From the Text. Definitions. Definitions. Definitions. Definitions. RSPT 2217 Basic Concepts & Principles. RSPT Basic Concepts

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1 RSPT 2217 & Principles Gardenhire Chapter 1; p From the Text Key Terms and page 2 Orphan Drugs Table 1-1; page 6 Abbreviations Table 1-2; page 8 Aerosolized Agents Table 1-3; page 9 Drug: Pharmacology: Respiratory Care Pharmacology: Pharmacy: Pharmacognosy: Pharmacogenetics: Therapeutics: Toxicology: Pharmaceutics: Pharmacokinetics: describe the time course and disposition of a drug in the body Pharmacodynamics: describe the mechanisms of drug action 1

2 Drug Regulation in the U.S. Drug Regulation in the U.S. Legislation 1906 first Food & Drug Act passed by Congress 1914 Harrison Narcotic Act is passed 1938 Food, Drug & Cosmetic Act is passed Drug Regulation in the U.S the Durham-Humphrey Amendment 1962 the Kefauver-Harris Law is passed as an amendment to the Food, Drug & Cosmetic Act of the Controlled Substances Act becomes effectives Drug Regulation in the U.S. Schedule 1 to 5 generally defines drugs of decreasing potential for abuse, increasing medical use and decreasing physical dependence Schedule 1 Schedule 2 Schedule 3 Schedule 4 Schedule 5 Naming Drugs Naming Drugs Drugs that are officially approved for clinical use will have accumulated at least five names: 1. Chemical name 2. Code name 3. Generic name 2

3 Naming Drugs 4. Official name 5. Trade name Sources of Drug Information Sources of Drug Information United States Pharmacopeia (USP) first published privately in 1820; given official status in 1906 (1 st Food & Drug Act) National Formulary (NF) first published privately in 1888; given official status in 1906 (1 st Food & Drug Act) Sources of Drug Information United States Pharmacopeia - National Formulary (USP-NF) in 1980, which was a revision year for the USP, the USP and NF were combined into a single volume Physician s Desk Reference (PDR) prepared by manufacturers Sources of Drug Information Hospital Formulary published by the American Society of Hospital Pharmacists Sources of Drugs 3

4 Sources of Drugs Today, the most common source of drug preparation is chemical synthesis Other sources and examples Animal: thyroid hormone, insulin, pancreatic dornase Plant: khellin, atropine Mineral: copper sulfate, magnesium sulfate, mineral oils Process requires an average of 14 yrs. Cost for R & D and pre- and post clinical trials is approximately $900 million per drug Only 1 in 10,000 chemicals identified as potential drugs will reach general clinical use Isolation and identification of the chemical Animal Studies toxicology studies, including mutagenicity, teratogenicity, carcinogenicity and effects on reproductive fertility Investigational New Drug (IND) approval IND application Phase 1 Phase 2 New Drug Application (NDA) following successful IND process, an NDA is filed with FDA upon approval detailed reporting system the drug is no longer considered experimental Phase 3 4

5 Orphan Drugs Orphan Drugs Orphan Drug drug biologic product for the diagnosis and treatment of a rare disease Rare Disease: Drugs may also be declared orphan if they are for a disease affecting more than 200,000 persons The Prescription The Prescription 1. Patient info 2. Superscription directs the pharmacist to prepare the medication; Rx symbol means recipe or take thou. 3. Inscription lists the name, strength, formulation and quantity of drug 4. Subscription directions for preparation 5. Transcription lists what is to be written on the label 6. Signature of prescriber The Prescription Since passage of the Controlled Substances Act of 1971 Over the Counter Drugs 5

6 Over-the-Counter Drugs OTC drugs Strength and amount per dose Over-the-Counter Drugs The problem is with self-treating Book example is of epinephrine - Primatene Mist delivers 0.2 mg per spray, which is about 1/2 of the usual aerosol dose of 0.5 mg Generic Substitutions Generic Substitutions Generic substitutions must be approved by physician on prescription Should be less expensive than proprietary Questions Self-assessment questions; page 10 Clinical scenario; page 10 6