accreditation
the status achieved by meeting the quality standards and requirements designated by the accrediting organization
adulterated product
a product that differs in drug strength, quality, and purity from the original
Affordable Care Act (ACA)
mandated healthcare coverage under threat of personal penalties for all US citizens by 2014
anabolic steroids
synthetic, performance enhancing drugs that mimic the human hormone testosterone; because of abuse by athletes, this drug has been reclassified by the DEA as a controlled substance
bioequivalence
similar strength and outcomes
brand name
the name under which the manufacturer markets patented drug; also known as the trade name
burden of proof
the obligation of a person or party filing a lawsuit to provide enough evidence to prove a case
certification
the process by which a professional organization grants recognition to an individual who has met certain predetermined qualifications
child-resistant container
a medication container with a special lid that cannot be opened by 80% of children under age 5 but can be opened by 90% of adults; designed to prevent child access to drugs to reduce the number of accidental poisonings
civil law
the category of law that concerns citizens and the crimes they commit against each other
controlled substance
a drug with potential for abuse; organized into five schedules of restriction that specify the way the drug must be stores, dispensed, recorded and inventoried
Controlled Substances Act (CSA)
a federal law created to combat and control drug abuse
criminal law
the category of law that addresses broken laws and regulation-offenses against the government as it represents the public
defendant
one who defends against accusations brought forward in a lawsuit
Drug Enforcement Administration (DEA)
the branch of the US Justice Department that is responsible for regulating the sale and use of drugs with abuse potential
Drug Quality and Security Act (DQSA)
an act to create regulatory oversight over small-batch medication compounding
epidemic
a regional widespread contagious disease
ethics
standards of behavior that all professionals are encouraged to follow
Food and Drug Administration (FDA)
the agency of the federal government that is responsible for ensuring the safety and efficacy of food and drugs prepared for the market
Food and Drug Modernization Act of 1997
The federal law that improved the regulation of small batch compounding biological products, medical devices, and food.
four Ds of negligence
include duty, dereliction, damages and direct cause
generic drug
a drug that contains the same active ingredients as the brand name product and delivers the same amount of medication to the body for a similar medicinal effect; acetaminophen is the generic drug for the brand Tylenol
Health Insurance Portability and Accountability Act (HIPAA)
a law passed by Congress that addressed the confidentiality of patient medical records as well as prescription records
Joint Commission
an independent governing body that sets standards for quality patient care and safety in hospitals and other healthcare facilities; this organization is responsible for the accreditation of hospitals
law
a rule that is designed to protect the public and is usually enforced through local, state or federal governments
law of agency and contracts
the general principle that allows an employee to enter into contracts on the employer's behalf
legend drug
a drug that requires a prescription; labeled "Rx only" on medication stock bottle
licensure
the granting of a license by a state board, usually to allow work in a profession to protect the public; all pharmacists must be licensed to practice by their state boards of pharmacy
malpractice
a form of negligence in which the standard of care was not met and was the direct cause of injury
Medicare Modernization Act
the federal law called the Medicare Prescription Drug, Improvement, and Modernization Act, which updated Medicare, added Medical D and C, and required the offer of annual MTM reviews for medicare patients, especially on high-cost drugs or with chronic conditions
methamphetamine (meth)
a highly addictive illegal stimulant made from specific OTC drug ingredients
misbranded product
a product whose label includes false statements about the identity or ingredients of the container's contents
National Association of Boards of Pharmacy (NABP)
an organization that represents the practice of pharmacy in each state and develops pharmacist licensure exams and Model Pharmacy Practice acts
National Council for Prescription Drug Programs (NCPDP)
A non-for-profit organization that issues an NCPDP Provider ID Number to pharmacies and providers of pharmaceuticals doing online transactions
National Drug Code (NDC) number
a unique number assigned to any brand name or generic drug products to identify the manufacturer, drug and packaging size
National Provider Identifier (NPI)
the unique number assigned to the provider by the federal government to allow authorized healthcare providers to process insurance claims for pharmacy reimbursement.
negligence
a tort civil case about carelessness that led to harm to someone else
new drug application (NDA)
the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States
Occupational Safety and Health Administration (OSHA)
an agency of the Department of Labor, whose primary mission is to ensure the safety and health of the US workers by setting and enforcing regulations and standards
orphan drug
a medication approved by the FDA to treat rare diseases
pandemic
a globally widespread contagious disease, or an epidemic that has reached an enormous international effort
patent drug
another name for an over-the-counter (OTC) medication
Patient Safety and Quality Improvement Act (PSQI)
A federal law passed in 2005 dedicated to promoting a culture of patient safety and quality assurance; it created a network of safety databases and the ability to create PSOs
Patient Safety Organizations (PSOs)
groups designed to collect and analyze error data from more than one health provider and offer quality improvement counsel
plaintiff
one who files a lawsuit for the courts to decide upon
professional standards
guidelines of acceptable behavior and performance established by professional associations
reasonable doubt
the standard of proof or evidence that the plaintiff must provide in a case involving crimes against the local, state or federal government
registration
the process of becoming enrolled on a list created by the state board of pharmacy in order to practice
schedule
a listing of controlled substances categorized for a specific level of restriction by the DEA according to their potential for abuse and physical or psychological dependence
standard
a guideline, benchmark, or desired level of quality to serve as the expected norm for a product or professional performace
standard of care
the usual and customary level of practice in the community
state boards of pharmacy
governing bodies responsible for the regulation of the practice of the pharmacy within the states.
statutory law
a law passed by a legislative body at either the federal, state, or local level
subpoena
a legal order
thalidomide
a drug prescribed for pregnant women in other countries in the 1960s, causing birth defects, but the FDA refused approval, saving many children from these effects
tort
the legal term in lawsuits for personal injuries that one citizen commits against another
U.S. Pharmacopeial Convention (USP)
the independent, nonprofit scientific organization responsible for setting and publishing official quality standards for all drugs sold in the US, as well as standards for practice
U.S. Pharmacopeia-National Formulary (USP-NF)
a resource published by the USP Convention that contains USP standards for medicines, dosage forms, drug substances, inactive ingredients, medical devices, and dietary supplements. It includes Chapters <795>, which addresses best practices for nonsterile compounding; <797>, which address sterile and hazardous compounding; and <800>, which addresses hazardous compounding, among other chapters that handle compounding issues
Verified Internet Pharmacy Practice Sites (VIPPS)
an accreditation of quality for Internet pharmacies that is recognized by 17 US cases