Pharmacy law Flash Cards

Three primary federal sources of oversight and standards for pharmacy practice

CMS (Centers for Medicare & Medicaid Services), FDA (Food and Drug Administration), and DEA (Drug Enforcement Administration)

Federal agency responsible for regulating controlled substances

DEA (Drug Enforcement Administration).

Non-narcotic drug classifications regulated as controlled substances

include Schedule IV and V drugs that have a lower potential for abuse compared to narcotics and other higher schedules. Hallucinogens, stimulants, and depressants.Examples include benzodiazepines and certain sleep medications.

Primary regulatory body that issues notices of violation for pharmacy practice infractions

The State Board of Pharmacy (along with federal oversight agencies such as the FDA or DEA).

Pharmacy offenses that can lead to criminal prosecution

Diversion of controlled substances, insurance fraud, illegal dispensing without a prescription, and falsification of pharmacy records.

Criminal Law

A division of law dealing with offenses against the state or society as a whole, focused on punishing offenders and deterring crime.

Civil Law

A division of law dealing with private disputes between individuals or legal entities, focused on compensating the injured party.

Appeal

A formal legal proceeding in which a higher court reviews the decision or judgment of a lower court.

Jurisdiction

The official power and legal authority granted to a court to adjudicate cases and render binding legal judgments over a specific territory or subject matter.

Respective regulatory domains of the FDA and DEA in pharmacy

: Regulates drug safety, efficacy, adulteration, misbranding, and approvals. DEA: Regulates the manufacture, distribution, and dispensing of controlled substances.

Core objectives and characteristics of pharmacy laws and regulations

They protect public health and safety, establish professional standards of practice, define scopes of practice for pharmacists and technicians, and outline disciplinary penalties for non-compliance.

Public Law vs. Private Law

Regulates relationships between private citizens and the government (e.g., constitutional, administrative, and criminal law). Private Law (Civil Law): Regulates relationships, rights, and duties between private individuals or organizations (e.g., contracts, property, and torts).

tort

A civil wrong or breach of legal duty (other than a breach of contract) that causes harm or loss to another party, resulting in legal liability.

Intentional Tort vs. Unintentional Tort

A willful, deliberate wrongful act resulting in injury (e.g., assault, battery, defamation). Unintentional Tort: Harm caused by negligence or an accidental failure to exercise reasonable care (e.g., dispensing the wrong medication due to carelessness)

Felony vs. Misdemeanor

Felony: A major crime punishable by death or incarceration in state or federal prison for more than one year (e.g., drug trafficking, severe insurance fraud). Misdemeanor: A less severe offense punishable by monetary fines or local jail sentences of up to one year (e.g., petty theft, minor regulatory infractions).

Negligence vs. Malpractice

Negligence: A general failure to use ordinary or reasonable care that a prudent person would exercise under similar circumstances. Malpractice: Professional negligence occurring when a licensed healthcare professional fails to meet the standard of care, directly causing patient harm.

State Supreme Court vs. U.S. Supreme Court

State Supreme Court: The highest judicial authority within a state court system, with final interpretation of state statutes and the state constitution. U.S. Supreme Court: The highest federal court in the nation, holding ultimate appellate jurisdiction over federal laws, treaties, and the U.S. Constitution.

Court case progression and Supreme Court review

Cases originate in trial courts with original jurisdiction, can advance to appellate courts upon appeal, and only a tiny percentage involving constitutional questions or federal statutes are reviewed by the U.S. Supreme Court.

Two main categories of criminal law

Felonies and misdemeanors (categorized by severity of offense and punishment), or substantive criminal law (defining crimes and penalties) and procedural criminal law (governing enforcement procedures).

Resolution of conflicts between federal and state pharmacy laws

Under the U.S. Constitution's Supremacy Clause, federal law overrides conflicting state law; however, states may enforce regulations that are stricter or more stringent than federal requirements in public health matters.

Role of ethical principles in pharmacy practice

Moral standards (including autonomy, beneficence, non-maleficence, and justice) that guide pharmacy personnel to protect patient welfare, maintain confidentiality, and uphold professional integrity.

Parties involved: Criminal Law vs. Civil Law

Criminal Law: Government (Prosecution) vs. Defendant (accused party). Civil Law: Plaintiff (injured party) vs. Defendant (alleged wrongdoer).

Burden of proof: Criminal Law vs. Civil Law

Criminal Law: Beyond a reasonable doubt (the highest legal standard). Civil Law: Preponderance of the evidence (more likely than not, greater than 50%).

Punishments and remedies: Criminal Law vs. Civil Law

Incarceration (jail/prison), criminal fines paid to the government, probation, or community service. Civil Law: Monetary damages (compensation for losses/injuries), injunctions, or specific performance.

Jury verdict requirements: Criminal Law vs. Civil Law

Typically requires a unanimous verdict for conviction or acquittal. Civil Law: Frequently permits a majority verdict depending on jurisdictional court rules.

Appeals process: Criminal Law vs. Civil Law

Only the convicted defendant may appeal (the prosecution cannot appeal an acquittal due to double jeopardy protections). Civil Law: Either party (plaintiff or defendant) may appeal an adverse court judgment.

Final decision terminology: Criminal Law vs. Civil Law

Criminal Law: Guilty or Not Guilty. Civil Law: Liable or Not Liable.