Sinopsis
Pharmacology is the study of drugs and their action on living organisms. A sound knowledge of basic pharmacologic principles is essential if the nurse is to safely administer medications and to monitor patients who receive these medications. This chapter gives a basic overview of pharmacologic principles that the nurse must understand when administering medications. The chapter also discusses drug development, federal legislation affecting the dispensing and use of drugs, and the use of botanical medicines as they relate to pharmacology.
Drug development is a long and arduous process, taking anywhere from 7 to 12 years, and sometimes even
longer. The United States Food and Drug Administration (FDA) has the responsibility of approving new drugs and monitoring drugs currently in use for adverse or toxic reactions. The development of a new drug is divided into the pre-FDA phase and the FDA phase (Fig. 1-1). During the pre-FDA phase, a manufacturer
discovers a drug that looks promising. In vitro testing (testing in an artificial environment, such as a test tube) using animal and human cells is done. This testing is followed by studies in live animals. The manufacturer then makes application to the FDA for Investigational New Drug (IND) status.
With IND status, clinical testing of the new drug begins. Clinical testing involves three phases, with each phase involving a larger number of people. All effects, both pharmacologic and biologic, are noted. Phase I lasts 4 to 6 weeks and involves 20 to 100 individuals who are either “normal” volunteers or individuals in the intended treatment population. If Phase I studies are successful, the testing moves to Phase II, and if those results are positive, to Phase III. Each successive phase has a larger subject population. Phase III studies offer additional information on dosing and safety. The three phases last anywhere from 2 to 10 years, with the average being 5 years.
Content
- FOUNDATIONS OF CLINICAL PHARMACOLOGY
- ANTI-INFECTIVES
- DRUGS THAT AFFECT THE NEUROMUSCULAR SYSTEM
- DRUGS THAT AFFECT THE RESPIRATORY SYSTEM
- DRUGS THAT AFFECT THE CARDIOVASCULAR SYSTEM
- DRUGS THAT AFFECT THE HEMATOLOGICAL SYSTEM
- DRUGS THAT AFFECT THE GASTROINTESTINAL AND URINARY SYSTEMS
- DRUGS THAT AFFECT THE ENDOCRINE SYSTEM
- DRUGS THAT AFFECT THE IMMUNE SYSTEM
- DRUGS THAT AFFECT OTHER BODY SYSTEMS
