Although the number of new drug shortages in the United States has declined to 186 in 2018 since a high of 267 in 2011, there have been 80 for the first half of 2019, according to the University of Utah Drug Information service.
“Shortages continue to be on the rise and in talking with our customers, we’ve discovered the problem continues to get worse. More medications are going on allocation or unavailable and what used to be short, periodic shortages have become long and drawn out, making it a continuous challenge for clinical leaders,” says Patrick Yoder, PharmD, CEO, LogicStream Health, a Minneapolis-based clinical process improvement and control software provider.
“Some medication shortages have been going on for years with no real sign of recovery,” he says.
“While the number of drug shortages has declined substantially in recent years, any drug shortage places substantial burdens on healthcare, providers who may have to ration medicines or identify alternative treatments,” says Andrew Powaleny, director, public affairs for Pharmaceutical Research and Manufacturers of America (PhRMA).
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“The issue of drug shortages demands attention and collaboration from all stakeholders involved in providing life-saving medicines to patients. This includes the biopharmaceutical companies producing brand-name medications, as well as generic drug and biosimilar manufacturers, wholesalers, distributors, pharmacies, and healthcare providers,” he says.
A survey conducted between March 6 and April 4, 2019 of 365 acute and non-acute care facilities across the country—members of Vizient, a healthcare performance improvement company headquartered in Irving, Texas—confirms the ever-present problem of drug shortages and their ramifications.
Nearly two-thirds of respondents report they managed at least 20 shortages from July through December 2018; 64%, more than 21; 33%, six to 20; and 3%, up to five. Thirty- eight percent report one or more medication errors directly related to a drug shortage in that same time period.
The most commonly reported items facing shortages, according to the survey, are controlled substances, local anesthetics, antibiotics, electrolytes, and emergency injectables such as “crash cart” drugs, many of which are low-cost generics.
Injectables comprise 39% of drug shortages in 2019, according to the University of Utah Drug Information Service.
Top causes of drug shortages
The FDA primarily attributes shortages to quality/manufacturing issues but also points to production delays, some caused by not receiving raw materials and components from suppliers, and drug discontinuations. An estimated 70% of shortages are caused by manufacturing and quality problems, according to the Healthcare Supply Chain Association.
“The FDA can't require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs,” says Charlie Kohler, spokesperson for the FDA. “With fewer firms making older, sterile injectable drugs, there is a limited number of production lines that can make these drugs. Raw material suppliers also are limited in the amount they can make due to capacity issues at their facilities.”