Life Science Leader Magazine

DEC 2013

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Pharma Business Drug Shortages: Why They Happen And How They Can Be Solved By Cliff Mintz, Ph.D., contributing editor U ntil the mid-2000s, prescription drug shortages were virtually unheard of in the U.S. However, they have been steadily rising since 2006 and are having a profound effect on the delivery of medical care and the regulatory approval of new medicines. "I had never heard of or personally experienced drug shortages until 2006," said Robert Campbell, M.D., co-chair of a newly formed group called Physicians Against Drug Shortages. Likewise, Sean Adams, M.D., a private-practice anesthesiologist concerned about ongoing drug shortages and their effect on patient care, offered, "Until six or seven years ago, I had never heard of drug shortages; physicians were always able to get the drugs they needed to treat their patients." Interestingly, a report from the University of Utah Drug Information Service showed that reported drug shortages grew from 70 in 2006 to 166 in 2009 and 210 in 2011. Many experts, including Campbell, expect the number of drug shortages to exceed 225 in 2013. Not all drugs are in short supply in the U.S. Most of the affected drugs (almost 80 percent) are sterile, generic injectables used for general anesthesia and pain management or to treat infectious diseases and cancer. "Because of prolonged shortages, physicians are increasingly being forced to either delay or withhold treatment or substitute less effective drugs," said Campbell. He added, "In addition to increasingly jeopardizing patient safety, this is contributing to rising rates of subpar patient care and poorer medical outcomes." Drug shortages are not only affecting patient care. In many cases, shortages 44 LifeScienceLeader.com have also had a negative impact on the progress and conduct of the human clinical trials required for new drug approvals. Oncology drug development has been the therapeutic area most affected by the shortages. This is because cancer, unlike other disease states, is typically treated with specific multidrug regimens with narrow therapeutic indexes. Consequently, a shortage of a single component of an approved treatment regimen can effectively eliminate its use as a comparator (control) treatment in clinical trials. "Shortages of specific generic chemotherapy agents continue to interfere with patient enrollment and oftentimes halt or delay the progress of oncology clinical trials," said Ali McBride, PharmD., Department of Pharmacy at the University of Arizona Cancer Center. In support of this, a survey conducted by the Hematology/Oncology Pharmacy Association for a 12-month period ending October 2011 revealed that drug shortages forced 44 percent of respondent institutions to either halt or delay patient enrollment in cancer clinical trials. The drugs frequently reported as being in short supply included fluorouracil, leucovorin, liposomal doxorubicin, and paclitaxel drugs commonly used to treat ovarian and breast cancers. "Unfortunately, while many people contend that drug shortages are beginning to abate, new drugs are December 2013 regularly being added to drug shortage lists in the U.S.," lamented Campbell. CAUSES OF DRUG SHORTAGES The FDA attributes over half (54 percent) of all drug shortages to quality or manufacturing issues that force drug production facilities to either partially or permanently shut down. These issues have been most pronounced for sterile-injectable drugs (most of which are generics), which are more complicated to manufacture than nonsterile products and, consequently, more likely to experience quality or production problems. To that point, in 2012, it was estimated that nearly a third of the sterile manufacturing industry's production capacity was not being utilized because of plant closings or temporary shutdowns to fix serious quality issues. Another factor contributing to drug shortages is consolidation in the pharmaceutical and contract manufacturing industries. This has resulted in a dwindling number of manufacturing and suppliers for a growing number of drugs. At present, according to a 2012 FDA report, over 50 percent of drugs in short supply have three or fewer manufacturers. Moreover, Physicians Against Drug Shortages' Campbell emphasized that only three manufacturers are responsible for producing 70 percent of the world's

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