READY-TO-ADMINISTER PACKAGING FOR HAZARDOUS DRUG PRODUCTS INTENDED FOR HOME USE

To advocate that pharmaceutical manufacturers provide hazardous drug products intended for home use in ready-to-administer packaging; further,

To advocate that regulators (e.g., the Food and Drug Administration) have the authority to impose requirements on pharmaceutical manufacturers to provide hazardous drug products intended for home use in ready-to-administer packaging; further,

To advocate that when hazardous drug products intended for home use are not available from manufacturers in ready-to-administer packaging, pharmacies repackage those drug products to minimize the risk of exposure; further,

To advocate that hazardous drug products intended for home use be labeled to warn that special handling is required for safety; further,

To advocate that pharmacists provide education to patients and caregivers regarding safe handling and appropriate disposal of hazardous drug products intended for home use.

Rationale

Home use of oral chemotherapy increases patient convenience and lowers healthcare costs, but it presents unique safety risks. In a hospital or clinic setting, healthcare professionals manage the risks posed by hazardous drugs, defined as any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity (NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings). In the home environment, however, patients and caregivers must be prepared to fill that role. Ready-to-administer packaging of hazardous drugs minimizes patient, caregiver, and family exposure to hazardous drugs, promotes patient adherence, and enhances safe medication use. Ready-to-administer packaging is defined as packaging that provides the product in a way that requires no manipulation before the patient or caregiver can administer the medication. In contrast, ready-to-use packaging may require a small amount of manipulation (e.g., reconstitution). These definitions are consistent with United States Pharmacopeia and Institute for Safe Medication Practices terminology. ASHP advocates that pharmaceutical manufacturers provide hazardous drug products intended for home use in ready-to-administer packaging, and that regulators have the authority to require manufacturers to (1) provide hazardous drug products intended for home use in ready-to-administer packaging, and (2) label hazardous drug products intended for home use to warn that special handling is required to ensure safety. ASHP further advocates that when hazardous drug products intended for home use are not available in ready-to-administer packaging, pharmacies repackage those drug products to minimize exposure risk for caregivers and others in the patient’s household. For example, intravenous drug products should be dispensed in a container designed so the patient or caregiver does not have to puncture a vial; tablets are split or crushed prior to dispensing; compounding of liquid medications is done by the pharmacy, if stability information for the drug product supports advanced compounding and transport; and all liquid medications are dispensed with a dispensing cap that can accommodate attachment of an oral syringe. Finally, ASHP advocates that patients and caregivers be provided education regarding safe handling of hazardous drug products from a qualified healthcare professional, preferably a pharmacist experienced in managing the risks of hazardous drug products.