“Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no longer be available; that’s not right.”
manufacturers interested in producing the product. In rare cases, the agency can tem- porarily import drugs from other coun- tries or unapproved sources. FDA did this with the anesthetic propofol, for example. The propofol shortages began in fall 2009 when two U.S.-based manu- facturers halted distribution and recalled several lots of propofol products due to quality problems. This action left only one company to supply propofol to the entire United States. FDA used its regulatory enforcement
discretion to temporarily allow the im- portation of fresenius propoven 1%, an unapproved drug, into the United States. FDA deemed the propofol product, ap- proved in other countries, comparable to the product used in the United States. While FDA can exercise some regula-
available.” He adds that physicians have no choice but to make drug substitutions that may not be in the patient’s best interest.
It’s critical that TMA and AMA exam- ine the drug shortage problem “because it affects patient safety and welfare,” he says, noting that the public has little, if any, knowledge of the problem. Dr. Speer sees patients at Texas Chil-
dren’s Hospital and within the Harris County Hospital District (HCHD). The district, like many health systems and outpatient facilities in Texas, has grap- pled with drug shortages for some time. During the summer, HCHD notified staff members that more than 75 drugs on its formulary were in short supply or on back order. The report listed antibi- otics, injectables, topical solutions, and one vaccine, and featured alternate med- ications and estimated resupply dates. “Part of the problem lies in increasing
consolidation of the drug industry,” Dr. Speer said. “There are many fewer com- panies in existence competing with one another. There is often only one compa- ny producing a given generic medication. If that one company ceases production, for whatever reason, there is no drug.” Additional factors influencing drug supply include scarcity of raw materials, manufacturing problems, and unexpect- ed demand. Business decisions within
26 TEXAS MEDICINE October 2011
the pharmaceutical industry could also be at play, such as cutting back on pro- ducing low-cost generic drugs in favor of more profitable brand-name drugs. Dr. Speer says some manufacturers may dial down or discontinue produc- ing some of the older generic drugs for financial reasons. According to FDA, as more versions of a drug become available, the price of a drug can decrease. If the costs associated with making a drug begin to outweigh sales profit, companies may wish to dis- continue making the drug in favor of newer, more profitable products. Couple this with a reduction in the number of companies making an older drug or a delay in manufacturing, and you have a recipe for shortages. In the wake of a shortage, FDA works with manufacturers to address low-risk (wrong expiration date on package) and high-risk (particulate in product or ste- rility issues) quality and safety problems. FDA may use its regulatory discretion to address shortages to mitigate any signifi- cant risk to patients. FDA can encourage remaining firms to ramp up supply. When a company needs a new manufacturing site or new raw material supplier, FDA can expedite the review of these changes. For prod- ucts in shortage or at risk for shortage, FDA can expedite the review of new
tory discretion in extreme circumstances, the agency can’t force a manufacturer to produce a product or impose a penalty on a manufacturer for not notifying FDA of a discontinuation. By law, manufacturers don’t have to
report plans to discontinue producing a product unless they are the sole manu- facturers of a drug that is life-supporting, life-sustaining, or intended for use in the prevention of a debilitating disease or condition.
Shortages increase costs Increasing drug shortages affect patient care and increase costs to the nation’s health system, according to a 2010 study by the American Society of Health- System Pharmacists (ASHP) in partner- ship with the University of Michigan Health System. The American Journal of Health-System Pharmacy published the study, “Impact of Drug Shortages on U.S. Health Systems” in July. The study’s authors surveyed 353 hospital pharmacy directors across the country to quantify the personnel re- sources required to manage the drug shortages, define the extent to which recent shortages affected health systems, and determine if there are adequate re- sources to manage the shortages. The study found labor costs associ- ated with managing shortages translate to an estimated annual impact of $216
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