DR NARENDRA KUMAR Assistant Professor Introduction Living Organism DRUG Physiological functions Physiology Pharmacology Chemical Reactions Biochemistry As per WHO Scientific group “Any Substance or product that is used and intended to be used to modify or explore the physiological system or pathological state for the benefit of the recipient “ Drug categories Prescription drugs Are used under only medical supervision and dispensed by an order of medical practitioner only OTC drugs Can be sold over the without prescription counter Sub divisions of Pharmacology Pharmacology Pharmacokinetics Pharmacodynamics Pharmacotherapeutics Deals with ADME process i.e. what the body does to the drug Deals with the biological effect of the drug ,its mechanism of action and relation b/w its plasma concentration ,its response and duration of action i.e. What the drug does to the body . Clinical application of pharmacodynamics and pharmacokinetics information to cure a disease . Deals with the comparative clinical evaluations of Clinical pharmacology new drug for developing its therapeutic efficacy and safety Toxicology Deals with the toxicity and poisonous effects of various chemicals and also with the symptoms and treatment of poisoning Pharmacology Chemotherapy Deals with the systemic infection or malignancy with drugs with selective toxicity for infecting organisms. Pharmacogenetics Deals with the study of inherited (single gene mediated)differences in the drug metabolism or drug response in humans. Pharmacogenomics Deals with the genetic make up (Genome) of individual to choose drug therapy . Pharmacoepidemeiology Deals with the study of use and effects of the drug in large population to establish risk: Benefit ratio of the drug . Pharmacovigilance Deals with the continuous monitoring for unwanted effects and other safety related aspects of marketed drugs . Science related to DAUP (Detection, Assessment. Understanding and Prevention) Sources of Information Drug Compendia Pharmacopoeias Formularies Non Official Official Martindale Pharmacopoeias Formulary British pharmacopoeias Pharmaceutical codex(by pharmaceutical Society of Great Britain ) United states Pharmacopoeias National Formulary (by American Pharmaceutical Association) Indian Pharmacopoeias National Formulary of India Non offical Compendia Serves as Secondary Source of drug Information both by Generic name and Trade name This Information is generalized and is not restricted to only those drugs which are approved for use by the legally constituted committee of that country . For Example : 1. AMA Drug Evaluation : by American Medical Association and Council on Drugs 2. Modern Drug Encyclopedia: by Yorkee Medical books , New York, USA 3. Physician’s Desk Reference (PDR) : by Medical Economics Publications ,USA 4. Martindale Extra Pharmacopoeias : by Pharmaceutical Society of Great Britain . DRUG NOMENCLATURE A drug generally has three categories of names: (a)Chemical name It describes the substance chemically, e.g. 1(Isopropylamino )-3-(1-naphthyloxy) propan-2 –ol for propranolol. (b) Non-proprietary / official name / Approved name Name in the official books accepted all over the world (c)Proprietary (Brand) name Crocin for Paracetamol Essential medicines Essential medicines, as defined by the WHO are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford." Orphan Drugs These are drugs or biological products for diagnosis/treatment/ prevention of a rare disease or condition, or a more common disease (endemic only in resource poor countries) for which there is no reasonable expectation that the cost of developing and marketing it will be recovered from the sales of that drug. e.g. sodium nitrite, fomepizole, liposomal amphotericin B,, rifabutin,, somatropin, digoxin immune Fab (digoxin antibody), liothyronine (T3) and many more. Governments in developed countries offer tax benefits and other incentives to pharmaceutical companies for developing and marketing orphan drugs (e.g. Orphan Drug Act in USA). Laws governing Drugs (Drugs Schedule ) AS per detailed in USP Vol.XXII and by NF Schedule I Includes the drugs with high potential of Abuse Eg. LSD, Heroin .Marijuana, Flunitrazepam and Methaqualone Schedule II Includes morphine ,codiene, pethidine, fentanyl, cocaine, amphetamine,methylphenidate, pentobarbital and secobarbital .these can be used under medical supervision only Schedule III The drugs with moderate physical and psychological dependence eg. Stanzolol, ketamine ,nalorphine ,thiopental ,suppository form of secobarbital and pentobarbital etc Schedule IV They have low potential for abuse and have limited physical and pshycological dependence eg. Long acting barbiturates ,Benzodiazapines, Propoxyphene ,Pentazocine ,Premolineolpidem and Zaleplon Schedule V They have minimal use abuse potential and minimum dependence liability eg Lamotil and formulation containing Codiene while others are OTC drugs., M-III- Mfg of medical devices M-II- Mfg of Cosmetics M1- Mfg of Homeopathi c Drugs MGMP APrescribed forms B-State fees C and C 1Biological and special products DImport of Drugs E 1Poisonous Substances F& Schedules K-Exemtions from provisions of chapter IV of drug act F(I)Standards Of Bacterial Vaccines FFOpthalmic preparations J-List of Ailments HPrescription Drugs F(III)G- Drugs with Label Umbilical tapes CAUTION F(II)Surgical dressings and bandage cloth Y- req. & guidelines on clinical trials, import & mfg of new drugs. X- Pshycotropic drugs req. special licences for mfg and sale N- equipments, entrance ,premises,furnitu re, apparatus & general provisions ODisinfectants fluids P- Expiry period P 1- Pack Sizes of drugs W-Names of drugs which can be marketed under generic names only . Schedules Q- Dyes ,colours, pigments used in cosmetics and soaps V-Patents & Proprietary medicine U & U1- Mfg Records T-requirments of factory premises, hygienic conditions for Ayurvedic & Unani drugs. R- Mechanical Contraceptives SStandards of cosmetics R-1- Medical devices Bibliography •Essentials of Medical Pharmacology -7th edition by KD Tripathi •Goodman & Gilman's the Pharmacological Basis of Therapeutics 12th edition by Laurence Brunton (Editor) •Lippincott's Illustrated Reviews: Pharmacology - 6th edition by Richard A. Harvey •Basic and Clinical pharmacology 11th edition by Bertram G Katzung •Rang & Dale's Pharmacology -7th edition by Humphrey P. Rang •Clinical Pharmacology 11th edition By Bennett and Brown, Churchill Livingstone •Principles of Pharmacology 2nd edition by HL Sharma and KK Sharma •Review of Pharmacology by Gobind Sparsh