Editor's Note: Creating an Intermediate Class of Drugs

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

An FDA advisory panel has recommendedfor the third time inless than 10 years that lovastatin20 mg not be made available as anonprescription drug. That news followstestimony by the American Society ofHealth-System Pharmacists and theAmerican Pharmacists Association, in aseparate but related issue, stronglyencouraging the FDA to create an intermediateclass of drugs, sometimesreferred to as "behind-the-counter"drugs. Both organizations submittedcompelling arguments for the creation ofa class of drugs that could be dispensedwith appropriate patient education andmonitoring but without a physician's prescription.

Benefits of creating such a class ofdrugs include improving access to carethat would benefit public health, reducinghealth care costs, improving patientsafety, avoiding overuse, improvedpatient adherence, and more fully engagingpatients in managing their ownhealth. From a selfish point of view thecomments to the FDA leadership, thehealth care community, and the publicagain reflect that the pharmacy professionis fully capable of assuming theseresponsibilities.

Many hospital pharmacists havebroader responsibilities than are routinelyoffered outside hospital care, includingtherapeutic substitution, dosage adjustment,therapeutic drug monitoring, andmuch more. This role expansion is theresult of early pharmacy pioneers, collaborativepractice, establishment of trust,shifting responsibilities from physicianswho are already overworked,and, most importantly, becausepharmacists haveproven themselves capableof performing these importantpatient care functionsand have asked for the opportunity.

Regrettably, I am skepticalthat it will be adopted at thepresent time. I suspect thatthe office-based medical communitywill remain opposedto an intermediate class ofdrugs for a time. Doctors seethis evolution through myopiceyes as a threat, ratherthan an opportunity to createrelationships with pharmacistswho, in many cases,would increase referrals to physiciansrather than let patients go untreated forconditions that require physician care.We should remain optimistic since virtuallyall physicians train in hospitals andwill be exposed to these expanded rolesand appreciate their availability whenthey enter private practice.

I am confident that most pharmacistspracticing in the retail setting generallywould welcome the opportunity toexpand their practice by managingpatients receiving drugs from an intermediateclass of drugs. I wonder whethercorporate executives from the majorchains are fully supportive. I understandthe concerns of ensuring availability ofappropriately trained pharmacists, thefinancial impact of taking on more work(especially initially), the risks associatedwith dealing with a litigious clientele, andmore. We must reassure them that it isour destiny to play a more important rolein our patients' health and we are committedand determined to do so.

Our associations are championing ourcollective cause, but our help is needed.We need to discuss this issue with ourpatients, our neighbors, and physiciansin-training. When the time is right, weneed to educate legislators. For now, weneed to be supportive of the concept anddo what we can to support professionalevolution.