Chapter 27 - Handling Hazardous Drugs in the Health Care Setting
Part 3 - Professional Services
| Manual Exhibits | Description |
|---|---|
| Manual Exhibit 3-27-A, | “Safe Handling of Hazardous Drugs for Public Health Nurses (PHN)” |
| Manual Exhibit 3-27-B, | “Hazardous Drug Waste Management” |
| Manual Exhibit 3-72-C, | “Spill Management and Control” |
| Manual Exhibit 3-27-D, | “Emergency Response to Occupational Exposures” |
| Manual Exhibit 3-27-E, | “Medical Surveillance” |
| Manual Exhibit 3-27-F, | “Facility Considerations and Exceptions” |
| Manual Exhibit 3-27-G, | “Hazardous Drug Acknowledgement of Risk Drugs” |
3-27.1 INTRODUCTION
- Purpose. This chapter describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection.
- Background. Health care workers (e.g. pharmacy and nursing personnel, physicians, operating room personnel, and environmental services) who prepare or administer HDs may face many health risks when exposed to these drugs in the workplace. National preventative measures and guidelines have been developed to provide employees with the greatest protection when handling or administering HDs. The Occupational Safety and Health Act of 1970 established the National Institute for Occupational Safety and Health (NIOSH), a research agency in the Centers for Disease Control and Prevention, Department of Health and Human Services, to study and assist workers to create safe and healthy work environments. Hazardous Drugs are various types of drugs associated with or suspected of causing adverse health effects when employees are exposed.
- Risks from HDs. The NIOSH defines a HD as one that may possess any of the following characteristics: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, structure, and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.
- Types of HDs. These drugs include but are not limited to antineoplastic drugs, antiviral drugs, hormones, some bioengineered drugs, and other drugs.
- Risk of Exposure. Workers may be exposed to HDs through inhalation and dermal absorption, and to a lesser degree, through ingestion and injection. There are a number of situations that may place employees at risk of exposure to HDs:
- Receiving, shipping, storage, or transportation;
- Preparation of individual doses;
- Administering HDs; and
- Waste handling and maintenance.
- Hazardous Drugs List. The NIOSH compiles a list of HDs used in health care.
- Policy. The Indian Health Service (IHS) will limit staff, contractor, and patient exposure to HDs to the lowest possible level. All HDs must be handled with all containment strategies in this chapter.
- Authorities.
- ANSI/ASHRAE/ASHE Standard 170-2013: Ventilation of Health Care Facilities.
- Hazardous Drugs, Handling in Health care Settings, U.S. Pharmacopeia 800.
- Federal Food, Drug, and Cosmetic Act, 21 USC 301 et. seq.
- Occupational Safety and Health Act of 1970, 29 USC 651 et. seq.
- Resource Conservation and Recovery Act (RCRA), 42 USC 6901 et. seq.
- 29 CFR Part 1910.
- U.S. Pharmacopeia (USP). Chapter <797> Pharmaceutical Compounding- Sterile Preparations. In: 2022 USP Compounding Compendium. Rockville, MD: USP Convention
- DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138), “NIOSH List of Antineoplastic and Other Hazardous Drugs in Health care Settings, 2016.”
- DHHS (NIOSH) Publication Number 2009-106, “Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs.”
- DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138). “NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care settings.”
- OSHA. 2016. “Controlling Occupational Exposure to Hazardous Drugs.” OSHA Publication.
- Definitions.
- Air Changes per Hour (ACH). A commonly used air exchange term that is calculated by dividing the air flow rate (in volume units per hour) by the room volume. Theoretically, it indicates how many times the entire volume of air in the room is replaced per hour. The ACH for rooms requiring positive pressure to adjacent spaces are based on supply air flow rates, while rooms requiring negative pressure are based on exhaust air flow rates.
- Biological Safety Cabinet (BSC). A type of ventilated cabinet often used for preparation of HDs. These cabinets use a combination of high efficiency particulate air (HEPA) filtration, vertical laminar flow, and containment to protect against particulates, aerosols, and vapors for personnel, product, or environmental purposes. The BSCs are divided into three general classes (Class I, Class II, and Class III). Class II BSCs are further divided into types (Type A1, Type A2, Type B1, and Type B2). Refer to USP <800> for greater detail.
- Cleaning. The process to remove contaminants, organic and inorganic material from objects and surfaces using water, detergents, surfactants, solvents, and/or other chemicals. Cleaning may not be performed while compounding activities are occurring.
- Closed System Drug-Transfer Devices (CSTD). Drug transfer devices that mechanically prohibit the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system.
- Compounding Aseptic Containment Isolator (CACI). A specific type of compounding aseptic isolator (CAI) that is designed for the compounding of sterile HDs. The CACI is designed to provide worker protection from exposure to undesirable levels of airborne drugs throughout the compounding and material transfer processes and to provide an aseptic environment with unidirectional air flow for compounding sterile preparations.
- Compounding Aseptic Isolator. An isolator specifically designed for compounding sterile, non-hazardous pharmaceutical ingredients or preparations. The CAI is designed to maintain an aseptic compounding environment throughout the compounding and material transfer processes.
- Containment Primary Engineering Control (C-PEC). A C-PEC is a ventilated device designed and operated to minimize worker and environmental exposures to HDs. Examples of C-PECs include: BSCs, CACIs, and containment ventilated enclosures (CVEs). C-PECs control emissions of airborne contaminants through the following:
- The full or partial enclosure of a potential contaminant source;
- The use of air flow capture velocities to trap and remove airborne contaminants near their point of generation;
- The use of air pressure relationships that define the direction of air flow into the cabinet; and
- The use of HEPA filtration on all potentially contaminated exhaust streams.
- Containment Secondary Engineering Control (C-SEC). The room with fixed walls in which the C-PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room.
- Containment Segregated Compounding Area (C-SCA). A type of C SEC with nominal requirements for airflow and room pressurization as they pertain to HD compounding.
- Containment Ventilated Enclosure (CVE). A full or partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants through HEPA filtration and prevent their release into the work environment.
- Deactivation. Treatment of a HD containment on surfaces with a chemical, heat, ultraviolet light, or other agent to transform the HD into a less hazardous agent.
- Decontamination. The inactivation, neutralization, or removal of HD contaminants on surfaces, usually by chemical means.
- Designated Area. A location identified for the receipt, storage, or compounding of HDs. Based on the type of HD handling conducted in these spaces, various environmental requirements may apply. May include: anterooms, buffer rooms, storage rooms, and compounding areas.
- Disinfection. The process of inhibiting or destroying microorganisms.
- Doff. The act of removing personal protective equipment.
- Don. The act of putting on personal protective equipment.
- Hazardous Drugs. Drugs associated with or suspected of causing adverse health effects. The NIOSH and USP <800> define a HD as one that may possess any one of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low, genotoxicity, or new drugs that mimic existing HDs in structure or toxicity.
- High Efficiency Particulate Air (HEPA) Filtration. An extended-medium, dry type filter in a rigid frame, having a minimum particle collection efficiency of 99.97% for particles with a mass median diameter of 0.3 μm when tested at a rated airflow in accordance with MIL STD 282 using IEST Recommended Standard RP-CC001.5.
- Personal Protective Equipment (PPE). Personal Protective Equipment includes all clothing and other work accessories designed to create a barrier against workplace hazards, including gloves, goggles, gowns, and respirators.
- Powered Air Purifying Respirator (PAPR). A PAPR is a type of air purifying respirator that uses a blower to force the ambient air through air purifying elements to an inlet covering.
- Receiving. The delivery of bulk products into a facility from a manufacturer or wholesaler.
- Regulated Medical Waste. The portion of the waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.
- Resource Conservation and Recovery Act. A Federal law that allows the Environmental Protection Agency (EPA) to regulate hazardous wastes from generation to transportation to treatment to storage and finally to disposal.
- Respirator. Either a tight-fitting filtering face mask, or a PAPR that protects the airways against harmful and hazardous substances.
- Safety Data Sheet (SDS). Documents produced by chemical manufacturers and importers that contain detailed chemical, physical, and hazard information about specific substances.
- Storage. Practices used to store bulk containers, as well as in-use quantities, of HDs in pharmacy storage areas.
- Transportation. Moving HDs within a health care setting.
3-27.2 RESPONSIBILITIES
- Director, IHS. The Director, IHS, will support and promote the implementation of a comprehensive HD program as defined by this chapter. The Director, IHS, will:
- Support a culture of safety;
- Ensure that IHS operations comply with the applicable Occupational Safety and Health Administration (OSHA) standards; and
- Support the development, implementation, and evaluation of HD programs in accordance with this chapter and the authorities listed in Section 3 27.1D.
- Chief Medical Officer, IHS. The IHS Chief Medical Officer (CMO) is administratively responsible for the issuance of this policy.
- Principal Pharmacy Consultant. The Principal Pharmacy Consultant (PPC) serves as the coordinator, consultant, and advisor for all matters relating to handling HDs throughout the IHS.
- Institutional Environmental Health Program Manager. The IHS Institutional Environmental Health Program Manager will provide assistance on occupational safety and health issues.
- Area Chief Medical Officer. Area CMOs will advise facility medical officers on the safe administration of HDs. Area CMOs will ensure the HD policies and procedures are implemented by facility medical staff located in their Area.
- Area Institutional Environmental Health Officers. Area-level Institutional Environmental Health Officers (IEHO) will serve as technical advisors to facility safety officers and assist with implementation of the HD policies and procedures within their respective geographical location.
- Area Pharmacy Consultants. Area Pharmacy Consultants will serve as technical advisors to facility safety officers and pharmacy managers located within their respective geographical location. They will take reasonable steps to ensure compliance and implementation of established guidelines for safe preparation and disposal of HDs.
- Area Nurse Consultants. Area Nurse Consultants will serve as technical advisors to facility nurse managers located within their geographical location and take reasonable steps to ensure the policies and procedures for administration and disposal of HDs are understood and implemented.
- Service Unit Chief Executive Officer. The Service Unit’s Chief Executive Officer or a designee is ultimately responsible for ensuring these HD policies and procedures are implemented and a designated HD safety officer is identified. Individuals and committees who may be involved in implementing these policies and procedures at the facility level include, (but are not limited to), the safety officer, infection control officer, facility engineer, risk manager, pharmacy chief, director of nursing, Pharmacy and Therapeutics Committee, and Safety Committee.
- Service Unit Pharmacy Director. The pharmacy director will:
- Provide access to SDSs for HDs the pharmacy distributes;
- Provide a warning on the label of HDs the pharmacy distributes, indicating special handling precautions are necessary; and
- Ensure HDs that will be used for patient treatment are handled only in the pharmacy during all processes involving drugs in powdered or granular form. Such processes would include reconstitution of powders and crushing of tablets.
- Facility Safety Officer. The Facility Safety Officer is responsible for providing technical assistance with regard to facility design, staff training, hazard communication, PPE selection and use, spill management, and waste handling.
- All IHS Staff Who Handle HDs. Indian Health Service employees, including but not limited to, pharmacy and nursing staff, physicians, operating room staff, and environmental staff are responsible for knowing the basic practices and precautions and for continually following established policy and procedures to prevent patient harm, employee exposure, and surface contamination. These employees are also responsible for reporting any spills or exposures, and making appropriate responses. Staff must also participate in annual training.
3-27.3 POLICIES AND PROCEDURES
All facilities must establish local policies and procedures consistent with all applicable statutory, regulatory, and federal guidelines, including, but not limited to the USP <800> to ensure safety during all phases of HD handling. Each facility will designate a qualified and trained HD Safety Officer who will be responsible for leading the development and implementation of local policies and procedures; facility regulatory compliance; and personnel competency. All local policies and procedures must be reviewed, updated in writing at least annually. Local policies and procedures minimally must include the following requirements:
- Requirements for medical surveillance for staff that regularly handle HDs.
- Local requirements for labeling HDs consistent with applicable statutory or regulatory requirements.
- Process for accessing and having the current SDS available and readily accessible for each HD.
- Personnel training before initial assignment and when any changes in practice occurs. Training must be consistent with Section 3-27.4 of this chapter.
- A written acknowledgement regarding the risks of handling HDs is required for personnel of reproductive capability who handle HDs (see Manual Exhibit 3-27 G “Hazardous Drug Acknowledgement of Risk Drugs”).
- The required PPE consistent with local policy as defined in Section 3-27.7F of this policy. All PPE must be available and utilized depending on HD and manipulation.
- Engineering controls must function properly and have regularly scheduled maintenance.
- Hazardous Drug spills training standards to ensure employees are trained in spill management and the use of PPE.
- Standard operating procedures (SOP) for handling HDs. All SOPs must at a minimum include:
- Hazard communication program;
- Occupational safety program;
- Designation of HD area;
- Receipt;
- Storage;
- Compounding;
- Use and maintenance of proper engineering controls (e.g. C-PECs, C SECs, and CSTD);
- Hand hygiene and use of PPE based on activity (e.g. receipt, transport, compounding, administration, spill and disposal);
- Deactivation, decontamination, cleaning, and disinfection;
- Dispensing;
- Transporting, including staff who transport;
- Administering;
- Disposal; and
- Spill Control.
- Recommended SOPs include medical surveillance and environmental monitor (e.g. wipe sampling).
3-27.4 REQUIRED TRAINING
All health care and environmental staff handling HDs must participate in appropriate regular training. Personnel must be trained prior to the introduction of a new HD or new equipment and prior to a new or significant change in process or SOP. All training must be done consistent with USP <800> and any other applicable regulatory and statutory provision, including OSHA standards, https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.120. The following nine topics must be included in any curriculum developed for training staff on handling HDs.
- Risks of Handling Drugs. Staff must be educated on the risks of handling HDs including the definition of a HD, characteristics and forms of HDs, exposure routes, acute and chronic adverse health effects of exposure, and reproductive issues.
- Personal Protective Equipment. Staff must be trained on the proper donning and doffing of PPE. The circumstances under which it will be worn, how long it will be worn, and limitations of PPE. Respiratory protection PPE will require additional training and respirator fit testing.
- Work Practices. Staff must be trained on work practices that reduce potential exposures including proper maintenance and use of C-PECs (if available), use of CSTD (if available), priming, and use of luer-lock connections. Those who prepare or administer HDs will be tested on knowledge, skills, and abilities of handling HDs annually regarding their work practices.
- Transporting Drugs. Staff must be trained on how drugs are transported safely in bulk form (prior to pharmacy processing), final form (for delivery to the patient), and used drugs (after partial administration to a patient, for example).
- Waste Disposal Management. Staff must understand the difference between trace and bulk HDs waste and how each type is handled. Staff must be aware of appropriate disposal methods for the type of hazardous waste generated. Personnel who are involved in handling HD waste must know where to access the spill kit. Refer to spill management plan in Section 3-27.4G.
- Management of Acute Exposures. Staff must be trained on immediate responses to acute exposures and the process of reporting the exposures.
- Spill Management Plan. Staff expected to clean up HD spills must be trained and proficient in the use of a spill kit. This includes familiarity with spill kit contents, how it is used, and how to evaluate spill size, and determine staff response(s). All plans must be consistent with USP <800> and any other applicable statutory or regulatory provisions. (See Section 3-27.13 of this policy “Spill Management and Control.”)
- Recordkeeping. Staff must report and document all HD spills and exposure and unintentional exposures and (or both) potential exposures to their immediate supervisor and document using the IHS-approved reporting system. Occupational exposures must be reported on the facility's OSHA 300 log.
- Medical Surveillance. Medical surveillance programs must be outlined including the frequency of medical surveillance, the need for medical surveillance, and how the records will be maintained. See Section 3-27.14 and Manual Exhibit 3-27-E, “Medical Surveillance” for guidelines.
3-27.5 ENGINEERING CONTROL PLANNING AND DESIGN HDs
Conditions that promote patient safety, worker safety, and environment protection must exist when engineering control planning and designing HDs. Signs designating the hazard must be prominently displayed before the entrance to the HDs area.
- Facility Design. When constructing or renovating a sterile compounding preparation area, the facility will refer to IHS Office of Environmental Health and Engineering Technical Handbook Volume 3, Chapter 21-4.10 - Design Requirements for Compounded Sterile and HD Preparation Areas.
- C-PEC Selection.
- When selecting appropriate C-PECs, the facility will refer to IHS Office of Environmental Health and Engineering Technical Handbook Volume 3, Chapter 21-4.10 - Design Requirements for Compounded Sterile and HD Preparation Areas.
- Hazardous Drugs must be prepared in a Class II, Type B2 BSC (preferred), Class III BSC, or CACI exhausted to the outside to maintain a sterile field and protect workers.
- Class II Type A2 and B1 BSCs can only be used when a drug's volume, toxicity and volatility is low. Hazardous Drugs that are volatile when handled must not be prepared in Type A2 or B1 BSC as they may recirculate air into the room.
- Containment Ventilation Enclosures may only be used for non-sterile manipulations, and may re-circulate air through redundant HEPA filters placed in series.
- Bag in/bag out filter assemblies for C-PECs are strongly recommended because they use enclosed HEPA filters. This type of assembly allows the removal of the filter with reduced risk of worker exposure when it is not possible to gas or vapor decontaminate the HEPA filters.
- Each C-PEC must be equipped with a continuous monitoring device to confirm adequate airflow before use.
- C-PEC Placement: Designated Areas.
- The C-PEC must be located in a room that is restricted to authorized personnel.
- Locate all C-PECs away from doors, aisles, open windows, air supply registers, or equipment that creates air movement. The C-PECs must also be located at least 1 meter or 3.3 feet from handwashing sinks, emergency eyewash/showers, and floor drains.
3-27.6 ENGINEERING CONTROL TESTING AND MAINTENANCE
- Equipment Testing and Operation.
- Pharmacy, infection control, and facility maintenance staff must collaborate to ensure that all designated areas used for handling HDs are regularly tested to ensure that proper environmental conditions, ACH, and pressure relationships are maintained.
- All C-PEC must be field performance tested, by qualified personnel, upon installation (prior to first use), after relocation, after any repair to internal components, after HEPA filter replacement, and every 6 months. The current field certification must be prominently displayed on the C-PEC
- Maintenance Activities.
- General.
- Facilities must develop a written safety plan for all routine maintenance activities performed on equipment or in areas that could be contaminated with HDs.
- Workers performing maintenance on any utility that may be contaminated with HDs must be familiar with applicable safety standards, warned about hazards, and trained in the appropriate work techniques and PPE needed to minimize exposure. This requirement applies to both in-house staff and contractors.
- Facilities maintenance must consult pharmacy regarding any task that may adversely affect proper pressure relationships and/or air cleanliness in designated areas so that appropriate precautions can be made or tasks modified to limit the impact to sterile and/or HDs handling.
- C-PECs.
- All C-PECs will be maintained in compliance with manufacturer recommendations.
- The facility safety officer or IEHO must review, in advance, all maintenance activities performed on the C-PEC and exhaust systems associated with HDs use not specifically addressed in the written safety plan. This review will assess PPE recommendations and work practices.
- The Pharmacy staff will remove all HDs and decontaminate the C PEC prior to beginning maintenance. After decontamination, maintenance staff will lockout or tag out the C-PEC consistent with OSHA Guidelines for Control of Hazardous Energy.
- Maintenance staff will decontaminate and bag C-PEC equipment and parts removed for replacement before they are taken from the containment area.
- Maintenance staff will bag used filters immediately upon removal from the C-PEC and handle as hazardous waste.
- Each C-PEC will be equipped with a continuous monitoring device to confirm adequate air flow before being returned to use.
- General.
3-27.7 PREVENTION OF EMPLOYEE EXPOSURE - GENERAL REQUIREMENTS
The following “general requirements” must be applied in all IHS facilities handling HDs. These requirements will be applied in addition to the requirements of the OSHA Hazard Communication Standard, Code of Federal Regulations (CFR), Title 29, Section 1910.1200.
- Assess the Hazards in the Workplace. Before any employee begins working with HDs, and on an annual basis, the entire workplace must be assessed to identify any potential hazards. This includes assessing work processes, from receiving the drugs, to preparation, through administration, and finally to waste disposal. The Pharmacy Chief and Facility Safety Officer, with the assistance from the Nursing Manager, Facility Manager, Employee Health, and IEHO, must conduct the hazard assessment. The assessment must include the following:
- Potential conditions for exposure (aerosolization, crushing, open setting vs. C-PEC);
- Equipment (C-PEC, closed system transfer devices, PPE);
- Physical layout of work areas;
- Types, forms, frequency, and volume of drugs to be handled;
- Equipment maintenance;
- Decontamination, deactivation, and cleaning (See Section 3-27.10C of this chapter for guidance);
- Waste handling and spill response;
- Waste disposal; and
- Routine operations.
- Work Practices. Work practices and equipment used to handle HDs will be reviewed on an annual basis. A HD safety officer, facility safety officer, and/or an Area IEHO can assist pharmacy staff in reviewing equipment and practices. Staff who regularly handle HDs will provide input on work practices.
- A facility may perform a risk assessment to determine alternative containment strategies and/or work practices. The facility must provide documentation of alternative strategies and reassess risk every 12 months. At a minimum, the assessment of risk must consider: type of HD, dosage form, exposure risk, packaging, and manipulation. The following types of HDs cannot be included on risk assessments: any bulk HD active pharmaceutical ingredient (API) and any antineoplastic HD requiring manipulation. Refer also to Manual Exhibit 3-27-F, “Facility Considerations and Exceptions.”
- If the facility chooses not to perform a risk assessment, all HDs must be handled with all containment strategies defined in USP <800>.
- Hazardous Drugs Inventory. A HD inventory must be reviewed by the Chief Pharmacist, or his/her designee, to determine if any are listed as HDs or meet the definition of a HD at least every 12 months. Each new drug or dosage form used at the facility will be reviewed against the facility’s list and the NIOSH HD list. Criteria used to identify HDs can be found in the most current version of the NIOSH list. If the information available on a drug is not sufficient to make an informed decision, the drug will be listed as hazardous until more information is available.
- Policies and Procedures to Handle Hazardous Drugs Safely per USP <800>. Facilities must establish policies and procedures to ensure safety during all processes of HD handling, consistent with USP <800> and other applicable statutory and regulatory provisions.
- Use and Maintain Equipment Properly. Facility maintenance, biomedical engineering, nursing, pharmacy, and infection control departments will develop procedures for using, maintaining, and verifying engineering controls used to reduce exposure to HDs. If an appropriate C-PEC is not available, facilities will outsource HD preparation by ordering prepared HDs from other facilities equipped with a C-PEC. Staff will only outsource to entities that meet applicable, federal statutory and regulatory provisions.
A C-PEC is not required if manipulations are limited to handling of final dosage forms (e.g., counting or repackaging of tablets and capsules) that do not produce particles, aerosols, or gasses, or non-antineoplastic drugs for which a risk assessment has determined such processes are appropriate. - Proper Use of Appropriate PPE. The designated HD Safety Officer will work with pharmacy, nursing, safety, and infection control staff to develop procedures for the selection, use, and disposal of PPE. Facility safety plans must describe the appropriate PPE based on the risk of exposure and activities performed.
Appropriate PPE must be worn during all phases of HD handling from receipt and storage, to compounding and transport, to administration and waste disposal. Standards must include requirements listed in Section 3 27.8 and be consistent with USP <800>. - Disposal of HDs waste. All HD waste, PPE used while handling HDs, and other materials possibly contaminated with HDs must be placed in appropriate waste containers and disposed of per local, state, and federal regulations. Standards must be consistent with Manual Exhibit 3-27-B, “Hazardous Drug Waste Management,” for more detailed information.
- Facility Considerations and Exceptions. Facilities that may dispense HDs infrequently or on a limited basis may follow exceptions to this chapter as listed in Manual Exhibit 3-27-F, “Facility Considerations and Exceptions.” A risk assessment must be performed prior to utilizing any of the exceptions listed in Manual Exhibit 3-27-F, “Facility Considerations and Exceptions.”
3-27.8 PERSONAL PROTECTIVE EQUIPMENT
Appropriate PPE must be worn during all phases of HDs handling from receipt and storage, to compounding and transport, to administration and waste disposal, including deactivation/decontamination, cleaning, disinfection, and spill control. Disposable PPEs must not be re-used. However, in times of PPE shortages, national guidance on PPE re use may be considered. Reusable PPEs must be decontaminated and cleaned after use consistent with Section 3-27.10C of this chapter.
- Gloves. All gloves will be powder free. “Chemotherapy" gloves must be selected in accordance with the facility’s risk assessment and guidance from manufacturers. When chemotherapy gloves are required, the product (gloves) must indicate that they meet American Society for Testing and Materials (ASTM) D6978 standards (or newest version). Regardless of the thickness of the glove, staff must use double gloves when handling concentrated forms of HDs. Gloves should be changed every 30 minutes unless otherwise recommended by the manufacturer’s documentation and must be changed when torn, punctured, or contaminated.
- Gowns. Gowns must be selected and worn in accordance with the facility’s risk assessment and manufacturer’s guidelines. Gowns must be disposable and must be made of a polyethylene coated or vinyl-coated material (non-linting and non absorbent) and shown to resist the permeability of HDs. Gowns must be changed per the manufacturer’s information if no information is available, then should be changed every 2 to 3 hours or after a spill or splash. Gowns must have closed fronts, long sleeves, and elastic or knit closed cuffs. Cloth laboratory coats are not appropriate to wear when handling hazardous or potentially HDs, because they do not provide any protection against contamination.
- Head, Hair, Shoe, and Sleeve Covers. All such PPEs must be selected and worn, in accordance with the facility’s risk assessment and manufacturer’s guidelines. A second pair of shoe covers must be donned before entering the C-SEC, and removed when exiting the C-SEC.
- Eye and Face Protection. Appropriate eye and face protection must be worn when there is a risk of splashing. When eye protection is required goggles must be worn rather than safety glasses, and must also be worn when using a face shield as a face shield alone is not sufficiently protective. An eyewash facility will be available in HDs preparation areas.
- Respirators.
- N-95 Respirator. For most activities requiring respiratory protection, a NIOSH-certified N-95 or more protective respirator is sufficient to protect against airborne particles; however, these respirators offer no protection against gases and vapors and little protection against direct liquid splashes. Surgical masks alone do not provide respiratory protection from drug exposure and will not be used to compound or administer drugs.
- Full-Face Chemical Cartridge-Type Respirator. Staff should use an appropriate full-face chemical cartridge-type respirator for events such as large spills when an intravenous (IV) bag breaks or a line disconnects and leaks, or when there is known or suspected airborne exposure to vapors or gases.
- Disposal of Used PPE. All PPEs that have been worn while handling HDs are to be considered contaminated with, at minimum, trace quantities of HDs. PPE must be placed in an appropriate waste container for further disposal per local, state, and federal regulations. The PPEs worn during compounding should be disposed of in the proper waste container before leaving the C-SEC. Chemotherapy gloves and sleeve covers (if used) worn during compounding must be carefully removed and discarded immediately into a waste container approved for trace contaminated waste inside the C-PEC or contained in a sealable bag for discarding outside the C-PEC.
3-27.9 RECEIVING, STORAGE, AND TRANSPORTATION
- Receiving.
- All HDs are required to be shipped to the facility in plastic, leak-proof containers with a secure lid and appropriate labeling consistent with all applicable statutory and regulatory requirements.
- All HDs will be delivered directly to the pharmacy, in accordance with facility policies regarding contractor/delivery access.
- When handling and opening containers, and unpacking HDs, staff must wear gloves.
- Staff must inspect all incoming shipments of HDs for crushing, leaks, or punctures.
- If container appears damaged, the container will be sealed and the shipper contacted regarding possible return or disposal.
- If evidence of any of the above is found, it should be treated as a spill: trained staff must don appropriate PPE and inspect the shipment; cleaning up any leakage or spilled contents; as necessary. Hazardous Drugs waste must be double bagged and disposed of as bulk HDs waste. (Refer to Manual Exhibit 3 27 B, “Hazardous Drug Waste Management” for more information.)
- If a damaged container must be opened, it will be done inside a C-PEC following safe work practices.
- Storage.
- All containers holding HDs will be labeled consistent with Food and Drug Administration requirements and other applicable statutory and regulatory requirements (in the appropriate languages) to indicate the contents.
- Staff will ensure there is adequate ventilation in the storage area to prevent a buildup of airborne contaminants. There must be at least 12 ACH in the room or storage area and be under negative pressure for antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage form.
- Hazardous Drugs must be stored in a manner that prevents spillage or breakage if the container falls.
- Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms must be stored separately from non- HDs in a manner that prevents contamination and personnel exposure. Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy.
- Transportation.
- Staff will wear gloves to prevent contamination when transporting a vial or syringe to a work area.
- Labeled HDs must be transported in containers that minimize the risk of breakage or leakage. Labeling must be consistent with applicable statutory and regulatory requirements.
- Strict control and possession of HDs must be maintained while transporting HDs. This means HDs will remain in the possession of and under the supervision of a person trained in the handling and transport of HDs. Because of their hazardous nature, HDs must not fall into the possession of someone not familiar with relevant precautions.
- If HDs are to be transported to a home care setting, they must be sealed in a bag or container and transported in a leak proof container with a lid.
- Public Health Nurses (PHN) may at times transport or otherwise come into contact with HDs. Established PHN competencies for this activity are required. The HDs information sheet provides tips on how to safely handle HDs and will be distributed to the individual PHN prior to any potential exposure to HDs. Refer to Manual Exhibit 3-27-A, “Safe Handling of Hazardous Drugs for Public Health Nurses (PHN)” for additional information.
- When shipping HDs to locations outside the entity, the entity must consult the Transport Information on the SDS.
3-27.10 HAZARDOUS DRUG PREPARATION
- General.
- Minimize manipulations by using liquid drugs, if available.
- Areas with HDs will be identified through signage and be restricted to authorized personnel. Consuming food or drink and putting on make up will be avoided in HD work areas.
- Automatic counting machines will not contain tablets and capsule forms of antineoplastic HDs. If permitted by the facility’s risk assessment, tablets and capsule forms of non-antineoplastic HDs may be placed in automated counting machines.
- Clean, dedicated equipment and care will be used when counting and pouring of HDs. Safety Data Sheets will be readily available to anyone who handles HDs.
- Containment Primary Engineering Controls.
- Use and Selection.
- Hazardous Drug operations that include mixing, counting, crushing, compounding powders, or pouring liquid forms of HDs will have a risk assessment performed to determine if these practices will take place in a C-PEC (except as allowed for counting final dosage forms as discussed in Section 3-27.7E. Examples of protective techniques include spiking or priming Intravenous tubing with a non-HDs solution in C-PEC.
- For details on the selection and placement of the appropriate C PEC, refer to Section 3-27.5C of this Chapter and IHS Chapter 21-4.10 - Design Requirements for Compounded Sterile and Hazardous Drug Preparation Areas.
- Operation.
- All staff using C-PECs will be trained in their proper use.
- Activities not requiring a sterile environment (checking labels, doing calculations, etc.) will be completed prior to accessing the C PEC.
- Access to the C-PEC will be limited to authorized and trained personnel who are engaged in the compounding.
- The C-PEC will remain “on” to enable the blower to operate continuously. If the C-PEC is turned “off” or loses power, it must first be cleaned then the front opening closed prior to restarting blower to prevent any contaminants from escaping. Follow manufacturer recommendations after restarting.
- Staff must place only those items for immediate use on a work surface. Crowding the interior space of the C-PEC can result in non-laminar air flow and decreased filter efficiency. A covered sharps container will be available in the C-PEC.
- Staff must prepare HDs on a chemotherapy preparation mat. The mat will not cover any grills in the C-PEC. The mat will be replaced at least daily and after any spills. It will be disposed as trace HDs waste. If heavily contaminated, the mat will be disposed as bulk HDs waste.
- When moving arms and hands in and out of the C-PEC, any movement will be perpendicular to the face opening of the C-PEC and not in a sweeping motion.
- Workers will refrain from resting their arms on the table edge at the face opening of a C-PEC as this can allow potentially contaminated air to flow into the work area. This can be alleviated by raising the arms from the table surface.
- The door to a HD preparation room must be kept closed at all times.
- Use and Selection.
- Deactivation, Decontamination, Cleaning, and Disinfection. All practices and procedures must be in compliance with USP <800>.
- All personnel who perform deactivating, decontaminating, cleaning, and disinfecting activities in HD handling areas must be trained.
- Appropriate PPE must be used during these activities (e.g. two pairs of chemotherapy gloves, impermeable disposable gowns; if splashing likely, use eye protection and face shield; if required by activity, respiratory protection must be used).
- Do not spray agents used for deactivation, decontamination, and cleaning. These agents will be applied through the use of wipes wetted with appropriate solution. Contact manufacturer or supplier for compatibility with cleaning agents.
- Other surfaces contacted by HDs will be cleaned routinely and will be decontaminated after every use.
- Work Practices.
- Areas must be designated for receiving, storing, and compounding sterile and nonsterile HDs.
- All personnel handling HDs must be trained annually prior to handling and if there are any significant changes to processes or new equipment. All training and competencies must be documented. Refer to USP <800> for required training components.
- Avoid pressurizing HD vials. When preparing HDs, extremes of positive and negative pressure in medication vials will be avoided. Venting devices such as filter needles or dispensing pins will be used when possible to reduce pressure differentials.
- Syringes and IV sets with Luer-lock fittings will always be used, and syringes must always be large enough so that they never need to be more than three-quarters full.
- Remove and dispose of gowns worn while preparing HDs before leaving the immediate HDs preparation area. The practice of hanging up gowns between uses is prohibited. To avoid spreading HD contaminants, PPE worn in HDs handling areas must not be worn to other areas.
- When HDs preparation is complete, the final product must be sealed in a plastic bag or other sealable container. Hazardous Drugs will be labeled with cautionary labeling and must be transported in containers that minimize the risk of breakage or leakage.
- Facilities must not transport any liquid hazardous or any antineoplastic drugs using pneumatic tubes.
- Facilities will develop processes to minimize surface contamination during transport of HDs from compounding areas to patient areas within the facility.
- CSTDs. If the dosage form is compatible with CSTDs, these must be used when compounding HDs. However, CSTDs are NOT a substitute for a C-PEC and will ONLY be used in a C-PEC.
3-27.11 HAZARDOUS DRUG ADMINISTRATION
- Parenteral Administration.
- The CSTDs must be used when administering antineoplastic HDs if the dosage form is compatible with CSTDs.
- Intravenous tubing will be spiked or primed with non-HD solution in a C- PEC. Priming of tubing will not allow the escape of HDs into the environment (e.g. avoid priming into a gauze pad, sink, or trash can).
- Appropriate PPE will be worn during all stages of drug administration (opening the outer bag, assembling the delivery system, delivering the drug to the patient, and disposing of all equipment used to administer the drugs). Refer to current version of NIOSH and USP <800> for detailed PPE guidance.
- Oral/Topical Administration.
- Aerosolized Administration.
- Aerosolized HDs will be administered in a private room that is under negative air pressure. The door to the room will remain closed during administration of the drug and for 10 minutes after administration has ended. A warning sign must be posted on the outside of the door to restrict entry to authorized individuals only.
- Appropriate PPE including gloves, gown, eye protection, and an appropriate full-face piece chemical cartridge-type respirator/powered air purifying respirator (PAPR) will be worn when handling aerosolized HDs or interacting with patients who are undergoing treatment with aerosolized HDs.
3-27.12 HD WASTE HANDLING
There is also potential exposure to HDs when handling waste from HDs operations and maintaining equipment that has been contaminated with HDs. Exposure risks include:
- Body Fluids. Handling body fluids or body fluid contaminated clothing, dressings, linens, etc. (Up to 7 days after treatment, depending on drug).
- Waste Containers. Handling waste containers, removing or disposing of contaminated PPE.
- Filters. Replacing filters in Containment Primary Engineering Controls;
- Performing preventive maintenance on equipment possibly contaminated with HDs;
- Plumbing or waste disposal concerns in rooms that accommodate patients receiving HDs;
- Ventilation concerns in rooms that store HD-contaminated equipment, materials, or clothes; and
- Spills.
- PPE. When handling contaminated linens, feces, or urine from patients who have received HDs, wear PPE in accordance with Section 3-27.8, “Personal Protective Equipment,” and facility policies and procedures.
- Dispose of PPE after each use/task, or whenever they become contaminated. Dispose of PPE as regular waste unless they are visibly soiled or/and contaminated. If PPE is visibly soiled or/and contaminated, dispose as trace HD waste.
- Wash hands with soap and water after removing gloves.
- Deactivation, Decontamination, Cleaning, and Disinfection. All personnel who perform deactivating, decontaminating, cleaning, and disinfecting activities in HDs handling areas must be trained.
- Appropriate PPE must be used during these activities (e.g. two pairs of chemotherapy gloves, impermeable disposable gowns; if splashing is likely, use eye protection and face shield; if required by activity, respiratory protection must be used).
- Do not spray agents used for deactivation, decontamination, and cleaning. These agents will be applied through the use of wipes wetted with appropriate solution. Contact manufacturer or supplier for compatibility with cleaning agents.
- Other surfaces contacted by HDs will be cleaned routinely and will be decontaminated after every use.
- Waste Handling and Transport. Refer to EPA Resource Conservation and Recovery Act (RCRA) Regulations for regulations on disposal of HD waste. Note that EPA HDs waste impacts the environment and NIOSH HDs impact those who handle HDs. Some NIOSH HDs may be EPA HDs waste, and some may not. To comply with regulatory requirements and to meet best practices, the following types of waste are considered:
- Acutely toxic HDs waste.
- Trace HDs waste.
- Bulk HDs waste.
- Excreta.
- Unused pharmaceuticals.
3-27.13 SPILL MANAGEMENT AND CONTROL
- Location of Spill Kits. Spill kits and respirators must be readily available and be located in all the immediate areas where exposures may occur. Each spill kit must contain the items listed in Manual Exhibit 3-27-C, “Spill Management and Control,” or a commercial chemotherapy spill kit may also be used. Signs must be readily available for restricting access to the spill area.
- Responsible Staff. Due to their specialized training and experience working with HDs, pharmacy, nursing, and/or environmental services staff will be responsible for cleaning up HD spills. Only individual staff who have received formal spill response training are permitted to clean up spills of HDs and be available at all times while HDs are being handled. Staff must receive training in spill management and the use of PPE and NIOSH-certified respirators.
- Appropriate PPE. Wear appropriate PPE (chemotherapy gloves, gown, respirator, etc.) as described in section 3-27.8 for cleaning up spills.
- Types of Spills. Refer to Manual Exhibit 3-27-C, “Spill Management and Control,” for additional information on responding to spills.
- Reporting of Spills. Incidents or spills involving HDs must be reported to the appropriate supervisor and within the approved IHS incident reporting system. If patients or visitors are potentially exposed to HDs, such exposure will be noted in the incident report.
- Emergency Response to Occupational Exposures. Immediate response is required to any uncontrolled occupational exposure to HDs. See Manual Exhibit 3-27-D, “Emergency Response to Occupational Exposures,” for minimum requirements for the following types of exposures:
- Skin Exposure or Contamination of Clothing.
- Eye Exposure.
- Exposure by Inhalation.
- Reporting of Occupation Exposure.
3-27.14 MEDICAL SURVEILLANCE
Indian Health Service staff who handle HDs should be enrolled in a medical surveillance program if they handle HDs as a regular part of their job assignment. Indian Health Service staff who contact HDs in rare circumstances may not be included. Those who are occupationally exposed through spills, body fluid exposure, etc., will always be medically evaluated. Medical surveillance must be done consistent with Manual Exhibit 3-27-E, “Medical Surveillance,” and any other applicable statutory or regulatory provision.3-27.15 REFERENCES
Oncology Nursing Society. Safe Handling of Hazardous Drugs. In: Polovich M, editor. 2nd ed. Pittsburgh, PA: Oncology Nursing Society; 2011.