Hydrocodone Products to Get More Severe, Schedule II Classification — Physician’s First Watch

Medical News |
August 22, 2014

Hydrocodone Products to Get More Severe, Schedule II Classification

By Amy Orciari Herman

Edited by André Sofair, MD, MPH

Combination hydrocodone products, currently considered Schedule III drugs, will be reclassified as Schedule II because of their high risk for abuse. The new regulation from the Drug Enforcement Administration will take effect in 45 days.

"Schedule II drugs ... are defined as drugs with a high potential for abuse, less abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical dependence," according to the DEA's definition. "These drugs are also considered dangerous."

The move means the drugs will be subject to tighter government regulations, including more stringent prescribing practices. The most commonly prescribed combination product affected by the ruling is hydrocodone plus acetaminophen (marketed as Vicodin or Lortab).

Reader Comments (10)

Lord Lee-Benner, MD, FACE Physician, Other, solo office practice

Bureaucratic nonsense, and unenlightened. Making this drug class II instead of class III will not have any appreciable effect except to make more work and raise the cost on physicians who have to deal with chronic pain patients. DEA costs have gone from $20. to $750. and the excuse is that doctors have to pay for government enforcement. I can see no benefit and only harassment of providers. As someone else has already pointed out, "The War On Drugs " doesn't work. And this is another example of this kind of stupidity. Who was the "genius" who thought this was a good idea, and who were the "sheep" who went along with it?


Patients will suffer - literally - from the increasing restrictions on narcotic pain killers. The FDA, as well as the individual physician,.need to keep this in mind. We are heading toward a "nation in pain" by imposing heavy restrictions.

We need to see a more balanced view here. Certainly, people may become addicted to a narcotic, and some do. But balance the relatively very small number of cases of addiction against the massive number of cases of people who have severe pain at any given moment. It makes no sense at all to cause many millions of humans to suffer, just to avoid addiction in a very small number by comparison.

Many people can't take NSAIDS, which, in any case, cause heart problems. And, it's been clearly shown that acetaminophen is a very dangerous drug - the number one cause of liver failure in the U.S.

What can we do? We can perhaps develop new pain killers that are as effective as narcotics, but that will take years. Meantime, we need to leave prescribing in the hands of physicians. Right now, many physicians are afraid to prescribe the most effective pain drugs we have. That means that patient suffering is rising, right along with restrictions imposed.

Please don't throw millions of pain patients under the bus, just to say you're working to reduce addictions.

Paula Millman, MD Physician, Family Medicine/General Practice, Albany, ca

This is a horrific idea!

Kurt Pulicicchio

Moving Hydrocodone to CII is so ridicules. It is equivalent to codeine which at the bottom of the pain killer list. It is good for Dental pain but not for anything else.

Bernard Atwell Physician, Pediatrics/Adolescent Medicine, Retired

I know a disease that causes real pain and was classified as "functional" because they could not find any pathology. The disease I am referring to Irritable Bowel Syndrome. By many it was thought to be nothing more then neurotic old men or women seeking attention and drugs for fun and that the neurosis was the real problem. With the relatively new discovery of Mastocytic Enterocolitis as the real cause of their distress I wonder if the powers that be are going stop these patients from getting the pain relief they need? I hope not.

KENETH STOUTENBOROUGH Physician, Palliative Medicine, Retired

I see this change in classification of hydrocodone as yet another attempt at fighting the "War On Drugs" which will fail like so many others. Until we accept that there are people who need pain medication to function and that abuse of narcotics is a disease not a crime we will never win this war.
As a retired board certified Hospice and Palliative Care physician I see it getting harder and harder for people who have legidimate needs for pain medications to get them. Physicians are getting more and more leary to prescribe anything for pain and this change will make it harder to get another drug for pain relief. Where are the advocates for people with pain?

Bortz Physician, Family Medicine/General Practice, Blossom Ridge Medicine

All this will do is take more time for physicians to fill these prescriptions. They can't be called in. Lots of staff time calling pt to let them know Rx's ready to pick up. Makes life harder for really ill people who might not have transportation to pick up rx's and take to pharmacy. Not sure how this is going to solve abuse problem. People are still abusing the Level II prescription items.

Jill St. Ambrogio, PhD Other, Other

Rather ludicrous that hydrocodone is restricted at pretty much the same time as Zyhydro is approved. Seems a bit too coincidental. I am not normally a conspiracy theorist, but I wonder how much pressure pharma put on the committee -- which receives up to 60% of its funding from pharma -- for the drug approval process. Shameful conflict.

Steve King Physician, Palliative Medicine

I don't quite see conspiracies in this. Rather it simply highlights the previous irrational scheduling of hydrocodone alone as a Schedule II drug while having it in combination with another drug as a Schedule III drug.
Before Zohydro came on the market, this didn't make much difference as there were no single hydrocodone products available.

Debbie Pilgrim, PharmD Other Healthcare Professional, PharmaCare Services

First comment--this ruling has such a tremendous implication for pharmacists, and we are not even given the courtesy of being included in the drop-down box as a professional category-shame on you!!!
Second comment-the rationale for the control of the drug is reasonable, but the manner in which you are controlling the situation is going to be detrimental to many patients who truly require pain management. Many states have the ability to monitor physicians and pharmacies who prescribe and dispense large quantities of any narcotic. Why not work with those currently established modalities to identify and "control" those who really need the controlling? This would allow the professional practitioners to actually help the patients who need pain management.
Third comment - research the patients who are receiving disability payments from the government who bring in prescriptions for large quantities of hydrocodone based medications and then proceed to sell them on the street. That might make the largest impact in the abuse of the drug and the ever sky-rocketing costs to healthcare. In my practice, I have refused to fill these once I determined the patient's intent.

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