By Kim Burns
Kim Burns is an associate professor at the LECOM School of Pharmacy in Erie, Pennsylvania, and is of counsel to the Carpenter Law Firm. She can be contacted at
Pharmacists are highly educated professionals in a highly regulated legal field. Legal compliance for pharmacy providers requires familiarity and compliance with a myriad of state and federal laws and regulations, including, but not limited to, state pharmacy practice acts and regulations, Medicaid and Medicare requirements, the Controlled Substances Act (CSA), the Food Drug and Cosmetic Act (FDCA), the Poison Prevention Packaging Act, and the Health Insurance Portability and Accountability Act (HIPAA).
The legal consequences of noncompliance with a law, regulation, or professional standard related to pharmacy practice may be imposed through civil, administrative, and/or criminal actions. Civil actions typically involve negligence or malpractice actions against the pharmacy or pharmacist. Previously, malpractice actions against pharmacists were based solely on inaccuracy in dispensing prescriptions. For example, a pharmacist would have been found to be negligent for inadvertently dispensing a drug other than that prescribed, resulting in the patient consuming the wrong medication and suffering an injury.
However, as the professional role of a pharmacist has expanded in recent decades to include more involvement in patient care (e.g., a more active role in disease-state management, clinical interventions, patient education and counseling, the administering of immunizations, and drug therapy management), so has the potential for professional liability. As a result, pharmacists are increasingly facing allegations of intellectual errors involving scenarios in which the pharmacist accurately filled the prescription as prescribed but failed to detect an inappropriate dose or duration of drug therapy, perform a drug review, or counsel the patient about potential side effects.
Pharmacies and pharmacists might face administrative and disciplinary actions by state boards of pharmacy if they are found to be noncompliant with state and/or federal laws or if they engage in unprofessional conduct. Disciplinary actions can range from a public reprimand to revocation of the pharmacy license that is required in order to practice at the state level.
Likewise, pharmacy providers have also faced criminal actions for violating various state and federal laws related to pharmacy. For example, federal and state controlled substance laws contain criminal penalties for dispensing controlled substance prescriptions that do not comply with legal requirements.
In addition to legal oversight, professional ethical standards have long been an integral part of pharmacy practice. Public recognition supports this concept, as pharmacists have consistently been highly rated by the public as being honest and ethical professionals. To help guide the pharmacist-patient relationship, pharmacists display and apply various ethical principles, such as beneficence, nonmaleficence, justice, autonomy, and fidelity. In addition, the pharmacy profession has its own formal code of ethics.
However, even with this guidance, ethical dilemmas within pharmacy practice can and do occur. Often, the moral parameters and personal values of the pharmacist may differ with community or patient values. When this occurs, there may be contrasting clinical decisions. For example, one specific ethical dilemma within pharmacy practice that has made national news in recent years involves how pharmacists view their role in dispensing lawfully prescribed emergency contraception prescriptions to patients.
The profession of pharmacy is guided by numerous regulations, laws, and ethical principles. As pharmacists continue to expand their role in health care, the legal and ethical aspects of the profession will also continue to expand. Knowing these basics will allow you to be ready if you encounter a case concerning pharmacy law.
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