PDC 001V: Hazardous Drugs Lifecycle From an Industrial Hygiene Perspective

CM Credit Hours: 3.5 

*Please note: PDCs are at an additional cost, and preregistration is required*
To register, please visit: https://aihaconnect.org/register

This course examines hazardous drugs and the industrial hygiene life cycle, focusing on occupational exposure and best practices across work environments—from drug development and manufacturing to healthcare and patient administration in clinical and home settings. It includes a review of compliance and regulatory guidance, along with examples of industrial hygiene programs and risk assessment strategies in both industry and healthcare. Instructors will share firsthand experience as practicing hygienists. Case study exercises will help participants strengthen risk communication and management skills using real-world hazardous drug scenarios and sampling data. In small groups, participants will develop written and verbal communications based on scenario results, risk assessments and professional interpretation, and offer hygiene program recommendations for corrective actions and continuous improvement.

*Note: This PDC will be conducted in Zoom. Please ensure the computer on which you will participate will allow Zoom to access all necessary computer systems including speakers, microphone, and camera.*

• Introduction and Background
o Definitions of key terms: hazardous drugs (HDs), highly potent active pharmaceutical ingredients (HPAPIs)
o Overview of relevant organizations: ISPE, USP, NIOSH, AIHA, ASHP, ONS and others
o Occupational exposure: defining "safe" using acceptable surface limits (ASLs), banding and ALARA principles
o Fundamentals of risk communication
• Industrial Hygiene in the Pharma and Biopharma Industry
o ISPE containment verification
o Key elements of HPAPI safe handling programs
o Risk assessment and management using occupational exposure bands (OEBs)
o Industrial hygiene data collection and management
• Industrial Hygiene in Healthcare Settings
o Application of the NIOSH hazardous drug list
o USP compounding hazardous drugs assessment of risk
o Environmental cross-contamination concerns in cleanroom pharmacies
o Staff and patient exposure in infusion areas and other departments
o Program elements: quantitative vs. qualitative approaches and realistic vs. limited sampling
o Surface sampling strategies for continuous improvement
• Case Study Exercises
o Participants will work in small groups of three to four to analyze a hazardous drug case study from either industry or healthcare, including industrial hygiene sampling results.
o Groups will develop and deliver a risk communication presentation tailored to both workers and leadership.
o Presentations will include interpretation of sampling data, risk assessment findings and recommendations for corrective actions and program improvements.
o Small groups will present to the full class of participants and be prepared for discussion and Q/A.
o All class participants and instructors will collaboratively learn from one another during the HD case study exercises. Each person will leave with best-practice industrial hygiene program strategies to help protect workers across all environments.
 

Upon completion, the participant will be able to:

• Describe and compare the regulatory and compliance landscape for hazardous drugs in the pharmaceutical, biopharmaceutical and healthcare industries.
• Compare and contrast industry and healthcare approaches to hazardous drug risk assessment, hygiene programs and sampling strategies.
• Prepare concise risk communication presentations to improve individual and organizational understanding of hygiene sampling results and best practices in hazardous drug risk management.
 

Participants will receive a PDF copy of AIHA's "Hazardous Drug Surface Contamination Guidance Document". 

Participants will learn best practices for conducting risk assessments, evaluating potential hazardous drug exposures and improving control systems to protect workers in any environment. They will also strengthen their risk communication skills.
 

None

Intermediate

Exposure Assessment

Risk Communication

Risk Management

Exposure Assessment

Hazard Communication

Regulatory compliance

Risk assessment and management

Toxicology

Virtual

Practitioner

Case Studies

Group activities

Hands-on demonstrations and practicum

Practical Application

Problem Solving /Practice Exercises

Small Group Discussion