Pharmaceuticals are arguably the most socially important healthcare product. (T/F)
true
Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing. (T/F)
true
Pharmaceutical sales are highest in which geographical regions?
The U.S., Western Europe, and Japan
The U.S. accounts for about __ of the world’s pharmaceutical revenues.
50%
Which of the following has fueled recent growth in the pharmaceutical industry?
population growth and increased life expectancies
According to the manual, which statement accurately describes the predicted relationship between pharmaceutical 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 healthcare providers. (T/F)
false
The high price of healthcare is explained by the high price of medicines. (T/F)
false
One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising. (T/F)
false
What influences the number of districts in a region?
the region’s population
What is an example of the regionalization of healthcare delivery systems?
California and Florida have different prescription reimbursement policies
The heart of a pharmaceutical sales team is the regional manager. (T/F)
false
Most DMs did not start as representatives. (T/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/F)
false
It usually only takes 1-2 calls to a physician before he or she commits to prescribing your product. (T/F)
false
The pharmacist may dispense a product other than what the physician prescribed. (T/F)
true
According to ch. 12 of the manual, which of the following would classify as “payers”?
employers
According to the manual, what defines “ethical pharmaceutical companies”?
researching and developing novel drugs
One of the most disappointing results of the pharmaceutical industry’s continued investment in R & D is the few new drugs being approved and in development. (T/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 American lifespan increased since 1890?
almost 30 years
What is a treatment group?
a group of patients assigned to receive a specific treatment
What is the main difference between a blinded and 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 are in the control
What does “asymptomatic” mean?
not exhibiting signs or symptoms
Which term denotes the study of bodily functions (as opposed to structures)?
physiology
In its broadest definition, a drug is any substance that produces a physical or psychological change in the body. (T/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 substance other than food intended to affect the structure or function of the body
Which statement about vitamins is correct?
most of the body’s required vitamins must be taken from outside the body
ADME testing measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolites it into waste material and then excretes it from the body.
true
ADME testing is primarily used in what field?
pharmacokinetics
Which statement about placebos is correct?
placebo effects can lead to withdrawal symptoms
On average, only about 5 of 4,000 drugs studied in the lab are eventually studied in people. (T/F)
true
Which statement is true about drugs taken sublingually?
sublingual drugs are absorbed directly and almost immediately into the bloodstream
What are 3 of the 7 rights of drug administration?
the right patient, the right drug, and the right dose
Pro-drugs are administered in an active form, which is metabolized into an inactive form. (T/F)
false
The kidney of an 85-year-old person excretes 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/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
About __ of the people in the U.S. are “slow acetylators”
50%
Which of the following statements about drug-drug interactions is INCORRECT?
Drug-drug interactions are always harmful
Smoking decreases the effectiveness of some drugs.
true
Which of the following statements about dietary supplements is INCORRECT?
Because dietary supplements are not drugs, interactions with drugs are not a concern
Which statements is/are INCORRECT about an ideal drug, or “magic bullet” as Ehrlich phrased it?
All are correct
- it does not exist
- it would be aimed precisely at a disease site
- it would not harm healthy tissues
Which statement accurately differentiates resistance from tolerance?
tolerance refers to a person’s diminished response to a drug after repeated use, while resistance applies to microorganisms’ or “cancel” cells’ abilities to withstand drug effects
Between 3% and 7% of hospital admissions in the US are estimated to be for treatment of adverse drug reactions. (T/F)
true
Which statement is true about the universal scale for quantifying the severity of an adverse drug reaction?
none of these statements are true because there is no such scale
- the severities of adverse drug reactions are quantified by their chronicity
- the severities of adverse drug reactions are quantified by their threat to life
Why is noncompliance a serious public health concern?
it increases the cost of medical care
Which of the following is NOT eligible for patent protection under US regulations?
companies can be granted patents for all of these things
- 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/F)
true
Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents. (T/F)
false
Legally, bioequivalence of different versions of a drug can vary up to
20%
Which of the following statements about biologics is INCORRECT?
they do not cause immune responses
“Large molecule” products are developed and manufactured by a chemical process.
false
What are drugs that attract or bind to cells receptors in order to mimic or enhance activities by endogenous chemical messengers?
agonists
Which term denotes how an API works in the body?
mechanism of action
What cements the active and inert 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
What components might cause patients’ different reactions to brand name and generic drugs?
difference in inactive ingredients
All cells have a nucleus. (T/F)
false
Which of the following does NOT affect drug response?
All of these factors influence drug response
- the patient’s genetic makeup, age, body size, and use of other drugs and dietary supplements
- the patient’s 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 reactions. (T/F)
false
What is the typical relationship between a drug’s site of administration and site of action?
they are usually somewhat removed from each other
What is CMAX?
the peak plasma concentration of a measuring curve
Which of the following is NOT a main concept in clinical pharmacology?
pharmacoprocesses
Which of the following is NOT a route of drug administration?
transfugal
How are intradermal drugs delivered?
by injections under the skin
What is an example of intravenous drug delivery?
an injection of anesthetic 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/F)
false
Only 3 companies account for nearly 90% of all drug wholesale sales. (T/F)
true
What type of sale bypasses the need for intermediary distributors?
manufacturer-direct sales
What is a group purchasing organization (GPO)?
an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members
Prescriptions dispensed by mail-order pharmacies are, on average, around __ than those dispensed by retail pharmacies.
3 times larger
Which of the following is NOT a type of non-stock sale?
All of these are examples of non-stock sales
- 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/F)
false
A company that owns and operates 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/F)
true
What should be included in the “description” section of a drug’s package insert information?
the drug’s proprietary name and the established name
Exclusivity gives exclusive __, is granted by the FDA, and can run concurrently with a patent or not.
marketing rights
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
Which of the following is NOT required by the FDA’s criteria for equivalency?
the drugs contain identical amounts of the same inactive ingredients
What list is generally considered the most reliable source of information on therapeutically equivalent drug products?
“Approved Drug Products with Therapeutic Evidence”
Which of the following is an Orange Book rating?
AA
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, performance, 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 can give your drug, the more likely that it will be prescribed
Pharmaceutical representatives do not typically store and secure their own drug samples. (T/F)
false
Sampling is sometimes the most important factor in a pharmaceutical rep’s success. (T/F)
true
The FDA approves storage conditions for drug products. (T/F)
true
Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for that amount. (T/F)
true
What is prohibited by Section 503 of the Federal Food, Drug, and Cosmetic Act, as amended by the Prescription Drug Marketing Act?
the sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples
The federal government does not regulate the drug sampling for a pharmaceutical representative. (T/F)
false
Which of the following is permitted by Section 503 of the Federal Food, Drug and Cosmetic Act?
None of these
- hospitals donating their prescription drug coupons to qualified charitable organizations
- hospitals donating their prescription drug samples to qualified charitable organizations
- hospitals selling their prescription drug samples to qualified charitable organizations at reduced costs
Which 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/F)
true
Medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors. (T/F)
false
In which cases can degraded drugs SOMETIMES still be used?
when the amount of remaining drug has not fallen lower than 85-90% of that stated on the label
Drug recalls are almost always negotiated with the FDA beforehand. (T/F)
true
Which problem would NOT be improved by electronic prescribing systems?
None of these
- 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 him/her or the mistake and ask for instructions on proper procedure
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 (i.e., from the discovery of the initial compound to FDA approval)?
10-15 years
Which of the following regulatory agencies is industry-based (i.e., run mainly by the companies themselves)?
Pharmaceutical Research and Manufactures of America (PhRMA)
Which of the following factors has simplified the pharmaceutical R&D process?
None of these
- an intensive regulatory process
- growing demand in the medical community for more complex data about pharmaceuticals
- the increasing number of procedures in Phase III trials
The landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients. (T/F)
true
According to the manual, which type of system is the best way to deliver healthcare?
a market-based system
How would increased pharmaceutical price controls affect the US healthcare system?
increased price controls would stifle innovation
Which of the following invests a greater percentage of sales in research than the biotech sector?
None of these
- the aerospace sector
- the communications sector
- the electronics sector
What was the intent of the Bayh-Dole Act and the Stevenson-Wylder Technology Innovation Act?
to hasten the commercialization of technologies that otherwise might not be used
According to the manual, what did the G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)?
there is poor collaboration between publicly- and privately-funded research centers
The aim of preclinical pharmacological studies to obtain data on the safety and effectiveness of the lead compound. (T/F)
true
Toxicity information in preclinical studies helps provide confidence about a drug’s safety. (T/F)
true
Pharmacological studies using animals are regulated under Good Laboratory Practice. (T/F)
true
Why do drugs administered to patients only contain APIs?
they dont
Which of the following does NOT affect a drug’s ability to permeate membranes?
the drug’s vesicles
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
Which of the following routes of administration do NOT completely bypass the liver?
rectal
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
which of the following does NOT affect a drug’s distribution to its target tissues?
all of these factors affect a drug’s ability to reach the target site
Which of these medical terms means “to apply the drug on the skin surface”?
transdermal
Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. (T/F)
true
According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies?
scientific objectives
Which statement about IRB is INCORRECT?
The members of the IRB/IEC must be experts in the topic of the study
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
Which of the following 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 to back in time (i.e. via chart reviews) to find exposure to 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 risk for the event (i.e. lung infections per year)?
incidence
Which of the following measures is used to describe the variability of the population mean?
standard error of the mean
Which of the following terms 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 and Cox proportional hazards analysis?
methods of survival analysis
What section of a clinical paper describes subject’s’ entry and exclusion criteria?
methods
Which document sets out how a trial is to be conducted (i.e. the study’s general design and operating features)?
protocol
When designing and performing clinical trials, several ethical constraints must be considered. Which of the following is NOT one of these ethical constraints?
geographic variations
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
Which of the following statements about vaccines is INCORRECT?
vaccine development focuses on how to reduce virulence while retaining the ability to produce immunity
What is an advantage of attenuated vaccines over inactivated vaccines?
attenuated vaccines are less expensive to produce
How are toxoids derived?
from toxins secreted by a pathogen
What is an estimated annual death toll for malaria?
1.5-3.5 million people
There are more white blood cells than red blood cells for the same volume in the human body. (T/F)
false
How was insulin primarily obtained from the 1930s to the 1980s?
porcine and bovine extracts
Which of the following are NOT types of cytokines?
monokines, interferons, and interleukins are all types of cytokines
Which of the following is NOT a type of hormones?
blood glucose
Which of the following is a basic gene therapy technique?
in vitro, in which patients’ genetically faulted tissues are removed, loaded with normal genes in vectors, and returned to the patients’ bodies
Which statement about stem cells is CORRECT?
Pluripotent stem cells can develop into many cell types, but not a new individual.
Leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells. (T/F)
true
Which of the following are types of vectors used in gene therapy?
retroviruses
Which of the following is NOT a type of stem cell?
semipotent
Traditional vaccines are prepared in a number of ways. Which of the following is NOT one of them?
insulin
Effective drug therapy is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life. (T/F)
true
Drug utilization review (DUR) programs…
have traditionally been used to ensure the appropriate, safe, and effective use of prescription drugs, but are increasingly shifting their focus to minimizing costs.
DUR programs involve retrospective monitoring of physicians’ prescribing patterns. (T/F)
true
A formulary is a list of prescription drugs approved by insurance coverage. (T/F)
true
The history of drug formularies in the US extends back to…
the American revolution
Which of these is NOT a type of formulary?
ALL
- a closed 3 tier formulary in which generic drugs are listed on tier 1
- a 5-tier formulary that is supplemented by a step therapy program
- an open formulary that places few restrictions on coverage or access
Which of the following is NOT a recent formulary trend?
the repel of Hatch-Waxman
What did the Hatch-Waxman Act do?
make it easier for generic manufacturers to compete with R&D companies
What is the opportunity cost?
the value of sacrificed alternative
According to your manual, the three primary entities that fund pharmaceuticals are employers, the government (Medicare and Medicaid), and _.
individuals
Which of these individuals would NOT be a member of a P&T committee?
a company’s medical liaison
Almost 98% of employed Americans are now covered by a HMO, a preferred provider, or a point-of-service plan. (T/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/F)
false
Ideally, when should brand strategy development for a new drug begin?
during phase II clinical trials
Which of the following is an example of an “expressive” value?
“I own a BMW because I want people to know that I’m a serious driving enthusiast”
According to your manual, which of the following is NOT an example of a “functional” value?
uniqueness
It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify. (T/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/F)
true
With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. (T/F)
false
How has DTC advertising changed over the last few decades?
DTC advertising has become an essential marketing tactic for both large and small brands
Pharmaceutical companies spend more on promotional activities than R&D. (T/F)
false
Which of the following would be MOST well-served by mass-market print and TV ads?
a brand that treats a very common chronic condition
Which of the following is the least commonly analyzed fluid for conducting a medical diagnostic test?
saliva
“Gold standard” testing achieves the greatest results among the diagnostic testing measurements. Gold standards provide the best understanding of what is happening to a patient so cost is not a factor when deciding to run these tests routinely. (T/F)
false
Every test has some risk. The risk may be the possibility of injury during the test, or it may be the need for further testing is the results are abnormal. (T/F)
true
For genetic testing, which of the below cell material is not commonly used for examination to check abnormalities of chromosomes, genes (including DNA), or both?
urine
There are 4 common sites for bone marrow aspiration and biopsy. Which of the below is not one of them?
the bottom bone of the foot
DEXA is the only method that may be used to make a definitive diagnosis of osteoporosis and to monitor the response to treatment. (T/F)
true
Which of the below tests uses a small needle censors (electrodes) to record the electrical activity in selected muscles and peripheral nerves during rest?
Electromyography (EMG)
Wearable and implantable test technologies currently in development will allow for constant monitoring of body chemistry and collection of previously inaccessible data. (T/F)
true
Diagnostic tests are never used to detect, confirm, or rule out the presence of a disease or medical condition. (T/F)
false
Diagnostic tests are done for a variety of reasons, which of the below is not a reason to perform a diagnostic test?
provide a single use purpose for scientific analysis
Many diagnostic tests are considered to be of a general therapeutic are and are not specified. (T/F)
false
The most sensitive screening tool to detect osteoporosis — a disorder characterized by fragile, weak bones due to a drop in bone mass and increased risk of fracture is the Arthrocentesis diagnostic test. (T/F)
false
Neurodiagnostic tests are done because of a patients illness or condition are most likely based in the central nervous system (brain or spinal cord). Which of the below is not a sign of nervous system disorder?
diarrhea
The Electroencephalogram (EEG or brain wave test) is a non-invasive procedure used to detect and record brain wave cell activity. (T/F)
true
A coronary anlogram is obtained by injecting an iodine-based dye or other contrast agent into the bloodstream and taking x-rays of the coronary arteries. (T/F)
true
How do companies use prescriber data?
to conduct research
Under PhRMA Code, which of the following is acceptable?
modest meals for staff members attending educational events
Under the AMA Guidelines on Gifts to Physicians from Industry, which gifts are NOT permitted?
gifts that are only given to doctors with high prescribing volumes
Under PhRMA code, which of the following actions by sales reps are permitted?
providing modest meals to staff members attending educational events
The PhRMA code on Interactions with Healthcare Professionals is only voluntary and not mandatory. (T/F)
true
Which of the following would NOT be considered acceptable promotional items under PhRMA code?
pens and clipboards designed to be used by patients in doctor’s offices
Under PhRMA Code, what is one 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?
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
Which of following is an 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 illegal to ask receptionists for personal information about your clients such as home phone numbers, birthdays, or hobbies. (T/F)
false
Which of the following is NOT a primary goal or function of the P&T committee?
to educate sales reps on legal and ethical guidelines for professional behavior
Which of the following is a major challenge facing family medicine?
managed care policies eroding patient-doctor relationships
According to your manual, family physicians diagnose and treat approx. what proportion of patients they see (as opposed to referring them to specialists)?
95%
Which of the following is NOT one of the steps on the Product Adoption Continuum?
ALL
- awareness
- adoption
- evaluation
Which of the following would be classified as a type of somatic psychiatric treatment?
drug therapy
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/are advantages of selling to residents?
residents are often more open-minded
What is drug utilization review (DUR)?
an MCO’s practice of monitoring prescribing patterns
What is the focus of the short call protocol?
beginning with a specific patient type
Who is the Medical Sales Liaison (MSL)?
someone employed by a pharmaceutical company who builds relationships with thought leaders and acts as an informational resource
What type of education for MSLs typically have?
graduate-level degrees
How do companies typically 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
Which of these is NOT a type of “pull through” program?
ALL
- adherence/persistence
- educational support
- therapeutic intervention
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/F)
false
What is the MOST LIKELY reason that a doctor would lack interest in one of your clinical studies?
the doctor does not like the way you are presenting it
Which of the following is NOT an effective method for reaching the 65+ market?
ALL
- being a Medicare Part D info resource
- knowing the physician-payer mix
- taking advantage of partnership programs
When a physician visits your hospital for a day, you should begin conversation by asking, “Can I help you?”
false
Which of the following is NOT a rule in making the most out of your sales calls?
your agenda, not theirs
Specialty care products are often prescribed by generalist physicians. (T/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/F)
true
Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. (T/F)
true
In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician. (T/F)
true
Blockbuster drug status typically translates into sales of just under $10 million annually. (T/F)
false
A generic drug manufacturer’s greatest challenge is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug. (T/F)
true
What differentiates an “orphan” drug from a “blockbuster” drug?
orphan drugs typically treat rare conditions
How long are most calls and visits to physicians’ offices (excluding waiting and driving time)?
only a few minutes
Which of the following is NOT a step in managing rumors?
counter attack
According to the text, which of the following is considered “going to the next level”?
staying focused
What is one of the primary job responsibilities of a retail pharmacist?
dispensing pharmaceuticals
What is NOT one of the ways in which pharmaceutical companies and reps categorize their customers?
ALL
- 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)?
US federal government
With respect to 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 mechanism of action?
the method by which a medication produces its therapeutic effects
What is plasma?
Fluid portion of blood
What is anaphylaxis?
An extreme sensitivity and reaction to a foreign substance, including medications
Which of the following is NOT a way in which CNS agents are used?
ALL
- analgesics
- anesthetics
- anti-convulsants
How do cholinergic agonists work?
by mimicking the actions of acetylcholine
Which of the following types of therapeutic agents is used to promote blood clot formation?
fibrinolytics
Which of the following is NOT a type of gastrointestinal agent?
prolactin inhibitors
What is one of the main functions of a tocolytic agent?
to suppress labor
Which of these conditions is NOT treated with antiandrogens?
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?
to carry oxygen
Which of the following is NOT a type of anti-infectant?
antimetabolites
What is one difference between entry-level and experienced resumes?
entry-level resumes 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
Pharmaceuticals are arguably the most socially important healthcare product
true
Pharmaceutical deveoplment is a big-risk undertaking, in which many promising leads prove disappointing
true
Pharmaceutical sales are highest in which geographical regions
The U.S., Western Europe, and Japan
The U.S. accounts for about __ of the world’s pharmaceutical revenues
50%
Which off the following has fueled recent growth in the pharmaceutical industry
population growth and increased life expectancies
According to your manual, which statement accurately describes the predicted relationship between pharmaceutical companies and genomic research facilities
partnerships between pharmaceuitcal companies and genomic companies will not prove immediately profitable
prescription drug therapy is not cost-effective for insurance companies and healthcare providers
false
the high price of healthcare is explained by the high price of medicines
false
one of the oldest and least efffective pharmaceutical marjeting techniques is DTC (direct-to-consumer) advertising
false
what influences the number of districts in a region
the region’s population
what is an example of the regionalization off healthcare delivery systems
California and Florida have difffernet perscription reimbursment policies
the heart of pharmaceutical sales is the regional manager
false
most DMs did not start as representatives
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
false
it usually only takes 1-2 calls to a physician before he or she commits to prescribing your product
false
the pharmacist may dispense a product other than what the physician prescribed
true
according to chapter 12 of your manual, which of the following would classify as “payers”
employers
according to your manual, what defines “ethical pharmaceutical companies
researching and developing novel drugs
one of the most diappointing results of the pharmaceutical industry’s continued investment in R & D is the few new drugs being approved and in development
false
thanks to modern medicines, how long are people newly diagnosed with HIV expected to live
another 50 years
how much has the average american lifespan 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 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 are 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 physical or psychological change in the body
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 off disease, or a substance other than food intended to affect the structure or function of the body
which statement about vitamins is correct
most of the bodys required vitamins must be taken in from outside the body
ADME testing measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material and then excretes it from the body.
true
ADME testing is primarily used in what field
Pharmacokinetics
which statement about placebos is correct
Placebo effects can lead to withdrawal symptoms.
on average, only about 5 off 4,000 drugs studied in the labratory are eventually studied in people
true
which statement is true about drugs taken sublingually
sublingual drugs are absorbed directly and almost immediately into the bloodstream
what are 3 off the 7 rights of drug administration
the right patient, rigt drug, and right dose
pro-drugs are administered in an active form, which is metabolized into an inactive form
false
the kidney of an 85-year-old persion excretes drugs only __ as efficiently as that of a 35-year-old person
around 50%
the normal age-related decrease in kidney function cem help doctors determine an appropiate dosage based soley on a person’s age
true
what differentiates a caplet from a tablet
caplets are shaped like capsules and have film coatings to aid in scallowing
what will you find the legend “Caution: federal law prohibits dispensing wihtout a prescription
on the label of all prescription drugs
what happens to slow acetylators
Drugs that are metabolized by N-acetyl transferase tend to reach higher blood levels and remain in the body longer.
About _ of the people in the U.S. are “slow acetylators”
50%
which of the following statements about drug-drug interactions is incorrect
drug-drug interactions are always harmful
Smoking decreases the effectiveness of some drugs
true
which of the following statements about dietary supplements is incorrect
because dietary supplements are not drugs, interactions with drugs are not a concern
which statement/s is/are incorrect about an ideal drug, or “magic bullet” as Ehrlich phrased it
it does not exist, it would be aimed percisely at a disease site, it would not harm healthy tissues
which statement accurately differentiates resistance from tolerance
tolerance refers to a person’s diminished response to a drug after repeated use, while resistance applies to microorganisms’ or “cancel” cells’ abilities to withstand drug effects
between 3% and 7% of hospital admissions in the United States are estimated to be for treatment of adverse drug reactoins
true
which statement is true about the universal scale for quantiffying the severity of an adverse drug reaction
there is no scale
why is noncomplience a serios public healthy concern
it increases the cost of medical care
which of the following is NOT eligible for patent protection under U.S. regulations
companies can be granted patents for all these things
drugs’ trade names are often unrelated to their intended use
true
Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents.
false
Legally, bioequivalence of different versions of a drug can vary by up to __.
20%
which of the following statements about biologics is incorrect
they do not cause immune response
“large molecules” products are developed and manuffactured by a chemical process
false
what are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers
agonists
Which term denotes how an API works in the body?
mechanism of action
What cements the active and inert 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
what components might cause patients’ different reactions to brand name and generic drugs
differences in inactive ingredients
all cells have a nucleus
false
which of the following does not affect drig response
the patients’ genetic makeup, age, body size, and use of other drugs and dietary supplements, the patient’s other conditions or diseases, whether or not the patient takes the drug properly
drug reactions are predictable becasue they do not occur after a person has been previously exposed to the drug one or more times without any allergic reactions
false
what is the typical relationship between a drug’s site of administration and site of action
they are usually somewhat removed from each other
what is CMAX
Peak plasma concentration on a measuring curve
which of the following is not a main concept in clinical pharmacology
pharmacoprocesses
which of the following is not a route of drug administration
transfugal
How are intradermal drugs delivered?
by injection under the skin
what is an example of intravenous drug delivery
an injection of anesthetic directly into the bloodstream
what are the major organs of the gastrointestinal system
the mouth, esophagus, stomach, liver, pancreas, gallbladder, small intestine, large intestine
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.
false
Only 3 companies account for nearly 90% of all drug wholesale sales.
true
what type of sale bypasses the need for intermediary distributors
manufacturer- direct sales
what is a group purchasing organization (GPO)
an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members
Prescriptions dispensed by mail-order pharmacies are, on average, around __ than those dispensed by retail pharmacies.
3 times larger
which of the following is not a type 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 presciption drug manufacturers association
false
a company that owns and operates three or fewer pharmacies is an
independent drug store
which section of a drug’s package insert infformation covers the usual dosage range
indications and usage
Drug labels must include indications and usage information, as well as contraindications.
true
what should be included in the “description” section off a drug’s package insert information
the drug’s proprietary name and the established name
Exclusivity gives exclusive _, is granted by the FDA, and can run concurrently with a patent or not.
marketing rights
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 patent protection
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
which of the following is not required by the FDA’s Criteria for Equivalency
the drugs contain identical amounts off the same inactive ingredients
A generic drug is __ to the originatory brand-name drug in dosage, strength, safety, and quality
bioequivalent
what list is generally considered the most reliable source of information on therapeutically equivalent drug products
“approved drug products with therapeutic equivalence”
which of the following is an Orange Book rating
AA
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, performance, 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 off a patent challenge
180 days
How is a drug sample closet or cabinet like a grocery store shelf?
the more visibility you can give your drug, the more likely that it will be prescribed
pharmaceutical representatives do not typically store and secure their own drug samples
false
Sampling is sometimes the most important factor in a pharmaceutical rep’s success.
true
the FDA approves storage conditions for drug products
true
pharmaceutical representatives must alwasy record the amount of drug samples left and obtain a signature for that amount
true
what is prohibited by Section 503 of the federal food, drug, and cosmetic act, as amended by the prescription drug marketing act
the sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples
the federal government does not regulate the drug sampling for a pharmaceutical representative
false
which of the following is permitted by Section 503 of the federal food, drug and cosmetic act
cannot donate or sell prescribtion drug samples
which 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
true
medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors
false
In which cases can degraded drugs SOMETIMES still be used?
when the amount off remaining drug has not fallen lower than 85-90% of that stated on the label
Drug recalls are almost always negotiated with the FDA beforehand.
true
Which problem would NOT be improved by electronic prescribing systems?
none: patients “doctor-shopping” for controlled substances, pharmacists misreading prescriptions, physicians wasting time calling pharmacies
what should you do if you recieve 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 him/ her of the mistake and ask for instructions posted on the packing slip
which area of drugs R&D has seen the largest cost increases
clinical trials
on average, how long does it take for a new drug to be developed (I.e., from the discovery of the initial compound to FDA approval)
10-15 years
which of the following regulatory agencies is industry- based (I.c., run mainly by the companies themselves)
Pharmaceutical research and manufactures of america (PhRMA)
which of the following factors has simplified the pharmaceutical R&D process
none: an intensive regulatory process, growing demand in the medical community for more complex data about pharmaceuticals, and the increasing number of precedures in Phase III trials
the landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients
true
according to your manual, which type of system is the best wat to deliever healthcare
a market-based system
how would increased pharmaceutical price controls affect the U.S. healthcare system
increased price controls would stifle innovation
which of the following invests a greater percentage of sales in research than the biotech sector
none: aerospace sector, communications sector, electronics sector
what was the intent of the Bayh-Dole Act and Stevenson-Wydler Technology Innovation Act
to hasten the commercialization of technologies that otherwise might not be used
according to your manual, what did the G10 medicines group recently report about the pharmaceutical industry in the european union (EU)
there is poor collaberation between publicly- and privately- funded research concerns
The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.
true
toxicity infformation in preclinical studies helps provide confidence about a drug’s safety
true
pharmacological studies using animals are regulated under good laboratory practice
true
Why do drugs administered to patients only contain APIs?
they don’t
which of the following does not affect a drug’s ability to permeate membranes
the drugs vesicles
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
which of the following routes of administration do no completely bypass the liver
rectal 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
which of the following does not affect a drug’s distribution to its target tissues
the drug’s lipid-solubility, the drug’s polarity, the vascular nature of the drug’s target tissue- all these facots affect a drug’s distribution to its target tissues
which of these medical terms means “to apply the drug on the skin surface”
transdermal
Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.
true
According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies?
scientific objectives
which statement about the IRB in incorrect
the members of the IRB/IEC must be experts in the topic of study
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
which of the following is an observational study that first identifies a group of subject with a certain disease and a control group without the disease, and then looks to back in time (e.g. via chart reviews) to find exposure to 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 risk for the event (e.g. lung infections per year)
incidence
which of the following measures is used to describe the variability of the populaton mean
standard error of the mean
which of the following terms 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 clincal paper describes subjects’ entry and exclusion criteria
methods
which document sets out how a trial is to be conducted (I.e. the study’s general design and operating features)
inclusion criteria
when designing and performing clincal trials, several ethical constraintes must be considered. which of the following is NOT one of these ethical constraints
geographic variations
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
which of the following statements about vaccines is incorrect
vaccines are types of “small molecule drugs”
what is an advantage of attenuated vaccines over inactivated vaccines
attenuated vaccines are less expensive to prepare
how are toxoids derived
from the toxins secreted by a pathogen
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
fasle
how was insulin primarily obtaines from the 1930’s to the 1980’s
porcine and bovine extracts
which of the following are not types of cytokines
interferons, interleukins, and monokines
which of the following is not a type of hormone
blood glucose
which of the following is a basic gene therapy technique
in vitro, in whihc patients’ genetically faulted tissues are removed, loaded with normal genes in vectors, and returned to the patients’ bodies
which statements about stem cells is correct
pluripotent stem cells can develop into many cell types, but not a new individual
Leukemia is a condition in which the bone marrow is unable to produce functional white blood cells to fight infection.
true
which of the following are types of vectors used in gene therapy
retroviruses
which of the following is not a type of stem cell
semipotent
Traditional vaccines are prepared in a number of ways. What way is NOT one of them?
insulin
Effective drug therapy is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life.
true
Drug Utilization Review (DUR) programs
have traditionally been used to ensure the appropriate, safe, and effective use of prescription drugs, but are increasingly shifting their focus to minimizing costs.
DUR programs involve retrospective monitoring of physicians’ prescribing patterns.
true
A formulary is a list of prescription drugs approved by insurance coverage.
true
The history of drug formularies in the U.S. extends back to…
the american revolution
which of these is not a type of formulary
All of these are types of formularies:
A. a closed three-tier formulary in which generic drugs are listed on Tier 1
B. a five-tier formulary that is supplemented by a step therapy program
C. an open formulary that places few restrictions on coverage or access
which of the following is not a recent formulary trend
the repeal of hatch-waxman
What did the Hatch-Waxman Act do?
make it easier for generic manufacturers to compete with R&D companies
What is opportunity cost?
the valuse of a sacrificed alternative
according to your manual, the three primary entities that fund pharmaceuticals are employers, the government (medicare and medicaid) and
individuals
which of these individuals would not be a member of a P&T committee
a company’s medical liason
Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.
false
pharmaceutical companies are more interested in acquiring and exploiting another’s brand than in acquiring another’s R&D and sales and marketing assets
false
ideally, when should brand strategy development for a new drug begin
during phase II clincal trials
which of the following is an example of a “expressive” value
“I own a BMW becuase I want people to know that I’m a serious driving enthusiast
according to you rmanual, which of the following is not an example of a “functional” value
uniqueness
It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify
true
To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs.
true
With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval.
false
How has DTC advertising changed over the last few decades?
DTC advertising has become an essential marketing tactic for both large and small brands
which of the following most strongly influences physicians’ prescribing habits
doctors’ personal experiences, and their patients’ unique situations
pharmaceutical companies spend more onpromotional activities than on R&D
false
which of the following would be most well-served by mass-market print and tv adds
a brand that treats a very common chronic condition
which of the below is the least commonly analyzed fluid for conducting a medical diagnostic test
salive
“gold standard” testing achieves the greatest results amoung the diagnostic testing measurements. gold standards provide the best understanding of what is happening to a patient so cost is not a factor when deciding to run these tests routinely
false
every test has some risk. the risk may be the possibility off injury during the test, or it may be the need for further testing if the results are abnormal
true
for genetic testing, which of the below cell materials is not commonly used for examination to check abnormalities off chromosomes, genes (including DNA) or both
urine
there are 4 common test sites for bone marrow aspiration and biopsy. which of the below is not one of them
the bottom bone of the foot
DEXA is the only method that may be used to make a definitive diagnosis of osteoporosis and to monitor the response to treatment
true
which of the below tests uses a small needle censors (electrodes) to record the esetrical activity in selected muscles and peripheral nerves during rest
electromyography (EMG)
wearable and implantable test technologies currenlty in development will allow for constant monitoring off body chemistry and collection of previously inaccessible data
true
diagnostic tests are never used to detect, confirm, or rule out the presence of a disease or medical condition
false
diagnositic testes are done for a variety of reasons, which of the below is not a reason to perform a diagnostic test
provide a single purpose for scientific analysis
many diagnostic tests are considered to be of a general therapeutic are and are not specified
false
the most sensitive screening tool to detect osteoporosis- a disorder characterized by fragile, weak bones due to a drop in bone mass and increased risk of fractire is the arthrocentesis diagnostic test
false
neurodiagnostic tests are done because of patients illness or condition are mostly based in the central nervous system (brain or spinal cord). which of the below is not a sign of a nervous system disorder
diarrhea
the electroencephalogram (EEG or brain wave test) is a non-invasive procedure used to detect and record brain wave activity
true
a coronary aniogram is obtained by injecting an iodine- based dye or other contrast agent into the bloodstream and takin x-rays of the coronary arteries
true
how do companies use prescriber data
to conduct research
Under PhRMA Code, what of the following is acceptable
modest meals for staff members attendign educational events
Under the AMA Guidelines on Gifts to Physicians from Industry, which gifts are NOT permitted?
gifts that are onlu given to doctors with high prescribing volumes
under PhRMA code, which of the following actions by sales reps are permitted
providing modest meals to staff members attending educational events
the PhRMA Code on interactions with healthcare professional is only voluntary and not mandatory
true
which of the following would not be considered acceptable promotional items under PhRMA Code
pens and clipboards designed to be used by patients in doctors’ offices
Under PhRMA Code, what is one 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
none of these: when the activity is intended to facilitate informational exchange, when the practitioner is acting as a bone fide advisory board consultant, when the practinioner is providing a legitimate service to the company
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 iff the lunch is clearly seperate from the CME portion of the conference
which of the following is an arm of the department of health and human services that investigates regulatory infarctions, provides compliance advice, and brings enforcement actions
offfice of inspector general
It is illegal to ask receptionists for personal information about your clients such as home phone numbers, birthdays, or hobbies. A. TRUE
B. FALSE
false
which of the following is not a primary goal or function of the P&T committee
to educate sales representatives on legal and ethical guidelines for professional behavior
which of the following is a major challenge facing family medicine
managed care policies eroding patient- doctor relationships
according to your manual, family physicians diagnose and treat approximately what proportion of patients they see (as ossposed to reffering them to specialists)
95%
which of the following are steps on the product adoption continuum
all: adoption, awareness, evaluation
which of the following would be classified as a type of somatic psychiatric treatment
drug therapy
Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists?
psychiatrists are usually on their way to the hospital at that time
What is/are an advantage/s of selling to residents?
residents are often more open-minded
What is drug utilization review (DUR)?
an MCO’s practice of monitoring prescribing patterns
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 pharmaceutical company who builds relationships with thought leaders and acts as an informational resources
what type of feducation do MSLs typically have
graduate-level science degrees
how do companies typically judge the MSL team’s contributions
return on education
what differentiates “push through” programs from “pull through” programs
sales representatives are more involved in “pull through” programs
which of these are a type of “pull through” program
all: adherence/ persistency, educaitonal support, theropeutic intervention
becasue pharmaceutical sales reps mostly out of their homes, it is not important that they work well in a team environment
false
what is the most likely reason that a doctor would lack interest in one of your clinical studies
the doctor does not like the way you are presenting it
which of the following are an effective method for researching the 65+ market
all: being a medicare part d information resource, knowing the physician-payer mix, taking advantage of partenership programs
when a physician visits your hospital display, you should begin the converstation by asking “can I help you”
false
which of the following is not a rule in making the most out of your sales calls
your agenda, not theirs
Specialty care products are often prescribed by generalist physicians.
false
side effects that might be considered merely minor annoyances in acute treatment can be a powerfful barrier to adoption in chronic therapies
true
Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms.
true
in some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician
true
Blockbuster drug status typically translates into sales of just under $10 million annually.
false
A generic drug manufacturer’s greatest challenge is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.
true
what differentiates an “orphan” drug from a “blockbuster” drug
orphan drugs typicalluy treat rare conditions
How long are most calls and visits to physicians’ offices (excluding waiting and driving time)?
only a few minutes
which of the following is not a step in managing rumoms
counter attack
according to the text, which of the following is considered “going to the next level”
staying focused
what is one of the primary job responsibilities of a retail pharmacist
dispensing pharmaceuticals
what is not one of the ways in pharmaceutical companies and representatives categorize their customers
companies and agents categorize their patients in all of these ways
which of the following are relatively new prescription drug benefits covered under the medicare prescription 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 you 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 abbriviation 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 mechanism of action
the method by which a medication produces its therapeutic effects
what is plasma
the fluid portion of the blood
What is anaphylaxis?
An extreme sensitivity and reaction to a foreign substance, including medications
which of the following are a way in which CNS agents are used
all: as analgesics, anesthetics, anti-convulsants
How do cholinergic agonists work?
by mimicking the actions of acetylcholine
which of the following types of therapeutic agents is used to promote blood clot formation
fibrinolytics
which of the following is not a type off gastrointestinal agents
protein inhibitors
what is one of the main functions off a tocolytic agent
to suppress labor
which of the conditions is not treated with antiandrogens
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 resumes
entry-level resumes 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
The FDA regulates the introduction of new drugs and enforces U.S. drug laws.
True
Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale.
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.
True
3,070 new meds are in development for cancer.
True
Define Off-label
Usage of a medication for purposes other than the specific ones appearing on the label
Toxicity
The extent, quality, or degree to which a substance is poisonous or harmful to the body
Institutional review Board (IRB)
A committee of physicians, staticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin.
Placebo
Inactive pill, liquid, or powder that has no treatment value aka sugar pill
Edema
Swelling
Asymptomatic
Without signs or symptoms
Clinical Pharmacology
The study of the effects and movement of drugs in the human body
Anatomy
The study of basic structures of the body
Physiology
The study of how those body structures function
Basic clinical pharmacology involves 3 main concepts
Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics
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 sites of action.
Pharmacokinetics
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.
Drug distribution & elimination
Drug delivery systems, route of administration , modes of excretion.
Plasma
The liquid portion of the blood that carries proteins and other substances
Organs
Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus
Brain of the cell that regulates all activities.
Proteins
A nutrient made up of of chains of amino acids
Fats
A nutrient stored in special body tissues as a great source of reserve energy
Carbohydrates
A nutrient that is the body’s immediate source of energy. It’s broken down to glucose and used for immediate metabolic reactions.
Vitamins
A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body.
Minerals
A nutrient necessary for bodily purposes such as the balance of body fluid
Water is NOT a nutrient
True
Body’s Major Systems
Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune
Absorption
How the drug passes from its side of administration into the bloodstream
Distribution
How the drug is dispersed among the organs after absorption into the blood
Metabolism
How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys
Excretion
How the drug is eliminated from the body. Usually drugs are eliminated via urine. They can also be excreted through the lungs, skin, or breast milk.
It takes about 10 years for a drug to hit the market
True
Routes of drug administration
Pg 26-29
Seven rights of drug administration
pg 30
Bioavailability
how quickly and how much of a drug reaches its intended target site of action
Bioequivalent
when they contain the same active ingredients and proceed virtually the same blood levels over time.
Therapeutic equivalence
Production of the same medicinal effect
Drug elimination and Excretion
pg 34
Drug Forms
Pg 35-38
Patent last 20 years
True
Inactive ingredients
Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body
Pharmaceutical Ingredients
Pg 54
BID
twice a day
Cmax
Peak plasma concentration on a measuring curve
Half-life
Period of time it takes for a specific amount of drug in the body to be reduced, through the excretion or elimination process, to exactly one-half that original amount
PRN
As needed
QD
Once a day
QID
Four times a day
Protein binding
the ability of certain drugs to bind to plasma protein.
TID
three times a day
Titration
the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects
Tmax
Time of peak plasma concentration on a measuring curve
STAT
Immediately
Primary wholesale distributors
Buy most of their drugs directly from manufacturers. Legally considered authorized distributors within the meaning of the PDMA because they usually have ongoing relationships with manufacturers
Secondary wholesale distributors
Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered authorized distributors of the manufacturers within the meaning of the PDMA
Distribution Terminology
Pg 60-61
Average wholesale price (AWP)
Published wholesale price of list price suggested by the manufacturer.
Chain drug store
Company that owns and operates four or more pharmacies
Drop shipment
Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler
Group purchasing organization (GPO)
An entity consisting of two or more hospitals or other healthcare entities that is formed to offer its members access to purchasing contracts for health supplies
Upcharge
Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution
Package Insert Info
Pg 63
Drug Patents
Pg 65
Terms pg 67
Orange Book ratings
A
AA
AN
AO
AP
AT
B
Hatch-Waxman Act
aka Drug Price Competition and Patent Term Restoration Act of 1984. Considered the most significant drug-related legislation affecting pharma and healthcare. H-W made it easier to bring generics to the marker by requiring FDA to only look at bioavailability studies in order to approve. Also gave protection to the research based manu’s by providing a 30 months automatic cooling off period
It is important not to change the order of a sample closet
True
Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples
True
Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically.
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
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.
True
In some situations, a physician may sign the paperwork before the number of samples has been recorded
True
Section 503
Prohibits sale, purchase, or trade of drug samples
E-sampling
Pg 72
Many pharmaceutical manufacturers set expiration dates every six months (June, December)
True
DEA regulates the distribution and use of narcotics and other controlled substances
True
FTC
Regulates general business practices to protect consumers against misleading claims and anticompetitive behavior
AMA
provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies
Benefits of Government-Industry Partnerhsips
Pg 79
Preclinical studies
pg 81
Pinocytosis
Involves the engulfing of fluids by a cell.
Transport Mechanisms
Passive diffusion, facilitated diffusion, active transport, pinocytosis
Absorption methods
Oral, Buccal, sublingual, rectal, subcutaneous, intramuscular, transdermal, topical, inhalation, intravenous
The liver is the major organ for metabolizing drugs. Secondary is kidney
True
CL= rate of drug elimination/drug concentration in blood
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.
True
Clinical Trials
pg 89
Subjects should be informed about the aims, methods, risks, and benefits of the trial
True
Four phases of clinical trials
Pg 90
Regulatory Requirement terms
Pg 92
Investigator
The person who conducts the trial. This person is normally an expert in the field. They should not be employed by the sponsor
Sponsor
The organization or individual that initiates the trial and finances the study,
Protocol
This document sets out how a trial is to be conducted
Epidemiology
The study of how factors influence disease and health in human populations.
Therapeutic
Antibodies
Vaccines
Pg 108
Toxoids
Derived from toxins secreted by a pathogen.Examples are diphtheria and tetnus vaccines.
Vector-based vaccines
Viruses and bacteria are detoxified and used as vehicles to carry vaccines. Example is the use of canary pox (a virus that infects birds but not humans) to carry envelope proteins for HIV treatment.
Peptide Vaccines
Chemically synthesized and normally consist of 8-24 amino acids
Adjuvants
pg 110
Cytokines are produced mainly by the leukocytes (white blood cells)
True
Hormones are intercellular messengers.
True
Retrovirus
Integrates genes to hose chromosomes, change of long term stability.
Adendovirus
This vector has a large capacity for foreign genes.
Liposomes
Vector does not have viral genes so they do not cause disease.
Naked DNA
they do not have viral genes and do not cause disease
Gene Therapy types
Retrovirus, adenovirus, adeno-associated virus, liposomes, naked DNA
Stem Cells
Pg 114
Managed Care
Pg 117
Formulary
List of prescription drugs approved by insurance coverage pg 118
Opportunity cost
pg 124
Branding
pg 113
Values
Function, Expressive, Central
Functional Values
Efficacy, safety, convenience, cost-effectiveness
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
Pharmetrics
impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal pg 144
Brands should be:
Easy to pronounce, easy to write and read, memorable, distinctive and different from competition
Direct-to-consumer (DTC)
pg 152
Factors that influence DTC
pg 153
Gifts
Pg 162
PhRMA Code
Now prohibits pens, mugs, objects with company logo
AMA Gift guidelines
Pg 165
Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value
True
Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work
True
Subsidies should not be accepted to pay for the costs of travel, lodging, or other personal expenses. Paying for a modest meal is OK
True
PhRMA Code on relationships
Pg 167
PhRMA FAQ
Pg 174
Nursing Structures
Pg 200
Sales techniques
pg 207
Medicare part D
pg 225
Organizing your day
Pg 239
Traits of Pharma sales Rep
Passion, Go the extra mile, be a resource, be creative, invest in yourself, authentic and real, love what they do, focus on service, cultivate support, believe, focus, macro-thinking, KIT, ask, keep accurate records
Glossary
271
Exclusivity is granted for an orphan drug for __
7 years
Patents are applied for with, and granted by the FDA.
False
Patents expire after how many years from the date of filing?
20 years
Generic drugs are not regulated by the Food & Drug Administration.
False
The most reliable source of information for determining therapeutically equivalent drug products are
ORange Book
Pharmaceutical representatives will typically store and secure their own drug samples
True
Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount.
True
The federal government does not regulate the drug sampling for a pharmaceutical representative
False
Storage conditions for drug products are based on data and information supplied by the manufacturer
True
Drug recalls are almost always negotiated with the FDA beforehand.
True
The PDMA is the Prescription Drug Manufacturers Association.
False
Primary wholesale distributors buy most of their drugs directly from __
manufacturers
The AWP is a published __ price, suggested by drug manufacturers.
wholesale
Rebates are also referred to as after-market arrangements.
true
Drug labels must include indications and usage information, as well as contraindications.
true
A patent owner has the right to exclude others from making, using, selling or importing into the US the __ it describes.
invention
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.
False
The Orange Book is considered the most authoritative manual on therapeutic __.
equivalence
The Hatch-Waxman Act is considered the most significant drug-related __ affecting the pharmaceutical industry since 1962.
legislation
First pass metabolism occurs when a drug administered orally is metabolized in the __.
Liver
Pharmacological studies using animals are regulated under Good Laboratory Practice.
True
Monoclonal antibodies are created in laboratories to target the __ of patients to kill cancer.
Cancer cells
The best way to deliver health care is through a __ system.
market based
The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for _.
clinical trials
The agency which regulates the distribution and use of narcotics and other controlled substances is _.
DEA
The FDA approves storage conditions for drug products.
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.
true
There are more white blood cells than red blood cells for the same volume in the human body.
false
Unlike the small molecule drugs (pharmaceuticals) described, large molecule drugs (biopharmaceuticals) are mainly protein-based.
true
The duration for Phase III of the clinical trial can typically last 3-5 years.
true
The aim of the Phase IV clinical trial is to examine the safety and effectiveness of the drug in the targeted disease group.
false
Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.
true
Which one of the below terms is not a route for excreting a drug from the body?
heart
Which of the below terms means “to apply the drug on the skin surface”?
transdermal
Diffusion is the random movement of molecules in fluid
true
Most drugs that are administered to patients typically contains just one active pharmaceutical ingredient.
false
Toxicity information in preclinical studies provides confidence about a drugs safety aspect.
true
The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.
true
Effective drug therapy typically is a cost-effective and highly valuable means of controlling total healthcare expenditures and improving quality of life.
true
Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.
false
DUR programs involve retrospective monitoring of physicians’ prescribing patterns.
true
The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies.
false
PBM’s tend to serve a local market through a network of pharmacies.
false
The chief motivating force in mergers and acquisitions within the pharmaceutical industry is the desire of one company to acquire and exploit more successfully the brands of another.
false
It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify.
true
To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs.
true
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
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.
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.
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.
true
One of the oldest and least effective pharmaceutical marketing techniques is the direct-to-consumer advertising.
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.
false
One of the most disappointing results of the pharmaceutical industry’s continued investment in R & D is the few number of new drugs being approved and in development.
false
The extent, quality, or degree to which a substance is poisonous or harmful to the body.
toxicity
The US accounts for about __ of all the world’s pharmaceutical revenues.
1/2
The most effective method for grabbing market share is:
comparative selling
Most visits by pharmaceutical reps are to pharmacies.
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.
false
Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan.
false
DUR programs involve retrospective monitoring of physicians’ prescribing patterns.
true
The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies
false
PBM’s tend to serve a local market through a network of pharmacies.
false
The chief motivating force in mergers and acquisitions within the pharmaceutical industry is the desire of one company to acquire and exploit more successfully the brands of another.
false
It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify
true
To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs.
true
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.
false
Specialty care products are often prescribed by generalist physicians.
false
In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician.
true
Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms.
true
Side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies.
true
The greatest challenge for a generics manufacturer is to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug.
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
Which is not a rule in making the most out of your sales call?
your agenda not theirs
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
clinical effect
The response produced by a medication
pathology
The practice of medicine dealing with the causes and nature of disease/death
New prescription drug benefits covered under the Medicare Prescription Drug Improvement & Modernization Act:
medicare part d
tertiary care
Highly specialized medical and surgical care for unusual or complex medical problems provided by a large medical center
Literally “disease producer”:
pathogen
A type of blood cell that helps the body fight infection and disease:
white blood cell
SS
Used when referring to medication dosage, means “one-half”:
Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume:
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
internist
is a physician that practices internal medicine
IDN
integrated delivery network
Another name for biologic compound is:
large molecule
SS is an abbreviation for:
semis
The _ 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
ML stands for:
milliliter
According to the text, depression is a disease that attacks the:
central nervous system