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Learning Objectives

  1. Identify controlled substance prescriptions that are not issued for a legitimate medical purpose.

  2. Recall key HIPAA-related concepts and describe common compliance issues.

  3. Describe three federal statutes used to prohibit and enforce healthcare fraud.

  4. Identify resources to remain up-to-date on state and federal pharmacy law changes.

Setting the Scene

Pharmacy practice is ever-evolving, and the same can be said for the laws and regulations that govern it. Even though states are the primary regulators of pharmacy practice, many governmental entities influence—both directly and indirectly—the daily operations and decisions that must be made to provide high quality patient care. Always remember, the rules and regulations serve as a framework for which pharmacists must practice within, but they alone are not enough to ensure competence. We encourage you to use the laws and regulations as another tool in your best-practices toolkit to serve your patients, knowing that it will likely raise more questions than it answers. This chapter cannot possibly reteach you pharmacy law, especially considering the substantial variation that exists among states. Instead, this chapter is structured to discuss key issues that community pharmacists encounter every day in practice—controlled substances, HIPAA, healthcare fraud, and tips for staying up-to-date.

Disclaimer: The readers must note that this chapter is for educational purposes only and is not intended to represent legal advice. If you have specific legal questions, please consult an attorney.


While controlled substances represent a small portion of all prescription drugs, they are the most highly regulated. Pharmacists are at the greatest risk of losing their license or being criminally charged with illegal drug diversion when these regulations are not followed. An excellent overview of these rules is the manual of the Drug Enforcement Agency (DEA) manual for pharmacists,1 and community pharmacists should be familiar with this manual.

Prescriptions for controlled substances must be for a legitimate medical purpose issued by an individual practitioner acting in the usual course of his or her professional practice.2 Although the prescriber has the primary responsibility to ensure the legitimacy of controlled substance prescriptions, pharmacists have a corresponding responsibility to dispense controlled substances only for legitimate medical purposes.2 If the pharmacist knew, or should have known, that a prescription was not issued for a legitimate medical purpose, the pharmacist may be held civilly and criminally liable.3 Because of the potential serious consequences to both pharmacists and patients, pharmacists must be able to identify prescriptions that are illegal on their face, and to identify red flags that indicate a prescription is not for a legitimate medical purpose.4 Here are a few examples of prescriptions that should raise red flags for community pharmacists.

Scenario #1. A patient presents a prescription for oxycodone 5 mg #15 for a 7-day supply to be taken as needed for extreme low back pain that was ...

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