NAPSR/CNPR Certification Exam Study Guide 2025

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 The pivotal trial is Phase of the clinical trial. - 3 Secondary wholesale distributors - Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered authorized distributors of the manufacturers within the meaning of the PDMA According to the text, depression is a disease that attacks the: - central nervous system Adendovirus - This vector has a large capacity for foreign genes. The FDA regulates the introduction of new drugs and enforces U.S. drug laws. - true A generic drug is to the originator brand-name drug in dosage, strength, safety, and quality. - bioequivalent Generic drugs are not regulated by the FDA. - false The Orange Book is considered the most authoritative manual on therapeutic . - equivalence The Hatch-Waxman Act is considered the most significant drug-related affecting the pharmaceutical industry since 1962. - legislation First pass metabolism occurs when a drug administered orally is metabolized in the . - Liver Pharmacological studies using animals are regulated under Good Laboratory Practice. - True Monoclonal antibodies are created in laboratories to target the of patients to kill cancer. - cancer cells The best way to deliver health care is through a system. - market based The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for . - clinical trials The FDA approves storage conditions for drug products. - true Patients with leukemia have a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells, which interfere with normal blood cell production - true There are more white blood cells than red blood cells for the same volume in the human body. - false Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein-based. - true The duration for Phase III of the clinical trial can typically last 3-5 years. - true The aim of the Phase IV clinical trial is to examine the safety and effectiveness of the drug in the targeted disease group. - false Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. - true Which of the below terms means "to apply the drug on the skin surface"? - transdermal Diffusion is the random movement of molecules in fluid - true Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient. - false Toxicity information in preclinical studies provides confidence about a drugs safety aspect. - true The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. - true Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - true Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - true PBM's tend to serve a local market through a network of pharmacies. - false The chief motivating force in mergers and acquisitions within the pharmaceutical industry is the desire of one company to acquire and exploit more successfully the brands of another. - false Exclusivity gives exclusive , which is granted by the FDA, and can run concurrently with a patent or not. - marketing rights Drug labels must include indications and usage information, as well as contraindications. - true To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs. - true Traits of Pharma sales Rep - Passion, Go the extra mile, be a resource, be creative, invest in yourself, authentic and real, love what they do, focus on service, cultivate support, believe, focus, macro-thinking, KIT, ask, keep accurate records Factors that influence DTC - the growth of managed care organizations, A more hollistic prevention-oriented definition of health, More mainstream acceptance, AIDs activism and patients rights movement, the availability of OTCs, the direct and targeted marketing revolution, the emergence of the internet, the heightened competitive arena, aging baby boomers Gifts - PhRMA Code prohibits no educational items pg 228 PhRMA Code - Now prohibits pens, mugs, objects with company logo AMA gift Guidelines - pg 231 Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value - true Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work - true Subsidies should not be accepted to pay for the costs of travel, lodging, or other personal expenses. Paying for a modest meal is OK - true PhRMA FAQ - pg 240 Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - true Medicare part D - pg 225 Organizing your Day - pg 307 Rebates are also referred to as after-market arrangements. - true Patents are applied for with, and granted by the FDA. - false Patents expire after how many years from the date of filing? - 20 years Generic drugs are not regulated by the Food & Drug Administration. - false The most reliable source of information for determining therapeutically equivalent drug products are - Orange Book Pharmaceutical representatives will typically store and secure their own drug samples - True Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount. - true The federal government does not regulate the drug sampling for a pharmaceutical representative - false Storage conditions for drug products are based on data and information supplied by the manufacturer - True Drug recalls are almost always negotiated with the FDA beforehand. - true The PDMA is the Prescription Drug Manufacturers Association. - False Primary wholesale distributors buy most of their drugs directly from - Manufacturers The AWP is a published price, suggested by drug manufacturers. - wholesale It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. - true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - false Brands should be: - Easy to pronounce, easy to write and read, memorable, distinctive and different from competition formulation - The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms: The greatest challenge for a generics manufacturer is to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug. - true "Pull through" refers to: - generating demand for your company's product Which of the following is not a part of the Seven Step Cascade of Emotion? - be a consultant, not a rep Which is a step to becoming an indispensable pharmaceutical sales rep? - asking feedback Which is not a step to plan for rumors? - counter attack According to the text, which of the following is considered "going to the next level?" - staying focused clinical effect - The response produced by a medication tertiary care - Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center Literally "disease producer": - pathogen A type of blood cell that helps the body fight infection and disease: - white blood cell Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume: - declining A low supply of oxygen due to low blood flow is - ischemia Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - true The acronym for pharmacokinetics is: - PK According to the text, there are classes of therapeutic drugs - US federal govt Another name for biologic compound is: - large molecule SS is an abbreviation for: - semi doses The is used to determine appropriate medical reimbursement. - coding system The origin, or cause, of a disease or a patient's symptoms: - etiology Where the tolerance of one medication may result in increased tolerance of another medication? - cross tolerance The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues, organisms: - pharmacology A substance that enhances the action of a drug or antigen: - adjuvant A site in the body which generally resides on a cell surface or within the cytoplasm. When stimulated or occupied, a biological change/activity takes place: - receptor Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. - true In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician. - true DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S. - true The most effective method for grabbing market share is: - comparative selling Subjects for clinical trials are selected on the basis of - scientific objectives The "road map" for a clinical research paper is called the . - abstract Pharmaceutical reps should thoroughly read sections of clinical studies when results are released. - all The three major areas in which biologics are used are prophylactic, , and replacement therapy. - therapeutic Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and . - individuals The key areas in hospitals that require special selling tactics are , formulary committee, and the medical education department. - pharmacy department The more a patient is asked to pay for his/her medication, the greater likelihood that he/she will refuse to fill the prescription, pr will not take the medication properly. - true Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources. - true Typically it only takes 1-2 calls to an individual physician before you can successfully get a physician to commit to prescribing your drug or product. - false One of the most disappointing results of the pharmaceutical industry's continued investment in R & D is the few number of new drugs being approved and in development. - false The extent, quality, or degree to which a substance is poisonous or harmful to the body. - toxicity The US accounts for about of all the world's pharmaceutical revenues. - 50% Specialty care products are often prescribed by generalist physicians. - false Among the biotechnology medications under development, about target cancer. - 50% A is an inactive medication with no treatment value, used in experimental studies. - placebo Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - true PBM's tend to serve a local market through a network of pharmacies. - false The chief motivating force in mergers and acquisitions within the pharmaceutical industry is the desire of one company to acquire and exploit more successfully the brands of another. - false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify - true DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - true