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By Janet Aschkenasy

The workers' compensation industry and the pharmacy benefit managers who help employers manage prescription medication are getting ready for a new class of painkillers, some of which have yet to receive Food and Drug Administration or other regulatory approval.

Some of the drugs may cause serious problems going forward, said Jim Andrews, executive vice president of pharmacy services for Healthcare Solutions Inc., a Georgia-based pharmacy benefit and case management company.

Among the more controversial new drugs that has generated industry buzz is Zohydro, a pain-killing drug comprised of pure hydrocodone but without acetaminophen. Acetaminophen, commonly found in Tylenol and other over-the-counter-pain relief medications, can cause liver damagewhen taken in high doses or for long periods of time.

Made by the specialty pharmaceutical manufacturer Zogenix Inc., Zohydro was developed to eliminate the risk posed by acetaminophen while retaining a long-acting analgesic effect so that the medication can be dosed every 12 hours. It was developed for the management of moderate-to-severe chronic pain requiring around-the-clock management.

In December 2012, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted against the approval of Zohydro, and a final decision from the full FDA is expected soon, Andrews said.

"It's got our attention right now," he said, since "it has yet to be determined whether Zohydro's benefits outweigh the risks."

One apparent risk is that the drug as currently formulated is not tamper resistant, and therefore not abuse-deterrent, meaning the sustained-release feature can easily be destroyed, providing a potential abuser a large dose all at once instead of over hours.

"One of the key concerns with Zohydro is that it was presented to the regulatory and medical community with no abuse deterrent," said Kate O'Lenic, a clinical pharmacist at Tampa, Fla.- based pharmacy benefit manager Healthesystems.

"There's a debate going on as to whether the FDA should start to mandate abuse-deterrent formulations for opioids," she said. "This debate is addressing whether generic versions of OxyContin should be abuse-deterrent, for instance."

In January, an FDA advisory panel voted to toughen restrictions on painkillers containing hydrocodone, and refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone, according to published reports. Only written prescriptions from a doctor would be allowed and distributors would be required to store the drugs in special vaults.

The FDA panel was divided 19-10, with "opponents expressing skepticism that the change would do much to combat abuse," the New York Times wrote, in a Jan. 25 article. The FDA isn't required to follow the panel's recommendations but typically does.

Hydrocodone is recognized as a highly abused substance, O'Lenic said. According to a 2011 report from the Drug Enforcement Administration's National Forensic Laboratory Information System, hydrocodone was 6th in the list of top 25 drugs found in law enforcement action laboratory samples. OxyContin was 5th, she said.

Another painkiller, Oxecta, manufactured by Pfizer and Acura Pharmaceuticals and approved by the FDA last year, has been licensed for the management of acute and chronic moderate to severe pain, where the use of an opioid analgesic is appropriate.

Rebranded from its former name Acurox, Oxecta is abuse deterrent in that snorting the drug can lead to severe burns, Andrews said. However there are no deterrent properties to prevent large orally consumed doses, he added.

Given the regulatory challenges and other unknowns, workers' compensation insurers and other risk experts are doing all they can on their own.

Don Hurter, corporate officer at Health Direct Inc. and a senior vice president for Medical Management Services at AIG in Maitland, Fla., said that since 2010, AIG has had a program developed in which it identifies certain sets of opioids to flag for review in the case of workers' compensation claims.

These include "any opioid equivalent dispensed at over 120 milligrams daily, any opioid dispensed for over 90 days, and any early dispensed form of a long lasting opioid with drug activity between eight and 72 hours."

When these drugs are prescribed they're flagged by the insurer for review by a nurse. If the nurse questions whether they are appropriate they're sent to a medical director for a peer discussion between the treating provider and another physician in his or her field of expertise.

The result has been a "75 percent impact rate" on the use of opioids outside of treatment guidelines said Hurter. In other words, in 75 percent of the cases where prescriptions are flagged this way, either a different drug is prescribed, there is a weaning off of the current drug or a "hard block" on dispensing the drug at all.

AIG actuaries estimate a potential of up to a 40 percent reduction in claims costs over time due to the practices Hurter describes.

Challenges on the Horizon

The development of newly engineered opium-based synthetics as a means to deal with the pain caused by on-the-job injuries is posing challenges for workers' comp carriers and employers -- challenges which are heightened every time a new opioid synthetic is approved for distribution.

An August report issued by the Kansas City, Mo.-based insurance broker Lockton Cos. underscores the risk of prescribing powerful painkillers beyond narrowly targeted uses. The "overwhelming consensus of evidenced-based medicine does not support [opioids'] long-term treatment protocol outside of very specific cases, most of which involve end-stage cancer treatment," according to author Keith Rosenblum, senior risk consultant for Lockton Cos.

That hasn't stopped millions of workers' compensation claimants from being prescribed Vicodin, OxyContin, or other forms of hydrocodone for work-related back pain over long periods of time, however, creating a problem where the cure can be much worse than the symptom, since it can literally be deadly. Nationally, 55 percent to 86 percent of all workers' compensation claimants with chronic pain are receiving opioids for relief, according to Lockton, and more than 15,000 Americans now die annually after overdosing on opioids, according to the Centers for Disease Control and Prevention -- more than from heroin, cocaine and all other illegal drugs combined.

Insurers, brokers, pharmacy benefit managers and their clients at firms with high rates of occupational injury are scrambling to address the problem, which the California Workers Compensation Institute (CWCI) recently dubbed a "national emergency."

"There has never been a more damaging impact on the cost of workers' compensation claims from a single issue than the abuse of opioid prescriptions for the management of chronic pain," Lockton stated in its 28-page report.

Statistics are daunting. A recent study by the National Center on Addiction and Substance Abuse at Columbia University found that between 1998 and 2008, hospitals nationwide reported a 400 percent increase in admissions related to prescription narcotic abuse and a 200 percent increase in prescription narcotic deaths.

While utilization of all prescription medications rose 61 percent during that time, the use of DEA-categorized Schedule II opioids -- such as Oxycodone, Fentanyl Citrate, Morphine, Methadone, Hydromorphone and Oxymorphone -- increased by 380 percent during the 10 years in question, Columbia researchers found.

Though the CWCI was able to report recently that increased public awareness of the problem led in 2011 to the first drop in use of Schedule II prescriptions dispensed in the California workers' comp system since 2007, payers are still going to have their hands full going forward, since this won't be the last new drug class.

JANET ASCHKENASY is a freelance writer based in New York.

March 1, 2013

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