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Overdoses of acetaminophen must be guarded against in workers’ comp cases.

By Tron Emptage, RPh, MA

Acetaminophen is one of the most popular medications in the United States. An effective fever reducer and painkiller, it is commonly found in many over-the-counter and prescription medications. When used as directed, it is considered to be safe; however, there is a strong connection between acetaminophen and liver damage when too much of the drug is consumed. In fact, most cases of acetaminophen-related liver damage are due to patients using more than the recommended daily dosage.


Last June, a joint meeting of three Food and Drug Administration (FDA) committees was held to discuss acetaminophen as it relates to liver toxicity. A key outcome of the meeting was the recommendation to reduce the maximum daily dosage, which is currently four grams, or 4,000 milligrams. No revised maximum daily amount was suggested. The group also called for Vicodin and Percocet, two prescription drugs heavy on acetaminophen, to be banned from the marketplace.


The FDA has not issued any formal rules resulting from the meeting and, while the FDA often follows the recommendations of its advisory panels, it is not required to do so. Therefore, until formal rulings are issued, it is important for workers’ compensation insurers to take proactive measures to reduce risk for their injured parties.


An April 2009 ruling requires manufacturers of over-the-counter pain relievers and fever reducers to revise their labeling. The ruling, which includes acetaminophen, states that labels must include warnings about potential safety risks, such as internal bleeding and liver damage. In addition, manufacturers must prominently display active ingredients on the drug labels of both packages and bottles.


The FDA has also embarked on an awareness campaign to educate the general public on the potential risks associated with acetaminophen usage. With its extensive use for all types of conditions, many consumers are unaware of the levels they are consuming. It’s often contained in migraine medication, prescription painkillers and cold medicines. That means consumers could easily be taking three times the recommended daily dosage, unknowingly putting themselves at risk for liver toxicity.


Acetaminophen is also commonly included in workers’ compensation formularies as it is contained in Vicodin, Percocet and Ultracet. According to the Progressive Medical 2009 Drug Spending Analysis, these drugs are among the top 10 most frequently dispensed medications for workers’ compensation claims.
Used in smaller amounts, acetaminophen is still considered to be safe. At higher doses, though, it increases the risk of liver failure and/or death, especially for those consuming high amounts of alcohol or for individuals with existing liver damage. According to the FDA, acetaminophen toxicity causes more than 400 deaths in the U.S. each year, and in 2007, the Centers for Disease Control and Prevention estimated it was the nation’s leading cause of acute liver failure.


While the future for acetaminophen is uncertain, for now it will continue to be extensively prescribed by medical professionals because it is cost-effective. For claims professionals, it is essential to take proactive steps in educating injured parties on proper usage.
  1. Communicate extensively. As indicated previously, 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% of the adults surveyed realized that Vicodin contains acetaminophen.

       Workers’ compensation insurers should issue regular communication to educate injured parties about the risks associated with acetaminophen, as well as which medications contain acetaminophen, to help them avoid overdosing through use of multiple products.

       The FDA offers flyers and other materials that encourage consumers to read and follow label directions. It’s also essential to educate injured parties on the importance of informing their doctors of any medications they take regularly, especially over-the-counter medications the physician may not have prescribed.
  2. Monitor utilization. A comprehensive drug utilization review program will enable workers’ compensation insurers to monitor an injured party’s intake of acetaminophen. Many pharmacy benefit managers offer this type of program. However, it’s important to engage in a multifaceted program that encompasses prospective, concurrent and retrospective reviews.

       A prospective program allows all involved parties to plan for future outcomes with upfront information. If potential problems are found, the claims professional may withhold the approval of the claim. At this point, a formulary is established based on the date and type of injury.

       Typically, 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 that checks duplication of therapy, multiple physicians, excessive dosage and drug-to-drug interactions. Depending on the medication formulary, the pharmacist may also be required to seek authorization from the pharmacy benefit manager or the claims professional.

       A retrospective program using historical data occurs after medications are filled. A pharmacy benefit manager typically works with a workers’ compensation insurer to determine which key areas they would like to review on a retrospective basis. Key areas often include setting thresholds for excessive quantity, early refill, high dollar amounts and certain classes of medications.
  1. Engage physicians. Establishing effective communication with physicians helps protect injured parties. It is important for workers’ compensation insurers to take steps to communicate recommendations of clinical reviews conducted by a pharmacy benefit manager to prescribing physicians.

       Alerting physicians to recommendations related to excessive duration or duplication of therapy and high dosages of specific medications is essential. This communication can be in the form of a letter or conference call with the physician. In addition, pharmacy benefit managers often have a clinical pharmacist or a physician available to explain the rationale for their recommendations directly to the prescribing physicians.
While acetaminophen is still considered to be safe when it is used as directed, workers’ compensation insurers should monitor injured-party usage as with any prescription medication. Not only will this mitigate risk by reducing opportunities for fraud, misuse and abuse, it will also yield cost savings per claim over time.
Tron Emptage, RPh, MA, (tron.emptage@progressive-medical.com) is executive vice president of Business Development and Clinical Services for Progressive Medical, a leading provider of cost containment solutions for the workers’ compensation and auto no-fault industries.

Tron Emptage, RPh, MA, is executive vice president of Business Development and Clinical Services for Progressive Medical, a leading provider of cost containment solutions for the workers' compensation and auto no-fault industries.

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