Acetaminophen is considered safe in small amounts. However, when used at higher doses, acetaminophen increases the risk for liver damage. According to a 2007 Centers for Disease Control and Prevention estimate, acetaminophen is the leading cause of acute liver failure in the United States. The Food & Drug Administration (FDA), reports that acetaminophen toxicity is the cause of more than 400 deaths in the United States each year. This information has led the FDA to call into question current standards for acetaminophen dosage and usage frequency.
In June 2009, a joint meeting of three key FDA advisory committees was held to discuss acetaminophen as it relates to liver toxicity. Key recommendations from that meeting included reducing the maximum daily dose for acetaminophen (currently four grams, or 4,000 milligrams) and banning Vicodin and Percocet from the marketplace.
While the FDA often follows the recommendations of its advisory panels, it is not required to do so. As this is written, the FDA has not issued any formal rules mandating new maximum dosage recommendations or banning prescription medications containing acetaminophen. Until formal rulings are issued, it is important that workers' compensation insurers take proactive measures to reduce the risk that acetaminophen may present to their injured parties. To reduce over-utilization of acetaminophen, insurers should:
1. Educate and Inform. The majority of the adverse effects associated with acetaminophen are due to patients unknowingly taking too much of the drug. According to a 2007 study published by the American Pharmacists Association, fewer than 15 percent of the adults surveyed realized that Vicodin contains acetaminophen.
2. Communicate. Workers' compensation insurers should issue communication to injured parties about the risks associated with acetaminophen. Injured parties may unknowingly be receiving additional acetaminophen-containing medications under a group health benefit or in popular over-the-counter pain or cold medications. It is also essential to educate injured parties on the importance of informing their doctors of any medications they take regularly, especially over-the-counter medications that the workers' compensation physician may not have prescribed.
3. Review. Insurers can monitor an injured party's intake of acetaminophen usage through a comprehensive utilization review plan that includes prospective, concurrent, and retrospective review components.
A prospective program begins before an injured party files a claim. The process involves analyzing prescription usage and determining how to handle prior authorization and generic substitution. This type of program prevents early refills, therapy duplications, and fulfillment of high quantities, and limits the number of physicians and pharmacies.
A concurrent drug utilization program occurs in real-time at the pharmacy. When a prescription is filled, it is audited for inappropriate use against a formulary, with reviewers watching for duplication of therapy, multiple physicians, excessive dosage, and drug-to-drug interactions. Depending on the medication formulary, the pharmacist may be required to seek authorization from the pharmacy benefit manager or the claims professional prior to filling the prescription. They may also be alerted to inappropriate or high dosing.
In a retrospective program, a pharmacy benefit manager works with the workers' compensation insurer to target key areas for review after the prescriptions have been filled. The review usually includes benchmarks for excessive quantity, early refills, high dollar amounts, and certain classes of medications.
4. Build Relationships. In workers' compensation cases, communication among all of the stakeholders is essential, especially when the treatment includes prescription medicines. Pharmacy benefit managers often have clinical pharmacists and physicians available to speak directly to the prescribers, helping to ensure that all pertinent information is passed through to everyone involved in the treatment plan.
While acetaminophen is still considered safe when used as directed, workers' compensation insurers and their pharmacy benefit managers should monitor the use of this and all other prescription medications used in the treatment of injured workers. This will lower risks by reducing opportunities for fraud, misuse and abuse, and yield cost savings per claim over time.
Tron Emptage, RPh, MA, is executive vice president of business development and clinical services for Progressive Medical, Inc., a provider of cost containment solutions for the workers' compensation and auto no-fault industries. He may be reached at [email protected].
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