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Workers’ compensation has seen a steady increase in prescriptions for topical compounded preparations, and prescriptions for sterile compounded drugs are appearing as well. In fact, the use of compounded drugs in workers’ compensation has increased nearly five-fold in the past five years. Along with increased use, the prices charged for compounds have risen, dramatically.

The quality of the preparation and the safety and efficacy of these “custom” compounds are largely unknown. Usually formulated with four to six different ingredients, compounded medications can come with staggeringly high costs, running into thousands of dollars per prescription. Compound pharmacy marketing materials tout numerous benefits of topical compounds. Compounders claim that applying topical drugs to the site of the injury theoretically avoids systemic absorption and subsequent side effects, and that combining multiple agents into a single preparation reduces the number of tablets or capsules needed and helps patients who have trouble swallowing oral preparations. Compounds can omit ingredients that cause an allergic or other adverse reaction in the patient.

Workers’ compensation payers are questioning the cost of compounds and struggling with how to assess their efficacy and appropriateness and determine appropriate reimbursement. Professionals from CompPharma’s pharmacy benefit managers (PBMs) sought answers to questions regarding compounded drugs, and just published its 41 page report on compounding.

The most common compounds in workers’ compensation are “topicals” – creams, gels or ointments that are applied to the skin and are intended to manage pain. Despite their prevalence, the report says there is very limited evidence to support the use of these preparations. Sterile products are occasionally prescribed for injured workers. Most medications billed through PBMs within this population are for implantable pain pumps. The most common medications used include clonidine, morphine, bupivacaine, hydromorphone, fentanyl, and baclofen.

In recent years some compounding pharmacies have begun pushing the boundaries by marketing new uses for existing medications. The Internet abounds with compounding companies making “therapeutic” claims for their special topical formulations. These claims have no supporting evidence of safety and efficacy. Some feature anecdotes and testimonials, but none provide suitable references. This is especially true of compounded topical pain medications. Specific formulations are claimed to be effective for neuropathic pain, inflammation, and so on. In this respect, compounding pharmacies are acting more like manufacturers without the burden of having to conduct clinical drug trials to provide evidence to back their claims.

The determination of whether a compounded medication is being appropriately used requires a comprehensive understanding of information that needs to be gathered from a variety of stakeholders. Cooperation and input from prescribers, patients, pharmacists, and claims handlers are often necessary when determining the appropriateness of compounds.

CompPharma’s research has not revealed any evidence that topical compounds are safe or effective. In fact, the evidence indicates that there is significant variation between the stated potency of a compounded product and the actual ingredients. As long as there are no regulatory requirements related to testing and post-dispensing safety surveillance, the procurement of compounded medications is indeed a situation where the prescriber must beware. While a lack of information does not prove a lack of efficacy, the lack of research suggests that ineffective topical compounded drugs are being used instead of FDA-approved drugs that have been shown to be safe and effective. The data presented also begs the question: if no strong clinical research supports the use of compounded medications, is a custom compound the right thing to do for the patient?

The battle over control and safety of compounding drugs has pitted the FDA against state boards of pharmacy. On one side, the FDA seeks to regulate the compounding of drugs that go beyond traditional compounding (individually based, specific to patient needs) into the realm of mega, non-prescription compounding. On the other, the states, spurred on by the compounding drug industry, seek to keep control by issuing new rules and passing new regulations.