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USP General Chapter <800>: A Pharmacy Professional's Guide to Handling and Compounding Hazardous Drugs
Hazardous drugs (HD) are drugs known to cause harm to humans and animals. These include agents in the cytotoxic antineoplastic (used for cancer chemotherapy), antiviral, hormonal, bioengineered , and other classes.1 The use of this term began with the American Society of Health-System Pharmacists (ASHP) in 1990,2 and it was later adopted by the National Institute for Occupational Safety and Health (NIOSH). Drugs considered hazardous by NIOSH include those that exhibit one or more of the following six characteristics: carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, organ toxicity at low doses in humans or animals, and drugs that mimic existing drugs in structure or toxicity.1 Published evidence on risks of HD exposure demonstrates a relationship with acute and chronic health issues ranging from skin rashes to reproductive issues and cancer.3 In the years since 1990, many guidelines have been developed related to handling of HDs, but their use was sporadic because the guidelines were not enforceable. The first legally enforceable standard4 for handling and compounding HDs, General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings (General Chapter <800> or <800>), was published in 2016 by the United States Pharmacopeial Convention (USP)5; it becomes official on July 1, 2018. The delayed official date allows time for facilities to implement the standard. Before release of the current version, <800> was published for public comment twice by USP, as per USP’s revision process. General Chapter <800> was developed and approved by the USP Compounding Expert Committee.6 In May 2016, USP published an erratum to <800> to remove a requirement that the containment secondary engineering control (C-SEC) be externally vented through high-efficiency particulate air (HEPA) filtration. Section 5.3 Facilities and Engineering Controls, Compounding was revised to indicate that the C-SEC used for sterile and nonsterile compounding must be externally vented, but HEPA filtration of the exhaust is not required. The erratum became official on June 1, 2016. The implementation date of July 1, 2018, remains.7 This continuing pharmacy educational program includes information about HDs and the USP General Chapter <800>, and also provides practical scenarios to reinforce the key concepts of <800>. For the convenience of those studying this program, the numerous acronyms used in this article are compiled in Table 1.
|Table 1. Acronyms used in this CE Program
||USP General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations
||USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations
||USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings
||Air changes per hour
||American Society of Health-System Pharmacists
||Compounding aseptic containment isolator
||Containment primary engineering control
||Containment segregated compounding area
||Containment secondary engineering control
||Compounded sterile preparation
||Closed system drug-transfer device
||Containment ventilated enclosure
||High-efficiency particulate air
||International Organization for Standardization
||National Institute for Occupational Safety and Health
||Occupational Health and Safety Administration
||Personal protective equipment
||Safety data sheets
||United States Pharmacopeial Convention
GENERAL OVERVIEW OF USP GENERAL CHAPTER <800>
The USP published General Chapter <800> with a public health motivation to provide a legally enforceable standard to limit occupational exposure to HDs to protect patients, health care personnel, and the environment from the effects of handling HDs.8 General Chapter <800> addresses handling HDs throughout the entire continuum of receipt, transfer, storage, compounding, dispensing, administration, and disposal of HDs. It applies to any personnel who handle or come into contact with HDs, including nurses, pharmacists, pharmacy technicians, physicians, physician assistants, veterinarians, veterinary technicians, home health care workers, and others. The scope of <800> includes health care settings, including all types of pharmacies. It does not include suppliers or the home, since those locations are not considered health care settings. General Chapter <800> focuses on containment, risk assessment, and work practices to minimize the risk of and limit exposure to HDs. USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations (<797>) currently includes a section on HDs, and that is the topic of another PowerPak program [https://www.powerpak.com/ph50/default.aspx]. The USP Compounding Expert Committee established an Expert Panel on Hazardous Drugs and developed <800> as a separate general chapter. The HD information in <797> will be removed once <800> becomes official on July 1, 2018. It is important to note that <800> supplements – but does not replace – general chapters <795> Pharmaceutical Compounding—Nonsterile Preparations, and <797>. General Chapter <800> has multiple sections, including three appendices and references.
Key to <800> is reference to the NIOSH List of Hazardous Drugs, which NIOSH maintains on its website, and reviews and republishes periodically. NIOSH also keeps a list of changes anticipated for the next HD list at https://www.cdc.gov/niosh/docs/2004-165/. NIOSH provides the criteria for inclusion as a HD, as mentioned in the Introduction of this program.
Cytotoxic chemotherapeutic drugs were originally developed in the 1940s when patients with lymphomas began receiving nitrogen mustard (mustard gas) as a therapeutic agent. Clinicians at the time wore only gloves, masks, and gowns for protection, since there were few safety standards in place. The use of chemotherapeutics grew significantly in the 1960s and 1970s, and as a result, reports of traces of chemotherapeutic agents in the urine of oncology nurses and later reports in health care workers of side effects similar to those of chemotherapy patients–nausea, vomiting, hair loss, and mouth sores—began to emerge in the late 1970s. Health professionals responded, especially those in hospitals, to identify the cause of these effects.9 Results of studies showed mutagenic activity in personnel working in horizontal laminar flow hoods. This was due to consistent contamination not only on the horizontal laminar air flow hoods but also in the air samples taken from pharmacies. Based on these findings, a new type of vertical laminar air flow hoods, biological safety cabinets (BSCs), were implemented as the new standard for the safe handling of HDs.10 In 1985 and again in 1990, the American Society of Health-System Pharmacists (ASHP) published a technical assistance bulletin on handling cytotoxic and HDs.2,11 This report and continuing concerns for health professional safety prompted the Occupational Safety and Health Administration (OSHA) in 1995 to issue a new guideline on controlling occupational exposure to HDs. In 2004, NIOSH issued the “NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.”12 ASHP provided, in 2006, Guidelines on Handling Hazardous Drugs.13 The original NIOSH list was updated in 2010, 2012, 2014, and 2016. NIOSH plans to update future lists about every 2 years.
USP GENERAL CHAPTER <800> REQUIREMENTS AND PERSONNEL
General Chapter <800> requires facilities that handle HDs to include <800> standards in occupational safety plans, and also requires health and safety management systems to include the following minimum items: a list of HDs; facility and engineering controls; competent personnel; safe work practices; proper use of appropriate personal protective equipment (PPE); and policies for HD waste segregation and disposal.14
To ensure the safety of health care professionals, patients, and the environment, General Chapter <800> requires the use of three of the NIOSH tables relating to HD types:
- Table 1 – Antineoplastics
- Table 2 – Nonantineoplastics
- Table 3 – Reproductive-only hazards
Each pharmacy and other health care setting must establish a list of the HDs they handle. This must be a comprehensive list, and include detail to the dosage form level. The use of NIOSH Table 5 PPE Information is not required by <800>, but it provides a comprehensive list for policy development based on the NIOSH hierarchy of controls.15 The hierarchy of controls concept uses an inverted pyramid to demonstrate that the control methods at the top (elimination, substitution, engineering controls) are potentially more effective and protective than those at the bottom (administrative controls, PPE). This concept is incorporated into <800>. According to NIOSH, following this hierarchy normally leads to the implementation of inherently safer systems, in which the risk of illness or injury has been substantially reduced.15 Based on this approach, <800> presents containment strategies and work practices best known to control hazardous drug contamination, including engineering controls, work practices, and PPE.
The NIOSH Hierarchy of Controls
Scenario: The personnel at ABC Pharmacy have been aware of the need for wearing the appropriate garb when compounding HDs. Several of the pharmacy personnel are surprised that NIOSH considers PPE as the lowest level of control. Since it is the least effective, is it really needed?
Response: PPE is needed for your protection when handling HDs. NIOSH stratifies the types of controls available when assessing any risk to personnel. Since patients need to be treated, removing the risk (the HD) is generally not practical. By placing PPE at the bottom point of the hierarchy of controls, NIOSH recognizes the utility of PPE; it is used to protect the end user (such as the pharmacist, technician, or nurse) from the hazard that may have escaped the more effective controls (removal, substitution, or engineering control). The PPE is vitally important to keep health care practitioners safe, since it provides the last level of defense.
Policies, Procedures, and Personnel
A HD facility must maintain policies and standard operating procedures (SOPs) to ensure the safe handling of HDs by personnel in all anticipated situations. SOPs should include information about a hazard communication program; occupational safety program; designation of HD areas; receipt, storage, compounding, use and maintenance of proper engineering controls, including containment primary engineering controls (C-PECs), C-SECs, and closed system drug-transfer device (CTSDs); hand hygiene; and use of PPE based on activities across the HD continuum (see Figure 1). Personnel must be trained on the procedures and their training must be documented. A designated person who is qualified and trained on developing and implementing procedures must be responsible for overseeing compliance with applicable laws, regulations, and standards. All personnel who handle HDs are responsible for understanding the fundamental precautions related to handling HDs and work to minimize the potential harm to themselves and to patients.
The HD Continuum
Scenario: The personnel at ABC Pharmacy understand that a preparation containing any HD component is considered an HD compound. Does the finished preparation need to be stored in a negative pressure area until the patient picks up the prescription? Does it need to be labeled as an HD on the patient label?
Response: The pharmacy's assessment of risk (see next section) needs to address the storage location of the finished HD compound. The outer bag in which an HD compound will be placed needs to be free of potential contamination, so proper technique needs to be used to ensure that practice. Evaluate how the compounder places the finished HD compound into the final packaging to be sure the outer packaging is free from contamination. Once that practice is established, the personnel may – if the assessment of risk allows it – place that prescription in the general pick-up area.
General Chapter <800> uses a risk-based approach that focuses on certain drugs and dosage forms that may pose a lower risk to health professionals. This includes the following:
- Drugs on the NIOSH list that are required to follow all containment strategies and work practices listed in <800>
- Drugs on the NIOSH list that may be exempted by the pharmacy to follow some or all <800> requirements if an assessment of risk is performed and alternative containment strategies and/or work practices are identified and implemented
The “assessment of risk” in <800> is a risk-based approach that enables certain dosage forms of HDs that are administered without modification (e.g., tablets, capsules) to be exempted from <800> requirements because they may not pose a significant risk due to exposure. HDs that can be considered for an assessment of risk include (1) antineoplastics on the NIOSH Table 1 that only need to be counted or packaged; (2) nonantineoplastic drugs, and (3) reproductive-only hazards. This is described in <800> Section 2, Box 1, Contaminant Requirements.16 Alternative strategies may be employed, including (1) using unit-dose or unit-of-use packaging; (2) storing HDs in lidded bins; (3) using closed system drug-
transfer devices (CSTDs); (4) handling HDs with chemotherapy gloves; and (5) dedicated “tackle boxes” for transport.17
Since compounded HDs need to conform to the quality standards for nonsterile and sterile compounding, the quality assurance, quality control, and documentation issues detailed in USP <795> and <797> must be followed.
Risk Assessment and Alternative Strategies
Scenario: The personnel of ABC Pharmacy are struggling with establishing their assessment of risk for oral agents that are not antineoplastics. Most drugs in NIOSH Tables 2 and 3 are oral agents that are received from the wholesaler in unit-dose or unit-of-use packaging. Some not available in those types of packaging are received in bottles of 100 tablets or capsules. The individual who has been assigned as the designated person is wondering if a negative pressure room needs to be constructed in which to store these medications. Or should this be done inside a biological safety cabinet (BSC)?
Response: Two types of drugs must be handled with all the above containment strategies (negative pressure room and C-PEC) and work practices included in <800>: (1) active pharmaceutical ingredients (API) of any hazardous drug on any of the NIOSH tables and (2) antineoplastics that must be manipulated. There is an allowance in <800> for antineoplastics that only need to be counted or packaged, or for any of the NIOSH Table 2 or 3 medications to be handled with alternative containment strategies. Oral agents in Tables 2 and 3 that already come in unit-dose or unit-of-use packaging provide a layer of protection, since no one other than the patient needs to directly handle the drug. Unit-dose and unit-of-use packaging can be considered the alternative strategy for the assessment of risk. For those Table 2 and 3 medications that must be counted out from larger bottles, the designated person needs to identify the reason they are on the NIOSH list and determine what, if any, additional precautions need to be taken to ensure safe practices for the pharmacy personnel. Information is available on the NIOSH list that links to further information concerning the reason the drug is on the list and the risk to personnel.
QUALITY CONTROL APPROACHES IN USP GENERAL CHAPTER <800>
Proper equipment and air quality control is critical for compounding both sterile and nonsterile HDs. Engineering controls protect cross-contamination from occurring. The three categories of engineering controls in <800> are primary, secondary, and supplementary levels. The primary control, C-PEC, is a ventilated device designed to minimize worker and environmental HD exposure when directly handing HDs. The C-SEC is the room in which the C-PEC is placed. Supplemental engineering controls such as CSTDs are controls that offer additional levels of protection. CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. They offer an additional level of protection and are recommended during compounding, and are required for administration of the HD, when the dosage form allows.18 For nonsterile HD compounding, an externally vented or redundant-HEPA filtered CPEC is required, such as a containment ventilated enclosure (CVE; commonly referred to as a “powder containment hood”), a Class I or II BSC, or compounding aseptic containment isolator (CACI). C-SEC requirements for nonsterile compounding include externally ventilation at 12 air changes per hour (ACPH), plus negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas.19 There are changes in the allowances and requirements for placement of C-PECs and of the design of the C-SEC. Since all compounding of HDs must be done in a negative pressure room, the “low use exemption” in current <797>20will not be allowed once <800> becomes official. However, a new configuration, a containment segregated compounding area (C-SCA), is allowed in <800>.21 The C-SCA differs from a cleanroom; it does not have to have HEPA-filtered ceiling air and does not have to be ISO classified. The beyond-use date (BUD) of any sterile compound mixed in a C-SCA is limited to 12 hours (see Table 2).
|Table 2. Facility Configurations Acceptable in Current <797> and in <800>
||Allowed in <797>
||Allowed in <800>
|Cleanroom suite: ISO 7 positive anteroom opening into ISO 7 negative buffer room with at least 30 air changes per hour
||Yes, with a pressure of at least 0.01 inches of water column negative relative to adjacent space
||Yes, with a pressure range of 0.01 to 0.03 inches of water column negative relative to adjacent space
|Containment segregated compounding area (C-SCA)
||Not addressed in <797>
|Biologic safety cabinet outside of a cleanroom
||Yes, if the room meets the requirements of a C-SCA: separate room, negative pressure range of 0.01 to 0.03 inches of water column negative relative to adjacent space, externally vented, at least 12 air changes per hour
|Compounding aseptic containment isolator outside of a cleanroom
||Yes, if it is in a negative room with at least 12 air changes per hour and optimally vented
||Yes, if the room meets the requirements of a C-SCA: separate room, negative pressure range of 0.01 to 0.03 inches of water column negative relative to adjacent space, externally vented, at least 12 air changes per hour
Scenario: The designated person at ABC Pharmacy is looking at an architectural drawing for a new negative pressure lab for sterile compounding. It contains a negative pressure ISO 8 anteroom and a negative pressure ISO 7 buffer room. Is that the correct configuration?
Response: No. An anteroom must always be positive pressure, and any anteroom opening into a negative pressure room for sterile compounding must be at least ISO 7. The anteroom serves to prevent contamination of the preparations being mixed in the buffer room. Positive pressure in the anteroom is used to prevent contamination from entering the buffer room. When the door between the anteroom and negative pressure buffer room is opened, some air will flow from the anteroom into the buffer room. For this reason, the air in the anteroom needs to be at least as clean as the ISO 7 buffer room, so the anteroom also must be ISO 7.
Personal Protective Equipment
PPE is important for the health professional to protect against occupational hazards of HDs. PPE includes gloves; gowns; head, hair, shoe, and sleeve covers; eye and face protection; and respiratory protection.22 PPE as defined by pharmacy policy must be worn when handling HDs at all times. See <795> for recommendations for garb to use when compounding nonsterile preparations and <797> for additional recommendations for garb to use when compounding sterile preparations.
The chemotherapy gloves worn when handling HDs must meet the American Society for Testing and Materials (ASTM) standard D6978 – 05 (2013).23 This standard is designed to test the permeability of specific chemotherapy agents against the material of which the gloves are made. The manufacturer’s information lists the time (in minutes) that the gloves may be used when compounding several different chemotherapy agents. The gloves are required to be powder-free because powder can absorb hazardous material. They must be inspected for defects prior to use and disposed if they have any defect. They must be sterile when used during sterile compounding. Chemotherapy gloves should be changed at least every 30 minutes unless the manufacturer recommends an alternative duration. Note that according to the HD section in <797>, which is currently official, gloves should be changed every 30 minutes, regardless of manufacturer recommendations. This is a case in which personnel who handle HDs are required to follow <797> until <800> becomes official on July 1, 2018. Gloves should also be changed if any kind of tear or puncture occurs. Personnel are required to wash hands with soap and water after removing gloves.24
Gowns for handling HDs are required to be disposable and long-sleeved with cuffs at the end. The gowns can be made of polyethylene-coated polypropylene or other laminate materials. Gowns must be designed to close in the back, not in the front. Personnel should change gowns according the manufacturer’s instructions. If no information from the manufacturer is available, then consider changing them every 2 to 3 hours and immediately after a spill. Note that gowns worn in hazardous areas must NOT be worn to other areas. If other clothing items are accidentally exposed to hazardous substances (such as following a spill), remove the item immediately to prevent exposure of the skin. Personnel should not take potentially contaminated clothing home to clean; they should be washed according to a facility’s policy.25
Covers for the Head, Hair, Shoes, and Sleeves
Head, hair, shoe, and sleeve covers provide protection from contact with hazardous residue. Shoe covers worn in HD areas must be removed before walking into other areas to prevent hazardous contamination.26
Face and Eye Protection
Health professionals must use appropriate eye and face protection if there is a risk of a spill or splash from a HD or its waste. Properly vented C-PECs provide eye (and respiratory) protection, so no additional protection is required when compounding. Goggles must be used when eye protection is needed during incidents or procedures such as a spill cleanup or opening the work tray of a C-PEC.27
Surgical masks are required when compounding any sterile medication (and should be considered for nonsterile compounding as well), but they do not provide respiratory protection for the compounder. Surgical masks provide protection from contamination of the compounded preparation. Respiratory protection provides protection for the compounder and may be required when unpacking HDs that are not contained in plastic, when cleaning up spills, during certain decontaminating and cleaning procedures, or when vapor or gas exposure is suspected. A facility’s policy should describe respirators that are acceptable and available at the facility.28
Personal Protective Equipment
Scenario: The pharmacy personnel in ABC Pharmacy's negative pressure lab compound only one HD product at a time. When they are finished, they respond to patients who come to the pharmacy counter. The technicians have asked whether they can leave the lab with their gown on, speak with a patient, and then return to the lab to compound another preparation.
Response: PPE exposed in HD compounding areas cannot be worn outside the negative pressure area. Doing so could spread contamination. The gowns used must be disposable, and must be removed when leaving the negative pressure lab, even if only one preparation was compounded or even if it will only be a few minutes before returning to the negative pressure lab.
It is critical that personnel who are handling agents along the HD continuum of receipt to disposition (see Figure 1) employ work practices to maximize containment and minimize contamination. In USP General Chapter <800> standards, antineoplastic HDs and all HD APIs are required to be unpacked in an area that is neutral/normal or negative pressure relative to the surrounding areas. They must not be unpacked in sterile compounding areas or in positive pressure areas.29 When transferred, HDs are required to be in containers that minimize the risk of breakage or leakage. HDs are required to be stored in a way that prevents spillage or breakage if the container fails; they should not be stored on the floor. Antineoplastic HDs and HD APIs must be stored away from non-HDs in an externally ventilated, negative pressure room, with at least 12 ACPH. Nonantineoplastic, reproductive risk only, and antineoplastic final dosage forms may be stored with non-HD inventory if permitted in the organization’s assessment of risk.30
Personnel who compound HDs must be compliant with USP <795> and <797> standards, and must compound using proper engineering controls. If a compounded product contains any HD ingredient, the preparation is considered hazardous. Personnel must administer HDs using protective devices and techniques, including closed system drug-transfer devices. Disposal of HD waste must be handled by trained personnel who follow procedures to protect themselves and the environment from HD contamination. Across the continuum, personnel must wear, remove, and dispose of appropriate PPE, and follow applicable federal and state laws and regulations.
Scenario: The designated person at ABC Pharmacy is concerned about the location at which HDs are received. Since HDs cannot be received in positive pressure areas, does that mean they must be received in a negative pressure area?
Response: HDs do not need to be received in a negative pressure area. A normal or neutral area is acceptable. The best approach is to designate a specific location in the receiving area where HDs can be segregated, such as a marked area on the counter used for receiving. The technician who unpacks the supplier totes needs to wear chemotherapy gloves (tested to ASTM D6978). In case of broken HDs inside the packaging, that person also needs to have other PPE and decontamination agents available, and need to know what steps to take if that occurs. Best practice includes placement of a plastic-backed mat on the counter prior to placement of HD packages, removal of the plastic-backed mat after receiving the HDs, and decontamination of the area after use.
Deactivation, Decontamination, and Cleaning
Deactivation, decontamination, and cleaning are critical components of handling HDs and USP General Chapter <800>, and all drug-handling areas and equipment are affected. In addition, compounding areas and devices must be disinfected according to <795> and <797>. Written procedures (SOPs) are required for cleaning. All personnel who perform deactivation, decontamination, cleaning, and disinfection activities in HD-handling areas are required to be trained and wear appropriate PPE. Agents for deactivating, decontaminating, cleaning, and disinfecting agents must be applied through the use of wipes — not by a spray bottle — to avoid spreading HD residue (see Table 3).31
Scenario: ABC Pharmacy's assessment of risk allows counting oral antineoplastics in the general pharmacy area. The pharmacy staff is wondering what precautions need to be taken with the counting tray and spatula used.
Response: The decontamination and cleaning of the counting tray and spatula needs to be included in the pharmacy's assessment of risk. One approach might be to designate a specific counting tray and spatula for counting oral antineoplastics, and decontaminate the tray and spatula after each use. Several commercially available prewetted wipe products could be used.
|Table 3. Agents Used in the Cleaning Process
||Type of Solution
|Deactivation and decontamination
||Properly diluted oxidizer approved by the Environmental Protection Agency and intended for use with hazardous drugs
||70% isopropyl alcohol (sterile for sterile compounding areas)
The Occupational Safety and Health Administration requires employers to have a hazard communication program.32 A hazard communication program ensures health professional safety during all steps in the continuum of handling HDs. Hazard communication is required; it must include a written plan that must describe how the standard will be implemented, that all containers of hazardous chemicals must be labeled with the identity of the material and hazard warnings; that safety data sheets (SDSs) must be available for each HD; and that the SDSs must be readily accessible to personnel in their work areas. Environmental wipe sampling for HD residue that has escaped containment should be performed frequently, including initially and then at frequent intervals. Locations for wipe sampling could include interior of the C-PEC, pass-through chambers, work surfaces, surfaces adjacent to C-PECs, areas outside of the HD buffer room, and in patient care areas where HD administration occurs.
Scenario: ABC Pharmacy complies with the environmental monitoring required by <797> for sterile compounding: viable electronic air sampling and surface sampling. The pharmacy staff wants to know whether additional monitoring is required or recommended for HDs.
Response: Since <800> supplements <795> and <797>, the monitoring required by those general chapters must continue. General Chapter <800 > recommends — but does not require — wipe sampling for detection of antineoplastic HDs that may have escaped containment.
Several companies market wipe sampling kits. The wipes are designed to detect a set of common antineoplastic agents. Directions are provided in the kits. If a containment is found, the area must be remediated, including decontamination and cleaning, proper PPE components, garbing practices, and aseptic technique to ensure the problem has been appropriately addressed. Repeating the wipe sampling will provide ongoing information as to whether further remediation is necessary.
General Chapter <800> includes several appendices that provide practical advice for HD handling and compounding. The appendices include:
- Acronyms, which defines the key acronyms used in <800> relating to HDs and compounding, similar to those in Table 1.
- Examples of designs for HD compounding areas, including optimal primary and secondary control designs, minimum ACPH for each design; and those designs that have limitations in primary and secondary controls.
- Types of BSCs, including Classes I, II, and III BSC, and Types A1, A2, B1, and B2 BSC.
SUMMARY AND RESOURCES
Personnel who handle HDs must be aware of several key points that support compliance with USP General Chapter <800>, which becomes official on July 1, 2018. These include the following:
- Download the NIOSH list of HDs and identify the drugs and dosage forms that are handled in the particular facility.
- Follow all containment strategies and work practices listed in <800> for all APIs of any HDs on the NIOSH list and for all antineoplastics that must be manipulated in any way (e.g., crushing, splitting, withdrawing for a parenteral dose).
- Determine whether other agents (antineoplastics that only need to be counted or packaged, any of the NIOSH Table 2 or 3 medications) will follow all the containment strategies and work practices listed in <800> or whether the pharmacy will perform an assessment of risk to establish alternative containment strategies and/or work practices to protect employees.
- If an assessment-of-risk approach is taken for any medications and dosage forms on the NIOSH list, a facility HD list must be developed and documented, and the list should be reviewed at least every 12 months and the review documented.
- Ensure there is a designated person who has the appropriate competence, experience, knowledge, and training on handling HDs.
- Ensure that all staff who handle HDs have signed an acknowledgment, demonstrating their understanding of the risks of the HDs they handle.
- Ensure that HDs that require all the strategies listed in <800> are compounded in a facility that has a room that meets four minimum criteria: fixed walls that is separate from nonhazardous compounding, is under negative pressure, is vented to the outside, and has an appropriate number of ACPH.
- Ensure that proper PPE is available and used by compounding staff.
- Ensure that proper decontamination and cleaning is performed to minimize HD contamination.
IThe online resources noted in Table 4 are available to assist personnel with these and other responsibilities related to HDs and HD compounding.
- National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By: Connor TH, MacKenzie BA, DeBord DG, Trout DB, O'Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (supersedes 2014-138).
- American Society of Health-System Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
- National Institute for Occupational Safety and Health. NIOSH hazardous drug exposures in healthcare. https://www.cdc.gov/niosh/topics/hazdrug/default.html. Accessed June 30, 2017.
- United States Code, Title 21, §321. http://uscode.house.gov/view.xhtml?req=%28official+compendium%29+AND+%28%28title%3A%2821%29%29%29
&f=treesort&fq=true&num=0&hl=true&edition=prelim&granuleId=USC-prelim-title21-section321. Accessed May 1, 2017.
- United States Pharmacopeial Convention. General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. USP 40-NF 35 (online). Accessed May 1, 2017.
- United States Pharmacopeial Convention. 2015–2020 Compounding expert committee work plan. http://www.usp.org/council-experts-expert-committees-overview/compounding-expert-committee-work-plan. Accessed May 1, 2017.
- United States Pharmacopeial Convention. Notice of intent to revise, USP Website http://www.usp.org/usp-nf/notices/hazardous-drugs-handling-healthcare-settings. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP website on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, http://www.usp.org/usp-healthcare-professionals/compounding/compounding-general-chapters/usp-general-chapter-hazardous-drugs-handling-healthcare-se. Accessed May 1, 2017.
- Davita VT, Chu E. A history of cancer chemotherapy, http://cancerres.aacrjournals.org/content/68/21/8643. Accessed May 1, 2017.
- Anderson RW, Puckett WH Jr, Dana WJ, et al. Risk of handling injectable antineoplastic agents. Am J Hosp Pharm. 1982;39(11):1881–1887.
- American Society of Health-System Pharmacists. ASHP technical assistance bulletin on handling cytotoxic drugs in hospitals. Am J Hosp Pharm. 1985;42:131-137.
- Centers for Disease Control and Prevention. NIOSH alert on Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, 2004. Publication number 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed May 1, 2017.
- American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006:63:1172-93.
- United States Pharmacopeial Convention. General chapter <800> Hazardous Drugs – Handling in Healthcare Settings. USP 40-NF 35 (online). Accessed May 1, 2017.
- NIOSH Hierarchy of Controls, https://www.cdc.gov/niosh/topics/hierarchy/. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 2, Box 1, Contaminant Requirements. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 2 List of Hazardous Drugs. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 5.3 Compounding. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 5.3.1 Non-sterile Compounding. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. USP 40-NF 35 (online). Section on Hazardous Drugs as CSPs. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 5.3.2 Sterile Compounding. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 7 Personal Protective Equipment. Accessed May 1, 2017.
- Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, ASTM D6978 – 05(2013). https://www.astm.org/Standards/D6978.htm. Accessed July 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 7.1 Gloves. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 7.2 Gowns. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 7.3 Head, Hair, Shoe, and Sleeve Covers. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 7.4 Eye and Face Protection. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 7.5 Respiratory Protection. Accessed May 1, 2017.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 10 Receiving. Accessed May 1, 2017.
- Kienle P, Douglass K. Perform an assessment of risk to comply with USP <800>. Pharm Purchas Prod. 2017;14(3):26,38-39. www.pppmag.com/article/2012.
- United States Pharmacopeial Convention. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, USP 40-NF 35 (online). Section 14 Deactivating, Decontaminating, Cleaning, and Disinfecting. Accessed May 1, 2017.
- Occupational Safety and Health Administration. What is hazard communication? Occupational Safety and Health Administration, Department of Labor. https://www.osha.gov/dsg/hazcom/whatishazcom.html. Accessed May 1, 2017.
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