It might be a little late to view this post as proactive (I intended to post last week but got distracted and forgot–apologies), but the DEA has reclassified tramadol (Ultram) as a Schedule IV substance. State laws are going to vary on what happens to previously non-controlled active prescriptions, so check with your pharmacist to be sure. It may not hurt, for those taking the drug regularly, to call your doctor and just have them re-issue the prescription, voiding any previous refills, following the rules for a controlled substance in your state, so you don’t run into any unanticipated problems when trying to get your pain medication filled.
More specifically, for those in Ohio, if your prescription was issued less than 6 months ago, and you have refills remaining but have not exceeded five full quantity refills (6 fills in total), and the prescription is NOT an electronic prescription (unless the pharmacy and prescriber e-rx systems are both certified to send/receive prescriptions for controlled substances), your remaining refills (up to 5 in total for the life of that specific prescription number, not 5 more from here forward) are valid until 6 months from the date the prescription was written. Your pharmacy may end up changing the prescription number to comply going forward, however, so the number you have on your bottle may have changed.
I was interested to hear this, because my husband (and the dog) take Tramadol for back problems. I’m not worried about the dog, but this does make me think my husband needs to call the doctor to see about a new prescription.
I guess this surprises me because based on my husband’s reaction, it’s not really that strong.
What are they going to do about dog scripts? Are we going to have to get them filled at normal pharmacies? (sometimes I have to do this with other drugs, sort of randomly)
I should say I’m not worried about the dog getting her medication. She needs it only when her back is giving her problems, unlike my husband whose back is in crisis daily, and my daughter is the dog’s vet, so she should be able to get the medicine.
This is how it was explained to me. Even though Tramadol isn’t a narcotic, what happens is that opiate receptors in the brain are bound, which in turn helps block pain signals sent from the central and reflex sympathetic nervous systems. While you don’t experience the euphoria of a narcotic, it still has addictive potential. However, it is still better to take tramadol than class III narcotics. On a US Federal level, the drug can be refilled up to five times. Your state may vary. In Florida a patient now has to be seen every three months to continue on a pain management regime of Tramadol.
If the vet has a DEA registration, they just have to follow the same rules they would for phenobarbital prescriptions for a dog with a seizure disorder.
Tramadol works through a couple of different mechanisms. One, it acts as a reuptake blocker of Serotonin and Norepinephrine, which, in parts of the CNS, is believed to augment descending pain blocking effects. These are the same effects we’re trying to use for the treatment of neuropathic pain (diabetic neuropathy, fibromyalgia, post-herpetic neuralgia as examples) with antidepressant class drugs like Amitriptyline (Elavil), Venlafaxine (Effexor) or Duloxetine (Cymbalta). Two, the drug is an incredibly weak mu-opiate receptor agonist. Three, after getting converted in the liver to an active metabolite (about 1/10th of the parent drug, iirc), known shorthand as M1, the active metabolite functions as a much stronger mu-opiate agonist. Largely due to that third effect, 50mg of tramadol is argued to be roughly equivalent to 5mg of oral morphine or hydrocodone. Some individuals do still experience euphoria from tramadol, even if not everyone does.
OK-so that’s why wasn’t allowed to prescribe it electronically today! I was kind of surprised but I thought maybe it was just that pharmacy. I have to say it’s about time. It should have been a controlled substance from day one.
It became controlled here in Georgia back on April 30th (right before the May 1st inventory so got to include it on there for the record keeping), so we already got all the “But my bottle says I have 6 refills remaining!” complaints out of the way; and most of our doctors are trained to the new way of doing things (at least, those doctors NOT still writing for Vicodin ES 7.5/750*) So the only thing I had to do today was the inventory at open.
I know this is based on Ohio only, but going only by federal law, does the way the Rx was written actually matter? I haven’t heard anything from corporate regarding the way written, only the whole refill and 6 month thing. If the Rx was escribed (in a state that doesn’t allow controlled escripts) or faxed without an original signature, is it still valid under federal law? And do you have a cite that I can bring to my PDM?
I had a script for this today, written by a dentist (of course), had to search for a store that still had some on the shelf to dispense. Why are dentists ALWAYS the ones to prescribe something off the wall?
FWIW tramadol is OTC where I am(not the USA) and no matter how much pain I was in I’d send my wife for codeine cough syrup which is also OTC because the two times I’ve tried tramadol capsules it made me feel STRANGE like stimulated and restless and wired up like caffeine which is the last way I want to feel in severe pain.
Seriously I can’t imagine someone enjoying tramadol.
That’s exactly what I experienced. I suffered from bad sciatica before a operation to help it and needed constant pain management. I tried a lot of things and tramadol just made me feel as you described. The best drug for me was Tylex (Tylenol w/ Codeine in the US). Thankfully I haven’t needed any in over a year now.
Ohio was actually set to make tramadol a schedule IV drug as of September 1st. The DEA and their ~45 day turn around time between the issuing of the final rule and the date that rule went into effect just beat us to the punch.
Yes, it actually matters, both in general, and in this specific case or so I’d argue until a lawyer with expertise in this area gainsays me. Title 21 CFR 1311 Subpart C is the overall federal rule with regards to issuing a controlled substance prescription electronically. With regards to tramadol, 1311.100(c) states:
An electronic prescription for a Schedule II, III, IV, or V controlled substance created using an electronic prescription application that does not meet the requirements of this subpart is not a valid prescription, as that term is defined in Section 1300.03 of this chapter.
I’d interpret that, based on how the DEA is interpreting the 6 month/5 refill thing (see their answer to opposition to proposed rule (1) found here), as well as the later reference under the subtopic Requirements for Handling Tramadol, sub-subtopic Prescriptions explicitly referencing both 21 CFR 1306 as well as subpart C of 21 CFR 1311, to mean that if the e-rx application for either the presciber or pharmacy has yet to be certified, it by definition fails part (c) and is no longer a valid prescription, even if at the time of issuance, it was.
1300.100(d) further backs me up on this (again, I’d argue) by stating:
A controlled substance prescription created using an electronic prescription application that meets the requirements of this subpart is not a valid prescription if any of the functions required under this subpart were disabled when the prescription was indicated as ready for signature and signed.
Underlined emphasis mine. At least with our application, the parts allowing a controlled substance to show up at all are, we’ve been told, disabled until our certification comes through, meaning a tramadol prescription issued prior to yesterday would fail part (d).
Further, unless the law in question is unconstitutional, the distinction between being illegal under state law but legal under federal is meaningless, as it applies to how we practice. Controlling law, according to my law professor, is the law which is more stringent. She (a BS of Pharmacy and JD both) stressed that point explicitly on numerous occasions. If it was e-scribed in a state not allowing controlled e-scriptions, state law should take precedence over the (comparatively) more relaxed federal law.
Around here, the dentists, while occasionally goofing up, tend to be very reasonable to deal with. Sure, I had one dentist call in a prescription for tramadol once with absolutely NO clue what dose it came in, how many could be given at once, how frequently it was to be dosed, and lamenting about more stringent requirements for prescribers then being discussed as far as how frequently they must access our Prescription Monitoring Program (when would he have time, he kvetched), but he at least listened to (and seemed to appreciate) my recommendation when I explained the dose (50-100mg per single dose of the IR product, I suggested starting with 50mg) and frequency (every 4-6 hours not to exceed 400mg/day, though I suggested every 6 hours to start), as opposed to some of the area family practice docs–some of whom are doing such delightfully (holds up sarcasm sign) wonderful things such as writing for oxycodone IR 15mg with directions “Take up to 17 tablets per day as needed”, who then get offended when we dare call to question them (anyone care to guess the given diagnoses?). I wish I was kidding, that’s from an actual prescription we received several months ago. I’ll take the sometimes clueless dentists any day over that.
Most individual pharmacists I know have been saying this for years. I happen to agree, as well, and so, while this is probably going to result in plenty of Hirka’s above example of “but the bottle says I can refill it!” patient complaints for us, at least we are (slightly) lessening the chance of further contribution towards our drug overdose epidemic (Ohio, under the CDC’s recent Vital Signs reporting in the MMWR, in 2012, was 12th in the nation in terms of number of opioid prescriptions (100.1 prescriptions issued per 100 persons), and 20th with regards to benzodiazepines (41.3 per 100 persons)).
That’s probably by proxy of the SNRI effects (serotonin/norepinephrine reuptake inhibitor) since both can be quite a bit activating in many individuals–moreso from the norepi than the serotonin, in my experience, though both very often play into that effect. Those also tend to explain why tramadol withdrawal can be quite beastly in those who have been on it long enough–you’re dealing with opioid withdrawal effects on top of SNRI withdrawal effects (the oh so wonderful sarcasm sign brain zaps being a hallmark example).
My dog has chronic pain and is on tramadol and gabapentin for management. The vet has been giving me the tramadol in 500ct bottles, so I reckon that is gonna stop. That amount is about a 5.5 month supply for her and only $20 through my vet.
I had a dog a few years ago that was treated at a different vet who charged out the wazoo for tramadol, so I was getting her scrips filled at a Harris Teeter pharmacy for about $5.00 a month. The trouble was the doc gave me a scrip for a 28 day supply and the pharmacy said they wouldn’t fill it until day 30. I was accused of drug seeking when all I was trying to do was make sure my poor doggie didn’t run out of her arthritis meds.
I suppose I’ll have to deal with going back for refills more often, but I have a couple month’s supply left for now. My little dachshund has to take 50mg 3x a day in addition to 100mg of gabapentin twice a day for her back pain.
It’s going to depend on the laws of your state. Federally, there aren’t any limits to quantity/day supply for Schedule 3-5 drug prescriptions. If your vet is fine with all of the reporting and paperwork requirements involved, and your state doesn’t have it’s own set of laws limiting quantity/day supply, they can still provide you with that 500ct bottle if they so choose.
:smack: That, as a pharmacist, is NOT the kindof story I like to hear.
Actually, no. Canine physiology differs from human physiology in quite a few ways, one of which is that they don’t necessarily get the same effects at the same doses that humans do. Dogs, per my former vet, tend to tolerate higher doses of Tramadol on a mg/kg basis (and Phenobarbital, per my epilepsy series pharmacy school professor) that would be capable of inducing a seizure in a human (or render them (semi-)comatose/in respiratory failure, in phenobarb’s case), and of course, while human thyroid replacement therapy generally ranges from 25 micrograms up to 300 micrograms once a day, dogs, particularly larger dogs, are dosed at 0.01-0.02 mg/lb (0.02-0.04 mg/kg), meaning a 120lb dog could end up starting at 600mcg twice daily, a dose which would be…er…quite unpleasant in a human, at least on a chronic basis.
I would have thought she would be wasted too, but surprisingly not. She does sleep a lot, but what 13 year old dog doesn’t? When she’s awake she’s still pretty sharp. Of course. being a dachshund she thinks she’s invincible, so I have to keep a close eye on her so she doesn’t hurt herself jumping off the sofa or climbing the stairs.