New FDA guidelines suggest limiting access to painkillers

On Oct. 24, the U.S. Food and Drug Administration announced a major change in the way painkillers will be distributed to patients in an effort to reduce abuse of prescription drugs in the country.¹ This news will have far-ranging ripple effects on the way pharmacists and pharmacy technicians practice their trade, as well as on the patients they treat.

Schedule II substance

With this announcement, the FDA recommended that Vicodin and other opioid painkillers with less than 15 milligrams of hydrocodone be treated as a Schedule II drug, as opposed to their current classification as Schedule III. Making them Schedule II would put them in the same class as oxycodone and morphine.

Because physicians are not allowed to call in a prescription for a Schedule II drug, reclassification would make it more difficult for both legitimate patients and addicts to get access to these opioids, as they would have to use a written prescription. Just as importantly, patients would have to see their doctors more often to get refills, since Schedule II drugs require a shorter time period between being replenished.

The FDA made this recommendation despite resistance from physicians and drug manufacturers. Many of them believe these new rules will put undue stress on patients who suffer from chronic pain.

But the Drug Enforcement Administration has been pushing for these changes for some time in an effort to combat prescription drug abuse. According to The New York Times, approximately 75 percent of all drug overdose deaths in the U.S. are from prescription drugs, and the number of deaths from opioids has risen 70 percent since 1999.² And with drugs containing hydrocodone making up about 70 percent of all opioid prescriptions, many believe the looser rules have contributed to their abuse.

Impact on pharmacies

These changes will have an immediate impact on the pharmacy profession and in pharmacy technician schools. Tighter restrictions on painkillers means that patients with chronic pain will have to interact with both their physician and pharmacy professional on a more regular basis. In turn, those health care providers will have to give instructions on the new guidelines, as well as work more closely with those patients to ensure they are getting their necessary medication.

While these developments are likely to cause inconveniences throughout the health care system, they should also serve to cut into the rising tide of prescription drug abuse in the U.S., a problem that has steadily been getting worse over the past 15 years.

¹ Clarke, Toni, “FDA Recommends Tightening Access to Hydrocodone Pain-Killers,” Reuters, Oct. 25, 2013. http://www.reuters.com/article/2013/10/25/us-fda-painkillers-idUSBRE99N1HH20131025
² Meier, Barry, “F.D.A. Urging Tighter Rein on Painkillers,” New York Times, Oct. 24, 2013. http://www.nytimes.com/2013/10/25/business/fda-seeks-tighter-control-on-prescriptions-for-class-of-painkillers.html?_r=0