Brenda Jensen, CPHT, CNMT, MBA

United States Pharmacopeia  (USP) chapter <800> (“hazardous drugs—handling in healthcare settings”) describes standards for the safe handling of hazardous drugs (HDs) that include use of engineering controls, personal protective equipment (PPE), and safe work practices. 

Medical surveillance is recommended for workers who routinely handle HDs because it may lead to early detection of health problems caused by exposure to these agents. It may also help uncover issues within a facility, such as inadequate procedures for handling HDs or lack of compliance to established procedures, ineffective or misused engineering controls or PPE, or weaknesses in employee training programs. The primary purpose of medical surveillance is to minimize adverse health effects from exposure to HDs. 

USP <800> states that a medical surveillance program should include the following: 

Completion of an exit examination when a worker’s employment ends, documenting the information on the employee’s exposure, medical, and reproductive history. Examination and laboratory evaluation should be guided by the individual’s history of exposures and follow the outline of the periodic evaluation. 

Development of a follow-up for workers who have shown health changes suggesting toxicity or experienced an acute exposure. This plan should include evaluation of administrative and engineering controls and equipment to ensure that all systems are accurately and appropriately implemented. 

Development of an organized approach to identify workers who are potentially exposed to HDs on the basis of their duties 

Initial baseline assessment (preplacement) of a worker’s health status and medical history. Data elements collected include a medical history, including reproductive and work history, to assess exposure to HDs, laboratory testing, and physical examination. 

Methods used to assess exposure history include a review of: 

Estimated number of HDs handled per week 

Estimated hours spent handling HDs per month and/or week 

Performance of a physical assessment and laboratory studies linked to target organs of commonly used HDs, such as a baseline complete blood count. Biological monitoring to determine blood or urine levels of specific HDs is not recommended in surveillance protocols but may have a role in the follow-up of acute spills with a specific agent. 

Records of HDs handled, with dosage forms and quantities 

Maintenance of medical records of surveillance according to Occupational Safety and Health Administration regulation concerning access to employee exposure and medical records 

Monitoring data to identify prevention failure leading to health effects; may occur in collaboration with the employee health service 

Monitoring workers’ health prospectively through periodic surveillance using the elements of data gathering described above 

Use of a contracted or entity-based employee health service to perform the medical surveillance while protecting confidentiality of the employees’ personal medical information 

If an exposure-related health change does occur, USP <800> recommends the following actions: 

Compare performance of controls with recommended standards; conduct environmental sampling when analytical methods are available. 

Develop and document a plan of action to prevent additional exposure of workers. 

Ensure that any exposed worker receives confidential notification of any adverse health effect. Offer an alternative duty or temporary reassignment. 

Provide and document a follow-up medical survey to demonstrate the plan’s effectiveness. 

Perform a medical examination that is tailored to the type of exposure. 

Provide ongoing medical surveillance of all workers at risk of exposure to HDs to determine whether the plan implemented is effective. 

Verify and document that all engineering controls are in proper operating condition. 

Verify and document that the worker complied with existing policies. Review policies for the use of PPE and employee compliance with PPE policies and use. Review availability of appropriate PPE. 

Medical surveillance programs track individual workers to determine if any health changes may be caused by exposure to HDs but may also help identify trends in large groups of workers, making it easier to correlate specific health changes with exposure to HDs and develop appropriate treatment plans. Identifying trends may also help pinpoint areas that need improvement in national standards related to employee training programs, engineering controls, PPE, and safe work practices related to handling HDs to, hopefully, limit the number of people negatively affected in the future. 

 is a consultant to sterile and nonsterile compounding pharmacies and owner of Compounding Consultants LLC in Sioux Falls, South Dakota.

Articles

Those who handle hazardous drugs on a regular basis should follow steps to minimize exposure.

USP  Recommends Medical Surveillance

United States Pharmacopeia (USP) Chapter <800> (“HAZARDOUS DRUGS— HANDLING IN HEALTHCARE SETTINGS”) describes standards for the safe handling of hazardous drugs (HDs) that include use of engineering controls, personal protective equipment (PPE), and safe work practices.

Medical surveillance is recommended for workers who routinely handle HDs because it may lead to early detection of health problems caused by exposure to these agents. It may also help uncover issues within a facility, such as inadequate procedures for handling HDs or lack of compliance to established procedures, ineffective or misused engineering controls or PPE, or weaknesses in employee training programs. The primary purpose of medical surveillance is to minimize adverse health effects from exposure to HDs.

USP <800> states that a medical surveillance program should include the following:

Completion of an exit examination when a worker’ s employment ends, documenting the information on the employee’ s exposure, medical, and reproductive history. Examination and laboratory evaluation should be guided by the individual’s history of exposures and follow the outline of the periodic evaluation.

Development of a follow-up for workers who have shown health changes suggesting toxicity or experienced an acute exposure. This plan should include evaluation of administrative and engineering controls and equipment to ensure that all systems are accurately and appropriately implemented.

Development of an organized approach to identify workers who are potentially exposed to HDs on the basis of their duties

Initial baseline assessment (preplacement) of a worker’s health status and medical history. Data elements collected include a medical history, including reproductive and work history, to assess exposure to HDs, laboratory testing, and physical examination.

Methods used to assess exposure history include a review of:

Estimated hours spent handling HDs per month and/or week

Performance of a physical assessment and laboratory studies linked to target organs of commonly used HDs, such as a baseline complete blood count. Biological monitoring to determine blood or urine levels of specific HDs is not recommended in surveillance protocols but may have a role in the follow-up of acute spills with a specific agent.

Records of HDs handled, with dosage forms and quantities

Maintenance of medical records of surveillance according to Occupational Safety and Health Administration regulation concerning access to employee exposure and medical records

Monitoring data to identify prevention failure leading to health effects; may occur in collaboration with the employee health service

Monitoring workers’ health prospectively through periodic surveillance using the elements of data gathering described above

Use of a contracted or entity-based employee health service to perform the medical surveillance while protecting confidentiality of the employees’ personal medical information

If an exposure-related health change does occur, USP <800> recommends the following actions:

Compare performance of controls with recommended standards; conduct environmental sampling when analytical methods are available.

Develop and document a plan of action to prevent additional exposure of workers.

Ensure that any exposed worker receives confidential notification of any adverse health effect. Offer an alternative duty or temporary reassignment.

Provide and document a follow-up medical survey to demonstrate the plan’s effectiveness.

Perform a medical examination that is tailored to the type of exposure.

Provide ongoing medical surveillance of all workers at risk of exposure to HDs to determine whether the plan implemented is effective.

Verify and document that all engineering controls are in proper operating condition.

Verify and document that the worker complied with existing policies. Review policies for the use of PPE and employee compliance with PPE policies and use. Review availability of appropriate PPE.

Medical surveillance programs track individual workers to determine if any health changes may be caused by exposure to HDs but may also help identify trends in large groups of workers, making it easier to correlate specific health changes with exposure to HDs and develop appropriate treatment plans. Identifying trends may also help pinpoint areas that need improvement in national standards related to employee training programs, engineering controls, PPE, and safe work practices related to handling HDs to, hopefully, limit the number of people negatively affected in the future.

Those who handle hazardous drugs on a regular basis should follow steps to minimize exposure.
 

United States Pharmacopeia (USP) General Chapter <800> (“Hazardous Drugs— Handling in Healthcare Settings”) introduced the concept of a “designated person”. The revisions to USP Chapters <795> (“Pharmaceutical Compounding&mdash;Nonsterile Preparations”) and <797> (“Pharmaceutical Compounding&mdash;Sterile Preparations”) also include references to a designated person or persons.

Yet who exactly is a designated person, and what does this person do? USP <795> and <797> define designated person(s) as 1 or more individuals assigned to be accountable and responsible for the operation and performance of the compounding facility and personnel. The chapters then go into detail about exactly what this means.

•  Ensure that follow-up is carried out if deviations, errors, or problems are identified

•  Ensure that formal, written quality assurance and control programs are established

•  Ensure that standard operating procedures (SOPs) are fully implemented

•  Establish, monitor, and document procedures for the handling and storage of components and/or compounded preparations

•  Evaluate whether an exception may be made to personnel preparation requirements when entering the compounding area

•  Evaluate whether individuals with certain conditions should be excluded from working in the compounding area

•  Monitor and observe compounding activities

•  Oversee the personnel training program

Oversight of the personnel training program includes ensuring that the program describes the required training and frequency and how competency will be assessed. It also entails the actual training of compounding personnel or overseeing the training performed by an assigned trainer. The program must equip personnel with the knowledge and skills needed to perform their assigned compounding tasks and must be documented.

USP <795> requires that the designated person(s) be identified in an SOP and also states that if a compounding facility has just 1 person responsible for all the compounding in the facility, that person is the designated person. 

•  Confirm the appropriateness of sterilizing filters

•  Ensure that appropriate air classification requirements are met

•  Ensure that corrective actions are documented and taken if deviations, errors, failures, or problems are identified

•  Ensure that International Organization for Standardization 5 areas are located, operated, maintained, monitored, and certified to have appropriate air quality

•  Ensure that SOPs are appropriate, imple- mented, reviewed, and documented at least every 12 months to ensure they reflect current practice and that they are revised and documented when necessary

•  Ensure that those entering the sterile compounding area maintain the quality of the environment

•  Evaluate whether an exception may be made to personnel preparation requirements when entering the sterile compounding area

•  Evaluate whether individuals with certain conditions should be excluded from working in the sterile compounding area

•  Select an appropriate and reliable source for components that cannot be obtained from an FDA-registered facility

According to both chapters, quality assurance and control programs must establish a system of adherence to procedures, address other quality problems, evaluate complaints and adverse events, and appropriate investigations and corrective actions. Designated person(s) must review and document the review of the program at least every 12 months. 

•  Be qualified and trained to develop and implement appropriate procedures

•  Ensure environmental control of the compounding and storage areas

•  Identify, document, and contain the cause of any discovered contamination

•  Maintain reports of sampling/testing performed, and act on the results

•  Review and document the review of SOPs at least every 12 months

•  Understand the rationale for risk-prevention policies

Keep in mind that the chapters do not dictate who may be a designated person. Each facility needs to determine the qualifications and training needed to fill this position. Training should start by reading and understanding applicable USP chapters as well as federal and state requirements. Facilities may divide the responsibilities of a designated person between 2 or more individuals or designate 1 person for multiple sites. The facility SOPs will need to describe these details. 

The Job Descriptions From USP Include Attention to Detail, Communication, and Leadership Skills Within a Compounding Facility 

Identify the Responsibilities of a “Designated Person”

United States Pharmacopeia (usp)general chapter <800> (“Hazardous Drugs— Handling in Healthcare Settings”) describes standards for the safe handling of hazardous drugs (HDs), including the use of engineering controls, personal protective equipment (PPE), and safe work practices. HDs are defined as those on the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

USP <800> requires that all personnel who handle HDs be trained based on their job functions before independently handling HDs and that the effectiveness of training be demonstrated. Personnel competency must also be reassessed at least every 12 months, and employees must be trained prior to the introduction of new equipment or a new HD and prior to a new or significant change in process or standard operating procedure (SOP). All training and competency assessments must be documented as well.

The chapter also mandates that training include at least the following areas:

Overview of entity’s list of HDs and their risks

Proper disposal of HDs and trace-contaminated materials

Proper use of equipment and devices (eg, engineering controls)

Response to known or suspected HD exposure

Review of the entity’s SOPs regarding handling of HDs

In addition, USP <800> requires policies and procedures that ensure worker safety during all aspects of HD handling. SOPs for handling HDs should include, as applicable:

Deactivation, decontamination, cleaning, and disinfection

Environmental monitoring (eg, wipe sampling)

Hand hygiene and use of PPE based on activity (eg, receipt, transport, compounding, administration, spill, and disposal)

Use and maintenance of proper engineering controls

When developing SOPs and personnel training and competency programs, start by identifying each HD handling activity performed within a facility. HD handling activities may include receipt, storage, compounding, dispensing, transport, administration, and disposal of HD waste. Consider environmental protection and patient and worker safety. For each HD handling activity, define the activity, the location where the activity will be performed, and any requirements for environmental monitoring, such as humidity and temperature. Include who is permitted to perform the activity, what training is needed, and how competency will be assessed. Also include PPE and hand hygiene requirements and cleaning procedures for each HD handling activity and location. USP <800> does not explicitly state all PPE requirements. Refer to table 5 on the NIOSH list for PPE recommendations by activity. For cleaning procedures, include deactivation, decontamination, cleaning, disinfection, frequency of activities, what agents to use, any dilution required, contact or dwell time, and documentation requirements.

SOPs and personnel training and competency programs must include how HDs will be received and unpacked. Describe the process, including the use of a tiered approach, starting with visual examination of the shipping container. Do not forget to detail how damaged packages will be handled and where the spill kit will be located. USP <800> indicates that PPE, including chemotherapy gloves, must be worn, so be sure to train personnel on exactly what to wear. Describe the process for moving HDs from the receiving area to the storage area. HDs must be stored in a manner that prevents spillage or breakage if the container falls.

Training and competency assessments specific to com- pounding must follow not only the requirements in USP <800> but also other appropriate USP standards for compounding, including those in chapter <795> for nonsterile compounding and chapter <797> for sterile compounding. Personnel must also be trained and pass competency assessments on the use, maintenance, and cleaning of each piece of equipment, as well as receive training regarding proper labeling, transport, stor- age, and disposal of HDs and use of safety data sheets based on the Globally Harmonized System of Classification and Labelling of Chemicals. All personnel who may be required to clean HD spills must receive proper training in spill management and the use of PPE and NIOSH-certified respirators. Personnel who transport, compound, or administer HDs must also document their training according to Occupational Safety and Health Administration standards and other applicable laws and regulations. 

Brenda Jensen, CPhT, CNMT, MBA, is a consultant to sterile and nonsterile compounding pharmacies and an owner of Compounding Consultants, LLC, in Sioux Falls, South Dakota.

USP general chapter <800> hazardous drugs—handling in healthcare settings. US Pharmacopeial Convention website. usp.org/compounding/general-chap- ter-hazardous-drugs-handling-healthcare. Accessed April 9, 2019.

USP  Encompasses Training, Assessment, and Standard Operating Procedures to Ensure Personnel Are Properly Prepared

How Does a Pharmacy Train Staff to Handle HDs?

United States Pharmacopeia (USP) general chapter <800> (“Hazardous Drugs—Handling in Healthcare Settings”) describes standards for the safe handling of hazardous drugs (HD, including the use of engineering controls, personal protective equipment (PPE), and safe work practices. HDs are defined as those on the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

		Overview of entity’s list of HDs and their risks

		Proper disposal of HDs and trace-contaminated materials

		Proper use of equipment and devices (eg, engineering controls)

		Response to known or suspected HD exposure

		Review of the entity’s SOPs regarding handling of HDs

		Deactivation, decontamination, cleaning, and disinfection

		Environmental monitoring(eg, wipe sampling)

		Hand hygiene and use of PPE based on activity (eg, receipt, transport, compounding, administration, spill, and disposal)

		Use and maintenance of proper engineering controls

When developing SOPs and personnel training and competency programs, start by identifying each HD handling activity performed within a facility. HD handling activities may include receipt, storage, compounding, dispensing, transport, administration, and disposal of HD waste. Consider environmental protection and patient and worker safety. For each HD handling activity, define the activity, the location where the activity will be performed, and any requirements for environmental monitoring, such as humidity and temperature. Include who is permitted to perform the activity, what training is needed, and how competency will be assessed. Also include PPE and hand hygiene requirements and cleaning procedures for each HD handling activity and location. USP <800> does not explicitly state all PPE requirements. Refer to table 5 on the NIOSH list for PPE recommendations by activity. For cleaning procedures, include deactivation, decontamination, cleaning, disinfection, frequency of activities, what agents to use, any dilution required, contact or dwell time, and documentation requirements. 

Training and competency assessments specific to compounding must follow not only the requirements in USP <800> but also other appropriate USP standards for compounding, including those in chapter <795> for nonsterile compounding and chapter <797> for sterile compounding. Personnel must also be trained and pass competency assessments on the use, maintenance, and cleaning of each piece of equipment, as well as receive training regarding proper labeling, transport, storage, and disposal of HDs and use of safety data sheets based on the Globally Harmonized System of Classification and Labelling of Chemicals. All personnel who may be required to clean HD spills must receive proper training in spill management and the use of PPE and NIOSH-certified respirators. Personnel who transport, compound, or administer HDs must also document their training according to Occupational Safety and Health Administration standards and other applicable laws and regulations.

USP general chapter <800> hazardous drugs—handling in healthcare settings. US Pharmacopeial Convention website. usp.org/compounding/general-chapter-hazardous- drugs-handling-healthcare. Accessed April 9, 2019.

USP  encompasses training, assessment, and standard operating procedures to ensure personnel are properly prepared.

United States Pharmacopeia (usp) chapter <800> hazardous drugs—handling in health care settings describes standards for the safe handling of hazardous drugs which include the use of engineering controls, personal protective equipment (PPE), and safe work practices.

Hazardous drugs are defined as those on the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs used in Healthcare Settings, although some of these drugs and dosage forms pose less of a hazard than others. In some circumstances, an assessment of risk (AOR) may be performed and implemented to determine alternative containment strategies and/or work practices.

It is important to understand that if an AOR is not performed and implemented on a specific hazardous drug or dosage form, it must be handled according to USP <800>. There are 2 instances when an AOR is not permitted.

An AOR is not permitted when handling hazardous drug active pharmaceutical ingredients (APIs). APIs are defined in USP <800> as “any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.”

An AOR is also not permitted when handling antineoplastic drugs that require manipulation, other than counting or repackaging. Instead, an AOR may be used to identify alternative containment strategies when handling final dosage forms of hazardous compounded preparations and when handling conventionally manufactured hazardous drug products, including antineoplastic dosage forms that do not require any further manipulation other than repackaging, unless required by the manufacturer. For other hazardous drugs, an AOR may be used to determine alternative containment strategies and/or work practices.

When performing an AOR, consideration must be given to the type of hazardous drug. The current NIOSH list is divided into 3 groups. Group 1 includes antineoplastic drugs, group 2 includes nonantineoplastic drugs that meet 1 or more of the NIOSH criteria for a hazardous drug, and group 3 includes drugs that primarily pose a reproductive risk. Consideration must also be given to the dosage form, risk of exposure, packaging, and any manipulation that might be required. The AOR needs to document what alternative containment strategies and/or work practices will be used for each applicable aspect of the hazardous drug handling process, including receipt, storage, compounding, dispensing, administration, transport and disposal. AORs must be reviewed at least every 12 months, and the review must be documented.

Let’s walk through a couple of scenarios:

A technician compounds a NIOSH group 2 topical hormone cream from APIs in a containment ventilated enclosure (CVE) located in a corner of the pharmacy designated for compounding. Is this permissible per USP <800>?

No. Hazardous-drug APIs must be handled per the containment requirements of USP <800>. The CVE must be located within a containment secondary engineering control that is externally vented, has a pressure of —0.01 to –0.03 inches of water column relative to adjacent areas, and has at least 12 air changes per hour. In addition, the CVE used in this example must itself either be externally vented or have redundant high-efficiency particulate air filters in series. An AOR may be used only when a compounded preparation made from a hazardous drug API is in its final dosage form.

A technician compounds a NIOSH group 2 topical hormone cream from APIs following the containment requirements of USP <800>. When the compounding is complete, the compounded preparation is checked by a pharmacist and then taken to the retail area, where it will be stored until dispensing. Is this permissible per USP <800>?

Yes. An AOR may be used to identify alternative containment strategies when handling final dosage forms of hazardous compounded preparations. The AOR will need to address storage, packaging, labeling, dispensing, and, if applicable, transport and disposal.

Keep in mind that the scenarios above discuss containment. USP <800> has additional requirements that include creating standard operating procedures for each aspect of the hazardous drug handling process, designating a person to oversee compliance, identifying hazardous drugs in use, and ensuring personnel are competent and trained, employ safe work practices, and use proper PPE. 

, is a consultant to sterile and nonsterile compounding pharmacies and an owner of Compounding Consultants LLC in Sioux Falls, South Dakota. 

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeial Convention website. usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Accessed February 19, 2019.

The views and opinions expressed are those of the author and are not endorsed by or affliated with United States Pharmacopeia. In some circumstances, an assessment of risk may be performed and implemented to determine alternative containment strategies and/or work practices.

If an assessment of risk is not conducted and implemented on a specific hazardous drug or dosage form, it must be handled according to the standard.