Drug shortages spur debate over role of compounding pharmacies

Persistent drug shortages have led healthcare providers, pharmacists and others to debate the role of compounding pharmacies as alternative sources of drugs in short supply.

In a letter released April 2, the National Community Pharmacists Association urged the Food and Drug Administration to “preserve the role” of compounders in providing access to scarce drugs.

The advocacy group Public Citizen took the opposite stance, arguing that allowing patients to use those drugs puts them at a safety risk. The group also said compounders can exacerbate drug shortages by creating more competition for the few manufacturers that produce the generic sterile injectable drugs that have made up the majority of drug shortages.

“Under no circumstances should the FDA rely on unregistered facilities, such as companies manufacturing drugs under the guise of pharmacy compounding, to supply the market with unapproved products in times of shortage,” the group said in a comment letter.

Drug shortages have steadily increased in recent years. There were 204 new drug shortages in 2012, a slight decrease from the record 267 new shortages reported in 2011, but almost triple the number of new shortages that occurred in 2006, according to the University of Utah Drug Information Service.

Drugs in short supply include cancer drugs, and electrolyte and nutrition products.

Legislation signed into law in July requires the FDA to put together a task force and strategic plan that is expected to help prevent and mitigate drug shortages. A public comment period for the strategic plan ended last month.

“Congressional allowances such as a tax incentive to entice manufacturers into the market of 'at-risk' medications or the expansion of production facilities where these medications are currently manufactured all seem reasonable,” Scott Knoer, the Cleveland Clinic's chief pharmacy officer, wrote in a comment letter to the FDA.

The recent recalls of drugs mixed by compounding pharmacies have further complicated how healthcare providers obtain drugs in short supply. Many compounders have stepped up as an alternative source of some scarce drugs, but there are lingering questions about how these pharmacies are regulated.

In addition to looking at the role of compounders, hospitals, pharmacists and drug companies have called for actions that include providing financial incentives to manufacturers to enter markets where products are in short supply, fast-tracking abbreviated new drug applications, developing new reimbursement policies for generic sterile injectables and increasing instances of importation of scarce drugs manufactured by foreign companies.

Some hospitals are moving forward with plans to mix sterile injectable drugs in their own facilities, while the shortages have led to increased interest and investment in some large national compounders.

“While most hospitals have contingency plans in place for drugs in short supply such as using multi-dose vials in lieu of emergency syringes or compounding in house—these efforts are not ideal or sustainable and may lead to unnecessary delays in patient care as well as medical errors,” Dr. Nirav Shah, the New York State commissioner of health, wrote in a comment letter.

The task force is expected to submit the strategic plan to Congress in July, an FDA spokesman said in an e-mail.

“The long-term goals of the task force are to not only carry out the strategic plan, but also to continue to do all that FDA can do to encourage firms to invest in quality, to make necessary upgrades to their facilities and to have sufficient capacity to continue to meet patient needs with safe, effective, high-quality drugs,” he added.