Hospital pharmacy employee exposure to hazardous chemicals and drugs during their preparation, handling, administration and storage.
- Under the Hazard Communication Standard (HCS), a hazardous chemical is any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified.
- Employers must follow all applicable provisions of the HCS [29 CFR 1910.1200] with respect to hazardous pharmaceuticals.
Application of the HCS:
- The HCS only applies to pharmaceuticals that the drug manufacturer has determined to be hazardous and that are known to be present in the workplace in such a manner that employees are exposed under normal conditions of use or in a foreseeable emergency (OSHA Frequently Asked Questions: Hazard Communication).
- The HCS does not apply to any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final form for direct administration to the patient (e.g., tablets, or pills). [29 CFR 1910.1200(b)(6)(vii)]. However, tablets, capsules, or pills which are designed to be dissolved or crushed by employees prior to administration to a patient are not in "final form" and are covered by the HCS. There may be situations where the tablet, capsule, or pill is dissolved or crushed to facilitate patient administration when that is not typically the way it is dispensed. The "final form" exemption would apply in this situation.
- Drugs (as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq), and regulations issued under that Act) are exempt from HCS labeling requirements when they are subject to the labeling requirements under that Act by the Food and Drug Administration. [29 CFR 1910.1200(b)(5)(iii)]
- See HCS for other exemptions that may apply in your workplace.
Requirements for HCS-covered pharmaceuticals:
- Employers must maintain readily available Safety Data Sheets (SDSs) for all hazardous chemicals, including hazardous drugs, that meet the HCS criteria [OSHA Letter of Interpretation, (January 3, 1994, Corrected April 14, 2009)].
- The National Institute for Occupational Safety and Health (NIOSH) provides an annually updated list of drugs considered hazardous.
- Resources such as product labeling, safety data sheets, your institution’s internal hazardous drug list, and the NIOSH hazardous drug list can be consulted to help determine which pharmaceuticals are HCS-covered hazardous drugs.
- Employers must provide employees (for example, personnel who are involved in any aspect of the handling of covered hazardous drugs such as physicians, nurses, pharmacists, housekeepers, employees involved in receiving, transport or storage) with effective information and training to apprise them of the hazards presented by hazardous drugs in the work area. [29 CFR 1910.1200(h)] Employee training shall include at least:
- Methods and observations that may be used to detect the presence or release of an HCS-covered hazardous drug in the work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of covered hazardous drugs being released, etc.).
- The physical, health, and other hazards of the covered hazardous drugs in the work area.
- The measures employees can take to protect themselves from these hazards, including specific procedures that the employer has implemented to protect employees from exposure to HCS-covered hazardous drugs, such as procedures to identify HCS-covered drugs as hazardous, appropriate work practices, emergency procedures (e.g., for spills or other dangerous employee exposure), and personal protective equipment to be used.
- The details of the hazard communication program developed by the employer, including an explanation of the labels received on shipped containers and the workplace labeling system used by their employer; the SDS, including the order of information and how employees can obtain and use the appropriate hazard information.
Recognized Controls and Work Practices
- Develop, implement and maintain a written hazardous drug safety and health plan to protect those employees who handle or are otherwise exposed to drugs that pose a health hazard.
- See Controlling Occupational Exposure to Hazardous Drugs (Section V, A), OSHA Safety and Health Topics webpage, for guidance in the development of a drug safety and health plan.
- Make available spill and emergency skin and eye decontamination kits and relevant SDSs (for guidance) at all nursing stations on floors where hazardous drugs will be administered.
- Post or make easily available to employees a list of drugs covered by hazardous drug policies and information on spill and emergency contact procedures.
- Hazard Communication. OSHA Safety and Health Topics Page.
- How does the Hazard Communication Standard apply to pharmaceutical drugs? OSHA. FAQs for the Hazard Communication Standard.
- Hazard communication standard and pharmaceuticals. OSHA Letter of Interpretation, (January 3, 1994, Corrected April 14, 2009).
- The Hazard Communications Standard as it applies to employees who prepare and administer drugs/medications. OSHA Letter of Interpretation, (June 11, 1991).
- FDA regulated drugs that pose a hazard would be covered by the HCS. OSHA Letter of Interpretation, (September 13, 1993).
- MSDS requirements for drugs. OSHA Letter of Interpretation, (August 13, 1993).
- QuickTips For Job Health and Safety on Hazardous Drugs in Health Care. OSHA and American Industrial Hygiene Association Alliance (August 29, 2013).
- Work precautions for handling hazardous drugs highlighted by NIOSH, OSHA, Joint Commission. OSHA Trade Release (April 7, 2011).
- Also see Hospital-wide Hazards - Hazardous Chemicals.