Intro pharma


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ppt by : Ma. Minda Luz M. Manuguid, M.D

Published in: Business, Health & Medicine

Intro pharma

  1. 1. Introduction to Pharmacology Ma. Minda Luz M. Manuguid, M.D.
  2. 2. Pharmacology  a branch of medical science that is concerned with the effects of a drug in the human body & the fate of the drug when taken into the body  also deals with interactions when 2 or more drugs are taken simultaneously
  3. 3. definitions Pharmacy – the production, preparation, & dispensing of drugs Pharmacist – one who is involved in the preparation & dispensing of drugs
  4. 4. definitions Pharmacology – the study of drugs Drugs – chemicals that have effects on living organisms (should be listed in the national pharmacopeia) Drug products – commercial preparations of drugs – contain the active ingredient combined with inactive ingredients (vehicles, excipients, binders, fillers) Medicines – drugs used for the prevention or treatment of illness Drug interactions – a change in the effects of a drug when taken concomitantly with another; due to effects on absorption, distribution, metabolism, excretion (ADME)
  5. 5. Medicines
  6. 6. Prohibited drugs
  7. 7. definitions Philippine National Drug Formulary (PNDF) – the national pharmacopeia: lists all the drugs that are being used in our country Therapeutics/Pharmacotherapeutics – clinical application of Pharmacology; the rational use of drugs in the treatment of diseases Toxicology – the study of adverse effects on humans of prophylactic & therapeutic drugs, food & beverage additives, and industrial chemicals incorporated into consumer products
  8. 8. definitions Pharmacodynamics – the effects of a drug on the body: Affinity, Potency, Efficacy Pharmacokinetics – what the body does to the drug: Absorption, Distribution, Metabolism, Excretion Pharmacotherapeutics – the rational use of drugs to treat diseases : Clinical application of Pharmacodynamics & Pharmacokinetics
  9. 9. classification origin/source: natural – plants, animal products, minerals Synthetic – man-made chemical structure  acid base procurement Rx – prescription – can be obtained only with a doctor’s prescription OTC – over the counter – doesn’t need a doctor’s prescription
  10. 10. classification according to body system affected  GI drugs, CNS drugs, etc. according to mechanism of action  H2 receptor blocker, sympathomimetic, etc. according to therapeutic use  diuretic, analgesic, anti-inflammatory, sedative, etc.  anti–pathogens (anti-microbial); function modifiers (anti-HPN); restoratives (replenish deficiencies)
  11. 11. classification  Category 0 – prophylactic drugs: used in the prevention of disease e.g. vaccines  Category I – drugs directed toward the etiology of the disease e.g. antibiotics  Category II – drugs used in treating specific disease processes e.g. chemoTx  Category III – drugs used to alleviate specific disease manifestations e.g. anti-diarrheal  Category IV – drugs used to treat nonspecific disease manifestations e.g. analgesics for pain  Category V – drugs that are used in a non-therapeutic manner e.g. anesthetics
  12. 12. nomenclature Chemical name – description of the molecular structure of the drug e.g. N-(4-hydroxyphenyl) acetamide 0fficial / Legal name – generic – name by which the drug is known; usually indicates the class of the drug e.g. Acetaminophen / Paracetamol Brand name – a name assigned to a drug by the manufacturer (pharmaceutical company):  e.g. Tylenol; Calpol; Tempra
  13. 13. drug discovery & development  discovery of a new potential drug for a particular condition  screening of a wide array of natural products/chemicals for the desired biologic activity  modification of a known molecule  rational drug design  biotechnology & gene cloning to synthesize new drug  preclinical safety & toxicity screening
  14. 14. toxicity screening  acute toxicity administration of progressively larger single doses up to the lethal dose “No-Effect” dose – largest dose at which a specific toxic effect is NOT seen Minimum Lethal Dose – smallest amount of the drug that can kill a study animal LD50 – dose that kills half of the experimental animal population  subacute / chronic toxicity administration of multiple doses to detect any adverse effects
  15. 15. toxicity screening mutagenicity – detection of possible ability to induce genetic alteration (mutation) carcinogenicity – detection of possible ability to induce abnormal clonal uncontrolled proliferation of genetically altered cells teratogenicity – detection of possible deleterious effects on the developing fetus
  16. 16. clinical drug trials  Phase I : test the drug on a small number of healthy volunteers (except in drugs with significant toxicity)  to determine the effects of a drug at different dosages &  to compare the effects of the drug on animals & on humans;  to detect toxicity  Phase II : test the drug on a small number of patients with the disorder to be treated –  to determine efficiency (Efficacy)  Phase III : test the drug on a large number of patients with the disorder  to strengthen the data on safety & efficacy  Phase IV : monitor patients already using the drug  to further establish safety & efficacy in actual therapeutic situations
  17. 17. drug development  years 1 – 2 : in vitro studies  years 2 – 4 : animal testing  years 4 – 8 : clinical / human testing  years 8 – 9 : new drug application; granting of patent  years 9 – 20 : marketing; post-marketing surveillance / safety monitoring  year 20 : patent expires; generics become available
  18. 18. Philippine National Drug Policy  promotion of rational drug use by health professionals & the general public  assurance of the provision of safe & efficacious drugs thru quality control  local production of drug products whenever possible to decrease dependence on importation  tailored procurement of drugs by the government to assure nationwide availability of quality drugs at the lowest possible cost  information campaigns to empower the general population to make informed choices in the use of medicines & other drug products
  19. 19. relevant laws Executive Order no. 49 : “Directing the Mandatory Use of the Philippine National Drug Formulary (PNDF) Volume I as the Basis for Procurement of Drug Products by the Government”  outlines procedures to be followed in the implementation of the order with regards to the responsibility of the Therapeutics Committee/Physician, certification or requisition & issue vouchers by a requisitioning officer, the Commission on Audit’s role in monitoring compliance, & for requesting drugs not in the PNDF
  20. 20. relevant laws  Republic Act no. 6675 : the Generics Act of 1988 – “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”
  21. 21. The Generics Act : state policy  To promote, encourage & require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising & promotion, prescription & dispensing of drugs  To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavour to make them available for free to indigent patients  To encourage the extensive use of drugs with generic names through a rational system of procurement & distribution  To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware & cognizant of their therapeutic effectiveness  To promote drug safety by minimizing duplication of medications &/or use of drugs with potential adverse drug interactions
  22. 22. relevant laws  Administrative Order no. 51 series of 1988: “Implementing Guidelines for the Department of Health Compliance with RA 6675(Generics Act of 1988)”  Administrative Order no. 63 series of 1989: “Rules & Regulations to Implement Dispensing Requirements Under the Generics Act of 1988”  Administrative Order no. 62 series of 1989: “Rules & Regulations to Implement Prescribing Requirements under the Generics Act of 1988”  Administrative Order no. 90 series of 1990: “Amendment to A.O.62 S.1989 Re: Rules & Regulations to Implement Prescribing Requirements”  Republic Act no. 9502 series of 2008: “Universally Accessible Cheaper and Quality Medicines Act of 2008”
  23. 23. Botika ng Barangay  The BnB program aims to promote equity in health by ensuring the availability and accessibility of affordable, safe and effective, quality, essential drugs to all, with priority for marginalized, underserved, critical and hard to reach areas.
  24. 24. Botika ng Barangay  The Botika ng Barangay (BnB) refers to a drug outlet managed by a legitimate community organization (CO/non-government organization (NGO) and/or the Local Government Unit (LGU), with a trained operator and a supervising pharmacist specifically established in accordance with Administrative Order No. 144 s.2004. The BnB outlet should be initially identified, evaluated and selected by the concerned Center for Health Development (CHD), approved by the National Drug Policy- Pharmaceutical Management Unit (NDP-PMU 50), and specifically licensed by the Bureau of Food and Drugs (BFAD) to sell, distribute, offer for sale and/or make available low-priced generic home remedies, over-the-counter (OTC) drugs and two (2) selected, publicly-known prescription antibiotic drugs (i.e. Amoxicillin and Cotrimoxazole).
  25. 25. Thank You !