Academic journal article The Review of Litigation

The Pharmacist's Duty to Warn in Texas Reconsidered within a National Framework*

Academic journal article The Review of Litigation

The Pharmacist's Duty to Warn in Texas Reconsidered within a National Framework*

Article excerpt

I. INTRODUCTION: PHARMACY'S CONTEMPORARY PRACTICE PARADIGM AND THE COURTS

Within the time span of the last twenty years, more or less, the practice of pharmacy has changed in dramatic ways. While at one time pharmacists were exclusively drug-oriented and focused on accurately filling drug prescriptions written by physicians,1 today's pharmacists are patient-oriented and trained to provide pharmaceutical care, care that goes beyond the dispensing function and includes planning drug therapies, caring for patients, and monitoring patients to ensure desired therapeutic outcomes.2 According to the U.S. Department of Health and Human Services, "Pharmacists in retail settings have become increasingly involved in patient counseling and other activities separate and distinct from the dispensing function; pharmacists in institutional settings have become increasingly involved in clinical activities and in all phases of the medication use process."3 Even the most casual observer of pharmacy practice, including the occasional patient who goes to the pharmacy to pick up a prescription and receives oral and written information and warnings about the medication's use-information and warnings that historically the pharmacist would not routinely have provided-realizes that pharmacists today play different roles than they have in the past.

Significantly, the changes in the professional vision and responsibilities of pharmacists-changes driven by the profession itself for a variety of reasons-have been validated by three realities external to the profession. First, the explosive development of new drug entities has resulted in more work for pharmacists.4 Second, the increased use of prescription medications for combating illness and disease has made possible, and even necessitated, greater roles for pharmacists in helping patients. The Institute of Medicine found that in 1998, nearly 2.5 billion prescriptions were filled in our nation's pharmacies at an estimated cost of $92 billion, while 3.75 billion drug prescriptions were given to hospital patients.5 Finally, congressional mandates contained in the federal Omnibus Budget Reconciliation Act of 1990 (OBRA), which went into effect on January 1, 1993,6 as well as various state regulatory schemes implementing the requirements of OBRA,7 have established that pharmacists' services are crucial to patient care. These federal and state statutory provisions place expansive duties on pharmacists designed to enhance patient care and to ensure that prescriptions are appropriate and will not result in adverse medical events.8 In short, the statutes make pharmaceutical care the standard of care.9 In this regard, OBRA mandates state drug use review programs requiring the provision of three essential services: first, prospective drug use review by pharmacists,10 which includes screening for potential drug therapy problems before prescriptions are filled,11 counseling patients,1 and obtaining, recording, and maintaining patient information;13 second, retrospective drug use review to identify patterns of fraud, gross overuse, or inappropriate or medically unnecessary care;14 and third, educational programming by each state's drug use review board.15

This evolution of pharmacy practice, from the traditional practice paradigm to the contemporary practice paradigm, has been recognized by some courts,16 including the Texas Court of Appeals in Austin.17 Indeed, the Texas court's view of the pharmacy profession, at least as the court describes it, has evolved over time and has tracked organized pharmacy's changing vision of the role of pharmacists and its modern emphasis on greater professional responsibilities. Thus, in 1976 the Texas Court of Civil Appeals in Austin declared that "it is a fair conclusion that the dispensing of prescription drugs has become more of a retail endeavor than a service endeavor."18 In 2000, however, the Texas Court of Appeals in Austin came to a new understanding and recognized that pharmacists possess significant expertise and do a great deal more than simply count pills and measure liquids. …

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