Tutorial Questions Week 5

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Jan 9, 2024

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Tutorial Questions Week 5 TQ 5.1: Pharmacovigilance Primer: What types of activities does pharmacovigilance include? What are the five different types of reports and when are they required? What type of changes in an approved product require a supplemental application? - Pharmacovigilance includes any activity that involve detecting, assessing, understanding, and preventing adverse events or other product related problems. The five types of reports required are: the 15-day alert report, the 15-day alert report follow up, the periodic adverse experience reports, the field alerts, and the annual reports. - The 15-day alert report is required when the applicant becomes aware of an adverse drug experience that is serious and unexpected as soon as possible, or within 15 days of notice. The 15-day follow up report is required if any new information is found or requested by the FDA regarding the investigation. After the first three years of approval, a periodic adverse experience report is required quartile for any adverse reports that do not fall within the 15-days. They must be filed within 30 days of the end of the quarter. The field reports alerts have a three days window for reporting manufacturing problems related to public health risks, such as mislabeling. Within 60 days if the anniversary of approval, an annual report is required to summarize all significant new information that could affect safety, effectiveness, or labelling of a drug product. A supplemental application is required if there are any changes in production or quality of a drug that could have a substantial adverse effect. A Practical Guide to FDA’s Food and Drug Law and Regulation, Fourth Edition TQ 5.2: Regulations and Statutes: What are the different forms that a Risk Evaluation and Mitigation Strategy can take under 21 U.S.C. §355-1(e)? How does the statute define “adverse drug experience” and “serious adverse drug experience”? Where can relevant “new safety information” originate for purposes of the statute and regulations? - A risk evaluation and mitigation strategy can be in the form of a medication guide or communication plan. The medication guide/patient package insert should be provided when the drug is dispensed to the patient. The communication plan can be in the form of sending letters to health care providers, disseminating information to encourage implementation by health care providers, or disseminating information to health care providers through professional societies. - The statute defines an adverse drug experience as “an event associated with the use of a drug in humans.” 21 U.S.C. §355-1(b)(1). This includes events that occur during the course of use of the drug, from overdose of the drug, from abuse of the drug, from withdrawal of the drug, and failures of the expected pharmacological actions of the drug. A serious adverse drug experience is defined as any adverse drug experience that results in death, immediate risk of death, prolonged hospitalization, significant interruption in normal life functions, or birth defects. 21 U.S.C. §355-1(b)(4) - New safety information can be derived from clinical trials, an adverse report, a postapproval study, or peer-reviewed biomedical literature.
21 U.S.C. §355-1(e)(2), (3) TQ 5.3:  What high-profile events led up to the 2007 amendments to the Food, Drug, and Cosmetic Act? What were the relevant conclusions of the 2006 IOM report that informed the 2007 amendments? - In 2004, the FDA came under fire after it was found that they approved the drug Vioxx, which was revealed to lead to high risks for myocardial infarctions and strokes associated with its use. In 2007, there was uproar again with the drug Avandia, which was also linked to increased risks of myocardial infarctions and strokes, but was approved despite the findings reflecting those risks. The 2006 IOM report recommended pre- and post- approval authority gaps, better systems for post-marketing adverse event detection and better communication of key safety information to the public, and finally, reform of the FDA organizational structure. 34 J. Legal Med. 193
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