Drug Shortages: Are Pharmacy Benefit Managers Part of the Solution?
"Exploring the obligations and potential roles of Pharmacy Benefit Managers (PBMs) in mitigating serious prescription drug shortages for the benefit of clients and society."
Pharmacy Benefit Managers (PBMs) are essential to the American healthcare system, connecting approximately 215 million Americans with their prescribing physicians and retail pharmacies. Many PBMs operate large, sophisticated dispensing operations. These capabilities could be invaluable in managing and mitigating the impact of drug shortages, which have become an increasing concern in the United States.
Drug shortages can disrupt patient care, leading to the use of less effective treatments, treatment delays, and compromised supply chains. In severe cases, patients may be left without access to necessary medications. The current mechanisms for addressing these shortages are inadequate, demanding more proactive and effective strategies.
PBMs have the potential to play a significant role in these responses. By leveraging their extensive networks and dispensing capabilities, PBMs can help ensure that patients receive the medications they need, even when supplies are limited. While their primary obligation is to their clients, their unique position confers a broader responsibility to contribute to the public health.
PBMs: Public Health Problem Solvers?
While commercial PBMs can significantly impact public health, they are not public institutions and do not have explicit societal obligations beyond their ordinary business activities, licensing requirements, and professional practice standards. Their primary obligations are to serve their clients’ objectives and their investors’ interests. However, there are circumstances where PBMs can incur implicit obligations to contribute to solutions for serious public health issues.
- Require manufacturers or drug distribution companies to provide alerts about potential shortages as part of contractual arrangements
- Adopt predictive analytical methods to detect potential drug shortages and to identify the patients most likely to be adversely affected by them
- Arrange for alternative manufacturers for critical drugs when more than one manufacturer exists
- Alert FDA and established reporting systems of shortages detected or predicted through inventory management processes and predictive analytics
- Alert manufacturers of predicted or observed increases in demand for critical drugs
- Follow and react to shortage notices issued by manufacturers, FDA, and professional organizations
- Alert pharmacists at time of dispensing and physicians at time of prescribing about drug shortage
- Notify patients of drugs in short supply and advise them to contact their physicians
- Provide a list to physicians of their patients on drugs in short supply with available alternatives
- Provide lists to pharmacies of patients who have been receiving drugs from them that are in short supply
- Notify payers about particular drug supply problems that will affect their plan members and the procedures put in place
- Work with public health officials to establish and activate protocols that prioritize patients for distribution within and outside client network
- Activate alternative supply procedures
Moving Forward: Collaboration and Clear Criteria
Life-threatening drug shortages are a public health problem that sometimes calls for health-care organizations and related industries to see themselves as public health agents and extend their capabilities beyond those that serve their ordinary constituencies. By establishing clear criteria and fostering collaboration, PBMs can play a crucial role in ensuring that patients receive the medications they need during times of shortage.