CNPR Final Exam 2025 Graded A

Pharmaceuticals - medicines and vaccines for human and animal use. products may have a brand name or be generic, and they may be prescription or OTC Diagnostic - equipment and supplies used in screening, detecting, and monitoring disease. can range from simple home testing kits to sophisticated imaging technologies Medical devices - advanced instrumentation and appliances used for medical therapy, such as joint replacements, implantable defibrillators, and pacemakers. Also includes drug delivery devices such as syringes, infusion pumps, metered dose inhalers, and trans-dermal patches Medical supplies - Commodity, high-volume supplies such as surgical gowns and gloves Durable medical equipment - reusable products for health-related use in the home such as walkers, wheelchairs, oxygen equipment, prosthetics, hospital beds Home-Based Care - Patients/consumers and their families and friends home health nurses and aides Primary Care (checkups and general health issues) - OB/GYN family/general practitioners internists Secondary Care (specialized outpatient consults) - specialists Tertiary Care (inpatient) - community hospitals academic medical centers skilled nursing facilities End-stage care - skilled nursing facilities hospitals hospices HMO - Health Maintenance Organization PBM - Pharmacy Benefit Manager act as intermediaries between pharmaceutical companies and large drug purchasers GMP guidelines - good manufacturing practices What is the average review time for a new drug? - 18 months DM - district manager RM - regional manager NAM - national account manager manufacturing & operations - this includes the supply chain, manufacturing trade, and distribution functions of the business In 2012 the FDA approved new drugs for use in the US (highest number since 1996) - 39 new treatments have been approved for Hep C - 2 new treatments for Alzheimer's disease are in development - 125 medicines are in development for cancer - 3070 new medicines are in development for diabetes - 281 new medicines are developed for HIV/AIDS - 185 approvable letter - letters sent by the FDA to the applicant indicating whether the new drug application meets necessary requirements asymptomatic - without signs or symptoms of disease edema - swelling indication - in terms of drug approval, the exact cause of purpose for which the FDA has approved that a drug can be prescribed IRB (institutional review board) - a committee of physicians, statisticians, community advocates, and others which ensures that a clinical trial is ethical and the rights of study participants are protected anatomy - the study of the basic structures of the body physiology - the study of how those body structures function clinical pharmacology - the study of the effects and movement of drugs in the human body pharmacodynamics - the study of what a drug does to the body pharmacokinetics - study of how a drug is processed by the body drug distribution and elimination - drug delivery systems, routes of administration, modes of excretion MAR - medication administration record AEs - adverse events ADME - testing that measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material, and then excretes it from the body drug kinetics - what the body does to the drug drug dynamics - what the drug does to the body 1st right of drug administration - right patient 2nd right of drug administration - Right medication 3rd right of drug administration - right dose 4th right of drug administration - right route of administration 5th right of drug administration - right time of delivery ASAP order - within 30 minutes of written order granules - small pill, usually accompanied by many others encased within a gelatin capsule tablet - made by compressing the powdered form of a drug and bulk-filling material under high pressure capsule - drug is contained in an external shell enteric coating - covering that keeps drugs from dissolving in the stomach and do not dissolve until they reach the intestine caplet - shaped like a capsule but has the form of a tablet elixir - a drug vehicle that contains water, alcohol, and sugars fluid extracts - concentrated solution of a drug removed from a plant source by mixing ground parts of a plant with a suitable solvent, and then separating the plant residue from the solvent mixtures/suspensions - an agent is mixed with a liquid but not dissolved tinctures - alcoholic preparations of a soluble drug spirits/essences - alcohol-containing liquids that may be used pharmaceutically as solvents liniments - liquid suspensions for external application to the skin to relieve pain and swelling gels or jellies - semisolid substances in non fatty bases that may be used for topical application emulsion - preparation in which two agents cannot be ordinarily combined or mixed receptor - a molecule with a specific three dimensional structure to which only very specific substances can fit and attach agonist - drugs that activate receptors antagonist - drugs that block receptors potency - refers to the amount of drug needed to produce an effect efficacy - refers to the potential maximum therapeutic response a drug can produce pharmacogenetics - the study of genetic differences in the response to drugs N-acetyl transferase - a liver enzyme that metabolizes certain drugs (for half of the people in the US works slowly) slow acetylators - drugs that are metabolized by this enzyme (N-acetyl) tend to reach higher levels and remain in the body longer than fast acetyls duplication - when two drugs with the same effect are taken (a drug-drug interaction) opposition (antagonism) - two drugs with opposing actions (drug-drug interaction) alteration - one drug may alter how the body absorbs, distributes, metabolizes, or excretes another drug drug-disease - refers to the worsening of a disease by a drug Type A (augmented adverse reaction) - involves an exaggeration of the drug's therapeutic effects Type B (idiosyncratic adverse reaction) - results from mechanisms that can not currently understood ex. skin rashes, jaundice, anemia, etc. Type C (chronic adverse reaction) - persists for a long time Type D (delayed adverse reaction) - take some time to develop Type E (end of use adverse reaction) - occur during drug withdrawal API - active pharmaceutical ingredient two basic categories: chemical and biological exicipents - inert ingredients in a drug formulation includes fillers, dyes, and flavors strength - refers to the amount of active pharmaceutical ingredient in the drug binders (excipient class) - cement the active and inert components of tablets together to maintain cohesive proportions fillers (excipient class) - used to make the drug sufficiently large for easy manufacture/patient consumption suspending/ dispersing agents (excipient class) - maintain a consistent concentration of the active ingredient through a drug product disintegrates (excipient class) - help break up tablets in the gastrointestinal tract to ensure full release of the pharmaceutical active ingredient lubricants (excipient class) - ease the release of tablets from the dyes that stamp them during the manufacturing process compression aids (excipient class) - help pills hold their shape when compressed printing inks (excipient class) - biologically safe dyes used for printing information on the exterior of tablets or capsules film former/coatings (excipient class) - protect against physical breakup, mask taste, etc. AUC - area under the curve, represents the extent of drug absorption or the quantity of a drug that appears in the bloodstream following oral administration BID - twice a day Bioavailability - the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug product and becomes available at the intended site of drug action cmax - peak plasma concentration on a measuring curve CNS - central nervous system CSF - cerebrospinal fluid duration of action - time interval within which a given dose of a drug is expected to have a therapeutic effect first pass effect - the metabolizing process in the liver that suppresses the amount of drug that eventually reaches the systemic circulation and the site of action lipid-soluble - ability to dissolve in lipids or fat tissue PRN - as needed QD - once a day TID - three times a day tmax - time of peak plasma concentration on a measuring curve titration - the process of adjusting drug doses to achieve maximum positive therapeutic effects while minimizing adverse/side effects Margin of safety - the difference between the usual effective dose and the dose that induces severe or life threatening side effects Rights of drug administration - right patient, right medication, right does, right route of administration, and right time of delivery Injection routes - intramuscular, intrathecal, intravenous, subcutaneous intramuscular - drugs given by direct injection into muscle tissue intrathecal - needle is inserted between to vertebrea in the lower spine an into space around the spinal cord intravenous - injected directly into the veins subcutaneous - needle inserted into the fatty tissue just beneath the skin Bioavailablility - how quickly and how much of a drug reaches its intended target site of action Bioequivalent - when drugs contain not only the same active ingredients but also produce virtually the same blood levels over time Therapeutic equivalence - production of the same medicinal effects Areas of drug elimination and excretion - Lungs, breast milk, sweat tears urine feces, bile, saliva, and exhaled air medication error - failure to administer drug in the correct form Powders - a drug that is dried and ground into fine particles pills - a single dose unit of medicine made by mixing the powdered drug with liquid such as syrup and rolling it into a round or oval shape granules - a small pill usually accompanied usually accompanied by many others encased within a gelatin capsule; quite often releasing medication over time tablet - pharmaceutical preparation made by compressing the powdered for of a drug and bulk filling material under high pressure; commonly used for anti acids and antiflatulents Capsules - medication dosage form in which the drug is contained in an external shell; can be pulled apart for access to contents sustained release - several doses of a drug in special coatings that dissolve at different rates Enteric Coating - dosage in special coating that doesn't digest in the stomach; only starts to digest in the intestines caplets - shaped like a capsule but has the form of a tablet the shape and file make swallowing easier gel caps - an oil based medication that is enclosed in soft gelatin capsule Emulsion - two agents that cannot ordinarily be combined or mixed otic drugs - control localized infections or inflammation and require very low dosages to be effective Types of drug despensing - OTC and prescription Type A (Augmented) drug reaction - exaggeration of the drug's therapeutic effects Type B (idiosyncratic) - results from mechanisms that are not currently understood; largely unpredictable Type C (continuing or chronic) - These persist for a long time Type D delayed - these take some time to develop Type E end of use - These occur during drug withdrawal Risk Factors - Use of several drugs, age, Pregnancy and breast feeding Excipients - inactive ingredients Parenteral - intravenous, intramuscular, subcutaneous Rectal - suppository Oral - tablet, capsule, liquid Transdermal - through the skin via creams or patches Binders - cement the active and inert components of tablets Fillers - used to make the drug sufficiently large for easy manufacture and consumption Glidants(flow enhancers) - added to powdered materials used in pill production to aid movement through tabletting machinery suspending/dispersing agents - maintain consistent concentration of the active ingredients throughout the drug product disintegrants - help break up the tablets int the GI tract Lubricants - ease the release of the tablets from the dies that stamp them during the manufacturing process AUC - represents the extent of the drug absorption or the quantity of the drug that appears in the bloodstream following oral administration Cmax - peak plasma concentration on a measuring curve First pass effect - metabolizing process in the liver that suppresses the amount of drug that eventually reaches the systemic circulation and the site of action onset of action - the time it takes for a drug to start having any intended affect after it is administered Protein Binding - the ability of certain drugs to bind to plasma protein QD - once a day QID - four times a day PRN - take as needed TID - three times a day Tmax - time of peak plasma concentration on a measuring curve BID - twice a day Authorized distributor - any distributor of a prescription drug that has a written agreement with the manufacturers of the prescription drug and conducts at least two transactions with the manufacturer of the prescription drug within any 24-month period Average whole price (AWP) - published whole sale price or list price suggested by the manufacturer Brokerage - the combination of -drop ship and dock to dock delivery services provided by wholesalers. Wholesalers do not bring the product into their warehouses Buy-side margin - refers to the early payment discounts and other earned or negotiated rebates and discounts received by wholesalers from drug manufacturers; increase in the value of wholesalers' inventories ad manufacturers' prices rise chain drug store - a company that owns and operates four or more pharmacies dock to dock delivery - wholesaler obtains the drugs to a dispenser own warehouse without taking the drugs into its own inventory drop shipment - the drug manufacturer directly delivers the drugs to a dispenser but the order and payments are made through a wholesaler Float - the time differential between when a wholesaler receives payment from its customer and when the payment is due to its supplier Group Purchasing Organization GPO - an entity consisting of two or more hospitals or other healthcare entities that is formed to offer its members access to purchasing contracts for health supplies In-state wholesaler - wholesaler that distributes drug products in a state in which it is physically located independent drug store - a company that owns and operates three or fewer pharmacies Integrated Delivery Network IDN - a financial management structure that unites hospitals, physicians ambulatory care site and managed care plans through ownership or exclusive formal agreements to provide a system to deliver a continuum of healthcare services Mail order pharmacy - a pharmacy that dispenses prescriptions to patients who submit their prescriptions by mail or fax manufacturer direct sale - the type of sale that bypasses the need for any intermediary distributor mass merchandiser - Department stores with a pharmacy non-stock sales - brokerage sales, dock to dock sales, drop shipments, and any form of sale not placed in inventory out of state wolesaler - a wholesaler that distributes drug products in a state in which it is not physically located pharmacy benefit management group - an entity that administers the prescription drug part of health insurance plans on behalf of plan sponsors such as self insured employers, insureance companies, and health maintenance organizations rebate - the amount that the manufacturer of the drug pays to an insurer or health plan for each unit of drug dispensed self warehousing - a type of distribution system where the retailer of the institutional dispenser takes on the task of distribution itself sell-side margin - wholesaler revenues that are generated from fees and other charges obtained from dispensers Upcharge - the percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution Orphan Drug (ODE) ` - 7 years exclusivity New Chemical entity - 5 years exclusivity Other Exclusivity - 3 years for a change if criteria are met Pediatric Exclusivity (PED) - 6 months added to existing Patents/exclusivity Patent Challenge - 180 days for ANDAs only Duration of a patent - 20 years Package insert - provide practitioners with essential information they need to prescribe the drug safely and effectively for the care of patients Orange Book - list of approved drug products with therapeutic equivalence A OBR - products for which there are no known or suspected bioequivalence problems AA OBR - products in conventional dosage forms with no bioequivalence problems AN OBR - solutions and powders AO OBR - Injectable oil solutions AP - injectable aqueous solutions AT - topical products B - drug products requiring further FDA investigation and review to determine equivalence ANDA - abbreviated new drug application How many days does a brand name company have to sue - 45 Generic drug first to file exclusivity - the first generic drug manufacturer to file an ANDA with the FDA on a new off-patent drug receives a six-month marketing exclusivity Single-source drug products - there is only one approved product available for that active ingredient and dosage form Multi-source drug prodcuts - pharmaceutically equivalent products are available from more than one manufacturer Hatch Waxman act - also known as the drug price competition and patent tem restoration act of 1984 most significant drug related legislation affecting pharmaceutical and healthcare industries since 1962 HW Act - made it easier to bring generic drugs to the market by requiring the FDA to only look at bioavailability studies in order to approve an ANDA chemical equivalents - multi-source products which contain essentially the same amounts of identical active ingredients in identical dosage forms which meet existing physical chemical standards Biological equivalents - chemical equivalents which when administered in the same amount will provide same biological or physiological availability as measured by blood and urine levels therapeutic equivalents - chemical equivalents which when administered in the same amount will provide same therapeutic effect as measured by the control of a symptom or disease generic substitution - the act of dispensing a different brand for the product prescribed pharmaceutical alternatives - drug products that have the same therapeutic effect and strength but differ in the salt, ester or dosage form and are administered by the same rout pharmaceutical substitution - the act of dispensing a pharmaceutical alternative for the product prescribed Therapeutic alternatives - drug products containing different therapeutic moieties but of the same pharmacological or therapeutic class can be expected to have similar therapeutic effects when administered in therapeutically equivalent doses PDMA - product development and management association drug sample - unit of drug not intended to be sold but to promote the sale Section 503 of Federal food drug and cosmetic act - prohibits the sale, purchase, trade or offer to sell, purchase or trade prescription drug samples and coupons USP US pharmacopoeia - the first comprehensive publication of drug standards USP-UF US Pharmacopoeia - National Formulary - current annual publication of certified drug standards verifying purity and ingredients Office of inspector general - an arm of the department of health and human services that investigates regulatory infractions, provides compliance advice and bring enforcement actions Federal trade commision - regulates general business practices to protect consumers against misleading and anti-competitive behavior Drug enforcement administration - regulates the distribution and use of narcotics and other controlled substances A patent owner has the right to exclude others from making, using, selling or importing into the US the it describes. - invention Which is not a rule in making the most out of your sales call? - your agenda not theirs Clinical Pharmacology - The study of the effects and movement of drugs in the human body The acronym for effective dose is: - ed Customers purchase products from people they like, trust, and respect. This is the: - likeability PLasma - The liquid portion of the blood that carries proteins and other substances Drug distribution & elimination - Drug delivery systems, route of administration , modes of excretion. Pathology - The practice of medicine dealing with the causes and nature of disease/death internist - is a physician that practices internal medicine new meds are in development for cancer - 3070 smalle molecule - A term used to refer to drugs that are non-biological (that is, chemical) in nature: IDN - integrated delivery network SS - Used when referring to medication dosage, means "one-half": medicare part D - New prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act: ophthamology therapy - Oral Glaucoma Therapy is classified as: The meaning of subcutaneous is: - beneath outer skin ex vivo - Outside a living body: Refers to medication dosage, means "hour": - h physiology - The study of how those body structures function Pharmetrics - impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal What do retail pharmacists do? - dispense pharmaceuticals Proteins - A nutrient made up of of chains of amino acids Functional Values - Efficacy, safety, convenience, cost-effectiveness Branding - strengthens bond between buyer and seller; competition differentiation pg 198 PhRMA Code on relationionships - pg 233 Brand values - functional values, expressive values, central value Functional values - what the brand does for me Expressive values - what the brand says about me central values - what the brand and I share at a fundamental level gene therapy types - Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA Exclusivity is granted for an orphan drug for - 7 years Nursing Structures - pg 268 Director of nursing - BSN MSN Unit manager with 24 hour responsibility for unit - RN, BSN Case Manager risk manager/infection control - RN, BSN House supervisor, works off shift - RN Charge Nurse oversees shift in unit - RN Clinical Care - RN Oral medication - LPN Protocol - This document sets out how a trial is to be conducted Exclusivity is granted for an orphan drug for years. - 7 Absorption methods - Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous Transport Mechanisms - Passive diffusion, facilitated diffusion, active transport, pinocytosis The agency which regulates the distribution and use of narcotics and other controlled substances is . - DEA The most important benefit of electronic prescribing is related to patient . - safety Which one of the below terms is not a route for excreting a drug from the body? - Heart The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies. - False Bioavailability - how quickly and how much of a drug reaches its intended target site of action Fats - A nutrient stored in special body tissues as a great source of reserve energy Carbohydrates - A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. travel time - What is one of the biggest time wasters for a pharmaceutical sales rep? Metabolism - How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Excretion - How the drug is eliminated from the body. Usually drugs are eliminated via urine. They can also be excreted through the lungs, skin, or breast milk. The heart of a pharmaceutical sales team is the - territory sales rep Average wholesale price (AWP) - Published wholesale price of list price suggested by the manufacturer. Half-life - Period of time it takes for a specific amount of drug in the body to be reduced, through the excretion or elimination process, to exactly one-half that original amount One of the oldest and least effective pharmaceutical marketing techniques is the direct- to-consumer advertising. - false A formulary is a list of prescription drugs approved by insurance coverage. - true