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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
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)
Medicines
Prohibited drugs
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
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
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
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)
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
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
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 toxicity
administration of multiple doses to detect any
adverse effects
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
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 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
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 !

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Introduction to Pharmacology Fundamentals

  • 1. Introduction to Pharmacology Ma. Minda Luz M. Manuguid, M.D.
  • 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. definitions Pharmacy – the production, preparation, & dispensing of drugs Pharmacist – one who is involved in the preparation & dispensing of drugs
  • 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)
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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).