Advanced PharmacologyNURS 503Study Guide for Exam 1Understand the role of the TN SBON (state board of nursing) All states have title protection Control of practice and licensure is withSBONSBON/BOM Scope of practice determined by the license In 24 states NPs totally autonomous; 20 states required to have some physiciancollaboration, 3 states physician supervision 5 states – practicing by protocol, having a collaborative practice agreement, some degreeof physician supervision State of Tennessee APNs Certificate of fitness DEAUnderstand the role of the FDA and the DEA FDA jurisdictionDrugs Standardization of nomenclature Approval process for new drugs and new indications Official labeling Surveillance of adverse effects Methods of manufacture and distributionMedical devices 1976 Medical devices amendment of the food, drug, and cosmetic actTwo types of reviews Standard for drugs that appear to have therapeutic qualities similar to thoseof one or more already marketed drugs in the treatment, diagnosisor prevention of a disease. Priority is given to a drug that appears to have significant improvementcompared to marketed products. Clinical trials may take severalyears unless the drug receives a priority review.At the heart of all FDA’s medical product evaluation decisions is a judgment about whether anew product’s benefits to users will outweigh its risks. No regulated product is tota … Purchase document to see full attachment
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