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Potent Compound Categorization and Safety

Since 1942, occupational health professionals in the pharmaceutical industry have recognized the potential for occupational disease caused by overexposure to active pharmaceutical ingredients (APIs), potent compounds and hazardous drugs. In their article, Health effects of exposure to active pharmaceutical ingredients (APIs), Heron and Pickering (2003) provided an in-depth review of adverse health effects within the industry.

More recently, the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) have had limited involvement regarding this issue. However, in cases where employees have experienced adverse health effects due to overexposures to potent compounds, OSHA has applied the general duty clause. Application of the general duty clause in cases where a hazardous substance does not have a permissible exposure limit is provided in their policy letter: Enforcement Policy for Respiratory Hazards Not Covered by OSHA Permissible Exposure Limits. In addition, in 2004, NIOSH released its alert titled Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs.

Preventing and controlling exposures

As the trend towards more potent pharmaceuticals continues, environmental health and safety professionals (EH&S) in the industry must respond by taking measures to prevent and control exposures. These measures include:

• Risks assessments for compounds early in development
• Placement of compounds into potent compound categorization or control banding schemes
• Occupational exposure limits (OELs) for active pharmaceutical ingredients
• Industrial hygiene monitoring for APIs
• Engineering controls to provide containment and prevent overexposures
• Potent compound handling and exposure control practices
• Potent compound safety training

Put our expertise to work for you

Since 2002, Affygility Solutions has assisted clients in developing and implementing comprehensive potent compound safety programs. Services provided have included:

• Risk assessments
• Potent compound categorization
• Material safety data sheets
• Occupational exposure limits
• Industrial hygiene monitoring
• Potent compound handling assessments
• Potent compound safety training
• Engineering control evaluations

and much more.

The EH&S and toxicology professionals at Affygility Solutions have performed 100s of potent compound categorizations and development of occupational exposure limits for active pharmaceutical ingredients. Contact us now to discuss how we can assist you in your potent compound safety program.