By: David Geller, CPCU, SCLA
“I’ve been working on drug shortages since 2001, for almost 20 years, and it is the number one most frustrating thing about working on shortages, how opaque things are… To not even, in some cases, know the name of the company that actually made a drug that I’m going to buy for our hospital system to use for our patients. That is just so frustrating.”—University of Utah pharmacist and drug shortages expert to Quartz.
Even prior to the COVID-19 outbreak, reports had been surfacing about the complications resulting from the complex supply chain that is involved in developing pharmaceutical drugs; especially with generics, which account for 90% of all prescriptions filled in the U.S., per CNN Business.
Now, it appears that the COVID-19 outbreak has brought the vulnerabilities in this stretched out supply chain to a head.
Take propofol for example. According to Quartz, propofol is “one of the main anesthetics used to keep Covid-19 patients comfortable while they’re connected to ventilators in intensive care.” One benefit of propofol includes the ability to move COVID-19 patients off the ventilator more quickly, which mitigates the possibility of infection as well as the possibility of side effects that can correspond with longer ICU stays. Additionally, the ability to move patients out of ICU at a faster rate enables hospitals to maintain some capacity for sick patients that are pouring in during this crisis.
However, the Quartz article, which incorporates in-depth research provided by the Bureau of Investigative Journalism, explained that the spate of illnesses caused by this pandemic had compelled a hospital in Illinois to increase their use of propofol fivefold, and ultimately led to their supply dwindling to just one day’s worth at one point, thus forcing staff to use alternative drugs with potentially bad side effects in lieu of propofol.
In addition to the potentially adverse effects that these propofol alternatives could cause patients, another dynamic has amplified the dangers involved as well. Quartz notes that, in March 2020, the Food and Drug Administration (FDA) informed a major pharmaceutical company that supplies 15% of the U.S.’s propofol that a plant inspection in India revealed “‘significant violations.’”
Violations in offshore drug manufacturing plants aren’t unprecedented. In 2019, the New York Times wrote about the findings of an FDA safety officer, who, over the course of five years, estimated that fraud or deceptive practices were ongoing in nearly 80% of the drug plants he inspected.
Among some of the issues described were secretly repeated tests, the development of fake data that misrepresented drug quality, and hidden laboratories. These practices reportedly led to generic drugs consisting of “toxic impurities, unapproved ingredients, and dangerous particulates reaching American patients.” In one instance, the officer discovered an employee in India trying to dispose a garbage bag of documents. The paperwork indicated that “the plant had knowingly released into Indian and other foreign markets vials of insulin containing metallic fragments.”
Even in a “normal” time, manufacturing propofol is time-consuming and complex, which may have, in part, previously resulted in mistakes and costly litigation. Quartz notes that, about a decade ago, a doctor was “double-dipping” into a “jumbo” vial of propofol to treat a number of patients, who then subsequently contracted hepatitis C. The manufacturer was reportedly brought into various lawsuits, and, per Quartz, a 2011 case resulted in a jury award of $356 million to just one couple.
With the increased urgency currently involved in replenishing the propofol supply, coupled with the exhausted and depleted force of medical workers that may be administering the drug, the risk for similar problems transpiring may be worth monitoring—and this is just for one drug alone.
Active Pharmaceutical Ingredients (API): Also a Cause for Concern
CNN Business notes that one in every three generic pills consumed by a U.S. resident is manufactured in India. However, of the active pharmaceutical ingredients (API), which are the raw materials necessary to develop these drugs, that India needs for production, 68% are imported from China.
When the COVID-19 outbreak first emerged in China back in January, per CNN Business, India struggled to procure the API’s and this led to a scramble to source the necessary components. Additionally, Quartz notes that, in response to this scare, India declined to export the raw materials that they were in possession of in March, evidence of the domino effect resulting from the heavily connected global medical supply chain.
A similar development transpired in Italy, when, per Quartz, an Italian commissioner seized a propofol shipment that was supposed to be delivered to Mexico. The article notes that this conjured fears that, in dire situations, countries may “keep critical medicines for themselves.”
The considerations for these shortages extend beyond COVID-19 treatments. According to CNN Business, “there is also a fear among pharma companies that they ‘may not have enough stocked-up API’s for their next set of commitments.’”
This fallout has appeared to generate momentum in different countries to bring drug manufacturing onshore. For example, the New York Times reported that a company has just signed a lucrative contract with the U.S. federal government “to manufacture generic medicines and pharmaceutical ingredients that are needed to treat Covid-19 but are now made overseas, mostly in India and China.”
However, it could take years for a country to successfully transition from outsourcing drug production to seamlessly bringing it back onshore. A chief legal and compliance officer for a pharmaceutical company told Quartz that the cost of setting up the plant and the process to get approved for production would be an extensive process.