to a countertop where recently prepared infusion products were placed; the presence of a sink in the clean room is contrary to published guidelines. 12,13 …”

Section: Resultsmentioning

confidence: 99%

“…Clinic A staff were advised to refrain from placing any infusion products in or adjacent to sinks and to ensure strict adherence to national standards for safe compounding. 12,13 This included reinforcing proper hand hygiene and medication preparation practices as well as implementing appropriate environmental controls in the pharmacy, including the removal of the clean room sink and the avoidance of any source of water near the hoods. Clinic A immediately moved chemotherapy preparation off-site and improved the building water system (cutting and capping many dead-end areas of piping back to the main line, increasing water system pressure, and regularly testing residual chlorine levels to ensure adequacy).…”

Section: Resultsmentioning

confidence: 99%

“…These findings underscore the continued need to increase awareness of existing guidelines for the safe preparation and handling of injectable medications and to expand infection control oversight across all outpatient settings. 12,13,35 In 2015, the CDC released a policy guide to assist health departments and policymakers to identify gaps in oversight of outpatient settings in their jurisdictions and pursue potential solutions. 36 The CDC is also working with state and federal partners to expand the uptake of infection prevention guidance materials in outpatient settings.…”

Section: Discussionmentioning

confidence: 99%

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Outbreak ofPantoea agglomeransBloodstream Infections at an Oncology Clinic—Illinois, 2012-2013

Yablon

Dantes

Tsai

et al. 2016

Infect. Control Hosp. Epidemiol.

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OBJECTIVE To determine the source of a healthcare-associated outbreak of Pantoea agglomerans bloodstream infections. DESIGN Epidemiologic investigation of the outbreak. SETTING Oncology clinic (clinic A). METHODS Cases were defined as Pantoea isolation from blood or catheter tip cultures of clinic A patients during July 2012-May 2013. Clinic A medical charts and laboratory records were reviewed; infection prevention practices and the facility's water system were evaluated. Environmental samples were collected for culture. Clinical and environmental P. agglomerans isolates were compared using pulsed-field gel electrophoresis. RESULTS Twelve cases were identified; median (range) age was 65 (41-78) years. All patients had malignant tumors and had received infusions at clinic A. Deficiencies in parenteral medication preparation and handling were identified (eg, placing infusates near sinks with potential for splash-back contamination). Facility inspection revealed substantial dead-end water piping and inadequate chlorine residual in tap water from multiple sinks, including the pharmacy clean room sink. P. agglomerans was isolated from composite surface swabs of 7 sinks and an ice machine; the pharmacy clean room sink isolate was indistinguishable by pulsed-field gel electrophoresis from 7 of 9 available patient isolates. CONCLUSIONS Exposure of locally prepared infusates to a contaminated pharmacy sink caused the outbreak. Improvements in parenteral medication preparation, including moving chemotherapy preparation offsite, along with terminal sink cleaning and water system remediation ended the outbreak. Greater awareness of recommended medication preparation and handling practices as well as further efforts to better define the contribution of contaminated sinks and plumbing deficiencies to healthcare-associated infections are needed. Infect Control Hosp Epidemiol 2017;38:314-319.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Outbreak ofPantoea agglomeransBloodstream Infections at an Oncology Clinic—Illinois, 2012-2013

Yablon

Dantes

Tsai

et al. 2016

Infect. Control Hosp. Epidemiol.

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“…Since 1991, more than 1000 Chinese CIVAS centres have been established, according to USP Chapter 797, which have dramatically reduced patient morbidity and mortality from contaminated or incorrectly mixed intravenous infusions. [1][2][3] However, large numbers of intravenous fluids are compounded in Chinese CIVAS centres, partly due to the large population, which makes it different from CIVAS in other countries. As a result, Chinese CIVAS has developed into an emerging pharmaceutical industry and a sub-discipline in hospital pharmacy science.…”

Section: Introductionmentioning

confidence: 99%

Chinese centralised intravenous admixture service (CIVAS), an emerging pharmaceutical industry: survey of the recent advances of CIVAS in China

Zhang

et al. 2017

Eur J Hosp Pharm

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PurposeTo present the results of a survey involving 97 centralised intravenous admixture service (CIVAS) centres in China to review the recent advances of Chinese CIVAS.Methods103 CIVAS centres in first- or second-class Chinese hospital settings were surveyed by email questionnaire.ResultsNinety-seven centres responded(response rate 94%). With regard to scale and output issues, large CIVAS centres with a daily output of more than 10 000 bags accounted for 10% while the per workbench and per square metre output varied dramatically among different centres. For personnel structure, 80% of CIVAS centres chose the combination model of pharmacy and nursing. For the CIVAS operation model, more than 80% of centres adopted the drug centralised compounding model.ConclusionCIVAS centres are playing an important role in Chinese hospital pharmacy and have developed into an emerging pharmaceutical industry. The development of Chinese CIVAS centres is very variable. With regard to the personnel structure, the pharmacy–nursing combination model is recommended, while the operation model should be selected according to specific hospitals. Universal guidelines for CIVAS operation and personnel training are urgently needed.

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“…theatre nurse or pharmacy technician) in a clean environment (i.e. using a laminar hood or a glove box isolator) to ensure quality, sterility, and safety of the preparation [ 12 ]. Non-adherence to protocol [ 10 ] or inadequate mixing [ 13 ] of cefuroxime in the syringe, which are likely with the unlicensed preparation, can result in dilution errors and contamination of purchased or prepared PFS.…”

Section: Introductionmentioning

confidence: 99%

Budget impact assessment of Aprokam® compared with unlicensed cefuroxime for prophylaxis of post-cataract surgery endophthalmitis

et al. 2015

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BackgroundIntracameral cefuroxime is recommended as prophylaxis against postoperative endophthalmitis (POE) following cataract surgery. Aprokam is the only licensed product for prophylaxis of POE, although unlicensed intracameral cefuroxime may be administered using pre-filled syringes (PFS), either prepared in hospital by reconstituting cefuroxime via serial dilution (prepared PFS), or commercially purchased (purchased PFS). This study aimed to estimate the potential budget impact of using Aprokam over unlicensed cefuroxime for intracameral administration.MethodsA budget impact model (BIM) was developed from UK NHS hospital perspective to estimate the economic impact of adopting Aprokam compared with purchased PFS or prepared PFS for the prophylaxis of POE following cataract surgery over a 5-year time horizon. The BIM incorporated direct costs only, associated with the acquisition, delivery, storage, preparation, and administration of cefuroxime. Resource utilisation costs were also incorporated; resource utilisation was sourced from a panel survey of hospital pharmacists, surgeons, and theatre nurses who are involved in the delivery, storage, preparation, quality assurance, or administration of cefuroxime formulations. Unit costs were sourced from NHS sources; drug acquisition costs were sourced from BNF. The model base case used a hypothetical cohort comprising of 1000 surgeries in the first year and followed a 5.2 % annual increase each year.ResultsThe model predicts Aprokam is cost saving compared with purchased PFS, with a modest increase compared prepared PFS over 5 years. There are total savings of £3490 with Aprokam compared with purchased PFS, driven by savings in staff costs that offset greater drug acquisition costs. Compared with prepared PFS, there are greater drug acquisition costs which drive an increased total cost over 5 years of £13,177 with Aprokam, although there are substantial savings in staff costs as well as consumables and equipment costs.ConclusionsThe lower direct costs of using Aprokam compared with purchased PFS presents a strong argument for the adoption of Aprokam where purchased PFS is administered. The additional benefits of Aprokam include increased liability coverage and possible reduction in dilution errors and contaminations; as such, in hospitals where unlicensed prepared PFS is used, modest additional resources should be allocated to adoption of Aprokam.

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ASHP Guidelines on Compounding Sterile Preparations

Cited by 78 publications

References 26 publications

Outbreak ofPantoea agglomeransBloodstream Infections at an Oncology Clinic—Illinois, 2012-2013

Outbreak ofPantoea agglomeransBloodstream Infections at an Oncology Clinic—Illinois, 2012-2013

Chinese centralised intravenous admixture service (CIVAS), an emerging pharmaceutical industry: survey of the recent advances of CIVAS in China

Budget impact assessment of Aprokam® compared with unlicensed cefuroxime for prophylaxis of post-cataract surgery endophthalmitis

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