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INTRODUCTION

About the Author: Dr. Jennifer Adams is a graduate of Boise State University, Idaho State University, and George Washington University. She serves as the Associate Dean for Academic Affairs at the Idaho State University College of Pharmacy providing oversight for the PharmD curriculum, experiential education, interprofessional education, and assessment. Dr. Adams teaches pharmacy law to third-year student pharmacists, oversees the professional development course series, and co-curricular activities for the college. Her previous experience includes working in hospital and community pharmacy settings and in association management at the American Pharmacists Association (APhA) and the American Association of Colleges of Pharmacy (AACP). She has received national awards in recognition of her leadership skills.

LEARNING OBJECTIVES

LEARNING OBJECTIVES

After completing this chapter, readers should be able to

  1. Describe the reasons for the evolution of pharmacy and drug regulation that have created the current legal environment for pharmacy practice organizations.

  2. Summarize and explain the basic provisions of major pharmacy practice and drug laws discussed in this chapter.

  3. Describe the manager’s role in monitoring a pharmacy’s compliance with applicable laws and professional standards.

  4. Explain the role of the manager in developing and maintaining appropriate policies that help prevent violations of the law in order to manage organizational risk.

  5. Analyze practice-based situations where laws and/or professional standards may have been violated; in these analyses, the reader will consider the implications (statutory, regulatory, and civil) of a manager’s actions in resolving problems that these situations present and then propose appropriate courses of action for the manager.

SCENARIO

Few examples of how much trust is put in the hands of a pharmacist and the extent to which that trust can be betrayed come close to the story of Robert Courtney, a former pharmacist from Kansas City. During the 9 years leading up to his arrest in August 2001, Courtney secretly diluted the chemotherapy drugs of over 4200 cancer patients to increase the profits of his home infusion pharmacy business. Courtney broke the law while betraying the trust of his patients and damaging the reputation of his profession.

Patients place their trust in pharmacists to do and know things that they themselves do not understand. State and federal laws provide additional layers of protection to shield the public from dangerous and/or contaminated drugs and from dangerous and/or dishonest professionals. But as with any protective system, it can be breached. Consider how Courtney accomplished his deception.

Courtney began by diluting chemotherapy drugs for patients who were near death. He started out by diluting the drugs only a bit, thinking no one would notice. Later, he became more bold and diluted medications to the point that only a trace of the prescribed dose remained. He started out cheating “just a little” and ...

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