Acetaminophen is considered safe in small amounts. However, whenused at higher doses, acetaminophen increases the risk for liverdamage. According to a 2007 Centers for Disease Control andPrevention estimate, acetaminophen is the leading cause of acuteliver failure in the United States. The Food & DrugAdministration (FDA), reports that acetaminophen toxicity is thecause of more than 400 deaths in the United States each year. Thisinformation has led the FDA to call into question current standardsfor acetaminophen dosage and usage frequency.

In June 2009, a joint meeting of three key FDA advisorycommittees was held to discuss acetaminophen as it relates to livertoxicity. Key recommendations from that meeting included reducingthe maximum daily dose for acetaminophen (currently four grams, or4,000 milligrams) and banning Vicodin and Percocet from themarketplace.

While the FDA often follows the recommendations of its advisorypanels, it is not required to do so. As this is written, the FDAhas not issued any formal rules mandating new maximum dosagerecommendations or banning prescription medications containingacetaminophen. Until formal rulings are issued, it is importantthat workers' compensation insurers take proactive measures toreduce the risk that acetaminophen may present to their injuredparties. To reduce over-utilization of acetaminophen, insurersshould:

1. Educate and Inform. The majority of theadverse effects associated with acetaminophen are due to patientsunknowingly taking too much of the drug. According to a 2007 studypublished by the American Pharmacists Association, fewer than 15percent of the adults surveyed realized that Vicodin containsacetaminophen.

2. Communicate. Workers' compensation insurersshould issue communication to injured parties about the risksassociated with acetaminophen. Injured parties may unknowingly bereceiving additional acetaminophen-containing medications under agroup health benefit or in popular over-the-counter pain or coldmedications. It is also essential to educate injured parties on theimportance of informing their doctors of any medications they takeregularly, especially over-the-counter medications that theworkers' compensation physician may not have prescribed.

3. Review. Insurers can monitor an injuredparty's intake of acetaminophen usage through a comprehensiveutilization review plan that includes prospective, concurrent, andretrospective review components.

A prospective program begins before an injured party files aclaim. The process involves analyzing prescription usage anddetermining how to handle prior authorization and genericsubstitution. This type of program prevents early refills, therapyduplications, and fulfillment of high quantities, and limits thenumber of physicians and pharmacies.

A concurrent drug utilization program occurs in real-time at thepharmacy. When a prescription is filled, it is audited forinappropriate use against a formulary, with reviewers watching forduplication of therapy, multiple physicians, excessive dosage, anddrug-to-drug interactions. Depending on the medication formulary,the pharmacist may be required to seek authorization from thepharmacy benefit manager or the claims professional prior tofilling the prescription. They may also be alerted to inappropriateor high dosing.

In a retrospective program, a pharmacy benefit manager workswith the workers' compensation insurer to target key areas forreview after the prescriptions have been filled. The review usuallyincludes benchmarks for excessive quantity, early refills, highdollar amounts, and certain classes of medications.

4. Build Relationships. In workers'compensation cases, communication among all of the stakeholders isessential, especially when the treatment includes prescriptionmedicines. Pharmacy benefit managers often have clinicalpharmacists and physicians available to speak directly to theprescribers, helping to ensure that all pertinent information ispassed through to everyone involved in the treatment plan.

While acetaminophen is still considered safe when used asdirected, workers' compensation insurers and their pharmacy benefitmanagers should monitor the use of this and all other prescriptionmedications used in the treatment of injured workers. This willlower 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 ofbusiness 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 reachedat [email protected].