Pharmaceutical Industry Practices and Drug Development, Exams of Nursing

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Pharmaceuticals are arguably the most socially important healthcare product - ANSWERS✔✔ True Pharmaceuticals is a high risk under-taking, in which many promising leads prove dissappointing - ANSWERS✔✔ True Pharmaceutical sales are highest in which geographical regions? - ANSWERS✔✔ The US, Western Europe and Japan What has fueled recent growth in the pharmaceutical industry? - ANSWERS✔✔ Population growth and increased life expectancy The US accounts for about ___ % of the world's pharmaceutical revenues - ANSWERS✔✔ 50% What statement accurately describes the predicted relationship between pharmaceutical companies and genomic research facilities? - ANSWERS✔✔ Partnerships between pharmaceutical companies and genomic research facilities will not prove immediately profitable. Prescription drug therapy is not cost effective for insurance companies and healthcare providers - ANSWERS✔✔ False The high price of healthcare is explained by the high price of medications - ANSWERS✔✔ False One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising - ANSWERS✔✔ False What influences the number of districts in a region - ANSWERS✔✔ The regions population

What is an example of the regionalization of healthcare delivery systems? - ANSWERS✔✔ California and Florida have different prescription reimbursement policies The heart of a pharmaceutical sales team is the regional manager - ANSWERS✔✔ False (its the Sales Reps) Most district managers did not start as reps - ANSWERS✔✔ False How many territories are in a typical district - ANSWERS✔✔ 8- What is the most effective method for grabbing market share - ANSWERS✔✔ Competitive selling Pharmaceutical reps mainly visit pharmacies - ANSWERS✔✔ False (they visit primary care, hospitals, pharmacies, specialists, etc.) It usually only takes 1-2 calls to a physician before he/she commits to prescribing your product - ANSWERS✔✔ False The pharmacist may dispense a product other than what the physician prescribed - ANSWERS✔✔ True According to chapter two of the manual, who would be described as payers - ANSWERS✔✔ Employers According to your manual, what describes ethical pharmaceutical companies? - ANSWERS✔✔ Researching and developing novel drugs One of the most disappointing results of a pharmaceutical industry's continued investment in R&D is the few new drugs being approved and in development - ANSWERS✔✔ False (its problems and negative results in clinical trials)

Thanks to modern medicines, how long are people newly diagnosed with HIV expected to live? - ANSWERS✔✔ Another 50 years How much has the average American lifespan increased since 1890? - ANSWERS✔✔ Almost 30 years What is a treatment group? - ANSWERS✔✔ A group of patients assigned to receive a specific treatment What is the main difference between a blind and double-blinded study? - ANSWERS✔✔ Double blind - neither staff nor participants know who is in the experimental or control groups What to asymptomatic mean? - ANSWERS✔✔ Not exhibiting signs or symptoms What term denotes the study of bodily functions (as opposed to structures) - ANSWERS✔✔ Physiology In its broadest definition, a drug is any substance that produces a physical or physiological change in the body - ANSWERS✔✔ True How does the Federal Drug and Cosmetic Act (FFDCA) define a drug? - ANSWERS✔✔ Any substance intended for use in diagnosis, cure, mitigation, treatment or prevention of disease, or a substance other than food intended to affect the structure or function of the body. Most of the body's required vitamins must be taken outside of the body - ANSWERS✔✔ True What is ADME testing? What does it measure? - ANSWERS✔✔ 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 and excretes it from the body.

ADME testing is primarily used in what field? - ANSWERS✔✔ Pharmacokinetics Placebo effects can lead to withdrawal symptoms - ANSWERS✔✔ True On average, only about __ out of 4,000 drugs studied in the laboratory are eventually studied in people. - ANSWERS✔✔ 5 Sublingual Drugs - ANSWERS✔✔ Drugs that are absorbed directly and almost immediately into the bloodstream What are the 7 rights of drug administration? - ANSWERS✔✔ right medication, right client, right dose, right time, right route, right reason and right documentation. Pro-drug - ANSWERS✔✔ a biologically inactive compound that can be metabolized in the body to produce a drug. (inactive becomes active) The kidney of an 85-year-old person excretes drugs only __ as efficient as that of a 35- year-old. - ANSWERS✔✔ Around 50% The normal age-related decrease in kidney function can help doctors to determine an appropriate dosage based solely on their age. - ANSWERS✔✔ True What differentiates a caplet from a tablet? - ANSWERS✔✔ Caplets are shaped like capsules and have a film coating to aid in swallowing. Where will you find the legend: "Caution: Federal Law prohibits dispensing without a prescription?" - ANSWERS✔✔ On the label of all prescription drugs What happens in slow acetylators? - ANSWERS✔✔ Drugs that are metabolized by N- acetyl transferase tend to reach higher blood levels and remain in the body longer. About ___% of people in the US are slow acetylators. - ANSWERS✔✔ 50%

Drugs interactions are always harmful - ANSWERS✔✔ False Smoking decreases the effectiveness of some drugs - ANSWERS✔✔ True Because dietary supplements are not drugs, interactions with drugs are not a concern.

• ANSWERS✔✔ False What statement accurately differentiates resistance from tolerance? - ANSWERS✔✔ Tolerance refers to someone's diminished response to a drug after repeated use, while resistance applies to microorganisms' or cancel cells' abilities to withstand drug effects. Ideal drug/Magic bullet (as Ehrlich phrased it) - ANSWERS✔✔ Does not exist, it would be aimed precisely at a disease site, and it would not harm healthy tissues. Between 3% and 7% of hospital admissions in the United States are estimated to be for treatment of adverse drug reactions. - ANSWERS✔✔ True Universal scale for quantifying the severity of an adverse drug reaction - ANSWERS✔✔ There is not such thing Why is noncompliance a serious public health concern? - ANSWERS✔✔ It increases the cost of medical care. What is not eligible for patent protection under US regulation? - ANSWERS✔✔ None, companies can be granted patents for anything. Drugs' trade name are often unrelated to their intended use. - ANSWERS✔✔ True Generic drugs are usually lower quality than the brand name drugs. - ANSWERS✔✔ False

Legally, bio-equivalence of different versions of a drugs can vary by up to ___% - ANSWERS✔✔ 20% Biologic can cause immune responses. - ANSWERS✔✔ True Large molecule products are developed by a chemical process. - ANSWERS✔✔ False What are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers? - ANSWERS✔✔ Anogists What term denotes how an API works in the body? - ANSWERS✔✔ Mechanism of action What cements the active and inert components together to maintain cohesive portions? - ANSWERS✔✔ Binders BID - ANSWERS✔✔ Twice daily PRN - ANSWERS✔✔ As needed Which components might cause patients' different reactions to brand name and generic drugs? - ANSWERS✔✔ Differences in inactive ingredients All cells have a nucleus - ANSWERS✔✔ False What is the typical relationship between a drug's site of administration and site of action? - ANSWERS✔✔ They are usually somewhat removed from each other. CMAX - ANSWERS✔✔ The peak plasma concentration on a measuring curve.

Routes of drug administration are: - ANSWERS✔✔ Buccal (mouth), Intramuscular (muscle injection), sublingual (IV), Intradermal (injection in skin) What are the major organs of the gastrointestinal system? - ANSWERS✔✔ Mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines NAMs - ANSWERS✔✔ Responsible for selling to distributors Large chain pharmacies are allowed to buy directly from drug manufacturers - ANSWERS✔✔ True Only 3 companies account for nearly 90% of all drug wholesale sales. - ANSWERS✔✔ True What type of sale bypasses the need for intermediary distributors? - ANSWERS✔✔ Manufacturer-direct sales What is a GPO (group purchasing organization)? - ANSWERS✔✔ An entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of it's members. Prescriptions dispensed by mail-order pharmacies are, on average, around ____ times larger than those dispensed by retail pharmacies. - ANSWERS✔✔ 3 What is another term for rebates? - ANSWERS✔✔ After-market arrangements PDMA - ANSWERS✔✔ Product Development and Management Association A company that owns and operates three or fewer pharmacies is an ________. - ANSWERS✔✔ Independent drug store Which section of a drug's package insert information covers the usual dosage rage? - ANSWERS✔✔ Indications and usage

What must drugs labels include? - ANSWERS✔✔ Indications, usage and contraindications What should be in the description section of a drug's package insert information? - ANSWERS✔✔ the drug's proprietary name and established name Exclusivity gives exclusive ______, is granted by the FDA, and can run concurrently with a patent or not. - ANSWERS✔✔ Marketing rights What differentiates exclusivity from a patent? - ANSWERS✔✔ Exclusivity is only granted upon the drug's FDA approval What is required of an invention for it to be worthy of patent protection? - ANSWERS✔✔ It must be novel, useful, and not obvious A generic drug is _____ to the originator brand-name drug in dosage, strength, safety and quality. - ANSWERS✔✔ Bio-equivalent What is not a requirement by the FDA's criteria for Equivalency? - ANSWERS✔✔ That the drugs contain identical amounts of the same inactive ingredients Approved Drug Products with Therapeutic Equivalence - ANSWERS✔✔ the most reliable source of information on therapeutically equivalent drug products. 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? - ANSWERS✔✔ Biological equivalents Generic Substitution - ANSWERS✔✔ The dispensing of an unbranded generic product for the product prescribed? What is the duration of a patent challenge? - ANSWERS✔✔ 180 days

Drug sample closet - ANSWERS✔✔ The more visibility you can give your drug, the more likely it will be prescribed Pharm reps typically store and secure their own samples - ANSWERS✔✔ True Sampling is sometimes the most important factor in a pharmaceutical rep's success - ANSWERS✔✔ True Who approves the storage conditions for a drug? - ANSWERS✔✔ The FDA Pharm reps must always record the amount of drug samples left and obtain a signature for the amount. - ANSWERS✔✔ True What is prohibited by Section 503 of the Federal Food, Drug and Cosmetic Act, as amended by the Prescription Drug Act? - ANSWERS✔✔ The sale, purchase, trade or offer to sell, purchase or trade prescription drug samples. Who regulates the drug sampling for a Pharm rep? - ANSWERS✔✔ The FDA United States Pharmacopoeial Convention - ANSWERS✔✔ Issues monographs that define how drugs should be stored, and what variance is allowed in their stated contents When can degraded drugs sometimes still be used? - ANSWERS✔✔ When the amount of the 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 - ANSWERS✔✔ True What area of drug R&D has seen the largest cost increases? - ANSWERS✔✔ Clinical Trials

On average how long does it take for a new drug to be developed? (from the discovery of initial compound to FDA approval) - ANSWERS✔✔ 10-15 years What regulatory agency is industry-based? (run mainly by the companies themselves)

• ANSWERS✔✔ Pharmaceutical Research and Manufacturers of America (PhRMA) 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. - ANSWERS✔✔ True According to your manual, which type of system is the best way to deliver healthcare? - ANSWERS✔✔ The market-based system How would increased pharmaceutical price controls affect the U.S healthcare system?
• ANSWERS✔✔ Increased price controls would stifle innovation What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology Innovation Act? - ANSWERS✔✔ To hasten the commercialization of technologies that otherwise would not be used. What did G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)? - ANSWERS✔✔ There is poor collaboration between publicly and privately-held research centers. Pre-clinical Pharmacological Studies - ANSWERS✔✔ The aim is to obtain data on the safety and effectiveness of the lead compound Toxicity information in pre-clinical studies helps provide confidence about a drug's safety. - ANSWERS✔✔ True What does not affect a drug's ability to permeate membranes? - ANSWERS✔✔ The drug's vesicles

Through which barriers can lipid-soluble drugs usually pass? - ANSWERS✔✔ Cell membranes How are weak acid drugs generally absorbed by the stomach? - ANSWERS✔✔ More quickly than weak basic drugs Which route of administration does not completely bypass the liver? - ANSWERS✔✔ Rectal administration Why are IV drug dosages easier to control than drugs administered transdermally? - ANSWERS✔✔ The entire dose is available in the bloodstream to be distributed to the target site. What affects a drug's distribution to its target? - ANSWERS✔✔ The drug's lipid solubility, polarity and the vascular nature of the drug's target tissue Transdermal - ANSWERS✔✔ To apply drugs to the skin's surface Carcinogenic Studies - ANSWERS✔✔ Identifies the tumor-causing potential of a drug What is the most important criteria in selecting subjects for a clinical study? - ANSWERS✔✔ Scientific objectives Clinical studies - Open label - ANSWERS✔✔ Phase I and IV Clinical studies- blinded - ANSWERS✔✔ Phase II and III If it is not possible to measure the direct effects of a drug, what is used instead? - ANSWERS✔✔ Surrogate markers such as blood pressure and cholesterol An observational study that first identifies a group of subjects with a certain disease and a control group without the disease, then looks back in time to find exposure to risk factors. - ANSWERS✔✔ Case-control study

Which measure of central tendency is the sum of all observations divided by the number of observations - ANSWERS✔✔ Mean This measurement describes the number of new events that occur during a specified period of time in a population at risk for the event (ie. lung infections per year). - ANSWERS✔✔ Incidence What measure is used to describe the variability of the population mean? - ANSWERS✔✔ Standard error of the mean The extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring. - ANSWERS✔✔ Validity What are the Kaplan-Meier analysis and the Cox proportional hazard analysis? - ANSWERS✔✔ methods of survival analysis What section of a clinical paper describes subjects' entry and exclusion criteria? - ANSWERS✔✔ Methods What document sets out how a trial is to be conducted? - ANSWERS✔✔ Protocol Large molecule drugs vs. Small molecule drugs - ANSWERS✔✔ larger are mainly protein based that develop in biological systems such as living cells. What is an advantage of attenuated vaccines over inactivated vaccines? - ANSWERS✔✔ Attenuated vaccines are less expensive to prepare How are toxoids derived? - ANSWERS✔✔ From the toxins secreted by a pathogen What is the estimated annual death tole for Malaria? - ANSWERS✔✔ 1.5 to 3.5 million people

There are more white blood cells than there are red blood cells for the same volume in the human body - ANSWERS✔✔ False How was insulin primarily obtained from the 30s to the 80s? - ANSWERS✔✔ Porcine and bovine extracts A condition in which the stem cells in bone marrow malfunction and produce an excessive number of immature white blood cells - ANSWERS✔✔ Leukemia Retroviruses - ANSWERS✔✔ A type of vector in gene therapy These have been used to ensure the appropriate, safe and effective use of prescription drugs, but are increasingly shifty in their focus to minimize costs - ANSWERS✔✔ Drug Utilization Review (DUR) programs A list of prescription drugs approved by insurance coverage - ANSWERS✔✔ Formulary The history of drug formularies extends in the US back to... - ANSWERS✔✔ The American Revolution What did the Hatch-Waxman Act do? - ANSWERS✔✔ Made it easier for generic manufacturers to compete with R&D companies What is opportunity cost? - ANSWERS✔✔ The value of sacrificed alternative Ideally, when should brand strategy and development for a new drug begin? - ANSWERS✔✔ During Phase II of clinical trials With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - ANSWERS✔✔ False What is most well received by mass market print and TV ads? - ANSWERS✔✔ A brand that treats a very common chronic condition

How to companies use prescriber data? - ANSWERS✔✔ To conduct research What is acceptable under PhRMA code? - ANSWERS✔✔ Modest meals for staff members attending educational events. An arm of the Department of Health and Human Services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions - ANSWERS✔✔ Office of Inspector General Family physicians diagnose and treat approximately ____% of patients as opposed to referring them to a specialist? - ANSWERS✔✔ 95% What is /are the advantages of selling to residents - ANSWERS✔✔ They are often more open-minded An MCO's practice of monitoring prescribing patterns - ANSWERS✔✔ Drug Utilization Review (DUR) Mood Stabilizers - ANSWERS✔✔ Used to treat manic-depressive illness and schizoaffective disorder What is the focus of a short call protocol? - ANSWERS✔✔ Beginning with a specific patient type Someone employed by a pharmaceutical company who builds relationships with thought leaders and acts as an informational resource - ANSWERS✔✔ Medical Science Liaison (MSL) What type of education do MSLs usually have? - ANSWERS✔✔ graduate-level science degrees

What differentiates push through programs from pull through programs? - ANSWERS✔✔ Sales reps are more involved in pull through What is the MOST LIKELY reason why a doctor would lack interest in your clinical studies? - ANSWERS✔✔ They do not like the way that you are presenting it What is a relatively new prescription drug benefit covered under the Medicare Prescription Drug Improvement & Modernization Act? - ANSWERS✔✔ Medicare Part D Pathogen - ANSWERS✔✔ A disease producer The type of blood cell that plays the most prominent roll in fighting infection and disease - ANSWERS✔✔ White blood cell This generally resides on a cell surface (or in the ctyoplasm) and causes a biological change or activity when stimulated. - ANSWERS✔✔ Receptor Renal pertains to: - ANSWERS✔✔ Kidneys What term denotes the practice of locating genes on a chromosome? - ANSWERS✔✔ Gene mapping What field is MOST concerned with drugs effects due to slight genetic differences? - ANSWERS✔✔ Pharmacogenomics What entity or entities funds the National Institutes of Health (NIH)? - ANSWERS✔✔ US Federal Government What does IDN stand for? - ANSWERS✔✔ Integrated delivery network What does the SS abbreviation stand for? - ANSWERS✔✔ Semis

Drugs that are non-biological (ie. chemical) in nature - ANSWERS✔✔ Small molecule H - ANSWERS✔✔ Hours The study of drugs' beneficial and toxic effects on living cells, tissues and organizms - ANSWERS✔✔ Pharmacology Specialized cells and tissues that work together to preform a specific body function for a common purpose - ANSWERS✔✔ Organs What is the mechanism of action? - ANSWERS✔✔ The method by which a medication produces its therapeutic effects The fluid portion of blood - ANSWERS✔✔ Plasma An extreme sensitivity or reaction to a foreign substance, including medications - ANSWERS✔✔ Anaphylaxis How do cholinergicagonists work? - ANSWERS✔✔ By mimicking the actions of acetylcholine A symptomatic drug that stimulates the alpha-adrenergic receptors - ANSWERS✔✔ Decongestant What is one of the main functions of a tocolytic agent? - ANSWERS✔✔ To suppress labor What types of patients are MOST likely to receive immune globulins? - ANSWERS✔✔ Patients with weakened immune systems What is iron's primary function in the body? - ANSWERS✔✔ Carrying oxygen