NEW YORK (Reuters)—Makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives, the course said on Thursday.
The FDA sent letters to 74 manufacturers of immediate-release opioids, notifying them that they will have to fund the development of courses for doctors, nurses and pharmacists, FDA Commissioner Scott Gottlieb said in a statement.
President Donald Trump and Gottlieb have promised to reduce opioid abuse in the United States, which has become a public health crisis that kills more than 100 Americans daily.
Makers of extended-release and long-acting formulations of the painkillers, which are more easily abused, are already required to pay for the training.
While the training will be offered as voluntary continuing education for healthcare professionals, the agency is also considering some form of mandatory education on opioids.
About 90 percent of all opioid pain medications prescribed in the United State – around 160 million prescriptions a year – are for the fast-acting formulations, the FDA said.
The FDA asked Endo International Inc to pull its long-lasting opioid painkiller, Opana ER, from the market in June, after a panel of advisers concluded that the drug’s benefits did not outweigh the risks of misuse.
According to the U.S. Centers for Disease Control and Prevention, opioids were involved in more than 33,000 U.S. deaths in 2015, the latest year for which data is available, and estimates show the death rate has continued rising.
On Thursday, Washington state sued OxyContin maker Purdue Pharma LP, becoming the latest state or local government to file a lawsuit seeking to hold pharmaceutical companies accountable for the opioid addiction crisis.
Patients with long standing musculoskeletal pain must be protected from the rabid anti-opiate sentiment currently occupying the national dialogue. For some who suffer with severe musculoskeletal pain, the difference between a miserable life and a productive, enjoyable one is the availability of some narcotic medications used on a daily basis. Those of us who treat these patients recognize this. Not long ago we were encouraged to recognize and treat those in chronic severe pain. Pain was to be documented as the ‘fifth vital sign’. Now we are being pressured to ignore the pain that might require narcotics to manage it. Both patient and physician are concerned, confused and conflicted. Frequently there are no safe and effective substitutes. I guarantee you that shifting from narcotic prescriptions to daily non-steroidal anti-inflammatories will result in more stomach ulcers, gastrointestinal bleeding, hypertension, kidney disease and heart attacks. High dose acetaminophen will encourage more liver disease and kidney problems. Physical therapy, weight loss, local poultices, acupuncture, meditation, braces and prayer all provide some, but limited relief in many patients. The issue is NOT narcotic use, it is narcotic ABUSE. As physicians we must support the needs of our patients while we improve our ability to identify those patients who are prone to abuse or worse, those who divert their narcotics. Meanwhile more funding for research into new and unique non-narcotic analgesics should be a high priority for our government.