A number of physicians, pharmacies and outsourcing facilities engage in the process of drug compounding. Although adherence to the Food and Drug Administration guidelines concerning the same including the United State Pharmacopeia standards are generally mandatory if not strongly suggested, issues continue to arise concerning sterility and safety of drug compounding on a rudimentary level. Compounded drugs are not approved by the FDA which means the safety and/or effectiveness of the drug has not been confirmed or necessarily subjected to clinical trials in a controlled environment. The definition of compounded drugs usually includes mixing or altering two or more drugs for a particular patient’s needs. The quality and purity of the compounded drug is further not confirmed leading to contamination and other control issues. Lack of oversight by the FDA also tends to promote issues concerning fraud, overpricing, and misrepresentation.
Drug compounding raises issues concerning the liability for its production and cuts the valid safety net of oversight by the FDA of the production and dissemination of drugs to consumers including workers’ compensation claimants. Lack of known and quantified regulatory controls subject the population to unknown and systemic dangers while allowing some to profit while all must pay for the costs associated with a breakdown in the system. Workers’ compensation claimants should not be test subjects in an exploratory laboratory when the main issue is getting those persons as healthy as possible and returned to work in a timely manner where applicable. Treating patients with supposition and conjecture should not require employers or others to pay for what may ultimately be worthless placebo or, even worse, harm the patient and/or possibly exacerbate an existing condition. Needless cost drivers do not assist claimants or insurers let alone employers in the market.
NAMIC opposes any legislation or any trend in the states to allow expansion of physicians, pharmacists or other outsourcing entities to compound pharmaceuticals for claimants especially for workers’ compensation claimants. The efficacy and need for drugs should be produced in professional facilities that adhere to FDA guidelines in research, development and testing of drugs that will ultimately be marketed to consumers. Allowance of exploratory compounding agents is too risky to subject to injured claimants especially since they may already be in a compromised position and not able to understand the ramifications of what is being asked of them. All should be able to rely on the FDA process and deviations should strongly be discouraged or disallowed. At a minimum, this practice should be closely scrutinized by state boards and only permitted under the most rigorous standards. The regulatory vacuum in this space is too disconcerting to allow the practice to continue without additional controls.
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