The Rising Tide of Topical Compounds

| | Evidence Based Medicine

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When Priscilla Lujan saw her doctor for an injury she sustained at work, the doctor prescribed a topical compound. This transdermal cream – composed of the antidepressant amitriptyline, the pain reliever tramadol and the cough suppressant dextromethorphan, was meant to treat Lujan’s knee and back pain. Tragically, some of the compound ended up on the rubber nipple of Lujan’s child’s bottle. As a result, the child died of multiple drug intoxication.

It is no longer news that more than 50 people in the U.S. die every day from prescription pain killer overdoses or that our nation is responding by putting tighter controls around prescribing and monitoring opioids. In the California workers’ compensation system, organ damage related to opioid treatment is increasing. This will not only increase mortality rates but also drive up costs around the opioid crisis. Are we creating an even bigger monster by repackaging these drugs into topical compounds without scientific evidence or FDA approval to ensure safety or efficacy?

Why Are Doctors Prescribing These Compounds?

Increasingly, doctors are prescribing topical compounds, like the one given to Lujan. These compounds pose a special challenge to utilization review practitioners. With very few controlled studies, evidence is lacking to support compounded medications. Often, these compounds are not FDA approved, as they combine a variety of medications that have not been tested together, such as the concoction given to Lujan. Furthermore, compounded medications do not have standardized dosages and durations for use and often lack standardized preparation protocols.

Despite the lack of scientific evidence to support use of compound creams in conjunction with lack of FDA approval and exorbitant costs with unproven benefits, the topical compound use in workers’ compensation cases has almost quintupled in the last five years.

Are Topical Compounds Worth It?

In a healthcare system where there is not enough money to cover the basic medical needs of our nation’s population, unproven compound creams are stealing millions of those dollars. In 2013, the California workers’ comp system alone reported a 14-fold increase at around $145 million. Each ingredient in a small tube of a compound cream can be billed individually, making the average price tag of a 30-day supply around $1100 per tube; some PBM’s report prices as high as $14,000 per tube for some compound creams.

While research moves forward, evidence-based treatment guidelines currently do not recommend topical compounds. Benefits to patients over oral pain medication or other over-the-counter pain creams or treatments are unproven. As with all investigational drugs, topical compounds should be reserved only for extreme cases in which the patient has failed all other available treatments.

Preventing Another Healthcare Crisis

Efficacies of topical compounds remain unproven and largely untested. Many of these drug combinations are not FDA approved for safe use. The drug combinations used to create these compounds can lead to tragic outcomes, and new complications are routinely discovered. Healthcare dollars are scarce and should be reserved for treatment that is proven to be safe, medically necessary, and backed by evidence-based research.

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