Erica Stewart, a stay-at-home mom, is one of the millions of Americans living with Lupus, an autoimmune disorder whereby the immune system attacks healthy cells. Her life and ability to take care of her six children depend on a drug called Plaquenil, the brand name of hydroxychloroquine, a drug that made headlines last month as a potential, but unproven treatment for COVID-19.
Stewart, who lives in West Virginia, said that when she tried to fill her standing prescription for Plaquenil last week, the pharmacist declined the request, blaming it first on her insurance and then later on a lack of supply.
“They said, pretty much, right now if you’re not a COVID patient that it was impossible for them to approve you because they do not want to be short in their pharmacy.”
Rising demand for products has caused many of the drug shortages the U.S. is facing but experts say additional drug shortages are on the way due to impacts in the supply chain. The shortages stem from a combination of factors; the U.S. relies on two countries, China and India, to manufacture pharmaceuticals, the supply chains in the U.S. use just-in-time ordering, and according to some pharmaceutical and logistic professionals, there is a lack of transparency in the drug supply chain.
Since January, U.S. imports from China have sharply declined due to the coronavirus. The U.S. sources many of its pharmaceuticals from China.
Last month, the Food and Drug Administration announced the first known drug shortage due to the coronavirus and stated that 20 more drugs were under watch. However, they did not disclose which drugs were in danger in order to prevent the disclosure of the manufacturing location of the drugs.
This information is considered proprietary in the U.S. and is protected from disclosure.
“If you look at a bottle, it will tell you who’s marketing the drug but it doesn’t necessarily tell you who manufactured it,” said Dr. Michael Ganio, director of pharmacy practice and quality at the American Society of Hospital Pharmacists.
Ganio believes this policy hinders medical professionals from providing the best care.
Not only do medical providers need this information in order to anticipate and prepare for drug shortages, said Ganio, but they also need this information to deal with quality issues in products.
There are best practices already in place to manage shortages but a lot of it is centered around knowledge of the shortages and where they are coming from said Ganio.
“If they disclose that the shortage of this one drug is caused by the coronavirus that then discloses the fact that the manufacture is occurring in China,” he said.
The U.S. pharmaceutical supply chain depends on one region, China, to source a large portion of its drug supply. This dependency on one region means the U.S. is susceptible to supply shocks that can cause large shortages in essential medicines.
The problem is not United States dependency on China but our dependence on drug manufacturing in one region.
More than 72% of active pharmaceutical ingredients or APIs are manufactured outside of the U.S., with 13% of API manufacturers supplying the U.S. coming from China, according to the FDA.
However, this number is understated because many other countries, including India, that provide finished drugs to the U.S. source their active ingredients from China, said Nada Sanders, professor of supply chain management at Northeastern University’s school of business.
Last week, India banned all exports of hydroxychloroquine, the drug Erica Stewart depends on to treat her autoimmune disorders.
“We see India saying since we are getting a trickle shortage from China, we’re going to cut back on our exports to the U.S. because we need it for our own people,” said Sanders.
Manufacturing facilities in China have also temporarily shut down. The FDA has postponed all drug inspections in China which have, in turn, caused delays in drug approvals.
Another issue is that hospitals and pharmacies in the U.S. operate with what is called a “just-in-time method,” meaning medicines and other medical supplies are ordered as they are needed, according to Sanders.
Most pharmacies will only carry a month or two of supplies, the distributor will also carry about another month or two of supplies and the pharmaceutical company itself may carry another month of supplies, according to Sanders.
Sanders believes that should supply interruptions continue, the U.S. public could start to see widescale supply shortages anywhere from two to six months from now.
Last week, the $2.5 trillion stimulus bill passed by congress included multiple provision expediting inspections and reviews for new drugs, mandatory manufacturer reporting of drug shortage information that is currently mandatory, and expansion of reporting requirements among others.
But Ganio said that while this is a step in the right direction, nothing has really changed. The knowledge still isn’t publically available to medical providers.