Challenge Question Series
April - June 2009
Question Explanation and Follow-Up
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June 22, 2009
Question: The primary purpose for an institutional review board or independent ethics committee is to:
Explanation: The correct answer is Safeguard patient wellbeing. The primary responsibility of IRBs/IECs is to safeguard subject wellbeing by providing independent oversight of clinical trials, including the scientific merit of the trial and its design and the competence of the investigator. Learn more about our newest online course, Pharmaceutical Ethics and Compliance, which explains the role ethics and compliance play in the pharmaceutical industry, including the reasons for ethical and regulatory compliance and the range of activities affected by these issues.
June 8, 2009
Question: The pharmaceutical industry spends the most money on which of the following marketing activities?
Explanation: The correct answer is Sampling. Estimates on promotional spending vary according to the methods used to collect data, but according to data for 2004 from IMS Health and CAM (now Cegedim Strategic Data [CSD]), the pharmaceutical industry spent between $28 and $48 billion on various efforts to reach physicians and patients with information related to their products, including:
- $7 to $20 billion on office-based promotions.
- $500 million on advertising in professional journals.
- $4 billion on direct-to-consumer advertising.
- $16 billion on sampling.
Learn more about this question with our course, The Pharmaceutical Industry, including the growth of the pharmaceutical industry from its early beginnings in pre-Revolutionary-War America to its present role as a multi-billion-dollar industry.
June 1, 2009
Question: Which of the following is traditionally considered to be the most important factor considered by P&T committees when making formulary decisions?
Explanation: Clinical efficacy and safety are traditionally considered to be the most important of all criteria regarding a pharmaceutical product. Learn more about this topic, as well as significant developments in the formulary process and pharmacy benefit management, particularly in terms of managed healthcare organizations, with our course, The Formulary Process.
May 26, 2009
Question: FDA approval of an NDA is based on evidence that the product is:
Explanation: Approval of an NDA by the FDA requires evidence that the drug is both safe and effective in human populations. Learn more about this with our course, Applications of Evidence-Based Medicine (EBM). This course is designed to provide you with an in-depth understanding of EBM and includes elements of pharmaceutical research and clinical trial designs and explains how to understand and interpret clinical reprints and clinical trial results.
May 18, 2009
Question: Which of the following represents the average effective patent life of a newly approved drug?
Explanation: Patents are good for 20 years from the date of application. However, it can take up to three years for the patent to be issued, and the FDA approval process can take up to 10 years. Consequently, the patent protection for most drugs actually lasts for only about seven years from the time it is approved by the FDA. Learn more about the drug discovery and development process with our course, The Pharmaceutical Industry.
May 11, 2009
Question: Medical benefits are provided for U.S. citizens age 65 and older by:
Explanation: Medical insurance for patients age 65 and over is provided by Medicare, which is a federal health insurance program administered by the Centers for Medicare & Medicaid Services (CMS). Medicare provides medical benefits for all U.S. citizens age 65 and over, as well as those who meet the disabled criteria. Find out more information about this subject with our course, 21st Century Physician, which includes a discussion of the 21st century patient population and patients’ reactions to direct-to-consumer advertising, informatics, and the Internet, and how these innovations affect patient/physician relationships.
May 4, 2009
Question: What was the first important step in the separation of pharmacy from medicine in North America?
Explanation: The first important step in the separation of pharmacy from medicine was the opening of an apothecary shop in Pennsylvania Hospital by Ben Franklin. Learn more about this and the growth of the pharmaceutical industry from its early beginnings in pre-Revolutionary-War America to its present role as a multi-billion-dollar industry, with our course, The Pharmaceutical Industry.
April 27, 2009
Question: The most common nutritional disorder in children is:
Explanation: Obesity is the most common nutritional disorder in children. Learn more about this and other related topics with our course, Nutrition: Wellness and Disease. Successful completion of this course prepares students to describe the role of nutrition in maintaining good health and in providing supportive therapy for patients with specific diseases, provide information about nutrients and nutritional standards, describe a healthy diet and lifestyle and the role of weight control, and discuss dietary risks linked to diseases and the role of enteral and parenteral nutrition in the treatment of seriously ill patients.
April 20, 2009
Question: According to current estimates, what percentage of the US healthcare dollar goes toward outpatient prescription drugs?
Explanation: The most recent data indicates that 10% of the nation's healthcare dollar was used to purchase prescription drugs. Learn more about this and other related topics such as strategies for managing the pharmacy benefit, including formularies, generic substitution, therapeutic interchange, drug utilization review, clinical practice guidelines, and outcomes research with our course, The Formulary Process--Managing the Pharmacy Benefit.
April 13, 2009
Question: The primary objective for applying evidence-based medicine (EBM) to clinical practice is to:
Explanation: The primary objectives of applying EBM to clinical practice are to facilitate treatment decisions that improve patient care and improve clinical outcomes. Gain an in-depth understanding of EBM with our Applications of Evidence-Based Medicine course, including how to comprehend and interpret clinical reprints and clinical trial results so that you can effectively utilize EBM with healthcare practitioners.
April 6, 2009
Question: When was the FDA established and what was its purpose at the time?
Explanation: The FDA was established in 1906 to administer the terms of the Food and Drug Act, which banned interstate transport of tainted, mislabeled, or impure food. Subsequent legislation expanded its regulatory powers over the pharmaceutical industry. Discover more about ethical and regulatory compliance, and the range of activities affected by these issues, with our newest course offering, Pharmaceutical Ethics and Compliance.
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