Several groups of doctors and health care officials are calling on the U.S. Food and Drug Administration (FDA) to modify its guidelines for opioid painkiller prescriptions. The proposed changes would include restrictions on “off-label” uses, meaning uses not explicitly approved by the FDA, and limits on the amount of time a doctor may prescribe a painkiller for a patient. The purpose of the changes would be to counter a growing rate of abuse and addiction to the powerful drugs, which has recently resulted in multiple adverse reactions and medication errors.
Abuse of prescription drugs is now the “fastest growing drug problem” in the U.S., according to the Centers for Disease Control and Prevention (CDC). The CDC says that about 27,000 people died from accidental drug overdoses in the U.S. in 2007, and an increased use, and abuse, of prescription opioid painkillers is responsible for much of that total. The government has already attempted crackdowns on “pill mills” and pharmacies that, they allege, sell painkillers to addicts without medical necessity. This includes widespread investigations of drug wholesalers that move large volumes of painkillers and other controlled medications. The latest recommendations would impact how pharmaceutical companies label and market their drugs, in addition to how doctors prescribe them.
In several petitions submitted to the FDA in recent weeks, groups of doctors are asking for changes to labeling and marketing regulations that would, first and foremost, prohibit marketing the most powerful painkillers for anything other than severe and acute pain issues. The proposed regulations would ban marketing the drugs for use with light or even moderate pain, as well as for treatment of chronic pain. Prescriptions for painkillers would also be limited to a maximum daily dosage equivalent to 100 milligrams of morphine, for a cumulative total of ninety days. While this would not necessarily stop abuse of these drugs by individual patients, it would place additional restrictions on the ability of doctors and pharmacies to provide drugs who might abuse them, intentionally or unintentionally.
A recent piece in the Boston Globe illustrates the importance of this issue to doctors, pharmacists, and other medical professionals charged with providing diligent care to their patients. A doctor writes about her own experiences dealing with patients who received an excess amount of painkillers, sometimes from hospital staff, and the difficulties in diagnosing and treating such patients. The doctor further argues that painkillers have become a common treatment for many chronic pain conditions where a “mutli-disciplinary effort” would better serve the patients’ needs, although this does not address the availability of such care to any particular patient, nor the means to pay for it.. Opioid painkillers can cause potentially harmful, even fatal, effects on their own, but they can also interact with other medications or prevent a patient from accurately providing a medical history or description of symptoms to a treating physician. This only makes harmful medication errors more likely.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 to see if you may recover damages.
More Blog Posts:
DEA Suspends Licenses of Drug Distributor and Two Pharmacies for Selling Excessive Amounts of Painkillers, Pharmacy Error Injury Lawyer Blog, May 22, 2012
Pain Patches Pose a Serious Risk to Children, FDA Warns, Pharmacy Error Injury Lawyer Blog, May 15, 2012
Child Overdoses on Painkiller Due to Virginia Pharmacy Error, Pharmacy Error Injury Lawyer Blog, May 7, 2012
Photo credit: ‘Pill.’ by Leonardini on stock.xchng.