Chapter 10: Legal Aspects of Drug Information Practice

Learning Objectives

After completing this chapter, the reader will be able to

• Describe the legal issues related to the provision of drug information (DI).

• Apply various legal theories that impose liability on pharmacists providing DI.

• Describe how pharmacists can help protect themselves from malpractice claims resulting from the provision of DI.

• Explain the Doctrine of Drug Overpromotion as it pertains to the 1997 Food and Drug Administration (FDA) Modernization Act (FDAMA).

• Identify the liability concerns inherent with off-label drug use and informed consent.

• Describe United States (U.S.) copyright law as it pertains to the provision of DI.

• Identify copyright, liability, and privacy issues arising from the Internet and social media.

• Describe the legal and ethical challenges emerging in telemedicine and cybermedicine.

• Describe the DI plan that addresses the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

• Explain the legal issues involved with industry support for pharmaceutical educational activities.

Key Concepts

1. Currently, most litigation concerning pharmacists involves negligence.

2. There are a number of ways in which tort liability can relate to the provision of DI: incomplete information, inappropriate quality information, outdated information, inappropriate analysis or dissemination of information.

3. There are at least three key areas of labeling and advertising liability: the learned intermediary rule, which is a defense to failure to warn actions; the doctrine of overpromotion, under which adequate warning is alleged to have been diluted by communications failing to adequately convey the full impact of the warning; and promotion of off-label use or FDA-unapproved indications.

4. Drug information is currently being obtained from a number of Wikis, blogs, and search engines and there is the possibility of drug information liability for information obtained from other Internet sources.

5. Pharmacists providing drug information must have a working knowledge of copyright law both to avoid liability and to protect their own literary works.

6. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule is not intended to disrupt or discourage adverse event reporting or drug information in any way.

7. The FDA, the American Council for Continuing Medical Education (ACCME), and the Pharmaceutical Research and Manufacturers of America (PhRMA) have established educational policies, guidelines, or guidances which allow communication between industry and the continuing medical education (CME) providers.

Introduction

An understanding of the legal aspects of drug information (DI) can help practitioners in day-to-day practice, as well as provide some possible ways to protect himself or herself in the legal system. This chapter is intended to examine legal issues and should not be considered legal advice.

There are a myriad of legal issues confronting the various facets of DI. These legal issues cross over a number of traditional legal specialties, including computer law, advertising law, privacy law, intellectual property law, telecommunications law, and tort law. This chapter provides an overview and discussion of the key legal issues involving intellectual property rights, ...