Written by: Kelvin Ofei, PharmD. Candidate, Class of 2021, Mercer University College of Pharmacy

 

What are Drug Shortages and What Causes Them?

 

Drug shortages can arise from various things that may or may not be independent of one another. Manufacturing difficulties can play a role and negatively affect the production of a drug product. One of the major challenges in manufacturing is the absence of raw materials needed to make a drug. This most often occurs when there are multiple manufacturers of a drug but only one producer of the raw material. 

It is estimated that 80% of the raw materials in the pharmaceuticals sold in the U.S. are imported from abroad. Voluntary recalls of drugs usually affect specific “lots” of drugs which occur because of lack of confidence in safety or for other reasons.  

This graph, from the FDA’s report “Drug Shortages: Root Causes and Potential Solutions, 2019”, shows that of the 163 drugs that went into shortage between 2013 and 2017, 62 percent went into shortage after supply disruptions occurred that were associated with manufacturing or product quality problems. 

 

Figure 1 - Drug Shortages

Source: https://www.fda.gov/media/131130/download

 

 

Ranitidine (Zantac) and Metformin ER are two of the most recent drug recalls issued by the FDA.

Natural disasters profoundly affect drug shortages as long term damage to a manufacturing facility hinders the production of the drug. We are currently experiencing a pandemic, and this is also something that affects production as workers may get sick, and manufacturers may not be able to produce the same volume. Hurricane Maria devastated Puerto Rico a few years ago and effectively caused shortages in IV saline bags.

Supply and demand issues can also create a problem as demand could increase beyond expectations or production capacity. One of the most recent examples of this is the Shingrix vaccine (2017). A lack of incentives to produce less profitable drugs can cause manufacturers to face intense price competition, which can lead to a “race to the bottom” in pricing.  

 

This graph, from the University of Utah Drug Information Service, shows the number of drug shortages per year, with each column representing a different year.  

 

Figure 2 - Drug Shortages

Source: https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics

 

 

This graph, also from the University of Utah Drug Information Service, shows the different drug classes which were in short supply due to drug shortages over the course of 5 years. 

 

Figure 3 - Drug Shortages

https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics

 

 

 

What Role Do Compounding Pharmacies Play During a Shortage? 

 

Compounding pharmacies can step in to create medications using just the active components and (excipients) and putting the medication in a customized compounded format that works best for the patient. This will keep the patient from having to go through the stress of trying to figure out what other drugs they should look at taking or even having to take less effective medicine.

Assisting hospitals in providing certain medications should a major shortage or pandemic occur, such as with Tamiflu or Fentanyl. Patients may be allergic to certain ingredients or inactive ingredients in a manufactured drug. Compounding pharmacies can make the drug without those allergens. 

Before the COVID Pandemic, Hospitals were already experiencing shortages of key injectable drugs. Unprecedented demand due to large numbers of critically ill patients with COVID-19 is worsening shortages, especially analgesics, sedatives, and paralytics. Advocacy efforts are successfully creating changes that may improve the current situation. The DEA is trying to combat the shortage situation by increasing annual production quotas of controlled substances necessary for COVID-19 care. View Press Release here.  

In addition to this, the FDA has provided guidance documents to compounding pharmacies, allowing for increased flexibility in the compounding and distribution of drug products. The new guidelines can be found here. 

  

 

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References

  1. Ventola CL. The drug shortage crisis in the United States: causes, impact, and management strategies. P T. 2011;36(11):740‐757. 
  2. https://www.pharmacist.com/unraveling-complexity-compounding-and-drug-shortages 
  3. https://www.fda.gov/media/132058/download 
  4. https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics 
  5. https://www.dea.gov/press-releases/2020/04/07/dea-takes-additional-steps-allow-increased-production-controlled 
  6. https://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents 

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