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Luna: The Problem With Treatment Guidelines and Drug Formularies

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Participating in legislative discussions across the country on the efficacy of adopting evidence-based medicine (EBM) treatment guidelines and drug formularies has given me a front row seat into an area of significant concern. 

Carlos Luna

Carlos Luna

The issue to which I’m referring exists among several stakeholder groups and vendor verticals in the workers’ compensation industry — an unclear, off-center understanding of EBM.

This issue is particularly concerning due to the fact that a rudimentary level of understanding exists on the topic, but not enough to provide informed, accurate guidance on the health benefits of statewide adoptions of EBM. The term “I know enough to be dangerous” is very apropos in this instance.

It is this high-level, broad-brush understanding of EBM that propels sentiments in the marketplace that the content and tools are designed simply for cost containment purposes used as mechanisms to say no to patients for justifiable needed care. The feeling in these circles is that EBM provides no real health benefit to the injured worker. 

Admittedly, there are widely used sources that are designed as cost containment tools masquerading as EBM content. These tools are draconian and overly simplistic. Their claims of being evidence-based does not align with trusted public national criteria, such as the National Academy of Medicine (formerly the Institute of Medicine) that have defined Standards for Developing Trustworthy Clinical Practice Guidelines.    

During a recent webinar on EBM treatment guidelines, a panel comprising workers’ compensation claims, managed care, medical and state-agency professionals discussed the obstacles and opportunities of treatment guidelines. While the panelists agreed on the focus of EBM being patient safety, they had various interpretations of what constitutes EBM. 

One panelist cited Texas Labor Code, Section 401.011 (18-a): 

“Evidence-based medicine” means the use of the current best quality scientific and medical evidence formulated from credible scientific studies, including peer reviewed medical literature and other currently scientifically based texts, and treatment and practice guidelines in making decisions about the care of individual patients.

In a 1996 editorial in the British Medical Journal, David Lawrence Sackett defined EBM as “…the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” It was further noted that the practice “…means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”

In 2005, EBM was defined as “… a set of principles and methods intended to ensure that to the greatest extent possible, medical decisions, guidelines and other types of policies are based on, and consistent with, good evidence of effectiveness and benefit.”

Properly done, the use of EBM is a process that entails the identification of high-quality scientific evidence, as defined by rigorous criteria, and synthesis of the entire body of evidence applicable to a given condition to guide, not dictate, medical practice.

Texas’ definition, while partially correct, is incomplete. Missing from the labor code are cornerstone principles such as the need for a systematic research process, the identification of high-quality scientific evidence through defined rigorous criteria, and a synthesis of the entire body of evidence applicable to the given medical condition.

By nature, the systemic research and development process of EBM addresses the concerns most often raised by opponents of the content:

  • The studies used in EBM are biased. A high-quality EBM development process incorporates comprehensive review and the grading of literature by qualified researchers. This determines if the studies are reliable, looking at study design, population sample, results, study sponsorship and potential conflicts of interest. Additionally, a trustworthy EBM source will not only use literature that has been subject to peer review, as Texas’ definition requires, but its final developed guidelines will also go through an external peer review process conducted by uninterested parties such as a state medical association or specialty medical society
  • EBM is one-size fits all, or cookie-cutter, medicine. The root definition of EMB defines it as the “conscientious, explicit and judicious use of the current best evidence in making decisions about the care of individual patients.” The evolution of the drug formulary concept is a great example of this. Today’s formularies provide drug recommendations appropriate to each patient’s condition and takes into account whether his condition is in the acute or chronic phase. Using the modern formulary concept ensures the right medication is prescribed for the right condition at the right time.
  • EBM removes the authority to treat a patient from the provider and delegates medical care to a guideline. It is true that some stakeholder groups have used EBM as a blunt instrument. They treat EBM as a definitive authority rather than a guide. As defined by Sackett in 1996, and still applies today, EBM requires the integration of individual clinical expertise from a provider with the best available external clinical evidence for the care of the patient. When clinical expertise is disregarded, the practice is no longer considered EBM. As I’ve stated in previous blogs, the patient/doctor interaction in the clinic will play a key role in eradicating the great drug epidemic that this country is currently grappling with. Providers need high-quality content and tools they can trust to educate and keep their patients safe.

The problem with treatment guidelines and drug formularies is not related to content, as each content provider has clearly defined its methodologies, for better or worse. The problem is a lack of understanding on the subject by individuals who are tasked with making decisions that ultimately impact an injured workers’ well-being. The standards for developing trustworthy EBM are not subjective. Content that is labeled as EBM should be measured meticulously to the appropriate standards.

The webinar I referenced earlier concluded with one of the moderators politely criticizing education that has previously been disseminated, intended to parse fact from fiction, about EBM. The comments assumed that all guidelines are created equal and that there is no room for accountability in workers’ compensation. I politely disagree.

If there is a platform where accountability is needed, its workers’ compensation. Our organizations deal with human beings when many of them are in their most vulnerable state — emotionally, physiologically and financially. We, who understand the complexities of the system and our respective industries, have a duty to be their advocates.

Carlos Luna is director of government affairs, MDGuidelines, for the Reed Group. This column appears here with permission.

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Moses Luna Feb 28, 2017 a 9:02 am PST

With Evidence Based Medicine, lawyers are only Messengers! Lawyers must use their legal skills to navigate the WC law to help the injured worker so they don't end up on the short end of the stick. This is where the best WC lawyers excell!

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