PHARM DDS
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New Drugs May be derived from the following: | 1 Plant or animal sources 2 Bi-products of microbial growth 3 Chemical synthesis 4 Molecular modification 5 Biotechnology |
Drug Discovery | 1 Target Selection (0-2 years) 2 Discovery and Screening (2-3 years) 3 Lead Selection (1-2 years) 4 Lead Optimization (1-2 years) |
The First Apothecary | Tribal Apothecary |
A continuous scroll contain history of drug therapy (16th century) contains more than 800 drug formulas | Ebers Papyrus |
Father of medicine, a Greek physician | Hippocrates |
Aureolus Theophrastus Bombastus von Hohenheim- transformation of pharmacy from a profession based primarily on __ to one based on __. | 1 botanical science 2 chemical science |
The most famous of all pharmacists, discovered lactic acid, citric acid, oxalic acid, tartaric acid, arsenic acid, glycerin, benzoic acid | Swede Karl Wilhelm Scheele |
Discovered morphine | Friedrich Serturner |
Isolated quinine and cinchonine from cinchona, strychnine and brucine from nux vomica | Caventou and Pelletier |
Isolated caffeine | Pelletier & Robiquet |
Isolated codeine | Robiquet |
Combined to indicate any recipe or formula or other standards required to make or prepare a drug, first used in 1580. | Pharmacopeia pharmakon - drug poiein - make |
1st American Pharmcopeia in 1778. | Lititz Pharmacopoeia |
1st USP Convention- | Washington, DC on January 1, 1820 |
1st USP was published (English & Latin). 272 pages, 217 drugs > Massachusetts Pharmacopeia | Dec.15, 1820 |
USP Revisions shall be every 5 years (before>>10 years) | 1940 convention |
Designating both the USP and NF as establishing legal standards set forth in the compendium monograph. | Pure Food and Drug Act by Pres. Theodore Roosevelt |
Provides uniform names of drugs and preparations and working directions for small-scale manufacture of popular pharm’l preps prescribed by physicians | National Formulary |
A monograph includes | 1 the name of the ingredient or preparation 2 Structural formula, empirical formula, MW, chemical names, Chemical Abstracts Service (CAS) registry number 3 the definition; packaging, storage, 4 labeling requirements; 5 specifications |
HPUS | Homeopathic Pharmacopeia of the US |
IP | International Pharmacopeia/ Pharmacopeia Internationalis (1951) |
Provides additional guidelines for drug quality required by certain practitioners and agencies | International Pharmacopeia |
EP or Ph Eur | European Pharmacopeia |
NA | NA |
The Mexican pharmacopeia | Farmacopea de los Estados Unidos Mexicanos |
Five Schedules for classification and control of drug substances that are subject for abuse: | Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act) |
Part of the MERCOSUR Pharmacopoeia, comprising Argentina, Brazil, Paraguay, and Uruguay. | Brazilian Pharmacopeia (Farmacopeia Brasilieira) |
Five Schedules for classification and control of drug substances that are subject for abuse: | Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act) |
ISO | International Standardization Organization |
Five Schedules for classification and control of drug substances that are subject for abuse: | Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act) |
Five Schedules for classification and control of drug substances that are subject for abuse: | Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act) |
ISO standards used in the pharmaceutical industry are those in the series __ to __ | ISO 9000 to ISO 9004. Standardization includes: QA, QC, QM |
Five Schedules for classification and control of drug substances that are subject for abuse: | Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act) |
First federal law in the United States designed to regulate drug products manufactured domestically | Food and Drug Act of 1906 drugs marketed interstate to comply with their claimed standards for strength, purity, and quality. |
Prohibited false claims of therapeutic effects, declaring such products misbranded. | 1912 Sherley Amendment |
Five Schedules for classification and control of drug substances that are subject for abuse: | Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act) |
Gives the FDA the authority to compile a list of currently marketed drugs. ___ each drug is assigned a unique and permanent drug code called ___ | 1 Drug Listing Act of 1972 2 National Drug Code (NDC) |
Ten Characters that identify manufacturer or distributor, drug formulation, size and type of packaging | National Drug Code (NDC) |
A law passed in the US to facilitate development of orphan drug. - “rare diseases and conditions” | Orphan Drug Act of 1983 |
Orphan Diseases | 1 Huntington's disease, 2 myoclonus, 3 ALS, 4 Tourette syndrome and 5 muscular dystrophy which affect small numbers of individuals residing in the United States. |
Moderate potential for abuse / dependence Acceptable medicinal qualities Doctor's prescription required | Schedule III |
Schedule I drugs | 1 Heroin 2 LSD 3 Marijuana 4 Ecstasy 5 Peyote |
Schedule II drugs | 1 Vicodin 2 Cocaine 3 Meth 4 Oxycontin 5 Adderall |
Schedule III drugs | 1 Tylenol with Codeine 2 Ketamine 3 Steroids 4 Testosterone |
Schedule IV drugs | 1 Xanax 2 Darvon 3 Valium 4 Ativan 5 Ambien 6 Tramadol |
Schedule V drugs | 1 Robitussin AC 2 Lomotil 3 Motofen 4 Lyrica |
Controlled studies demonstrate no risk | Category A |
No evidence of risks in humans | Category B |
Risk cannot be ruled out | Category C |
Potential evidence of risk | Category D |
Contraindicated in pregnancy | Category X |
Use of various herbs and dietary supplements and addressed the need to regulate the labeling claims made for these product a disclaimer must appear on the product: “This product is not intended to diagnose, treat, cure, or prevent any disease.” | Dietary Supplement Health and Education Act of 1994 and the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 |
It is a voluntary action taken by a company at any time to remove a defective drug product from the market. | Drug Product Recall |
Reported problems may include product defects, product adulteration, container leakage, improper labeling, unexpected adverse reactions | MedWatch (Drug Product Recall) |
Contemporary Role of Pharmacists | 1 Community pharmacies 2 Patient care institutions 3 Managed care 4 Home health care 5 Military and government services 6 Academic settings 7 Professional associations 8 Pharmaceutical research 9 Manufacturing industry |
Pharmacy Practice Standards | 1 General management and administration of pharmacy 2 Processing the prescription 3 Patient care functions 4 Education of health care professionals and patients |
Pharmacist Code of Ethics | I. A pharmacist respects the covenantal relationship between the patient and pharmacist II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner III. A pharmacist respects the autonomy and dignity of each patient IV. A pharmacist acts with honesty and integrity in professional relationships. V. A pharmacist maintains professional compétence VI. A pharmacist respects the values and abilities of colleagues and other health professionals. VII. A pharmacist serves individual, community, and societal needs VIII. A pharmacist seeks justice in the distribution of health resources. |
Methods of Drug Discovery | 1 Random Screening 2 Molecular manipulation 3 Molecular designing 4 Drug metabolites 5 Serendipity |
Testing of synthetic organic compounds for biologic activity | Random Screening |
Chemical alteration of previously characterized organic compound to enhance its usefulness. | Molecular manipulation |
To design a drug that interferes specifically with known or suspected biochemical pathway or mechanism of disease process. | Molecular designing |
For Prodrugs | Drug metabolites ex. Enalaprilat as metabolite of enalapril |
By good chance | Serendipity |
What steps are involved in developing a new drug? | 1 In vitro studies (0-2 years) 2 Animal Testing (IND) 3 Clinical Testing (NDA) 4 Marketing (20 years) |
Drug Sources | 1 Plants 2 Animals 3 Mineral / Earth Sources 4 Synthetic / Semi-synthetic sources 5 Microbiological sources 6 Genetic Engineering |
Drugs of Plant Sources | 1 Reserpine from Rauwolfia serpentina 2 Vinca rosea – Periwincle, Rosas de baybayon |
Techniques which influence cells’ ability to produce proteins __, __ Common to each technique is the ability to manipulate and produce __ | 1 rDNA 2 mAb 3 proteins |
Gene Splicing products | 1 Human insulin 2 Human growth hormone 3 HepaB vac 4 epoetin alfa 5 interferon. |
1st FDA approved mAb | Muromonab |
2 major branches of Pharmacology | 1 Pharmacokinetics 2 Pharmacodynamics |