Article ID Journal Published Year Pages File Type
3327388 Health Policy and Technology 2014 8 Pages PDF
Abstract

•Drug shortages are caused by quality problems and manufacturing delays.•Communication and coordination will decrease the number of drug shortages.•The public/private communication alternative offers the greatest benefit to the greatest number of stakeholders.•Stakeholders will be able to coordinate action and attack causes of the shortage.•The FDA should implement the public/private communication center alternative.

Provision of safe and effective anesthesia relies on an adequate and uninterrupted supply of anesthetic drugs and drugs used to manage complications throughout the perioperative period. The confluence of regulatory and communication barriers impede the ability of the pharmaceutical industry, government and healthcare institutions to effectively respond to anesthetic drug shortages. These impediments directly threaten the health and safety of patients undergoing surgical and diagnostic procedures in the United States. The most common causes of drug shortages are product or quality issues and manufacturing capacity issues.This paper presents 2 policy alternatives directed towards the most common causes of drug shortages; an FDA-operated stakeholder communication center and a public/private partnership communication center. The feasibility of the 2 alternatives was assessed against 5 criteria including population benefit, ethics and equity, cost feasibility, administrative feasibility and political feasibility. Selection of the most favorable alternative was based on the final score from a decision matrix presenting evaluation criteria weighed against each proposed alternative.The final result reveals the public/private communication center as the most feasible alternative. This is consistent with stakeholder agreement that early, accurate communication and coordination will help mitigate and prevent present and future shortages. Specifically, the public/private center will improve the current state of communication, protect proprietary information and provide stakeholders with information regarding manufacturing, supply, distribution, and business issues encouraging coordination of action to attack the root causes of drug shortages.

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