Hazardous Drugs

Safe Handling of Hazardous Drug Policy

Version 1: Updated 3/12/2018

Introduction

Purpose

This 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.

Definition

Hazardous 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.

Responsibilities

Departments, Chairpersons, Supervisors and Directors with employees who handle hazardous drugs on a regular basis must:

  • Ensure that employees follow the procedures outlined in this policy.
  • Develop additional written procedures as appropriate and ensure that employees follow these procedures.
  • Comply with the Hazard Communication Program as it applies to hazardous drugs. This means ensuring that hazardous drugs are labeled appropriately and that SDSs are available for all drugs in liquid, powdered, and gaseous form.
  • Develop a plan for cleaning up spills of hazardous drugs and provide spill kits to all areas where hazardous drugs are administered. (Hazardous drug spill kits are available from various manufacturers). Whenever possible, spills of LIQUID hazardous drugs will be handled by employees in the area of the spill.
  • Ensure that appropriate personal protective equipment (PPE) is available and worn by employees.
  • Ensure that tasks involving hazardous drugs in powdered form are performed in a controlled area inside a chemical fume hood, biological safety cabinet (Biological Safety Cabinet or BSC, vertical flow hood), or other containment primary engineering control (C-PEC) as defined in United States Pharmacopia USP 800. Such tasks would include reconstitution of powders or crushing of tablets. For hazardous drugs used in the healthcare setting, these tasks will be performed in the appropriate pharmacy.

Employees who handle hazardous drugs will:

  • Comply with the procedures outlined below and with department- or site-specific procedures related to handling hazardous drugs.
  • Report any exposures (skin or eye contact or inhalation of an aerosol or dust) to their supervisors and to the University Physician’s office by calling 353-9137. A Claimed OccupationalInjury or Illness report must be completed by the employee and supervisor.
  • Workers must report spills to their supervisor.

Environmental Health and Safety will:

  • Respond to spills of hazardous drugs in areas where appropriate PPE is not available.
  • Respond to large spills that are beyond the capacity of employees in the vicinity of the spill.
  • Respond to all releases of hazardous gases.
  • Provide telephone advice/assistance to any employee who will be cleaning up any spill of hazardous drugs.
  • Provide hazardous waste pick up services for spills involving the drugs regulated by the EPA.
  • Follow-up any employee exposure incident with a site visit and investigation.

The Pharmacy and Clinic Facility will:

  • Provide access to SDSs for hazardous drugs that it distributes. These SDSs are available by calling the pharmacy that distributed the drug.
  • Provide a warning on the label of hazardous drugs that it distributes, indicating that special handling precautions are necessary.
  • Ensure that hazardous drugs that will be used for patient treatment are handled in the pharmacy and clinic facility during all processes involving drugs in powdered or granular form. (Such processes would include reconstitution of powders and crushing of tablets.)

 

Procedures

Handling of Liquid Hazardous Drugs

Equipment Needed:

Employees must wear gloves that are protective against the hazardous drug they are using.

  • For chemotherapy and other hazardous drugs, employees must wear gloves tested for use with chemotherapy drugs in the appropriate size.
  • Gloves are required during handling of hazardous drugs (e.g., drug preparation, initial administration, changing of IV bags, and discontinuation of chemotherapy and other hazardous drugs). If there is a potential for leaking or splashing, such as during compounding and administration, double gloves are required. Refer to the PPE Assessment for various operations handling hazardous drugs in Appendix B.
  • If there is a potential for splashing, employees must also wear a cuffed gown that is resistant to permeability by hazardous drugs and a face shield and/or splash goggles. (Splash goggles are required when eye protection is needed.) The employee's department must provide these items.
Work Practices:

General:

  • Employees must wash their hands before donning and after removing gloves. Gloves or clothing that become contaminated must be changed as soon as possible. Employees will be trained in proper methods to remove contaminated gloves and gowns.
  • IV tubing connection sites must be taped unless they have Luer-lock fittings.
  • If IV sets are primed at the administration site, they will be primed with compatible IV fluid before the IV bag is spiked. IV containers with venting tubes should not be used. Alternately, IV sets can be primed in a C-PEC at the Pharmacy.
  • Air will be expelled from syringes by the Pharmacy in their C-PEC.

Administration:

  • A plastic-backed absorbent pad will be placed under the tubing during IV push administration to catch any leakage. Sterile gauze will be placed around any push sites for absorbing leakage.
  • If syringes, IV bottles and bags, or pumps become contaminated with drug solution, they must be wiped clean with sterile gauze as soon as possible without interfering with the administration.
  • Infusion sets and pumps, which should have Luer-lock fittings, should be watched for signs of leakage during use.
Disposal:
  • Used and empty bottles, syringes, IV bags, and tubing will be placed in a yellow biohazard box (yellow bags).
  • Bottles, syringes without needles, IV bags and tubing containing unused or partially used hazardous drugs labeled for disposal will be placed into black chemo bins for proper disposal.
  • Contaminated gloves and other disposable PPE will be placed in a yellow biohazard box or bag.
  • Gloves and other disposable PPE that are not contaminated may be placed in the trash.
  • Needles and syringes must not be crushed, clipped, or capped, but will be placed directly in the yellow sharps box.

 

Reporting Incidents or Spills Involving Hazardous Drugs

Incidents or spills involving hazardous drugs must be reported to the appropriate departments as indicated below.

Personnel Exposure

Overt contamination of gloves, clothing, skin or eyes will be treated as follows:

  1. Remove contaminated gloves or clothing (if applicable).
  2. Wash the affected skin area with soap (not germicidal cleaner) and lukewarm water. (Hot water will open pores and increase skin absorption.) (For eye exposure, immediately flush the affected eye with water or isotonic eyewash designated for that purpose for at least 15 minutes.)
  3. For direct eye contact,
    • Obtain medical attention as soon as possible. Employees should go to the emergency room or current urgent care provider serving the University.
    • Fill out the Claimed Occupational Illness or Injury form and submit as appropriate.
    • Inform the appropriate area manager.

Spills of Liquid Hazardous Drugs

  • For information about the hazards of the spilled drug, contact the area pharmacy.
  • Whenever possible, spills of LIQUID hazardous drugs will be handled by employees in the area of the spill, according to Appendix C. Pregnant employees shall leave the area of a spill and not participate in the cleanup.
  • Employees may call EHS at 517-355-0153 from 8:00 AM to 5:00 PM, Monday-Friday for telephone advice or assistance cleaning up the spill. After hours call MSU Police at 517-355-5222 and indicate you need to contact the EHS Hazmat Pager. EHS will respond to large spills that are beyond the capacity of employees in the vicinity of the spill.

Handling and Spills of Powdered or Aerosolized Hazardous Drugs

Reconstitution 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 Considerations

Antineoplastic 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 Health

Employees are encouraged to contact Occupational Health with any questions regarding health considerations while working with antineoplastic agents.

 

Training

Supervisors 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:

  • MSU Hazard Communication or Right-To Know (online at EHS Web site via Ability LMS)
  • MSU Safe Handling of Hazardous Drugs (online at EHS Web site via Ability LMS)

There may be additional training requirements that must be met before working with hazardous drugs such as:

  • Hazardous waste training
  • Biological safety training
  • N-95 Respirator fit-testing and training
  • Bloodborne Pathogens Training (human areas)
  • Site-Specific Training
  • Other training may be required depending on your job duties

Inventory and SDS Maintenance

Individual 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 Spaces

MSU 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