Chapter 28. Compliance with Regulations and Regulatory Bodies

Dr. Clark is an Associate Professor in the Pharmacy Sciences Department at Creighton University School of Pharmacy and Health Professions. He earned a B.S. and an M.S. in pharmacy from the College of Pharmacy, University of Illinois at Chicago, and a Ph.D. in social and administrative sciences in pharmacy at the University of Wisconsin–Madison School of Pharmacy. Dr. Clark has practiced in a variety of community and institutional pharmacy settings and has served as professional affairs manager for the National Association of Boards of Pharmacy (NABP). His teaching and research interests include pharmacy practice management, pharmacy law, patient safety, pharmacists' work environments, and the pharmacy benefits management (PBM) industry.

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 the major pharmacy 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 for the protection of patient privacy.

5. Analyze practice-based situations where laws and/or professional standards may have been violated. In these analyses, consider the implications (statutory, regulatory, and civil) of a manager's actions in resolving any problems presented by these situations and propose appropriate courses of action for the manager.

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 secretively diluted the chemotherapy drugs of over 4,200 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. As with any system, though, 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 then slid down a slippery slope until he was convicted of his crimes and sentenced to 30 years in prison. As stated in a newspaper feature about his case:

“The path to hell leads one step at a time,” says Mike Ketchmark, the brash but persistent ...