The DEA recently published its final rule(www.federalregister.gov) in the Federal Register that moved hydrocodone combination products (HCPs) from Schedule III to the more restrictive Schedule II, as was recommended by the HHS assistant secretary. The rule takes effect on Oct. 6, so family physicians need to prepare for what this change will mean for their patients, as well as for their own day-to-day operations.
HCPs are the most prescribed medications in America, with 135 million prescriptions filled in 2012. This is 25 percent higher than the No. 2 prescribed medication levothyroxine, according to family physician Donald Teater, M.D., of Clyde, N.C., who is medical adviser to the National Safety Council (NSC).
The swell in HCP prescriptions can be attributed to the willingness with which physicians and patients write and fill the scripts, respectively, and because there is a longstanding but incorrect impression that these drugs are the best pain relief option, Teater told AAFP News. Unfortunately, the CDC has shown that the overarching boom in opioid drug prescriptions is directly correlated with the alarming increase in deaths from prescription drug overdoses.
But the rescheduling of HCPs to Schedule II will change this, he said.
"If the patient needs a refill, (he/she) will have to call (his/her) doctor, come in for an appointment, the doctor has to write a new prescription, and it takes more effort," Teater said. "This makes (the process) a little more difficult and makes doctors a little more aware of how much people are taking their medication."
- On Oct. 6, the DEA will move hydrocodone combination products from Schedule III to Schedule II, so family physicians need to prepare for the change.
- Refills will be valid only if the original prescription was written before Oct. 6 and is filled before April 8, 2015.
- New hydrocodone combination prescriptions issued on Oct.6 or later must comply with Schedule II regulations.
After scrutinizing the DEA regulation, Prescriber's Letter recently issued recommendations(preview.hs-sites.com) to help physicians prepare for the Oct. 6 rescheduling implementation date. Among key points covered are the following:
- Prescribers may wish to use their electronic health records system to identify patients who currently are receiving chronic hydrocodone combination drugs and schedule a visit with them before Oct. 6 to discuss alternative pain management options.
- Refills will be valid only if the original prescription was written before Oct. 6 and is filled before April 8, 2015. However, some pharmacy dispensing software products will not be able to process existing refills starting on Oct. 6, so prescribers should be prepared to work with pharmacists to supply new scripts when necessary.
- Prescriptions for HCPs issued on Oct.6 or later must comply with Schedule II regulations, which means no refills and no over-the-phone or fax submissions (except in rare situations). Electronic transmission of prescriptions is valid only if legal in the prescriber's state.
- If appropriate and allowed by a prescriber's state, the prescriber can write multiple HCP prescriptions on the same date for up to a 90-day supply, indicating the earliest fill date on each script.
Prescriber's Letter also is offering a patient handout(cdn2.hubspot.net) to help patients better understand how these changes affect them.
Chance to Offer Alternative Approach
One of the most common misconceptions about hydrocodone is that it's a strong pain medication. A number of review articles have examined this belief and have demonstrated that ibuprofen is actually a better pain reliever, Teater said.
The NSC plans to release a series of white papers on hydrocodone -- and opioids in general -- to coincide with the DEA rule change, with the first to be published online in early October, he noted. The first white paper will compare and contrast the efficacy of various types of pain medications.
The paper includes findings from a Cochrane Review on the treatment of postoperative pain, which found that a combination of OTC low-dose ibuprofen (200 mg) and acetaminophen (500 mg) provided better pain relief than oxycodone (15 mg), oxycodone (10 mg) combined with acetaminophen (650 mg), or naproxen sodium (550 mg), according to Teater.
"We are hoping that (physicians) will begin to realize that the anti-inflammatory medications are better pain medications that are easier to prescribe and recommend," he said. "Hopefully, as the public starts to learn this as well, they will start going to the pharmacy, getting some over-the-counter ibuprofen and acetaminophen, take them together and have very good pain relief."
Efficacy studies referenced in the white paper showed that 200 mg of ibuprofen is about 80 percent as strong as the prescription-strength 800 mg version. "Moving up to prescription strength, you do not gain a lot of pain-relieving capabilities, but it will increase the side effects," said Teater.
The Cochrane Collaboration's findings also found that even for renal colic, which is considered one of the worst types of pain, nonsteroidal anti-inflammatory drugs (NSAIDs) provided pain relief that was as good as or better than that provided by opioids. Moreover, the pain relief from NSAIDs lasted longer and had fewer side effects.
Teater shared a personal experience related to these findings. Back in March, he said he presented to the ER in tremendous pain from a kidney stone. A nurse walked into his room with a morphine IV, and he asked if he could have an NSAID IV instead.
"I had complete pain relief with this anti-inflammatory," he said. "It turned out the stone was still there and I had to have surgery. But (the NSAID) completely took away my pain, better than morphine ever had in the past."
Teater's experience bolsters his optimism about what the DEA rescheduling of hydrocodone could lead to.
"As we start to make this change from the hydrocodone combination products to the non-steroidal anti-inflammatories, we are going to find that we are treating pain better with fewer side effects," Teater said. "This is a movement that will improve our treatment of pain as well as reduce the number of people getting addicted and overdosing."
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