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Unformatted text preview: PHCY 6100 Teixeira Introduction to Drugs and Pharmacy 1. DRUG (medicinal agent) & DISEASES 2. The heritage of Pharmacy: a. Pharmacist or Apothecary (wiseman, priest, magician:) preparation and dispensing of drugs 3. History of Drug Therapy: a. Ebers papyrus: egyptians; 16th century B.C., 700 different drugs (botanic, animal, mineral). b. Hippocrates, Dioscorides, Galen: greek; Ethics, pharmaceutical botany, galenic pharmacy. c. Paracelsus: swiss; Specific drug to specific disease (chemical pharmacy). d. 18th‐19th century: swedish, german, french pharmacists (Scheele, Sertürner, Pelletier, Robiquet); Scientific research. e. In USA: indigenous drugs used by american indians; before 19th century all drugs were imported from Europe then later American pharmacists get scientific and technologic expertise from Europe. 4. Drug Standards: need for uniform standard to ensure quality of drug products a. Contemporary official compendia = The United States Pharmacopeia (USP) & the National Formulary (NF) b. 1st Pharmacopeia, 1580: Bergamo (Italy) c. 1st USP, 1820: prepared by physicians only; in English and Latin (international language of medicine) d. USP33/NF28: is an official public standards‐setting authority for all prescription and over‐
the counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. The United States Pharmacopeia–National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. The USP–NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances and preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipient monographs are in the NF. New USP 34‐NF 29 will be published in Nov.1, 2010! e. National Formulary (NF): popular drugs, preps and excipients that were not admitted to the original USP. President Roosevelt in 1906 signed into law as legal standard. Combined w/ USP in 1980. f. International pharmacopeia: published by world health organization (WHO) g. Homeopathic pharmacopeia of the United States (HPUS): “like cures like” h. USP DI : United States Pharmacopeia Drug Information is available as a publication and computer database with info on pharmaceutical products including indications, pharmacology, side effects, and dosage to help health care professionals and the public. 1 PHCY 6100 Teixeira 5. Drug Regulation and Control: a. FDA= Food and Drug Administration b. The FDA is responsible for drug regulation and control of SAFETY & EFFECTIVENESS c. SULFANILAMIDE elixir prepared with diethylene glycol (1938); THALIDOMIDE used as a tranquilizer during pregnancy caused phocomelia (1960). 6. INDA or Investigational New Drug Application: before the drug may be tested clinically on humans 7. NDA= New Drug Application: drug’s sponsor seeking approval for marketing 8. Drug Abuse Prevention and Control: 1970; under the DEA (Drug Enforcement Administration) in the Dept. of Justice. Drugs are classified according to the manner in which they may be legally obtained by the patient. a. O.T.C. (Over‐the‐counter): safe enough for use by the layman for self‐treatment; No prescription required. b. Legend drugs: too dangerous for self‐medication and useful only after expert diagnosis; “Caution: federal law prohibits dispensing without prescription”. c. Schedule drugs: drug substances known to be subject to public abuse (physical/psychological dependence); regulated by the DEA. i. 5 “schedules” provide for decreasing levels of control: schedule I, high potential for abuse with no accepted medical use (e.g. LSD) through schedule V, low potential for abuse. 9. FDA Pregnancy Categories: risk versus benefit ratio ; depends on stage of pregnancy and amount of medication taken; 5 categories based on potential for causing birth defects a. Category A: least potential b. Category B c. Category C d. Category D e. Category X: highest potential; the drug is contra‐indicated during pregnancy because data exists that the drug may be implicated as a teratogen and the risk versus benefit ratio does not support the use of the drug. 10. Black Box Warnings (BBW): labeling requirements for high risk medicines a. Chloramphenicol b. Antidepressant medications c. Reminder ads are not allowed for these products 11. National Drug Code (NDC): permanent number assigned to a drug product by the FDA before sale or distribution in the USA. 12. Patents: a. 20‐year patent term b. Extension: 5‐year c. Extended‐release dosage form of the same drug 13. Drug product recall: FDA MedWatch Program; recall for product defects, adulteration, container leakage, improper labeling, unexpected adverse reactions, etc. 14. The pharmacist’s contemporary role & Pharmaceutical Care 15. Pharmacy Practice Standards 2 PHCY 6100 Teixeira 3 ...
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