ENHANCING THE SAFETY OF HAZARDOUS DRUG PRODUCTS HANDLING

To advocate that pharmaceutical manufacturers and wholesale distributors employ decontamination practices to eliminate surface contamination on packages of hazardous drugs (HDs); further,

To advocate that pharmaceutical manufacturers develop closed-system transfer device compatible, ready-to-administer HD products; further,

To advocate for standardized labeling and package design for HDs that would alert handlers to the potential presence of surface contamination; further,

To advocate for pharmacist involvement in the development of policies, procedures, and operational assessments regarding administration of HDs.

Rationale

Hazardous drugs (HDs) present well-known risks to healthcare workers who handle them. Most HDs are administered orally or intravenously; however, other routes of administration are sometimes used, such as intrathecal, intraventricular, or intravesicular administration, or perfusion into a vessel or organ cavity. The protective precautions required for administration through these routes is well described in United States Pharmacopeia (USP) General Chapter 800, the ASHP Guidelines on Handling Hazardous Drugs, the Oncology Nursing Society’s Safe Handling of Hazardous Drugs, and other sources.

Healthcare providers are required to use personal protective equipment and other protective devices, such as closed-system transfer devices (CSTDs), when the dosage form allows. To reduce the risks to healthcare providers, ASHP encourages device and pharmaceutical manufacturers and the Food and Drug Administration (FDA) to deploy new production and processing standards to mitigate exposures, including label and package design that alerts handlers to the possibility of contamination. In addition, manufacturers and the FDA should develop CSTD-compatible, ready-to-administer HD drug products with the goal that CSTDs be utilized for all routes of administration of HD products as a best practice.

 HDs are sometimes administered through other routes (e.g., Ommaya reservoirs, intraperitoneal infusion) for which protective precautions are not as well described or CSTD use is not possible. However, when such use is not possible, an assessment of risk will identify gaps and ensure there are pharmacy-guided policies to address the handling, compounding, and administration for all healthcare staff coming into contact with HDs during administration via nontraditional routes. Such policies should also address any specialized training for staff in procedural areas, or the availability of a staff member with HD-specialized training to assist in the administration of the drug (e.g., a “chemo nurse”).

ASHP encourages all healthcare settings to conduct an interprofessional, proactive assessment of the risk of such procedures to evaluate the potential exposure risks for healthcare providers and identify mitigating measures. Given their depth of knowledge regarding the handling of HDs, the pharmacy workforce should be involved in the development of policies, procedures, and operational assessments regarding administration of HDs in such circumstances.

The outer surfaces of vials of HDs have been shown to be contaminated, unwittingly exposing pharmacy and other personnel handling those vials to hazardous substances. ASHP advocates that individuals involved in drug distribution, receiving, and inventory control adhere to safe handling guidelines, including ASHP guidelines and USP General Chapter 800, to avoid undue exposure to hazardous substances. Recognizing the limits of these best practices, pharmaceutical manufacturers have a responsibility to provide vials that are devoid of surface contamination by ensuring adequate vial-cleaning procedures such as using decontamination equipment and protective sleeves during the manufacturing process.