Nursing Pharm 101

NURSING PHARM 101 Assignments, Chapter 1, Introduction to Drugs 1. How does the term pharmacology differ from the term clinical pharmacology? Give examples of how nurses utilize pharmacology in clinical practice Pharmacology is the study of biological effects of chemicals Clinical Pharmacology, is a branch of pharmacology that utilze the drug in treating, preventing, and diagnosing diseases. How nurses utilize pharmacology in clinical practice Administration of drugs Assessing drug effects Intervening to management the drug regimen more tolerable Providing client education about the drug regimen Monitoring the overall patient care plan 2. Briefly describe the phases involved in each step of developing and approving new drug in the United States Phase 1 Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Phase 2 Study Participants: Up to several hundred people with the disease/condition. Length of Study: Several months to 2 years Purpose: Efficacy and side effects In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically involving a few hundred patients, these studies aren't large enough to show whether the drug will be beneficial. Approximately 33% of drugs move to the next phase Phase 3 Study Participants: 300 to 3,000 volunteers who have the disease or condition Length of Study: 1 to 4 years Purpose: Efficacy and monitoring of adverse reactions Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. These studies involve 300 to 3,000 participants. Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects Approximately 25-30% of drugs move to the next phase