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FDA Working to Lessen Patient Impact from Drug Shortages

by Patrick E. Clarke

During the past few years, the number of drug shortages has continued to increase. As a result of these shortages, health care professionals sometimes face situations where they need to identify suitable alternative medications to treat their patients.

In 2010, there were 178 drug shortages reported to FDA, a record high. This increase has not escaped the agency’s attention.

“There has been an immense amount of concern in the health care community about drug shortages, especially given the rising number of shortages in critical areas of medicine,” said Valerie Jensen, associate director, Drug Shortage Program, at FDA’s Center for Drug Evaluation and Research.   “In 2011, FDA has continued to see an increasing number of shortages, especially those involving older, sterile injectable drugs.”

On the front line

While FDA works with drug companies to resolve drug shortages, health care professionals may need to identify other treatments for their patients. Sometimes, health care professionals can help patients understand that a delay in treatment is better than suboptimal or potentially harmful treatment.

In hospitals and health systems, the pharmacy department can play an important role in developing and implementing appropriate strategies and processes for informing practitioners of shortages and ensuring the safe and effective use of therapeutic alternatives.

Health care professionals are encouraged to inform FDA when they become aware of a shortage; sometimes that is the first notification the agency receives. Another way to assist is to alert FDA if there is information on the Web site that doesn't agree with what health care professionals are experiencing.

When shortages occur, faxed and e-mailed advertisements are often sent to pharmacies from unknown distributors offering these drugs at higher prices than the pharmacy would normally pay. Pharmacists should be leery of such offers.  If a drug is in shortage, these sellers may take advantage by price gouging or by selling drugs that have expired, were diverted, or may be counterfeit. Pharmacists should report these communications to FDA’s Office of Criminal Investigations

Reasons for drug shortages

The major reason for recent drug shortages has been unanticipated manufacturing problems. These problems have affected product quality and sometimes caused firms to voluntarily halt production. Some problems may involve lower risks, such as the wrong expiration date on the package, or significant issues such as particulates in the product or sterility problems.

FDA works with companies to evaluate the risks of the quality problems against the benefits of getting medically necessary drugs to patients. In some cases, the company can continue to market the product by notifying health care professionals about the problem and what they should be aware of when using the product.

A firm’s decision to stop marketing a product is another factor that contributes to shortages. Usually, older drugs are discontinued by companies in favor of newer, more profitable drugs. FDA cannot force companies to manufacture a drug that is in short supply, and cannot require a firm to keep producing a drug it chooses to discontinue manufacturing. Other reasons for drug shortages include supply shortages, reformulations, unanticipated demand, new therapeutic guidelines or disease outbreaks.

Responding to Drug Shortages

FDA can take several steps to mitigate drug shortages. FDA works with other firms making the drugs that are in shortage to help them ramp up production, if they are willing to do so.

In certain situations, when manufacturers of the FDA-approved drug are not able to immediately resolve a shortage of a medically necessary drug and the product has a critically important role in medicine, FDA identifies foreign versions of the product with the same active ingredient manufactured by reputable firms. “FDA does not always find a firm willing and able to import a drug during a shortage, however it is something we explore,” said Jensen.

The agency uses enforcement discretion for the limited importation of the foreign version until the shortage of the FDA-approved version is resolved. FDA evaluates the drug for quality and to ensure no significant risks for U.S. patients.

Information about the imported version of the drug and how patients can access the supply is posted on the FDA Drug Shortage Web site, along with the “Dear Healthcare Professional” letter from the company importing the drug.

Useful links:

To report a drug shortage to FDA via email and to see a current list of drug shortages: drugshortages@fda.hhs.gov.

For health care professionals/pharmacies with concerns about drug price gouging due to shortages, contact FDA’s Office of Criminal Investigations at: http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm

The American Society of Health System Pharmacists lists drug shortages, resolved shortages, drugs no longer available and has advice to pharmacists who have to look outside normal supply chains for drugs: http://www.ashp.org/shortages