References

NIOSH Alert: Preventing Exposure to Antineoplastic Drugs (US Guidance)

The National Institute for Occupational Safety and Health (NIOSH) requests assistance in preventing occupational exposures to antineoplastic drugs (drugs used to treat cancer) and other hazardous drugs in health care settings. Health care workers who work with or near hazardous drugs may suffer from skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers.

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NIOSH Alert Summary (US Guidance)

Health care workers who work with or near hazardous drugs may be exposed to these agents in the air or on work surfaces, clothing, medical equipment, or patient urine or feces. Hazardous drugs include those used for cancer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs (see Appendix A of NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings for a list of hazardous drugs). The health risk depends on how much exposure a worker has to these drugs and how toxic they are.

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CETA Isolator Applications Guide (US Guidance)

The introduction of USP Chapter 7971 in January 2004 along with increased pressure from some State Boards of Pharmacy has led to more robust implementation of environmental controls by facilities involved in the compounding of sterile preparations. In some cases, barrier isolators intended for compounding sterile preparations are used either as an alternative or as an adjunct to traditional methods. Isolator use for sterile compounding is relatively new to the United States. Few isolator standards exist and none of those that are in place have been developed with pharmacy compounding in mind. This guide is intended to provide an overview of isolators and assist individuals considering their use in purchasing, installation and commissioning issues.

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Handling Cytotoxic Drugs (European Guidance)

Handling cytostatic drugs requires a number of organizational and technical systems in order to guarantee the best possible protection for personnel. This booklet focuses on various ways of protecting personnel from potential hazards through the careful handling of cytostatic drugs, and for this reason, product protection is only briefly discussed. Furthermore, we have chosen not to present different national legal requirements. Instead, we have tried to describe best practices to ensure the highest possible degree of protection for humans and the environment. In particular, we have concentrated on putting theoretical knowledge into practice. Therefore, you will find a checklist to test your knowledge in the Appendix.

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Standard Practices to Ensure Safe Cytotoxic Drug Reconstitution International Review

Cytotoxic Reconstitution Services (CRS) have been developed in hospital pharmacies throughout the world. Their aim has been to reduce the number of persons handling antineoplastic agents, thus diminishing the risks for themselves, the nursing staff and the patients. Recent evidence has suggested that pharmacy staff could be exposed to significant amounts of cytotoxic materials despite normal safety measures, 1-5. The goal of this review was to catalogue the standard practices, guidelines and regulations issued by hospital pharmacy associations, governmental health and safety authorities and medical agencies, concerning the types of safety cabinets recommended in each country and to determine if there was concordance.

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Use of Negative Isolators for Cytotoxic Reconstitution Cleanroom Magazine Article

The United Kingdom is unique in that probably 90% of all cytotoxic reconstitutions in hospital pharmacies are now carried out in isolators. Most of these isolators are negative pressure. Other countries are starting to follow this practice, notably Australia at one end of the world, and Scandinavia at the other.

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Handling Cytotoxic drugs in the Workplace

This guide aims to provide practical advice to employers and healthcare workers on how to prevent or reduce the risks associated with handling cytotoxic drugs and related waste.

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CETA Compounding Isolator Testing Guide (US Guidance)

The purpose of this document is to establish an industry-based minimum set of testing criteria appropriate for all Compounding Isolators used pursuant to USP Chapter 797 1. Compounding Isolators consist of Compounding Aseptic Isolators used for compounding sterile preparations and Compounding Aseptic Containment Isolators used for compounding sterile hazardous drug preparations in pharmacy applications. While this document gives general guidance or referenced guidance through relevant industry documents, it is not the intention to set the specific acceptance criteria. It is the manufacturer's responsibility to determine exact testing procedures consistent with these guidelines and assign appropriate values pertaining to acceptance criteria that is consistent with user requirements. This guide has also been established to create a uniform approach for field certifiers to allow consistent and repeatable testing at all facilities.

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USP 797 (US Guidance) Full Text Download

The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, variability in the intended strenght of correct ingredients that exceeds either monograph limits for official articles or 10% for nonofficial articles, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations (CSPs). Contaminated CSPs are potentially most hazardous to patients when administered into body cavities, central nervous and vascular system, eyes and joints, and when used as baths for live orangs and tissues. When CSPs contain excessive bacterial endotoxins, they are potentially most hazardous to patients when administered into the central nervous system.

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