New narcotic limits from the FDA

[Praziquantel86]

USA Today (2/10, Rubin) reports, "The Food and Drug Administration [FDA] announced Monday that it was stepping up efforts to reduce unsafe use of 24 narcotics products -- methadone pills, fentanyl patches and extended-release pills containing morphine, oxymorphone and oxycodone, such as OxyContin."
The "products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the [FDA] and the Drug Enforcement Agency [DEA]," the New York Times (2/10, A13, Harris) adds. But, according to Dr. John K. Jenkins, director of the FDA's new drug center, "the current restrictions have failed to 'fully meet the goals we want to achieve.'"
The agency "has issued a number of warnings on prescription pain relievers in recent years and some companies already have plans to manage the drugs' risks," the AP (2/10, Perrone) notes. "Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," Dr. Jenkins said. "According to [the] FDA, about 3.7 million patients were taking the drugs under scrutiny in 2007. A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately."
The Wall Street Journal (2/10, Dooren) reports that "a major part of the new program will be efforts to educate doctors about appropriate prescribing of the products. 'This obviously is going to be the largest risk management program we've undertaken,'" Dr. Jenkins said. Although Dr. Jenkins and other FDA "officials wouldn't speculate about what the final risk-mitigation program would look like, it could have elements of a program designed to limit the use of the acne drug isotretinion (commonly known by the brand name Accutane) by women of child-bearing age because the product causes birth defects. That program requires doctors, pharmacists, and patients to register and meet certain requirements in order to get a new prescription each month." The FDA "sent letters to 16 manufacturers of 24 products. ... The letters told the drugmakers of agency plans to require a risk evaluation and mitigation strategy, or REMS, 'to ensure that the benefits of the drugs continue to outweigh the risks.'"
Dr. "Jenkins called the new program a multi-pronged and complex effort that will take several months to put in place, after an initial meeting with the drug manufacturers, scheduled for March 3," HealthDay (2/9, Mozes) added.
"Additional steps will include discussions with other federal agencies -- such as the [DEA] -- patient and consumer advocates, representatives of the pain and addiction treatment communities, and other healthcare professionals," MedPage Today (2/9, Gever) noted. A "public meeting would be held in late spring or early summer to allow for broader public input and participation," according to Dr. Jenkins.



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Any idea how/when this might take effect? I think it's a pretty good idea overall, but I think it'll lead to quite a few unhappy patients and doctors alike.

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[WVUPharm2007]

Well...being that hydrocodone is by far and away the #1 selling Rx medication, this can be nothing but a gigantic pain in the ass to retail pharmacists.

 

[VCU2011]

Well...being that hydrocodone is by far and away the #1 selling Rx medication, this can be nothing but a gigantic pain in the ass to retail pharmacists.

didn't look like they made any mention of hydrocodone as far as i saw. The day retail pharmacists go on strike will be the day hydrocodone goes CII- there was a rumor about this a couple years ago and patients were freaking out that they weren't going to be able to get their refills!

 

[MountainPharmD]

didn't look like they made any mention of hydrocodone as far as i saw. The day retail pharmacists go on strike will be the day hydrocodone goes CII- there was a rumor about this a couple years ago and patients were freaking out that they weren't going to be able to get their refills!

Not just a rumor...it was going to happen until everyone from Doctors to patients threw a fit.

Hydrocodone is by far and away the most abused narcotic.

 

[meister]

Vicodin as a CII is ridiculous. Ugh sometimes this country is so unbearable in its nanny-state charasteristics when it comes to narcotics.

 

[Phlame217]

We're already seeing CII shortages, atleast in my region. Meprozine isn't available, and we're now limited on our orders of percocet 5, 7.5, and 10's to 5 bottles an order. We easily clear that since we sit right next door to a pain managment clinic. Its quite a headache.

 

[Pharmavixen]

But is it appropriate for all these opioids to be handed out willy nilly when the data on the long-term use of opioids for non-cancer pain is inconclusive?

The problem is doctors who can't say no to their patients.

Today at the jail, we had this community dr freaking on our clerk because one of his pts ended up in our care. Initially he refused to tell us what medications the pt was on until we told him what his charges were (something we can't do, legally). Eventually, he faxed a list over, and of course the guy (who was receiving care for his diabetes), was on Oxycontin 120 mg tid, Cesamet 1 mg bid, Ritalin (I forget how much). He needed all these Oxys to deal with the pain of his peripheral neuropathy, but no insulin, or metformin, or... And the dr says on this fax that he's concerned the patient is scamming. So......why does he keep on prescribing all these Oxys?

I can't count the # of times doctors have gotten testy because I've had the temerity to suggest that their pt might be scamming. Guys go to jail for selling their Oxycontin, get out, and their doctor goes right on prescribing Oxycontin. To young, healthy guys. What is this??

[/rant]

If I may add, pharmacists frequently have to hand over narcotics whilst staring down the barrel of a gun. Doctors don't have this problem. So what gives??

 

[Praziquantel86]

Eventually, he faxed a list over, and of course the guy (who was receiving care for his diabetes), was on Oxycontin 120 mg tid, Cesamet 1 mg bid, Ritalin (I forget how much). He needed all these Oxys to deal with the pain of his peripheral neuropathy, but no insulin, or metformin, or... And the dr says on this fax that he's concerned the patient is scamming. So......why does he keep on prescribing all these Oxys?

Seems like a great argument for restricting control. Painkillers have the same issue that antibiotics have, the doctors just can't say no. With stuff that is so easily abused and diverted, there needs to be some accountability in the system.

 

[Pharmavixen]

Furthermore, giving out all these opioids for fibromyalgia and other kinds of non-cancer pain isn't practising evidence-based medicine.

 

[meister]

Seems like a great argument for restricting control. Painkillers have the same issue that antibiotics have, the doctors just can't say no. With stuff that is so easily abused and diverted, there needs to be some accountability in the system.

The solution is to make antibiotics CII, right?

No, because as you've both pointed out having certain chemicals be a gigantic pain in the ass to prescribe doesn't really stop the problem. You're both suggesting it's the doctor's fault for giving controls to "young, healthy guys." How do you know these guys are healthy? Who are you to judge? I'm deducing from you referring to "jail" and "charges" that you work in a jail facility, don't you think that alters your views just a wee bit? Do you really think you should be basing your judgments on your clinical experience with convicted felons?!

Furthermore I have no idea what your point is about pharmacists having to hand out narcotics "staring down the barrel of a gun" with respect to doctor prescribing habits. If you think a prescription has been written illegitimately, then, at least under California pharmacy law, you are well within your legal right to refuse to fill the prescription.

This is not a one-way street, and in fact it is a direct reflection of a cultural problem in the US when it comes to illicit substances and their abuse. It is intimately linked with the drug war and with drug prohibition. We will get nowhere if we keep treating certain drugs as magical chemicals that turn you into a ****** the second you touch them. You want to stop filling prescriptions for drug addicts? Stop throwing drug addicts in jail with little utilized avenues to wean their addictions.

 

[Carboxide]

But is it appropriate for all these opioids to be handed out willy nilly when the data on the long-term use of opioids for non-cancer pain is inconclusive?

The problem is doctors who can't say no to their patients.

Today at the jail, we had this community dr freaking on our clerk because one of his pts ended up in our care. Initially he refused to tell us what medications the pt was on until we told him what his charges were (something we can't do, legally). Eventually, he faxed a list over, and of course the guy (who was receiving care for his diabetes), was on Oxycontin 120 mg tid, Cesamet 1 mg bid, Ritalin (I forget how much). He needed all these Oxys to deal with the pain of his peripheral neuropathy, but no insulin, or metformin, or... And the dr says on this fax that he's concerned the patient is scamming. So......why does he keep on prescribing all these Oxys?

I can't count the # of times doctors have gotten testy because I've had the temerity to suggest that their pt might be scamming. Guys go to jail for selling their Oxycontin, get out, and their doctor goes right on prescribing Oxycontin. To young, healthy guys. What is this??

[/rant]

If I may add, pharmacists frequently have to hand over narcotics whilst staring down the barrel of a gun. Doctors don't have this problem. So what gives??

You can't say what someone's charges are? Where do you live? In Michigan that is all public knowledge...you can walk into a police station and check out the records of anyone you want, unless it is juvenile/sealed/deleted.

 

[Praziquantel86]

The solution is to make antibiotics CII, right?

No, because as you've both pointed out having certain chemicals be a gigantic pain in the ass to prescribe doesn't really stop the problem. You're both suggesting it's the doctor's fault for giving controls to "young, healthy guys." How do you know these guys are healthy? Who are you to judge? I'm deducing from you referring to "jail" and "charges" that you work in a jail facility, don't you think that alters your views just a wee bit? Do you really think you should be basing your judgments on your clinical experience with convicted felons?!

Furthermore I have no idea what your point is about pharmacists having to hand out narcotics "staring down the barrel of a gun" with respect to doctor prescribing habits. If you think a prescription has been written illegitimately, then, at least under California pharmacy law, you are well within your legal right to refuse to fill the prescription.

This is not a one-way street, and in fact it is a direct reflection of a cultural problem in the US when it comes to illicit substances and their abuse. It is intimately linked with the drug war and with drug prohibition. We will get nowhere if we keep treating certain drugs as magical chemicals that turn you into a ****** the second you touch them. You want to stop filling prescriptions for drug addicts? Stop throwing drug addicts in jail with little utilized avenues to wean their addictions.

Are you referring to my quote or to the poster above me? I never said anything about working in a jail, "staring down the barrel of a gun" or anything like that.

I just said there needs to be some more accountability in the system. The system refers to everyone involved in the prescribing process, including doctors, pharmacists, patients, nurses, and whoever else might be providing care.

Doctors feel the pressure of undertreating a legitimate pain patient vs. overtreating an addict. Pharmacists feel the pressure of being unable to conclusively prove that a patient is, in fact, doctor shopping or using multiple pharmacies. Patients demand narcotic painkillers for conditions that do not warrant their use.

Without some sort of oversight, it is impossible for these three completely different factors to be reconciled.

 

[Carboxide]

You know, my pharmacy has gotten this thing now...a computer system where if they suspect someone is a drug seeker, they can look and see what prescriptions have been filled where and when for that patient. That's how they keep out doctor shopping - if they suspect it, they pop the info in the system and it'll tell them if that patient has been filling multiple scripts from multiple doctors at multiple pharmacies.

Is this common to have?

 

[meister]

Are you referring to my quote or to the poster above me? I never said anything about working in a jail, "staring down the barrel of a gun" or anything like that.

Pharmavixen.

I just said there needs to be some more accountability in the system. The system refers to everyone involved in the prescribing process, including doctors, pharmacists, patients, nurses, and whoever else might be providing care.

I think giving pharmacists access to medical records would help in this particular situation. I'm not sure what you mean by accountability.

Doctors feel the pressure of undertreating a legitimate pain patient vs. overtreating an addict. Pharmacists feel the pressure of being unable to conclusively prove that a patient is, in fact, doctor shopping or using multiple pharmacies. Patients demand narcotic painkillers for conditions that do not warrant their use.

Without some sort of oversight, it is impossible for these three completely different factors to be reconciled.

What sort of oversight are you talking about? If the doctor can't prove the patient is lying and neither can the pharmacist, then __________?

This is a societal problem we have to deal with. It is intimately linked with illegal drugs and the drug war. Why is this patient wasting valuable healthcare dollars to get high? What is the underlying cause of America's insatiable appetite for illicit substances?

Once we start addressing the actual problem we can stop these weird situations from ever occurring, or at least occurring at a reduced rate.

 

[Praziquantel86]

Pharmavixen.

I think giving pharmacists access to medical records would help in this particular situation. I'm not sure what you mean by accountability.

What sort of oversight are you talking about? If the doctor can't prove the patient is lying and neither can the pharmacist, then __________?

This is a societal problem we have to deal with. It is intimately linked with illegal drugs and the drug war. Why is this patient wasting valuable healthcare dollars to get high? What is the underlying cause of America's insatiable appetite for illicit substances?

I agree that it is a societal problem. It's not so much the average patient wanting to get high, it's that the average patient wants a quick fix to their problem. This is where I draw the parallel towards antibiotics. Sniffle = azithromycin, pain in the leg = hydrocodone.

As far as oversight goes, I think something equivalent to the current system for prescribing Suboxone might work. The physician would have to justify the added effort towards prescribing the drug, and the patient would be limited to one prescribing physician.

If this system were extended to cover only chronic pain patients (i.e., those receiving refills on their painkillers) it would allow acute pain patients to receive their necessary medications while severely limiting abusers of the system. If such a linked system were in place, it would be fairly easy to identify anyone who was abusing the process.

 

[Pharmavixen]

You're suggesting it's the doctor's fault for giving controls to "young, healthy guys."

Yup.

How do you know these guys are healthy? Who are you to judge? I'm deducing from you referring to "jail" and "charges" that you work in a jail facility, don't you think that alters your views just a wee bit? Do you really think you should be basing your judgments on your clinical experience with convicted felons?!

I've been a pharmacist for 23 years; eleven at the jail, twelve in retail. Before that, I did a residency specializing in the treatment of drug and alcohol abuse, and I've had additional training in methadone dispensing.

I've filled scripts for Oxycontin where the patient is selling practically outside the door of the pharmacy.

As I've mentioned before, the US is 5% of the world's population but uses 90-95% of the world's opioids. There is massive over-prescribing going on.

I don't want to start a doctor vs pharmacist flame war, but we pharmacists are in a position where we are obligated to fill prescriptions presented to us unless there's a clearly justifiable clinical reason not to. I can get disciplined by my college if I refuse to fill scripts on just a suspicion. Doctors have a lot more leeway, but for various reasons are opening these pain clinics and giving out lots of opioids to, like I said, young, healthy people with non-cancer pain, and the evidence for prescribing opioids in that instance is weak at best.

Furthermore I have no idea what your point is about pharmacists having to hand out narcotics "staring down the barrel of a gun" with respect to doctor prescribing habits. If you think a prescription has been written illegitimately, then, at least under California pharmacy law, you are well within your legal right to refuse to fill the prescription.

Under Ontario law, I have the same option. But if I phone the dr and verify that the prescription is legit, I have to fill it unless it's clinically inappropriate in some way that isn't debatable.

Never thought that I, as a Canadian, would have to explain about guns to an American I mean literal, bullet-projecting firearms. The last store I worked in, we were held up 3 times in 6 months. It was either addicts or the bikers who feed them, and this problem is exacerbated by doctors who over-prescribe.

This is not a one-way street, and in fact it is a direct reflection of a cultural problem in the US when it comes to illicit substances and their abuse. It is intimately linked with the drug war and with drug prohibition. We will get nowhere if we keep treating certain drugs as magical chemicals that turn you into a ****** the second you touch them. You want to stop filling prescriptions for drug addicts? Stop throwing drug addicts in jail with little utilized avenues to wean their addictions.

Totally valid points