Pharmacy Benefit Manager symbol intertwined with a supply chain link, against a backdrop of worried patients.

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?

Pharmacy Benefit Manager symbol intertwined with a supply chain link, against a backdrop of worried patients.

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.

One such circumstance arises when these organizations reach a certain size and possess capabilities applicable to a particular public health problem, such as serious drug shortages. Some PBMs might address these issues based on their organizational ethos, while others may need to justify their involvement to their clients and investors on more concrete grounds.

Here are the Actions PBMs can take to prevent and ameliorate serious drug shortages:
  • 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
One justification for PBM involvement stems from the requirement that PBMs hold a variety of licenses based on the services they provide and where they provide them. Most, for example, have licenses as third-party administrators, pharmacy benefit managers, and dispensing pharmacies. These licenses give them certain advantages via the higher barrier they create for potential competitors. In return, licensing agencies and the people they protect can expect PBMs to serve their interests.

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.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1038/clpt.2012.224, Alternate LINK

Title: Pharmacy Benefit Managers And Their Obligations During Serious Prescription Drug Shortages

Subject: Pharmacology (medical)

Journal: Clinical Pharmacology & Therapeutics

Publisher: Springer Science and Business Media LLC

Authors: J R Teagarden, R S Epstein

Published: 2013-02-01

Everything You Need To Know

1

What exactly are Pharmacy Benefit Managers (PBMs) and what do they do?

Pharmacy Benefit Managers, or PBMs, are organizations that manage prescription drug benefits on behalf of health insurers, employers, and other payers. They act as intermediaries between drug manufacturers, pharmacies, and patients, negotiating drug prices, creating formularies, and processing prescription claims. PBMs play a significant role in determining which drugs are covered by insurance plans and how much patients pay for their medications. Given their position they are able to impact the availability of drugs, in the context of drug shortages.

2

Why are drug shortages a problem?

Drug shortages are a significant concern because they can disrupt patient care, potentially leading to the use of less effective treatments, delays in necessary treatments, and compromises in the supply chain. In severe cases, patients might not have access to the medications they urgently need. The lack of adequate mechanisms to address these shortages necessitates more proactive and effective strategies to ensure a consistent and reliable drug supply for patients.

3

How can Pharmacy Benefit Managers (PBMs) help with drug shortages?

PBMs can leverage their extensive networks and dispensing capabilities to ensure patients receive necessary medications even when supplies are limited. Actions include requiring manufacturers to provide shortage alerts, using predictive analytics to detect potential shortages, arranging for alternative manufacturers, and alerting relevant parties like the FDA, pharmacists, physicians, and patients. Their involvement is critical due to their ability to influence the supply chain and ensure patient access to medications.

4

Do Pharmacy Benefit Managers (PBMs) have a responsibility to help solve public health problems like drug shortages?

While commercial PBMs primarily serve their clients' and investors' interests, they can also incur implicit obligations to address serious public health issues like drug shortages. This obligation arises when PBMs have the capabilities and reach to significantly impact such problems. Addressing these issues can be justified because PBMs hold licenses that create higher barriers for competitors, implying a responsibility to serve the broader interests of those protected by these licenses.

5

What specific steps can Pharmacy Benefit Managers (PBMs) take to prevent or reduce the impact of drug shortages?

PBMs can take several actions to prevent and alleviate serious drug shortages, including requiring manufacturers to provide shortage alerts, using predictive analytics to detect potential shortages, arranging for alternative manufacturers, and alerting relevant parties. They can also work with public health officials to prioritize patients for distribution and activate alternative supply procedures. These measures help ensure that patients receive the medications they need during times of shortage.

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