In 2008, a shortage of pig intestines, used in the manufacture of the blood anticoagulant heparin, was associated with the drug product’s contamination in China and led to many deaths around the globe. This event demonstrated the significance of a shortage of supplies needed to manufacture a particular drug and its effect on public health.
According to the Premier healthcare alliance, a performance-improvement alliance of 2500 US hospitals and 75,000 healthcare sites, drug shortages cost US healthcare providers at least $200 million annually. “These drug shortages increase the risk to patients due to the introduction and use of unfamiliar drugs to work around the shortages,” states a Premier press release from March 2011.
For many years, FDA has run a Drug Shortage Program aimed at addressing “potential or actual shortages of drugs that have a significant impact on public health.” Current shortages are kept up to date on the site. Among the most recent shortages listed are Genentech’s Tamiflu for Oral Suspension and several injections. The information provided on the site is provided voluntarily by manufacturers (they are not required to do so). The agency encourages healthcare professionals and patients as well to notify it about any other known shortages at email@example.com.
In 2010, there were 178 drug shortages reported to FDA, 132 of which involved sterile injectable drugs, according the agency’s frequently asked questions (FAQ) website for the program. This year, to date, there has been “an increasing number of shortages, especially those involving older sterile injectable drugs,” says the site. These shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding.
For the most part, these shortages have been caused by quality and manufacturing issues, says the FDA FAQ website. Other causes are tied to delays with getting raw materials or components from suppliers, or discontinuations of certain products (which FDA does not have the authority to stop). “With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs,” says the FDA website.
The agency works with companies to address quality and manufacturing problems and to help ramp up production, where appropriate, by expediting the approval of new production lines or raw-material sources. The agency also, in some cases, approaches overseas companies that may be able to fill any gaps in product shortages.
Earlier this year, two US Senators introduced the Preserving Access to Life-Saving Medications Act (S. 296) to amend the Federal Food, Drug, and Cosmetic Act to provide FDA with improved capacity to prevent drug shortages, including the way the agency prioritizes reinspections. According to the draft legislation, the Secretary of the US Department of Health and Human Services would have to submit an annual report to Congress about actions taken to address drug shortages all through the supply chain. To date, the bill is still in committee. A companion House bill, H.R. 2245, is also in committee.
Many groups have been lobbying Congress on this topic. For example, drug shortages are a key issue for cancer patients. The Association of Community Cancer Centers hosted a Capitol Hill briefing on July 13, 2011, to present data from a new survey showing that 94% of reporting facilities in 2010-2011 experienced an oncology drug shortage. Eighty-four percent of those facilities said they had to “temporarily modify or suspend a chemotherapy regimen for their patients because they were unable to obtain a specific drug,” according to a blog on the ACC site.
I find it surprising that manufacturers are not required to alert FDA to shortages, whether pending or imminent, considering the impact a shortage can have on patient care and the industry in general. Even the FDA itself says that “significant public health consequences that can result from drug shortages,” on its FAQ site. Manufacturers are also not required to report the reasons for shortages or the shortages’ expected duration. They are required, however, to let FDA know six months in advance about any discontinuations of sole-source products.
FDA is holding a public workshop on this topic on Sept. 26, 2011, in Silver Spring, Maryland. The focus will be on how FDA’s Center for Drug Evaluation and Research is addressing the issue, the causes and impacts of shortages, and potential strategies for preventing them in the future. Let’s hope the workshop helps move forward the pending legislation in Congress so that regulators, industry, and healthcare providers can better prepare for and control the effects of drug shortages in the future.