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NAPSRx Study Guide 2022
Pharmaceuticals - Medicines/ vaccines /human and animal use.
/ trademark (brand) name or generic/and prescription or over-the counter.
Diagnostic - All Equipment /supplies- screening/detecting, and monitoring disease./
Medical Devices - Advanced instrument /medical therapy, / joint replacements, defibrillators, and pacemakers./includes drug delivery devices such as syringes, infusion pumps, metered-dose inhalers, and transdermal patches.
Medical Supplies - Commodity, supplies such /surgical gowns and gloves.
Durable Medical Equipment - Reusable products/ walkers, wheelchairs, oxygen equipment, prosthetics and hospital beds.
What countries are pharmaceutical sales the highest? - United States, Western Europe, and Japan.
The U.S. accounts for roughly __________ of the world's pharmaceutical revenues. - 50%
Two factors have significantly contributed to recent growth in the pharmaceutical industry are? - Population growth/ increasing life expectancies.
What is the predicted relationship between pharmaceutical companies and genomic research facilities? - Partnership will not prove immediately profitable.
Prescription drug therapy is cost effective for insurance companies and health care providers. True or False?
The high price of health care is explained by the high price of medicines. True or False? - False
One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising. True or False? - 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.
What is the heart of a pharmaceutical sales team? - District Manager.
How many territories are in a typical district? - 8-
What is the most effective method for grabbing market share? - Comparative selling.
The average review time for a new drug is 18 months, down from almost 3 years in 1996. True or False? - True
What are some questions reps should ask a physician? - Why do you prefer the competitor's drug to ours? What do they like and dislike about it? Which patient types is the drug being used for? What are the results and side effects, if any?
Note: Careful questioning and listening enables reps to craft effective messages based on each physician's specific needs.
What is a treatment group? - A group of patients assigned to receive specific treatment.
What is the main difference between a blinded and double-blinded study? - In a double blinded study, neither the staff nor the study participants know which subjects are in the experimental group and which subjects are in the control group.
What does asymptomatic mean? - Without signs or symptoms of disease.
What is an approvable letter? - Letters sent by the FDA to the applicant indicating whether the new drug application (NDA) or abbreviated new drug application (ANDA) for a product meets the necessary requirements and whether or not the agency believes that it can approve the application or abbreviated application if specific additional information or material is submitted or specific conditions (e.g., certain changes in labeling) are agreed to by the applicant.
What is a blinded or masked study? - A study in which participants do not know whether they are in the experimental or control group of a research study. Those in the experimental group get the medications or treatments being tested, while those in the control group get standard treatment or no treatment.
What is a control or control group? - The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What is a double-blind or double-masked study? - A study in which neither the participants nor the study staff know which participants are receiving the experimental treatment and which patients are in the control group. These studies are performed so neither the patient nor doctor expectations about the experimental drug can influence the outcome.
What is edema? - Swelling.
What are fast-track drugs? - Fast-track drug approval is provided for drugs that meet medical needs for patients with serious or life-threatening conditions.
What is indication in terms of drug approval? - The exact cause or purpose for which the FDA has approved that a new drug can be prescribed.
What is the institutional review board (IRB)? - A committee of physicians, statisticians, community advocates, and others which ensures that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials in the U.S. must be approved by the IRB before they begin.
What does the term "off label" mean? - Usage of a medication for purposes other than the specific ones appearing in the labeling.
What is a placebo? - A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.
What is the placebo effect? - The effect produced by a placebo due to the expectations of the patient. The effect in placebo-controlled clinical trials is generally measured by comparing the effect observed in patients receiving the placebo treatment to the effect observed in patients receiving the active treatment.
What is study protocol? - The general design and operating features of a trial. It is distinguished from the study manual operations by its generality and absence of specific details needed for day-to-day execution of the trial.
Define toxicity. - The extent, quality, or degree to which a substance is poisonous or harmful to the body.
Define "anatomy" - The study of the basic structures of the body.
Define "physiology" - The study of how those body structures function
Define "clinical pharmacology" - The study of the effects and movements of drugs in the human body.
What is the broadest definition of a drug? - Any substance that produces a physical or psychological change in the body.
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 a disease or a substance other than food intended to affect structure of function of the body.
What is true about vitamins? - Most of the body's required vitamins must be taken in from outside the body.
What does ADME testing measure? - 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.
ADME testing is primarily used in what field? - Pharmacokinetics
What is true about placebos? - Effects can lead to withdrawal symptoms.
On average, what percent of drugs are studied in the lab are eventually studied in people? - 5 of 4000
What is true about drugs taken sublingually? - Are absorbed directly and almost immediately into the bloodstream.
What are 3 of the 7 rights of the drug administration? - The right patient, the right drug, and the right dose.
Pro-drugs are administered in the active for, which is metabolized into an active form. - 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 disease in kidney function can help doctors determine an appropriate dosage based solely on a person age. - 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 "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 Unites States are slow acetylators. - 50%
Smoking decreases the effectiveness of some drugs. - True
What about drug-drug interaction is not correct? - Drug interaction are always harmful.
What about dietary supplements is incorrect? - Because dietary supplements are not drugs, interacting with drugs is not a concern.
Between what percent of hospital admissions in the Unites States are estimated to be for treatment of adverse drug reactions? - Between 3% and 7%
Why is noncompliance a serious public health concern? - Increasing medical care cost.
Legally bioequivalence of different versions od a drug can vary by up to what? - 20%
How are intradermal drugs delivered? - By injecting 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 and large intestines.
What differentiates exclusivity from a patent? - Exclusivity is only granted upon the drugs 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
What 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 the therapeutically equivalent drug products? - Approved Drug products with therapeutic equivalence
Exclusivity gives exclusive ____________, is granted by the FDA and can run concurrently with a patent or not.
What is an orange book rating? - B
What is the term for chemical equivalents which when administered in the same amounts will provide the same biological or physiological availability as measured by blood and urine levels? - Biological equivalents
What term denotes the dispensing of an unbranded generic product for the product prescribed? - Generic substitution
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 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.
Do pharmaceutical representatives typically store and secure their own drug samples? - Yes
What is sometimes the most important factor in a pharmaceutical representatives success? - Sampling
What approves storage conditions for drug products? - FDA
Pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for the 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.
Which entity issues monographs that define how drugs should be stored and what variance is allowed in their states contents? - United States Pharmaceutical Convention
How would increased pharmaceutical price controls affect the US healthcare system? - Increased price controls would stifle innovation.
What was the intent of the Bayh-Dole act and the Stevenson-Wydler technology innovation act? - To hasten the commercialization of technologies that otherwise might not be used.
According to your manual what did the G 10 medicines group recently report about the pharmaceutical industry in the European Union? - There is poor collaboration between publicly and privately funded research centers.
What is the aim of preclinical pharmacological studies? - To obtain data on the safety and effectiveness of the lead compound.
Toxicity information in preclinical studies helps provide what? - Confidence about a drugs safety.
Pharmacological studies using animals are regulated under what? - Good laboratory practice
Why do drugs administered to patients only contain API's? - They don't
Which of the following does not affect a drugs 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 not 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.
What medical term means to apply the drug on the skin surface? - Transdermal
Carcinogenicity studies are meant to identify the tumor causing potential of a drug. - True
According to NIH ethical guidelines, which of the followers is the most important criteria in selecting subjects for clinical studies? - Scientific objects
Which statement about the IRB is 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 1 and 4 trials are often open label, but phase 2 and 3 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 that disease, and then looks to back in time (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 (lung infections per year)? - Incidence
How was insulin primarily obtained from the 1930's to the 1980's? - Porcine and bovine extracts
Name the types of cytokines. - Lymphokines, monokines, and growth factors
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 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. - 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 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 if prescription drugs, but are increasingly shifting their focus to minimizing costs.
DUR programs involve retrospective monitoring of physicians prescribing patterns. - True
What is a formulary? - A list of prescription drugs approved by insurance coverage.
The history of drug formularies in the US extends back to... - The American Revolution
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 value 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 members 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 organization, or a point of service plan, - False
Ideally, when should brand strategy development for a new drug begin? - During phase 2 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 am a serious driving enthusiast.
According to your manual, which of the following is not an example of s functional value? - Uniqueness
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? - Under no circumstances
Under PhRMA code, may a company sponsor a lunch at a 3 day conference if part of it includes an educational program for which attendees may choose to receive CME credit? - Yes, but only if the lunch is clearly separate from the CME portion of the conference.
Which of the 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
Is it illegal to ask receptionists for personal information about your clients charts such as home phone numbers, birthdays, or hobbies? - No
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
According to your manual, Family physicians diagnose and treat approximately what proportion of patients they see (as opposed to referring then to specialists)? - 95%
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 often see patients on the hour for 45 minutes.
What is an advantage 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 used in treatment of manic depression illness and schizoaffective disorder? - Mood stabilizers
What is the focus of the short call protocol? - Beginning with a specific patient type.
Who is the medical science liaison (MSL)? - Someone employed by pharmaceutical companies who build relationships with thought leaders and acts as an information resource.
What type of education do MSL's usually have? - Graduate level science degrees
How do companies typically judge the MSL team's contributions? - Return on edication
What differentiates push through programs from pull through programs? - Sales representatives are more involved in pull through programs.
Because pharmaceutical sales representatives work 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.
When a physician visits your hospital display, you should begin conversion by asking, can i help you? - False
