Narcotic Drugs Restricted By FDA

By Margarita Nahapetyan

According to a new statement on the U.S. Food and Drug Administration Web site, certain opioid drugs such as fentanyl, methadone, hydromorphone, morphine, oxycodone and oxymorphone will undergo a new control program to ensure that their benefits outweigh their risks.

Many medical practitioners may lose their right to prescribe twenty four popular narcotics as part of this new program in order to reduce the injuries and death outcomes that result from these medicines' inappropriate use, federal drug officials announced earlier this week.

All the above mentioned products are classified as Schedule II narcotics and have already been restricted according to rules jointly administered by the Food And Drug Administration and the Drug Enforcement Agency. However, the present restrictions have failed to "fully meet the goals we want to achieve," said Dr. John K. Jenkins, director of the FDA's Office of New Drugs, part of the Center for Drug Evaluation and Research.

"What we are talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products," Dr. Jenkins said in a news conference. "This is going to be a massive program."

U.S. regulators have sent letters to 16 pharmaceutical companies of brand-name and generic opioid painkillers inviting them to a March 3 meeting in order to discuss ways and possibilities to reduce problems associated with overuse of these drugs. The manufacturers will also be required to find ways to impose stronger measures to reduce abuse of the drugs.

Hundreds of deaths occur and thousands of people are injured each year in the United States because they were not informed about how to properly take the prescribed drugs like OxyContin or Duragestic, or if legitimate prescriptions get into the hands of people other than the intended patient, Dr. Jenkins said. The blame for all this is shared among doctors who prescribe inappropriately, patients who do not pay much attention to the instructions or get a wrong access to the medicines, and companies that have been illegally selling their products.

Patients should be careful to follow the directions and take all medication exactly as prescribed, not just swallow pain relievers. Patients have been known to chew extended release pills which will release all of the medication at once instead of over a period of time, causing a drug overdose, whether intentional or not. The problems of drug abuse rest with both the physician and the patient and until some method of control can be found that does not violate the privacy of the patient, deadly results will continue to happen.

Jenkins said the agency started this program in order to implement "a relatively massive new program," because "the rates of misuse and abuse [of opiates] have risen over the past decade." He also said that the FDA was better able to address the problem, because the Food and Drug Administration Amendments Act of 2007 gave the agency the authority to regulate opioids.

There will be no immediate changes for medical practitioners or users of extended-release pain pills. An estimated 21 million prescriptions for extended-release opioids were written for 3.7 million patients in 2007, Jenkins said. They are extremely effective in reducing pain, which many medical studies suggest is widely undertreated in patients who suffer serious illness.

The agency pointed out that previous efforts to reduce the abuse and misuse of extended-release products such as putting additional warning instructions on product labels, did not work. Jenkins suggested that authority should make the new effort to cut down on abuse and misuse more effective than previous plans.

"Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," the agency said in a statement. "The FDA believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access."

The report showed that the number of adults aged 18 to 25 years who were found to use pain killers for non-medical reasons raised from 4.1 per cent in 2002 to 4.6 per cent in 2007 with a smaller raise reported among adults with ages of 26 and up. The report also showed that non-medical use of pain killers among teenagers with ages of 13 to 17 dropped from 3.2 per cent in 2002 to 2.7 per cent in 2007. Such medications included both extended- or controlled-release forms the agency wants to restrict as well as immediate-release.

The FDA generally avoids interfering with the practice of medicine because the state medical boards govern everything that doctors do. Instead, the agency usually tries to provide doctors with the best and latest information, and then allows them to decide how to better use it.