NCM-106a-Module-1.pdf

1 Module 1: FUNDAMENTAL CONCEPTS OF PHARMACOLOGY Action: A description of the cellular changes that...

1 Module 1: FUNDAMENTAL CONCEPTS OF PHARMACOLOGY Action: A description of the cellular changes that occur as a result of the drug. Understanding the Fundamental Concepts of Pharmacology Contraindication: A list of conditions for which the drug should not be given. Pharmacology- the branch of medicine concerned with the uses, effects, and modes of action of drugs. Cautions: A list of conditions or types of patients that warrant closer observation for a specific side effects Paracelsus- is the Father of Pharmacology. when given the drug. Branch of Pharmacology Side Effects and Adverse Reactions: A list of possible unpleasant or dangerous secondary effects, Pharmacodynamics- What the drug does to body other than the desired effects. Pharmacokinetics- What the body does to drug Pharmacotherapeutics- The study of the use of drugs Interactions: A list of other drugs or food that may Pharmacy-Preparing suitable dosage forms alter the effect of the drug and usually should not Posology-The study of drug dosage be given during the same course of therapy. Toxicology-The study of nature, effects and detection SOURCES OF DRUG INFORMATION of poisons 1. Drug Handbook Dose- Refers to the quantity of drug administered at one time (ex: 500mg PARACETAMOL) 2. Physician Desk Reference (PDR) 3. Packet Insert Dosage-Refers to the amount of drug that should be given over time (ex: 500mg PARACETAMOL three times a day for 3 days) 4. Nursing Journal Drugs- Dutch droog, meaning dry; are chemical substances that 5. Medical Let have an effect on living organisms. 6. MIMS (Monthly Index of Medical Specialties) Medicines- therapeutic drugs used in the treatment of diseases. Drug Standards and Legislations Naming Drugs in 3 Ways (Drug Nomenclature) Drug Standards 1. Chemical Name- are the scientific names based on the Are rules set to assure consumers that they get what molecular structure of the drug. they pay for. The exact formula of the drug. Describes the drug’s chemical The law says that all preparations called by the same structure. Includes chemical constitution of the drugs. drug name must be of uniform strength, quality and 2. Trade Names a commercial name granted by a naming purity. authority for use in marketing a drug/device product in a 1906 Pure Food And Drug Act or Federal Food and particular jurisdiction. Drugs Act or Wiley Act or, First government attempt to establish consumer Brand Names- the brand name is developed by the company protection in the manufacture of drugs and foods. requesting approval for the drug and identifies it as the exclusive Required all drugs marketed to meet minimal property of that company. When a drug is under patent standards of strength, purity and quality. (US) protection, the company markets it under its brand name. Also known as proprietary name, is chosen by the drug company and A legislation passed in 1906 to ensure the sanitary is usually a registered trademark owned by that specific preparation of consumable goods. The Pure Food and manufacturer. Drug Act required accurate ingredient labeling and prohibited the sale of adulterated and misbranded 3. Generic Name- means the name of a genus. This term is food and drugs. usually used to name a class or category of products or services. Common or general name assigned to the drug; Is the official or Food and Drug Administration (FDA) non-proprietary name for the drug. Concerned with general safety standards in the Different Drug Information production of drugs, foods, and cosmetics. Indications: A list of medical conditions or diseases Responsible for approval and removal of products on for which the drug is meant to be used. the market. University of St. La Salle, College of Nursing Prepared by: Lachica, T. 2024-2025 NCM 106a  2 1938 Food, Drug. and Cosmetic Act 1992: Drug Relation Act Establish to prevent adulteration of and tampering The regulation were changed to increase the with drugs, food and, cosmetics: approval rate of drugs used to treat AIDS and cancer. The pharmaceutical companies pay a user All labels must be accurate and must include the fee at the time they file the application for the new generic names. drug. The fee is for the FDA drug approval process. All new products must be approved by the FDA before 1997: Food and Drug Administration public release. Modernization Act “Warning” labels must be present on certain There are five provisions in this act, which include the preparations, for example, “may cause following: drowsiness”, may cause “nervousness”, and “may be habit forming”. 1. review and use of new drugs is accelerated; 2. drugs can be tested in children before marketing; 1952: Durham-Humphrey Amendment to the 1938 Act 3. clinical trial data is necessary for experimental drug The Durham-Humphrey Amendment to the Food, Drug use for serious or life-threatening health conditions; and Cosmetic Act of 1938 distinguished between 4. drug companies are required to give information on drugs that can be sold with or without “off-label” drugs (non-FDA approved drugs) and prescription and those that should not be refilled their uses and costs; and without a new prescription, such as narcotics, 5. drug companies that plan to discontinue drugs hypnotics, or tranquilizer. must inform health professionals and clients at least 6 months before stopping drug production. 1962: Kefauver-Harris Amendment to the 1938 Act Nurse Practice Act The Kefauver-Harris amendment to the Food, Drug and Cosmetic Act of 1938 resulted from the widely Every state has its own laws regarding drug publicized thalidomide tragedy of the 1950s in administration by nurses. which pregnant European woman who took Generally, nurses cannot prescribe or administer thalidomide (tranquilizer) during the first trimester drugs without a health care provider’s order, but of pregnancy gave birth to infants with extreme limb state laws vary. A practicing nurse should request a deformities. copy of the nurse practice act in the state in which she Kefauver-Harris amendment tightened controls on or he is licensed. drug safety, especially experimental drugs, and In some states, a nurse who administers a drug required that adverse reactions and contraindications without a physician’s order is in violation of the nurse must be labelled and included in the literature. practice act and could have her or his license 1970: The Controlled Substances Act revoked. In 1970 The Controlled Substances Act (CSA) of the In a civil court, the nurse can be prosecuted for giving Comprehensive Drug Abuse Drug Abuse Prevention the wrong drug or dosage, omitting a drug dose, or and Control Act, Title II, was passed by Congress. giving the drug by the wrong route This act, designed to remedy the escalating problem Nursing Practice Act of drug abuse, included several provisions: Offenses related to wrong administration of drugs 1. The promotion of drug education and research into RA 9173- An act providing for a more responsive the prevention and treatment of drug dependence; nursing profession, repealing for the purpose of RA 2. The strengthening of enforcement authority; no. 7164, otherwise known as "The Philippine 3. The establishment of treatment and rehabilitation Nursing Act of 1991 facilities; 4. The designation of schedules, or categories, for The legal terms for these offenses are the following: controlled substances according to abuse liability. Misfeasance. Negligence; giving the wrong drug or 1978: Drug Regulation Reform Act drug dose that results in the client’s death This reform act shortened the time in which new Nonfeasance. Omission; omitting a drug dose that drugs could be developed and marketed. results in the client’s death Malfeasance. Giving the correct drug but by the wrong route that results in the client’s death University of St. La Salle, College of Nursing Prepared by: Lachica, T. 2024-2025 NCM 106a