Compounding HD and the Necessary PPE
“The most common issue I see in compounding hazardous drugs is the proper use of PPE, protective personal equipment.”
Personal protective equipment (PPE) is the “last line of defense” against exposure to hazardous drugs (HDs) when compounding. A recent survey of 183 pharmacy practitioners compounding HDs, conducted by Boiano in the Journal of Occupational and Environmental Hygiene 2015, revealed that 47% did not double glove and 10% did not wear any gloves. In addition, 20% did not wear the recommended gown.
Although not mandated for compounding in USP <800>, closed system transfer devices (CSTDs) should be used when the dosage form allows, as evidence has shown a reduction in frequency and levels of HD exposure when compared to the use of a needle and syringe in a biological safety cabinet (BSC).
Compounding HD and the Necessary PPE.
Closed system transfer devices:
Proper negative pressure compounding must be used if CSTDs are not employed. Negative pressure compounding is very difficult to do properly and generally results in an increase in time to prepare drugs. Therefore, CSTDs offer the additional potential advantage of reducing the time it takes to properly prepare HDs, while enhancing worker protection. A CSTD is not a substitute for a containment primary engineering controls (C-PEC) when performing HD compounding.
CSTDs MUST be used during administration of HDs, so depending on how the drugs are administered, IV tubing must be primed with a neutral solution. The CSTD must be attached to the bag or tubing before the doses are dispensed. Pharmacy must dispense the final HD dose ready for administration without further manipulation.
Personal protective equipment:
Necessary PPE includes gloves and gowns; head, hair, sleeve, and shoe covers; and eye, face, and respiratory protection. Additional detail is provided below for each:
When chemotherapy gloves are required, they must meet American Society for Testing and Materials (ASTM) Standard D6978 (or its successor). Chemotherapy gloves should be worn for handling all HDs, including non-antineoplastics and for reproductive risk only HDs. Chemotherapy gloves must be powder-free because powder can contaminate the work area and can adsorb and retain HDs. Gloves must be inspected for physical defects before use. Do not use gloves with pin holes or weak spots.
When used for sterile compounding, the outer chemotherapy gloves must be sterile. Chemotherapy gloves should be changed every 30 minutes, unless otherwise recommended by the manufacturer’s documentation, and must be changed when torn, punctured, or contaminated. Hands must be washed with soap and water after removing gloves.
When gowns are required, they must be disposable and shown to resist permeability by HDs. Gowns must be selected based on the HDs being handled. Disposable gowns made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of uncoated materials. Gowns must close in the back and must have no front opening, be long sleeved, and have closed cuffs that are elastic or knit. Gowns must not have seams or closures that could allow HDs to pass through.
The HD-resistant gown cannot be worn longer than the time indicated by the gown manufacturer. In the absence of permeation information, operators should change the gown every 2-3 hours or immediately after a spill or splash. To avoid spreading HD contamination and exposing other health care workers, a gown that was used in an HD handling area should never be worn in other areas.
Head, hair, shoe covers
Head and hair covers (including beard and moustache, if applicable), shoe covers, and sleeve covers provide protection from contact with HD residue. When compounding HDs, a second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC. Shoe covers worn in HD handling areas must not be worn to other areas to avoid spreading HD contamination and exposing other health care workers.
Disposable sleeve covers may be used to protect areas of the arm that may come in contact with HDs. Disposable sleeve covers made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of uncoated materials.
Eye and face protection
Many HDs are irritating to the eyes and mucous membranes. Appropriate eye and face protection must be worn when there is a risk for spills or splashes of HDs or HD waste materials when working outside of a C-PEC; for example, administration in the surgical suite, working at or above eye level, or cleaning a spill. A full face-piece respirator provides eye and face protection. Goggles must be used when eye protection is needed. Eye glasses alone or safety glasses with side shields do not protect the eyes adequately from splashes. Face shields in combination with goggles provide a full range of protection against splashes to the face and eyes. Face shields alone do not provide full eye and face protection.
Personnel who are unpacking HDs that are not contained in plastic should wear an elastomeric half-mask with a multi-gas cartridge and P100-filter until assessment of the packaging integrity can be made to ensure no breakage or spillage occurred during transport. If the type of drug can be better defined, a more targeted cartridge can be used.
Surgical masks do not provide respiratory protection from drug exposure and must not be used when respiratory protection from HD exposure is required. A surgical N95 respirator provides the respiratory protection of an N95 respirator, and like a surgical mask, provides a barrier to splashes, droplets, and sprays around the nose and mouth.
For most activities requiring respiratory protection, a fit-tested NIOSH-certified N95 or more protective respirator is sufficient to protect against airborne particles. However, N95 respirators offer no protection against gases and vapors and little protection against direct liquid splashes (see the Centers for Disease Control and Prevention’s (CDC’s) Respirator Trusted-Source Information).