Post on 06-May-2015
description
Introduction to Pharmacology
Ma. Minda Luz M. Manuguid, M.D.
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
definitions
Pharmacy – the production, preparation, & dispensing of drugs
Pharmacist – one who is involved in the preparation & dispensing of drugs
definitionsPharmacology – the study of drugsDrugs – 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)
Medicines
Prohibited drugs
definitionsPhilippine 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
definitionsPharmacodynamics – 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
classificationorigin/source:
natural – plants, animal products, minerals Synthetic – man-made
chemical structure acidbase
procurementRx – prescription – can be obtained only
with a doctor’s prescription OTC – over the counter – doesn’t need a
doctor’s prescription
classificationaccording 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)
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
nomenclatureChemical 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 druge.g. Acetaminophen / Paracetamol
Brand name – a name assigned to a drug by the manufacturer (pharmaceutical company): e.g. Tylenol; Calpol; Tempra
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
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 toxicityadministration of multiple doses to detect
any adverse effects
toxicity screeningmutagenicity –
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
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
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
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
relevant lawsExecutive 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
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”
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
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”
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.
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).
Thank You !