Chapter 1 Drug Definitions, Standards, and Information Sources PDF

Chapter 1 Drug Definitions, Standards, and Information Sources Clayton’s Basic Pharmacology for Nurses, 19th edition Michelle Willihnganz, MS, RN, CNE 1  Lesson 1.1 Drug Definitions, Standards, and...

Chapter 1 Drug Definitions, Standards, and Information Sources Clayton’s Basic Pharmacology for Nurses, 19th edition Michelle Willihnganz, MS, RN, CNE 1  Lesson 1.1 Drug Definitions, Standards, and Information Sources (1 of 2) 1. Differentiate between the chemical, generic, and brand names of drugs. 2. Identify the various methods used to classify drugs. 3. Identify sources of drug information available for healthcare providers. 2  Lesson 1.1 Drug Definitions, Standards, and Information Sources (2 of 2) 5. Discuss the difference between prescription and nonprescription drugs. 6. Describe the process of developing and bringing new drugs to market. 7. Differentiate between the Canadian chemical names and the proper name of a drug. 3  Foundations of Pharmacology (1 of 3)  Pharmacology deals with the study of drugs and their actions or effects  From Greek words pharmakon and logos  Physiotherapy uses water, light, and heat  Psychotherapy identifies stressors and methods used to reduce them 4  Foundations of Pharmacology (2 of 3)  Therapeutic methods are approaches to treating illnesses  Diet therapy  Drug therapy  Physiotherapy  Psychotherapy  Therapeutic methods are often used in combination 5  Foundations of Pharmacology (3 of 3)  Biologic therapy: A new class of drugs; has transformed treatment of patients with disorders that attack the body’s own organs, tissues, and cells  Biologic agents are large, complex proteins manufactured in a living system 6  Chemical Name  Most meaningful to the chemist  Chemist understands the exact chemical constitution of the drug and the exact placement of its atoms or molecular groupings 7  Generic and Brand Names  Generic name: Important to know because formularies use them; not capitalized  Official name: Listed by FDA  Brand or trademark: Registered by manufacturer; capitalized 8  Audience Response Question 1  Which name(s) of a drug should the nurse use when teaching a patient about a new prescription? a) Trade b) Generic and trade c) Generic and chemical d) Official 9  Drug Classifications  Body system classification (e.g., cardiovascular, gastrointestinal)  Therapeutic use or clinical indications (e.g., antacids, antibiotics)  Physiologic or chemical action (e.g., anticholinergics, calcium channel blockers) 10  Further Classifications  Prescription: Requires an order by a health professional licensed to prescribe drugs  Nonprescription: Over-the-counter (OTC) drugs sold without a prescription  Illegal or recreational drugs: Used for nontherapeutic purposes; obtained illegally  Biosimilar: Biologic product that is close in structure/function to an existing approved biologic product 11  Resources for Drug Information  Official source for American drug standards  The United States Pharmacopeia (USP)/National Formulary (NF)  USP Dictionary of USAN and International Drug Names  Sources for prescription and nonprescription drugs  Package inserts  Nursing journals  Electronic databases 12  Audience Response Question 2  Which source of information is best for the nurse to obtain drug information? a) Physicians’ Desk Reference (PDR) b) Nursing journals c) United States Pharmacopeia (USP) and National Formulary (NF) d) Electronic databases 13 Common Sources of Drug Information  Electronic databases  Cumulative Index of Nursing and Allied Health (CINAHL)  Lexicomp  ePocrates  DailyMed 14  United States Drug Legislation  Federal Food, Drug, and Cosmetic Act (1938, 1951, 1962)  Controlled Substances Act (1970): Defined five classifications or schedules of controlled substances  Schedule I  Schedule II  Schedule III  Schedule IV  Schedule V 15  Audience Response Question 3  Which entity is responsible for monitoring drug safety in the United States? a) Drug Enforcement Agency (DEA) b) Department of Justice (DOJ) c) U.S. Food and Drug Administration (FDA) d) World Health Organization (WHO) 16  Audience Response Question 4  Which drug schedule indicates drugs with the highest risk for abuse? a) Schedule I b) Schedule II c) Schedule III d) Schedule IV e) Schedule V 17  Controlled Substances (Slide 1 of 2)  Manufacturers, prescribers, and dispensers must register with the DEA : Requirements must be met to dispense scheduled medications  Controlled substances in hospitals: Inventory and dispersion control records 18  Controlled Substances (Slide 2 of 2)  Possession of controlled substances by individuals: Nurses may not have controlled substances in their possession  Effectiveness of drug legislation: Enforcing laws regarding the proper distribution and use of drugs is dependent on many organizations working together to ensure understanding of reasons for drug legislation 19  New Drug Development  Rules and regulations evolved by FDA divide into four stages  Preclinical research and development: Average time is 18 months  Clinical research and development: May require 2 to 10 years; average is 5 years  New Drug Application (NDA) review: Average time is 17 months  Postmarketing surveillance 20  Tracking  Fast tracking: Used to expedite drug development and approval for life-threatening illnesses  Parallel tracking: Used for patients with life- threatening illnesses who cannot participate in controlled trials, when there is no other alternative 21  Postmarketing Surveillance Stage  Ongoing review of adverse effects of new drugs  Black box warning  Indicates a very serious life-threatening problem  Probability of a drug acquiring a new black box warning or being withdrawn from the market within 25 years of being released is 20% 22  Rare Diseases and the Development of Orphan Drugs  National Organization for Rare Disorders estimates that 6000 rare health conditions exist in about 20 million Americans  Orphan drugs: Medicines developed for rare disorders  Orphan Drug Act, 1983: Promotes development of products that demonstrate promise for diagnosis or treatment of rare diseases or conditions 23  Audience Response Question 5  How many years on average does it take for a drug to be brought to market from the time of its conception? a) 2 to 3 b) 4 to 7 c) 8 to 15 d) 12 to 18 24  Canadian Drug Names  Official drug name: Any drug described specifically in the Food and Drug Regulations; there are some dissimilarities in brand names between Canada and the U.S.  Chemical name: Most meaningful to chemist  Proper name: Nonproprietary or generic name used to describe an official drug in Canada  Brand name 25 Sources of Drug Information in Canada  Compendium of Pharmaceuticals and Specialties (CPS)  Patient Self-Care: Helping Patients Make Therapeutic Choices  Compendium of Self-Care Products (CSCP) 26  Canadian Drug Legislation (1 of 2)  Food and Drugs Act (1927), Food and Drug Regulations (1953, 1954, 1979): Protect the public in Canada through the Therapeutic Products Directorate  National Association of Pharmacy Regulatory Authorities (NAPRA)  Assigns drugs to four categories  Schedule I, II, III, and Unscheduled 27  Canadian Drug Legislation (2 of 2)  Controlled Drugs and Substances Act (1997)  Establishes requirements for the control and sale of narcotics and substances of abuse in Canada  Schedules I to VIII 28 Questions? 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