The Erosion of the Patient?Provider Relationship

James C. McAllister III, MS, FASHPPharmacy Times Editor, Health-Systems Pharmacy Section

Mr. McAllister is a health-systems consultant based in Chapel Hill, North Carolina.

On February 1, 2008, the FDAissued a public health advisoryon varenicline (Chantix) alertingproviders and patients to new safetywarnings related to possible neuropsychiatricsymptoms with the drug's use.In the same advisory, a physician directorfor the FDA validated varenicline'seffectiveness while acknowledging itsrisks and the need for close monitoringof patients by health professionals. Isuspected that the FDA would continueto monitor adverse event reports,encourage its manufacturer (Pfizer) tocontinue to study the drug, and possiblyrequire a black box warning in the productliterature. This strategy is typical insimilar situations and appropriately encouragesphysicians and pharmacists tocollaborate with the patient to ensureits safety and efficacy.

I was stunned by the May 23, 2008,Federal Aviation Administration (FAA)decision to order pilots and air trafficcontrollers to stop taking vareniclineimmediately. The FAA decision appearsto have been made in response to manyarticles published the day before in thelay press, which cited a report by theInstitute for Safe Medication Practices(ISMP). Researchers at ISMP and WakeForest University had reviewed 988 adverseevent reports related to vareniclineuse that were turned in to the FDA in thefourth quarter of 2007. The researchersconcluded that the data "providea strong signal that the risks of vareniclinetherapy have been underestimatedand show a wide spectrum of seriousinjuries are being reported in large numbers,"but acknowledged that its manufacturerand the FDA shouldtake further steps, includingconducting more clinicaltrials. The researchers alsocautioned that the data donot definitively prove that thedrug caused the symptomsreported.

The FAA decision, in myopinion, was not made basedon scientific evidence, butrather in response to sensationalizedmedia reports ofthe findings of ISMP reviewers.Because pilots risk theloss of their livelihood if theyare noncompliant with theFAA order, however, suchdecisions are quite effective in changingpilot and air traffic controller behavior.

I understand that public awarenessabout medication-related adverseevents is at an all-time high (which isa good thing), and that organizations—including government agencies—feelcompelled to promote patient safety toavoid public relations nightmares if anadverse event occurs. Airline pilots andcontrollers have responsibilities for thesafety of the flying public. If vareniclineconsumed by pilots and controllers putspassengers at risk, why shouldn't otherworkers, who might potentially also puttheir customers at risk, be banned fromconsumption as well? Should school busdrivers, railroad engineers, and truckdrivers be made to stop taking varenicline?What about pharmacists whocheck hundreds of medication ordersevery day? Should their employers insistthat they not be taking medicationsthat have neuropsychiatric side effects?What about surgeons, nurses, or policeofficers?

We talk about the importance of evidence-based medicine and the valueproposition of collaborative providerseffectively managing individualized therapy.The review of "possible" adverseevent reports is a long way from awell-designed clinical trial. Decisions torestrict a drug's use in groups of individualsshould be made based on reviewof scientific literature by qualifiedexperts, as has been done by the FDAfor decades. Otherwise, the decisionto prescribe and follow a drug therapyregimen should be made collaborativelyby providers and patients following arisk?benefit determination. To do otherwisethreatens the pursuit of optimaldrug therapy outcomes for individualizedcare.

This decision has Health InsurancePortability and Accountability Act implicationsthat I have not even describedand is equally worrisome from a precedentialperspective. I think that thisevent threatens the provider?patientrelationship and should be carefullymonitored to ensure that the erosionof provider roles and the shift of drugtherapy oversight to employers do notproliferate. What do you think?