Safe Handling of Hazardous Drug PolicyVersion 1: Updated 3/12/2018 Show
IntroductionPurposeThis policy has been developed to promote safe work practices for all employees who receive, prepare, administer, handle or dispose of hazardous drugs or clean up spills of these drugs. It is important to minimize occupational exposure to these drugs because of the risk of adverse health effects. This policy is based on Occupational Safety and Health Administration (OSHA’s) updated Controlling Occupational Exposure to Hazardous Drugs. Further information on specific drugs can be found on the Safety Data Sheet (SDS), the DrugBank web site, the Manufacturers’ Safe Handling Guideline (MSHG) and Food and Drug Administration (FDA) label. DefinitionHazardous Drug: Defined by the American Society of Health System Pharmacists in 1990 as being a drug which displays one or more of the following characteristics: genotoxicity, carcinogenicity, teratogenicity or fertility impairment, or serious organ or other toxic manifestation at low doses in experimental animals or treated patients. The National Institute of Occupational Safety and Health (NIOSH) revised the definition in 2004 to include drugs that exhibit one or more of the following six characteristics in humans or animals: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the other criteria. Appendix A of this policy lists drugs that are considered hazardous by NIOSH as well as any additional drugs that have been determined to be hazardous by Michigan State University (MSU). Additionally, all investigational drugs will be handled as hazardous drugs unless there is adequate information available about potential toxicity and exposure risks to patients and employees to exclude them. ResponsibilitiesDepartments, Chairpersons, Supervisors and Directors with employees who handle hazardous drugs on a regular basis must:
Employees who handle hazardous drugs will:
Environmental Health and Safety will:
The Pharmacy and Clinic Facility will:
ProceduresHandling of Liquid Hazardous DrugsEquipment Needed:Employees must wear gloves that are protective against the hazardous drug they are using.
Work Practices:General:
Administration:
Disposal:
Reporting Incidents or Spills Involving Hazardous DrugsIncidents or spills involving hazardous drugs must be reported to the appropriate departments as indicated below. Personnel ExposureOvert contamination of gloves, clothing, skin or eyes will be treated as follows:
Spills of Liquid Hazardous Drugs
Handling and Spills of Powdered or Aerosolized Hazardous DrugsReconstitution and handling of powdered hazardous drugs will occur only in the pharmacy or in other areas approved by EHS. Tablets of hazardous drugs which may produce dust or potential exposure to the handler must be counted in the pharmacy in a C-PEC. (Capsules, i.e., gel-caps or coated tablets, are unlikely to produce dust unless broken in handling.) Any hazardous drug tablets that must be crushed prior to administration must be handled in the Pharmacy C-PEC. Occupational Health ConsiderationsAntineoplastic Agent Medical Surveillance Program - MSU has a voluntary medical surveillance program for employees who are potentially exposed to antineoplastic drugs during mixing or administration. Work options while pregnant, nursing or attempting to conceive - Employees are encouraged to work with their supervisors to identify and implement reasonable accommodations. University Physician's Office- Occupational HealthEmployees are encouraged to contact Occupational Health with any questions regarding health considerations while working with antineoplastic agents. TrainingSupervisors of employees who handle hazardous drugs must make their employees aware of the potential health effects of these drugs, as required by the MiOSHA Hazard Communication Standard. The supervisor should refer to the SDS for information about the hazards. The supervisor must also communicate and enforce proper handling procedures, and must advise employees on how they are to handle emergencies, including personnel exposure and spills. A list of required trainings includes:
There may be additional training requirements that must be met before working with hazardous drugs such as:
Inventory and SDS MaintenanceIndividual Pharmacy units shall maintain an inventory of hazardous drugs and SDS for the hazardous drugs in their possession. The inventory shall be updated annually. Both the inventory of hazardous drugs and the associated SDS’s must be available to employees and EHS. Use of Hazardous Drugs in Animal Facilities and Research SpacesMSU Veterinary Medical Center has a separate Hazardous Drug Policy document. Refer to the VMC Policies and Procedures for specific guidance on safe handling in the Veterinary Medical Center. Researchers who use hazardous drugs in research animal rooms may be required to follow some or all of the policies in this document. Each Animal Use Form will be reviewed by EHS and Campus Animal Resource (CAR) staff. A predosing meeting will be called with the research team, CAR and EHS staff to produce an Animal Hazard Control Form specific to each experiment. Use of Hazardous Drugs in MSU research laboratories falls under the requirements of the MiOSHA Hazardous Work in Laboratories standard and the MSU Chemical Hygiene Plan. References
Appendices
What document is the source for a list of hazardous drugs?This hazardous drug list will be posted on the NIOSH Web site at www.cdc.gov/niosh. The OSHA hazard communication standard [29 CFR 1910.1200] requires employers to develop a hazard communication program appropriate for their unique workplace.
Which action is recommended to reduce the risk of exposure when administering hazardous medications?Donning two pairs of gloves tested against chemotherapy agents during all handling activities. Wearing a disposable gown made from a low permeable fabric with back closure.
What is the highest risk of exposure to hazardous drugs?The highest risk of exposure occurs during the preparation of hazardous drugs because the drugs are at their most concentrated state at that time. Engineering controls, such as the proper use of BSCs, are the most effective means of reducing employee exposure.
What are the 3 risk groups for hazardous drugs?Pharmaceuticals as Workplace Hazards
Group 1 is antineoplastic drugs (roughly, chemotherapy medications). Group 2 is other drugs (not antineoplastic) that are hazardous, while Group 3 are drugs that may interrupt fertility in women or men or that may get into breast milk.
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