The Clinical Costs of Pharmachologic Post-Market Surveillance

Every drug a doctor prescribes requires an intimate knowledge of the drug's pharmacology, side effects, and possible drug interactions. Nowhere is this more true than antiarrhythic drugs. Concern over side effects with government regulators has reached a fever pitch since there is realization that all the pre-market randomized controlled trials often fail to identify later problems with medications. A classic example of this is dronedarone, initially heralded as a "safer" amiodarone substitute, but was later implicated in rare instances of fulminant hepatic failure.

While post-market surveillance of medications is both necessary and warranted, it is interesting to me how the grunt work of this surveillance (and most other grand regulatory schemes) falls squarely on the backs of physicians rather than the drug companies who manufacture and profit from the medications.

Case in point: the FDA's REMS program. REMS stands for "Risk Evaluation and Mitigation Strategy" and is a program developed by the FDA "to manage known or potential serious risks associated with a drug product. It is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks." It covers an increasingly large array of medications.

But what does this grand plan require the drug companies to do?

Drug companies must create a database.

But for doctors who prescribe these antiarrhythmic medications and are board-certified to do so, we now have to perform a "one-time" re-certification that involves filling out a form and agreeing, in writing, to mandated patient appointment frequencies and minimum requirements for patient education that must be conducted during our office visits.

Such is the case with Pfizer's antiarrhythmic medication dofetilide (marketed as Tikosyn). Realize this "re-certification" comes AFTER we have all had to conduct a training regimen and were already registered with the company to prescribe the drug.

The REMS program, begun in 2008, grew more inclusive (and intrusive) after identification of a White House "crisis" involving prescription drug abuse of opioid analgesics that surfaced in April of this year. This edict has now trickled down to the clinical front lines of care with some very significant clinical consequences.

As clinical volumes rise, doctors are finding it increasingly difficult to reach the Utopian vision of frequent patient follow-up for drug surveillance for the pharmaceutical industry. Certainly, if there is clinical reason to do so (marginal renal function, higher-dose therapy, confounding medical issues) we see patients more frequently as needed. But in stable, relatively healthy patients who have a history of safely using these medications, we are left to wonder if the FDA's surveillance program has the potential to limit our ability to see new patients in favor of only managing established patients on chronic medication regimens that require close follow-up.

Clearly, there should be a balance. For many doctors (myself included) we have had to resort to using a nurse practitioner to assist with this requirement to offload the crush of such mandated patient visits. But for doctors in smaller, more rural settings where ancillary care providers are harder to come by, I suspect others will quickly saturate their clinics with regulated patient visits or else just not offer these medications to their patients.

This balance of safety and quality care to the oncoming tsunami of patients sure to hit our door in 2014 is an interesting dilemma not easily solved. Still, innovative ways to avoid top-down regulations that are crushing doctors with mandated (and often clinically unnecessary) care will go a long way to improving the quantity of care we are able to provide our growing population of patients.

-Wes