Pharmacy Law and Ethics

Pharmacy Law, Ethics, and Regulatory Agencies

Law and Ethics in Pharmacy

• Laws, standards, and ethics regulate pharmacy and drugs.
• A law is a rule established by a governing body.
• Laws protect society, maintain order, and uphold living standards.
• Violating a law results in criminal penalties.
• Standards, established by professional organizations, provide practice guidelines.
• Professionals in a field share a common philosophy that dictates appropriate etiquette.
• Adherence to legal and ethical standards is the responsibility of pharmacists and technicians.
• Ethics are values determining right and wrong in personal relationships, influenced by morals, behaviors, and societal factors.
• Medical ethics evaluates merits, risks, and social concerns related to medical activities.

Code of Ethics in Pharmacy

• The American Pharmacists Association (APhA) developed a Code of Ethics for Pharmacists based on overarching principles.
• Beneficence: Actions benefit patients and customers without prejudice.
• Fidelity: Promises are kept, patient needs are met accurately and punctually, and patient confidentiality is maintained.
• Veracity: Truthfulness is essential for patient care, preventing drug diversion, and ensuring accurate medication error reporting.
• Justice: Actions must be lawful, fair, and equal for all.
• Autonomy: Pharmacy staff supports pharmacists with initiative, reliability, dependability. Patient involvement in healthcare decisions is encouraged and acknowledged.
• All actions in a pharmacy should primarily benefit patients with consistency.
• Actions should consider consequences, acting without consideration is detrimental to patients and the pharmacy.
• Interaction expectations include sensitivity, kindness, patience, reliability, and tact from pharmacy staff.

Legal Language

• Professions commonly develop specific language; legal terminology supports pharmacy technicians.
• Key legal terms include:
  • Assumption of risk: Patient responsible for problems that occur as a result of not following medical advice.
  • Defendant: Person or group facing charges in court.
  • Deposition: Oral testimony outside of court.
  • Interrogatory: A written set of questions answered under oath in court.
  • Jurisdiction: Court authority to hear and judge a case.
  • Litigant: Party to a lawsuit.
  • Litigation: Lawsuit or contest in court.
  • Plaintiff: Person initiating a civil lawsuit, or the government in a criminal case.
  • Statute of limitations: Law limiting the period to sue, varying from one to three years.
  • Subpoena: Order to appear as a witness or be deposed.

Governing Bodies

• Laws are created by federal, state, and local governments in the United States.
• The federal government is divided into three branches:
  • Legislative: Congress (House of Representatives and Senate) creates laws.
  • Executive: President, VP, and cabinet enforces the law.
  • Judicial: Supreme Court and lower courts interpret the law.
• The federal government creates, enforces, and interprets laws for the population.
• State and local governments determine the specifics of laws within their jurisdiction.
• Regulatory agencies are departments creating rules within a specific expertise area.
• The FDA regulates pharmacy as part of the Department of Health and Human Services and regulates all drugs besides illegal ones.
• The FDA initiates, implements, and enforces legislation related to drug administration.
• The FDA approves drugs, OTC labeling, and sets drug manufacturing standards.
• The FDA ensures medical drugs and devices are safe and effective. The FDA can approve or deny new drug applications, and even conduct inspections.
• Potential drugs undergo preclinical testing, human clinical trials, and FDA regulatory approval, taking 10-15 years costing millions.
• About 1 in 1,000 potential drugs enter human clinical trials after preclinical testing.
• Drug clinical trials are divided into phases:
  • Phase 0: Exploratory testing of the drug is carried out on 10-15 human volunteers.
  • Phase I: 20-80 human volunteers determine toxicity and safety of the drug.
  • Phase II: Assesses efficacy and minor side effects on 100-300 human volunteers.
  • Phase III: Assesses clinical efficacy on 1000-3000 subjects with the target condition.
  • Phase IV: Can be performed to test other conditions on a number of subjects based on trial end points.
• 9 of 10 drugs fail during human testing.
• FDA approval requires committee review specializing in the drug class based on its anticipated use.
• US regulations for medical drugs and devices are stringent.

Types of Law

• Laws evolve with society with constitutional, statutory, administrative, common, and international law types.
• Constitutional law: Federal and state constitutions dictate.
• Statutory law: Legislation establishes statutes.
• Administrative law: Government administrative agencies create.
• Common law: Judges create based on rulings.
• International law: Rooted in treaties.
• Civil Law: It focuses on private citizens' rights and is also case law, which includes tort and contract law.
• Criminal law: Relates to offenses against the general public or society like harming the general public.
• Tort Law: Derived from civil law.

Criminal Law

• Regulates the relationship between individuals and society, with violations considered "harming the public".
• Practicing pharmacy without a license is a criminal violation that may lead to government prosecution.
• Offenses include misdemeanors, felonies, and treason.
• Violation leads to due process and an ability to defend themselves against all charges.
• It governs dishonesty and misleading pharmacy practices.

Misdemeanors

• Punishable by fines and possible jail time up to a year, generally served in a city or county jail.
• Minor offenses are called infractions, which are punishable by fines, such as traffic violations.
• Classes are grouped differently.

Felonies

• Serious violations are punishable by significant fines and imprisonment exceeding a year, sometimes in a state penitentiary.
• Murder and rape are felonies.
• First-degree felonies evoke harsh penalties and can lead to a loss of rights.
• Voting can be reinstated after completion.

Treason

• It involves acts to overthrow the government.
• Examples include attempts to assassinate high government individuals and destroying government buildings.
• They differ from acts deemed acts of war.

Civil Law

• It governs relationships within society regarding noncriminal acts.
• It can involve individuals, agencies, or organizations.
• It governs unprofessional conduct like libel, slander, and privacy violations like personal injury.
• Also known as case law.
• Cases are decided by judges or juries.
• Tort and contract law are directly tied to pharmacy practice.
• Administrative law is significant in pharmacy regulation.

Tort Law

• Allows redress/remedies for harm caused by another's wrongful acts, typically in the form of monetary compensation.

• It addresses private wrongs.

• Medical malpractice is regulated under tort law.

• Plaintiffs bringing the tort against the defendant are legally responsible.

• Plaintiffs must also prove their damage.

  • Examples of this law include libel and slander.
  • Tort Law has:
    • Intentional Torts (with intent).
      • Assault is attempting to touch or harm someone.
      • Battery is the assault
    • Unintentional torts (without intend to harm)
      • Negligence involves failing to meet the standard of care, malpractice if occurring within a profession like improper Medicare counseling.

• Negligence cases require proving the defendant owed a duty of care and breached it which led to the plaintiff's injury.

Contract Law

• Agreements creating obligations, that can be written or verbal contracts.
• Contract law is affected by the Uniform Commercial Code and facilitates uniformity in US sales.
• Parties barred from contracting include minors, those who are mentally unstable, and/or those intoxicated.

Administrative Law

• Consists of rules from federal agencies.
• It is called regulatory law.
• Congress gives administrative law authority.
• Enacted by the legislature.
• Examples of these laws are instituted by OSHA, IRS, FDA, SSA, and CMS.

Violations of the Law

• Classified as misdemeanors or felonies.
• Theft is an example of a misdemeanor, whereas drug-selling, burglary, and arson are examples of felonies.
• An individual violating the law becomes a criminal, and that individual requires help from an accessory. -Violations may result in fines, revocation, or suspension of licenses, set by state law.
• The pharmacy also makes rules but is still an administrative agency.

Violations of Pharmacy Law

• Fraud: This involves promises of miracle cures and is dishonest.
• Libel: Involves false advertisements of quality of care.
• Slander: This involves the pharmacist calling another unqualified.
• Negligence: This involves injury by a pharmacist.
• Abuse: This involves the wrong medication being prescribed.

Pharmacy Law at the State Level

• Primarily a state function based on citizen protection.
• State laws, which differ, are based on pharmaceutical practices.
• Licenses to practice without minimal.
• Successful completion is required. -Pharmacy boards provide a sub-agency of licensing.
• Licensure gained is not revoked, though actions of suspension are present.
• Pharmacists have federal and state constitutions. Most cases register of 1-2 years. Evidence is also accepted. -Revoked and canceled based on special circumstances.
• Model acts allow regulation on a better level.

Laws, Points, Differences, and Federal Regulation

• Points to remember in this act involve a unique regulation of state laws.
• Differences between the state levels do follow what the law finds.
• Federal level sets regulation.

Pure Food and Drug Acts of 1906

• Congress passed its purpose in 1906.
• The Act was deemed inadequate. For Example:
• No cosmetics
• No authority was present.
• Manufacturers were able to make false statements.

1912 to 1914

• Congress addressed issues including the powers of fraudulent drugs. Fraud is an example of the amendments to the act.
• Restrictions and directives are placed, including restrictions surrounding a distribution of coco leaves.

The Food, Drug, and Cosmetic act of 1938

• Included regulations and amendments were further formed.
• This requires manufactures to ensure purity.
• Allows testing and the investigation use of humans.

Durham-Humphrey of 1951

• Legend drugs were created during this act. Clear selection is also present.

Kefauver-Harris of 1962

• Ammends of 1962 allowed drug distribution effectiveness. Prescription of the act was placed under review.

Comprehensive Drug Abuse Prevention of 1970

• Act allows for a controlled substance to maintain strong records. These are placed in five classifications.
• Act design to update what is dangerous, making sales and substance illegal.
• Standards also exist.

The Poison Act of 1970

• Act allows for child resistant packaging. However, it requires a pharmacist to dispense.