1. Identify the stages of drug development and how the drugs are tested at each phase. - ANS: Phase 1: Testing of a new compound in health subjects, for
... [Show More] the purpose of establishing the tolerance of health human subjects at different doses, defining its pharmacological effects at anticipated therapeutic levels, and studying its absorption, distribution, metabolism, and excretion patterns in humans.
Phase 2:Controlled clinical evaluation is done on patients with a specific disease or disorder to determine the medications possible uses and short term risks. Usually the study is conducted on only several hundred subjects or less.
Phase 3: Controlled and uncontrolled clinical trials of a drugs safety and efficacy in hospital and outpatient settings. Gather precise information on drugs efficacy for specific indications to determine if there is a wider range of adverse effects on those that it did in a small study. They try to identify what way the drug is best administered (PO, IV, IM...). If the drug is approved this information forms what goes on the drug label. Phase 3 solidifies phase 2.
Page 33. Pharm 3rd ed.
2. Differentiate between the prescribing of medications by physicians, nurses, and physician's assistants. - ANS: Physicians-Their focus is related to pharmacology is on the understanding of biochemistry and prescribing for a given pathophysiology. Their emphasis is on the disease and the drug, with less emphasis on the impact of the patient. NPs-nurse practitioners prescribed a drug free given pathophysiology, their nursing background leads them to place equal emphasis on understanding the impact the drug will have on the patient. Patient education is a central focus of an NPs practice. PAs-The focus of the PA's practice is similar to that of the physician. p.7-8 Pharm 3rd Ed.
3. What factors are associated with clinical judgment when prescribing medications? - Is there a clear indication for drug therapy? What drugs are effective in treating this disorder? What is the goal of therapy with this drug? Under what conditions is it determined that a drug is not meeting the goal in a different therapy or drug should be tried? Are there unnecessary duplications with other drugs the patient is already taking? Would an over-the-counter drug be just as useful as a prescription drug? What about the cost? Where is the information to answer these questions? P.6 Pharm third edition
4. What is the criteria for choosing an effective drug? - 1.) Pharmacodynamic factors of a drug must be specific and selective to the target tissues affected by the disease to have the greatest therapeutic effect with the least adverse effects. The relationship between the drugs desired therapeutic effects and it's adverse effects is called it's therapeutic index. Drugs with the low therapeutic index may require close monitoring for toxicity and versus facts, where is drugs with a wide therapeutic index are fairly safe and require less monitoring. Pharmacodynamics means the study of the effects of the drug on the body. 2.) Pharmacokinetic factors. This is how the body reacts to the drug. It is the study and analysis of the time course of the drug in the body. How well are the drugs absorbed and eliminated. 3.) therapeutic factors 4.)safety 5.)Cost 6.) patient factors 7.) adverse drug reactions 8.) Provider factors p.25-28 Pharm 3rd edition
5. How does hypoalbuminemia affect the process of prescribing? - ANS: Reduced drug dosages may be indicated in these cases. http://www.nottingham.ac.uk/nmp/sonet/rlos/bioproc/plasma_proteins/6.html In a pt with hypoalbuminemia drugs especially antibiotics are unable to bind as needed with albumin which means there is more of the drug free in the plasma then there would be in a pt with a normal albumin level.Drug-plasma protein binding forms a "reservoir" of drug, but only the free (unbound) drug is available to the tissues to exert a therapeutic effect. [Show Less]