Introduction To Drugs PDF
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Maria Renee Cantil,RN
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Summary
This document provides an introduction to drugs and pharmacology. It discusses different sources of drugs, including plants, animals, and inorganic compounds. The document also explores the importance of drug standards and legislation, including the 1997 Food and Drug Administration Modernization Act.
Full Transcript
CHAPTER I INTRODUCTION TO DRUGS BY: MARIA RENEE CANTIL,RN 1 PHARMACOLOGY Pharmacology is the study of the biological effects of chemicals Nurses deal with pharmacotherapeutics, or clinical pharmacology. Some drug effects are therapeutic, or helpful, but others are...
CHAPTER I INTRODUCTION TO DRUGS BY: MARIA RENEE CANTIL,RN 1 PHARMACOLOGY Pharmacology is the study of the biological effects of chemicals Nurses deal with pharmacotherapeutics, or clinical pharmacology. Some drug effects are therapeutic, or helpful, but others are undesirable or potentially dangerous (adverse effects) DRUGS are medicines or other substances used to modify or improve physiologic or pathologic effect/condition when ingested or otherwise introduced into the body. 2 NURSE’S RESPONSIBILITY Administering drug Assessing drug effects Intervening to make the drug regimen more tolerable Providing patient teachings about drugs and the drug regimen Monitoring the overall patient care plan to prevent medication errors 3 SOURCES OF DRUGS #1 Natural Sources Plants Synthetic version of the active chemical found in a plant Main component of the growing alternative therapy movement 4 DRUGS EXAMPLES: PLANTS 5 Digoxin is a cardiac glycoside isolated from the foxglove plant Digitalis purpurea. Its effects on the heart were first described by Withering (1785) 6 An opium “high” is very similar to a heroin “high”; users experience a euphoric rush, followed by relaxation and the relief of physical pain. What is its effect on the body? Opium inhibits muscle movement in the bowels leading to constipation. It also can dry out the mouth and mucous membranes in the nose. 7 Ricinus communis, the castor bean or castor oil plant, is a species of perennial flowering plant in the spurge family, 8 SOURCES OF DRUGS #2 Natural Sources (cont.) Animal products Used to replace human chemicals that are not produced because of disease or genetic problems Genetic engineering Many of these preparations are now created synthetically 9 SOURCES OF DRUGS #3 Inorganic compounds Salts of various elements can have therapeutic effects in the human body Synthetic Sources Genetic engineering alter bacteria to produce chemicals that are therapeutic and effecti Original prototypes 10 DRUG EXAMPLES : INORGANIC 11 Aluminum hydroxide is a medication used in the management and treatment of acid indigestion. It is in the antacid class of drugs. 12 Fluoride toothpaste is very effective in preventing tooth decay. The amount of fluoride in toothpaste is usually enough to reduce decay. In areas where the water supply has fluoride added, fluoride toothpaste gives extra protection. 13 People commonly use iron for preventing and treating different types of anemia caused by low iron levels. The more iron you have in your body, the more you can produce the haemoglobin necessary for generating enough red blood cells. Taking iron supplements boosts the production of red blood cells in the body, resulting in optimal health function 14 Gold is used most often to treat rheumatoid arthritis. It is sometimes also used to treat juvenile rheumatoid arthritis and psoriatic arthritis. Gold appears to work best in the early stages of arthritis Gold injections, also known by the brand name Myocrisin, are made from a compound called sodium aurothiomalate, which contains gold. They belong to a group of drugs known as disease modifying anti-rheumatic drugs (DMARDs). 15 DRUG STANDARDS AND LEGISLATION Drug standards United States Pharmacopeia National Formulary (USP-NF) a. met high standards for therapeutic use b. patient safety c. quality d. purity e. strength f. Packaging safety g. dosage form 16 DRUG PACKAGING WITH DOSAGE AND ROUTE ADMINISTRATION DRUG STANDARDS AND LEGISLATION st The Philippine Pharmacopeia (PP) 1 edition April 2004 and any supplement thereto, is hereby declared and adopted as the official book of the standards and references for the determination of the identity, purity, and quality of pharmaceutical products and crude plant drugs in the Philippines. DRUG STANDARDS AND LEGISLATION 1997: The Food and Drug Administration Modernization Act 5 provisions: 1) review and use of new drugs is accelerated 2) drugs can be tested in children before marketing 3) clinical trial data are necessary for experimental drug use for serious or life-threatening health conditions. 4) drug companies are required to give information on “off label drugs” and their uses and costs (e.g. Vancomycin (most antibiotics – Surgical prophylaxis off-label) 5) drug companies that plan to discontinue drugs must inform health professionals and patients at least 6 months before stopping drug production. DRUG EVALUATION Preclinical Trials Chemicals tested on laboratory animals Phase I Studies Chemicals tested on human volunteers Phase II Studies Drug tried on informed patients with the disease Phase III Studies (COVID19 VACCINES) Drug used in vast clinical market passed safety data milestone for EMERGENCY USE AUTHORIZATION (EUA) Phase IV Studies Continual evaluation of the drug (for more side & adverse effects not discovered in previous trials) DRUG EVALUATION 1938: Food, Drug, and Cosmetic Act -empowered the FDA to ensure drug safety by monitoring and regulating the manufacture and marketing of drugs. a )Tested for harmful effects b) Labels with accurate information c) Enclosed detailed literature (druglit) in the packaging that explains adverse effects. 1978: Drug Regulation Reform Act shortened the time in which new drugs could be developed and marketed. It protects patients’ rights and investigational process and promote research. Chemical names describes the drug chemical structure. Generic names is the official nonproprietary name for the drug; universally accepted. Brand or Trade names known as proprietary name, is chosen by the drug company and is usually a registered trademark owned by that specific company. GENERIC, BRAND NAME AND CHEMICAL NAME DRUG GENERIC NAMES Chemicals that are produced by companies involved solely in the manufacturing of drugs Bioavailability of the drug “Dispensed as written” (DAW) Important in drugs that have narrow safety margins Products that are available without prescription for self-treatment of a variety of complaints. Some of these agents were approved as prescription drugs. Later were found to be very safe and useful for patients example: loratadine (Claritin) Many of these drugs were “grandfathered” (drugs originally marketed before 1938 w/o approved NDAs). OVER-THE-COUNTER DRUGS #2 Nurses should consider several problems related to OTC drug use: Taking these drugs could mask the signs and symptoms of underlying disease, making diagnosis difficult. Taking these drugs with prescription medications could result in drug interactions and interfere with drug therapy. Not taking these drugs as directed could result in serious overdoses. ORPHAN DRUGS #1 Drugs that have been discovered, but are not financially viable and therefore have not been “adopted” by any drug company The study reported that 86.5% of identified orphan drugs had evidence of serious adverse events The Orphan Drug Act of 1983 Designed to promote the development and manufacture of orphan drugs, for the treatment of rare diseases. (ALS – Lou Gehrig’s Disease – Ice Bucket Challenge) ORPHAN DRUGS ACT #2 3 primary incentives: a) federal funding of grants and contracts to perform clinical trials of orphan products b) 50% tax credits for cost of clinical testing c) exclusive (PATENT) right to market the drug for 7 years from marketing approval date. ORPHAN DRUGS CONTROLLED SUBSTANCES #1 The Controlled Substances Act of 1970 Control over the coding of drugs and the enforcement of these codes to the FDA and the Drug Enforcement Agency (DEA), a part of the U.S. Department of Justice. Prescription, distribution, storage, and use of these drugs are closely monitored. Local policies and procedures might be even more rigorous. CONTROLLED SUBSTANCES #2 Provisions: a) promotion of drug education and research into the prevention and treatment of drug dependence b) Strengthening of enforcement authority c) Establishment of treatment and rehabilitation facilities. E.g. TRC our current affiliation agency for PSYCHIA d) Designation of schedules or categories for controlled substances according to abuse liability. CONTROLLED SUBSTANCE ACT OF 1970 SCHEDULE I- ONLY WITH APPROVED PROTOCOL(ex. Heroin, marijuana) SCHEDULE II-WRITTEN RX ONLY, NO REFILLS(ex.morphine oxycontin) SCHEDULE III-WRITTEN RX OR ORAL RX, 5 REFILLS IN 6 MONTHS, CONTAINER MUST HAVE WARNINGS(ex. testosterone, tylenol with codeine) SCHEDULE IV- WRITTEN ORAL RX, 5 REFILLS(ex. benzodiazepines like valium) SCHEDULE V-WRITTEN RX OR OTC(ex. Cough meds like robitussin) SOURCES OF DRUG INFORMATION #1 Drug Label Drug labels have specific information that identifies a specific drug Understanding how to read a drug label is essential Package Insert Prepared by the manufacturer Contains all the chemical and study information that led to the drug’s approval Difficult to understand and read Reference Books Physician’s Drug Reference (PDR) Drug Facts and Comparisons AMA Drug Evaluations Lippincott’s Nursing Drug Guide (LNDG) Journals Internet THANK YOU…