September 5, 2011
FDA Report Raises Concerns Over Medicine Shortage
A recent Food and Drug Administration (FDA) report has some worrying about shortages of cancer drugs and other essential medicines, AFP reporter Jean-Louis Santini claimed in a Sunday article.
Both name-brand and generic drugs are included, the AFP writer says. While most of them are used exclusively by hospitals (including things like sterile injections, anesthetics, certain antibiotics, and IV treatments), it has nonetheless become a cause for concern.
"FDA hears from patients and also from healthcare professionals and organizations about the terrible impact the shortages have had," spokeswoman Shelly Burgess told Santini. "We continue to do all we can under our current authority to address shortages when they occur."
However, those efforts, Burgess told Santini, are hampered by the fact that the FDA lacks the authority to--in the words of the AFP reporter--"force private pharmaceutical companies to produce certain drugs or even require them to notify the agency when they plan to discontinue one."
On the FDA website, the organization notes that there were a record number of drug shortages in 2010, and that they expected that trend to continue throughout 2011, particularly among older sterile injectable medications.
"When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address risks involved to prevent harm to patients," they also said. "FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients“¦ FDA works with other firms who manufacturer the drug, asking them to ramp up production, if possible, in order to prevent or mitigate a shortage."
However, according to Santini's report, a June American Hospital Association (AHA) survey of more than 800 hospitals discovered that nearly all of them had exhausted their supply of an important medication over the past six months. Furthermore, 80% of them reported being forced to delay patient treatments as a result, and 70% said that they were ultimately forced to turn to less effective treatments.
"We really need to take a very careful look at what is going on," Mike Cohen, a pharmacist at the Institute for Safe Medical Practices, told the AFP. "I have never seen anything like this and I have been a pharmacist for over 40 years,"
On the Net:
- Food and Drug Administration (FDA)
- American Hospital Association (AHA)
- Institute for Safe Medical Practices (ISMP)