Because Ned Said: Drug Shortage or Not, That Is the Question

There have been many recent conversations about drug shortages in the drug and pharmacy industry. One such example is the glucagon-like peptide-1 receptor agonist drug shortage popping up in this corner of the world. Although it may seem on its face to be a clear-cut answer as to whether there is a drug shortage, there are a lot of different factors that go into that determination. For example, just because the FDA proclaims that a drug shortage is resolved, does it really mean that one no longer exists? I think not.

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Although some industry stakeholders would lead folks to believe a drug shortage is resolved, others would argue that simply is not the case based on a regulatory agency statement. A series of facts need to be analyzed to be dispositive, and when they bubble up, the results could prove surprising to one side or the other.

Drug shortages can be caused by a variety of factors, and several different stakeholders should factor into monitoring, identifying, and responding to these shortages.

The determination of a drug shortage is a collaborative effort, involving manufacturers, regulatory agencies, health care providers, and other stakeholders. By working together, these entities should aim to identify, report, and mitigate drug shortages to ensure that patients have access to the medications they need. If a drug shortage indeed does exist, alternate resources such as compounding pharmacies and 503B outsourcers could be utilized to produce copies of drugs to alleviate drug demand in the presence of a shortage.

Determinants of Drug Shortages

1. Manufacturers

Pharmaceutical manufacturers should be relied on as a critical source of information about drug shortages. When a manufacturer anticipates or experiences issues such as production problems, quality control issues, or supply chain disruptions, they should be transparently reporting that potential shortage to regulatory agencies. A potential inherent conflict of interest could arise, however, if such a duty to report clashes with an adverse revenue impact on the bottom line.

2. Regulatory Agencies

The FDA should be playing a significant role in monitoring drug shortages. Manufacturers are required to notify the FDA of any disruptions in the supply of certain medications, particularly those that are critical to public health. The FDA maintains a list of current drug shortages on its website and works with manufacturers to mitigate these shortages. If it is doing its job correctly, the FDA should be responding to concerns from the entire supply chain and not just manufacturers. The administration should also be monitoring public health and complaints emerging from practitioners and patients alike when drug products simply are not available.

3. Health Care Providers and Pharmacies

Pharmacists and health care providers are in a position to notice drug shortages firsthand as they try to fill prescriptions. They may report shortages to manufacturers or regulatory agencies, contributing to the overall understanding of the extent and impact of shortages. When pharmacies are not able to obtain medications in quantities sufficient to provide patients with adequate supply, this should be a red flag.

4. Wholesale Distributors

Distributors play a role in the supply chain and may identify shortages based on their inventory levels, the inability to obtain certain medications from manufacturers, and challenges in providing them to practitioners and pharmacies.

5. Professional Organizations

Organizations such as the American Society of Health-System Pharmacists and other professional groups actively monitor and report on drug shortages. They provide resources and updates to health care providers about shortages and alternative therapies.

6. Public Health Organizations

Government and nongovernmental public health organizations may also track drug shortages, particularly those that affect public health initiatives, such as vaccines or treatments for infectious diseases.

Factors Contributing to Drug Shortages

1. Manufacturing Issues

Problems in the manufacturing process, such as equipment failures, quality control issues, or contamination, can lead to production delays.

2. Raw Material Supply

Shortages of active pharmaceutical ingredients or other raw materials can affect the ability to produce finished medications.

3. Regulatory Compliance

Changes in regulations or the need to comply with new standards can disrupt production.

4. Market Dynamics

Business decisions, such as a manufacturer choosing to discontinue a product or focusing on more profitable drugs, can lead to shortages of less profitable medications.

5. Increased Demand

Sudden increases in demand for certain drugs can lead to shortages. This could occur because of a public health crisis or when a new drug becomes so life-changing or has such beneficial and material treatment outcomes that it cannot be produced and made available fast enough.