Crisis Averted? Manufacturers Scurry to Meet Demand for Drugs

Matthew T. Corso
Published: Saturday, Mar 12, 2011
Figure. National Drug Shortages, January 2001 to December 31, 2010The shortage, which began in 2009, accelerated in 2010, and has shown no signs of abatement so far in 2011, according to Erin R. Fox, PharmD, manager of the Drug Information Service at University of Utah Health Care, which provides data for the American Society of Health-System Pharmacists (ASHP) Drug Shortage Resource Center. Dr Fox has led the drug shortages project since 2001.

“Through December 2010 we’ve tracked 211 new shortages, and that’s the most ever,” Fox said. This compares with 149 new shortages in 2008 and 166 in 2009 (Figure), according to the Drug Information Service’s data.

While the shortages include a variety of drugs, such as antimicrobials and anesthetic agents, the FDA reports that about 75% involve chemotherapy sterile injectables for cancer patients.

“Already in 2011 we have seen recalls due to quality issues and have seen new shortages occur as a result,” said Captain Valerie Jensen, RPh, the FDA’s Associate Director of the Drug Shortage Program.

In explaining one of the key reasons for the shortage, Fox, who is also associate professor (adjunct) in the Department of Pharmacotherapy at the University of Utah College of Pharmacy in Salt Lake City, added, “What makes chemotherapy drugs so different to deal with is basically there are no alternatives and they’re not easy to substitute. It’s a disaster.”

The shortages of chemotherapy agents (Table) are “definitely affecting patient care,” according to Bona E. Benjamin, BS Pharm, Director of the Medication-Use Quality Improvement for the practice development division of the ASHP.

“Regarding oncology drug shortages, we’ve gotten anecdotal reports that some patients are not getting drugs when they should be, that they’re not getting all of the drugs they need, or are not getting any drugs at all for a time,” Benjamin said. “And that means patients are not getting the best outcome that they should.”

Her contentions about patient care are corroborated by Ali McBride, PharmD, MS, a clinical pharmacy specialist at the Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital, in St. Louis, Missouri. “We’re seeing a lot of shortages,” McBride said. His unit has delayed patients starting chemotherapy until they were able to get an emergency supply of a drug. In some cases, he said, autologous transplants also have been delayed.

One example he gave concerns the shortage of intravenous (IV) etoposide, a chemotherapeutic agent used in a variety of cancers, including lung cancer. In response to the shortage, some physicians have been switching from an IV to an oral formulation. “This increases the risk of dosage errors because patients usually have to double up on the oral medication,” McBride said. “This is truly a crisis, when patients can’t get the treatment regimen that they need,” he said.

In an attempt to find solutions for the shortages, ASHP, the Institute for Safe Medication Practices (ISMP), the American Society of Anesthesiologists, and the American Society of Clinical Oncology convened a Drug Shortages Summit in Bethesda, Maryland, in November 2010.

The summit found that a major cause of the shortages is that fewer manufacturers are producing the sterile injectables, most of which are generic, thereby limiting contributors to the supply chain. Consequently, manufacturing and production-line problems result in stunted supply. The problem of few suppliers came sharply to light when two of the largest sterile injectable manufacturers, Teva Pharmaceuticals and Hospira Inc., had to shut down some production lines in 2010 because of difficulty in meeting required quality control standards.

“Not many people are manufacturing (the target drugs) these days. There’s just not enough resiliency in the supply chain,” Fox said.

Benjamin concurred. “It’s very complex to produce sterile injectables, especially if you’re talking about cytotoxic drugs such as chemotherapy agents,” she said.

Table 1: Chemotherapy Drugs in Short SupplyAsked to comment on the FDA’s understanding of the shortages, Captain Jensen said:

“In general, the older sterile injectable drugs are being made by fewer and fewer manufacturers each year. The firms continuing to make these older injectables have limited capacity and only so many products can be made on the existing manufacturing lines. The firms often discontinue these older drugs in favor of newer, more profitable drugs. Unfortunately, when a quality problem develops at one manufacturer or there is any delay or a discontinuation by a manufacturer, a shortage usually develops due to the limited ability of the remaining firms to meet the shortfall. The recent shortages have mainly been caused by a large number of quality issues, as well as delays and discontinuations.”

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