Chapter 1: The Foundation of Pharmacology: Quality and Safety PDF

Chapter 1 The Foundation of Pharmacology: Quality and Safety  Is the following statement True or False? Question #1 Pharmacology is the use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes....

Chapter 1 The Foundation of Pharmacology: Quality and Safety  Is the following statement True or False? Question #1 Pharmacology is the use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes. 2 Copyright © 2025 Wolters Kluwer. All rights reserved.  False Answer to Question #1 Rationale: Pharmacology is the study of drugs that alter functions of living organisms. 3 Copyright © 2025 Wolters Kluwer. All rights reserved.  Pharmacology: study of drugs that alter Pharmacology functions of living organisms and Drug Therapy #1 Pharmacotherapy (drug therapy): use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes Medications: drugs given for therapeutic purposes 4 Copyright © 2025 Wolters Kluwer. All rights reserved.  Effects of medications Pharmacology oLocal: act mainly at the site of application and Drug Therapy oSystemic: taken into the body, circulated via #2 the bloodstream to sites of action, and eventually eliminated from the body 5 Copyright © 2025 Wolters Kluwer. All rights reserved.  Plants Drug Sources Animals Minerals Synthetic compounds 6 Copyright © 2025 Wolters Kluwer. All rights reserved.  Classifications Drug oClassified according to effects on Classifications Particular body systems and Prototypes Therapeutic uses #1 Chemical characteristics 7 Copyright © 2025 Wolters Kluwer. All rights reserved.  Prototypes Drug Individual drugs that represent groups of Classifications drugs and Prototypes Often the first drug of a particular group to #2 be developed Morphine (represents opioid analgesics) Penicillin (represents beta-lactam antibacterial drugs) 8 Copyright © 2025 Wolters Kluwer. All rights reserved.  Most common Drug Names Generic name (chemical or official) Brand (trade) name May be prescribed and dispensed by either name Using different drug names (i.e., generic or trade names) increases confusion and the risk of misuse. 9 Copyright © 2025 Wolters Kluwer. All rights reserved.  Is the following statement True or False? Question #2 Over-the-counter medications are not regulated by law. 10 Copyright © 2025 Wolters Kluwer. All rights reserved.  False Answer to Question #2 Rationale: Over-the-counter medications are regulated by various drug laws. 11 Copyright © 2025 Wolters Kluwer. All rights reserved.  Two routes of access to therapeutic drugs Prescription and oPrescription Nonprescription Written by a licensed healthcare provider, Drugs such as a physician, dentist, or nurse practitioner oOver-the-counter (OTC) Do not require prescription Regulated by various laws 12 Copyright © 2025 Wolters Kluwer. All rights reserved.  Which law (and its amendments) requires that Question #3 official drugs meet standards of purity and strength? A. Durham-Humphrey Amendment B. Comprehensive Drug Abuse Prevention and Control Act C. Food, Drug, and Cosmetic Act of 1938 D. Controlled Substances Act 13 Copyright © 2025 Wolters Kluwer. All rights reserved.  C. Food, Drug, and Cosmetic Act of 1938 Answer to Question #3 Rationale: The Food, Drug, and Cosmetic Act of 1938 requires that official drugs meet standards of purity and strength as determined by chemical analysis or bioassay. The Durham-Humphrey Amendment designates which medications must be prescribed by a healthcare professional; the Comprehensive Drug Abuse Prevention and Control Act regulates the manufacturing and distribution of controlled substances; and the Controlled Substances Act categorizes controlled substances according to therapeutic usefulness and potential for abuse. 14 Copyright © 2025 Wolters Kluwer. All rights reserved.  Passed in 1970 Comprehensive Title II: Controlled Substances Act Drug Abuse oRegulates manufacturing and distribution of Prevention and Narcotics, depressants Control Act Stimulants, hallucinogens Anabolic steroids 15 Copyright © 2025 Wolters Kluwer. All rights reserved.  Schedule I Categories of Schedule II Controlled Schedule III Substances Schedule IV Schedule V 16 Copyright © 2025 Wolters Kluwer. All rights reserved.  Enforces Controlled Substances Act Drug Enforcement Registers individuals and companies legally Administration empowered to handle controlled substances (DEA) Regulates documentation and handling of controlled substances 17 Copyright © 2025 Wolters Kluwer. All rights reserved.  FDA’s CDER: Approval of oApproves new prescription drug annually Prescription and oApproves drugs for OTC availability Nonprescription oDetermines need for clinical trails Drugs 18 Copyright © 2025 Wolters Kluwer. All rights reserved.  Responsible for ensuring safety and efficacy of U.S. Food and drugs before they can be marketed Drug Since 1962, specific testing standards must be Administration applied. (FDA) #1 Clinical trials oPhases 1 to 4 19 Copyright © 2025 Wolters Kluwer. All rights reserved.  Approves many new drugs annually U.S. Food and oBoth prescription and OTC Drug May change status from prescription to OTC Administration oPotential advantages and disadvantages (FDA) #2 20 Copyright © 2025 Wolters Kluwer. All rights reserved.  Rights off Medication Administration Safety in Drug Quality and Safety Education for Nurses Administration (QSEN) National Patient Safety Goals o“Do Not Use” list of unacceptable abbreviations oTargeted High-Risk Activities The Institute for Safe Medication Practices (ISMP) oHigh-Alert Medications oPregnancy Categories for Safety oBeers Criteria 21 Copyright © 2025 Wolters Kluwer. All rights reserved.  Pharmacology and textbooks Sources of Drug Drug reference books Information Journal articles Internet sites 22 Copyright © 2025 Wolters Kluwer. All rights reserved.  American Hospital Formulary Service Authoritative Drug Facts and Comparisons Sources Less authoritative oPhysicians’ Desk Reference (PDR) 23 Copyright © 2025 Wolters Kluwer. All rights reserved.  Concentrate on therapeutic classifications and Strategies for their prototypes. Studying Connect new drug information to known Pharmacology #1 similar drugs or prototypes. Focus on drugs’ main characteristics. Use own words when taking notes or writing drug information cards. 24 Copyright © 2025 Wolters Kluwer. All rights reserved.  Keep an up-to-date drug reference readily Strategies for available. Studying Write notes, answers to review questions, Pharmacology #2 definitions of new terms, and trade names of medications directly into your pharmacology textbook. 25 Copyright © 2025 Wolters Kluwer. All rights reserved.