The Ethics of Drug Shortages



March 26, 2018

(by guest blogger Rachel Wolthoff)

Your hospital has a critical shortage of amino acids to use in I.V. nutrition solutions. As a pharmacist, you face a tough choice: use the remaining amino acids to compound a parenteral nutrition solution for a young adult with cancer, or for three premature babies who don’t yet have the ability to swallow. Who gets the treatment?

This is not just a theoretical question. Drug shortages have been a problem in the U.S., often impacting the quality of care. Sometimes drug substitutions are needed to make up for the lack.  One example is from 2006, where patients with childhood lymphoma who received substituted chemotherapy treatments had an increased risk of relapse. At that time, 75% of oncologists had to resort to drug substitutions due to drug shortages. This has often led to patient harm.

Today, global disasters are creating a similar type of resource problem. American drug companies such as Amgen, Baxter, Eli Lilly, Johnson & Johnson, and Pfizer have large manufacturing facilities in Puerto Rico, one of the hardest-hit areas by Hurricane Maria in September of 2017. The storm crippled drug manufacturing on the island by disrupting electrical, water, and transportation systems. Even today many facilities are running well below capacity. The deluge of wind and rain from Maria caused the already tenuous supply chain of intravenous fluids to dry up.

Drug shortages are more than just a business problem of supply and demand; there are a host of ethical concerns:

  • Drug wholesalers, hospitals, and pharmacies may ration critical drug supplies, such as intravenous fluids and chemotherapy.

  • Unfair allocation decisions may violate distributive justice.

  • Physicians and other providers may be forced to use less effective or riskier treatments, violating the Hippocratic principle of avoiding harm.

  • A patient’s autonomy may be limited by what the pharmacy can order from the wholesaler.

  • The sole supplier of a life-saving drug during a shortage may increase prices to capitalize on the monopoly.

Medical ethics should be a part of every drug shortage conversation, from the bedside to Washington, D.C. Doctors, pharmacists, hospitals, drug companies, insurance companies, and patients must have a seat at the table to ensure that each patient receives quality, ethical drug therapy.

Sources:

Abassi, L. (2016, January 29). Drug Shortages: Ethics and Implications. American Council on Science and Health: www.acsh.org/news/2016/01/29/drug-shortages-ethics-and-implications

Char, D. S., & Magnus, D. P. (2015, August). Ethics of Disclosure Regarding Drug Shortages That Affect Care. Anesthesia & Analgesia.

Med, N. E. (2013, December 19). Survey of Oncologist about Shortages of Cancer Drugs. The New England Journal of Medicine.

Thomas, K. (2017, October 23). U.S. Hospitals Wrestle with Shortages of Drug Supplies Made in Puerto Rico. www.nytimes.com/2017/10/23/health/puerto-rico-hurricane-maria-drug-shortage.html

 

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