To understand this week’s story we first have to understand how habit-forming medicines are currently prescribed in the U.S. The Drug Enforcement Agency divides potentially addictive substances into different schedules. Schedule II controlled substances are prescription medicines that have a high potential for abuse and severe dependence. They include all the opiate (narcotic) pain medicines, like morphine, oxycodone, and fentanyl. These medications must be prescribed on a paper prescription that has special security markings that prevent copying. The prescription must be taken to the pharmacy by the patient, and cannot be faxed or phoned in. And the prescription can at most prescribe a 90 day supply of the medication without refills.
Schedule III controlled substances are prescription medicines that have less potential for abuse and dependence than the medicines in Schedule II. It includes many medications that include an opiate medicine with a non-opiate in the same tablet. Examples include hydrocodone with acetaminophen (marketed as Vicodin, Lortab, or Norco), tylenol with codeine, and hydrocodone with ibuprofen (Vicoprofen). Prescriptions for these medicines can be called in or faxed by physicians to pharmacies, can be written for more than a 90 day supply at a time, and can include refills.
In the last decade the number of prescriptions for Schedule III pain relievers has skyrocketed, as has the number of people taking hydrocodone for non-medical reasons. Prescription drugs are now a leading cause of addiction.
After years of consideration and debate, the Food and Drug Administration released a statement this week recommending that all pain medications containing hydrocodone be reclassified as Schedule II. The new policy is likely to take effect next year. This would include medications such as Vicodin, Lortab, Norco, and Vicoprofen, as well as their generic equivalents.
Proponents of the plan hope this will stem the tide of prescription medicine misuse. Opponents, like the National Community Pharmacists Association and the American Cancer Society, charge that this will inconvenience legitimate patients seeking pain relief. I suspect both sides are right – both legitimate and illegitimate users of hydrocodone will be inconvenienced.
Though I’m ambivalent about the new policy, I’m reminded of a similar change a few years ago regarding pseudoephedrine (Sudafed), a nasal decongestant. Pseudoephedrine used to be over-the-counter, but because it was being used to manufacture methamphetamine – or crystal meth, a dangerous and illegal stimulant – the new law limited the amount of pseudoephedrine that can be purchased at one time and required that the patient show identification at the pharmacy to purchase it.
My objection to the pseudoephedrine rules is simply that in the several years since the new restrictions, no one has published a study (as far as I know) showing that the street price of crystal meth is higher, that the number of crystal meth addicts is lower, or any other objective measure suggesting that the new restrictions have been effective in decreasing the quantity of crystal meth available on the black market. Nevertheless, regardless of effectiveness, once a tighter regulation is in place, it is never rescinded.
I expect much the same with the new restrictions on hydrocodone – permanent inconvenience without ever measuring whether there is a benefit.
F.D.A. Urging A Tighter Rein On Painkillers (New York Times)
FDA Recommends New Limits on Pain Drugs (Wall Street Journal)
Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (Food and Drug Administration)