FDA Changes Explained
Over the last decade there is no doubt that prescription drug abuse has become an issue; with hydrocodone containing drugs topping the list. Based on federal data, 75 percent of drug overdoses are tied to prescription drugs; additionally, drugs that contain hydrocodone accounts for an estimated 70 percent of all opioid prescriptions.
Hydrocodone drugs include Vicodin & Lortab, as well as those drugs that are a combination of OTC drugs and hydrocodone (Tylenol 3). Yesterday, the Federal Drug and Food Administration outlined a list of measures that it is recommending to help handle this epidemic. FDA Changes to hydrocodone, The FDA wants to treat these drugs similar to the way they treat other highly abused and powerful drugs like Oxycotin. This comes as the numbers of prescription and the production of the pills have grown out of control. According to the NY Times, “In 2011, about 131 million prescriptions for hydrocodone-containing medications were written for about 47 million patients; that totals about five billion pills.”
As it stands today, a patient can go to their pharmacy and refill a Hydrocodone containing drug prescription five times over a six-month period before needing to call or see the doctor for a new prescription. On average the drugs listed above are normally prescribed on average for a two-week period. The usage time and prescription amount do not always directly correlate to each other, and usually leaves excess pill that are often sold or taken for non-medical usage by the patient or others.
- The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription.
- New Storage and record-keeping requirements.
- The type of individual that can prescribe these drugs.
The FDA recommend regulations would halve the requirement time to go back to a doctor for a new prescription, from six month to three months. This is technically done through the reclassification of Hydrocodone containing drugs as a Schedule II medication instead of a Schedule III. Schedule II drugs are drugs legally prescribed but have a high rate probability rate of abuse. Ultimately leading to Hydrocodone containing drugs following the same regulations as oxycodone (ingredient in OxyContin-methadone and fentanyl), Adderall and Ritalin.
While the news that the FDA is backing these recommendations are news worthy, such efforts have been in the making for years. However as with anything that is federally regulated, and brings in billions annually, it is always difficult. A majority of states across the US have passed their own regulation to combat and curb prescription drug abuse. The Florida senate presented a bill to combat the prescription drug abuse problem in Florida in early 2012 and the Governor signed that bill on April 2012. However when the US Senate Drug Caucus attempted a similar act by holding hearings in July 2012 lobbyists mobilized in droves to derail the measure stating there would be increase cost burden on patients by making them see their doctor every three months vs. six months. The bill passed the senate but ultimately met its death in the US House of Representatives.
As the FDA makes these recommendations there are several groups protesting the recommendations. Such groups currently include the Nation Community Pharmacist Association, American Chronic Pain Association, and various lobbyists.
Unlike the bill the US Senate attempted to get through, the recommendations would only require the approval of the department of Health and Human Services and adoption by the Drug Enforcement Administration, which has also advocated for such a measure in the past. If the department of HHS approves the FDA recommendations we can see this regulation go into effect in 2014.