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CNPR 2014

All Quizzes and Study Guide

QuestionAnswer
Pharmaceuticals are arguably the most socially important healthcare product. T or F. TRUE
Pharmaceutical development is a high risk undertaking, in which many promising leads prove disappointing. T or F. TRUE
Pharmaceutical sales are highest in which geographical regions? US, Western Europe, Japan
The US accounts for about ____ of the world's pharmaceutical revenues. 50%
What has fueled recent growth in the pharmaceutical industry? Population growth and increased life expectancies
What is the predicted relationship between pharamaceutical companies and genomic research facilities? Partnerships between pharmaceutical companies and genomic companies will not prove immediately profitable
Prescription drug therapy is not cost effective for insurance companies and health care providers. T or F. FALSE
The high price of healthcare is explained by the high price of medicines. T or F. FALSE
One of the oldest and least effective pharmaceutical marketing techniques is DTC (Direct to Consumer) advertising. T or F. FALSE
What influences the number of districts in a region? The region's population
What are examples of the regionalization of healthcare delivery systems? CA and FL have different prescription reimbursement policies.
The heart of a pharmaceutical sales team is the regional manager. T or F. FALSE
Most DMs did not start as representatives. T or F. FALSE
How many territories are in a typical district? 8 to 12
What is the most effective method for grabbing market share? Comparative selling
Pharmaceutical reps mainly visit pharmacies. T or F. FALSE
It ususally only takes 1-2 calls to a physician before he or she commits to prescribing your product. T or F. FALSE
The pharmacist may dispense a product other than what the physician prescribed. T or F. TRUE
What classifies as a payer? Employers
What defines ethical pharmaceutical companies? Researching and developing novel drugs
One of the most dissapointing results of the pharmaceutical industry's continured investment in R&D is the few new drugs being approved and in development. T or F. FALSE
Thanks to modern medicines, how long are people newly diagnosed with HIV expected to live? Another 50 years
How much has the average life span increased since 1890? Almost 30 years
What is a treatment group? A group of patients assigned to receive a specified treatment
What is the main difference between a blinded and a double blinded study? In a double blinded study, neither the study staff nor the study participants know which subjects are in the experimental group and which in the control.
What does asymptomatic mean? Not exhibiting signs or symptoms
What term denotes the study of bodily functions (as opposed to structures)? Physiology
In its broadest definition, a drug is any substance that produces a physiological or physical change in the body. T or F. TRUE
How does the Federal Food, Drug, and Cosmetic Act (FFDCA) define a drug? Any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or a substnace other than food intended to affect the structure or function of the body.
Most of the body's required vitamins must be taken in from outside the body. T or F. TRUE
ADME testing measures the rate at which the body absorbs the drugs, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material, and then excretes it from the body. T or F. TRUE
ADME testing is primarily used in what field? Pharmocokinetics
Placebo effects can lead to withdrawl symptoms. T or F. TRUE
On average, only about ____ of 4,000 drugs studied in the laboratory are eventually studied in people. 5
What type of drugs are absorbed directly and almost immediately into the bloodstream. Sublingual drugs
What are the 7 rights of drug administration? The right patient, the right drug, the right dose, right route, right time, right technique and right documentation
Pro-drugs are administered in an active form, which is metabolized into an inactive form. T or F. FALSE
The kidney of an 85 year old person exceretes drugs only ____ as efficiently as that of a 35 year old person. Around 50%
The normal age related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person's age. T or F. TRUE
What differentiates a caplet from a tablet? Caplets are shaped like capsules and have film coatings to aid in swallowing
Where will you find the legend "Caution: Federal Law prohibits dispensing without a prescription? On the label of all prescription drugs
What happens in slow acetylators? Drugs that are metabolized by N-acetyl transferase tend to reach higher blood levels and remain in the body longer
What percentage of the people in the US are slow acetylators. 50%
Drug-drug interactions are always harmful. T or F. FALSE
Smoking decreases the effectiveness of some drugs. T or F. TRUE
Because dietary supplements are not drugs, interactions with drugs are not a concern. T or F. FALSE
What statements did Ehrlich phrase about an ideal drug/ magic bullet? It does not exist, it would be aimed precisely at a disease site, it would not harm healthy tissues.
What differentiates resistance from tolerance? Tolerance reffers to a person's diminished response to a drug after repeated use, while resistance applies to microorganisms' or cancel cells' ablities to withstand drug effects.
Between ____ and ____ of hospital admissions in the US are estimated to be for treatment of adverse drug reactions. 3% -7%
There is a universal scale for quantifing the severity of an adverse drug reaction. T or F. FALSE
Why is noncompliance a serious public health concern? It increases the cost of medical care
What is eligible for patent protection under US regulations? The drug itself, the method of delivering and releasing the drug into the bloodstream, the way the drug is made
Drugs' trade names are often unrelated to their intended use. T or F. FALSE
Like food and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents. T or F. FALSE
Legally, bioequivalence of different versions of a drug can vary by up to ____. 20%
What are Called "large molecule drugs", derived from living materials, cause an immune response, vaccines? Biologics
Large molecule products are developed and manufactured by a chemical process. T or F. FALSE
What are drugs that attracts or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers? Agonists
What denotes how and API works in the body? Mechanism of action
What cements the active and intert components together to maintain cohesive portions? Binders
What does the medical abbreviation BID denote? Twice a day
What is the medical abbreviation for as needed? PRN
Which components might cause patients' different reactions to brand name and generic drugs? Differences in inactive ingradients
All cells have a nucleus. T or F. FALSE
What affects drug response? The patients' genetic makeup, age, body size, use of other drugs and dietary supplements, other conditions or diseases, whether or not the patient takes the drug properly
Drug reactions are predictable because they do not occur after a person has been previously exposed to the drug one or more times without any allergic reaction. T or F. FALSE
What is the typical relationship between a drug's site of adminitration and site of action? They are usually somewhat removed from each other
What the peak plasma concentration on a measuring curve? CMAX
What are the three main concepts of clinical pharmacology? Drug Distribution and Elimination, Pharmacodynamics, Pharmacokinetics
Transfugal is a route of drug administration. T or F. FALSE
How are intradermal drugs delivered? Injection under the skin
What is an example of intravenous drug delivery? An injection directly into the bloodstream
What are the major organs of the gastrointestinal system? Mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines
Who is normally responsible for selling to distributors? NAMs
How often do secondary drug wholesale distributors buy their drugs directly from manufactures? Sometimes
By FDA law, large chain pharmacies are not allowed to buy directly from drug manufactures. T or F. FALSE
How many companies account for nearly 905 of all drug wholesale sales? 3
What type of sale bypasses the need for intermediary distributors? Manufacturer-direct sales
What is an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members? Group purchasing organization (GPO)?
Prescriptions dispensed by mail-order pharmacies are, on average, around ____ larger than those dispensed by retail pharmacies. Three times
What are the types of non-stock sale? Brokerage sales, dock-to-dock sales, drop shipments
What is another term for rebates? After-market arrangements
The PDMA is the Prescription Drug Manufacturers Association. T or F. FALSE
A company that owns and opperates three or fewer pharmacies is an ____. Independent drug store
Which section of a drug's package insert information covers the usual dosage range? Indications and usage
Drug labels must include indications, usage information, and contradictions. T or F. TRUE
What should be included in the description of a drug's package insert information? The drug's proprietary name and the established name
What gives exclusive marketing rights, is granted by the FDA, and can run concurrently with a patent or not? Exclusivity
What differentiates exclusivity from a patent? Exclusivity is only granted upon the drug's FDA approval
What is required of an invention for it to be worthy of a patent? It must be novel, useful, and not obvious
A generic drug is ____ to the originator brand-name drug in dosage, strength, safety, and quality. Bioequivalent
What is required by the FDAs Criteria for Equivalency? Drugs are adequately labeled, contain identical amounts of the same active ingredients, involve the same dosage form and route of administration.
What list is generally considered the most reliable source of information on therapeutically equivalent drug products? Approved Drug Products with Therapeutic Equivalence" aka Orange book
What are the orange book ratings? (7 total) A, AA, AN, AO, AP, AT, B
What is the term for chemical equivalents which, when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels? Biological equivalents
What term denotes a drug that is identical or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route, quality, performace, characteristics, and intended use? Generic
What term denotes the dispensing of an unbranded generic product for the product prescribed? Generic substitution
What is the duration of a patent challenge? 180 days
How is a drug sample closet or cabinet like a grocery store shelf? The more visibility you give your drug, the more likely that it will be prescribed
Pharmaceutical representatives do not typically store and secure their own drug samples. T or F. FALSE
Sampling is sometimes the most important factor in a pharmaceutical rep's success. T or F. TRUE
The ____ approves storage conditions for drug products. FDA
Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for that amount. T or F. TRUE
What is prohibited by Section 503 of the Federal Food, Drug, and Cosmetic Act, as ammended by the Prescription Drug Marketing Act? The sale, purchase, trade, or offer to sell, purchase, or trade prescription drug samples
The federal government does not regulate the drug sampling for a pharmaceutical rep. T or F. FALSE
What entity issues monographs that define how drugs should be stored, and what variance is allowed in their stated contents? United States Pharmacopoeial Convention
Storage conditions for drug products are based on information supplied by the manufacturer. T or F. TRUE
Medications are usually unaffected by changes in temperature, light, humidity, and environmental factors. T or F. FALSE
In what cases can degraded drugs sometimes still be used? When the amount of remaining drug has not fallen below 85-90% of that stated on the label.
Drug recalls are almost always negotiatied with the FDA beforehand. T or F. TRUE
What problems could be improved by electronic prescribing systems? Patients doctor shopping for controlled substances, pharmacists misreading prescriptions, physicians wasting time calling pharmacies.
What should you do if you receive a shipment from your employer and you notice that there are twice as many samples as what is posted on the packing slip? Call your sales manager to inform them of the mistake and ask for instructions on proper prodecure.
Which area of drug R&D has seen the largest cost increases? Clinical trials
On average, how long does it take for a new drug to be developed (from the discovery of the initial compound to FDA approval)? 10 to 15 years
What regulatory agency is indutrsy based (run mainly by the companies themselves)? Pharmaceutical Research and Manufactures of America (PhRMA)
What factors have made the pharmaceutical R&D process more complex? An intensive regulatory process, growing demand in the medical community for more Complex data about drugs, the increasing number of procedures in Phase III trials
The landmark FDA Modernization Act of 1997 was a major step forward in ____. Enabling the safe and effective new drugs and biologics to be made available sooner
What type of system is the best way to deliver healthcare? Market-based system
How would increased drug price controls affects the US healthcare system? They would stifle innovation
What was the intent of the Bayh-Dole Act and the Stevenson-wydler Technology Innovation Act? To hasten the commercialization of technologies that otherwise might not be used
What did the G10 Medicines Group recently report about the drug industry in the European Union (EU)? There is poor collaboration between publicly and privately funded research centers.
The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. T or F. TRUE
Toxicity information in preclinical studies helps provide confidence about a drug's safety. T or F. TRUE
Pharmacological studies using animals are regulated under ____. Good Laboratory Practice
Do drugs administered to patients only contain APIs? No
What affects a drug's ability to permeate membranes? The drug's chemical composition, polarity, size
Through which barriers can lipid-soluble drugs usually pass? Cell membranes
How are weak acid drugs generally absorbed by the stomach? More quickly than weak basic drugs
What routes of administration completely bypass the liver? Intravenous administration, transdermal administration
Why are intravenous drug dosages easier to control than drugs administered transdermally? The entire dose is available in the bloodstream to be distributed to the target site.
What affects a drug's distribution to its target tissues? Drug's lipid solubility, polarity, the vascular nature of the drug's target tissue
What term means to apply the drug on the skin surface? Transdermal
What studies are carried out to identify the tumor-causing potential of a drug. Carcinogenicity
According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies? Scientific objectives
What acts as a third party to oversee the welfare of the trial subjects, the investigator must inform them of any changes in the research activity, they have the right to stop a trial or require that procedures and methods be changed? IRB/IEC
Which phases of clinical studies are open label and which are blinded? Phase I and IV trials are often open label, but Phase II and III are double blinded or at least blinded.
If it is not possible to measure the direct effects of a drug what is used instead? Surrogate markers such as blood pressure and cholesterol levels
What is an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time to find exposure risk factors? Case-control study
Which measure of central tendency is the sum of all observations divided by the number of observations? Mean
Which measurement describes the number of new events that occur during a specified period of time in a population at rish for the event? Incidence
What measure is used to describe the variability of the population mean? Standard error of mean
What term denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring? Validity
What are the Kaplan-Meier analysis and Cox proportional hazards analysis? Methods of survival analysis
What section of a clinical paper describes subjects' entry and exclusion criteria? Methods
Which document sets out how a trial is to be conducted? Protocol
When designing and performing clinical trials, several ethical constraints must be considered. what are these restraints? Independent review, scientific validity, social value
The members of the IRB/IEC must be experts in the topic of the study. T or F FALSE
What are the Seven Ethical Requirements 1) social value 2) scientific validity 3) fair subject selection 4)informed consent 5) favorable risk-benefit ratio 6) independent review 7) respect for human subjects
First experiment in which a drug is tested on the human body. the primary aim of the trial is to assess the safety of the new drug Phase I Clinical Trial
Aim is to examine the safety and effectiveness of the drug in a targeted disease group Phase II clinical trial
Aim is to confirm the efficacy of the drug in a much larger patient group, anywhere from several hundred to tens of thousands. also known as a multi site trial. referred to as the pivotal trial Phase III Clinical Trial
Post-marketing approval to monitor the efficacy and side effects of the drug in an uncontrolled real-life situation, also known as post-market surveillance trail Phase IV Clinical Trial
The person who conducts the trial. Responsibility is to make sure that GCP is being used. not employed by the sponsor and should make no gain from the success of the drug Investigator
A collections of information prepared and updated by the sponsor for the investigator. it contains all of the data relevant to the drug under investigation Investigators brochure
Subjects should be thoroughly educated about the study aims, methods, risks, benefits, and alternatives Informed Consent
Documents that show how a trial is to be conducted contains the rationale for the clinical trial, methodology, number of subjects recruited, the markers to show effectiveness of the drug, statistical methods used to analyze the data, directions to protect Protocol
Set out the conditions under which a person may or may not be included in the trial. may Include the disease type, medical history, age group, sex, etc. Inclusion and Exclusion Criteria
Document in which all the information relating to a subject is recorded. Case Report Form
What is used to monitor the effects of the drug. May be changes in blood pressure, cholesterol, blood glucose levels, etc? Surrogate Markers
The starting point for measurement. best understood as a general idea in linguistic form that helps us describe reality. Abstract Concept
Measurable change in one variable that occurs concurrently with changes in another variable. positive is represented by change in the same direction. negative is represented by concurnet changes in opposite directions. Association
An attribute of a concept that does not vary Constant
What defines how well a test or experiment measures up to its claims. whether the operational definition of a variable actually reflects the rue theoretical meaning of a concept? Construct validity
Extent to which a test adequately represents the subject matter content or behavior to be measures- commonly used in evaluation acheivements or proficinency tests Content validity
Measure that can take on any value with in a given interval or set of intervals. An innate number of possible values Continuous variable
A value that depends on variations in another variable Dependent variable
The measure that is represented by a limited number of values Discrete Variable
What evaluates whether the indicator appears to measure the abstract concept? Face Validity
What is manipulated to affect variations or responses in another variable? Independent Variable
Variables that classify objects according to type and logical order, but also require the differences between levels of a category are equal. Interval data
Variables that classify objects according to type or characteristic Nominal Data
To create a measure of an abstract concept Operationalize
Variables that classify objects according to type or kind but also have some logical order Ordinal Data
Ability of an indicator to correctly predict an outcome Predictive quality
Any variable with a potential value that is influenced by chance. modeled by probability density functions Random Variable
What has a zero starting point and classifies objects according to type and logical order, but also require that differences between levels of categories be equal? Ratio data
The consistency or repeatability of your measurements is? Reliability
As association between two variable that can be better explained by or depends greatly on a third variable is? Spurious Association
Holding the value of one variable constraint in order to clarify associations among other variables Statistical Control
Process whereby one reaches a conclusion about a population on the basis of information obtained from a sample drawn from that populatoin Statistical inference
The extent to which a measurement is an accurate representation of the concepts Validity
A measure of a concept that can take on more than one value from one observation to the next Variable
What is one way in which large molecule drugs differ from small molecule drugs? Large molecule drugs are mainly protein based drugs that develop in biological systems such as living cells
After vaccination, what may be needed to maximize the vaccines immunological effects? Booster
Vaccine development focuses on how to reduce virulence while retaining the ability to o what? Produce immunity
Vaccines are what types of drugs? Large molecule
Vaccines contain antigenic components that are obtained from or derived from what? The pathogen
What is an advantage of attenuated vaccines over inactivated vaccines? Attenuated vaccines are less expensive to prepare
What is derived from the toxins secreted by the pathogen? Toxoids
What is the estimated annual death toll for malaria? 1.5 to 3.5 million people
There are more white blood cells than red blood cells for the same volume in the human body. T or F. FALSE
How was insulin primarily obtained from the 1930s to the 1980s? Porcine and bovine extracts
What are types of cytokines? Interferons, interleukins, monokines
Blood glucose is a type of hormone. T or F. FALSE
What technique involves in vitro, in which patients genetically faulted tissues are removed, loaded with normal genes in vectors and returned to the patients bodies. Basic gene therapy technique
What stem cells can develop into many cell types, but not a new individual. Pluripotent
Leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of ____ white blood cells Immature
What type of vectors are used in gene therapy? Retroviruses
Which are not a type of stem cell; multipotent, pluripotent, semipotent, or totipotent Semipotent
Traditional vaccines are prepared in many ways except atenuated, insulin, inactivated or toxoids? Insulin
Effective drug therapy is a cost-effective and highly valuable means of controlling total health care expenditures and improving quality of life. T or F. TRUE
What has traditionally been used to ensure the appropriate, safe, and affective use of prescription drugs, but are increasingly shifting their focus to minimizing costs. Drug utilization review (DUR) programs
DUR programs involve ______ monitoring of physicians prescribing patterns. Retrospective
What is a list of prescription drugs approved by insurance coverage? Formulary
The history of drug formularies in the US extends back to ____. The american revolution
What are recent formulary trends? Multi-tier strategies, prior authorizatoin, step therapy
What made it easier for generic manufacturers to compete with R&D companies? The Hatch-Waxman Act
What is the value of a sacrificed alternative? opportunity cost
The three primary entities that fund pharmaceuticals are ____. Employers, the government, individuals
Almost 98% of employed Americans are now covered by a HMO, a preferred provider organizatoin, or a point of service plan. T or F. FALSE
Pharmaceutical companies are more interested in acquiring and exploiting another's brands than in acquiring another's R&D and sales and marketing assets. T or F. FALSE
Ideally, when should brand strategy development for a new drug begin? During Phase II clinical trials
"I own a BMW because I want people to know that I am a serious driving enthusiast" is an example of what type of value? An expressive value
What are some examples of functional value? Convenience, efficacy, safety
It is rare for drug companies to explore, develop, and promote expressive values with which patients might identify. T or F. 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. T or F. TRUE
With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. T or F. FALSE
What type of advertising has changed over the last few decades by becoming more of an essential marketing tactic for both large and small brands DTC
What most strongly influences physicians' prescribing habits? Doctors' personal experiences, and their patients' unique situations
Pharmaceutical companies spend more on promotional activities than R&D. T or F. FALSE
What is most well served by mass market print and TV ads? A brand that treats a very common chronic condition
How do companies use prescriber data? To conduct research
Modest meals for staff members attending educational events is allowed under PhRMA code. T or F. TRUE
Drug samples for personal use, given that the physician is retired, are allowed under the AMA guidelines. T or F. TRUE
The PhRMA Code on Interactions with Healthcare Professionals is ____. Voluntary
A stethoscope is considered an acceptable promotional item under PhRMA code. T or F. TRUE
Under PhRMA code, what is an example of an acceptable patient education item? An anatomical model valued under $100
Under what circumstances does PhRMA code permit a company to provide entertainment or recreational activities to healthcare practitioners? Under no circumstances
Under PhRMA code, may a company sponsor a lunch at a 3-day conference if part of it includes an educational program for which attendees may choose to receive CME credit? Yes, but only if the lunch is clearly separate from the CME portion of the conference
Gifts given only to physicians with high prescribing volumes is allowed. T or F. FALSE
Pens and clipboards designed to be used by patients in doctors' offices are considered acceptable promotional items under PhRMA code. T or F. FALSE
What is the arm of the Department of Health and human services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions? Office of Inspector General
It is legal to ask receptionists for personal information about your clients such as home phone numbers, birthdays, or hobbies. T or F TRUE
Educating sales reps on legal and ethical guidelines for professional behavior is a goal of the P&T committee. T or F. FALSE
What is a major challenge facing family medicine? Managed care policies eroding patient-doctor relationships
Family physicians diagnose and treat approximately what proportion of patients they see? 95%
What are the steps of the Product Adoption Continuum? Awareness, evaluation, trial, adoption
Drug therapy is a type of somatic psychiatric treatment. T or F. TRUE
Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists? They often see patients on the hour for 45 minutes
What is an advantage of selling to residents? They are often more open minded
What is drug utilization review (DUR)? An MCO's practice of monitoring prescribing patterns
Used in the treatment of manic-depressive illness and schizoaffective disorder. Mood stabilizers
What is the focus of the short call protocol? Beginning with a specific patient type
Who is the medical science liaison (MSL)? Someone employed by a drug company who builds relationships with thought leaders and acts as an informational resource
What type of education do MSLs typically have? Graduate level science degrees
How do companies usually judge the MSL team's contributions? Return on education
What differentiates push through programs from pull through programs? Sales reps are more involved in pull through programs
Because pharmaceutical sales reps mostly work out of their homes, it is not important that they work well in a team environment. T or F. FALSE
What are the types of pull through programs? Pull through support, educational support, adherence/persistency, therapeutic intervention
What is the most likely reason that a doctor would lack interest in one of your clinical studies? Does not like the way you are presenting it
What are some effective methods for reaching the 65+ market? Being a medicare part D information resource, knowing the physician-payer mix, taking advantage of partnership programs
When a doctor visits your hospital display, you should begin conversation by asking, "can I help you?". T or F. FALSE
"Your agenda, not theirs" is a rule in making the most out of your sales call. T or F. FALSE
Specialty care products are more often prescribed by generalist doctors. T or F. FALSE
Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. T or F TRUE
Acute medication, such as antibiotics, are used to address short term illnesses or symptoms. T or F. TRUE
In some medical cases, a therapy my be initiated by a specialist and monitored and maintained by a primary care physician. T or F. TRUE
Blockbuster drug status typically translates into sales of just under $10 million annually. T or F. FALSE
A generic drug manufacture's greatest challenge is often ____. To replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.
What differentiates an orphan drug from a blockbuster drug? Orphan drug typically treat rare conditions
How long are most calls and visits to a doctors office? Only a few minutes
Counter attack is a step in managing rumors. T or F. FALSE
What is considered going to the next level? Staying focused
What is one of the primary job responsibilities of a retail pharmacist? Dispensing pharmaceuticals
What are some ways drug companies and reps categorize their customers? Acute care vs. chronic care, office based vs. hospital based, primary care vs. specialty care.
Which of the following are relatively new prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act? Medicare Part D
Which term means “disease producer”? Pathogen
Which type of blood cell plays the most prominent role in fighting infection and disease? White blood cell
Which of the following generally resides on a cell surface (or in the cytoplasm) and causes a biological change or activity when stimulated? Receptor
Renal pertains to: Kidneys
What term denotes the practice of locating genes on a chromosome? Gene mapping
What field is MOST concerned with drug effects due to slight genetic differences? Pharmacogenomics
Which entity or entities fund/s the National Institutes of Health (NIH)? United States Federal Government
With respect to the material in your manual, what does IDN stand for? Integrated delivery network
What is SS an abbreviation for? Semis
What term is used to denote drugs that are non-biological (i.e., chemical) in nature? Small molecule
When referring to medication dosage, which medical abbreviation denotes “hour”? H
Which of the following terms denotes the study of drugs' beneficial and toxic effects on living cells, tissues, and organisms? Pharmacology
What are specialized cells and tissues that work together to perform a specific body function for a common purpose? Organs
What is the method by which a medication produces its therapeutic effects? The mechanism of action
What is the fluid portion of the blood? Plasma
What is an extreme sensitivity and reaction to a foreign substance, including medications? Anaphylaxis
What are the ways in which CNS agents are used? Analgesics, anethetics, anti-convulsants
How do cholinergic agonists work? by mimicking the actions of acetylcholine
What is considered a sympathomimetic drug that stimulates the alpha-adrenergic receptors? Decongestant
Which of the following is NOT a type of gastrointestinal agents? (gallstone solubizing agents , H2 antagonists, laxatives, prolactin inhibitors) Prolactin inhibitors
What is one of the main functions of a tocolytic agent? Suppress labor
Which of these conditions is NOT treated with antiandrogens? (acne, dyspepsia , masculinization in women , polycystic ovarian syndrome ) Dyspepsia
which types of patients are MOST likely to receive immune globulins? Patients with weakened immune systems
What is iron's primary function in the body? Carrying oxygen
Which of the following is NOT a type of anti-infectant? Antimetabolites
What is one difference between entry-level and experienced résumés? Entry-level résumés are more likely to begin with the education section than the experience section.
Which statement about targeted cover letters is true? Targeted cover letters are always tailored to specific companies.
Referring to medication dosage, what means of each? A.A.
Referring to medication dosage, what means before meals? A.C.
The primary US Association of Health Plans, which includes health maintenance organizations (HMOs), preferred provider organizations (PPOs), and other forms of managed care, and utilization review organizations (UROs) AAHP (American Association of Health Plans)
The rate at which a drug is taken into a persons bloodstream within a specified time period can vary form person to person. Absorption Rate
The process in which a medication is absorbed into the bloodstream Absorption
Anticholinergic side effects (dry mouth, blurred vision, urinary retention) AC
A specialized FDA mechanism implemented in the early 1990s to speed approval of drugs that represent a major advance in addressing serious or life threatening diseases for which effective alternative treatments exist. Accelerated Approval
Angiotensin-converting enzyme inhibitors. a class of drugs used to treat cardiovascular conditions such as hypertension and chronic heart failure ACE Inhibitors
The FDAs official response to an NDA. the message may be an approval letter, approvable letter, or non-approvable letter. Action Letter
A biological active product of a medications metabolism Active Metabolite
Condition or illness that only lasts for a short period of time. ex. common cold Acute illness
In terms of diseases or conditions, abrupt onset and short term Acute
Referring to medication dosage, means "freely" AD. LIB
Situations where two or more medications are used together and the clinical effect is equal to the sum of their individual effects Additions
The proper use of a medication by a patient. involves taking the medication on the correct schedule outlined by a physician, and using the proper technique Adherence
Substance that enhances the action of a drug or antigen. its therapy is the use of a second form of treatment in addition to the primary therapy. ex. having chemo in addition to surgery or radiation Adjuvant
Acronym for absorption, distribution, metabolism, and excretion. tests performed to asses the impact of a drug on the human body (pharmacokinetics). the ideal product will be rapidly absorbed, distibuted to the target organ, broken down (metabolized) eff ADME
An unwanted negative consequence sometimes associated with the use of drug therapy. a more precise term than "side effect", as some side ffects may be therapeutically useful. synonyms are "adverse effects" and "adverse events" Adverse Drug Reaction
An unwanted effect a medication may have on a person Adverse Effect
An unanticipated event that involves risk to the subject and that results in harm to the subject or others Adverse Event
Atrial fibrillation abbreviation is? AF
The measure of the binding of an antibody to an antigen Affinity
A drug capable of combining with receptors to initiate drug interactions Agonist
Manner in which client responsibilities are allocated among sales reps in a drug company Alignment
A national associated based out of chicago that represents more than 700,000 medical doctors in the US. defines ethical standards that doctors should observe in their relationships with drug companies and in their prescribing behavior AMA (American Medical Association)
Organization for pharmacy directors. is the national professional society dedicated to pharmaceutical care in managed healthcare environments AMCP (Academy of Managed Care Pharmacy)
The national professional society of pharmacists, founded in 1852, it was the first and still is the largest professional association of pharmacists in the US. members include practicing pharmacist, pharmaceutical scientists, pharmacy students, and pharm American Pharmaceutical Association (APhA)
An organic compound containing an O-C-N group Amide
The building blocks of peptides/proteins Amino Acid
A glycoprotein that is deposited extracellularly in tissues Amyloid
A type of pain reliever Analgesic
Similar in chemical and physical structure Analouge
An extreme sensitivity to a foreign substance, including medications Anaphylaxis
Supplemental health services that facilitate diagnosis and treatment, including lab work and x-rays Ancillary Care
Abbreviated New Drug Application ANDA
A male specific reproductive hormone Androgen
A peptide have two forms, I and II. I is converted to II by an enzyme, angiotensin-converting enzyme. II constricts blood vessels to increase blood pressure. Angiotensin
An interaction where one medication may reduce the effects of another medication. Antagonism
A protein secreted by B cells when they are stimulated by an antigen. act specifically against particular antigens in an immune response. Antibody
The substance, usually protein based, that stimulates productions of antibodies so as to meet the perceived threat Antigen
Acetaminophen (tylenol) (Abbreviation) APAP
Antigen presenting cell (Abbreviation) APC
The part of a drug formulation that is responsible for achieving a therapeutic effect API (active pharmaceutical ingredient)
Shorthand for Active pharmaceutical ingredient API
An FDA response to a NDA that lists major issues to be resolved before marketing approval can be granted Approvable Letter
A test or trial Assay
Disease in which the body's immune system is turned on itself Autoimmune disease
A national average of list prices charge by wholesalers to pharmacists. although it is supposed to reflect the sum pharmacies pay wholesalers for the drugs they sell, in reality it is often more like a "sticker price"- considerable higher than the act Average Wholesale Price (AWP)
Strength of binding, especially the binding of an antibody to an antigen Avidity
White blood cells that develop in the bone marrow and are the source of antibodies. also known as b lymphocytes B cells
Used when referring to medication dosage, means "twice a day" B.I.D.
Rod shaped bacteria Bacillus
A type of virus that destroys bacteria, also called phage Bacteriophage
Class of drugs used for various indications, but particularly for the management of cardiac arrhythmias and cardio-protection. while once first time treatment for hypertension, their role was downgraded as they did not perform as well as other drugs. the Beta Blocker
a molecule that attaches specifically to an active biological molecule or receptor by chemical bonds Binding Ligand
A measure of the rate and extent of medication absorption Bio-availability
Drugs derived from biologic sources Biopharmaceuticals
The use of biological processes to develop to manufacture such products such as drugs. includes vaccines Biotechnology
The barrier of cells that surround the blood vessels serving the CNS. Blood-Brain Barrier
Bulk pharmaceutical chemical BPC
Constipation (Abbreviation) C
Complementary or alternative medicine (Abbreviation) CAM
The arm of the FDA concerned with regulation of most biologic products. the mission stated on its webpage is "to protect and enhance the public health through regulation of biologic products including blood, vaccines, therapeutics, and relaxed drugs CBER (Center for Biologic Evaluation and Research)
Center for biologic evaluation and research CBER
Cluster of differentiation (Abbreviation) CD
A part of the US department of health and human services, recognized as the lead federal agency for protecting the health and safety of americans at home and abroad through programs addressing disease prevention and control, environmental health CDC (Center for Disease Control and Prevention)
The unit of the FDA with responsibility for oversight of all non-biologic drugs and selected biologics. approves such drugs for clinical trials, sets drug manufacturing standards, approves drugs for US marketing, reviews drug labeling and promotions CDER (Center for Drug Evaluation and Research)
complementary DNA (Abbreviation) cDNA
A collection of cells that will proliferate indefinitely when provided with appropriate space to grow and fresh medium to feed on Cell Line
The fundamental self-contained unit of life. in complex organisms, cells are the building blocks of tissues and organs, each charged with particular specialized tasks. every human cells homes the entire genome Cell
System of tissue that include the spinal cord and brain Central Nervous System
Code of Federal Regulation (Abbreviation) CFR
cycstic fibrosis transmembrane conductance regulator (Abbreviation) CFTR
current good manufacturing practice (Abbreviation) cGMP
The use of toxic drugs in the treatment of cancer Chemotherapy
congestive heart failure (Abbreviation) CHF
The FDA approval information about a medication. includes all the necessary information a medical doctor needs to correctly and safely use a medication. this is usually based on the manufacturers guidelines. synonymous with Prescribing Information and Pro Circular
The response produced by medication Clinical Effect
The mechanism that the FDA uses when it is concerned that a study may pose an unreasonable risk to subjects. CDER may either delay the start of an early-phase trial on the basis of information in the IND, or stop an ongoing study. the sponsor must addres Clinical Hold
Professionals (usually physicians) charged with overseeing the administration of an experimental compound in clinical trials. also referred to simply as investigators. the one in charge at a site is known as the principal investigator Clinical Investigators
The study of the effects of medications in humans Clinical Pharmacology
Research study conducted with patients, usually to evaluate a new treatment or drug. each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease." Clinical trial
Most or all participating physicians are housed in an HMO owed facility, which typically has an onsite pharmacy. this centralization increases opportunities to manage utilization. Variants include the staff-model HMO and the group-model HMO Closed Model
Chemistry, manufacturing and control(Abbreviation) CMC
The process of assigning formal, standardized medical codes to patient medical records. when a patient goes into a clinic or hospital, a medical record is created. the medical record will include patient identifying and demographic information. it will a Coding Systems
Hospitals, usually unaffiliated with an academic institution or teaching facility, offering medical and surgical care and sometimes even highly specialize services to the local population. Community Hospital
The extent to which a patient follows the regimen ordered by his/her physician during a designated time frame. along with persistence, it is a component of adherence Compliance
A distinct substance formed by a chemical union of two or more ingredients in definite proportion to weight. in the pharmaceutical context, a compound is not, properly speaking, a medicine or drug until clinical (human) trials have begun Compound (Chemical Compound)
A term used synonymously with disease Condition
The possible risk a medication may provide for patients with certain conditions. the risks involved with this particular condition may outweigh the benefits Contraindication
Drugs classified under the Controlled Substances Act of 1970 as having significant potential for addiction/abuse. there are 5 controlled substance categories known as schedules. Schedule 1 drugs, the most highly controlled, have high potential for abuse Controlled Substances
Chronic obstructive pulmonary disease (Abbreviation) COPD
A class of non-steroidal anti-inflammatory drugs that work by blocking COX-2, an enzyme whose activity contributes to inflammation COX-2 (cyclooxygenase-2) Inhibitors
Case report form (Abbreviation) CRF
Clinical research organization (Abbreviation) CRO
Where the tolerance of one medication may result in increased tolerance of another medication Cross Tolerance
Clinical trial certificate (Abbreviation) CTC
Clinical trial notification (Abbreviation) CTN
Clinical trial exemption(Abbreviation) CTX
An enzyme that forms a cyclic compound Cyclase
A substance that contains iron and acts as a hydrogen carrier for the eventual release of energy in aerobic respiration Cytochrome
The method of counting cells using a cytometer Cytometry
A unit of measure equal to the mass of a hydrogen atom Dalton
Dividing a group of physicians and other potential prescribers for a certain category of drugs into ten segments based on anticipated prescription volume. the highest volume prescribers are in decile 10. it allows drug companies to place a value on sales Deciling
Often used interchangeably with route of administration, but more specifically refers to the method through which a drug is delivered to the intended organ or receptor site within the body. Delivery Mechanism
Used to define a product discussion with a physician. could include discussion of scientific data concerning a product and or presentation of information from the FDA approved prescribing information Detail
An organization in which healthcare professionals exchange information on the discovery, development, evaluation, and utilization of drugs. it is noted for the educational programs it provides healthcare professionals. DIA (Drug Information Association)
A test which indicates the presence of disease Diagnostic
Artificial removal of waste products from the body. in can involve "cleansing" of either the blood or the digestive tract Dialysis
The lower reading obtained when blood pressure is measured. it is the period when the heart chambers are relaxing and refilling with blood. Diastolic Pressure
Redistribution of molecules and compounds to reach equilibrium Diffusion
The search for molecules or compounds that can produce therapeutic results. chemical compounds are investigated in lab settings. when promising candidates have been identified, it ends and preclinical research begins. Discovery
Programs to diagnose, educate, and or provide ongoing health status supervision to people with diseases or conditions (usually chronic) in order to prevent exacerbation of their health problems and unnecessary consumptions of health care resources---aka Disease Management
During drug development, the delivery of the drug to target areas of the body following absorption. on the commercial side, it involves the movement of market ready drugs from manufacturing sites to sites of consumer purchase or use. Distribution
A molecule that encodes operating instructions for our bodies DNA - Deoxyribose nucleic acid,
Degree earned by physicians who attend a college of osteopathic medicine. these colleges emphasize a holistic approach to health, focusing on the role of the musculoskeletal system in illness. DO (Doctor of Osteotherapy)
How much of, and how frequently, a medication should be taken. Dosage
How much of a medication is given to a patient at a time Dose
A representation of the clinical effect of a medication, versus the dose given Dose-response Curve
The way in which a drug enters the body, such as orally, IV, inhalation. Drug Delivery
The physical nature of the drug being administered (tablet, liquid.. ) Dosage form
Time period where the medication effects persist Duration of Action
Effective dose (Abbreviation) ED
Drug dose that causes a defined magnitude of response in a given subject. ED50 is the median dose that causes 50% of maximal response Effective Dose
The degree to which a medication produces a therapeutic effect Efficacy
Establishment inspection report ELA
Via metabolism and excretion, the removal of medication from the body Elimination
Enzyme linked immunosorbent assay Elisa
A poison released by a bacterium when the cell wall is broken Endotoxin
A coating on a tablet which protects it from stomach acids Enteric Coating
A measure of disorder Entropy
A protein synthesized by the body Enzyme
A branch of medical science that deals with the incidence, distribution, and control of disease in a population Epidemiology
Erythropoietin (Abbreviation) EPO
Extrasyramidal symptoms (Abbreviation) EPS
Inflammation of the esophagus Esophagitis
Expressed sequence tag EST
Electronic standards for transmission of regulatory information ESTRI
Patented prescription drugs Ethical Drugs
The origin, or cause, of a disease or a patients symptoms. when the origin is unknown the disease is called idiopathic Etiology
Outside of a living body Ex Vivo
The inert substances that are a part of almost every drug formulation, in contrast to the active ingredient. they include coloring, flavors, and preservatives. their purposes include enhancing or maintaining the stability, bioavailability, tolerability, Excipients
The elimination of a drug form the body, typically through urine or feces. it is one of the principal means by which the concentration of a drug in tissues is reduced and drug action is therefore ended. Excretion
Information from a gene is transcribed and translated, which results in the production of a protein. Expression
The FDA requirements that drug advertisements and promotions equivalently apprise consumers of positive and negative aspects of medication. ex. if they extol a drugs efficacy, the drugs advertisements must also provide prominent coverage of side effects Fair Balance
A physician who provides comprehensive health care to people regardless of age or sex, placing an emphasis on the family unit. similar to a general practitioner, but usually have completed a family practice residency Family Practitioner (FP)
A law that made sweeping changes to the Federal Food, Drug, and Cosmetic Act of 1938. it was designed to streamline clinical research and make it easier to test and market new drugs. among other things, it established a fast track process for high priori FDA Modernization Act of 1997 (FDAMA)
Food and drug administration FDA
A statute requiring for the fist time that manufacturers prove the safety of a drug before marketing it. among other things, the law states that all print advertisements for drugs must contain a short statement of side effects, contraindications Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
The metabolism of an oral medication by the liver before it reaches the body's systemic circulation First Pass Effect
The list of drugs that a managed care organization favors for use by its enrollees. use of drugs not on the MCO list may be forbidden outright or discouraged through high copayment requirements. most lists encourage use of lower-cost generic drugs Formulary
The substances comprising all active and inert drug ingredients, including fillers, colors, and other excipients used to prepare dosage forms Formulation
US regulatory agency with consumer protection and enforcement of anti trust laws. it regulates the advertising of OTC drugs, with a few exceptions, while the FDA regulated the advertising of prescription drugs. its antitrust arm monitors the anticompetit FTC (Federal Trade Commision)
Refers to medication dosage, means "gram" G/GM
Good automated manufacturing practice (Abbreviation) GAMP
Good clinical practice (Abbreviation) GCP
The insertion of genes into selected body cells for uses such as triggering production of therapeutic agents, enhancing susceptibility to a therapeutic agent that has previously been ineffective, reducing susceptibility of healthy cells to a therapeutic Gene Delivery
The identification of genes on a chromosome, and the distance between various genes, for the purpose of understanding the importance of genes in disease and illness Gene Mapping
Insertion of normal or genetically altered genes into cells to treat genetic disorders and chronic diseases. also known as gene delivery Gene Therapy
A doctor who attends to a variety of medical problems in patients of all ages, rather than focusing on a narrow specialty. unlike a family practitioner, they have now completed a family practice residency General Practitioner (GP)
Copies of drugs for which the patents have expired Generics
The microscopic packets that contain DNA, through which characteristics are passed from one generation to the next. many gene based test exist to determine whether a person has a gene mutation associated with a particular disease. each gene is a segment Genes
A form of biotechnology in which genetic material is manipulated to produce desired characteristics. it is also known as recombinant technology. it has been used to manufacture such drugs as insulin, interferon, and growth hormones Genetic Engineering
The entire DNA of a cell Genome
The study of genes and gene function Genomics
Gastroesophageal refulx disease GERD
Gastrointestinal GI
A type of excipients commonly known as flow enhancers. they are added to the powders used in pill production to ease movements through the manufacturing equipment. Talc is one example. Glidants
Good laboratory practice GLP
A carbohydrate that is linked to a lipid or protein Glycoconjugate
Good manufacturing practice GMP
G-protein coupled receptor GPCR
An entity consisting of two or more member hospitals, clinics, or other healthcare entities than band together to obtain favorable purchasing terms for supplies including pharmaceuticals, biologics, and medical surgical equipment. when members make purch GPO (Group Purchasing Organization)
Generally recognized as safe GRAS
Refers to medication dosage, means "drops" GT/GTT
Refers to medication dosage, means "at bedtime" H.S.
Refers to medication dosage, means "hour" H
Shorthand for headache HA
The time required for 1/2 of the concentration of a medication to be eliminated from the body Half-life
Shorthand for human anti-mouse antibody HAMA
Shorthand for hydrochlorothiazide HCTZ
The oxygen carrying pigment of red blood cells. tests of its concentration and for abnormal types identify anemia and other blood diseases Hemoglobin
Shorthand for high efficiency particulate air HEPA
relating to the liver Hepatic
Inflammation of the liver Hepatitis
human growth hormone hHG
Shorthand for human genome project HGP
Also known as the Kennedt-Kassebaum law. A federal law with two main components 1) the first pertains to health insurance "portbaility"- the ability to qualify immediately for comparable health insurance coverage after changing employers 2) referred to HIPAA (Health Insurance Portability and Accountability Act of 1996)
Shorthand for human immunodeficiency virus HIV
The most restrictive form of MCO, which strives to control health-care and pharmacy costs by placing sharp limits on the network of covered providers and on utilization of services and products, including drugs. there are two basic models. HMOs (Health Maintenance Organizations)
Proteins that are chemical messengers in the body hormone
A special care setting for people who are terminally ill and their families. Services include both physical care and counseling Hospice
A physician who oversees the care of patients when they are in the hospital. this practitioner will keep the patients PCP apprised of progress and return the patient to the PCPs supervision at discharge. PCPs avoid the inconvenience of visiting the hospit Hospitalist
high performance liquid chromatography HPLC
Hypertension aka high blood pressure HTN
Soluble in water Hydrophillic
Insoluble in water Hydrophobic
a set of hospital rooms equipped with special equipment, typically used for patients whose conditions are unstable and require close monitoring. specialized forms of it include neonatal, surgical, and cardiac ICU (Intensive Care Unit)
Insulin dependent diabetes mellitus (Abbreviation) IDDM
Integrated delivery network. a single organization usually built around a hospital or health system, which offers an arry of impatient and outpatient services IDN
Independent ethics committee (Abbreviation) IEC
Insulin-like growth factor (Abbreviation) IGF
The study of the bodys defense mechanisms against foreign materials that may cause disease or infection Immunology
A drug that suppresses the natural functioning of the immune system, used mainly to reduce the chance of rejection of a transplanted organ Immunosuppressant
Within a glass, in a test tube, or other artificial environment In vitro
Taking place within a living body In vivo
Investigational new drug (Abbreviation) IND
Independent physicians who have formed a loose association for contracting purposes contract to see HMO patients as part of their private practices. because IPAs are less cohesive than group practices, and work in geographically dispersed offices, opport Independent Practice Association (IPA) Model
FDA approved for diagnosis or treatment of a symptom, risk factor, condition, or disease Indicated
FDA approved condition for which a medication may be marketed Indication
Healthcare provided in institutional setting to patients staying for at least 24 hours. hospitals, skilled nursing facilities, and hospices all provide inpatient services Inpatient Care
Administering a medication into a body orifice Instillation
Committee of patient advocates, healthcare professionals, and laypersons such as clergy who serve as "watchdogs" to protect the rights and welfare of people participating in clinical trials. they make certain that proposed trials include such safeguard Institutional Review Boards (IRBs)
A physician who specializes in oversight of patients admitted to hospitals ICUs. a variant on a hospitalist Intensivist
Between cells Intercellular
A physician in training in the first year after graduating medical school Intern
A physician who practices internal medicine Internist
Within cells Intracellular
Independent review board IRB
A low supply of oxygen due to low blood flow Ischemia
International organization for standardization ISO
Compounds with the same molecular formula that differ in structure or configuration. this different version of an existing product may reduce side effects or have some other beneficial characteristics. because they can can be patented separately, they al Isomer Drugs
An enzyme that catalyzes the transfer of a phosphate group Kinase
The FDA approved information about medication. includes all the necessary information a medical doctors needs to correctly and safely use the medication Label
Limulus amebocyte lysate LAL
A synonym for biologic compounds, which typically consist of large proteins. because of their size, they must often be injected rather than administered orally in a pill or a capsule Large Molecule
The initial entry of a drug in the marketplace, or the entry of an established drug into a new market for which the manufacturer has received an additional indication LAunch
Lethal dose (Abbreviation) LD
The "bad" cholesterol that is carried into the blood and is the main cause of harmful fatty buildup in arteries. high levels increase the risk of heart disease LDL (Low Density Lipoprotein) Cholesterol
A treatment idea that has shown enough promise to warrant being explored further Lead
Drugs that enhance quality of life, but are not considered medically necessary. ex. Viagra Lifestlye Drugs
A molecule that binds to another molecule Ligand
An enzyme involved in DNA replication Ligase
A reagent for determining the quantity of bacterial endotoxins. it is obtained from the aqueous extracts of circulating amebocytes of the horseshoe crab Limulus Amebocyte Lysate
A spherical vesicle formed by a lipid enclosing an aqueous part Liposome
An initial dose of a medication that will provide the necessary plasma concentration levels for therapeutic benefit Loading Dose
Logarithmic function of the partition coefficient LOG P
A chronic inflammatory disease of connective tissue, affecting the skin and internal organs Lupus Erythematosus
A malignant tumor of the lymph nodes Lymphoma
Marketing authorization (Abbreviation) MA
Monoclonal antibody (Abbreviation) MAb
Maximum allowable carry over (Abbreviation) MAC
A dose of medication that keeps/maintains the necessary plasma concentration levels for therapeutic benefit Maintenance Dose
A largely but not exclusively private health insurance sector made up of organizations (MCOs) that emphasize controls to ensure cost effective care. typically, a central administrator is paid a fixed amount of money per member, per month and is at risk f Managed Care
The lowest dose of a medication that will provide the maximum therapeutic benefit Maximum Effect Dose
Master cell bank (Abbreviation) MCB
Micro-gram (Abbreviation) MCG
The health insurance program for the poor and disabled administered by each state and funded by money from the state and federal government. in contrast to medicare, which is insurance for persons age 65 or older and certain disabled persons, it is for p Medicaid
Used in the diagnosis, treatment, or prevention of diseases or conditions, or to affect the structure or function of the body.unlike drugs, they produce their principal benefit in some way other than chemical action in or on the body. the many varieties Medical Devices
A non-profit organization whose membership consists of marketing professionals form the drug, medial device, and diagnostic industries Medical Marketing Association
Health care professionals in a drug company who work closely with key opinion leaders in the relevant therapeutic area to share preliminary findings from ongoing clinical trials, information about planned phase 4 studies, and data on off label drug use w Medical Science Liaisons (MSLs)
Known as the hospital insurance component of medicare. it pays for inpatient hospital stays, relatively brief care in skilled nursing facilites, some home healthcare, and hospice care Medicare Part A
Known as the medical insurance component of medicare. it helps pay for physician services provided outside hospitals, lab and radiology services, ambulance service, outpatient hospital care, durable medical equipment, and some other medical services that Medicare Part B
New prescription drug benefits covered under the Medicare Prescription Drug Improvement and Modernization Act. provided by private health plans and is a voluntary program for medicare beneficiaries. all beneficiaries may obtain prescription drug coverage Medicare Part D Prescription Drug Benefit
Federally funded health insurance for persons age 65 or older, as well as younger persons with certain disabling conditions such as end-stage renal disease. it includes both part A and Part B Medicare
The science of diagnosing, treating, or preventing disease and other damage to the body or mind. also used to refer to any substances to treat or prevent disease or other damage to the body or mind Medicine
A chemical process of tranformation Metabolism
A product of metabolism Metabolite
Milligram MG
Myocradial infarction aka heart attack MI
The lowest amount of a medication that is able to produce an appreciable effect Minimum Effective Dose
Milliliters ML
Messenger RNA mRNA
Minute primitive bacteria without a rigid cell wall. this type of pneumonia causes atypical pneumonia in humans Mycoplasma
Abnormal or defective formation of the bone marrow Myelodysplasia
Malignant tumor cells Myeloma Cells
Nausea N
Trade group for the pharmaceutical and biotech industry. they represent sales reps for those industries as they educate, train, create standards, and provide current information for pharmaceutical sales professionals. they also provide accredited trainin National Association of Pharmaceutical sales Representatives (NAPSRx)
A division of the US department of health and human services and the CDC. the principal source of health statistics for the nations, they gather data on illness and disability and the use and availability of health services. National Center for Health Statistics (NCHS)
The deferally funded medical research organization based in Bethesda, Md. it spends billions of dollars each year on research to enhance understanding of disease. the information they have produced regarding mechanisms of disease has contributed to drug Nations Institutes of Health (NIH)
New chemical entity NCE
new drug application NDA
new molecular entity NME
nuclear magnetic resonance NMR
nuclear overhauser effects NOE
Used when referring to medication dosage, means "not to be repeated" NON Repeat
type of FDA response to an NDA. lists major deficiencies that will preclude approvale if not corrected. Non-approvable Letter
A disfavored alternative to a preferred drug, which may not be on the payer formulary at all. it usually carries a high copayment to discourage use and may also involve restrictions such as a prior authorization requirement Non-preferred Drug
A molecule composed of nucleotides joined together Nucleic Acid
A compound consisting of a nitrogen-containing base, a sugar, and a phosphate group Nucleotide
obsessive compulsive disorder OCD
Use of a drug for a purpose in a dosage form, dosage regimen, population, or other parameter other than those approved by the FDA as stated on the product label. doctors are free to experiment with off-label uses, but drug companies cannot promote such u Off-Label Drug Use
Orthostatic hypotension. low blood pressure upon standing up, especially from a lying position, causing the person to feel dizzy OH
The group within a US regulatory agency responsible for ensuring the integrity of programs administered by that agency. the one of greatest interest drug industry is in the department of health and human services. it combines its enforcement role with an OIG (Office of the Inspector General)
Molecule containing up to 20 nucleotides joined by phosphodiester bonds. above this length, the term "polynucleotide" is used Oligonucleotide
the study and treatment of cancer Oncology
electronic validation of a drug benefit claim at the location where a prescription is dispensed. the purpose is to determine potential coverage problems before the drug is dispensed to the patient. Online Adjudication
time period between the administration of a medication and its therapeutic effect Onset of Action
The provision of reimbursement for drugs that are not on a MCO or PBM formulary. while the payer favors use of formulary drugs, it will also offer coverage for non-formulary products, but usually with higher copayments Open Formulary
operational qualification OQ
Drugs for rare diseases and conditions affecting fewer than 200,000 people or a drug that is to be administered to fewer than 200,000 US patients in any given year in the US. to encourage development of treatments for these small markets, congress passed Orphan Drugs
over the counter. non prescription OTC
Someone receiving medical or surgical care that does not require an overnight stay in the treatment facility. it may be provided in a variety of venues, including a physician office, a clinic, or a hospital Otitis Media
Used when referring to medication dosage, means "after meals" "post cibum" P.C.
Used when referring to medication dosage, means "as needed" "pro re nata" P.R.N.
The FDA approved information about a medication. Includes all the necessary information a medical doctor needs to correctly and safely use a medication, based on the manufacturers guidelines. also known as product circular, prescribing information, and p Package Instert
an inspection by the FDA of a manufacturing site to verify data submitted in support of an NDA or ANDA and assess compliance with current good manufacturing practices. the program covers domestic and foreign manufacturers of both finished dosage form prod PAI (Pre-approval Inspection)
a worldwide epidemic Pandemic
phase 4 clinical studies conducted on a drug after it has won FDA marketing approval for the indication being studied. PAR (Post-Approval Research)
A drug designed to bypass the gastrointestinal tract. IVs and injections are common routes of this administration. ulike drugs that are administered orally or through enteral tubes, which only gradually reach the bloodstream, these drugs go directly into Parenteral Drug
injection Parental
Literally "disease producer". most frequently used in reference to infectious agents, such as bacteria Pathogen
the mechanism and cellular events leading to the development of a disease Pathogenesis
the practice of medicine dealing with the causes leading to the development of a disease Pathology
Interest groups for certain diseases or consumer segments that lobby for healthcare reform, additional research funding, and/or more generous insurance coverage. these groups are in increasingly powerful force in healthcare Patient Advocacy Groups
Physicians whom patients see for routine checkups and general healthcare needs, in contrast to specialist. PCPs (Primary Care Physicains)
Pharmacodynamics (Abbreviation) PD
Prescription drug user free act PDUFA
After one dose, the maximum concentration of a medication in the blood Peak Drug Concentration
A molecule containing a number of amino acids linked together Peptide
Through the skin Percutaneous
An enzyme that catalyzes the oxidation of substances in the presence of hydrogen peroxide Peroxidase
The negative logarithm of H3O+ ion concentration. the scale ranges from 1 to 14, less than 7 is acidic and greater than 7 is basic PH
the engulfment of a particle or microorganism by leukocytes Phagocytosis
The main trade and lobbying group for drug makers in the US, whose stated mission is "to conduct effective advocacy for public policies that encourage discovery or important new medicines for patients by pharmaceutical/biotechnology research companies" Pharmaceutical research and Manufacturers of america (PhRMA)
the study of a medications mechanism of action and the effects the medication has on the body Pharmacodynamics
the study of how an individuals genetic inheritance affects the bodys response to drugs Pharmacogenomics
The study of the effects on a medication as it goes through the body. includes absorption, distribution, excretion, and metabolism Pharmacokinetics
The study of chemical beneficial and toxic effects on living cells, tissues, and organisms. Pharmacology
Doctor of Pharmacy degree. the advanced degree for pharmacists. requires four years of professional study, following a minimum of two years of pre-pharmacy study, for a total of six academic years following high school PharmD
Pharmacokinetics (Abbreviation) PK
product license application PLA
The responses seen in patients taking placebo in clinical research studies Placebo Effect
The inactive control used in clinical research studies. may also be called a "sugar pill" Placebo
protein found in the blood plasma. often binds to medications. Plasma Protein
fluid portion of the blood Plasma
a cytoplasmic DNA that is capable of autonomous replication Plasmid
A molecule consisting of many joined amino acids, but not as complex as a protein Polypeptide
a descriptive term which is relative t the amount of medication required to achieve an effect. Potency
a situation where adding medications together achieves a better clinical effect than the sum of their effects individually. Potentiation
Studies in which a drug is tested in vitro and on animals. safety information form animal studies are used to support a drug application Preclinical Studies
"physicians and depending upon state regulations, nurse practitioners, pharmacists, and PAs who have the legal authority to write prescriptions" Prescribers
Favorable formulary status health plans usually accord to drugs for which they have negotiated a rebate contract. the favorable status usually translates into a lower copayment than for alternative products. Preferred Drug
"the FDA approved information about a medication. includes all the necessary information that a prescriber needs to correctly and safely use a medication, based on the manufacturers guidelines." Prescribing information
A US law enacted to educe the risk of prescription drugs that are counterfeit, adulterated, or expired being sold to the american public. it banned the sale, purchse, or tade of drug smaples and drug coupons, banned reimportation of prescription drugs Prescription drug marketing Act of 1987 (PDMA)
in health systems that use primary care physicians Primary Care
A non-government entity that provides health insurance benefits, including blue cross and blue shield plans, commercial insurers, and managed care plans Private Insurer
A "house brand" OTC drug that usually sells for less than the equivalent national brand Private Label
A test which provides predictive information as the future course and outcome of a disease Prognostic
An agent that is used to prevent the development of a disease or condition Prophylactic
A protein that has many functions, including mediation of the inflammatory process" Prostaglandins
An enzyme that acts on proteins Protease
the study of protein expression of normal and diseased cells and tissues Proteomics
Shorthand for paroxysmal supraventricular tachycardia PSVT
Shorthand for peptic ulcer disease PUD
A substance or agent that causes feer Pyrogen
Used when referring to medication dosage, means "once a day" "quaque die" Q.D.
Used when referring to medication dosage, means "4 times a day" "quarter in die" Q.I.D.
Acronym for "every" when referring to medication dosage ex. Q12h = every 12 hours Q
Quality assurance (Acronym) QA
Quality control (Acronym) QC
Recombinant DNA. DNA that has been cut and spliced in order to alter the genetic code - (Acronym) rDNA
A chemical substance to react in a specific manner that can therefore be used to detect or produce another substance. they are sometimes used to manufacture a drug substance. Reagent
A site in the body that generally resides on a cell surface within the cytoplasm. when a receptor is stimulated or occupied, a biological change/activity takes places. Receptor
Formally the Drug Topics Red book. an annual reference work containing pricing information for prescription and OTC products, NDC numbers for FDA approved drugs, and Orange book coeds reflecting FDA evaluations of therapeutic equivalence" Red book
pertaining to the kidneys Renal
a physician who has graduated from medical school but is undergoing additional training in his or her specialty. most specialties require at least three years of training and many require four or more. Resident
"recurrent stenoisis, a condition in which the blood vessel or heart valve has narrowed" Re-Stenosis
an enzyme that cuts DNA into short segments restriction enzyme
sales calls in which a junior sales rep is accompanied by a sales manager or more senior sales rep. the purpose is to train and evaluate the performance of the less experienced sales representative Ride Along
ribose nucleic acid RNA
"shorthand for prescription. derived from the latin word for ""recipe""" Rx
"used when referring to medication dosage, means ""wihtout""" S
a carbohydrate Saccharide
severe combined immune deficiency SCID
"outpatient services from specialists and hospital care, both inpatient and outpatient. in non-emergency situations, access often requires a referral from a PCP." Secondary Care
The ability of a therapeutic dose of a drug to affect its intended target without affecting other parts of the body. Selectivity is generally desirable in a drug. Selectivity
an unwanted effect a medication may have on a person Side Effect
The difference at one nucleotide in a DNA sequence among individuals Single nucleotide Polymorphism
Drugs that are non-biologic (chemical) in nature Small Molecule
Shorthand for shortness of breath SOB
Shorthand for Standard operating procedure SOP
conferences and meetings at which experts discuss topics of clinical or practical interest to drug company customers. the drug company may sponsor teh conference or meetings as a promotional device to enhance relationships with the relevant customers. Speaker Programs
"a physician with advnace training in a highly specific area of medicine, such as a cardiologist or oncologist. in some health plans, they cannot be seen without a referral from a gatekeeper physician, such as general practitioner." Specialist
"used when referring to medication dosage, means ""one-half""" SS
federal laws with combined effect of prohibiting any physician from referring medicare and medicaid patients to entities in which the physician or an immediate family member of the physician has an ownership interest or with which the physician or family Stark I and II
"situation in which a drug level remains somewhat stable, because the rate of absorption equals the rate of elimination" Steady-State Concentration
"an undifferentiated cell with the potential to become any type of specialized cell. most embryo cells are this kind of cell. they might provide an unlimited source of healthy adult cells, such as bone, muscle, liver, or blood to treat people with various Stem Cell
"member of a large family of structurally similar lipid substances, but difference classes of them have different functions." Steroid
beneath the outer skin Subcutaneous
"situation in which two or more drugs are used together, and the clinical effect is equal to the sum of their individual effects." Summation
"elimination or prevention of manifestations of a disease. these treatments may be necessary over the entire lifetime of a person with a chronic disease. in the context of organ transplants, it involves the use of drugs to avert the bodys immune response Suppression
"a delivery mechanism that dispenses a drug in the body gradually, ensuring a steady level in the blood and relatively long term effect. can be administered less frequently than those that are metabolized more quickly." Sustained Release
"changing over from a previously utilized drug to a new drug for the same condition, disease, or risk factor." Switching
"subjective sensations related to a disease or condition. they are indicators that the diagnostician learns about only through patient self-report . by contrast, signs are manifestations that can be seen by the diagnostician and or objectively measured" Symptoms
situation in which adding medications together achieves a better clinical effect than the sum of their effects individually. Synergism
the bloodstream Systemic Circulation
the effects a medication may have on the body Systemic effects
"used when referring to medication dosage, means ""three times a day""" T.I.D
a specific protein or enzyme upon which a drug acts Target
the ability to cause abnormal development or malformation of the fetus Teratogenicity
"highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center, usually serving a region or state having highly sophisticated technology" Tertiary Care
"1) receipt by a physician of items of negligible value 2) fair market compensation for services actually rendered by the physician 3) discounts on drug prices, as long as the same discount is offered to other similarly situated physicians" Stark Law Safe Harbor Exceptions
a clinical discipline. include the basic internal medical specialties Therapeutic Area
a system of grouping drugs by common therapeutic indication. less broad than therapeutic area. hundreds can exist. Therapeutic Category
Drugs that share both an indication and a method of operation Therpeutic Class
defines the necessary conetration of a medication in blood or tissue to achieve the desired effect Therapeutic Concentration
two drugs that are roughly interchangeable in safety and efficacy when used at roughly the same dose to treat the same health problems. do not have to have the same active indredients Therapeutic Equivalents
"measure to determine the safety of a medication. a ratio which compares the dose which produces toxicity, to the dose which produces the desired effects" Therapeutic Index
Treatment and healing of a disease Therapeutic
section of an organ that consists of a largely homegnous population of cell types Tissue
"the manipulation of the dose of a medication based on the response by a patient, until the desired effct is achieved. it may be moved up or down based on the clinical response by the patient." Titration
Traditional medicine (Acronym) TM
Tumor necrosis factor (Acronym) TNF
Increase in bodys resistance to the effects of a drug, leading to the need for higher doses to produce the same benefits Tolerance
The degree to which a drug or other substances is poisonous to an animal or person. Also, the actual occurance of adverse events in people taking the drug. the acceptable level of it will vary depending on the conditoin for which a drug is used. Toxicity
Division of medical and biological science concernced with the study of the harmful effects of varioussubstances, including drugs Toxicology
The process of transfer of genetic information from DNA to RNA Transcription
Shorthand for Transfer RNA tRNA
Shorthand for treatment Tx
Evaluation by a health plan or healthcare instiution of the cost efficacy of care decision made by a group of physicians. DUR is a sub category of evaluations of resource use Utilization Review
Shorthand for Vomiting V
a biologic that the immune system recognizes as a disease-causing agent. the antibodies produced by the body as a result protect the body against a more serious attack by the same antigen. some have essesntially eliminated some diseases from the US and ma Vaccine
"a drug target (typically a protein) that has been proven to have an effect on human health. therefore, interventions affecting that target have therapeutic potential ." Validated Target
documentary proof offered by a drug manufacturer to the FDA that its manuftacuring processes will produce the same drug product batch to batch and year to year Validation
Shorthand for a carrier vector
Minute infectious agents. can replicate only within living host cells, cause many types of illness virus
A type of blood cell that helps the bdy fight infection and disease. theses cells originate in the bone marrow and then travel to other parts of the body. also known as a leukocyte White blood cell
Shorthand for world health organization WHO
entitites that purchase drugs from drug companies and then resell and deliver them to pharmacies. drug companies often collaborate with them to monitor demand and ensure product availability in the marketplace wholesalers
Shorthand for world trade organization WTO
Transplanation of cells, tissues, or organs from non-human animal sources into humans" Xenotransplantation
Shorthand for zollinger-ellison syndrome z
The FDA regulates the introduction of new drugs and enforces U.S. drug laws. T or F. TRUE
Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. T or F. TRUE
Average review time for a new drug 18 months
Sales Team Pg 7
The ""engine of innovation,"" focused on discovering or inventing promising new product." Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the business. Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. T or F. TRUE
Presently, 3,070 new meds are in development for cancer. T or F. TRUE
Usage of a medication for purposes other than the specific ones appearing on the label Define Off-label
The extent, quality, or degree to which a substance is poisonous or harmful to the body Toxicity
"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." Institutional review Board (IRB)
Inactive pill, liquid, or powder that has no treatment value aka sugar pill Placebo
Refers to Swelling Edema
Without signs or symptoms Asymptomatic
The study of the effects and movement of drugs in the human body Clinical Pharmacology
The study of basic structures of the body Anatomy
The study of how those body structures function Physiology
Basic clinical pharmacology involves 3 main concepts Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Study of the biochemical and physiological effects of drugs and their mechanisms of action i.e. the study of what a drug does to the body. It describes the therapeutic effects of drugs (pain relief, blood pressure reduction, their side effects and their Pharmacodynamics
Study of how a drug is processed by the body, with emphasis on the time required for absorption, duration of action, distribution, and method of excretion. The study of how the body affects drugs. Pharmacokinetics
"Drug delivery systems, route of administration , modes of excretion." Drug distribution & elimination
The liquid portion of the blood that carries proteins and other substances Plasma
"Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin)" Organs
Brain of the cell that regulates all activities. Nucleus
A nutrient made up of of chains of amino acids Proteins
A nutrient stored in special body tissues as a great source of reserve energy Fats
A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions. Carbohydrates
"A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body." Vitamins
A nutrient necessary for bodily purposes such as the balance of body fluid Minerals
Water is NOT a nutrient T or F. TRUE
"Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune" Body's Major Systems
How the drug passes from its side of administration into the bloodstream Absorption
How the drug is dispersed among the organs after absorption into the blood Distribution
How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys Metabolism
"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." Excretion
It takes about 10 years for a drug to hit the market T or F. TRUE
Routes of drug administration Pg 26-29
Seven rights of drug administration pg 30
how quickly and how much of a drug reaches its intended target site of action Bioavailability
when they contain the same active ingredients and proceed virtually the same blood levels over time. Bioequivalent
Production of the same medicinal effect Therapeutic equivalence
Drug elimination and Excretion pg 34
Drug Forms Pg 35-38
Patent last 20 years T or F. TRUE
Inactive ingredients "Added to provide bulk, strength, aid "
Pharmaceutical Ingredients Pg 54
twice a day BID
"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" Half-life
As needed PRN
Once a day QD
Four times a day QID
the ability of certain drugs to bind to plasma protein. Protein binding
three times a day TID
the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects Titration
Time of peak plasma concentration on a measuring curve Tmax
Immediately STAT
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 Primary 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 Secondary wholesale distributors
Distribution Terminology Pg 60-61
Published wholesale price of list price suggested by the manufacturer. Average wholesale price (AWP)
Company that owns and operates four or more pharmacies Chain drug store
"Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler" Drop shipment
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 Group purchasing organization (GPO)
Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution Upcharge
Package Insert Info Pg 63
Drug Patents Pg 65
Orange Book ratings "Terms pg 67 - A, AA, AN, AO, AP, AT, B"
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 bioavailabili Hatch-Waxman Act
It is important not to change the order of a sample closet T or F. TRUE
Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples T or F. TRUE
Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically. T or F. TRUE
"Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be subjected to extremes of temperature, moisture, and contamination. T or F." TRUE
"A sample closet or cabinet is essentially similar to a grocery store shelf. The more visibility you can give your drug, the more likely it will be used. T or F." TRUE
"In some situations, a physician may sign the paperwork before the number of samples has been recorded. T or F." TRUE
"Prohibits sale, purchase, or trade of drug samples" Section 503
E-sampling Pg 72
"Many pharmaceutical manufacturers set expiration dates every six months (June, December). T or F." TRUE
DEA regulates the distribution and use of narcotics and other controlled substances. T or F. TRUE
Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior FTC
provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies AMA
Benefits of Government-Industry Partnerhsips Pg 79
Preclinical studies pg 81
Involves the engulfing of fluids by a cell. Pinocytosis
"Passive diffusion, facilitated diffusion, active transport, pinocytosis" Transport Mechanisms
"Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous" Absorption methods
The liver is the major organ for metabolizing drugs. Secondary is kidney. T or F. TRUE
CL= rate of drug elimination/drug concentration in blood. T or F. 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. T or F." TRUE
Clinical Trials pg 89 101
"Subjects should be informed about the aims, methods, risks, and benefits of the trial. T or F." TRUE
Four phases of clinical trials Pg 90 102
Regulatory Requirement terms Pg 92 104
The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor Investigator
"The organization or individual that initiates the trial and finances the study," Sponsor
This document sets out how a trial is to be conducted Protocol
The study of how factors influence disease and health in human populations. Epidemiology
Therapeutic Antibodies
Vaccines Pg 148
Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines. Toxoids
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. Vector-based vaccines
Chemically synthesized and normally consist of 8-24 amino acids Peptide Vaccines
Adjuvants pg 150
Cytokines are produced mainly by the leukocytes (white blood cells). T or F. TRUE
Hormones are intercellular messengers. T or F. TRUE
"Integrates genes to hose chromosomes, change of long term stability." Retrovirus
This vector has a large capacity for foreign genes. Adendovirus
Vector does not have viral genes so they do not cause disease. Liposomes
they do not have viral genes and do not cause disease Naked DNA
"Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA" Gene Therapy types
Stem Cells Pg 154
Managed Care Pg 157
Formulary List of prescription drugs approved by insurance coverage pg 158
Opportunity cost pg 164 Bottom
Branding pg 173
"Function, Expressive, Central" Values
"Efficacy, safety, convenience, cost-effectiveness" Functional Values
6 stages of brand strategy "Brand positioning, brand personality, brand values, unique values of the brand that support the values, how the brand appears to its audience, internal commitment"
"impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal pg 144" Pharmetrics
"Easy to pronounce, easy to write and read, memorable, distinctive and different from competition" Brands should be:
Direct-to-consumer (DTC) pg 192
Factors that influence DTC pg 193
Gifts Pg 202
"Now prohibits pens, mugs, objects with company logo" PhRMA Code
AMA Gift guidelines Pg 205
Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value. T or F. TRUE
Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work. T or F. 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. T or F." TRUE
PhRMA Code on relationships Pg 207
PhRMA FAQ Pg 214
Nursing Structures Pg 240
Sales techniques pg 249
Medicare part D pg 266
Organizing your day Pg 281
"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" Traits of Pharma sales Rep
Glossary 271
Exclusivity is granted for an orphan drug for ____ 7 years
"Patents are applied for with, and granted by the FDA. T or F." FALSE
Patents expire after how many years from the date of filing? 20 years
Generic drugs are not regulated by the Food & Drug Administration. T or F. 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. T or F. TRUE
Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount. T or F. TRUE
The federal government does not regulate the drug sampling for a pharmaceutical representative. T or F. FALSE
Storage conditions for drug products are based on data and information supplied by the manufacturer. T or F. TRUE
Drug recalls are almost always negotiated with the FDA beforehand. T or F. TRUE
The PDMA is the Prescription Drug Manufacturers Association. T or F. FALSE (Prescription Drug Marketing Act)
Primary wholesale distributors buy most of their drugs directly from ______ manufacturers
The AWP is a published ______ price, suggested by drug manufacturers. wholesale
Rebates are also referred to as after-market arrangements. T or F. TRUE
Drug labels must include indications and usage information, as well as contraindications. T or F. TRUE
A patent owner has the right to exclude others from making, using, selling or importing into the US the invention it describes. T or F TRUE
Exclusivity gives exclusive ______, which is granted by the FDA, and can run concurrently with a patent or not. marketing rights
Exclusivity is granted for an orphan drug for _______ years. 7
A generic drug is ______ to the originator brand-name drug in dosage, strength, safety, and quality. bioevuivalent
Generic drugs are not regulated by the FDA. T or F. 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. T or F. 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 agency which regulates the distribution and use of narcotics and other controlled substances is _______. DEA
The FDA approves storage conditions for drug products. T or F. TRUE
The most important benefit of electronic prescribing is related to patient ______. Safety
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. T or F. TRUE
There are more white blood cells than red blood cells for the same volume in the human body. T or F. FALSE
Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein-based. T or F. TRUE
The duration for Phase III of the clinical trial can typically last 3-5 years. T or F. TRUE
The aim of the Phase IV clinical trial is to examine the safety and effectiveness of the drug in the targeted disease group. T or F. FALSE
Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. T or F. 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. T or F. TRUE
Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient. T or F. FALSE
Toxicity information in preclinical studies provides confidence about a drugs safety aspect. T or F. TRUE
The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. T or F. TRUE
Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. T or F. TRUE
Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. T or F. FALSE
DUR programs involve retrospective monitoring of physicians' prescribing patterns. T or F. 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. T or F. FALSE
PBM's tend to serve a local market through a network of pharmacies. T or F. 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. T or F. FALSE
It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. T or F. 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. T or F. TRUE
"With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. T or F." FALSE
DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. T or F. TRUE
Subjects for clinical trials are selected on the basis of _____ scientific objectives
The pivotal trial is Phase ______ of the clinical trial. 3
"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
A formulary is a list of prescription drugs approved by insurance coverage. T or F. TRUE
Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and ______. 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. T or F." TRUE
The key areas in hospitals that require special selling tactics are ______, formulary committee, and the medical education department. Pharmacy department
Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources. T or F. TRUE
One of the oldest and least effective pharmaceutical marketing techniques is the direct-to-consumer advertising. T or F. FALSE
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. T or F. 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. T or F. 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%
The most effective method for grabbing market share is: Comparative selling
Most visits by pharmaceutical reps are to pharmacies. T or F. 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
The heart of a pharmaceutical sales team is the Regional Manager. T or F. FALSE
Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. T or F. FALSE
DUR programs involve retrospective monitoring of physicians' prescribing patterns. T or F. 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. T or F. FALSE
PBM's tend to serve a local market through a network of pharmacies. T or F. 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. T or F. FALSE
It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. T or F. 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. T or F. TRUE
With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. FALSE
DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. 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. T or F. FALSE
Specialty care products are often prescribed by generalist physicians. T or F. FALSE
In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician. T or F. TRUE
Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. T or F. TRUE
Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies. T or F. TRUE
The greatest challenge for a generics manufacturer is to replicate a drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug. T or F. TRUE
What is one of the biggest time wasters for a pharmaceutical sales rep? Travel time
"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
What do retail pharmacists do? Dispense pharmaceuticals
Which is a step to becoming an indispensable pharmaceutical sales rep? Asking feedback
Which is not a step to plan for rumors? Counter attack
Customers purchase products from people they like, trust, and respect. This is the.. Likeability
According to the text, which of the following is considered going to the next level? Staying focused
The response produced by a medication Clinical effect
The practice of medicine dealing with the causes and nature of disease/death Pathology
New prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act: Medicare part d
Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center Tertiary care
Literally a "disease producer" Pathogen
A type of blood cell that helps the body fight infection and disease: White blood cell
Used when referring to medication dosage, means "one-half" SS
Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume: Declining
The substances comprising all active and inert pharmaceutical ingredients, including fillers, colors, and other excipients used to prepare dosage forms Formulation
A low supply of oxygen due to low blood flow is: Ischemia
The acronym for pharmacokinetics is: PK
According to the text, there are ___ classes of therapeutic drugs. US federal govt
Oral Glaucoma Therapy is classified as: Ophthalmology therapy
Is a physician that practices internal medicine Internist
Another name for biologic compound is: Large molecule
SS is an abbreviation for: Semis
What is used to determine appropriate medical reimbursement? Coding system
A term used to refer to drugs that are non-biological (that is, chemical) in nature: Small molecule
The origin, or cause, of a disease or a patient's symptoms Etiology
Used when referring to medication dosage, means "as needed" PRN
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
Refers to medication dosage, means "hour" H
Outside a living body: Ex vivo
The meaning of subcutaneous is: Beneath outer skin
The acronym for effective dose is: ED
According to the text, depression is a disease that attacks the: Central nervous system
ML stands for: Milliliter
Created by: chanshealy