Pharmacology

(Subject Code) | BATCH 2021

LICEO DE CAGAYAN UNIVERSITY
TRANSCRIBED BY: Sarah Mae C. Ido
LECTURER/S: Insert name of professor
INTRODUCTION TO
REFERENCES: PPT, Handouts, Internet, textbook DRUGS
3. Inorganic Compound
PHARMACOLOGY - salts of various chemical elements can have
- is the study of the biological effects of chemicals, therapeutic effects on the human body.
the branch of medicine concerned with drug uses, - salt, water, and oxygen.
effects, and modes of action.

PHARMACOTHERAPEUTICS
- or clinical pharmacology is the branch of
pharmacology involving drugs used to treat,
prevent, or diagnose disease.

SOURCE OF DRUGS
1. Animal Source
- are used to replace human chemicals that fail to be 4. Synthetic drugs
produced because of disease or genetic problems. - created from a series of chemical reactions
- obtained from the animal drug: - do not exist in nature
1. Heparin - Scientists use genetic engineering to alter bacteria
2. Insulin to produce chemicals that are therapeutic and
3. Thyroxin effective.
4. Vitamin B12 - example: Phenobartibal, Sulfa, and
5. Cod liver oil Cephalosporins
6. Anti-toxic sera
2. Plant Source 5. Synthesized drugs
- are an important source of chemicals that are - created artificially in the laboratory but in
developed into drugs. imitation of a naturally occurring drug.
- an example of a plant drug that is processed using - example: Epinephrine
a synthetic version type of drug is dronabinol
(Marinol), which contains the active ingredient DRUG EVALUATION
delta-9-tetrahydrocannabinol found in marijuana. - After a chemical that might have therapeutic value
These drugs help prevent nausea and vomiting in is identified, it must undergo a series of scientific
cancer patients. tests to evaluate its actual therapeutic and toxic
- obtained from plant drug effects. This process is tightly controlled by the U.S.
1. Aloe Vera Food and Drug Administration (FDA), an agency of
2. Lemon Balm the U.S. Department of Health and Human Services
3. Basil that regulates the development and sale of drugs.
4. Peppermint
5. Marigold 1. Pre-Clinical Test
6. Lavender - chemicals that may have therapeutic value are
7. Rosemary tested on laboratory animals for two main purposes:
8. Ricinus Communis (1) to determine whether they have the presumed
9. Digitalis purpurea effects in living tissue and (2) to evaluate any
10. Papaver somniferum adverse effects. Animal testing is important because

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unique biological differences can cause very
different reactions to the chemical.

At the end of the preclinical trials, some chemicals

are discarded for the following reasons:
i. The chemical lacks therapeutic activity when used
with living animals.
ii. The chemical is too toxic to living animals to be
worth the risk of developing into a drug.
iii. The chemical is highly teratogenic (causing
adverse effects on the fetus). FIGURE 1.3 Phases of drug development.
iv. The safety margins are so small that the
chemical would not be useful in the clinical setting. 6. Phase IV Studies
- After a drug is approved for marketing, it enters a
2. Phase I Studies phase of continual evaluation or phase IV study.
- uses human volunteers to test the drugs. - Prescribers are obligated to report to the FDA any
- The volunteers are fully informed of possible risks untoward or unexpected adverse effects associated
and may be paid for their participation. with drugs they are using, and the FDA continually
- Women of childbearing potential are sometimes evaluates this information.
not good candidates for phase I studies because the
chemicals may exert unknown and harmful effects LEGAL REGULATION OF DRUGS
on a woman’s ova. - The FDA regulates the development and sale of
drugs.
3. Phase II Studies
Table 1.5 Federal Legislation Affecting the Clinical Use of Drugs
- allows clinical investigators to try out the drug in
patients who have the disease that the drug is
designed to treat.
- Patients are told about the possible benefits of the
drug and are invited to participate in the study.

4. Phase III Studies

- involves the use of the drug in a vast clinical
market.
- Prescribers are informed of all the known
reactions to the drug and precautions required for its
safe use.
- Prescribers then evaluate the reported effects to
determine whether they are caused by the disease or
by the drug.

5. Food and drug administration approval

- Drugs that finish phase III studies are evaluated by
the FDA, which relies on committees of experts
familiar with the specialty area in which the drugs
will be used. Only those drugs that receive FDA
committee approval may be marketed.

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FOOD AND DRUG ADMINISTRATION quantities of certain schedule V drugs may be
PREGNANCY CATEGORIES purchased without a prescription directly from a
pharmacist. The purchaser must be at least 18 years
Category A: Adequate studies in pregnant women of age and must furnish suitable identification. All
have not demonstrated a risk to the fetus in the first such transactions must be recorded by the
trimester of pregnancy, and there is no evidence of dispensing pharmacist.
risk in later trimesters.
Category B: Animal studies have not demonstrated GHB or Gamma Hydroxybutyrate (C4H8O3)
a risk to the fetus but there are no adequate studies - is a central nervous system (CNS) depressant that
in pregnant women, or animal studies have shown is commonly referred to as a “club drug” or “date
an adverse effect, but adequate studies in pregnant rape” drug.
women have not demonstrated a risk to the fetus - is abused by teens and young adults at bars,
during the first trimester of pregnancy, and there is parties, clubs, and “raves” (all-night dance parties),
no evidence of risk in later trimesters. and is often placed in alcoholic beverages.
Category C: Animal studies have shown an
adverse effect on the fetus but there are no adequate LSD
studies on humans; the benefits from the use of the - a synthetic crystalline compound, lysergic acid
drug in diethylamide, that is a potent hallucinogenic drug.
pregnant women may be acceptable despite the
potential risks, or there are no animal reproduction Ketamine
studies and no adequate studies in humans. - is a synthetic compound used as an anesthetic and
Category D: There is evidence of human fetal risk, analgesic drug and also (illicitly) as a hallucinogen
but the potential benefits from the use of the drug in
pregnant women may be acceptable despite its Generic Drugs
potential risks. - drugs sold by their chemical
Category X: Studies in animals or humans name; not brand (or trade) name products
demonstrate fetal abnormalities or adverse
reactions; reports indicate evidence of fetal risk. Orphan Drugs
The risk of use in a pregnant woman clearly - drugs that have been discovered but are not
outweighs any possible benefit. available for use by those who could benefit from
them, usually because they are not financially
DRUG ENFORCEMENT AGENCY SCHEDULES profitable
OF CONTROLLED SUBSTANCES
Over-The-Counter Drugs
Schedule I (C-I): High abuse potential and no - drugs that are available without a prescription for
accepted medical use (heroin, marijuana, LSD) self-treatment of a variety of complaints
Schedule II (C-II): High abuse potential with
severe dependence liability (narcotics,
amphetamines, and barbiturates)
Schedule III (C-III): Less abuse potential than
schedule II drugs and moderate dependence liability
(nonbarbiturate sedatives, nonamphetamine
stimulants, limited amounts of certain narcotics)
Schedule IV (C-IV): Less abuse potential than
schedule III and limited dependence liability (some
sedatives, antianxiety agents, and non-narcotic
analgesics)
Schedule V (C-V): Limited abuse potential.
Primarily small amounts of narcotics
(codeine) are used as antitussives or antidiarrheals.
Under federal law, limited

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