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 !