A Deeper Look at Drug Shortages in the U.S.
Drug shortages can occur for a number of reasons. The Pharmaceutical Research and Manufacturers of America (PhRMA) lists the most common as changes in clinical practices, inventory practices of wholesalers and pharmacies, raw material shortages, changes in hospital and pharmacy contractual relationships with suppliers and wholesalers, natural disasters, and manufacturing issues.
Brexit in the UK and European Union has caused pharmaceutical companies that supply drugs there to stockpile drugs in order to guarantee inventories. But the U.S. doesn’t have that excuse.
Recently, in the U.S., there has been a shortage of an anti-anxiety drug, buspirone. The American Society of Health-System Pharmacists (ASHP) lists shortages, and as of Jan. 31, 2019, noted shortages of buspirone tablets manufactured by Accord Healthcare, Mylan and Teva Pharmaceutical, and that the companies “did not provide a reason for the shortage.”
Accord’s were on back order with an estimated release date of late-March 2019. Mylan said theirs were also on back order and estimated a release date of late-January to early-March, although for some dosages they had no estimated release date. Teva also suggested release dates of early- to mid-February or early-March for some dosages.
There were, however, buspirone tablets available from Par Pharmaceutical.
“This is potentially messing with people’s clinical stability,” Dennis Glick, a psychiatrist in Greenbelt, Md., told The New York Times. “When you have a patient with a complicated and balanced regimen, you really don’t want to just arbitrarily have someone come off the medicine.”
Glick said he had been in practice for 34 years “and I honestly don’t recall issues like this interfering with care until maybe a couple of years ago.”
Another example of a shortage is the new shingles vaccine, Shingrix. Although the vaccine, marketed by GlaxoSmithKline, was approved and recommended for adults 50 years and older in October 2017, it has been extremely difficult to find, with physicians unable to acquire it and recommending patients check with local drugstore pharmacies, which also are reporting back orders and shortages. GSK’s response is there was “unprecedented demand.”
The New York Times writes, “Persistent shortages have plagued hundreds of drugs in recent years, from morphine to intravenous fluids, and many psychiatric medications used to treat schizophrenia, as well as some stimulants used to treat attention deficit hyperactivity disorder, are in short supply. Some of the worst shortages are of generic, or non-brand-name, drugs like buspirone, whose prices have been driven so low that many manufacturers say they cannot turn a profit on them.”
The generic shortages have been common and severe enough that in January 2018, five healthcare system, the U.S. Department of Veterans Affairs (VA), Intermountain Healthcare, Ascension, SSM Health and Trinity Health, formed a not-for-profit generic drug company called Civica Rx.
Civica Rx expects to offer 20 generic drugs this year and within three to five years, believes it will offer up to 100 generic medicines. The interest from hospitals dramatically exceeded expectations, and Civica Rx now has about 800 participating hospitals and raised more than $160 million from its members, which along with the original groups now includes HCA Healthcare, the Mayo Clinic, The Catholic Health Initiatives and others.
The New York Times reports that the buspirone shortage seems to be caused by interrupted production at Mylan’s factory in Morgantown, West Virginia, which supplies about a third of the U.S.’s supply of the drug. The U.S. Food and Drug Administration (FDA) has, The Times reports, “said the facility was dirty and that the company failed to follow quality control procedures.”
Although that is one reason for a shortage in a specific market, the generic market’s competitive issues appear to be at least part of the problem. Civica Rx suggests that in the generic market, consolidation of the generic companies, manufacturing problems, and resultant steep price increases, have caused the shortages. It has also led, in some cases, to a generic drug being manufactured by only a single company, which can then set the prices high.
“There are very, very old drugs that have been used not only for decades, some for almost a century,” Civica Rx chief executive officer Martin VanTrieste told Reuters. “When hospitals can’t have them, they are forced to cancel patient treatments or find alternative treatments. In most cases, that is suboptimal care or no care at all.”
And in fact, a study conducted at the University of Chicago on behalf of three healthcare organizations and released in January 2019, found more than 90 percent of U.S. hospitals had to “identify alternative therapies to mitigate the impact of drug prices increases and shortages.”