NAPSRx Study Guide |243 questions fully solved & updated 2024

Pharmaceuticals Medicines and vaccines for human and animal use. Products may have a trademark (brand) name or be generic; and they may be prescription or over-the counter. Diagnostic Equipment and supplies used in screening, detecting, and monitoring disease. Can range from simple home testing kits to sophisticated diagnostic imaging technologies. Medical Devices Advanced instrumentation and appliances used for medical therapy, such as joint replacements, implantable defibrillators, and pacemakers. Also includes drug delivery devices such as syringes, infusion pumps, metered-dose inhalers, and transdermal patches. Medical Supplies Commodity, high-volume supplies such as surgical gowns and gloves. Durable Medical Equipment Reusable products for health-related use in the home, such as 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 and increasing life expectancies. What is the predicted relationship between pharmaceutical companies and genomic research facilities? Partnerships between pharmaceutical companies and genomic research facilities will not prove immediately profitable. Prescription drug therapy is cost effective for insurance companies and health care providers. True or False? True 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? 8-12 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. Pharmaceutical reps mainly visit pharmacies. True or False? False. Pharmaceutical reps mainly visit/target physicians. It usually takes only 1-2 calls on a physician before he or she prescribes your product. True or False? False. Your success ultimately depends on your relationship with the physician. This takes time. Persistence is key. The pharmacist may dispense a product other than what the physician prescribed. True or False? True. The pharmacist can either (1) dispense a generic; (2) The pharmacist calls the doctor and requests permission to dispense a different medication. According to chapter 2 of your manual which of the following classifies as payers? (a) employers (b) patients (c) pharmacists (d) physicians (a) employers Some third party payers include the insurance company, the employer, managed care organization, or the U.S. government (Medicare/Medicaid). What defines ethical pharmaceutical companies? Pharmaceutical companies that research and develop novel drugs. Thanks to modern medicine how long are people newly diagnosed with HIV expected to live? Another 50 years. How much has the average American lifespan increased since 1890? 30 years 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. Define "pharmacodynamics" Study of biochemical and physiological effects of drugs and their mechanisms of action, i.e., the study of what a drug does to the body. Drug dynamics (pharmacodynamics) describes the therapeutic effects of drugs (e.g., pain relief, blood pressure reduction), their side effects, their sites of action (i.e., which tissues they act on), and their mechanisms of action (i.e., how they act on those tissues). A drug's effects on the body may be influenced by many factors, such as a person's age and genetic makeup and disorders the person has other than the one being treated.