pharmacy law and ethics, safety and infection control (10%)

• statutes

  • laws passed by federal, state, local legislatures
  • often assign power to create legislation and delegate regulatory committee to oversee
• regulations

  • clarify and explain statues
• tort

  • where a private wrong is committed against individual/property
  • individual may seek compensation
  • can be intentional (malpractice) or not (negligence)
• misdemeanor

  • punishable by community service, parole, fine, imprisonment for a year or less
• felony

  • serious crime
  • usually end in imprisonment for over a year
• centers for disease control and prevention (CDC)

  • federal agency
  • investigates, identifies, prevents, controls disease
  • other institutes are under oversight (ex: NIH)
• centers for medicare and medicaid services (CMS)

  • formerly health care financing administration
  • regulates administration of medicare, medicaid, state children's health insurance, hipaa, clinical laboratory improvement amendments
  • inspects to ensure compliance
• drug enformce administration (DEA)

  • regulates legal trade in narcotic/dangerous drugs
  • manages national narcotics intelligence system
  • works with other agencies to prevent illegal drug trafficking
  • have coordinated jurisdiction over drug offenses w/ FBI
• food and drug administration (FDA)

  • ensures safety, efficacy, security of drugs, biological products, med devices, food, cosmetics
  • reviews and approves new drugs applications (NDAs), new generic equivalents, new therapeutic indications
• the joint commission

  • evaluates and accredits health care organizations and programs
  • establish and enforce standards focusing on quality of safety of care provided
• occupational safety and health administration (OSHA)

  • division of US department of labor
  • oversees administration of occupational safety and health act
  • establishes and enforces protective standards
  • reaches out to employers through assistance and consultation programs
• state boards of pharmacy (SBOP)

  • registers, regulates pharmacy facilities, pharmacists, pharmacy technicians
  • each state's board is responsible for maintaining a state pharmacy act
  • monitors and has ability to revoke licenses
• state pharmacy law

  • pertains to actual practice of pharmacy
  • license pharmacies and professionals
  • determine standards
  • can add restrictions to existing law
• federal pharmacy law

  • mainly pertains to manufacturing, marketing, distribution of drugs
• the pure food and drug act of 1906

  • provided for federal inspection of meat products
  • forbade manufacture, sale, transport of adulterated food products/poisonous medicine
  • was proved inadequate
  • didn't cover cosmetics
  • no authority granted to ban unsafe drugs
  • didn't stop manufacturers from saying false statements about their drugs
  • no requirement to label contents of products
• sherley amendment of 1912

  • prohibits labeling medicines with false therapeutic claims intended to defraud
  • passed in attempt to overcome weaknesses of pure food and drug act
• food, drug, and cosmetic act of 1938 (FDCA)

  • limits interstate commerce to safe and effective drugs
  • manufacturers are required to submit evidence that drugs were safe before marketing
  • all drugs needed warnings and directions
  • new drugs were required to be tested clinically
  • drugs used as diagnostic agents, therapeutic devices, cosmetics were required to be regulated
  • established the FDA
  • regulated who can prescribe legend drugs
• label

  • a display of written, printed, graphic matter upon immediate container of any article
  • information on outer portion of package
• labeling

  • all labels and other written, printed, graphics either on or accompanying drug
  • includes the package itself and its inserts
• legend drugs

  • can only be prescribed by a licensed practitioner
• labeling requirements for dispensed medication

  • pharmacy name and address
  • serial/rx number
  • date of fill
  • expiration date
  • prescriber's name
  • patient's name
  • directions of use
  • cautionary statements
• requirements for legend drug label

  • established name and quantity of each active ingredient
  • statement of new quantity
  • statement of usual dosage
  • federal legend
  • route of administration
  • federal warning in case dependency occurs
  • name of all inactive ingredients if not oral
  • unique lot/control number
  • statement specifying type of container to be used for dispensing
  • name and place of business of manufacturer, packer, distributor
  • expiration date
• legend drug labeling requirements

  • description of chemical structure
  • clinical pharmacology
  • indications and usage
  • contradictions (when drug shouldn't be used)
  • warnings of side effects/potential hazards
  • precautions
  • adverse side effects
  • drug abuse/dependence
  • dosage
  • statement to how drug is supplied
  • date of most recent revision to labeling
• OTC label requirements

  • product name
  • name/address of manufacturer and distributor
  • established name of all active and inactive ingredients
  • net contents
  • required cautions and warnings
  • name of any potentially habit-forming drug contained
  • adequate directions for use