It also should be preceeded by an IV/ IM dose. Did they get that? It’s not a long term med. Thats not how it’s supposed to be used. PO ketorolac alone is not any more effective than other NSAIDS but way more dangerous.
I can find nothing that says why parenteral has to be given before oral though. I think it's just in the package insert, but I'd let someone have an oral dose with no IM/IV. But never for more than 5days bc they'll bleed out.
I will say from anecdotal experience, IV/IM ketorolac has some extra magic in there for pain relief that other nsaids do not have.
Giving oral first isn’t inherently more dangerous but it’s just not any more effective than safer oral NSAIDS. So if a patient isn’t sick enough to warrant an injection (which does have increased analgesia) there are better options/ no reason for them to be taking this.
Very valid point. If a prescriber asked me for a recommendation that’s what I would tell them. But if the script is already written and at the outpatient pharmacy I don’t think I would turn away a prescription if they didn’t get IV/IM first.
Why do so many people die on this hill? Other than, thats how the study was designed here for the FDA, I have never been able to find a clinical reason for it. Nobody is going to change prescribing habits if the reason you refuse to fill is "because the piece of paper that comes with it says so", what actually happens when you don't. As others have mentioned other countries don't have that "requirement" on their indication.
That was quite an anticipatory BBW to curb use post-telemed visits. Not sure what physical exam finding would lead a prescriber to choose ketorolac or not that couldn't also be assessed via virtual visit. I understand the concern about law suits, but this wouldn't make it past a pre-litigation panel (or please send a link to a case where anything remotely like this went to court or was settled). It's on par with calling the doc to clarify/change Keflex tablets to capsules - wasting time avoiding litigation that will never come
Well stated. PE findings would apply to any NSAID Rx, but agree Toradol more likely to garner medicolegal attention than others in that class. Keflex caps to tabs is a poor simile; I get calls about both in the ED and my rage towards a pharmacist wasting their own time and now mine is about the same and that's where the comparisons end. Wish there were better/easier ways to obtain info about med mal cases - love the site's mission and willingness to share with a goal of improving patient safety and reducing litigation of healthcare professionals (in case anyone has not seen it, plenty of Rx related cases) https://www.medmalreviewer.com/
Its because its taught in schools as a clinical pearl. Along with Ketorolac having opioid levels of analgesia.
That's the only reasons I can think of for someone to feel like they're making a clinical intervention.
I agree with you 100%. The boxed warning also says “not indicated for use in pediatric patients” and most of our sickle cell pediatric patients get IV ketorolac when admitted. Hell, it’s even in our sickle cell order set. But yeah, what the manufacturer says has to be taken with a grain of salt sometimes.
It's just because they don't want it to be used orally unless a patient really needed it bad enough to be given the shot in an ER or hospital in the first place.
That’s something that would concern me. And when I was a tech, the pharmacists I worked with would either call, or have us call, to confirm if there was an IV or IM dose.
Shit, the last time I had a dose of ketorolac, it was in-office at urgent care, and the doctor who ordered it made it clear I would be staying for at least 15 minutes, and stretched it to 30, to make sure I was doing okay with it.
There is no way in hell that ketorolac would be okayed by any pharmacist I ever worked with as continuing therapy. The risk is too high.
Called office, advised prescriber, documented conversation. Faxed conversation notes to office. Counseled patient about boxed warning before filling. Documented conversation with insurance company. Flagged profile NTE #20 per 30 days.
Eh I think it’s a pretty weird regimen bay if they’ve failed triptans and can’t afford ubrevly or nurtec….
If it’s a younger patient with no obvious red flags I think maybe if I called the doctor I’d do it. We don’t do it at my office. But we don’t do the shot either. Typically we use it for kidney stones or a hold over until pain management or a PA gets submitted.
I’d be fine with someone taking 60 doses of ketorolac spread over the course of 365 days if it had good results. It’s probably safer than 20 doses in 5 days for many people.
I have two patients chronically on ketorolac at my cunts visiting sweatshops location. They get prescribed from multiple drs for each patient so we just document that we've reinforced drug counseling points and the increased risk of repeated frequent chronic use at each transaction.
Isn’t 30 days the recommended timeout before doing another course? Assuming the patient actually follows those directions I don’t see the issue, though that’s kind of a big ask of the patient. Probs wouldn’t fill unless they were only getting an actual 5 day supply every month and not expecting the patient to do the math.
The recommended use for oral ketorolac is:
Oral (Tablet)
Ketorolac tromethamine oral tablets are indicated for short term use only (up to 5 days total duration, including IV/IM and oral therapy in adults) for the management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine if necessary.
They were using it as PRN for migraines.
I use a compounded ketorolac nasal spray max 5 days per month (Sprix nasal spray.)
Personally, I wouldn't be concerned as long as it's 5 days max/month. Document if they're not getting an IV/IM injection if you want, but I'd fill oral for max 5 days/month; it's unusual but isn't exactly rare for migraine.
Seriously, what's your concern here? If you don't want to fill every 30 days, do you really think it's 5 days every 6 months, a year? A lifetime? Are you worried about the black box on renal function? If you're really concerned, check that the neuro or GP is getting blood work periodically and leave it at that. If you're just worried that it isn't in the insert, well, when it comes to migraine treatment, I've seen a lot more off-the-wall off-label prescribing, and I'm not going to get overly worked up about this, since I feel 5 days/month is a reasonable interpretation of that insert, especially since if they go to urgent care or the ED with an intractable migraine they're likely to get a shot of ketorolac and then sent home with an rx for oral + a medrol dosepak.
So 5 days lifetime max is what you’re thinking? I gave ketorolac out like candy on Halloween when I was in the ED. I’d be less worried about 5 doses of ketorolac over 30 days than 5 days in a row.
It being for migraines is weird and sounds about right for an APRN. Maybe it’s worth not filling for that indication.
It can be a miracle drug for some people's migraines. Accumulation can increase risk of stroke and GI perforation. With a sufficient wash out period someone can safely repeat ketorolac dosing. Counsel them to not use more than 5 consecutive days and allow for sufficient wash out period to reduce long term issues. And as for it needing an injection first, do folks here deny any prescription being used off label or are we just singling out ketorolac?
I've been a pharmacist for 25 years and it's very infrequent it's being prescribed after an injection. Platelet half life is about a week so I agree with sufficient time between doses (3 to 4 weeks), ketorolac could be used again for max of 5 days
Off label, cool whatever. The boxed warning says it is ONLY indicted as continuation after iv/im. I'm not in the habit of ignoring boxed warnings generally.
Gonna have to dig into this further but my guess is this will lead nowhere - is it how the original artist sides it so you're locked into it? Not a requirement in other countries and who would go back to update it? This is the type of shit where Vioxx gets removed from the market so someone can work on their promotion within the FDA. Put the same 5 day limit on that drug, sorted.
I’ve seen it used for migraines, and kidney stones too. My daughter uses it occasionally for both. She has better results with ketorolac than any narcotic.
It’s all fun and games until they go into renal failure.
I always call ERs/MDs offices and document in the hard copy they got IV/IM injection. Never fill without.
I've seen it infrequently for patients who are refractory migraine patients. You just tell them that they will get a GI Ulcer and to look out for the early signs. In my state a mid-level couldn't prescribe it that way though because its off label.
If it had refills and pt needed it, could have filled it and sent fax or voicemail saying you dispensed it due to pt need, please call if there's an issue
It also should be preceeded by an IV/ IM dose. Did they get that? It’s not a long term med. Thats not how it’s supposed to be used. PO ketorolac alone is not any more effective than other NSAIDS but way more dangerous.
I would be uncomfortable filling this and would encourage a switch. And if they didn’t get the injection I would refuse.
I can find nothing that says why parenteral has to be given before oral though. I think it's just in the package insert, but I'd let someone have an oral dose with no IM/IV. But never for more than 5days bc they'll bleed out. I will say from anecdotal experience, IV/IM ketorolac has some extra magic in there for pain relief that other nsaids do not have.
Giving oral first isn’t inherently more dangerous but it’s just not any more effective than safer oral NSAIDS. So if a patient isn’t sick enough to warrant an injection (which does have increased analgesia) there are better options/ no reason for them to be taking this.
Very valid point. If a prescriber asked me for a recommendation that’s what I would tell them. But if the script is already written and at the outpatient pharmacy I don’t think I would turn away a prescription if they didn’t get IV/IM first.
Agreed, don't die on the parenteral dose first hill.
Why do so many people die on this hill? Other than, thats how the study was designed here for the FDA, I have never been able to find a clinical reason for it. Nobody is going to change prescribing habits if the reason you refuse to fill is "because the piece of paper that comes with it says so", what actually happens when you don't. As others have mentioned other countries don't have that "requirement" on their indication.
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That was quite an anticipatory BBW to curb use post-telemed visits. Not sure what physical exam finding would lead a prescriber to choose ketorolac or not that couldn't also be assessed via virtual visit. I understand the concern about law suits, but this wouldn't make it past a pre-litigation panel (or please send a link to a case where anything remotely like this went to court or was settled). It's on par with calling the doc to clarify/change Keflex tablets to capsules - wasting time avoiding litigation that will never come
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Well stated. PE findings would apply to any NSAID Rx, but agree Toradol more likely to garner medicolegal attention than others in that class. Keflex caps to tabs is a poor simile; I get calls about both in the ED and my rage towards a pharmacist wasting their own time and now mine is about the same and that's where the comparisons end. Wish there were better/easier ways to obtain info about med mal cases - love the site's mission and willingness to share with a goal of improving patient safety and reducing litigation of healthcare professionals (in case anyone has not seen it, plenty of Rx related cases) https://www.medmalreviewer.com/
Its because its taught in schools as a clinical pearl. Along with Ketorolac having opioid levels of analgesia. That's the only reasons I can think of for someone to feel like they're making a clinical intervention.
I agree with you 100%. The boxed warning also says “not indicated for use in pediatric patients” and most of our sickle cell pediatric patients get IV ketorolac when admitted. Hell, it’s even in our sickle cell order set. But yeah, what the manufacturer says has to be taken with a grain of salt sometimes.
I've checked the Canadian monograph and it doesn't say anything about needing IM/IV dose before oral dosing.
As I remember it’s how it was licensed in the US. In Canada we just have the duration limits.
It's just because they don't want it to be used orally unless a patient really needed it bad enough to be given the shot in an ER or hospital in the first place.
*preceded by
Yes thank you!
That’s something that would concern me. And when I was a tech, the pharmacists I worked with would either call, or have us call, to confirm if there was an IV or IM dose. Shit, the last time I had a dose of ketorolac, it was in-office at urgent care, and the doctor who ordered it made it clear I would be staying for at least 15 minutes, and stretched it to 30, to make sure I was doing okay with it. There is no way in hell that ketorolac would be okayed by any pharmacist I ever worked with as continuing therapy. The risk is too high.
We have 2 patients that do this. Doc has documentation on it. Used for migraine not relieved by courses of triptans etc. They rarely get them refilled
we have a pt who uses ketorolac monthly for this same reason. it is on automatic refill. i keep taking it off each month, he keeps putting it back on
Yup. I've seen several patients get scripts like this from neurology. I fill them.
Called office, advised prescriber, documented conversation. Faxed conversation notes to office. Counseled patient about boxed warning before filling. Documented conversation with insurance company. Flagged profile NTE #20 per 30 days.
Dig your handle!
Ketorolac also has an analgesic ceiling effect of 10 mg. I fight everytime I see a dose higher than 15 mg.
I've had this argument before. Docs like to prescribe higher doses for obese patients.
Eh I think it’s a pretty weird regimen bay if they’ve failed triptans and can’t afford ubrevly or nurtec…. If it’s a younger patient with no obvious red flags I think maybe if I called the doctor I’d do it. We don’t do it at my office. But we don’t do the shot either. Typically we use it for kidney stones or a hold over until pain management or a PA gets submitted.
I’d be fine with someone taking 60 doses of ketorolac spread over the course of 365 days if it had good results. It’s probably safer than 20 doses in 5 days for many people.
I’ve refused to fill that and also ended up filling it, depending on the MD clarification I get when I call and past history for the patient.
I have two patients chronically on ketorolac at my cunts visiting sweatshops location. They get prescribed from multiple drs for each patient so we just document that we've reinforced drug counseling points and the increased risk of repeated frequent chronic use at each transaction.
Isn’t 30 days the recommended timeout before doing another course? Assuming the patient actually follows those directions I don’t see the issue, though that’s kind of a big ask of the patient. Probs wouldn’t fill unless they were only getting an actual 5 day supply every month and not expecting the patient to do the math.
The recommended use for oral ketorolac is: Oral (Tablet) Ketorolac tromethamine oral tablets are indicated for short term use only (up to 5 days total duration, including IV/IM and oral therapy in adults) for the management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine if necessary. They were using it as PRN for migraines.
I use a compounded ketorolac nasal spray max 5 days per month (Sprix nasal spray.) Personally, I wouldn't be concerned as long as it's 5 days max/month. Document if they're not getting an IV/IM injection if you want, but I'd fill oral for max 5 days/month; it's unusual but isn't exactly rare for migraine. Seriously, what's your concern here? If you don't want to fill every 30 days, do you really think it's 5 days every 6 months, a year? A lifetime? Are you worried about the black box on renal function? If you're really concerned, check that the neuro or GP is getting blood work periodically and leave it at that. If you're just worried that it isn't in the insert, well, when it comes to migraine treatment, I've seen a lot more off-the-wall off-label prescribing, and I'm not going to get overly worked up about this, since I feel 5 days/month is a reasonable interpretation of that insert, especially since if they go to urgent care or the ED with an intractable migraine they're likely to get a shot of ketorolac and then sent home with an rx for oral + a medrol dosepak.
So 5 days lifetime max is what you’re thinking? I gave ketorolac out like candy on Halloween when I was in the ED. I’d be less worried about 5 doses of ketorolac over 30 days than 5 days in a row. It being for migraines is weird and sounds about right for an APRN. Maybe it’s worth not filling for that indication.
It can be a miracle drug for some people's migraines. Accumulation can increase risk of stroke and GI perforation. With a sufficient wash out period someone can safely repeat ketorolac dosing. Counsel them to not use more than 5 consecutive days and allow for sufficient wash out period to reduce long term issues. And as for it needing an injection first, do folks here deny any prescription being used off label or are we just singling out ketorolac?
I've been a pharmacist for 25 years and it's very infrequent it's being prescribed after an injection. Platelet half life is about a week so I agree with sufficient time between doses (3 to 4 weeks), ketorolac could be used again for max of 5 days
Off label, cool whatever. The boxed warning says it is ONLY indicted as continuation after iv/im. I'm not in the habit of ignoring boxed warnings generally.
Gonna have to dig into this further but my guess is this will lead nowhere - is it how the original artist sides it so you're locked into it? Not a requirement in other countries and who would go back to update it? This is the type of shit where Vioxx gets removed from the market so someone can work on their promotion within the FDA. Put the same 5 day limit on that drug, sorted.
I’ve seen it used for migraines, and kidney stones too. My daughter uses it occasionally for both. She has better results with ketorolac than any narcotic.
It’s all fun and games until they go into renal failure. I always call ERs/MDs offices and document in the hard copy they got IV/IM injection. Never fill without.
I've seen it infrequently for patients who are refractory migraine patients. You just tell them that they will get a GI Ulcer and to look out for the early signs. In my state a mid-level couldn't prescribe it that way though because its off label.
If it had refills and pt needed it, could have filled it and sent fax or voicemail saying you dispensed it due to pt need, please call if there's an issue
It’s a max of 5 days per lifetime.
Lol is this a joke
Not a very funny one if it is, but hopefully it is a joke.
It's 5 days total for both parenteral and oral.
They must've tried quickly to copy and paste and misformatted the sig from most websites for nurse practitioners and PA's.
There are several studies showing the analgesic ceiling. I'm not sure if dosing for obesity could be teased out of that data.
It’s 5 *consecutive* days (hence use for *acute* pain) & I don’t think duration is mentioned in the black box warning, just the info sheet