CHDHP Exam Content Outline

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Certified Hazardous Drug Handling Pharmacist (CHDHP)

Official Examination Content Outline

This document provides the official content outline for the Certified Hazardous Drug Handling Pharmacist (CHDHP) examination. The exam certifies that a healthcare professional possesses the core competencies required to lead and manage a comprehensive hazardous drug (HD) safety program that protects patients, healthcare workers, and the environment in compliance with regulatory and accreditation standards.

Examination Specifications

Name of Credential Certified Hazardous Drug Handling Pharmacist (CHDHP)
Certification-Issuing Body The Council on Pharmacy Standards (CPS)
Designation Awarded CHDHP
Target Population Pharmacists responsible for managing hazardous drug programs.
Primary Reference Standards USP <800>, NIOSH Hazardous Drugs List, OSHA regulations
Examination Length 120 multiple-choice items
Administration Time 3.0 hours

Examination Content Outline

The CHDHP examination is weighted according to the five domains listed below, which cover the full lifecycle of hazardous drug management, from program oversight to staff training and accountability.

Domain 1: Program Management and Regulatory Oversight 20%
Domain 2: Facility Design and Environmental Controls 20%
Domain 3: Safe Handling, Compounding, and Dispensing 30%
Domain 4: Administration, Disposal, and Emergency Management 20%
Domain 5: Training, Competency, and Professional Accountability 10%

Domain 1: Program Management and Regulatory Oversight (20%)

Task 1: Manage a comprehensive Hazardous Drug (HD) Safety Program.
  • Develop and maintain the organization's list of hazardous drugs based on NIOSH criteria.
  • Conduct an Assessment of Risk (AoR) to determine alternative containment strategies for specific dosage forms.
  • Establish a multidisciplinary committee to oversee the HD safety program.
  • Develop and maintain written policies and procedures for the entire HD lifecycle.
  • Maintain all required documentation and records for regulatory review.
Task 2: Manage continuous readiness for regulatory and accreditation inspections.
  • Apply USP General Chapters <795>, <797>, and <800> to daily operations.
  • Ensure compliance with Occupational Safety and Health Administration (OSHA) standards for worker safety.
  • Prepare for and respond to inspections from state boards of pharmacy and other state agencies.
  • Integrate HD safety practices to meet accreditation standards from The Joint Commission, DNV, or other bodies.
  • Develop and execute corrective action plans in response to inspection findings.
Task 3: Implement and monitor informatics solutions for HD tracking and safety.
  • Utilize EHR and pharmacy information systems to identify and flag HDs at all stages of the medication-use process.
  • Implement electronic systems for documenting staff training, competency, and medical surveillance.
  • Manage informatics tools for tracking HD inventory from receipt to disposal.
  • Utilize incident reporting software to track and analyze HD-related spills, exposures, and adverse events.
  • Evaluate new technologies that can enhance the safety and monitoring of HD handling.

Domain 2: Facility Design and Environmental Controls (20%)

Task 1: Design and manage compliant hazardous drug storage and handling areas.
  • Ensure HDs are stored in a manner that prevents spillage, contamination, and personnel exposure.
  • Designate specific areas for the receipt, storage, and compounding of HDs.
  • Ensure containment secondary engineering controls (C-SECs) are externally ventilated with appropriate air changes and pressure.
  • Verify that all surfaces of C-SECs are smooth, seamless, and non-porous.
  • Manage access to areas where HDs are handled to authorized personnel only.
Task 2: Evaluate and maintain engineering controls for HD handling.
  • Differentiate between various types of containment primary engineering controls (C-PECs), such as Class II BSCs and C-PECIs.
  • Ensure all C-PECs are certified every six months and function correctly.
  • Manage the proper placement of C-PECs within the C-SEC to maintain containment.
  • Apply knowledge of supplemental engineering controls, such as closed-system transfer devices (CSTDs).
  • Develop contingency plans for engineering control failures or downtime.
Task 3: Manage environmental quality control and surface monitoring.
  • Develop and implement a routine environmental wipe sampling plan to detect HD surface contamination.
  • Interpret surface sample results and develop corrective action plans for positive findings.
  • Implement a comprehensive program for deactivation, decontamination, cleaning, and disinfection.
  • Select appropriate agents for each step of the cleaning process based on the HDs handled.
  • Maintain complete documentation of all cleaning activities and surface sampling results.

Domain 3: Safe Handling, Compounding, and Dispensing (30%)

Task 1: Manage the safe receipt, unpacking, and storage of hazardous drugs.
  • Establish procedures for identifying HD packages upon arrival from suppliers.
  • Ensure appropriate personal protective equipment (PPE) is used when unpacking HDs.
  • Manage the process for handling damaged HD packages to prevent exposure.
  • Implement a system for immediately segregating and storing HDs in designated negative-pressure storage areas.
  • Comply with regulations regarding the secure storage of controlled substance HDs.
Task 2: Manage the proper use of Personal Protective Equipment (PPE).
  • Select appropriate PPE (e.g., gowns, gloves, head/hair/shoe covers, respiratory protection) based on the handling activity.
  • Ensure chemotherapy gowns are disposable, resistant to permeability, and changed per USP standards.
  • Mandate the use of double-gloving with ASTM D6978-rated chemotherapy gloves for compounding and administration.
  • Establish and validate procedures for the proper donning and doffing of all required PPE.
  • Manage the disposal of contaminated PPE in appropriate waste containers.
Task 3: Apply safe work practices to all HD compounding and manipulation.
  • Apply aseptic technique within a C-PEC for the sterile compounding of HDs.
  • Utilize appropriate techniques to minimize aerosol generation during compounding.
  • Require the use of CSTDs for the compounding of antineoplastic HDs.
  • Establish procedures for the safe manipulation of non-sterile HDs (e.g., crushing tablets) in a C-PEC.
  • Implement a final check process to verify the accuracy and integrity of prepared HDs.
Task 4: Ensure the safe labeling, packaging, and transport of hazardous drugs.
  • Label all prepared HDs with conspicuous warnings (e.g., "Chemotherapy - Handle with Care").
  • Package HDs in a manner that protects them from damage and prevents leakage during transport.
  • Use transport containers that are leak-proof, puncture-resistant, and secure.
  • Develop procedures for handling HD spills that may occur during transport.
  • Ensure transport personnel are trained on the risks and proper handling procedures.

Domain 4: Administration, Disposal, and Emergency Management (20%)

Task 1: Integrate safety precautions into the administration of hazardous drugs to patients.
  • Collaborate with nursing leadership to develop policies for safe HD administration.
  • Ensure appropriate PPE (including rated gloves and gowns) is available and used at the bedside.
  • Mandate the use of CSTDs for the administration of antineoplastic HDs.
  • Educate nursing staff on safe handling techniques to protect both themselves and the patient.
  • Develop protocols for managing patient waste (excreta) after HD administration.
Task 2: Manage the compliant disposal of all hazardous drug waste.
  • Differentiate between trace and bulk HD waste and the required disposal containers.
  • Ensure all HD waste is segregated into appropriately labeled, leak-proof containers.
  • Manage the disposal process in compliance with EPA, state, and local regulations.
  • Maintain complete records of all HD waste disposal for regulatory compliance.
  • Train all staff on the correct procedures for segregating and disposing of HD waste.
Task 3: Develop and manage a comprehensive spill and exposure response program.
  • Develop policies and procedures for managing HD spills of various sizes.
  • Ensure spill kits are readily available in all areas where HDs are handled.
  • Establish a clear protocol for responding to acute personnel exposures, including immediate care and medical evaluation.
  • Conduct drills to ensure staff are competent in responding to spills and exposures.
  • Manage the documentation, investigation, and follow-up of all spills and exposures.
Task 4: Manage the medical surveillance program for personnel.
  • Establish a process for baseline and periodic health evaluations for at-risk personnel.
  • Develop a clear post-exposure follow-up and evaluation plan in collaboration with occupational health.
  • Maintain confidential medical records in compliance with institutional and legal requirements.
  • Implement a system for personnel to report any concerns about their health related to HD exposure.
  • Ensure personnel understand the purpose, process, and voluntary nature of medical surveillance.

Domain 5: Training, Competency, and Professional Accountability (10%)

Task 1: Develop and validate a comprehensive HD training and competency program.
  • Design initial and annual training for all personnel who handle HDs, including pharmacists, technicians, nurses, environmental services staff, and other at-risk personnel.
  • Ensure training covers all aspects of safe handling, from receipt to disposal.
  • Develop practical competency assessments for key skills (e.g., donning/doffing PPE, CSTD use, spill response).
  • Validate staff compounding technique for sterile and non-sterile HDs.
  • Maintain complete and accessible records of all personnel training and competency assessments.
Task 2: Apply ethical and professional standards to the hazardous drug program.
  • Foster a non-punitive culture of safety that encourages the reporting of errors, exposures, and unsafe practices.
  • Apply ethical principles when investigating and responding to incidents of non-compliance or exposure.
  • Uphold professional accountability for the safety of all patients and staff involved in the HD handling process.
  • Ensure transparent communication with staff regarding environmental monitoring results and program risks.
  • Advocate for the resources necessary to maintain a safe and compliant HD handling environment.

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