6 things you need to know about hydrocodone reclassification

AMA Wire
Email this page

If you prescribe hydrocodone combination products, prescribing these medications to the patients who need them to alleviate pain just became more complicated. A new rule from the Drug Enforcement Administration (DEA) taking effect Oct. 6 reclassifies these drugs as Schedule II controlled substances, prohibiting refills and establishing other restrictions that will require major changes to prescribing practices.

These are the six key points you need to know so you can take appropriate action over the next few weeks:

  • Refills aren’t allowed for prescriptions that are written beginning Oct. 6. Be prepared to issue new hard-copy or electronic prescriptions for patients. Note that eScripts can only be used if state law permits and the prescriber is certified to ePrescribe Schedule II substances. Pharmacies also must be certified to accept eScripts for controlled substances.
  • Prescriptions issued before Oct. 6 won’t necessarily qualify for refills; plan to issue new ones. Although the DEA rule allows refills of prescriptions issued before Oct. 6 until April 8, 2015, other factors could prevent patients from getting those refills. Several states have published notices that they will treat hydrocodone combination product prescriptions issued before Oct. 6 in the same way they will handle prescriptions issued after the rule’s implementation date. In addition, any state laws that are more stringent than the DEA rule will govern refills. Meanwhile, some pharmacy quality and safety processes may not allow refills for prescriptions issued before Oct. 6, and some health insurers will not pay for those refills.
  • Prescriptions can’t be called in or faxed. Make sure to plan ahead for any patients who may need refills. The new rule prohibits pharmacies from filling prescriptions delivered over the phone or via fax, so you’ll need to issue written scripts. The only exception to this rule is emergency treatment, which would allow physicians to call in a limited quantity of the medication to cover the emergency period only. Pharmacies are required to report prescribers to the DEA if they make such a request and do not give the pharmacy a written prescription within seven days.
  • Allied health professionals might not be able to write prescriptions for these drugs going forward. Check your state’s restrictions around Schedule II substances to confirm whether any non-physician members of your team who have prescriptive authority will be able to continue issuing prescriptions for hydrocodone combination products. You may need to modify your collaborative practice agreements accordingly. 
  • Multiple prescriptions may be issued at one time under certain circumstances. The new rule does allow a patient to receive prescriptions that would total a 90-day supply, if the prescriber has determined it is appropriate to see the patient only once every 90 days. Each prescription must include written instructions that specify the earliest date it may be filled. In addition to sound medical judgment and established medical standards, make sure to base your practice’s policy on issuing multiple prescriptions on relevant federal and state laws.
  • Patients should be notified of the new requirements and processes. Make sure your patients understand that their new prescriptions will not be refilled and are aware of the procedures they will need to follow going forward.

Download a printable fact sheet (log in) containing this information as well as details about how the new rule will impact patients and pharmacists for a convenient office reference or handout.

“The AMA is strongly committed to combating prescription drug abuse and diversion while at the same time preserving patient access to medically necessary treatments for pain,” AMA President Robert M. Wah, MD, said in a news release. “This new fact sheet explains how new regulatory changes impact both physicians and pharmacists, which will help ensure patients continue having access to the care they need under the new federal rule.”

The AMA and other groups have warned the DEA about the potential unintended consequences of reclassifying hydrocodone combination products since the agency made the proposal early last year. Eliminating phoned-in prescriptions and refills  could make it difficult for some patients to get the pain relief they need, especially patients in nursing homes and those with persistent pain and disabilities.

Visit the AMA’s Web page on combating prescription drug abuse and diversion under “federal agency and administration activities” to learn more about this advocacy work.

Email this page

Comments

as a substance abuse counselor, I am glad to see these changes in place. Protections for both prescriber and patient are in effect here, and this may lead to earlier identificaiton and referrall to treatment to those who are devloping a dependency... Having said that, we all need to recognize that the Opioid addict needs to have care made available, without bias, using evidence based treatment interventions and referral to immediately available sources for that treatment. It is time to recognize the epidemic and begin to treat it , especially in large health care institutions and in geographic areas where treatment may not be readily available.
RE: counselorjim Another point of view. As an attorney in public service I have spend years protecting children from parents who abuse substances, of all kinds. But as a person with chronic pain this is a real burden. For example it limits my travel because I have a limited supply and must be home to get a prescription. The general population is not aware there is a monthly restriction placed on pharmacies by the DEA. I know my doctor is frustrated that some of his patients, myself included, are, sometimes, unable to get a timely refill because the pharmacy doesn't have the medication in stock. I agree that in a limited number of cases this change may be a help but most drug abuse is from those who have illegally obtain the drugs or unethical practitioners over prescribing, Michael Jackson for example, Elvis Presley, also. I don't have a solution but, in my opinion, this is not the solution and more of a burned for law abiding citizens and responsible physicians. I would like to thank the AMA for this web site which helps me in my legal research involving medical issues.
As a patient with pain issues, I now find out I will need to physically go to my pharmacy to get my medication. This is like having another appointment. I have too many appointments as it is. Also, states had better get in gear because they will need extra money (i.e. taxes) for more handivans and cab vouchers for people who cannot drive and will need to go get their rx. This will be torture for patients as the vans will not wait for the pharmacist to fill the prescription and they will then need to call to be picked up. As I see it, this could take a patient at least 2 hours to get their rx. My pharmacy delivers and is very busy and it has taken an hour to to my rx and then waiting for a handivan to pick a person up. The vans need one hours notice. This does not include travel time. It's just too much for a person in pain. Since money talks, remember this is going to be very expensive for tax payers.
To add to my earlier post, I don't want to get addicted to pain medication, who does? There are some medications that could reduce the amount of oral pain medication a patient needs but insurers/medicare won't pay for them. They are compounded creams. They contain the same pain medications but are in a cream so you don't get addicted and you cannot adulterate to another form. My cream was prescribed by a doctor of pain and contains 4% ketamine, 6% gabapentin, 10% ketoprophine and 2% lidocaine. This is topical and so can be applied directly to the source of pain instead of in the case of oral medication which treats parts of the body that may not have as much pain. My experience has been that doctors do not even know what this medication is and neither do patients. There are lots of different combinations of drugs that can be used in the cream. I believe that if patients could get this medication at a reasonable cost there would be a lot fewer addicts. My rx is $130.00 for a 10 day supply. The individual drugs that go into this cream are no where near that cost. Medicare will not cover it and so most insurance companies will not either. I've called everywhere and was actually told by a medicare rep that they will pay for the addictive oral drugs and if I get addicted, they will pay for my rehab but they will not pay for the cream.
Counselorjim, its very obvious you don't suffer with chronic pain. Morons are going to find a way to get or make drugs no matter what laws are made by nonsuffers. Your only making it harder on we who are stuck with idiots making laws that need relief and the abusers your referring too, will only find something worse to abuse.
Just a little add on to my previous post. I'm 62 ,was injured 11 years ago in an industrial explosion that almost took my left arm off, my arm and fingers burn constantly even with the hydrocodone. It only eases the burn but when you hurt like I do any relief is welcome. I've been without any scince Oct 6 while my doctor is trying to appease the morons who make laws. If I seem bitter , walk a mile in MY shoes. I'm diabetic and my sugars levels have went stoopid because of the added pain. I can not eat anything and my sugar still rises. Tell me how to fix this plz.
Hollyfire, I feel for you. I tried the patches, all they did was make my already numb fingers and skin numb, didn't help the burn at all. Just my two cent's.
Well, yesterday was one of the most difficult days I have had after a few years of unceasing pain. Why? Because I tried to refill my hydrocodone and was told that was no longer possible due to the federal law kicking in October 2014. I was NEVER advised about this in advance by my pain management's office (nor as their excuse, they said the Sam's pharmacy where I fill my Rxs should have advised me). The pain mgt group required me to drive to their main office (a 65 mile round trip) as the satellite office closest to my community is only open Friday am and this was Monday. After 2 hours on the phone (8 calls as they at first tried to say I was not a patient... I had been a REGULAR PATIENT for over 3 years), they told me I could pick up my Rx at the front desk. I get there and they made me wait for two hours. No reason given. And this was to get a new Rx because my REFILL (a second from the original Rx provided) was denied due to the law. <br/> When I asked why, over the past year no one had mentioned this was going to happen, they said it wasn't their responsibility to advise patients. This is a huge group through Sarasota Memorial Hospital. What I have been put through by this group would fill a book. <br/> I suffer terribly with crippling pain. My life has been ruined. I can no longer do any of the things I enjoyed. I have been forced to live with the pain. It has affected every aspect of my life. And now, in order to get my 4 pills of 10/325 hydro/apap<br/> A day, I will have to EVERY MONTH actually SEE the doctor in order to be hand given an Rx, drive that to my pharmacist (oh, yes; and endure threats from the insurance company who insists we fill all through the mailaway service; sorry, Aetna and Costco but my doctor couldn't care less about your rules). Oh, and about scheduling that monthly doctor appointment... GOOD LUCK WITH THAT!! That was 30 minutes extra delay AFTER receiving my Rx. Seems the Friday that I needed to be seen next was the Friday before the doctor was to have a week off so they had just blocked the entire Friday. They said I then had to drive to this main office (65 mile round trip) which was already 2 cities away from me instead of the location 1 city away. <br/> All of this is COSTLY in gas, time, and unnecessary aggravation WHILE IN PAIN!!!<br/> "Reducing stress will help with pain". Ha! <br/> I am struggling so even mentally as I am fighting the desire to CURSE EVERY PERSON WHO CONTRIBUTES TO MY AGONY TO HAVE SOME OF THIS AGONY SO THEY MAY HAVE A GLIMPSE OF JUST HOW POWERFUL THIS PAIN CAN BE!!! <br/> How awful to lose bladder and bowel control due to the pain. How awful to sleep only the sleep of sheer exhaustion because laying down is a high pain position. As is sitting. <br/> I have a new dietary aide. It's called extreme pain. I've lost over 40 pounds this past year. I'm struggling to get through each day. I have NEVER ABUSED pain pills. I have NEVER been "high" from pain pills. But then, I also have not been free of pain in so many years, now, that I think I understand why people choose death. <br/> As for the people that are choosing to abuse? I am not in their shoes. I have always worked hard and strived to be a good and generous person. But I can swear to you that extreme pain changes you down to your very soul. <br/> Oh... I forgot. That last appointment? I was handed an Rx for MORPHINE. I was in shock. Don't want to give me more hydrocodone but let's start me on morphine? With ZERO discussion even after I question interactions with the other medications they are giving me including Trazadone and Klonapin?! Seriously? <br/> When I went to pain management, I thought THAT was what I was going to GET: management of my pain. My experience has been NOT that. Instead, they only seem interested in getting out early (9 of my 10 appointments, the day before, someone would call to change my appointment time to earlier in the day. I'd get there and STILL wait hours). Just more aggravation. I FEAR my future days.
outlawthepain, What I mentioned was not the patches. I tried those also. They only helped me in the spot they stuck to and they didn't stick well in the summer. What I meant (and forgive me if I misunderstood) is more like a hand cream but for all parts of your body anywhere you have pain at that time. I burnt myself over the weekend and since any pain is magnefied with me, it wouldn't quit burning. I used just a dab (it's like gold to me so just a dab) and I was able to continue my day. Although this is a minor annoyance, I give it to you as my most recent example. I also have a terrible muscle spasm in my neck caused by a osteopathic doctor (I am no longer seeing since today!) and the cream helps with that. I don't know anything about diabetes so I don't know if you could try it but if you can it's worth a shot. Iwould rather be able to use this than take opioids but it is so expensive I try to conserve it as much as possible. If you do, I hope you can get some relief. To mayufeelmypain, you sound like me on Oct. 6. I was calling everyone and writing everyone. Don't think it will do much good. The law doesn't care for the individual until there are lots and lots of individuals raising h*ll. I can relate to your level of frustration. I blew up at my nurse on the 6th and had to appologize today. It just seems like I have to fight so hard all the time and I get so tired, sick and tired. I have terrible days. I just want you to know that I heard you and you are not the only person who feels your head exploding everytime yet another thing is added to the pile of **** on your head and you don't know if that will be the one that will make the pile come crashing down and crush you. As to your experience with the professionals, keep looking if you can. Of course, then they'll say you're doctor shopping. Can't win with these people but don't let'em beat you. I have hope there is someone out there who can help me. Maybe they are still in med school or even high school! JEESH, I never talk this way in my own head when I can't get out of bed but your thoughts and frustration hit a cord so thankyou. I have never before written on this type of forum but I think I need to reach out to people like you so I don't feel so alone with the grief. Might even join facebook.
I almost went to the emergency room last night. The pain in my arm was so severe. I've been to the ER before for the same problem and one of the reasons I had the hydrocodone was to keep me out of the ER. When this new law took effect, I decided I would just take a lot more acetaminophen to avoid the extra work to get a hard copy rx so when I went to my Dr I didn't get the rx. Now I'll have to make an unscheduled appointment to my Dr to get the rx. My Dr told me to only take 325 mg acetaminophen twice per day when they started to recommend this dosage about 2 months ago. Now I am taking a lot more regardless of the recommendation. Is this going to destroy my liver? Who knows? It seems this thread has ran it's course so I don't know if anyone will even read this but I had to get it out there while I wait for my Dr to get to her office since I can't sleep. Good luck out there.

Pages

Show Comments (19)
Dr. Celeste Philip
Nov 29, 2016
The Sunshine State’s surgeon general offers insights on difficult choices faced amid local spread of the mosquito-borne illness.