DEA Makes Official Change for Hydrocodone Combination Products to CII

[BF7]

http://www.empr.com/dea-makes-offic...1&spJobID=361973234&spReportId=MzYxOTczMjM0S0


"The U.S. Drug Enforcement Administration (DEA) announced it will publish the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to Schedule II tomorrow in the Federal Register. This Rule follows the recommendation by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and is supported by the DEA's own evaluation of clinical data."

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[WhiteSnows]

A lot of patients will suffer from this if it is approved.

 

[D1CE K]

DEA are too sensitive. Just give the people what they want.

 

[owlegrad]

I was just about to post this! Saw it on FB. All I can think of is how much more work this means for me. God I hope CVS will go to the electronic C2 ordering soon...

 

[WhiteSnows]

A lot of patients who have cancer rely on Vicodin and stuffs with additional refills. Now they have to go back to the doctors every month for a new Rx. Imagine how annoying it is.

 

[All4MyDaughter]

A lot of patients who have cancer rely on Vicodin and stuffs with additional refills. Now they have to go back to the doctors every month for a new Rx. Imagine how annoying it is.

They can get three months' worth of scripts at a time, though. That should help a bit.

 

[WhiteSnows]

They can get three months' worth of scripts at a time, though. That should help a bit.

It helps a little bit. Non-CII can have up to 5 refills and a little bit less strict for early refill. Change vicodin to C-II will definitely gonna make it difficult for the patients who use slightly more pills each month because of break thru pain.

 

[KidPharmD]

It helps a little bit. Non-CII can have up to 5 refills and a little bit less strict for early refill. Change vicodin to C-II will definitely gonna make it difficult for the patients who use slightly more pills each month because of break thru pain.

The patients I had that used MSContin for maintenance and MS-IR for breakthrough don't seem to have a problem with treating their pain when managed appropriately. For cancer pain, they should not be using the same thing for maintenance and breakthrough. It should be two different prescriptions.

I know that most CVS's are going to have to get 2 or 3 more safes for the CII's

I wonder how long they will give to comply.

 

[owlegrad]

I know that most CVS's are going to have to get 2 or 3 more safes for the CII's

We already put hydrocodone in it's own safe! CVS was a little ahead on this (in my market at least).

 

[WhiteSnows]

The patients I had that used MSContin for maintenance and MS-IR for breakthrough don't seem to have a problem with treating their pain when managed appropriately. For cancer pain, they should not be using the same thing for maintenance and breakthrough. It should be two different prescriptions.

I know that most CVS's are going to have to get 2 or 3 more safes for the CII's

I wonder how long they will give to comply.

We also have a lot of patient have rheumatoid Arthritis and are on these pain meds. Many patients who are stable on pain meds are now required to go back to see their doctors more frequent for a new Rx. That will overload the healthcare systems. However, with the current shortage of primary providers I think It can be a good opportunity for pharmacists to advance and fill the need of healthcare.

 

[KidPharmD]

We also have a lot of patient have rheumatoid Arthritis and are on these pain meds. Many patients who are stable on pain meds are now required to go back to see their doctors more frequent for a new Rx. That will overload the healthcare systems. However, with the current shortage of primary providers I think It can be a good opportunity for pharmacists to advance and fill the need of healthcare.

Everyone seems to be under the impression that getting a new CII requires a billed office visit. Most pediatricians who write stimulants only see their patients once a year. They right 3 at that time, and then the other 3 times per year the parents just pick up new Rx's at the front desk.

 

[WhiteSnows]

Everyone seems to be under the impression that getting a new CII requires a billed office visit. Most pediatricians who write stimulants only see their patients once a year. They right 3 at that time, and then the other 3 times per year the parents just pick up new Rx's at the front desk.

I thought C-II requires a physical evaluation before issuance. I read it somewhere in federal law. Still, doctors can phone in to verbally issue a new Rx for C-III, but with C-II it is not possible.

 

[genesis09]

The rescheduling of hydrocodone/apap has been approved. There is no more what ifs about this anymore. The official change over will be on Monday, October 6. T#3 and Tramadol can still be called in.

 

[lt23]

Yup, they are doing that in California too. Before they had the safe, they used to treat Norco 10's like C-IIs making pharmacist count it and keep a perpetual log.

We already put hydrocodone in it's own safe! CVS was a little ahead on this (in my market at least).

 

[maria1oh]

Cvs stores also have the hydrocodone in a separate safe in central Ohio. It takes up too much space in our already cramped pharmacy. The fastest mover is the Norco 5/325 and we get the small 100 count bottles.

 

[BidingMyTime]

Eh, I think this will just make things harder for people who need pain relief, and the abusers will still find ways to get their drugs (because they won't care about following the law.) Still, it won't be overly burdensome, as has been mentioned, doctors can still mail out 3 months worth of RX's to a patient, or have them pick them up at a desk, an actual physical examination is not needed (whitesnows mentions it being required by federal law, it is no required, although if a doctor is investigated by the DEA, the DEA does look at stuff like this, so doctors may be hesitant to do this for too many of their patients or may require all their patients have an appointment every 3 months.)

It will make storage in pharmacy more difficult, but not in a major way. I suspect RX's for tramadol & Tyl#3 will go way up, as hydrocodone's RX's go down.

 

[Tom Applewood]

FML...

It's not just retail, folks, now, in LTC and hospice, we're going to have to page an on-call physician at 2am Saturday/Sunday for fricking Norco or Vicoprofen and get emergency authorizations, and hope in vain they'll send us the actual hardcopy Rx later the next week. They (physicans) already can't handle the way the system works now, with the occasional oxy/ms contin/roxanol... HTF are they ever going to keep up with us for 10-times the volume of RXs from hydrocodone/apaps! Clearly, the DEA didn't listen to the vast majority of people during the commenting period before this ruling. FML and F our government.

Plus, every other resident in a nursing home has an Rx for prn Norco, which they WILL forget to re-order before the weekend, and it will be all out of partial fills, and will need a new Rx. Previously, it simply involved renewing a standing order from the home.

 

[Momus]

This is BS. It means I have to log like 50 scripts in a day to the book... fu3k.

 

[WVUPharm2007]

I was just about to post this! Saw it on FB. All I can think of is how much more work this means for me. God I hope CVS will go to the electronic C2 ordering soon...

They do in PA. This is going to be great for me. All hydrocodones will move to eScript. Woohoo.

 

[trailerpark]

Good! I hope this gets people off of hydrocodone. The USA has 4.6% of the world's population yet we consume 99% of the hydrocodone... Do we really have 99% of the pain in the whole world?

 

[WVUPharm2007]

People will just switch to Tylenol #4 if it becomes that annoying. They are roughly equianalgesic.

 

[FarmD711]

Any word on Tussionex, Hydocodone/Homatropine syrup etc? Or is it only the APAP/Ibu combos?

 

[WVUPharm2007]

Any word on Tussionex, Hydocodone/Homatropine syrup etc? Or is it only the APAP/Ibu combos?

Does it have hydrocodone? To schedule II it goes.

 

[owlegrad]

They do in PA. This is going to be great for me. All hydrocodones will move to eScript. Woohoo.

I was referring to CSOS, I just couldn't recall the name at the time. As far as I know, no CVS uses CSOS. If any do, I would be very curious to hear about it. What do you mean by eScript?

 

[WVUPharm2007]

I was referring to CSOS, I just couldn't recall the name at the time. As far as I know, no CVS uses CSOS. If any do, I would be very curious to hear about it. What do you mean by eScript?

Electronic prescriptions? Those things you get 300 of a day? In PA, they can send CIIs through their phone.

 

[owlegrad]

Electronic prescriptions? Those things you get 300 of a day? In PA, they can send CIIs through their phone.

So you expect to get more hydrocodone prescriptions by eRx now that they are C2s?

 

[WVUPharm2007]

So you expect to get more hydrocodone prescriptions by eRx now that they are C2s?

Yes. Because its the only lazy way to do it now.

 

[owlegrad]

Yes. Because its the only lazy way to do it now.

Gotcha. In FL we do not get any CIIs electronically. We only recently started getting ANY controls electronically. In fact you have to be approved to send controls and so far I have not gotten any. I wish more used eRx.

 

[npage148]

I really couldn't care less. What I hope is it cuts down on the ER sending everyone out with 10# norcos. Everyone is America loves their narcotics, maybe it's time they start jumping through some hoops (if their back isn't too bad). I'd be happier if we just took them off the market

 

[pharmacy7424]

DEA mentioned that, like other C2's, prescribers may write multiple Rx's authorizing up to a 90-day supply.

To the best of my knowledge, there is no days supply limit per federal law on any controlled substance in the CS Act.

With this announcement, they have effectively changed the law to limit to a max of a 90 D/S.

Comments?

 

[dblock05]

DEA mentioned that, like other C2's, prescribers may write multiple Rx's authorizing up to a 90-day supply.

To the best of my knowledge, there is no days supply limit per federal law on any controlled substance in the CS Act.

With this announcement, they have effectively changed the law to limit to a max of a 90 D/S.

Comments?

I am on my rotation right now so I haven't taken the law exam or have studied heavily for it but it is my understanding that there is no day supplys limit on a SINGLE prescription per federal law.

If a prescriber is giving you multiple prescriptions at the SAME time for the SAME drug then they can only give you a 90 day supply (ex: Doctor giving you a Rx for Vyvanse 20 mg for August, September, and October)

 

[josh6718]

Yes. Because its the only lazy way to do it now.

I dread the day, at least until prescribers are able to properly use the e-script software.

I could imagine:

Dispense quantity "1 unspecified"
'DAW 1' on Demerol
Morphine "ER" 30 mg tablets 1 tablet every 4-6 hours

Not to mention receiving a script you don't feel comfortable filling (and/or are out of stock) and aren't able to give the patient the script back...

 

[FarmD711]

Does it have hydrocodone? To schedule II it goes.

Oh good. Hopefully Tussionex scripts are replaced with Iophen if it's going CII because it seems like every 5th script I check lately is a Tussionex.

 

[KidPharmD]

FML...

It's not just retail, folks, now, in LTC and hospice, we're going to have to page an on-call physician at 2am Saturday/Sunday for fricking Norco or Vicoprofen and get emergency authorizations, and hope in vain they'll send us the actual hardcopy Rx later the next week. They (physicans) already can't handle the way the system works now, with the occasional oxy/ms contin/roxanol... HTF are they ever going to keep up with us for 10-times the volume of RXs from hydrocodone/apaps! Clearly, the DEA didn't listen to the vast majority of people during the commenting period before this ruling. FML and F our government.

Plus, every other resident in a nursing home has an Rx for prn Norco, which they WILL forget to re-order before the weekend, and it will be all out of partial fills, and will need a new Rx. Previously, it simply involved renewing a standing order from the home.

Except the DEA stated that a small majority of comments made on the ruling supported the change. If you don't believe them, make a public records request for all the comments and find out for yourself.

On another note, I imagine that we are about to see a lot more tramadol than we see now come through community pharmacies.

 

[drhenPharmD]

If you start filling emergency 72-hr supplies of hydrocodone and never get the hardcopy from the physician. Do you get in trouble?

I believe the CSA says you must report the physician to the nearest DEA office, but I can definitely see pharmacists getting on some kind of list for reporting one too many "never-got-the-hardcopy" emergency c2s.

 

[npage148]

If you start filling emergency 72-hr supplies of hydrocodone and never get the hardcopy from the physician. Do you get in trouble?

I believe the CSA says you must report the physician to the nearest DEA office, but I can definitely see pharmacists getting on some kind of list for reporting one too many "never-got-the-hardcopy" emergency c2s.

Don't fill phone ins. Simple

 

[drhenPharmD]

Don't fill phone ins. Simple

What if it's Saturday night and the patient needs pain relief and the wait-time at the ER is 2 hrs.
I guess your patients who were controlled on hydrocodone will have to pray Tylenol/codeine or tramadol works.

I'm sincerely curious, do you feel your responsibilities as a pharmacist include helping patients in this situation. Or is it the doctor's problem?

 

[drhenPharmD]

Also, anyone know the approx. cross tolerance of hydrocodone to codeine?

 

[npage148]

What if it's Saturday night and the patient needs pain relief and the wait-time at the ER is 2 hrs.
I guess your patients who were controlled on hydrocodone will have to pray Tylenol/codeine or tramadol works.

I'm sincerely curious, do you feel your responsibilities as a pharmacist include helping patients in this situation. Or is it the doctor's problem?

I feel a patient with a well developed pain mgmt protocol from a upstanding practice will never be in a situation where they will run out on a Saturday night. Or they will e-scribe it instead lf phone in (legal in my state). the respectable clinics i deal with have a zero phone in policy. If a patient has an acute situation which requires c2 level narcotic to manage its not something that should be managed via phone with the MD. It would need face to face assessment and then a paper rx would be given

Phone ins are an easy way for drug seakers to get pills either by calling them in themselves or by using a doctor with low morals. So you have a issue of constantly chasing down hard copies or your need to triple verify the legitimacy of the script which likely can't be done Saturday night anyways.

Think about it, a hard copy given to a patient usually has all the information an rph would use to test the person calling in the rx (npi, license #, DEA number) so these are useless questions to catch anything but the most rookie drug seakers.

 

[CardinalGirl210]

Don't fill phone ins. Simple

I agree. I'm a new RPh, but I see how it takes 2 weeks or more for most offices just to get back to us on a refill request (which ends up being denied anyway). No way would I give a 3 day supply on CII for them only to ignore my calls and faxes when they don't send me the hardcopy! Too much of a headache!

 

[maria1oh]

I believe they are allowed to prescribe an emergency supply for however long they need to depending on the length of the emergency. It might vary by state.
Based off my experience, if you call the office to follow up they will ignore it or low priority it, but if you remind them that you need to report them to the DEA,they almost always promptly deliver it. One office even mentioned they would hand deliver it!

 

[KidPharmD]

What if it's Saturday night and the patient needs pain relief and the wait-time at the ER is 2 hrs.
I guess your patients who were controlled on hydrocodone will have to pray Tylenol/codeine or tramadol works.

I'm sincerely curious, do you feel your responsibilities as a pharmacist include helping patients in this situation. Or is it the doctor's problem?

Then they go sit for 2 hrs in the ER. Patient's should take some responsibility with making sure that they don't run out of medication (and refills/extra scripts) on a weekend or holiday.

The exception for call in "emergency" prescriptions rarely exist outside the LTC/Hospice arena. The exemption was put in for things that had not been thought of. However, in the community setting I have never encountered one that actually did constitute an emergency. It is possible that more rural pharmacists (>1hr to a hospital) could encounter some that I wouldn't.

 

[eagles22]

What if it's Saturday night and the patient needs pain relief and the wait-time at the ER is 2 hrs.
I guess your patients who were controlled on hydrocodone will have to pray Tylenol/codeine or tramadol works.

I'm sincerely curious, do you feel your responsibilities as a pharmacist include helping patients in this situation. Or is it the doctor's problem?

As far as my experience goes, most people do not die of pain. They die from what is causing the pain. Hence, the pain relief is not the actual solution if it's a true emergency. Send them to the ED to be properly evaluated which would be a responsible thing to do.

 

[Wheresmyaricept]

As far as my experience goes, most people do not die of pain. They die from what is causing the pain. Hence, the pain relief is not the actual solution if it's a true emergency. Send them to the ED to be properly evaluated which would be a responsible thing to do.

Pain can cause a drastic decrease in quality of life. I've experienced pain before that was so bad that it kept me up all night crying. Tylenol and NSAIDs did nothing to touch the pain. I went to the ED and they were going to give me ibuprofen. I had to insist on something else before I got ultracet. I wasn't even going to argue for anything stronger because at that point I was just drained and felt like I wanted to die. Now if I wasn't trained or experienced enough to know otherwise, most people would've taken the ibuprofen script and figured it would've helped. The tramadol dulled the pain enough for me to be able to sleep, which is all I wanted at that point.

So I really don't think it's a good idea to tell someone they're not going to die from their pain, but rather they might die from the infection they have. What if they're already being treated for the tooth infection that is causing so much pain? Or a kidney stone? The pain doesn't resolve instantly once you start taking antibiotics or flomax...the pain persists. You try to tell someone to just wait it out. You know as well as I do the majority of the general public waits until it's really severe before they even ask for help. They've already waited it out and clearly it isn't getting better.

Most walk in clinics won't even write a script for a controlled. Most EDs nearby only write enough for a 1 day supply. So for someone experiencing pain, this change really sucks and the last thing they need is someone to tell them "you're not going to die from pain" because from their perspective, they would rather die than experience any more pain.

 

[Vandalia]

I feel a patient with a well developed pain mgmt protocol from a upstanding practice will never be in a situation where they will run out on a Saturday night. Or they will e-scribe it instead lf phone in (legal in my state). the respectable clinics i deal with have a zero phone in policy. If a patient has an acute situation which requires c2 level narcotic to manage its not something that should be managed via phone with the MD. It would need face to face assessment and then a paper rx would be given.

I can only recall one situation where an "emergency prescription" for a CII was authorized over the phone - and that was because it was the fault of the pharmacy. It was when I was a med student (years ago) on a rural family medicine rotation - i.e., a small town where physician, pharmacist and patient all knew each other. 70 (or so) yo woman received her monthly prescription for oxycodone on a Friday and dropped it off at a Giant Eagle type-pharmacy to be filled the next day - Saturday. Patient comes Saturday at 3pm to pick it up and prescription (Rx) has disappeared. The pharmacist knew (a) she had filled it like clockwork for the last 5 years, and (b) he and the tech remembered her dropping it off the day before. A frantic search of the pharmacy didn't turn up anything. So he called the attending physician who authorized an emergency "refill" until Monday with a duplicate written script to be provided on Monday. Apparently, a pharmacy tech found the missing original script on Monday morning - it had worked itself up and behind the counter draw.

So that is one situation where a primary care physician might authorize an emergency refill on a CII - if a pharmacist calls and said they goofed. Otherwise, as one of out primary care guys tells his patients - if you call and say you need an emergency refill on a controlled substance, the underlying emergency had better be the lead story on the 11 o'clock news. Tornadoes do happen ....but they are very rare.

 

[BidingMyTime]

FML...

It's not just retail, folks, now, in LTC and hospice, we're going to have to page an on-call physician at 2am Saturday/Sunday for fricking Norco or Vicoprofen and get emergency authorizations, and hope in vain they'll send us the actual hardcopy Rx later the next week.

I hadn't thought of that, I can see that being a major headache. I would do a call-in for LTC (hospice can fax for CII's.) As for others, because they forgot to call in for a refill before 6:00pm Friday, they are on their own. It would have to be an very unusual circumstance for me to do a 72hour ES from a regular doctr, because as has been mentioned, its like pulling teeth to get the hard copy mailed (and when it is, it will usually have the wrong date or wrong something else on it.)

 

[trailerpark]

I hadn't thought of that, I can see that being a major headache. I would do a call-in for LTC (hospice can fax for CII's.) As for others, because they forgot to call in for a refill before 6:00pm Friday, they are on their own. It would have to be an very unusual circumstance for me to do a 72hour ES from a regular doctr, because as has been mentioned, its like pulling teeth to get the hard copy mailed (and when it is, it will usually have the wrong date or wrong something else on it.)

It's like pulling teeth to get the hard copy? I thought you were supposed to call the DEA immediately if it doesn't arrive in 72 hours. You have no obligation to remind the doctor. You'll see how fast he responds when the DEA is calling.

 

[BidingMyTime]

It's like pulling teeth to get the hard copy? I thought you were supposed to call the DEA immediately if it doesn't arrive in 72 hours. You have no obligation to remind the doctor. You'll see how fast he responds when the DEA is calling.

Well, ya do have a good point there. However, my pharmacy does try to stay on the good side of doctors by giving them frequent reminders about the deadline.

 

[Digsbe]

I think between now and implementation we should be educating patients on hydrocodone products of the change that is about to happen and what it means to have their medication now be a CII. More than likely people who take it chronically will need a refill within the 40+ days before it goes into effect and if you tell them beforehand how the change will impact them there may be less confusion, fighting and problems at the pharmacy and possibly in the physician's office too. It will likely still be somewhat of a nightmare early on but it can be minimized I think with educating patients and prepping pharmacy staff.

I do think some chains need to look at their workflow to accommodate the larger quantity of CII medications. I hear in some states it is illegal for techs to handle CII scripts and I know where it is legal for a tech to work on them the pharmacy policy may be to only have the pharmacist dispense the CIIs. Unless the pharmacy hires more pharmacists or they change how CIIs are dispensed I fear a workload crisis to some degree. Regardless it's going to be more of an administrative burden either way.

 

[Aether2000]

perhaps a reality check is in order. Hydrocodone is the most prescribed drug of all classes of drugs in the United States with over 127 million prescriptions issued last year. it is also the most abused drug in the United States. It also has long been misclassified by the government as a less addictive drug thereby promoting it's use over other C-II semisynthetics. ER doctors, PCPS and surgeons all drastically over prescribed this medication for 4 decades leading to rampant drug sharing in the population and 10-100 times the amount prescribed and used in other western populations. Now 97% of all hydrocodone in the world is consumed by our 6% of the world population. This over prescribing has created a gateway drug effect to the more potent drugs (MED per tablet) and long term use of opioids only rarely seen in other countries. Patients are maintained long term on these drugs to avoid withdrawal, not because the medications are very effective for chronic pain. No less than 7 studies have shown patients on high dose chronic opioids when weaned to nothing or very low doses, have the same amount of pain. And high doses lead to overdose and death esp.when used with alcohol or benzos. Given the many docs that don't give a flip and prescribe opioids long term without seeing their patients, this change in hydrocodone status will force most docs to engage in diligent prescribing rather than behaving like drug dealers. Hopefully there will be far fewer opioid scripts in the near future.