UNIT DOSE PACKAGING AVAILABILITY

To advocate that pharmaceutical manufacturers provide all medications used in health systems in unit dose packages or, when applicable, in packaging that optimizes medication safety, improves operational efficiency, and reduces medication waste; further,

To urge that the Food and Drug Administration require pharmaceutical manufacturers to provide stability data to support the repackaging of medications outside of their original manufacturer bulk containers in the interest of public health, healthcare worker and patient safety, and reduced waste.

Rationale

The benefits of unit dose drug administration were well established in the 1960s. Despite these benefits, some drugs are not available from manufacturers in unit dose packages. One reason sometimes cited for this lack of availability is that because unit dose packages make up a relatively small portion of business for many manufacturers, some manufacturers are making a business decision to discontinue this form of packaging. When manufacturers do not provide drugs in unit dose form, the pharmacy must repackage them, introducing opportunities for error and healthcare worker or patient harm. Increasingly, however, pharmaceutical manufacturers are including verbiage on bulk medication bottles and within package inserts that state “dispense in original container” or similar language. These statements are typically declared without any rationale, studies, or analytical support. The statements and the lack of external data regarding stability of medications when repackaged have created hardships for health-system pharmacies trying to provide medications in a ready-to-use form for timely administration. This practice may perpetuate drug shortages and lead to avoidable and costly medication and packaging waste. Although it may not be practical for FDA to mandate unit dose packaging to optimize medication and patient safety, improve operational efficiency, and support the interest of public health, FDA could encourage such packaging in other ways, such as by developing packaging guidelines for the pharmaceutical industry. In cases in which unit dose packaging is not practical, manufacturers should at a minimum provide package sizes or medication stability data that would reduce waste.