Opioid Issues Generate Increased Discussion, Activity
Efforts to address the abuse and misuse of opioids in workers’ comp are moving full steam ahead on a number of fronts. Among the latest are proposed opioid guidelines for the California system, a study attesting to the value of sophisticated drug testing combined with targeted interventions, a national drug summit, state and federal pushback on a controversial new drug, and anticipated approval to reschedule some opioids.
Workers’ comp practitioners are teaming up with experts throughout the country to address the prescription drug epidemic. While their successes are coming slowly, advocates believe their message is taking hold among a wide spectrum of influencers.
“It’s high time we act to stop this preventable epidemic, and I am pleased the Food and Drug Administration and Drug Enforcement Agency have finally answered the call of duty,” said Sen. Joe Manchin, D-W.Va. “By recommending rescheduling hydrocodone combination drugs from a Schedule III drug to a Schedule II drug, the FDA has helped save hundreds of thousands of lives, and the DEA should follow suit by implementing that recommendation as quickly as possible.”
Manchin made the comments in a letter to the DEA as the public comment period for the proposal ended. He was one of the original sponsors of the Safe Prescribing Act, which would reclassify medications, such as Vicodin, that combine hydrocodone with less potent painkillers like acetaminophen.
Manchin also took the FDA to task for not taking action on the rescheduling proposal sooner. “Since that rescheduling petition was originally filed in 1999, the lifetime nonmedical users of hydrocodone have also more than doubled and currently exceed 24 million Americans,” Manchin said. “Hydrocodone combination products are currently the top selling controlled substance in the United States by far with over 139 million prescriptions sold in 2010 alone. We must address this epidemic before it gets even stronger.”
Manchin’s frustration with the government’s action on the issue is echoed by Dr. Andrew Kolodny, chief medical officer of Phoenix House, and president of Physicians for Responsible Opioid Prescribing, an organization that has been at the forefront of efforts to prompt federal action. He says the FDA in particular has taken too long to address what started with a campaign to convince the medical community that opioids were safe and effective for treating chronic pain.
“A campaign was launched to convince doctors it was a good way to treat chronic pain. The FDA may have believed the same misinformation. But by 2002, there was good evidence that a terrible mistake had been made,” Kolodny said. “If the FDA had tightened the reins in response to obvious overprecribing, this epidemic would not have turned into the mess it is today. Instead of narrowing on-label indications to prevent marketing for chronic pain, they did the opposite.”
One of the newer opioid medications gaining attention was released on the market in March. The drug Zohydro contains 10 to 50 milligrams of hydrocodone, not in combination with other drugs, thereby making it already a Schedule II medication.
Despite claims by the manufacturer, Zogenix Inc., that it is less potent than other opioids on the market, workers’ comp stakeholders have raised concerns. They note that it can easily be crushed by those seeking an immediate high, and the fact that it is solely hydrocodone.
“Zohydro ER is a Schedule II controlled substance with no abuse deterrent properties and risk for addiction, abuse, and misuse,” wrote Kendra Karagozian, director of clinical strategy for pharmacy benefit management company myMatrixx in a blog posting. “Additionally, the Official Disability Guidelines have already declared it a non-formulary or ‘N-drug,’ requiring a utilization review or authorization prior to dispensing.”
The drug was a major topic of discussion at the recently held Rx Drug Abuse Summit, the third annual such meeting. One of the discussion issues was the fact that the FDA approved the drug in October despite an 11-2 vote against releasing it by the FDA’s own Anesthetic and Analgesic Drug Products Advisory Committee.
Attorneys general from more than half the states and several members of Congress have joined an effort to restrict the use of Zohydro despite the FDA approval. While initially asking the FDA to reconsider its decision, a more recent letter requested the Department of Health and Human Services to overturn the action.
Massachusetts Gov. Deval Patrick took the unusual step of trying to ban the drug entirely, a move that was blocked by a preliminary injunction. The Board of Registration in Medicine followed up the ruling by imposing restrictions that would require physicians to complete a risk assessment and pain management treatment agreement with patients before prescribing the drug. The agreement would require drug screening and monitoring of patients.
A new study that combined laboratory quantitative drug testing with clinical interventions targeting at-risk injured workers on chronic opioid therapy is giving credence to the idea of using these tests as a way to help deter abuse of opioids among injured workers. The study by Progressive Medical/PMSI in partnership with Millennium Laboratories showed a decrease in all measures of utilization, especially opioids which was down 32 percent. There was also a 51 percent decrease in benzodiazepines.
“The significance of the study was really to show that by having a clinical intervention outreach tool [that shows a] prescriber inconsistent [drug] tests, and making sure there is follow-up, you can end up having higher control of your narcotics utilization in the workers’ comp population,” said Matthew Foster, clinical pharmacy manager for Progressive/PMSI and one of the study’s authors.
Foster said the workers were identified as high risk through a proprietary algorithm that examines multiple factors such as medical usage and whether there are multiple physicians and pharmacies involved. The urine drug testing was done via Millennium’s process of using liquid chromatography tandem mass-spectrometry, an advanced procedure that experts say is able to specify all drugs and metabolites present or absent in a specimen.
“The surprise takeaway, and it really was a surprise to me, was the decrease in opioid prescriptions,” said Joseph Paduda, principal of Health Strategy Associates, author of the ManagedCareMatters blog, and a consultant for Millennium. “What that says to me is that when treating physicians find out how many opioids and how many drugs their patients are getting from them and other sources (because in all likelihood this reduction was from getting multiple drugs from multiple prescribers), when they have that information it affects [their] prescribing.”
Paduda said there is also a positive return on investment for payers, as a drug test costs far less than monthly prescriptions for certain opioids.
“That’s not to say it’s a panacea because certainly it is not,” Paduda said. “But it says that A) way too many opioids are being prescribed, and B) as soon as physicians find out with objective evidence [what is going on], they take steps to drastically reduce prescriptions.”
Paduda and other workers’ comp stakeholders are also looking to the increasing use of guidelines to reduce the unnecessary prescribing of opioids. California’s Guideline for the Use of Opioids to Treat Work-Related Injuries is among the latest (see box).
“We agree [with most of the comments]. There was nothing earth shattering in there,” Foster said. “It’s just a guideline, not a rule or mandate.”
Among the many recommendations were:
- Opioid medications should only be used for treatment of acute pain when the severity of the pain warrants it and after determining that other non-opioid pain medications or other therapies will not provide adequate pain relief or are contraindicated for medical reasons. They should only be prescribed at the lowest dose that provides pain relief, for a limited time, and with no refill prior to reassessment.
- In order for opioids to be prescribed beyond the acute phase, there should be no contraindicated comorbidities, non-opioid treatments should be continued, urine drug testing should be performed and reveal no aberrant results, and patients should be carefully monitored, both for improvement in pain and function, as well as indications for discontinuing opioids.
- The Controlled Substance Utilization Review and Evaluation System, California’s prescription drug monitoring program, should be accessed to see if there is simultaneous use of other narcotic medication.
- Patients should be cautioned about the potential adverse effects of opioids, including impact on alertness. Driving and operation of heavy equipment should be discouraged while on these medications.
- Short-acting opioids may be indicated for a limited duration to manage moderate to severe post-operative pain and to obtain sleep, especially in the immediate post-operative period.
- Patients with chronic pain may be candidates for treatment with opioids if pain management and functional improvement have not been achieved with other treatment modalities and a variety of additional conditions are met, which are outlined.
- Decisions to increase opioids for chronic pain patients should be made jointly by both the provider and the patient. It is the responsibility of the provider to inform the patient that current evidence shows a dose-related increase in adverse events.
- Providers should be increasingly vigilant for doses above 80 mg/day morphine equivalent dose, as the known risk of adverse events rises while the evidence for increased benefit remains weak. Clinicians should conduct semiannual attempts to wean workers whose dose is above 80 mg/day MED and who have been on that dose or higher for at least six months.
Several commenters compared the proposed guidelines to those recently announced by the American College of Occupational and Environmental Medicine. One of the main differences was the recommended cutoff level for MED. The California guidelines recommend a cutoff of 80mg/day MED, and ACOEM’s suggest 50.
A representative of Coventry Workers’ Compensation Services suggested that the division might consider revisiting that recommendation.
One commenter questioned whether the guidelines would address the effects of hyperalgesia, as well as the treatment protocols to assist a patient being weaned from opioids with this factor.
The California Applicants Attorneys Association, which represents injured workers, suggested language be added to allow for a grace period of up to one year to allow the treating physician to provide documentation justifying continuous use of the prescribed opioid before the medication could be discontinued. The group also suggested the guidelines clearly state that an injured worker could not be cut off the medications without a tapering protocol. Finally, the CAAA said the document should address situations in which pain cannot be adequately managed with non-opiate medications after the patient has been tapered off opioids.