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Law Final

QuestionAnswer
General definition of law Requirements for human conduct applying to all persons within their jurisdiction. Provides framework for people to resolve disputes. Socially prescribed process. Remain flexible and vague.
4 market failures Public goods, Externalities, Natural monopolies, Information asymmetry
Definition of public good Necessary and beneficial commodities that private entities will not supply because there is no incentive
Definition of orphan drug Drugs that are sufficiently safe and effective to be marketed, but the # of pts who need them is so small that not commercially feasible for manufacturer to market them
Definition of externality When production or consumption of good affects someone who doesnt fully consent to effect and when costs of good not fully incorporated in the price of good
Definition of natural monopoly When fixed costs of providing a good are high relative to variable costs of producing the good
Who makes up the legislature Elected body of people with the responsibility to enact laws. (congress = senate + house of representatives)
Legislature makes what kind of law? Statutes
Administrative agencies create law through what? Hearings
Who creates administrative agencies Congress
What are the 3 federal administrative agencies that influence pharmacy law? Department of Health and Human Services (DHHS), federal trade commission (FTC) and drug and enforcement administration (DEA)
Definition of information assymetry when consumer is uninformed about the true value of a good
The 2 state level administrative agencies that regulate pharmacy practice State Board of Pharmacy, State Department of Health Services
What is the Federal Register? A document published daily containing proposed and final regulations and notices
What does CFR stand for? Code of Federal Regulations
What is the CFR? A document published yearly that contains final regulations divided and indexed by subject matter
What is the type of law made by the courts called? Judicial opinion
What are the 4 origins of a bill Lobbying groups, citizens, government officials, president
Definition of criminal law Government v. Private party. Use probable cause and grand jury. Burden of proof beyond reasonable doubt.
Definition of civil law Private party v private party. Alleging injury, based on statue or common law legal rights with objective to compensate injured party.
Definition of administrative actions Violation of a statue or regulation or an act that warrants an investigation
What did the Dietary Supplement of Nonprescription Drug Consumer Protection Act (DSHEA) of 2006 do? Implemented mandatory reporting of serious AEs thru MedWatch.
What disclaimer must accompany any structure/function claim a dietary supplement makes? That the FDA has not evaluated the claim, and state the dietary supplement is NOT intended to diagnose, treat, cure, or prevent any disease
USP United States PHarmacopoeia- estabishes approved titles, definitions, and descriptions for drugs. Set standards for identity, quality, strength, purity, packaging, stability, labeling
USPC US Pharmacopeial Convention. Independent of FDA, publishes USP. USPC publishes compendiums used as legal resources of drug standards
USP=NF USP National Formulary Standards, contains monograph of active and inactive ingredients and serves as official compendium for drug standards in the US
USP-FCC Food Chemicals Codex, sets standards for purity and quality of food ingredients, includes preservatives, flavorings, colorings, and nutrients. Published every 2 years
HPUS Homeopathic Pharmacopeia of US. Sets standards for homeopathy products. Regulated by FDCA, recognized by fDA
Class 1 Product recall Issued when reasonable probability that product will cause serious adverse health consequences or death
Class II product recall Occurs when product may cause temporary or medically reversible adverse health consequences but the probability of serious adverse consequences is remote
Class III product recall Applies to products that are not likely to cause adverse health consequences
Medical Device Amendment of 1976 Devices not classified as drugs, required classification of device according to function, premarket approval, establishment or performance standards, conformance with GMP regulations, and adherence to record and reporting requirements
FDCA definition of adulteration prepared, packed, held in conditions where may be contaminated,not made with GMP. Part or whole of any filthy, putrid, decomposed substance. If strength differs or quality below what stated in compendium. Contain unsafe coloring additive
FDCA definition of misbranding Labeling is false or misleading, word or statement not prominently placed, tricky wording used. Label must include: name and place of manufacturing, quantity (weight), measure, proportion active ingredient, name inactive ingredient alphabetical
NDC code 1st 5 digits: manufacturer/distributer. 2nd 4 digits: strength, dosage form, formulation. 3rd segment: package size, type of drug
FDCA definition of new drug Not generally recognized among experts as safe and effective for use
Definition of GRASE Generally Recognized as Safe and Effective: if manufacturer can prove this, their product may not be considerd a new drug
5 ways an approved drug becomes a new drug 1. new substance 2. new combination 3. new proportion 4. new intended use 5. change dosage, method, or duration of administration
Phase I clinical trials Small # of people, to examine basic pharmacology (metabolism, bioavailability, toxicity). Purpose to detect adverse drug effects
Phase II clinical trials Small # of patients who actually have disease. Purpose: determine efficacy of drug and dosage
Phase III clinical trials Large # patients performed in clinical settings; use double-blinded with placebo group. Purpose: safety and efficacy
Process for new drug to become approved drug IND application, if approved or 31 day without FDA rejection, become clinical trials (1-3) and submit NDA
Definition of REMS Risk Evaluation & Mitigation Strategy-risk mgmt program established under FDAAA 2007 to manage patient safety in high risk drugs
Definition of ETSAU Elements to Ensure Safe Use-may be required under REMS to ensure patient safety.
2 Things the Durham-Humphrey Amendment of 1952 did Established 2 classes of drugs (OTC and RX) and authorized oral prescription refills
Expiration Date definition the final day the drug is expected to meet the requirements of USP drug monograph for drug
BUD definition Beyond Use Date: established by pharmacies, drug stability not guaranteed past date, should not exceed exp date
CPA definition Collaborative Practice Agreement: Written contractual agreements in the form of protocols and procedures
NTI Definition Narrow Therapeutic Index: safe and effective use of these drugs require careful titration and patient monitoring
2 things the Prescription Drug Marketing Act of 1987 did 1. Prohibits resale of prescription drugs purchased by hospitals & health systems. 2 wholesale distributors of rxs required to be licensed by the state
Pedigree definition Record containing information on every transaction changing ownership of the drug
3 components of OBRA '90 Rebates, demonstration projects, drug use reviews
What does DUR stand for? Drug use review
3 components of DUR Retrospective review, educational programs, prospective review
What does Pro-DUR stand for? Prospective drug use review
Definition of "best price" The lowest price at which they sell the product to any customer
Definition of AMP Average Manufacturer Price - on average, how much the manufacturer charges the wholesaler in a quarter
OBRA '90 Rebate states... Requires manufacturers to provide drug products to Medicaid program at their best rice
What are the OBRA '90 demonstration projects? OBRA-funded demonstration projects to evaluate whether DUR requirements would result in improved patient care and decreased costs
What are the OBRA '90 Retrospective DUR? Performed by DUR board made up of physicians and pharmacists, review medication trends and data over specified time periods, attempt to evaluate med use
What are the OBRA '90 educational programs? Conferences, face-to-face meetings with prescribers or pharmacists, written materials
3 components of OBRA '90 Pro-DUR Screening, counseling, documentation
Elements of Counseling in Pro-DUR Name/describe drug, form,dose,duration, special precautions, directions for handling & storage, common/severe AE, interactions & CI, self-monitor, refill, missed dose
Elements of Screening in Pro-DUR 7 general categories of potential problems: duplication, Drug-disease int., drug-drug int., allergies, incorrect dose, duration, clinical abuse/misuse
OBRA '90 3 requirements for documentation 1. Name, address, telephone, DOB, gender. 2. Significant individual hx 3. Pharmacist comments relevant to drug therapy
4 Purposes of OBRA '90 documentation requirements 1.Reminder to RPh 2. Reference to other RPhs 3.Show enforcement officials that OBRA'90 requirements being met 4.Show surveyors who need records what was done in connection to outcome of interest
What does HIPAA stand for?
Created by: steponmegrace