1 - INTRODUCTION.pdf

PHARMACOLOGY NCM 106  THE NIGHTINGALE’S PLEDGE I solemnly pledge myself before God and in the presence of this assembly, to pass my life in purity and to practice my profession faithfully. I will abstain from whatever is deleterious and mischievous, and will not take or knowing...

PHARMACOLOGY NCM 106  THE NIGHTINGALE’S PLEDGE I solemnly pledge myself before God and in the presence of this assembly, to pass my life in purity and to practice my profession faithfully. I will abstain from whatever is deleterious and mischievous, and will not take or knowingly administer any harmful drug. I will do all in my power to maintain and elevate the standard of my profession, and will hold in confidence all personal matters committed to my keeping and all family affairs coming to my knowledge in the practice of my calling. With loyalty will I endeavour to aid the physician in his work, and devote myself to the welfare of those committed to my care. CHARLES CULLEN  Greek PHARMAKON + LOGOS ( medicine ) ( study ) Medicine – a substance taken into the body to treat an illness PHARMACOLOGY ✓ Study of the biological effects of chemicals. ✓ The science concerned with drugs, their sources, appearance, chemistry, actions and uses. NATURAL SOURCES: Plants NATURAL SOURCES: Animal Products Inorganic compounds SYNTHETIC SOURCES: DRUG LAWS Pure Food and Drug Act (1906) ✓ Required labelling of drugs Its main purpose was to ban foreign and interstate traffic in adulterated or mislabelled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary. Federal Food, Drug and Cosmetic Act (1938) ✓ Mandated tests for toxicity and means for recall empowering FDA Gave authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulphanilamide, a sulphanilamide medication where the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form. It replaced the earlier Pure Food and Drug Act of 1906. Durham-Humphrey Amendment (1951) ✓ Labelling of “May not be distributed with out a Prescription” This bill required any drug that was habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, “Caution: Federal law prohibits dispensing without prescription.” OVER-THE-COUNTER MEDICINE is also known as OTC or non-prescription medicine. All these terms refer to medicine that you can buy without a prescription. They are safe and effective when you follow the directions on the label and as directed by your health care professional Kefauver-Harris Act (1962) ✓ Investigation not just for safety but also for efficacy Required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects. required that evidence of effectiveness be based on adequate and well-controlled clinical studies conducted by qualified experts. Controlled Substances Act (1970) Control of drugs potential for abuse The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. Orphan Drug Act (1983) Provide incentives for development of “Orphan drugs” The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases. (Philippines) Any person may import any orphan drug/orphan product for compassionate use: Provided, That they secure a compassionate special permit from the Food and Drug Administration (FDA) in accordance with DOH Administrative Order No. 4, series of 1992, and any future guidelines that may be issued on the same. Generic Act - Philippines (1988) OTC Drugs An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names. GENERIC ACT (1988) TERMINOLOGIES “Generic Name or Generic Terminology” is the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official generic name as determined by the Bureau of Food and Drugs of the Department of Health. “Active Ingredient” is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product. “Chemical Name” is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound. “Drug Product” is the finished product form that contains the active ingredients, generally but not necessarily in association with inactive ingredients. “Drug Establishment” is any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines. “Drug Outlets” means drugstores, pharmacies, and any other business establishments which sell drugs or medicines. “Essential Drugs List” or “National Drug Formulary” is a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on an internationally accepted criteria. It shall consist of a core list and a complementary list. “Core List” is a list of drugs that meets the health care needs of the majority of the population. “Complimentary List” is a list of alternative drugs used when there is no response to the core essential drug or when there is a hypersensitivity reaction to the core essential drug or when, for one reason or another, the core essential drug cannot be given. “Brand Name” is the proprietary name given by the manufacturer to distinguish its product from those of competitors. “Generic Drugs” are drugs not covered by patent protection and which are labelled solely b their international non- proprietary or generic name. FDA EVALUATION PROCESS FOR DRUGS ✓ Preclinical trials (Theoretically may have therapeutic activity) ✓ Phase 1 (Cleared for human testing) ✓ Phase 2 (Cleared for limited clinical testing) ✓ Phase 3 (Cleared for large scale clinical studies) ✓ Phase 4 (Approved for marketing by FDA) Continued evaluation FDA- Food and Drug Administration Placebo Effect  FDA PREGNANCY CATEGORIES CATEGORY PREGNANT ANIMAL TEST NEGATIVE FETAL EFFECT WOMEN TEST A yes yes none B yes (?) yes (+) none C none yes (+) uncertain D yes (+) yes (+) (benefits > risk) X yes (+) yes (+) (benefits < risk) Teratogenic – Note: No Drug should be taken during pregnancy unless clearly needed regardless of pregnancy category.  12 RIGHTS OF MEDICATION ADMINISTRATION 1. Drug 5. Dose 9. Information 2. Patient 6. Documentation 10. Refuse 3. Time 7. Assessment 11. Preparation 4. Route 8. History Evaluation 12. Storage THANK YOU!