Our neverending focus on narcotics

by rcentor on February 15, 2004

I rant so often about this topic. But it is important, and a great dilemma. U.S. Is Working to Make Painkillers Harder to Obtain

Top DEA officials confirm that the agency is eager to change the official listing of the narcotic hydrocodone — which was prescribed more than 100 million times last year — to the highly restricted Schedule II category of the Controlled Substances Act. A painkiller and cough suppressant sold as Lortab, Vicodin and 200 generic brands, hydrocodone combined with other medications has long been available under the less stringent rules of Schedule II

The DEA effort is part of a broad campaign to address the problem of prescription drug abuse, which the agency says is growing quickly around the nation. But the initiative has repeatedly pitted the agency against doctors, pharmacists and pain sufferers, and it is doing so again with the hydrocodone proposal.

Pain specialists and pharmacy representatives say that the new restrictions would be a burden on the millions of Americans who need the drug to treat serious pain from arthritis, AIDS, cancer and chronic injuries, and that many sufferers are likely to be prescribed other, less effective drugs as a result.

If the change is made, millions of patients, doctors and pharmacists will be affected, some substantially. Patients, for instance, would have to visit their doctors more often for hydrocodone prescriptions, because they could not be refilled; doctors could no longer phone in prescriptions; and pharmacists would have to fill out significantly more paperwork and keep the drugs in a safe. Improper prescribing would carry potentially greater penalties.

This issue has no easy solution. Patients will suffer under the new rules. Abusers will figure out ways to obtain drugs. Physicians will get caught in the middle. But you know the story.

The entire article is well done, and describes both sides of the issue. I particularly like this quote:

Susan Winkler of the American Pharmacists Association said her organization is concerned that the “ripple effects” would be substantial and negative.

“Our members and doctors would have increased liability if [hydrocodones] are rescheduled, and that will inevitably reduce prescribing,” she said. “We urge the DEA to make sure their decision is based on science and will make the situation better, not worse.”

And rarely are these decisions based solely on science.

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{ 6 comments }

Trent McBride February 15, 2004 at 8:44 pm

This situation does have an easy solution. Don’t rescedule! It’s really quite that simple. The right to put a substance in your own body is a fundamental liberty. The fact that the government will deprive pain patients of needed medications only to restrict everyone’s liberty is repulsive.

Stef February 16, 2004 at 2:47 pm

The realities of this situation may not readily be resolved by good science, although it is important to acknowledge the lack of good science in this area.

To be fair to the DEA, the fact driving their interest in rescheduling hydrocodone to level II is the very substantial recent rise in abuse of prescription narcotics. No matter which numbers you track, and all have flaws, every single available statistic suggests substantial and possibly massive increases in the abuse of prescription pain medication in the past 3-10 years.

That fact justifies a careful response on the part of society, but it does not lead ineluctably to justifying the DEA’s intent to reschedule hydrocodone, given its positive uses on behalf of patients.

The obvious use for outpatient opiates is for pain control. The trial data is limited, but suggests outpatient opiates for noncancer pain do work to reduce pain and possibly to increase functioning. In at least one survey of >300 patients on opiates in outpatient pain clinics, >90% felt that their pain relief (which was generally moderate pain relief) really improved their overall quality of life and functioning. We would not want to stop the appropriate treatment of these patients.

Observational studies of pain control in these contexts leave it fairly unclear what percentage of carefully managed chronic pain patients actually develop true addictive problems. It is not even proven that carefully managed prescribing by doctors is the actual source of all the prescription drug abuse going on out there, ie it may be some totally careless doctors or pharmacy-level diversion that is at work. Putting pressure on all doctors to reduce prescribing of opiates may not reduce the amount of abuse going on at all, but it may result in loss of access to pain medicine for patients who do have pain.

In one study I have seen presented, if one simply counts the percentage of patients who take their opiates perfectly and exactly as the doctor prescribed without ever losing a prescription, taking an extra pill, etc. it is about 55% (ie the same percentage who take antihypertensives exactly as prescribed). The misbehaviors of the remaining 45% include some who probably are engaging in addictive or abusive behaviors, and many whose behavior is “not quite right” but probably not a sign of abuse, ie taking an extra pill from time to time. The best clinical teaching I have seen on this issue advocates the use of close monitoring and follow-up by physicians, along with the development of information networks that would help physicians check up on on their own patients to sort out if any are obtaining prescriptions from multiple sources, There is little data to prove the value of these practices but they seem sensible to me until we have data.

Rescheduling the drugs may induce many doctors to stop prescribing pain meds where they are needed.I would favor education of physicians and the availability of systems to help physicians identify doctor-shoppers, etc. as opposed to generalized inducements not to prescribe pain medication. I believe rescheduling to Schedule II may be unhelpful to patients who have pain.

John Anderson February 17, 2004 at 10:07 pm

Too bad the DEA isn’t all that concerned with Ritalin and other mind-benders given to schoolchildren more easily than M&M’s.

There was a case last year in which a seven-year-old was expelled for giving a lemon-drop to a classmate because it was a mentholated cough drop – classified as a drug by the school. Are adults going to be targeted now? Too bad aspirin has such a short shelf-life, I’d start stockpiling.

GruntDoc February 18, 2004 at 1:31 am

This rescheduling could also have the unintended consequence of increasing Schedule II medication prescription. In Texas, any med above Schedule III needs a government issued prescription, with a state monopoly on printing and distribution, and some reasonably restrictive rules about keeping copies, etc.

So, my choice for my patient with a broken arm is Tylenol #3 (acetaminophen with 30mg of codeine, a study-proven dog of a pain killer), or filling out a special order form for my patient with acute pain.

Here’s where this backfires: if I’m going to the trouble of getting and filling out the state prescription, why not give percocet, which is a better pain med, and is still Schedule II? I’m giving even better pain meds that I’ve been avoiding due to, mainly, the paperwork and oversight hassels, but this could compell me to get the State prescriptions and start using them.

The Law of Unintended Consequences awaits another government regulation.

(Cross posted on my blog).

Bhavesh Patel February 18, 2004 at 8:47 am

In my experience, most people who need pain meds are truly suffering. In our day and age, as physicians, we should be able to relieve unecessary pain and suffering.

A blanketwide system that makes it difficult for us to execute this mandate, because a few bad apples, is effectively punishing everyone for the actions of a few.

What should be done is this:

1) information should be better. It should be easier to find out who doctor shops and pharmacy shops for prescriptions. Rather than put something on schedule II, maybe there should be a centralized database where filled prescriptions of opiates are uploaded (anonymously by use of PINs). When there are aberrencies, those PINs are investigated.

2) The DEA should crack down on the 1500 emails I get that purport to help me get Vicodin over the internet. There are probably more abusers getting their fix this way than going to the doctor.

3) Look for bags of vicodin when people are coming back from Tijuana.

Just a few ideas that I think are infinitely better than increasing regulation.

Bhavesh

John February 23, 2004 at 9:45 pm

Personnaly, I take Vicodin, but avoid it whenever possible. It’s great when my backpain feels like half a kidney stone, but too annoying when the pain is less. This month I’ve taken it once; last month probably 10 times. Is there some reason that we can’t trust most folks to know when they hurt?

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