The Importance of Effective Communication in the Workplace, Exams of Nursing

Download The Importance of Effective Communication in the Workplace and more Exams Nursing in PDF only on Docsity! NAPSRX/CNPR EXAM 2 Questions And Correct Answers Verified Latest 2024-2025 Guaranteed Pass Grade A + UPDATED!! Drug Discovery - ANSWER>>• Unlike small molecule drugs (pharmaceuticals), large molecule drugs (biopharmaceuticals) are mainly protein-based o These protein-based drugs are similar to natural biological compounds found in human body or they're fragments that mimic active part of natural compounds Discovery of Pharmaceuticals - ANSWER>>commences w/ scanning hundreds of compounds, whether w/ actual materials (irrational approach) or virtual simulations (rational approach) • Pharmaceuticals are new chemical entities (NCE) and are produced (synthesized) in manufacturing plants using techniques based on chemical reactions of reactants Discovery of Biopharmaceuticals - ANSWER>>researchers have to examine compounds w/in humans o Ex. Hormones or other biological response modifiers and how they affect biological processes o In some cases, study pathogens such as influenza virus or bacteria to derive vaccines o In other cases, researchers copy these biological response modifiers and use them as replacement therapy o Protein-based drugs are manufactured in biological systems, such as living cells, producing desired protein molecules in large reaction vessels or by extraction from animal serum o Becoming increasingly important • More potent and specific—more similar to proteins w/in body therefore more effective in treating our diseases Areas of Biopharmaceuticals - ANSWER>>• Prophylactic→ preventive as in vaccines • Therapeutic→ antibodies • Replacement therapy→ hormones, growth factors Biologics - ANSWER>>FDA definition is: o Biological product subject to licensure under Public Health Service Act is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, a blood component or derivative, allergenic produce, or analogous product, applicable to prevention, treatment or cure of diseases or injuries to humans. Biological products include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology, such as interferons and erythropoietins. Biologics encompass many different protein-based drugs, and include blood products such as clotting factors extracted from blood. Vaccines - ANSWER>>• Basis of vaccination is that administering small quantity of a vaccine (antigen that has been treated) stimulates our immune system and causes antibodies to be secreted to react against foreign antigen Subunit Vaccines - ANSWER>>• Use only part of bacteria or virus instead of entire pathogen • Part is derived from outside envelope protein of pathogen • Requires knowledge of genome sequence of pathogen by identifying open reading frames (ORF) that potentially encode novel antigenic surface proteins known as epitopes, which bind to antibodies • When identified, ORFs are cloned to express protein epitopes using self-replicating plasmids • Binding properties of epitopes can be studied using enzyme linked immunosorbent assay (ELISA) or fluorescent activated cell sorter (FACS) • Leading candidates of epitopes are injected into animals to determine whether they elicit any antibody response o Those that work are selected and optimized to become vaccine candidates w/ further tests before human clinical trials o Also working on multiple epitope subunit vaccines which can provide different antigenic binding sites Vector-based Vaccines - ANSWER>>• Viruses and bacteria are detoxified and used as vehicles to carry vaccines • Subunit vaccines are being delivered by carrier vehicles to elicit immune response • Multiple types of envelope proteins can be delivered w/ this method • Clinical trials w/ this type of vector-based vaccines are being investigated DNA Vaccines - ANSWER>>• Aka nucleic vaccines or genetic immunization • Host (patient) is directly injected w/ selected viral genes which contain engineered DNA sequences that code for antigens • Hosts own cells take up these genes and express antigens which are then presented to immune cells and activate immune response Peptide Vaccines - ANSWER>>• Chemically synthesized and normally consist of 8-24 amino acids • Relatively small • Aka peptidomimetic vaccines as they mimic epitopes • Complex structures of cyclic components, branched chain or other configurations can be built into peptide chain • They possess conformations similar to epitopes and can be recognized by immune cells • An in silico vaccine design approach has been used to find potential epitopes • Critical aspect of peptide vaccines is to produce 3D structures similar to native epitopes of pathogen Adjuvant - ANSWER>>• Vaccines formulated w/ certain substances to enhance immune response • Latin adjuvare→ to help • Most common adjuvants for humans are aluminum hydroxide, aluminum phosphate and calcium phosphate • Others include bacteria and cholesterol • Mineral oil emulsions normally adjuvants used in animal studies • Adjuvant known as Freund's Complete Adjuvant consists of killed tubercle bacilli in water-in-mineral oil emulsion • Freund's Incomplete Adjuvant is water-in-oil emulsion • Both effective in stimulating immune response but cause unacceptable side effects in humans 3 Mechanisms Adjuvants Help Immune Response - ANSWER>>• Adjuvants help immune response by forming reservoirs of antigens and providing sustained release of antigens over long period • Adjuvants act as non-specific mediators of immune cell function by stimulating or modulating immune cells • Adjuvants can serve as vehicles to deliver antigen to spleen and/or lymph nodes where immune response is initiated Alzheimer's Disease - ANSWER>>• Vaccine being tested contains small protein called B amyloid (AB) o This protein forms abnormal deposits or "plaques" in the brains of individuals w/ Alzheimer's o It's believed that AB deposition Causes loss of mental fxn by killing brain neurons o AB vaccination stimulates immune system to clean up plaques and prevent further AB deposits o Phase II clinical trial was halted because 15 of 360 patients developed severe brain inflammation • Studies showed that AB did generate desired antibody response • Acceptable vaccine may still be possible by modifying epitope to reduce inflammation effects Pneumococcal - ANSWER>>• In Oct 2006, FDA approved use of Prevnar for immunization of infants and toddlers against otitis media middle ear infection Human Immune System - ANSWER>>• Remarkable system for combating foreign substances that invade body • Protects us from infections by pathogens such as viruses, bacteria, parasite and fungi • Important aspect of immune system is self-non-self recognition fxn by means of markers present on protein called major histocompatibility complex (MHC) o Substances w/out such markers are discerned and targeted for destruction • For some, immune system lacks normal discrimination capability and revers to attack and destroy their own body cells as if they're foreign o Gives rise to autoimmune disease such as rheumatoid arthritis, diabetes, MS, and lupus o Also occasion when immune system response w/ undue sensitivities to innocuous substances such as airborne pollen leading to allergies as in case of asthma and hay fever • Immune responses are mediated through lymphocytes called B cells and T cells o Lymphocytes are particular type of white blood cells o White blood cells (leukocytes) are dividted into granulocytes (neutrophils 55-70%, esosinophils 1-3% and basophils .5-1%) and agranulocytes (lymphocytes {B and T cells} 20-40% and monocytes 1- 6%) o There are 5000-10000 white blood cells per mL of blood compared w/ 5 million red blood cells in same volume • When pathogens enter human body, cells called macrophages (big eaters) engulf and ingest pathogens (antigens) o Antigens are processed by macrophages and parts of antigens are displayed on surface in form of short peptide chains bound to MHC protein o These antigen-presenting cells (APC) of macrophages and dendritic cells activate immune response by sensitizing B and T cells Cytokines - ANSWER>>• Produced mainly by leukocytes (white blood cells) • Potent polypeptide molecules that regulate immune and inflammation fxns as well as hemopoesis (production of blood cells) and wound healing • 2 major classes o Lymphokines and monokines • Cytokines produced by lymphocytes are lymphokines • Interferons (IFN) and interleukins (IL) • Cytokines produced by monocytes are monokines • Other interleukins and tumor necrosis factor (TNF) • Different types of white blood cells o Growth factors Hormones - ANSWER>>• Intercellular messengers • Typically steroids (control level of water and salts excreted by kidney), polypeptides and amino acid derivatives • Maintain homeostasis Insulin - ANSWER>>• Produced in pancreas by B cells in region called islets of Langerhans • Polypeptide hormone consisting of 2 chains: A chain w/ 21 amino acids w/ internal disulfide bond and B chain w/ 30 amino acids • 2 disulfide bonds joining these 2 chains together • Molecular weight is around 6.8 kDa • Regulates blood glucose level w/in narrow range of 3.5-8mmol/L of blood • Originally obtained from porcine and bovine extracts o Bovine insulin differs from human insulin by 3 amino acids and it can elicit antibody response that reduces its effectiveness o Porcine insulin differs in only 1 amino acid • Enzymatic process can yield insulin identical to human form • Insulin is produced via rDNA process it was first recombinant biopharmaceutical approved by FDA (early 1980s) o Removes reliance on animal sources of insulin and ensures that reliable and consistent insulin is manufactured under controlled manufacturing processes Human Growth Hormone (hGH) - ANSWER>>• Polypeptide w/ 191 amino acids • Secreted by pituitary gland • Stimulates production of insulin-like growth factor 1 (IGF-1) from liver • Positive effects of hGH are mediated by IGF-1 system which also includes specific binding proteins • Major fxn is promotion of anabolic activity due to increase in metabolic processes • Biological effects of hGH are stimulation of protein synthesis, elevation of blood glucose level and improvement of liver fxn o To date, FDA hasn't approved any gene therapy product o Number clinical trials are in progress o Ethical considerations for gene therapy Gene Therapy Techniques - ANSWER>>o In vitro method • Some of patients tissues which have genetic fault are removed • Cells are selected from these tissues and normal genes are loaded into cells w/ vectors • Modified cells are then returned to patient to correct genetic fault o In situ method • Genes encapsulated by vectors are injected directly into tissues to be treated • w/ both methods, genes are first loaded onto vectors and a number of vectors are used Retrovirus - ANSWER>>• preferred vector for gene therapy • integrates genes to host chromosomes, chance of long-term stability. • Major disadvantage is that integration is random, mostly on dividing cells Adenovirus - ANSWER>>vector for gene therapy has large capacity for foreign genes • Disadvantage is that it has transient fxn of genes Adeno-associated virus - ANSWER>>• vector for gene therapy • integrates genes to host chromosomes • Major disadvantage is that it has small capacity for foreign genes Liposomes - ANSWER>>• vector for gene therapy • doesn't have viral genes so they do not cause disease • Much less efficient than viruses Naked DNA - ANSWER>>• vector for gene therapy • do not have viral genes so do not cause disease • Major disadvantage is that its an inefficient gene transfer Gene Therapy Trials - ANSWER>>• First gene therapy trial was conducted in Sept 1990 o 4 year old girl w/ SCID (Bubble Boy syndrome) treated in Cleveland, OH and is still doing well 10yrs after treatment o Another girl w/ same disorder underwent gene therapy and is also doing well • More than 400 gene therapy clinical trials have been conducted, mainly on cancer, but not many cases worked o in 1999, 18 yr old boy in Pennsylvania unexpectedly died from reaction to gene therapy when he was treated for metabolic disease • This trial raised many issues and many trials w/ discrepancies and unreported adverse events were suspended by FDA • FDA has since introduced tighter controls for gene therapy trials Stem Cell Categories - ANSWER>>Totipotent Pluripotent Multi-potent Totipotent - ANSWER>>• Stem Cells • Obtained from embryos that are less than 5 days old • Have full potential to develop into another individual and every cell type • After 5 days and several cycles of cell division, totipotent cells form hollow sphere of cells called blastocyst • Blastocyst has outer layer of cells surrounding clusters of cells • Those cells on outside continue to divide and grow into placenta and supporting tissues Pluripotent - ANSWER>>• Stem cells • Clusters of cells on inside divide and form virtually all cell types except placenta and supporting tissues which give rise to human being • Continue to develop, differentiate, and specialize into different cells • Become the specialized stem cells (blood, skin, and nerve stem cells) Multi-Potent - ANSWER>>• Differentiated stem cells • They have potential to produce specialized cells Avenues for Stem Cell Research - ANSWER>>o Pluripotent • Obtained by 2 methods: • Harvest clusters of cells from blastocysts of human embryos • Isolation of pluripotent cells from fetuses in terminated pregnancies o Multi-potent • Derived from umbilical cords or adult stem cells • Because of specialization of these cells, their potential to develop into myriad of different cells is limited o Burning issue is ethics of obtaining pluripotent stem cells from embryos and fetuses Autologous Transplant - ANSWER>>patient donates bone marrow or stem cells before treatment for reinfusion later. This happens when patient is receiving radiotherapy or chemo in such high dose that bone marrow is destroyed. Bone marrow stem cells collected previously are reinjected into patient to reinforce immune system Pharmaceuticals - ANSWER>>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 - ANSWER>>equipment and supplies used in screening, detecting, and monitoring disease. can range from simple home testing kits to sophisticated imaging technologies Medical devices - ANSWER>>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 - ANSWER>>Commodity, high-volume supplies such as surgical gowns and gloves Durable medical equipment - ANSWER>>reusable products for health- related use in the home such as walkers, wheelchairs, oxygen equipment, prosthetics, hospital beds Home-Based Care - ANSWER>>Patients/consumers and their families and friends home health nurses and aides Primary Care (checkups and general health issues) - ANSWER>>OB/GYN family/general practitioners internists Secondary Care (specialized outpatient consults) - ANSWER>>specialists Tertiary Care (inpatient) - ANSWER>>community hospitals academic medical centers skilled nursing facilities End-stage care - ANSWER>>skilled nursing facilities hospitals hospices HMO - ANSWER>>Health Maintenance Organization PBM - ANSWER>>Pharmacy Benefit Manager act as intermediaries between pharmaceutical companies and large drug purchasers GMP guidelines - ANSWER>>good manufacturing practices What is the average review time for a new drug? - ANSWER>>18 months DM - ANSWER>>district manager RM - ANSWER>>regional manager NAM - ANSWER>>national account manager manufacturing & operations - ANSWER>>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) - ANSWER>>39 ______ new treatments have been approved for Hep C - ANSWER>>2 _______ new treatments for Alzheimer's disease are in development - ANSWER>>125 ______ medicines are in development for cancer - ANSWER>>3070 _____ new medicines are in development for diabetes - ANSWER>>281 ____ new medicines are developed for HIV/AIDS - ANSWER>>185 approvable letter - ANSWER>>letters sent by the FDA to the applicant indicating whether the new drug application meets necessary requirements tablet - ANSWER>>made by compressing the powdered form of a drug and bulk-filling material under high pressure capsule - ANSWER>>drug is contained in an external shell enteric coating - ANSWER>>covering that keeps drugs from dissolving in the stomach and do not dissolve until they reach the intestine caplet - ANSWER>>shaped like a capsule but has the form of a tablet elixir - ANSWER>>a drug vehicle that contains water, alcohol, and sugars fluid extracts - ANSWER>>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 - ANSWER>>an agent is mixed with a liquid but not dissolved tinctures - ANSWER>>alcoholic preparations of a soluble drug spirits/essences - ANSWER>>alcohol-containing liquids that may be used pharmaceutically as solvents liniments - ANSWER>>liquid suspensions for external application to the skin to relieve pain and swelling gels or jellies - ANSWER>>semisolid substances in non fatty bases that may be used for topical application emulsion - ANSWER>>preparation in which two agents cannot be ordinarily combined or mixed receptor - ANSWER>>a molecule with a specific three dimensional structure to which only very specific substances can fit and attach agonist - ANSWER>>drugs that activate receptors antagonist - ANSWER>>drugs that block receptors potency - ANSWER>>refers to the amount of drug needed to produce an effect efficacy - ANSWER>>refers to the potential maximum therapeutic response a drug can produce pharmacogenetics - ANSWER>>the study of genetic differences in the response to drugs N-acetyl transferase - ANSWER>>a liver enzyme that metabolizes certain drugs (for half of the people in the US works slowly) slow acetylators - ANSWER>>drugs that are metabolized by this enzyme (N-acetyl) tend to reach higher levels and remain in the body longer than fast acetyls duplication - ANSWER>>when two drugs with the same effect are taken (a drug-drug interaction) opposition (antagonism) - ANSWER>>two drugs with opposing actions (drug-drug interaction) alteration - ANSWER>>one drug may alter how the body absorbs, distributes, metabolizes, or excretes another drug drug-disease - ANSWER>>refers to the worsening of a disease by a drug Type A (augmented adverse reaction) - ANSWER>>involves an exaggeration of the drug's therapeutic effects Type B (idiosyncratic adverse reaction) - ANSWER>>results from mechanisms that can not currently understood ex. skin rashes, jaundice, anemia, etc. Type C (chronic adverse reaction) - ANSWER>>persists for a long time Type D (delayed adverse reaction) - ANSWER>>take some time to develop first pass effect - ANSWER>>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 - ANSWER>>ability to dissolve in lipids or fat tissue PRN - ANSWER>>as needed QD - ANSWER>>once a day TID - ANSWER>>three times a day tmax - ANSWER>>time of peak plasma concentration on a measuring curve titration - ANSWER>>the process of adjusting drug doses to achieve maximum positive therapeutic effects while minimizing adverse/side effects Margin of safety - ANSWER>>the difference between the usual effective dose and the dose that induces severe or life threatening side effects Rights of drug administration - ANSWER>>right patient, right medication, right does, right route of administration, and right time of delivery Injection routes - ANSWER>>intramuscular, intrathecal, intravenous, subcutaneous intramuscular - ANSWER>>drugs given by direct injection into muscle tissue intrathecal - ANSWER>>needle is inserted between to vertebrea in the lower spine an into space around the spinal cord intravenous - ANSWER>>injected directly into the veins subcutaneous - ANSWER>>needle inserted into the fatty tissue just beneath the skin Bioavailablility - ANSWER>>how quickly and how much of a drug reaches its intended target site of action Bioequivalent - ANSWER>>when drugs contain not only the same active ingredients but also produce virtually the same blood levels over time Therapeutic equivalence - ANSWER>>production of the same medicinal effects Areas of drug elimination and excretion - ANSWER>>Lungs, breast milk, sweat tears urine feces, bile, saliva, and exhaled air medication error - ANSWER>>failure to administer drug in the correct form Powders - ANSWER>>a drug that is dried and ground into fine particles pills - ANSWER>>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 - ANSWER>>a small pill usually accompanied usually accompanied by many others encased within a gelatin capsule; quite often releasing medication over time tablet - ANSWER>>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 - ANSWER>>medication dosage form in which the drug is contained in an external shell; can be pulled apart for access to contents sustained release - ANSWER>>several doses of a drug in special coatings that dissolve at different rates Enteric Coating - ANSWER>>dosage in special coating that doesn't digest in the stomach; only starts to digest in the intestines caplets - ANSWER>>shaped like a capsule but has the form of a tablet the shape and file make swallowing easier Cmax - ANSWER>>peak plasma concentration on a measuring curve First pass effect - ANSWER>>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 - ANSWER>>the time it takes for a drug to start having any intended affect after it is administered Protein Binding - ANSWER>>the ability of certain drugs to bind to plasma protein QD - ANSWER>>once a day QID - ANSWER>>four times a day PRN - ANSWER>>take as needed TID - ANSWER>>three times a day Tmax - ANSWER>>time of peak plasma concentration on a measuring curve BID - ANSWER>>twice a day Authorized distributor - ANSWER>>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) - ANSWER>>published whole sale price or list price suggested by the manufacturer Brokerage - ANSWER>>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 - ANSWER>>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 - ANSWER>>a company that owns and operates four or more pharmacies dock to dock delivery - ANSWER>>wholesaler obtains the drugs to a dispenser own warehouse without taking the drugs into its own inventory drop shipment - ANSWER>>the drug manufacturer directly delivers the drugs to a dispenser but the order and payments are made through a wholesaler Float - ANSWER>>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 - ANSWER>>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 - ANSWER>>wholesaler that distributes drug products in a state in which it is physically located independent drug store - ANSWER>>a company that owns and operates three or fewer pharmacies Integrated Delivery Network IDN - ANSWER>>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 - ANSWER>>a pharmacy that dispenses prescriptions to patients who submit their prescriptions by mail or fax manufacturer direct sale - ANSWER>>the type of sale that bypasses the need for any intermediary distributor mass merchandiser - ANSWER>>Department stores with a pharmacy AT - ANSWER>>topical products B - ANSWER>>drug products requiring further FDA investigation and review to determine equivalence ANDA - ANSWER>>abbreviated new drug application How many days does a brand name company have to sue - ANSWER>>45 Generic drug first to file exclusivity - ANSWER>>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 - ANSWER>>there is only one approved product available for that active ingredient and dosage form Multi-source drug prodcuts - ANSWER>>pharmaceutically equivalent products are available from more than one manufacturer Hatch Waxman act - ANSWER>>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 - ANSWER>>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 - ANSWER>>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 - ANSWER>>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 - ANSWER>>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 - ANSWER>>the act of dispensing a different brand for the product prescribed pharmaceutical alternatives - ANSWER>>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 - ANSWER>>the act of dispensing a pharmaceutical alternative for the product prescribed Therapeutic alternatives - ANSWER>>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 - ANSWER>>product development and management association drug sample - ANSWER>>unit of drug not intended to be sold but to promote the sale Section 503 of Federal food drug and cosmetic act - ANSWER>>prohibits the sale, purchase, trade or offer to sell, purchase or trade prescription drug samples and coupons USP US pharmacopoeia - ANSWER>>the first comprehensive publication of drug standards USP-UF US Pharmacopoeia - National Formulary - ANSWER>>current annual publication of certified drug standards verifying purity and ingredients Office of inspector general - ANSWER>>an arm of the department of health and human services that investigates regulatory infractions, provides compliance advice and bring enforcement actions Federal trade commision - ANSWER>>regulates general business practices to protect consumers against misleading and anti-competitive behavior Drug enforcement administration - ANSWER>>regulates the distribution and use of narcotics and other controlled substances Proteins - ANSWER>>A nutrient made up of of chains of amino acids Functional Values - ANSWER>>Efficacy, safety, convenience, cost- effectiveness Branding - ANSWER>>strengthens bond between buyer and seller; competition differentiation pg 198 PhRMA Code on relationionships - ANSWER>>pg 233 Brand values - ANSWER>>functional values, expressive values, central value Functional values - ANSWER>>what the brand does for me Expressive values - ANSWER>>what the brand says about me central values - ANSWER>>what the brand and I share at a fundamental level gene therapy types - ANSWER>>Retrovirus, adenovirus, adeno- associated virus, liposomes, naked DNA Exclusivity is granted for an orphan drug for - ANSWER>>7 years Nursing Structures - ANSWER>>pg 268 Director of nursing - ANSWER>>BSN MSN Unit manager with 24 hour responsibility for unit - ANSWER>>RN, BSN Case Manager risk manager/infection control - ANSWER>>RN, BSN House supervisor, works off shift - ANSWER>>RN Charge Nurse oversees shift in unit - ANSWER>>RN Clinical Care - ANSWER>>RN Oral medication - ANSWER>>LPN Protocol - ANSWER>>This document sets out how a trial is to be conducted Exclusivity is granted for an orphan drug for _______ years. - ANSWER>>7 Absorption methods - ANSWER>>Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous Transport Mechanisms - ANSWER>>Passive diffusion, facilitated diffusion, active transport, pinocytosis The agency which regulates the distribution and use of narcotics and other controlled substances is _______. - ANSWER>>DEA The most important benefit of electronic prescribing is related to patient ______. - ANSWER>>safety Which one of the below terms is not a route for excreting a drug from the body? - ANSWER>>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. - ANSWER>>False Bioavailability - ANSWER>>how quickly and how much of a drug reaches its intended target site of action Fats - ANSWER>>A nutrient stored in special body tissues as a great source of reserve energy Carbohydrates - ANSWER>>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 - ANSWER>>What is one of the biggest time wasters for a pharmaceutical sales rep? Pharmacological studies using animals are regulated under Good Laboratory Practice. - ANSWER>>True Monoclonal antibodies are created in laboratories to target the ________ of patients to kill cancer. - ANSWER>>cancer cells The best way to deliver health care is through a ________ system. - ANSWER>>market based The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for _____. - ANSWER>>clinical trials The FDA approves storage conditions for drug products. - ANSWER>>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 - ANSWER>>true There are more white blood cells than red blood cells for the same volume in the human body. - ANSWER>>false Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein-based. - ANSWER>>true The duration for Phase III of the clinical trial can typically last 3-5 years. - ANSWER>>true The aim of the Phase IV clinical trial is to examine the safety and effectiveness of the drug in the targeted disease group. - ANSWER>>false Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. - ANSWER>>true Which of the below terms means "to apply the drug on the skin surface"? - ANSWER>>transdermal Diffusion is the random movement of molecules in fluid - ANSWER>>true Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient. - ANSWER>>false Toxicity information in preclinical studies provides confidence about a drugs safety aspect. - ANSWER>>true The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. - ANSWER>>true Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - ANSWER>>true Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - ANSWER>>false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - ANSWER>>true PBM's tend to serve a local market through a network of pharmacies. - ANSWER>>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. - ANSWER>>false Exclusivity gives exclusive ______, which is granted by the FDA, and can run concurrently with a patent or not. - ANSWER>>marketing rights Drug labels must include indications and usage information, as well as contraindications. - ANSWER>>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. - ANSWER>>true Traits of Pharma sales Rep - ANSWER>>Passion, Go the extra mile, be a resource, be creative, invest in yourself, authentic and real, love what The federal government does not regulate the drug sampling for a pharmaceutical representative - ANSWER>>false Storage conditions for drug products are based on data and information supplied by the manufacturer - ANSWER>>True Drug recalls are almost always negotiated with the FDA beforehand. - ANSWER>>true The PDMA is the Prescription Drug Manufacturers Association. - ANSWER>>False Primary wholesale distributors buy most of their drugs directly from ______ - ANSWER>>Manufacturers The AWP is a published ______ price, suggested by drug manufacturers. - ANSWER>>wholesale It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. - ANSWER>>true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - ANSWER>>false Brands should be: - ANSWER>>Easy to pronounce, easy to write and read, memorable, distinctive and different from competition formulation - ANSWER>>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. - ANSWER>>true "Pull through" refers to: - ANSWER>>generating demand for your company's product Which of the following is not a part of the Seven Step Cascade of Emotion? - ANSWER>>be a consultant, not a rep Which is a step to becoming an indispensable pharmaceutical sales rep? - ANSWER>>asking feedback Which is not a step to plan for rumors? - ANSWER>>counter attack According to the text, which of the following is considered "going to the next level?" - ANSWER>>staying focused clinical effect - ANSWER>>The response produced by a medication tertiary care - ANSWER>>Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center Literally "disease producer": - ANSWER>>pathogen A type of blood cell that helps the body fight infection and disease: - ANSWER>>white blood cell Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume: - ANSWER>>declining A low supply of oxygen due to low blood flow is - ANSWER>>ischemia Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - ANSWER>>true The acronym for pharmacokinetics is: - ANSWER>>PK According to the text, there are ___ classes of therapeutic drugs - ANSWER>>US federal govt Another name for biologic compound is: - ANSWER>>large molecule SS is an abbreviation for: - ANSWER>>semi doses The ___________ is used to determine appropriate medical reimbursement. - ANSWER>>coding system 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. - ANSWER>>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. - ANSWER>>false The extent, quality, or degree to which a substance is poisonous or harmful to the body. - ANSWER>>toxicity The US accounts for about ____ of all the world's pharmaceutical revenues. - ANSWER>>50% Specialty care products are often prescribed by generalist physicians. - ANSWER>>false Among the biotechnology medications under development, about _____ target cancer. - ANSWER>>50% A _____ is an inactive medication with no treatment value, used in experimental studies. - ANSWER>>placebo Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - ANSWER>>false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - ANSWER>>true PBM's tend to serve a local market through a network of pharmacies. - ANSWER>>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. - ANSWER>>false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify - ANSWER>>true DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - ANSWER>>true Because pharmaceutical sales reps work mostly out of their home it is not important for a rep to work well in a team environment. - ANSWER>>false 6 stages of brand strategy - ANSWER>>Brand positioning, brand personality, brand values, unique values of the brand that support the values, how the brand appears to its audience, internal commitment Edema - ANSWER>>swelling Hatch-Waxman Act - ANSWER>>aka Drug Price Competition and Patent Term Restoration Act of 1984. Considered the most significant drug- related legislation affecting pharma and healthcare. H-W made it easier to bring generics to the marker by requiring FDA to only look at bioavailability studies in order to approve. Also gave protection to the research based manu's by providing a 30 months automatic cooling off period Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples - ANSWER>>true Institutional review Board (IRB) - ANSWER>>A committee of physicians, staticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin. 5 rights of drug administration - ANSWER>>Right dose, right patient, right medication, right route of administration, right time of delivery Minerals - ANSWER>>A nutrient necessary for bodily purposes such as the balance of body fluid Water is NOT a nutrient - ANSWER>>true Hormones are intercellular messengers. - ANSWER>>true AMA - ANSWER>>provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies Benefits of Government-Industry Partnerhsips - ANSWER>>pg 90 Off-Label - ANSWER>>Usage of a medication for purposes other than the specific ones appearing on the label preclinical studies - ANSWER>>studies in which drugs are tested in vitro and on animals The liver is the major organ for metabolizing drugs. Secondary is kidney - ANSWER>>true Pinocytosis - ANSWER>>Involves the engulfing of fluids by a cell. In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANSWER>>true In vitro assays are increasingly being see because they are usually less expensive, offer more rapid results, and are not as prone to negative publicity. - ANSWER>>true Investigator - ANSWER>>The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor Subjects should be informed about the aims, methods, risks, and benefits of the trial - ANSWER>>true clinical trials - ANSWER>>research study conducted with human patients Four phases of clinical trials - ANSWER>>pg 125 Regulatory Requirement terms - ANSWER>>Pg 126 The FDA regulates the introduction of new drugs and enforces U.S. drug laws. - ANSWER>>True Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - ANSWER>>True Average review time for a new drug - ANSWER>>18 months Sales Team - ANSWER>>Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - ANSWER>>Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - ANSWER>>Manufacturing & Operations In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANSWER>>True 3,070 new meds are in development for cancer. - ANSWER>>True Define Off-label - ANSWER>>Usage of a medication for purposes other than the specific ones appearing on the label Toxicity - ANSWER>>The extent, quality, or degree to which a substance is poisonous or harmful to the body Institutional review Board (IRB) - ANSWER>>A committee of physicians, staticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin. Placebo - ANSWER>>Inactive pill, liquid, or powder that has no treatment value aka sugar pill Edema - ANSWER>>Swelling Asymptomatic - ANSWER>>Without signs or symptoms Clinical Pharmacology - ANSWER>>The study of the effects and movement of drugs in the human body Anatomy - ANSWER>>The study of basic structures of the body Distribution - ANSWER>>How the drug is dispersed among the organs after absorption into the blood Metabolism - ANSWER>>How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Excretion - ANSWER>>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. It takes about 10 years for a drug to hit the market - ANSWER>>True Routes of drug administration - ANSWER>>Pg 26-29 Seven rights of drug administration - ANSWER>>pg 30 Bioavailability - ANSWER>>how quickly and how much of a drug reaches its intended target site of action Bioequivalent - ANSWER>>when they contain the same active ingredients and proceed virtually the same blood levels over time. Therapeutic equivalence - ANSWER>>Production of the same medicinal effect Drug elimination and Excretion - ANSWER>>pg 34 Drug Forms - ANSWER>>Pg 35-38 Patent last 20 years - ANSWER>>True Inactive ingredients - ANSWER>>Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body Pharmaceutical Ingredients - ANSWER>>Pg 54 BID - ANSWER>>twice a day Cmax - ANSWER>>Peak plasma concentration on a measuring curve Half-life - ANSWER>>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 PRN - ANSWER>>As needed QD - ANSWER>>Once a day QID - ANSWER>>Four times a day Protein binding - ANSWER>>the ability of certain drugs to bind to plasma protein. TID - ANSWER>>three times a day Titration - ANSWER>>the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects Tmax - ANSWER>>Time of peak plasma concentration on a measuring curve STAT - ANSWER>>Immediately Primary wholesale distributors - ANSWER>>Buy most of their drugs directly from manufacturers. Legally considered authorized distributors within the meaning of the PDMA because they usually have ongoing relationships with manufacturers Secondary wholesale distributors - ANSWER>>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 Distribution Terminology - ANSWER>>Pg 60-61 Average wholesale price (AWP) - ANSWER>>Published wholesale price of list price suggested by the manufacturer. Chain drug store - ANSWER>>Company that owns and operates four or more pharmacies E-sampling - ANSWER>>Pg 72 Many pharmaceutical manufacturers set expiration dates every six months (June, December) - ANSWER>>True DEA regulates the distribution and use of narcotics and other controlled substances - ANSWER>>True FTC - ANSWER>>Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior AMA - ANSWER>>provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies Benefits of Government-Industry Partnerhsips - ANSWER>>Pg 79 Preclinical studies - ANSWER>>pg 81 Pinocytosis - ANSWER>>Involves the engulfing of fluids by a cell. Transport Mechanisms - ANSWER>>Passive diffusion, facilitated diffusion, active transport, pinocytosis Absorption methods - ANSWER>>Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous The liver is the major organ for metabolizing drugs. Secondary is kidney - ANSWER>>True CL= rate of drug elimination/drug concentration in blood - ANSWER>>True In vitro assays are increasingly being see because they are usually less expensive, offer more rapid results, and are not as prone to negative publicity. - ANSWER>>True Clinical Trials - ANSWER>>pg 89 Subjects should be informed about the aims, methods, risks, and benefits of the trial - ANSWER>>True Four phases of clinical trials - ANSWER>>Pg 90 Regulatory Requirement terms - ANSWER>>Pg 92 Investigator - ANSWER>>The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor Sponsor - ANSWER>>The organization or individual that initiates the trial and finances the study, Protocol - ANSWER>>This document sets out how a trial is to be conducted Epidemiology - ANSWER>>The study of how factors influence disease and health in human populations. Therapeutic - ANSWER>>Antibodies Vaccines - ANSWER>>Pg 108 Toxoids - ANSWER>>Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines. Vector-based vaccines - ANSWER>>Viruses and bacteria are detoxified and used as vehicles to carry vaccines. Example is the use of canary pox (a virus that infects birds but not humans) to carry envelope proteins for HIV treatment. Peptide Vaccines - ANSWER>>Chemically synthesized and normally consist of 8-24 amino acids Adjuvants - ANSWER>>pg 110 Cytokines are produced mainly by the leukocytes (white blood cells) - ANSWER>>True Hormones are intercellular messengers. - ANSWER>>True Retrovirus - ANSWER>>Integrates genes to hose chromosomes, change of long term stability. Subsidies should not be accepted to pay for the costs of travel, lodging, or other personal expenses. Paying for a modest meal is OK - ANSWER>>True PhRMA Code on relationships - ANSWER>>Pg 167 PhRMA FAQ - ANSWER>>Pg 174 Nursing Structures - ANSWER>>Pg 200 Sales techniques - ANSWER>>pg 207 Medicare part D - ANSWER>>pg 225 Organizing your day - ANSWER>>Pg 239 Traits of Pharma sales Rep - ANSWER>>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 Glossary - ANSWER>>271 Exclusivity is granted for an orphan drug for ____ - ANSWER>>7 years Patents are applied for with, and granted by the FDA. - ANSWER>>False Patents expire after how many years from the date of filing? - ANSWER>>20 years Generic drugs are not regulated by the Food & Drug Administration. - ANSWER>>False The most reliable source of information for determining therapeutically equivalent drug products are - ANSWER>>ORange Book Pharmaceutical representatives will typically store and secure their own drug samples - ANSWER>>True Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount. - ANSWER>>True The federal government does not regulate the drug sampling for a pharmaceutical representative - ANSWER>>False Storage conditions for drug products are based on data and information supplied by the manufacturer - ANSWER>>True Drug recalls are almost always negotiated with the FDA beforehand. - ANSWER>>True The PDMA is the Prescription Drug Manufacturers Association. - ANSWER>>False Primary wholesale distributors buy most of their drugs directly from ______ - ANSWER>>manufacturers The AWP is a published ______ price, suggested by drug manufacturers. - ANSWER>>wholesale Rebates are also referred to as after-market arrangements. - ANSWER>>true Drug labels must include indications and usage information, as well as contraindications. - ANSWER>>true A patent owner has the right to exclude others from making, using, selling or importing into the US the ____ it describes. - ANSWER>>invention Exclusivity gives exclusive ______, which is granted by the FDA, and can run concurrently with a patent or not. - ANSWER>>marketing rights Exclusivity is granted for an orphan drug for _______ years. - ANSWER>>7 A generic drug is ______ to the originator brand-name drug in dosage, strength, safety, and quality. - ANSWER>>bioevuivalent Generic drugs are not regulated by the FDA. - ANSWER>>False Which of the below terms means "to apply the drug on the skin surface"? - ANSWER>>transdermal Diffusion is the random movement of molecules in fluid - ANSWER>>true Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient. - ANSWER>>false Toxicity information in preclinical studies provides confidence about a drugs safety aspect. - ANSWER>>true The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. - ANSWER>>true Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. - ANSWER>>true Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - ANSWER>>false DUR programs involve retrospective monitoring of physicians' prescribing patterns. - ANSWER>>true The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies. - ANSWER>>false PBM's tend to serve a local market through a network of pharmacies. - ANSWER>>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. - ANSWER>>false It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. - ANSWER>>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. - ANSWER>>true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - ANSWER>>false DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - ANSWER>>true Subjects for clinical trials are selected on the basis of _____ - ANSWER>>scientific objectives The pivotal trial is Phase ______ of the clinical trial. - ANSWER>>3 The "road map" for a clinical research paper is called the _______. - ANSWER>>abstract Pharmaceutical reps should thoroughly read _______ sections of clinical studies when results are released. - ANSWER>>all The three major areas in which biologics are used are prophylactic, _______, and replacement therapy. - ANSWER>>therapeutic A formulary is a list of prescription drugs approved by insurance coverage. - ANSWER>>true Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and ______. - ANSWER>>individuals 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. - ANSWER>>true The key areas in hospitals that require special selling tactics are ______, formulary committee, and the medical education department. - ANSWER>>pharmacy department Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources. - ANSWER>>true With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - ANSWER>>false DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. - ANSWER>>true Because pharmaceutical sales reps work mostly out of their home it is not important for a rep to work well in a team environment. - ANSWER>>false Specialty care products are often prescribed by generalist physicians. - ANSWER>>false In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician. - ANSWER>>true Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - ANSWER>>true Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. - ANSWER>>true The greatest challenge for a generics manufacturer is to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug. - ANSWER>>true What is one of the biggest time wasters for a pharmaceutical sales rep? - ANSWER>>travel time "Pull through" refers to: - ANSWER>>generating demand for your company's product Which of the following is not a part of the Seven Step Cascade of Emotion? - ANSWER>>be a consultant, not a rep Which is not a rule in making the most out of your sales call? - ANSWER>>your agenda not theirs What do retail pharmacists do? - ANSWER>>dispense pharmaceuticals Which is a step to becoming an indispensable pharmaceutical sales rep? - ANSWER>>asking feedback Which is not a step to plan for rumors? - ANSWER>>counter attack Customers purchase products from people they like, trust, and respect. This is the: - ANSWER>>likeability According to the text, which of the following is considered "going to the next level?" - ANSWER>>staying focused clinical effect - ANSWER>>The response produced by a medication pathology - ANSWER>>The practice of medicine dealing with the causes and nature of disease/death New prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act: - ANSWER>>medicare part d tertiary care - ANSWER>>Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center Literally "disease producer": - ANSWER>>pathogen A type of blood cell that helps the body fight infection and disease: - ANSWER>>white blood cell SS - ANSWER>>Used when referring to medication dosage, means "one-half": Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume: - ANSWER>>declining The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms: - ANSWER>>formulation A low supply of oxygen due to low blood flow is: - ANSWER>>ischemia