A month ago, the National Pain Report asked if the news media was missing the point on the pain medication story. We quoted two leaders, one doctor and one researcher, as saying that the chronic pain patient’s need for medication and society’s need to combat narcotic pain medicine abuse are separate, but may be conflated in a way that is hurting some people in pain.
In Florida, one of the first states where the pain medication abuse surfaced, a reporter at Orlando’s WESH-TV has been looking at the issue. Brett Connolly has been looking into whether legitimate pain patients are being denied prescriptions and his reporting shows how complex the problem is.
Neither the Food and Drug Administration nor the Drug Enforcement Administration took responsibility for legitimate pain patients being denied prescriptions. The FDA says that any individual instances of pharmacists not filling prescriptions is an issue for state regulators. The DEA, which rescheduled hydrocodone last fall, says that pharmacists who refuse to fill real prescriptions are not doing their jobs.
The Government Accountability Office reported this year that the FDA and DEA – the two agencies that oversee drug products – should be working closer together on this issue.
The FDA regulates drugs in accordance with their efficacy, safety and quality. For example, FDA might approve an opioid painkiller based on clinical evidence indicating the drug alleviates pain, is safe for use in patients with pain and is manufactured to appropriate standards.
The DEA regulates drugs primarily in accordance with their risk of abuse and medical benefit. Under the Controlled Substances Act (CSA), DEA is able to “schedule” many drugs if it believes they pose a risk of abuse. Drugs are classified according to a sliding scale of medical benefits and potential harms. A schedule V drug, for example, has a recognized benefit and a relatively small risk of misuse or abuse. A schedule II drug, in contrast, may have a medical benefit, but a substantial risk of misuse or abuse.
In our reporting, it is obvious that leaders in pain management are uneasy what the new and stricter regulations may be doing to legitimate pain patients.
Dr. Richard Radnovich, a nationally known pain medicine specialist from Boise, Idaho said, “The problem is that we have blurred the lines between 2 distinct problems: chronic pain treatment and substance abuse. The DEA is concerned with the latter. Medical providers just need to do a good job with the former: that is, show that they are using opioids for a legitimate medical purpose; and provide adequate medical care and supervision.”
Dr. Steve Passik, Vice President of Clinical Research and Advocacy at Millennium Health said, “Prescription drug abuse is a massive problem and we have to deal with it, but I’d also to see more consideration given to the person in pain in the dialogue going forward.”
In Florida, Connolly’s reporting has spurred Florida’s Board of Pharmacy to form a special committee called the Controlled Substances Standard Committee. The committee is holding its first meeting next month. The group is set to address issues of pharmacists who will not fill legitimate prescriptions and figure out how to better protect Florida’s ailing.