To comply with state practice acts and OBRA '90, pharmacacy practice must include clincial technology, such as devices and instruments, not just drugs, according to a group of leading scientists, educators, and attorneys who have issued a manifesto.
Pharmacy has a narrow window of opportunity to look beyond its myopic focus on drugs and take charge of clinical technologies, according to an international group of healthcare leaders who have proposed a new practice paradigm.
Instead of just managing drugs, pharmacists should also be the healthcare professionals in charge of the safe, effective, and economical use of devices, instruments, and diagnostics under the tenets of Pharmaceutical Clinical Technology (PCT). More than 140 international leaders in pharmacy, pharmacy education, law, medicine, and biomedical engineering have signed onto a manifesto. The document is a medical, scientific, educational, professional, and legal analysis of how to implement pharmacy practice acts.
The endorsers of this manifesto believe that some in pharmacy have put all of the profession's eggs in the pharmaceutical care basket, but a potentially fatal flaw is that they never asked the rest of health care whether they needed or wanted R.Ph.s in that role. Outgoing president Peter Kielgast noted at the International Pharmaceutical Federation's recent annual meeting that pharmaceutical care is still not an integral part of any healthcare system. Calling for a "reality check," he added that pharmaceutical care would not work without a covenant with patients and payers.
Pharmaceutical care "could end up as a cruel hoax that might never succeed," said Albert Wertheimer, Ph.D., professor of pharmacy practice, director, Center for Pharmaceutical Health Services Research, Temple University School of Pharmacy. "On the other hand, Pharmaceutical Clinical Technology is a practical, workable framework with a high probability of what the profession needs to stay relevant. I am a true believer that the foundation of PCT can be the salvation for the profession of pharmacy."
PCT is the brainchild not of a pharmacist but of an Arizona-based physician, Ari Heller, M.D., who is codirector of the Pharmaceutical Clinical Technology Project. He compares PCT with a pharmacy school with three floors: basic science, clinical science, and social and administrative science. But instead of teaching only drugs, each floor would also incorporate clinical technologies. Such a discipline-based approach would then become the basis of pharmacy practice in all settings.
"Think of it as a two-by-two table," Heller said. "The X axis is drugs and clinical technology. On the Y axis is diagnosis and treatment. That table represents the PCT process of patient care."
Unlike pharmaceutical care, which pharmacy has tried to ram down the rest of health care's throat, PCT allows pharmacists to stake out a turf that is currently unclaimed, according to proponents. No other healthcare professional owns clinical technology.
Pharmacy has about a two-year window of opportunity to seize the PCT high ground, according to Wertheimer, a pharmacy educator whose international reputation extends far beyond pharmacy. "PCT isn't something for pharmacy at the expense of other people because it doesn't involve one group stealing another group's cookies," he said. "If we don't do it, someone else is going to jump in. That should be rationale enough, but more than a defensive measure, PCT is an opportunity."
The legal framework for PCT already exists in state pharmacy practice acts and OBRA '90, which all include devices (clinical technologies) used in the prevention, diagnosis, and treatment of human disease. "When pharmacists and pharmacist- attorneys read the pharmacy acts and OBRA '90, they see only drugs," said Heller. "They have a blind spot. However, when M.D.s, biomedical engineers, and nonpharmacist- attorneys read the pharmacy acts, they see the symmetry between clinical technology and drugs."
Pharmacy law experts have concluded that by ignoring devices, pharmacists, pharmacy schools, and state pharmacy boards are not complying with the law, said Heller. "There is a void between what pharmacists are actually doing and what they're supposed to be doing according to the law," he told Drug Topics. "PCT is simply an implementation of the scope of practice. It's not a new invention; it's just a nuts-and-bolts approach to how to implement the law correctly. Essentially our manifesto provides a road map to do that."
For more information about PCT, or to request a copy of the manifesto, e-mail email@example.com.
Carol Ukens. Pharmacy leaders offer new practice paradigm--PCT.