WASHINGTON — The number of drug shortages reported annually has nearly tripled over the last five years, with much-needed drugs such as chemotherapy, anesthetics and electrolytes disproportionately affected.
FDA sometimes can mitigate or even prevent a shortage, but this requires extensive cooperation from manufacturers. In the event of a shortage, the federal government has little or no authority over the type or amount of drug the manufacturers produce.
Should pharmaceutical manufacturers be required to inform FDA six months in advance if they are discontinuing any drug?
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Growing Trend of Drug Shortages
Howard Koh, MD, Assistant Secretary of Health
In 2005, 61 drug shortages were reported to FDA. By 2010, that number had grown to 178, with 132 of those involving sterile injectable drugs, despite that these drugs comprise a small percentage of the overall prescription drug market. According to FDA officials, this trend has continued into 2011, which will see an even greater number of drug shortages by year’s end. (Drug shortages have had a detrimental effect on VA healthcare. See sidebar, page xxx.)Testifying at a recent hearing held by the House Energy and Commerce Health Subcommittee, Howard Koh, MD, Assistant Secretary of Health, said, “These injectables include critical products such as oncology drugs, anesthetics, parenteral nutrition drugs and many drugs used in emergency rooms.”
Oncology drugs account for 28% of shortages, followed by antibiotics at 13%. During 2010 and 2011, 118 shortages (93% of the total) involved drugs classified as “medically-necessary,” and 41% were both medically necessary and sole source drugs, Koh said.
There is no single reason a drug shortage occurs, Koh noted. Factors include industry consolidation, issues of quality, manufacturing challenges, changes to inventory and distribution practices, production delays, discontinuation for business reasons, unanticipated increased demand and shortage of raw materials.
As for why generic injectables are so strongly affected, Koh said that it may have to do with the long manufacturing processes for such drugs, many of which now occur at off-shore sites. “There is also the aging of facilities where this work is ongoing,” Koh said.
Quality issues caused by these issues have been quite disturbing, Koh said. “We’re actually tracking products that have been found to have pieces of glass or pieces of metal in sterile products meant to be injected into patients.”
Broader economic troubles also impact the profit margin on manufacturing drugs in general, and the profit margin on generic drugs is relatively narrow, Koh said.Drug Shortages Tripled in Last Five Years; Critical Medications Unavailable Cont.
FDA’s Limited Ability
While FDA can control the quality of drugs being sold, it cannot require a firm to make a drug. However, if given enough notice, it can work with manufacturers to prevent or alleviate the impact of a shortage.
If a manufacturer decides to stop making a drug and informs FDA ahead of time, the agency can encourage other firms to ramp up production. FDA also can expedite review of submissions from manufacturers that may include extending expiration dates, increasing capacity or using a new raw material source, if a shortage of raw materials in the root problem.
According to Koh, FDA was able to prevent 38 drug shortages in 2010. Thus far in 2011, the agency has prevented 99.
In one example, a recent shortage of the drug cytarabine, used to treat certain types of leukemia, resulted from crystal formation in the vials. FDA worked with the manufacturer and found that, if the vials were warmed, the crystals would dissolve and the danger to patients was mitigated. The manufacturer was then able to ship the vials with a letter to healthcare professionals notifying them to inspect for crystal formation and, if present, to warm the vials to dissolve crystals to ensure patient safety.
These types of solutions depend on close communication between manufacturers and FDA, however. At the hearing, Rear Adm. Sandra Kweder, MD, FDA deputy director, explained that the agency always could use earlier warnings.
“[In] the majority of cases of shortages we could have been notified, and in the majority we were not notified,” Kweder said. “It’s getting better, but we still have a large percentage of shortages where we did not know it was coming.”
Currently, manufacturers are not required to inform FDA they are discontinuing a drug unless it is a sole source, medically necessary drug, in which case they must inform FDA six months in advance.
“When they inform us in advance, we work very closely with them to understand the problem and see if this shortage would be something that would be critical for patients,” Kweder explained. “For example, if a company is making a product that 20 other companies make, that’s not exactly a critical public situation. But for these sterile injectables, that’s not the case. So we will work with companies to fix the problem and avoid an interruption in production.
“Now, that is not always possible. When it’s not possible and it looks like a company may have to interrupt production, we go to other manufacturers, and we talk to them about their capacity to increase their production. They usually can’t turn that around on a dime. But we work with them to facilitate ramping up.”
While informing FDA early is imperative, Kweder cautioned that early public notification may not always be in everyone’s best interests. Public notification could result in increased demand as hospitals begin stocking up or hoarding drugs. Also, what looks like a shortage at first may only be a distribution problem upon further examination.
“We think very carefully about when is the right time to make a public announcement about a potential shortage,” Kweder said. “Sometimes you see what looks like a shortage in one part of the country, but there’s plenty of it and more so in another part. We take that potential for making things worse very, very seriously.”
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