CHDHP Certification Review

Certified Hazardous Drug Handling Pharmacist (CHDHP) Review

A Review Guide for the Certified Hazardous Drug Handling Pharmacist (CHDHP) Exam

Block 1: Foundations & Regulatory Framework

ACPH: Air Changes Per Hour

AoR: Assessment of Risk

ASHP: American Society of Health-System Pharmacists

BOP: Board of Pharmacy

BSC: Biological Safety Cabinet

CACI: Compounding Aseptic Containment Isolator

C-PEC: Containment Primary Engineering Control

C-SCA: Containment Segregated Compounding Area

C-SEC: Containment Secondary Engineering Control

CSTD: Closed System Drug-Transfer Device

EPA: Environmental Protection Agency

HD: Hazardous Drug

HEPA: High-Efficiency Particulate Air

NIOSH: National Institute for Occupational Safety and Health

OSHA: Occupational Safety and Health Administration

PAPR: Powered Air-Purifying Respirator

PPE: Personal Protective Equipment

SDS: Safety Data Sheet

SOP: Standard Operating Procedure

USP: United States Pharmacopeia

  • The primary goal of an HD handling program is to protect healthcare personnel, patients, and the environment from exposure to hazardous drugs.
  • A hazardous drug is any drug identified as hazardous by NIOSH or that meets specific criteria for toxicity.
  • HDs can cause a range of health effects, including cancer, reproductive toxicity, and organ damage.
  • Exposure can occur at any point in the drug's lifecycle, from receipt to administration and disposal.
  • The fundamental principle of HD safety is containment.
  • This involves using a combination of engineering controls, administrative controls (SOPs), and PPE.
  • A comprehensive safety program is required for any facility that handles HDs.
  • The designated person (often a pharmacist) is responsible for overseeing this program.
  • The program must be based on a thorough risk assessment of all handling activities.
  • The ultimate aim is to minimize exposure to as low a level as reasonably achievable.
  • USP <800> provides standards for the safe handling of hazardous drugs in healthcare settings.
  • Its purpose is to promote patient safety, worker safety, and environmental protection.
  • The chapter applies to all healthcare personnel who handle HDs, including pharmacists, technicians, nurses, and environmental services staff.
  • It covers all aspects of the HD lifecycle, from receipt to disposal.
  • USP chapters below <1000> are considered mandatory where they are incorporated by regulatory bodies like state boards of pharmacy.
  • USP <800> is designed to be harmonized with other USP chapters, such as <795> for non-sterile compounding and <797> for sterile compounding.
  • It establishes minimum standards for facility design, engineering controls, PPE, and work practices.
  • The chapter requires each entity to maintain a list of the HDs it handles.
  • It also requires the designation of a qualified and trained person to be responsible for the program.
  • A CHDHP must be a subject matter expert on every section of USP <800>.
  • The National Institute for Occupational Safety and Health (NIOSH) maintains the official list of hazardous drugs used in healthcare.
  • This list is the primary reference for determining which drugs are subject to USP <800> handling requirements.
  • A drug is considered hazardous if it exhibits one or more of six characteristics in humans or animals: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure/toxicity profiles of new drugs that mimic existing hazardous drugs.
  • The list is updated periodically (typically every 2-3 years).
  • The CHDHP is responsible for reviewing new drugs against the NIOSH criteria to determine if they should be handled as hazardous.
  • The NIOSH list is organized into three groups.
  • Group 1: Antineoplastic drugs (e.g., chemotherapy).
  • Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria (e.g., certain antivirals, hormones).
  • Group 3: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding.
  • Each entity must maintain its own customized list of HDs based on its specific formulary.
  • The Occupational Safety and Health Administration (OSHA) is the primary federal agency responsible for ensuring worker safety.
  • OSHA's Hazard Communication Standard requires employers to inform employees about the chemical hazards they are exposed to at work.
  • This includes providing access to Safety Data Sheets (SDSs) and providing training on chemical hazards.
  • While OSHA does not have a specific standard for HDs, it can use the General Duty Clause to cite employers for failing to provide a safe workplace.
  • OSHA often references consensus standards, like USP <800>, as evidence of recognized hazards.
  • State Boards of Pharmacy are the primary enforcers of USP chapters.
  • The Environmental Protection Agency (EPA) regulates the disposal of hazardous waste under the Resource Conservation and Recovery Act (RCRA).
  • Some chemotherapy drugs are considered RCRA-hazardous waste.
  • The Joint Commission also has standards related to medication management and environmental safety that apply to HDs.
  • A CHDHP must be aware of the overlapping requirements of all these agencies.
  • Healthcare workers are exposed to low levels of HDs over long periods of time.
  • The primary routes of exposure are inhalation of aerosols, dermal absorption, and ingestion (e.g., hand-to-mouth).
  • Exposure can also occur through accidental injection (needlesticks).
  • Studies have shown widespread contamination of surfaces in areas where HDs are handled.
  • Acute health effects of exposure can include skin rashes, nausea, and allergic reactions.
  • Chronic health effects are the primary concern and are much more serious.
  • These include an increased risk of cancer, adverse reproductive outcomes (infertility, miscarriage, birth defects), and organ damage.
  • The risk is often related to the cumulative dose of exposure over a career.
  • A CHDHP's main job is to design systems that prevent these exposures.
  • This is accomplished by breaking the chain of exposure at every step of the handling process.

Block 2: Facility Design & Engineering Controls

  • Engineering controls are the foundation of worker protection and are the most effective way to control HD exposure.
  • Containment Primary Engineering Control (C-PEC): This is the ventilated device designed to minimize worker exposure, such as a Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI).
  • Containment Secondary Engineering Control (C-SEC): This is the room in which the C-PEC is placed. It has specific requirements for pressure, air changes, and ventilation.
  • The relationship between the C-PEC and C-SEC is critical.
  • The C-PEC provides primary containment of the drug.
  • The C-SEC provides secondary containment in case of a spill or escape from the C-PEC.
  • A Containment Segregated Compounding Area (C-SCA) is a separate, negative pressure room with at least 12 ACPH that can be used for sterile HD compounding with a shorter beyond-use date.
  • A CHDHP must be an expert in the design and certification of these engineering controls.
  • These facility requirements are a major focus of USP <800>.
  • They represent a significant investment for healthcare facilities.
  • The C-PEC is the hood or isolator where all manipulation of HDs must occur.
  • For sterile compounding, a Class II Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI) must be used.
  • A Class II BSC provides personnel, product, and environmental protection.
  • It uses a curtain of air at the front to prevent aerosols from escaping and HEPA-filtered air to maintain sterility.
  • A CACI is a completely enclosed "glovebox" system that provides a higher level of personnel protection.
  • For non-sterile compounding, a Class I BSC or a Containment Ventilated Enclosure (CVE) can be used.
  • A key requirement is that the C-PEC must be externally vented.
  • This prevents contaminated air from being recirculated back into the room.
  • C-PECs must be certified by a qualified professional every six months.
  • The CHDHP is responsible for ensuring that the correct type of C-PEC is used and that it is properly maintained.
  • The C-SEC is the room where the C-PEC is located.
  • For HD handling, the C-SEC must be externally vented.
  • It must be physically separate from other areas.
  • It must have a negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas.
  • Negative pressure ensures that air flows into the room, not out of it, preventing contaminants from escaping.
  • The room must have a sufficient number of Air Changes Per Hour (ACPH).
  • For sterile HD compounding, the C-SEC buffer room must have at least 30 ACPH.
  • For non-sterile HD compounding, the C-SEC must have at least 12 ACPH.
  • A pressure gauge must be present to continuously monitor the room pressure.
  • The CHDHP must understand these complex HVAC requirements and work with facility engineers to ensure they are met.
  • Non-sterile HD compounding includes activities like crushing tablets or preparing oral suspensions.
  • This must be performed in a dedicated C-PEC (e.g., a CVE or Class I BSC).
  • The C-PEC must be located in a C-SEC that is externally vented and has at least 12 ACPH.
  • The C-SEC must be under negative pressure relative to adjacent areas.
  • If the C-PEC is a pass-through isolator, it can be located in a room without these requirements, provided it is maintained under negative pressure.
  • All personnel must wear appropriate PPE, including double gloves and a gown.
  • A separate set of equipment (mortars, pestles, spatulas) must be dedicated for use with HDs.
  • The final compounded product must be dispensed in a way that minimizes exposure risk (e.g., using an oral syringe).
  • The CHDHP is responsible for developing and validating the cleaning procedures for all equipment.
  • These requirements are designed to protect staff from exposure to powders and aerosols.
  • Sterile HD compounding requires adherence to both USP <797> (for sterility) and USP <800> (for containment).
  • It must be performed in a C-PEC (Class II BSC or CACI) that provides an ISO Class 5 environment.
  • The C-PEC must be located in an ISO Class 7 buffer room (the C-SEC).
  • The C-SEC must be under negative pressure and have at least 30 ACPH.
  • The C-SEC must be adjacent to an ISO Class 7 ante-room.
  • The ante-room must be under positive pressure relative to the non-HD areas but negative relative to the C-SEC.
  • Alternatively, compounding can occur in a Containment Segregated Compounding Area (C-SCA).
  • A C-SCA is a negative pressure room with at least 12 ACPH, but it does not need to be ISO classified.
  • However, products compounded in a C-SCA have a much shorter beyond-use date (12 hours).
  • A CHDHP must be an expert in these complex cleanroom design and certification standards.

Block 3: Personal Protective Equipment (PPE)

  • PPE is the last line of defense against exposure, used in addition to engineering and administrative controls.
  • The type of PPE required depends on the specific HD and the handling activity.
  • PPE must be selected based on its ability to protect against the specific chemical hazard.
  • All PPE used for HDs must be considered contaminated and disposed of as hazardous waste.
  • Staff must be thoroughly trained on the proper selection, use, and disposal of all PPE.
  • Competency in donning (putting on) and doffing (taking off) PPE must be demonstrated.
  • Doffing must be done in a way that prevents self-contamination.
  • PPE should never be worn outside of the HD handling area.
  • The CHDHP is responsible for creating a comprehensive PPE program.
  • This includes selecting appropriate PPE and developing clear policies for its use.
  • Gloves: Must be chemotherapy gloves that meet the ASTM standard D6978.
  • Double gloving is required for compounding and administering HDs.
  • The outer glove should be sterile for sterile compounding.
  • Gloves must be changed every 30 minutes during compounding or immediately when torn or contaminated.
  • Gowns: Must be disposable, resistant to permeability by HDs, and close in the back.
  • Gowns must be changed per manufacturer's information for permeation or every 2-3 hours if no information is available.
  • Shoe covers: Two pairs are required for entering sterile HD compounding areas.
  • Head and hair covers are also required.
  • Eye and face protection (goggles and a face shield) must be worn when there is a risk of splashes or spills.
  • A surgical mask is not adequate respiratory protection but can protect from splashes.
  • Surgical masks do not provide respiratory protection from drug aerosols or vapors.
  • An N95 respirator is sufficient for protecting against airborne particles but not against gas or vapors.
  • An elastomeric half-mask with a multi-gas cartridge and P100-filter should be used when vapor exposure is a risk.
  • A Powered Air-Purifying Respirator (PAPR) provides a higher level of protection and may be needed for certain high-risk activities like cleaning up large spills.
  • Personnel who need to wear a tight-fitting respirator (like an N95) must undergo a formal fit-testing procedure.
  • This is a requirement of OSHA's Respiratory Protection Standard.
  • Fit-testing must be done annually.
  • The CHDHP must conduct a risk assessment to determine when respiratory protection is needed.
  • This includes activities outside of the C-PEC, such as unpacking HDs not contained in plastic.
  • A complete respiratory protection program is a key component of HD safety.
  • Donning is the process of putting on PPE.
  • It should be done in a specific sequence to ensure full coverage.
  • Typically, shoe covers are donned first, followed by hair/beard covers, face mask, and then gown. Gloves are last.
  • Doffing is the process of removing PPE.
  • This is a critical step, as the outside of the PPE is considered contaminated.
  • The goal is to remove the PPE without touching the contaminated exterior with bare skin.
  • Gloves are typically removed first, followed by the gown (turning it inside out as it is removed).
  • Hand hygiene must be performed immediately after removing PPE.
  • The specific sequence for donning and doffing should be defined in a formal SOP.
  • Personnel must be trained on and demonstrate competency in these procedures.

Block 4: The HD Handling Lifecycle

  • HDs must be unpacked in an area that is neutral or negative pressure. They cannot be unpacked in sterile compounding areas.
  • Personnel unpacking HDs must wear appropriate PPE, including chemotherapy gloves.
  • A spill kit must be readily available in the receiving area.
  • HDs must arrive from the supplier in sealed containers that are visually inspected for damage upon receipt.
  • Damaged containers should be treated as a potential spill and handled accordingly.
  • The outer shipping container should be removed in the receiving area.
  • The inner container should be wiped down with a suitable decontaminant.
  • HDs must be immediately delivered to the designated HD storage area.
  • They should not be stored in general inventory areas.
  • This first step is a critical point for preventing the spread of contamination throughout the facility.
  • HDs must be stored in a manner that prevents spillage or breakage.
  • They must be stored separately from non-hazardous drugs.
  • This separation prevents contamination of the general stock and reduces the risk of selection errors.
  • The storage area must be externally vented and have negative pressure relative to surrounding areas.
  • This prevents contaminants from escaping into the rest of the pharmacy.
  • HDs requiring refrigeration must be stored in a dedicated refrigerator within this negative pressure area.
  • The shelves should have raised lips to prevent items from falling off.
  • HDs should not be stored on the floor.
  • Warning labels indicating "Hazardous Drug" must be clearly visible on shelves and bins.
  • The CHDHP must ensure that the storage area meets all USP <800> requirements.
  • All compounding of HDs must occur within a C-PEC located in an appropriate C-SEC.
  • Personnel must be fully gowned in appropriate PPE before entering the compounding area.
  • A plastic-backed preparation mat should be placed on the work surface of the C-PEC to contain any small spills.
  • A Closed System Drug-Transfer Device (CSTD) should be used for the compounding and administration of antineoplastic HDs when the dosage form allows.
  • CSTDs are devices that mechanically prohibit the transfer of contaminants into the system and the escape of HDs out of the system.
  • Negative pressure techniques must be used when withdrawing from vials to prevent aerosolization.
  • All final compounded products must be placed in a sealed container and labeled appropriately.
  • The outer glove must be removed and discarded in the C-PEC before removing the final product.
  • The final product must be wiped down before leaving the C-PEC.
  • The CHDHP must develop and validate all SOPs for safe compounding.
  • Final HD products must be clearly labeled with a warning that they are hazardous.
  • They must be dispensed in sealed, crush-resistant containers to protect against breakage and leakage during transport.
  • Pneumatic tube systems should not be used to transport liquid HDs due to the risk of breakage.
  • If a pneumatic tube system is used for any HD, the facility must have a specific procedure for decontaminating the system in case of a leak.
  • Personnel transporting HDs should be trained on what to do in case of a spill.
  • For manufactured solid dosage forms (tablets, capsules), counting and repackaging should be done carefully to avoid generating dust.
  • Automated counting machines should not be used for HDs unless they are dedicated and can be properly decontaminated.
  • The CHDHP should audit the dispensing and transport processes to ensure compliance with SOPs.
  • These steps are critical for preventing the spread of contamination outside of the pharmacy.
  • Clear labeling is key to alerting all downstream handlers (nurses, patients) to the hazardous nature of the drug.
  • The risk of exposure is high during the administration of HDs.
  • Nurses must wear appropriate PPE, including double gloves and a chemotherapy gown, when administering injectable HDs.
  • A Closed System Drug-Transfer Device (CSTD) is required for the administration of antineoplastic HDs when the dosage form allows.
  • IV tubing should be primed with a non-drug solution in the pharmacy C-PEC before the HD is added.
  • Crushing tablets or opening capsules of HDs should be avoided.
  • If it must be done, it should be performed in a plastic pouch to contain any dust.
  • All materials used in the administration (e.g., tubing, empty bags, used PPE) are considered contaminated waste.
  • The CHDHP must collaborate closely with nursing leadership to develop and implement safe administration policies.
  • This includes providing training and education to all nursing staff who handle HDs.
  • Ensuring safety at the bedside is a critical part of the comprehensive HD program.
  • This is a four-step process for cleaning all areas and equipment used for HD handling.
  • Deactivation: Renders the HD inert or inactive. This is typically done with an oxidizer like peroxide or sodium hypochlorite (bleach).
  • Decontamination: Removes the inactivated HD residue. This is done after deactivation, using an agent like alcohol or sterile water.
  • Cleaning: Removes organic and inorganic material. This is done with a germicidal detergent.
  • Disinfection: Destroys microorganisms. This is required for sterile compounding areas and is done with an EPA-registered disinfectant.
  • The specific agents and frequency of each step must be defined in a formal SOP.
  • The CHDHP is responsible for validating the effectiveness of this cleaning process.
  • All staff who perform these tasks must be trained and demonstrate competency.
  • Appropriate PPE must be worn throughout the entire process.
  • This is a critical, and often misunderstood, part of preventing residual surface contamination.
  • All materials that come into contact with HDs must be managed as hazardous waste.
  • This includes all used PPE, compounding supplies, and empty vials and syringes.
  • Trace contaminated items (like empty vials and used gowns) are typically disposed of in yellow waste containers.
  • Bulk contaminated items (like partially used IV bags) may be considered RCRA-hazardous waste.
  • RCRA-hazardous waste must be disposed of in black waste containers and handled by a licensed hazardous waste vendor.
  • The EPA regulates the disposal of this waste.
  • Sharps contaminated with HDs must be placed in a hazardous-rated sharps container.
  • The CHDHP must develop clear policies for the segregation and disposal of all HD waste.
  • All staff must be trained on these procedures.
  • Improper disposal can pose a risk to environmental services staff and the environment.

Block 5: Program Management & Oversight

  • USP <800> allows for an exception to some of its strictest containment requirements for certain dosage forms.
  • This exception is made through a formal Assessment of Risk (AoR).
  • An AoR can be performed for specific HDs on the NIOSH list that are in their final, solid dosage form (e.g., intact tablets or capsules).
  • The AoR allows an entity to develop alternative containment strategies and work practices for these drugs.
  • For example, an AoR might allow for counting these tablets in the general pharmacy area instead of a negative pressure room.
  • However, an AoR cannot be performed for any antineoplastic drugs that require manipulation or any active pharmaceutical ingredient (API).
  • The AoR must be documented and reviewed at least every 12 months.
  • The designated person (CHDHP) is responsible for overseeing the AoR process.
  • This is a key area where the pharmacist's professional judgment is applied.
  • The goal is to provide a safe alternative while still protecting staff.
  • All personnel who handle HDs must receive job-specific training before they begin their duties.
  • This training must cover the facility's SOPs, proper use of PPE, and spill management.
  • The effectiveness of this training must be demonstrated through a competency assessment.
  • Competency must be reassessed at least every 12 months.
  • All training and competency assessments must be documented.
  • This documentation is a key requirement of USP <800>.
  • The CHDHP is responsible for developing and overseeing this training and competency program.
  • The program should be tailored to the specific roles and responsibilities of different staff members (e.g., pharmacy vs. nursing).
  • Personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs.
  • A robust training program is essential for a successful safety culture.
  • USP <800> requires that a medical surveillance program be made available to all healthcare workers who handle HDs.
  • The purpose is to monitor for potential health effects from HD exposure and to detect any issues at an early stage.
  • The program should include a baseline assessment of the worker's health before they begin handling HDs.
  • It should also include periodic follow-up assessments.
  • The program should track any reported symptoms or health changes.
  • It should also include a plan for follow-up and care in the event of a known exposure.
  • The CHDHP works with occupational health to develop and implement this program.
  • Participation in the program is typically voluntary for the employee.
  • This is a key component of a comprehensive occupational health and safety program.
  • It demonstrates the organization's commitment to the long-term health of its staff.
  • Environmental monitoring involves testing the environment for contamination.
  • For HDs, this is done through surface wipe sampling.
  • Wipe sampling is used to detect and measure the amount of residual HD contamination on work surfaces.
  • USP <800> requires that a wipe sampling program be implemented.
  • Sampling should be performed routinely (e.g., every six months).
  • The sampling plan should include a variety of surfaces, both inside and outside the C-PEC.
  • Examples of areas to sample include the floor in front of the BSC, counters, and doorknobs.
  • Currently, there are no universally accepted standards for what constitutes a "safe" level of contamination.
  • The goal is to use the results as a quality indicator to assess the effectiveness of cleaning procedures and containment strategies.
  • The CHDHP is responsible for developing the wipe sampling plan and for interpreting and acting on the results.
  • There must be a formal policy and procedure for managing HD spills.
  • All personnel who handle HDs must be trained on this procedure.
  • Spill kits must be readily accessible in all areas where HDs are handled.
  • The first step in managing a spill is to contain it and restrict access to the area.
  • Personnel cleaning the spill must don appropriate PPE, including respiratory protection for larger spills.
  • The spill should be cleaned using the materials in the spill kit, working from the outside of the spill inward.
  • All spill cleanup materials must be disposed of as hazardous waste.
  • The area must be decontaminated and cleaned after the visible spill is removed.
  • All spills must be documented in a formal incident report.
  • The CHDHP is responsible for ensuring the adequacy of the spill management program.

The NIOSH List of Hazardous Drugs

The foundational assessment tool. It is the primary resource used to identify which drugs in an organization's formulary must be handled according to USP <800> standards. The CHDHP uses this list to create and maintain the entity-specific list of HDs.

Assessment of Risk (AoR) Template

A structured document used to formally evaluate the risk of specific HD dosage forms (e.g., intact tablets) and to define alternative containment strategies. It typically includes the drug name, dosage form, potential for exposure, and the specific alternative procedures to be followed.

USP <800> Compliance Checklist

A detailed checklist, often provided by consulting groups or professional organizations like ASHP, that breaks down every requirement of USP <800>. The CHDHP uses this tool to conduct a thorough gap analysis of the organization's practices against the standard's requirements.

Air Changes Per Hour (ACPH)

A critical metric for C-SEC ventilation. It measures how many times the entire volume of air in a room is replaced in one hour. It is calculated from the room's volume and the airflow rate supplied by the HVAC system.

ACPH=(Total Airflow in CFM × 60 min/hr) / Room Volume (ft³)

Interpreting Wipe Sample Results

This is not a formula but a data interpretation skill. The lab report for a wipe sample will provide a result in mass per unit of area (e.g., nanograms/cm²). The CHDHP compares this result to the organization's established action level to determine if cleaning procedures are effective or if further investigation is needed.

  • Containment is Everything. The entire framework of HD safety is built on the principle of keeping the hazardous drug contained and away from the healthcare worker.
  • The Hierarchy of Controls is Your Guide. Always prioritize higher-level controls. Engineering controls (like a BSC) are more effective than administrative controls (like a policy), which are more effective than PPE.
  • You Can't Manage What You Don't Measure. A successful program relies on data from sources like environmental wipe sampling, medical surveillance, and audits to verify that controls are working and to drive continuous improvement.
  • There is No "Safe" Level of Exposure. For carcinogenic drugs, it is assumed that there is no safe level of exposure. The goal is always to minimize exposure to as low as reasonably achievable (ALARA).
  • USP <800> is the Minimum Standard. It represents the floor, not the ceiling. A great HD program is built on a culture of safety that goes beyond simply checking the boxes of the regulations.
  • Be a Collaborative Champion. Implementing a comprehensive HD safety program requires collaboration with nearly every department in the hospital. The CHDHP must be an effective communicator, educator, and leader.
  • Every Step in the Lifecycle is a Potential Point of Exposure. A holistic view is essential. Safety efforts must address every point where the drug is handled, from the loading dock to the patient's bedside and final disposal.
  • Protecting Staff Protects Patients. A program that keeps healthcare workers safe from exposure also fosters a culture of care and attention to detail that ultimately benefits patient safety as well.
  • Documentation is Your Proof of Compliance. From training records to competency assessments to spill reports, meticulous documentation is non-negotiable and the key to surviving a regulatory inspection.
  • This is an Occupational Health Issue. The CHDHP is not just a pharmacy specialist; they are a key leader in the organization's overall occupational health and safety program.
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