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