When our compounding pharmacy conducts media scans, we frequently find items about rampant pharmaceutical shortages for human and animal health care. These shortfalls have been newsworthy for the past two years – and will continue to be so for the foreseeable future.
The U.S. Food and Drug Administration (FDA) recently convened a drug shortage workshop for drug manufacturers, health care providers, and other stakeholders. The outlook: drug shortages will get worse before they get better. In the workshop transcript, FDA states that sterile injectable drugs, especially chemotherapeutics and anesthetics, are the most vulnerable and pose the biggest public health threat. Why are injectables in short supply? Because of manufacturer capacity issues, industry consolidation (leading to lack of redundancy), and manufacturing challenges. There’s also another factor: older injectable drugs are less economically attractive.
In 2010 according to FDA data, 54% of overall sterile and nonsterile drug shortages were attributable to product quality or good manufacturing practices (GMP) issues. That same year 21% were due to manufacturing delays and capacity issues, 11% were because of discontinuation, and 5% arose from raw material or active pharmaceutical ingredient (API) issues. The 2011 data is pending, but the percentage of shortages attributable to product quality or good manufacturing practices will likely be higher than 2010’s figure of 54%.
That leaves 9% of shortages unaccounted by 2010 FDA data. The American Society of Health-System Pharmacists has discerned other factors: less-than-desirable inventory management practices, such as stockpiling prior to price increases and hoarding prompted by rumors of an impending shortage; natural disasters that prompted heightened demand to treat disaster victims; and unanticipated demand spikes arising from new indications, new therapeutic guidelines, or disease outbreaks.
FDA aims to prevent and mitigate shortages of medically necessary drugs by encouraging early notification and ramped-up production by manufacturers, using regulatory discretion, expediting reviews of new manufacturing lines and API suppliers, and allowing temporary imports from other countries (like they did in 2010 and 2011 with propofol, Foscarnet, Ethiodol, Thiotepa, norepinephrine, Xeloda, levoleucorvorin, and leucovorin). But many other pharmaceuticals will remain on the short list because they do not fit the definition of medically necessary. The term is defined by FDA as “a product that is used to treat or prevent a serious disease or medical condition for which there is no other alternative drug available in adequate supply that is judged by medical staff to be an adequate substitute.”
What’s the good news? Whether or not your human or veterinary pharmaceutical of choice is “medically necessary,” a compounding pharmacy like Monument Pharmacy might be able to produce it –by prescription only – while it is off-market due to back-order or manufacturer discontinuation. Bear in mind, however, that federal regulations prohibit a compounding pharmacy from producing pharmaceuticals for food- or food-producing animals.
