After completing this chapter, the reader will be able to
- Describe the legal issues related to the provision of drug information (DI).
- Determine the applicability of 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 U.S. copyright law as it pertains to the provision of Drug Information.
- Identify copyright, liability, and privacy issues arising from the Internet.
- Formulate a plan to deal with the major provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
- Explain the legal issues involved with industry support for pharmaceutical educational activities.
- Currently, most litigation concerning pharmacists involves negligence.
- There are a number of ways in which tort liability can attach to the provision of DI: incomplete information, inappropriate quality information, outdated information, and inappropriate analysis or dissemination of information.
- 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 non-FDA-approved indications.
- DI is currently being obtained from a number of Wikis, blogs, and search engines, and there is possibility of DI liability for information obtained from the Internet and electronic journals.
- Pharmacists providing DI must have a working knowledge of copyright law both to avoid liability and to protect their own literary works.
- The HIPAA Privacy Rule is not intended to disrupt or discourage adverse event reporting or DI in any way.
- 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 that allow communication between industry and the Continuing Medical Education (CME) providers.
* An understanding of the legal aspects of DI can help practitioners in day-to-day practice, as well as provide some possible ways to protect oneself in the legal system. This chapter is intended to examine legal issues and should not be considered legal advice.
There are myriad 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, torts, privacy, and advertising and promotion that may arise in the provision of DI.
Decades after the genesis of drug information services, the legal duties of pharmacists providing DI are still evolving. Today, most pharmacy curriculums and PGY-1 residencies include DI, realizing ...