Eye on ethics: The road not taken

Q: You are the clinical program director for a pharmacy chain. A drug manufacturer is rolling out a new Rx-to-OTC switch and has proposed an unusual marketing plan. Pharmacists would educate patients and monitor their drug therapy with postmarketing surveillance. The compensation would be small, but the high-profile project would be the first of its kind. What do you do?

Whether in retail or institutional settings, the business of dispensing drugs is no longer profitable. To minimize the use of expensive pharmacists, pharmacy layouts have been micromanaged and dispensing systems have been reengineered with robotics, software, and packaging. The time "freed up" by these so-called improvements has been consumed by the Part D debacle, the anticipation of Medicaid reimbursement cuts, and managing large numbers of technicians. As the profession looks toward MTM services to ensure its future, pharmacy systems seem to be pushing pharmacists and patients farther apart.

Many technology-driven ideas are in the works, intended to reduce adverse effects and errors and review compliance. Focusing on increasingly minute details ignores one critical and often overlooked factor: the patient. Patients can't be jammed into paradigms; they won't read a raft of warning leaflets; and their fears, cognitive qualities, and physical illnesses go with them to every medical appointment and trip to the pharmacy. Tracking a patient's compliance, understanding of drug therapy, and adverse effects requires a professional relationship with that patient, and personal interaction.

If clinical directors and academics do not want to involve their pharmacists in patient monitoring and reporting adverse effects, legislators might hand this opportunity to software designers and 1-800 operators. There is now legislation in the Senate that proposes requirements for postmarketing surveillance and a registry of trials and other ventures to protect the public from adverse drug effects. A similar proposal would establish requirements for the reporting of adverse effects from OTCs and supplements.

Some pharmacists are well positioned to provide this kind of service. There are companies founded and staffed by R.Ph.s who package and dispense study medication for clinical trials and monitor patients enrolled in trials. These pharmacists educate patients on the proper use of study drugs and evaluate adverse effects should they arise; they work independently of, yet in tandem with, drug trials.

Postmarketing surveillance is a job tailor-made for pharmacists. Nutritional supplements, custom compounding, and data mining were also once considered to be radical new ideas. Participating in the design of adverse drug reaction monitoring services and being at the table when contracts are signed should be the goal of every clinical director. Leaders who pass up an opportunity to improve patient care are selling their staff pharmacists short.

Disclaimer: This column highlights ethical situations that often occur in pharmacy practice. It is designed to stimulate discussion on how to deal with these situations and is not intended as legal advice. Pharmacists who need immediate assistance should consult their attorneys, employers, state boards of pharmacy, and state and federal laws.

THE AUTHOR has practiced long-term care and community pharmacy in Oregon for more than a decade and has served on numerous professional and community boards.