Drug Shortage Crisis – How Hurricane damage is impacting drugs in the United States
By CHHS Extern Nicole Kulaga
In 2017, Hurricane Maria devastated Puerto Rico, claiming the lives of an estimated 4,645 people. Almost a year later, Puerto Rico and the nation as a whole, are still recovering. While officials have restored 95% of the power grid, more than 250 schools are set to close permanently, and drug shortages are impacting healthcare providers throughout the United States.
Puerto Rico is home to an estimated 101 pharmaceuticals including drugs for heart disease, cancer, diabetes, arthritis, H.I.V., blood thinners, and IV saline bags. Factories in Puerto Rico “make 13 of the world’s top-selling brand-name drugs, from Humira, the rheumatoid arthritis treatment, to Xarelto, a blood thinner used to prevent stroke.” Pharmaceutical giants who manufacture in Puerto Rico include“Johnson & Johnson, Pfizer, Eli Lilly, Amgen, Bristol-Myers Squibb, AbbVie, Merck, and Baxter”. Baxter International is a company that accounts for “43% of the United States’ IV solution market and the bulk of that had been produced in Puerto Rico.” Methotrexate, a drug that is manufactured in Puerto Rico, is used to fight childhood leukemia among other diseases. Unfortunately, after the hurricane, “all five manufacturers of the injectable form of the drug have reported shortages of the product.” As of July 29th, 2018, there remains a shortage of the drug methotrexate.
As of July of 2018, there were 431 entries into the nationwide drug shortage list, some of which are drugs that are manufactured in Puerto Rico. Drugs that are on the shortage list that are manufactured in Puerto Rico include Azithromycin Injection, Atenolol tablets Belatacept injections, and Potassium Chloride Injections. Azithromycin is an antibiotic, made by Pfizer. Atenolol is an active ingredient in Tenoretic, a hypertension medication produced by Almatica. Belatacept is an active ingredient in Nulojix, a medication used for kidney transplants produced by Bristol-Myers Squibb. Finally, Potasium Chloride is an active ingredient in the K-Tab which is used for Potassium deficiency which is produced by AbbVie.
Many of these companies are being proactive to prevent damage in the future. The U.S. Food and Drug Administration (FDA) released a statement that encouraged companies to “have backup lines, and facilities and raw material suppliers, [be] prepared for when things go wrong” to help prevent future shortages. In addition to preventative efforts, all manufacturers must be in compliance with the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) which requires disclosure of any disruptions that impact the supply of the drugs.
However, despite existing preventative efforts, natural disasters inevitably occur and drug shortages remain an issue. In response to this crisis, the FDA created the Drug Shortages Task Force to create long-term solutions to drug shortages. The task force, led by Keagan Lenihan, will expand on the FDASIA. One possible outcome of this taskforce is the creation of a “critical drugs list” which would label certain medications as essential and therefore must have an uninterrupted drug supply.
The task force will continue to work to resolve manufacturing issues through the use of new technologies. The FDA has already created the “emerging technology program” which works with companies on the implementation of new technologies. New methods of manufacturing pharmaceuticals is one solution to a multifactorial problem.
Natural disasters will always be a threat to a company’s productivity. Hurricane Maria devastated Puerto Rico, and the impacts of the destruction can still be felt today in the lives that were lost, homes that were destroyed, and medicines that have not been available to those that need them. Fortunately, with the creation of the Drug Shortages Task Force, the issue of drug shortages can be mitigated and efforts can be made so that when the next disaster hits, people are prepared.