Summary of the NIOSH Publication using the framework of the recent workshop as a basis for material, e.g., History and Process for the Alert, Health and Safety Issues Related to Hazardous Drugs, Work Practice Controls in the Administration of hazardous Drugs, Personal Protective Equipment Needed for Safe Handling of Hazardous Drugs, Contamination studies, Hazardous Waste Handling, Medical Surveillance and Alternative Duty, etc.
How OSHA sees the NIOSH publication being used, e.g., by compliance officers (what OSHA standards apply), where solutions to problems can be found, education/training programs, the OSHA web page concerning hazardous drugs, and working relationships between NIOSH, OSHA and JCAHO. OSHA has an alliance with JCAHO
1:37 - 1:42
Veterans Health Administration - Pharmacy Benefits Management SHG (119)
Note: Bruce R. Harrison, a Clinical Pharmacy Specialist at the VAMC St. Louis, was a member of the group that assisted NIOSH with their publication. he was not available for the conference call but provide additional input to the questions and answers added following the call.
If you did not have time to ask your question(s) during this conference call, you may e-mail it to firstname.lastname@example.org or you can contact him at (202) 273-9743
Final note: Start perparing for winter driving - Winter road conditions are on line in many states, e.g., Wisconsin
Note: The Office of Occupational Safety and Health has contacted officials of agencies and/or organizations for this conference call that can represent their agency/organization's and/or are expects in their field. However, verbal statements and/or paraphrased questions and answers (found at the bottom of this agenda), are informational and have not been cleared as policy in-of-themselves. Links have been provided to this call that allow agency/organizational polices to be viewed. Questions and answers are viewed on the intranet only.
A workshop was held jointly NIOSH and OSHA October 3-5, 2004, to familiarize healthcare professionals with the recently publishe d NIOSH Alert on Hazardous Drugs and to discuss implementation of the recommendations contained in that Alert. http://www.cdc.gov/niosh/topics/hazdrug/conference.htmlAGENDA of Workshop
Notes from Pharmacy Benefits Management SHG (119): On January 1, 2004, a new standard on compounding sterile products from the United States Pharmacopeia (USP) became effective. This new standard has the weight of federal regulations and could be enforced by state boards of pharmacy and referenced by JCAHO surveyors as they inspect healthcare facilities. This new standard referred to as the USP Chapter 797, Pharmaceutical Compounding -- Sterile Compounding will apply to all practice settings in which compounded sterile preparations (CSP) are compounded and applies to all healthcare facilities involved in the preparation, compounding, and storage of sterile products. The VHA Pharmacy Benefits Management Strategic Healthcare Group (PBM SHG) has recently formed a Compounded Sterile Preparations (CSP) Work Group to plan for and assist VHA hopsitals with the implementation of the provisions of the USP Chapter 797 .
Questions and Answers:
Question: When are chemotherapeutic drugs a hazard?
Answer: NIOSH - The half-life of chemotherapeutic drugs are usually 48 hours, but can be as long as 7 days after administration. The precautions needed will depend on the drug and circumstances. There are publications that can assist in determining precautions such as oncology nurse guides. Additional explanation/clarification from Bruce R. Harrison:
Chemotherapy, or hazardous, drugs as defined in the NIOSH Alert are potentially hazardous at any point they are handled or stored in any medical facility, from the time they arrive from an outside source through disposal as a hazardous waste.
After administration to a patient, urine, sweat, sputum, or blood may contain significant quantities of active drug. The half-life of these drugs varies greatly, from a few minutes to many hours. Metabolites of the platinum derivatives continue to be excreted in very low concentrations in the urine for weeks after a dose. For guideline purposes, most of these agents are cleared from the system within 48 hours. Therefore, most guidelines recommend handling patient’s body fluids, etc. with appropriate PPE and disposal [for at least the first 48 hours]. </ intranet> Study guide for chemotherapeutic drugs.
Question:What about the washing of linen?
Answer: NIOSH - Adequate washing of linen my be difficult, i.e., all drugs may not be easily washed out of the line. Additional explanation/clarification from Bruce R. Harrison:
A recent study (not yet published ) from Belgium demonstrated that even after 2 cycles through a medical facility linen processing system, that some chemotherapy agents remained in detectable quantities.</ intranet>
Question:Should pregnant women be removed from the administration of chemotherapeutic drugs?
Answer: NIOSH – Generally, yes since accidental exposures can occur and all routes/locations of exposure can be difficult to control/determined. Additional explanation/clarification from Bruce R. Harrison:
There are legal implications here. The empl oyer cannot deny a pregnant employee work in a particular area just because she is pregnant. The following statements are from our local policy:
Employees who are pregnant, planning a pregnancy (male or female), breast feeding, or who have a written statement from a physician that provides medical reasons why they should not be exposed to HDs, will be allowed to avoid contact with these agents. The employee is responsible for notifying the supervisor of any limitations on their duties and for providing a copy of the written physician's statement. Supervisors will provide such employees with alternative tasks or responsibilities, if they so desire. The employee has the right to make the final decision whether to continue duties that involve exposure to cytotoxic agents or whether to accept alternative assignments. < /intranet>
Answer: NIOSH/OSHA - USP 797 should be reviewed and this is being looked at. Additional explanation/clarification/comment from Bruce R. Harrison:
Chapter 797 makes no mention negative pressure and makes little attempt to address handling of hazardous drugs. Revisions to 797 may address this issue and provide appropriate guidance. Sound industrial hygiene would dictate use of negative pressure where hazardous agents are handled and have the potential for employee exposure. Exposure to chemotherapy agents is well documented in the literature.
Question:Should filters, used to control exposure to hazardous drugs, be handled as hazards? Should the filters be placed in red bags?
Answer: OSHA - Yes, PPE should be used but red bags may not be appropriate.
Question:What are safe exposure levels for hazardous drugs?
Answer: NIOSH/OSHA FDA has exposure data that can be used to determine safety, which are obtained from the manufacturer needed to get the drug approved. Additional explanation/clarification/comment from Bruce R. Harrison:
If the FDA has this info, it may indeed be part of the INDsubmission, but this is generally not available to the end user, i.e. nurse, pharmacist, physician. End users primarily see only the official package insert, but this document never contains exposure limit info, and generally provides little occupational safety info. Its primary purpose is to provide patient safety info, dosing, side effects, etc. Most but not all manufacturers publish an occupational exposure limit (OEL), or some similar exposure estimate, in the MSDS for a particular product. However, this info is internally generated (by the drug company) and is not peer reviewed. </ intranet>
Question: When are Material Safety Data sheets required for hazardous drugs?
Answer: OSHA - For larger Pharmacies where more than 800 pills of a hazardous drug are handled, or where the manufacturer has/provides an MSDS an MSDS should be maintained.
Notes: 29 CFR 1910.1200 requires any drugs posing a health hazard (with the exception of those in solid, final form for direct administration to the patient, i.e., tablets or pills) be included on lists of hazardous chemicals to which employees are exposed.
Additional explanation/clarification/comment from Bruce R. Harrison: The VA has had a long standing policy requiring MSDSs for hazardous (i.e. cytotoxic or chemotherapy) drugs (VA Circular 10-85-97). Locally we maintain MSDSs on all hazardous drugs. We now use the list of hazardous drugs published in the NIOSH Alert. Although the OSHA Hazard Communication Standard exempts FDA drugs when in solid final form (ostensibly tablets, capsules, etc), it does not apply if these dosage forms may be altered, such as by crushing to ease administration to patient who has difficulty swallowing or for preparation of a suspension or solution for products not available as a liquid. I assure you that this occurs daily in hospitals and pharmacies across the country, and in some cases in relatively large amounts. Safety managers and industrial hygienists in VA facilities should not make assumptions about the intended use of “solid” dosage forms. Any drug that is potentially hazardous should be included in the Hazard Communication Program and an MSDS should be available (despite the above mentioned exemption) recognizing that employees will be exposed to dusts from broken or crushed tablets or capsules whether accidentally or during routine care of patients.