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Thomas H. Connor - One of the best experts on this subject based on the ideXlab platform.
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survey of guidelines and current practices for safe handling of antineoplastic and other Hazardous Drugs used in 24 countries
Journal of Oncology Pharmacy Practice, 2019Co-Authors: Patricia I Mathias, Barbara A Mackenzie, Christine A Toennis, Thomas H. ConnorAbstract:PurposeA survey of guidelines and current practices was conducted to examine the safe handling procedures for antineoplastic and other Hazardous Drugs that are used in 24 countries including the Am...
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new approaches to wipe sampling methods for antineoplastic and other Hazardous Drugs in healthcare settings
Pharmaceutical Technology in Hospital Pharmacy, 2016Co-Authors: Thomas H. Connor, Jerome P SmithAbstract:Purpose At the present time, the method of choice to determine surface contamination of the workplace with antineoplastic and other Hazardous Drugs is surface wipe sampling and subsequent sample analysis with a variety of analytical techniques. The purpose of this article is to review current methodology for determining the level of surface contamination with Hazardous Drugs in healthcare settings and to discuss recent advances in this area. In addition it will provide some guidance for conducting surface wipe sampling and sample analysis for these Drugs in healthcare settings. Methods Published studies on the use of wipe sampling to measure Hazardous Drugs on surfaces in healthcare settings Drugs were reviewed. These studies include the use of well-documented chromatographic techniques for sample analysis in addition to newly evolving technology that provides rapid analysis of specific antineoplastic. Results Methodology for the analysis of surface wipe samples for Hazardous Drugs are reviewed, including the purposes, technical factors, sampling strategy, materials required, and limitations. The use of lateral flow immunoassay (LFIA) and fluorescence covalent microbead immunosorbent assay (FCMIA) for surface wipe sample evaluation is also discussed. Conclusions Current recommendations are that all healthcare settings where antineoplastic and other Hazardous Drugs are handled include surface wipe sampling as part of a comprehensive Hazardous drug-safe handling program. Surface wipe sampling may be used as a method to characterize potential occupational dermal exposure risk and to evaluate the effectiveness of implemented controls and the overall safety program. New technology, although currently limited in scope, may make wipe sampling for Hazardous Drugs more routine, less costly, and provide a shorter response time than classical analytical techniques now in use.
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surface wipe sampling for antineoplastic chemotherapy and other Hazardous drug residue in healthcare settings methodology and recommendations
Journal of Occupational and Environmental Hygiene, 2016Co-Authors: Thomas H. Connor, Matthew D Zock, Amy H SnowAbstract:ABSTRACTSurface wipe sampling for various Hazardous agents has been employed in many occupational settings over the years for various reasons such as evaluation of potential dermal exposure and health risk, source determination, quality or cleanliness, compliance, and others. Wipe sampling for surface residue of antineoplastic and other Hazardous Drugs in healthcare settings is currently the method of choice to determine surface contamination of the workplace with these Drugs. The purpose of this article is to review published studies of wipe sampling for antineoplastic and other Hazardous Drugs, to summarize the methods in use by various organizations and researchers, and to provide some basic guidance for conducting surface wipe sampling for these Drugs in healthcare settings. Recommendations on wipe sampling methodology from several government agencies and organizations were reviewed. Published reports on wipe sampling for Hazardous Drugs in numerous studies were also examined. The critical elements of...
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clarification about Hazardous Drugs
American Journal of Health-system Pharmacy, 2012Co-Authors: Thomas H. Connor, Barbara A Mackenzie, Gayle D DebordAbstract:We read with interest the article by Traynor[1][1] that appeared in the September 1 issue of AJHP and would like to clarify a potential misconception—that the National Institute for Occupational Safety and Health (NIOSH) recommends all Hazardous Drugs be handled in the same manner, regardless of
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exposure to Hazardous Drugs in healthcare an issue that will not go away
Journal of Oncology Pharmacy Practice, 2011Co-Authors: Jill Davis, Robert Mclauchlan, Thomas H. ConnorAbstract:The Journal of Oncology Pharmacy Practice (JOPP) was first published in June 1995 as the official journal of the International Society of Oncology Pharmacy Practitioners (ISOPP). In a supplement to that issue, as part of a review of the ISOPP IV symposium presentations, an article by Professor Graham Sewell was included titled ‘Pharmaceutical issues: preparation and handling’. This article raised concerns about various aspects of quality and safety associated with cytotoxic drug reconstitution. It discussed the use of cytotoxic safety cabinets versus isolators, the use of early ‘closed systems’ and even the possible future use of robotics. In the 15 years since that first publication, interest in the handling of Hazardous Drugs used to treat cancer patients has not waned. At the recent ISOPP XII symposium held in Prague in May 2010, ten presentations and seven submitted abstracts on the topic of safe handling were included. From the highly technical use of robotics and the use of specialized closed systems to the basic use of personal protective equipment (PPE) in under-resourced countries, this subject remains highly topical. One reason for the interest in this topic is the inability to quantify the occupational risk of handling anticancer Drugs. It is well recognized that patients treated with therapeutic doses of these Drugs may develop second cancers years later. However, the risk associated with long-term very low level exposure to these agents is not currently measurable. A basic tenet of employment is the provision of a safe workplace. It may be impossible to remove all risk but it is imperative that risk is minimized. Large pharmaceutical companies manufacturing anti-cancer Drugs do so in totally enclosed environments with workers wearing full respirator suits reminiscent of movies of outbreaks of a deadly virus. But it is financially completely beyond individual hospitals, institutions and clinics to supply such protective equipment. The smaller the preparation facility, the less viable it is to introduce expensive protective measures. Many pharmaceutical companies have improved the presentation of their anti-cancer drug products in several ways. The Drugs are generally presented, when stability allows, in liquid form – this means less manipulation is required to prepare a dose. The Drugs are generally packaged in plastic containers – this means less chance of vial breakage. When compatibility problems arise and do not permit plastic packaging, and glass containers are required, these are generally protected in some way to avoid breakage and leakage e.g., an ‘overcoat’ of plastic is placed over the vial. These improvements in packaging are applauded. However, it is known that external chemical contamination of drug vials arriving from the manufacturer is a problem. Manufacturers must accept responsibility for ensuring that only clean product leaves their facilities. It is discouraging when every safeguard is taken to protect staff preparing anti-cancer Drugs, to find that a major source of contamination is the outside of the drug vials themselves. Before we place all the responsibility onto the manufacturers, we must first ensure that we are doing everything possible ourselves to reduce the contamination of the environment and ourselves and we still have quite a long way to go. The paper by Shin-ichi Sugiura et al. ‘Risks to health professionals from Hazardous Drugs in Japan: a pilot study of environmental and biological monitoring of occupational exposure to cyclophosphamide’ in this issue of The Journal describes a pilot study performed in 2006 looking at cytotoxic drug environmental contamination in two similar hospital departments.
Stephen F. Eckel - One of the best experts on this subject based on the ideXlab platform.
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application of the 2015 proposed niosh vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of Hazardous Drugs
Journal of Oncology Pharmacy Practice, 2019Co-Authors: Charlotte M Forshay, Stephanie A Salch, Shawn O Streeter, Stephen F. EckelAbstract:PurposeThe National Institute for Occupational Safety and Health (NIOSH) released a proposed protocol in 2015 to evaluate the vapor containment abilities of closed system transfer device technologies in order to provide meaningful comparisons between products. This study assessed the vapor containment ability of closed system transfer devices when following the methodology as outlined by the 2015 NIOSH proposed protocol.MethodsThis study evaluated six closed system transfer device brands following the draft NIOSH vapor containment protocol. The testing evaluated each closed system transfer device brand during both compounding (Task 1) and administration (Task 2). Five pre-specified steps for each task were repeated for a total of four manipulations per device. The Thermo Scientific™ MIRAN SapphIRe XL Infrared Analyzer was used to detect isopropyl alcohol vapor levels after each step.ResultsFor Task 1, two closed system transfer device products (PhaSeal™ and Equashield®) adequately contained the isopropyl ...
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patterns and characteristics associated with surface contamination of Hazardous Drugs in hospital pharmacies
American Journal of Health-system Pharmacy, 2019Co-Authors: Stephanie A Salch, William C. Zamboni, Beth A Zamboni, Stephen F. EckelAbstract:PURPOSE The surface contamination levels of 5 commonly used Hazardous Drugs in hospital pharmacies are summarized, identifying practice patterns associated with contamination. METHODS Contamination testing data were compiled to evaluate surface contaminants of 5 Hazardous Drugs (docetaxel, paclitaxel, cyclophosphamide, ifosfamide, and 5-fluorourcil). Data from 5,842 wipes over 6 years were collected from 338 hospital pharmacies. The contamination level for each drug was categorized as nondetectable (ND; ≤10 ng/ft2), low (between 10 and ≤100 ng/ft2), medium (between 100 and ≤1,000 ng/ft2) or high (>1,000 ng/ft2). Surface exposures for each drug were summarized based on location, contamination at first and subsequent wipe events, and the use of a closed system transfer device (CSTD). RESULTS The majority of contamination results corresponded to locations at or near Hazardous drug preparation, but also occurred in areas where Hazardous Drugs were not prepared. There was a higher incidence of contamination levels (high, medium, and low, respectively) at first wipe event (10.2%, 17.4%, and 17.7%) compared to subsequent wipe events (5.8%, 12.2%, and 13.6%) (p < 0.0001). There was a lower incidence of contamination levels at institutions that used CSTDs (6.3%, 12.8%, and 14.4%) compared to institutions that did not use CSTDs (14.2%, 17.9%, and 17.3%) (p < 0.0001). CONCLUSIONS The majority of highest contamination levels corresponded to locations where Hazardous Drugs were prepared. While the rate of contamination was lower at subsequent wipe events and at institutions that used CSTDs, contamination was not completely eliminated in either scenario.
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Development and evaluation of a novel product to remove surface contamination of Hazardous Drugs
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2016Co-Authors: Joshua Cox, Vonni Speed, Sara O’neal, Terry Hasselwander, Candice A. Sherwood, Stephen F. Eckel, William C. ZamboniAbstract:Background Even while following best practices, surface exposures of Hazardous Drugs (HDs) are high and numerous. Thus, it is important to develop new products to reduce the surface contamination of HDs. Hazardous Drug Clean (HDClean™) was developed to decontaminate and remove HDs from various types of surfaces and overcome the problems associated with other cleaning products. Methods HDClean was evaluated to remove mock surface exposures of HDs (docetaxel, paclitaxel, ifosfamide, cyclophosphamide, 5-FU, and cisplatin) from various types of surfaces. In two separate cancer centers, studies were performed to evaluate HDClean in reducing surface contamination of HDs in the pharmacy departments where no closed system transfer device (CSTD) was used. In a third cancer center, studies were performed comparing the effectiveness of a CSTD + Surface Safe compared with CSTD + HDClean to remove HDs. Results HDClean was able to completely remove mock exposures of a wide range of HDs from various surfaces (4 and 8 sq ft areas). Daily use of HDClean was equal to or more effective in reducing surface contamination of HDs in two pharmacies compared with a CSTD. HDClean was significantly more effective in removing HDs, especially cisplatin, compared with Surface Safe and does not have the problems associated with decontamination solutions that contain sodium hypochlorite. Conclusion These studies support HDClean as an effective decontaminating product, that HDClean is more effective than Surface Safe in removing HDs and is equal to or more effective than CSTD in controlling HD surface exposures.
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economic and microbiologic evaluation of single dose vial extension for Hazardous Drugs
Journal of Oncology Practice, 2012Co-Authors: Erinn C Rowe, Scott W Savage, William A Rutala, David J Weber, Maria F Gergenteague, Stephen F. EckelAbstract:Purpose: The update of US Pharmacopeia Chapter 797 in 2008 included guidelines stating that single-dose vials (SDVs) opened and maintained in an International Organization for Standardization Class 5 environment can be used for up to 6 hours after initial puncture. A study was conducted to evaluate the cost of discarding vials after 6 hours and to further test sterility of vials beyond this time point, subsequently defined as the beyond-use date (BUD). Methods: Financial determination of SDV waste included 2 months of retrospective review of all doses prescribed. Additionally, actual waste log data were collected. Active and control vials (prepared using sterilized trypticase soy broth) were recovered, instead of discarded, at the defined 6-hour BUD. Results: The institution-specific waste of 19 selected SDV medications discarded at 6 hours was calculated at $766,000 annually, and tracking waste logs for these same medications was recorded at$770,000annually.Microbiologictestingofvialextensionbeyond 6 hours showed that 11 (1.86%) of 592 samples had one colonyforming unit on one of two plates. Positive plates were negative at subsequent time points, and all positives were single isolates most likely introduced during the plating process. Conclusion: The cost of discarding vials at 6 hours was significant for Hazardous medications in a large academic medical center. On the basis of microbiologic data, vial BUD extension demonstrated a contamination frequency of 1.86%, which likely represented exogenous contamination; vial BUD extension for the tested Drugs showed no growth at subsequent time points and could provide an annual cost savings of more than $600,000.
Luci A Power - One of the best experts on this subject based on the ideXlab platform.
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ashp guidelines on handling Hazardous Drugs
American Journal of Health-system Pharmacy, 2018Co-Authors: Luci A Power, Joseph W CoyneAbstract:ASHP published its first guidance on Hazardous Drugs (HDs) in 1983 as part of the 1983–84 ASHP Practice Spotlight: Safe Handling of Cytotoxic Drugs.[1][1],[2][2] This was followed by technical assistance bulletins in 1985 and 1990 and the ASHP Guidelines on Handling Hazardous Drugs in 2006.[3][3
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multicenter evaluation of a new closed system drug transfer device in reducing surface contamination by antineoplastic Hazardous Drugs
American Journal of Health-system Pharmacy, 2018Co-Authors: Sylvia Bartel, Timothy Tyler, Luci A PowerAbstract:Purpose Results of a study to evaluate the effectiveness of a recently introduced closed system drug-transfer device (CSTD) in reducing surface contamination during compounding and simulated administration of antineoplastic Hazardous Drugs (AHDs) are reported. Methods Wipe samples were collected from 6 predetermined surfaces in compounding and infusion areas of 13 U.S. cancer centers to establish preexisting levels of surface contamination by 2 marker AHDs (cyclophosphamide and fluorouracil). Stainless steel templates were placed over the 6 previously sampled surfaces, and the marker Drugs were compounded and infused per a specific protocol using all components of the CSTD. Wipe samples were collected from the templates after completion of tasks and analyzed for both marker AHDs. Results Aggregated results of wipe sampling to detect preexisting contamination at the 13 study sites showed that overall, 66.7% of samples (104 of 156) had detectable levels of at least 1 marker AHD; subsequent testing after CSTD use per protocol found a sample contamination rate of 5.8% (9 of 156 samples). In the administration areas alone, the rate of preexisting contamination was 78% (61 of 78 samples); with use of the CSTD protocol, the contamination rate was 2.6%. Twenty-six participants rated the CSTD for ease of use, with 100% indicating that they were satisfied or extremely satisfied. Conclusion A study involving a rigorous protocol and 13 cancer centers across the United States demonstrated that the CSTD reduced surface contamination by cyclophosphamide and fluorouracil during compounding and simulated administration. Participants reported that the CSTD was easy to use.
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handling Hazardous Drugs are our safety programs effective
American Journal of Health-system Pharmacy, 2006Co-Authors: Luci A PowerAbstract:This issue of AJHP features the “ASHP Guidelines on Handling Hazardous Drugs.”[1][1] This document comes 26 years after the first English-language guidelines on safe handling of cytotoxic Drugs were published in the Australian Journal of Hospital Pharmacy. [2][2] The recommended safety programs
Robert Mclauchlan - One of the best experts on this subject based on the ideXlab platform.
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exposure to Hazardous Drugs in healthcare an issue that will not go away
Journal of Oncology Pharmacy Practice, 2011Co-Authors: Jill Davis, Robert Mclauchlan, Thomas H. ConnorAbstract:The Journal of Oncology Pharmacy Practice (JOPP) was first published in June 1995 as the official journal of the International Society of Oncology Pharmacy Practitioners (ISOPP). In a supplement to that issue, as part of a review of the ISOPP IV symposium presentations, an article by Professor Graham Sewell was included titled ‘Pharmaceutical issues: preparation and handling’. This article raised concerns about various aspects of quality and safety associated with cytotoxic drug reconstitution. It discussed the use of cytotoxic safety cabinets versus isolators, the use of early ‘closed systems’ and even the possible future use of robotics. In the 15 years since that first publication, interest in the handling of Hazardous Drugs used to treat cancer patients has not waned. At the recent ISOPP XII symposium held in Prague in May 2010, ten presentations and seven submitted abstracts on the topic of safe handling were included. From the highly technical use of robotics and the use of specialized closed systems to the basic use of personal protective equipment (PPE) in under-resourced countries, this subject remains highly topical. One reason for the interest in this topic is the inability to quantify the occupational risk of handling anticancer Drugs. It is well recognized that patients treated with therapeutic doses of these Drugs may develop second cancers years later. However, the risk associated with long-term very low level exposure to these agents is not currently measurable. A basic tenet of employment is the provision of a safe workplace. It may be impossible to remove all risk but it is imperative that risk is minimized. Large pharmaceutical companies manufacturing anti-cancer Drugs do so in totally enclosed environments with workers wearing full respirator suits reminiscent of movies of outbreaks of a deadly virus. But it is financially completely beyond individual hospitals, institutions and clinics to supply such protective equipment. The smaller the preparation facility, the less viable it is to introduce expensive protective measures. Many pharmaceutical companies have improved the presentation of their anti-cancer drug products in several ways. The Drugs are generally presented, when stability allows, in liquid form – this means less manipulation is required to prepare a dose. The Drugs are generally packaged in plastic containers – this means less chance of vial breakage. When compatibility problems arise and do not permit plastic packaging, and glass containers are required, these are generally protected in some way to avoid breakage and leakage e.g., an ‘overcoat’ of plastic is placed over the vial. These improvements in packaging are applauded. However, it is known that external chemical contamination of drug vials arriving from the manufacturer is a problem. Manufacturers must accept responsibility for ensuring that only clean product leaves their facilities. It is discouraging when every safeguard is taken to protect staff preparing anti-cancer Drugs, to find that a major source of contamination is the outside of the drug vials themselves. Before we place all the responsibility onto the manufacturers, we must first ensure that we are doing everything possible ourselves to reduce the contamination of the environment and ourselves and we still have quite a long way to go. The paper by Shin-ichi Sugiura et al. ‘Risks to health professionals from Hazardous Drugs in Japan: a pilot study of environmental and biological monitoring of occupational exposure to cyclophosphamide’ in this issue of The Journal describes a pilot study performed in 2006 looking at cytotoxic drug environmental contamination in two similar hospital departments.
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reducing workplace cytotoxic surface contamination using a closed system drug transfer device
Journal of Oncology Pharmacy Practice, 2010Co-Authors: Jim Siderov, Sue Kirsa, Robert MclauchlanAbstract:Background. The potential for staff exposure to antineoplastic agents exists in the workplace despite current recommended safe handling procedures. Reliance on cytotoxic drug safety cabinets (CDSC) to provide total protection from exposure to Hazardous Drugs is insufficient. Preventing workplace contamination is the best strategy to minimise exposure. PhaSeal® is a commercially available system for ensuring the leak-free transfer of Hazardous Drugs, fitting both the NIOSH and ISOPP definitions of a closed system. To date, there have been no published studies examining the use of a closed system drug transfer device (PhaSeal®) under Australian conditions.The purpose of this study is to determine the impact of a closed system drug transfer device on cytotoxic surface contamination in the cytotoxic preparation areas of two Australian metropolitan public hospitals.Method. This was a pre- and post-intervention study in which chemical contamination was tested at baseline then at five and 12 months after the int...
Firouzan Massoomi - One of the best experts on this subject based on the ideXlab platform.
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manufacturers recommendations for handling spilled Hazardous Drugs
American Journal of Health-system Pharmacy, 2010Co-Authors: Richard Gonzalez, Firouzan MassoomiAbstract:Occupational exposure to Hazardous Drugs is a real risk to health care personnel.[1][1] This risk encompasses all points of handling from drug manufacture to managing waste.[2][2] Spills represent the worst case scenario of exposure to a Hazardous drug. Because of new Hazardous Drugs entering the
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implementation of a safety program for handling Hazardous Drugs in a community hospital
American Journal of Health-system Pharmacy, 2008Co-Authors: Firouzan Massoomi, Bill Neff, Amy Pick, Paula L DanekasAbstract:Purpose. The implementation of a safety program for handling Hazardous Drugs in a community hospital is described. Summary. A committee of representatives of the departments of pharmacy, nursing, human resources, safety, radiology, performance improvement, employee health, and environmental services and members of the hospital administration was formed to formally address the management of Hazardous Drugs in a community, not-for-profit, adult hospital in Omaha, Nebraska. Published guidelines and regulations were reviewed to determine the hospital’s compliance with the handling of Hazardous Drugs. A knowledge deficit regarding the risk and severity of occupational exposure to Hazardous Drugs was identified. A formal education plan was immediately implemented providing inservice education to all staff who may come into contact with Hazardous Drugs. Each drug was electronically tagged in the hospital computer system. The nitrile gloves used in the pharmacy were switched to a brand tested for resistance to chemotherapy drug permeation. The use of personal protective equipment for all health care workers who may come into contact with Hazardous Drugs was also instituted. Waste stream management was addressed, and a new waste stream was identifed and implemented to address chemicals regulated by the Resource Conservation Recovery Act. Nursing, pharmacy, and housekeeping personnel were extensively educated on the different waste streams and the importance of segregating waste at the point of use. All gloves for housekeeping and laundry service staff were replaced with Hazardous-drug-rated nitrile gloves. Conclusion. A gap analysis allowed a multidisciplinary team to establish a safety program for managing Hazardous Drugs in a community hospital.
