AVAILABILITY AND USE OF APPROPRIATE VIAL SIZES

To advocate that pharmaceutical manufacturers provide drug products in vial sizes that reduce pharmaceutical waste and enhance safety; further,

To collaborate with regulators, manufacturers, and other healthcare providers to develop best practices on the safe and appropriate use of single-dose, single-use, and multiple-dose vials.

Rationale

A 2016 study estimated that the U.S. may spend close to $2 billion on oncology drug products that are discarded because they come in vials in which the volume of drug product exceeds what is needed for most doses. Since that landmark study, policymakers, healthcare providers, and payers have been calling for action on vial sizes. The Centers for Medicare & Medicaid Services (CMS) has begun to require that billing for Part B drug products distinguish between claims for those received by a patient and those for discarded drug product, and the Office of the Inspector General (OIG) of the Department of Health and Human Services has initiated a study to determine the cost of such waste. Considerable savings could be gained if vial sizes more closely matched doses, and one of the goals of the OIG study is to determine how much could be saved by using vial sizes available overseas that more closely match doses. As one analysis has pointed out, pharmacoeconomic analyses done in the U.S. typically do not incorporate leftover drug product in cost calculations, which may inflate cost-effectiveness ratios, and drug manufacturers may be exploiting that omission. In contrast, the United Kingdom National Institute for Clinical Excellence requires manufacturers to include the cost of leftover drug in manufacturers' submissions, and vials of two cancer drugs studied (bortezomib and pembrolizumab) contain 1 mg and 50 mg, respectively, in the U.K., and 3.5 mg and 100 mg in the U.S. Further, the availability of different vial sizes can enhance patient and worker safety. Vial sizes that more closely match doses can minimize preparation time and steps, reducing employee fatigue and the number of opportunities for error.

ASHP advocates that pharmaceutical manufacturers provide drug products in vial sizes that reduce drug waste (e.g., multiple-dose vials or single-dose vials of differing doses), and that regulators, manufacturers, and healthcare providers cooperate to develop and implement best practices for drug vial optimization.