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
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).