Ncm 106

pharmacology theory
1st semester SY 2020-2021
NCM 106 LECTURE/THEORY
• 3 units lecture
• COURSE DESCRIPTION:
This course deals with the pharmacodynamics,
pharmacokinetics, clinical/therapeutic uses and toxicology of
drugs. Emphasis is given on how a drug works to anticipate when
giving a drug to a patient are of paramount importance since
nursing responsibilities include administering drugs, assessing
drug effects, intervening to make a drug more tolerable, and
providing teaching about drugs and the drug regimen.
• PRE-REQUISITE:
Math 1, Biochemistry, Anatomy & Physiology, Microbiology
UC-PVM
• PHILOSOPHY: UC believes that education is the
foundation of a progressive nation in the rearing
of the youth towards civil efficiency and the
development of moral character that the benefits
of higher education should be made accessible
to everyone who deserves it.
• VISION: UC envisions itself as a community of
scholars aggressively involved in the pursuit of
knowledge who help preserve Filipino Culture
and values to act positively by training them to
think critically and creatively.
• MISSION: UC’s mission is to provide functional
knowledge and skills, dynamic interaction and
leadership in various disciplines for a better
quality of life.
Why is the study of
Pharmacology important for
nurses?
You are embarking on an exciting journey of discovery as you
begin or continue your study of pharmacology. Much of what
you learning will apply to your personal and family life as well as
your professional life as a nurse.

The purpose of this subject is to help you learn about medicines

and the why, what, how, when, and where they are used in daily
life.
Bon voyage!!
Activity 1
Instruction:
1. Kindly do research on the following
2. Handwritten, DO NOT ENCODE, may use a notebook, coupon bond or pad paper
3. to be submitted before the end of the day (11:59PM)
4. take a picture/scan the output and send to the group chat
5. write your name (Family Name, First Name, MI) and ID number in every page of
your work

• A. History of Pharmacology in a timeline

• B. Sources of Drugs
• C. Phases of Drug Development or Trails
• D. Legal Legislations of Drugs here in the Philippines
• E. Sources of Drug Information
• F. Discuss Pharmacodynamics and Pharmacokinetics
If you will become a drug
what would you be and
why?
 Introduction to Nursing Pharmacology
• Pharmacology is the study of chemicals—drugs—on living tissues and how
these chemicals help diagnose, treat, cure, and prevent disease or correct the
pathophysiology of living tissues.
The term pharmacology is derived from two Greek words: pharmakon,
the Greek word for drugs, and logos, the Greek word for science.
Deals with the study of drugs and their actions on living
organisms. Clayton et al, 2007
The study of biological effects of chemicals. Karch, 2013.
Introduction to Nursing Pharmacology

• Drugs are chemicals that are introduced into the body to cause some sort of
change.
• Derived from the Dutch term droog meaning dry
• are chemical substances that have an effect on living organisms.
• Therapeutic drug/medicine substances that can cure or arrest disease, relieve
symptoms, ease pain and provide other benefits. It includes essential vitamins
and minerals that may be given to correct deficiency diseases.
• used in the prevention or treatment of disease.
• Drug therapy, also called pharmacotherapy, is the use of drugs to prevent,
diagnose, or treat signs, symptoms, and disease processes.
THERAPEUTIC METHODS- Approaches to
Therapy
1. Drug Therapy/Pharmacotherapy treatment with drugs. is the use of
drugs to prevent, diagnose, or treat signs, symptoms, and disease
processes.
2. Diet Therapy treatment by diet.
• Low salt for CVD patients
3. Physiotherapy treatment with natural physical forces like water, light
and heat.
4. Psychological Therapy Identification of stressors and methods to reduce
or eliminate stress and /or the use of drugs.
• The nurse is in a unique position regarding drug
therapy because nursing responsibilities include
the following:
• Administering drugs
• Assessing drug effects
• Intervening to make the drug regimen more
tolerable
• Teaching clients and caregivers about accurate
administration of medications, nonpharmacologic
treatments to use with or instead of pharmacologic
treatments, and when to contact a health care
provider.
• Monitoring the overall patient care plan to prevent
medication errors
SOURCES OF DRUGS
NATURAL AND SYNTHETIC

1. NATURAL
a. plants
b. animals
c. inorganic compounds.
Sources of Drugs
Natural
a. Plants
A number of plants have medicinal qualities and have
been used for centuries as natural remedies for injuries
and illnesses. Pharmaceutical firms harvest these plants
and transform them into drugs that have a specific purity
and strength sufficient to treat diseases.
Plants

• Alkaloids
• Glycosides
• Gums
• Resins
• Oils
PLANT PRODUCT

Ricinus communis Seed

Oil
Castor oil (Neolid)

Digitalis purpurea (foxglove Leaves

plant) Dried leaves
Digitalis leaf

Papaver somniferum Unripe capsule

(poppy plant) Juice
Opium (paregoric)
Morphine (Roxanol)
Codeine
Papaverine (Pavabid)
PLANTS
Ricinus communis
• Caster oil (Neolid)
Digitalis purpurea (foxglove plant)

• Digitalis leaf
Papaver somniferum (poppy plant)

• Opium (paregoric)
• Morphine (Roxanol)
• Codeine Papaverine (Pavabid)
Papaver somniferum oil
Willow Tree
aspirin-pain reliever
Sources of Drugs
b. Animals
Byproducts of animals, including humans, are a source for drugs
because they contain hormones that can be reclaimed and given to
patients who need increased hormonal levels to maintain homeostasis.
For example, Premarin is a drug that contains estrogen that is
recovered from mare urine. This is used as hormonal therapy to manage
menopausal symptoms.
Insulin is another hormonal drug that is used to regulate blood
sugar levels in patients with diabetes mellitus. Insulin can be recovered
from humans using DNA technology
Animals

• Hormones
• Oils
• Enzymes
• Vaccines
Sources of Drugs
c. Inorganic Compounds
Salts of various chemical elements can have therapeutic effects in the
human body. Aluminum, fluoride, iron, and even gold are used to treat
various conditions.
Our body requires trace elements of minerals in order to maintain
homeostasis.
Minerals are inorganic crystal substances that are found naturally on earth.
Patients lacking an adequate level of these materials may take specific
mineral based drugs to raise the level of minerals.
For example, an iron supplement is a common mineral-based drug that is
given to patients who suffer iron deficiency, a condition which can lead to
fatigue. Iron is a natural metal that is an integral part of body proteins such
as
hemoglobin that carries oxygen throughout the body. Minerals are
obtained from
animal and plant sources.
Minerals
• Metallic

• Non-metallic
Elements Used for Their Therapeutic Effects

ELEMENT THERAPEUTIC USE

Aluminum Antacid to decrease gastric acidity

Management of hyperphosphatemia
Prevention of the formation of phosphate urinary stones

Fluorine Prevention of dental cavities

(as fluoride) Prevention of osteoporosis

Gold Treatment of rheumatoid arthritis

Iron Treatment of iron deficiency anemia

Sources of Drugs
Synthetic/ Chemical Derivatives
Great strides in molecular biology and biochemistry enable scientists to create
manmade drugs referred to as synthetic drugs. A synthetic drug is produced
using chemical synthesis, which rearranges chemical derivatives to form a
new compound.
Sulfonamides are a common group of synthesized drugs that are used to treat
many infections including bronchitis, pneumonia, and meningitis. Sulfonamides
are designed to prevent the growth of bacteria.
2. SYNTHETIC SOURCES
-Produced in the laboratory, genetically engineered to alter
bacteria to produce chemicals that are therapeutic and
effective.
- created using man-made chemicals rather than
natural ingredients.
- Example: arterolane- the experimental anti-malaria drug.
• The general stages of synthetic drug discovery are similar
to those of natural drug discovery.
• The main difference between the two is the origin of the
lead compounds. In natural drug discovery, the lead
compounds come from natural sources (i.e. plants), while
in synthetic drug discovery, the lead compounds are
typically generated in labs by combinatorial chemistry.
https://www.cancerquest.org/patients/discovery-and-
development-drugs
Sources of Drugs
 Drug Evaluation

a) Preclinical Trials
In preclinical trials, chemicals that may have therapeutic value are tested on
laboratory animals for two main purposes:
(1) to determine whether they have the presumed effects in living tissue
and
(2) to evaluate any adverse effects.
Reasons why some chemicals are discarded
for the next phase
• The chemical lacks therapeutic activity when used with living animals.
• The chemical is too toxic to living animals to be worth the risk of developing into
a drug.
• The chemical is highly teratogenic (causing adverse effects to the fetus).
• The safety margins are so small that the chemical would not be useful in the
clinical setting.
 Drug Evaluation
b) Phase 1 Studies (i)
A phase I study uses human volunteers to test the drugs.
These studies are more tightly controlled than preclinical trials and are performed
by specially trained clinical investigators.
The volunteers are fully informed of possible risks and may be paid for their
participation. Usually, the volunteers are healthy, young men.
Reasons why some chemicals are discarded
for the next phase
• They lack therapeutic effect in humans.
• They cause unacceptable adverse effects.
• They are highly teratogenic.
• They are too toxic.
• Some chemicals move to the next stage of testing despite undesirable effects. Ex.
minoxidil (Loniten), an antihypertensive was found to effectively treat malignant
hypertension, but it caused unusual hair growth on the palms and other body
areas.
• However, because it was so much more effective for treating malignant
hypertension at the time of its development than any other antihypertensive
drug, it proceeded to phase II studies. (Now, its hair-growing effect has been
channeled for therapeutic use into various hair-growth preparations such as
Rogaine.)
 Drug Evaluation

c) Phase 2 Studies (ii)

A phase II study 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.
Those who consent to participate are fully informed about possible risks and are
monitored very closely, often at no charge to them, to evaluate the drug’s effects.
Performed in hospitals, clinics, and doctors’ offices.
Reasons why some chemicals are discarded
for the next phase

• It is less effective than anticipated.

• It is too toxic when used with patients.
• It produces unacceptable adverse effects.
• It has a low benefit-to-risk ratio, meaning that the therapeutic
benefit it provides does not outweigh the risk of potential adverse
effects that it causes.
• It is no more effective than other drugs already on the market,
making the cost of continued research and production less attractive
to the drug company.
 Drug Evaluation
c) Phase 3 Studies (iii)
A phase III study involves 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 Role:
1. They are informed of all the known reactions to the drug and precautions required for its safe
use.
2. They need to observe patients very closely, monitoring them for any adverse effects.
3. They keep tract on patient’s journals and record any symptoms they experience.
4. They evaluate the reported effects to determine whether they are caused by the disease or by
the drug.
5. They collaborate with the drug company that is developing the drug and then, collected
information is shared with the FDA.
HOW A DRUG IS REMOVED FROM FURTHER
STUDY?
1. A drug that produces unacceptable adverse effects or
unforeseen reactions. In some cases, the FDA may have
to request that a drug be removed from the market.
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.
• An approved drug is given a brand name (trade name) by the pharmaceutical
company that developed it.
• The generic name of a drug is the original designation that the drug was given
when the drug company applied for the approval process.
• Chemical names are names that reflect the chemical structure of a drug.
• The entire drug development and approval process can take 5 to 6 years.
• The FDA regards public safety as primary in drug approval, so the process
remains strict; however, it can be accelerated in certain instances involving the
treatment of deadly diseases
 Drug Evaluation
c) Phase 4 Studies (iv)
After a drug is approved for marketing, it enters a phase of continual
evaluation, or phase IV study.
Prescribers are obligated to report to the FDA any untoward or unexpected
adverse effects associated with drugs they are using, and the FDA continually
evaluates this information.
Some drugs cause unexpected effects that are not seen until wide distribution
occurs. Sometimes, those effects are therapeutic.
For example, patients taking the antiparkinsonism drug amantadine
(Symmetrel) were found to have fewer cases of influenza than other patients,
leading to the discovery that amantadine is an effective antiviral agent
In other instances, the unexpected effects are dangerous.
In 1997, the diet drug dexfenfluramine (Redux) was removed from the
market only months after its release because patients taking it developed
serious heart problems.
REVIEW: STAGES OF DRUG DEVELOPMENT/DRUG
EVALUATION
1. Preclinical Trials- animal testing
2. Phase I- Human volunteers are used to test the drug.
3. Phase II- The drug is tried in patients who have the disease that the drug is
designed to treat.
4. Phase III- Use of the drug in a vast clinical market. Only those drugs that
receive FDA committee approval may be marketed.
5. Phase IV- continual evaluation. ei. Amantadine ( Symmetrel) for
antiparkinsonism is effective antiviral agent for flu.
NOTE: The entire drug development and approval process can take 5-6 years, or
as long as 13 years and more.
Memory Jogger:
An approved drug is given a brand name/trade name by the pharmaceutical
company that develop it. This is usually italicized.
Just for Laughs
ACTIVITY 2
Instruction:
1. Handwritten, DO NOT ENCODE, may use a notebook, coupon bond or pad paper
2. to be submitted before the end of the day (11:59PM)
3. take a picture/scan the output and send to the group chat
4. write your name (Family Name, First Name, MI) and ID number in every page of your work
5. to be submitted on our GC

• Mr. Gatan Labi, a Filipino living in Baguio is in favor of the

legalization of the marijuana plant because in his conviction this
plant can cure many illnesses. He testifies that this plant is an
effective analgesic. However, before he could endorse it to the
public for use, he knows that this plant will have to undergo a
process. In 150 words, discuss the stages of drug development.
ACTIVITY 3
Instruction:
1. Handwritten, DO NOT ENCODE, may use a notebook, coupon bond or pad
paper
2. to be submitted before the end of the day (11:59PM)
3. take a picture/scan the output and send to the group chat
4. write your name (Family Name, First Name, MI) and ID number in every page of
your work
5. to be submitted on our GC

• Compare and contrast the difference and

similarities of steps in drug development and
vaccine development
• If you are given the chance to develop a new
drug, what would be called and what would it
be for and why?
LEGAL REGULATION OF DRUGS

A. Safety During Pregnancy

Why is there a need for Pregnancy Category?
1. Required by the FDA as part of the standards for testing and safety for
each new drug.
2. The categories indicate a drug’s potential or actual teratogenic effects,
especially in the nervous system.
3. Offers guidelines for use of that particular drug in pregnancy.
NOTE: In cases in which a drug is needed, it is recommended that the
drug of choice be one for which the benefit outweighs the potential risk.
Food and Drug Administration
Pregnancy Categories
5 Categories
1. Category A: Adequate studies in pregnant women have not
demonstrated a risk to the fetus in the first trimester of pregnancy,
and there is no evidence of risk in later trimesters.
2. Category B: Animal studies have not demonstrated a risk to the
fetus but there are no adequate studies in pregnant women, or
animal studies have shown an adverse effect, but adequate studies
in pregnant women have not demonstrated a risk to the fetus
during the first trimester of pregnancy, and there is no evidence of
risk in later trimesters.
3. Category C: Animal studies have shown an adverse effect on the fetus but there
are no adequate studies in humans; the benefits from the use of the drug in
pregnant women may be acceptable despite its potential risks, or there are no
animal reproduction studies and no adequate studies in humans.
4. Category D: There is evidence of human fetal risk, but the potential benefits from
the use of the drug in pregnant women may be acceptable despite its potential
risks.
5. Category X
- Studies in animals or humans demonstrate fetal abnormalities or
adverse reaction; reports indicate evidence of fetal risk.
- The risk of use in a pregnant woman clearly outweighs any possible
benefit.

NOTE: Regardless of the designated Pregnancy Category or presumed

safety, no drug should be administered during pregnancy unless it is
clearly needed.
 DRUG PREGNANCY
CATEGORY
1. Amoxicillin B
2. Ascorbic Acid A
3. Lipitor X
4. Thalidomide X
5. Multivitamins A
6. N-acetylcysteine B
7. Aspirin D
8. Captopril D
9. Clonidine B
10. Gentamycin D
B. The Controlled Substances

What is the Controlled Substances Act of 1970?

• This regulates the manufacturing, distribution, and
dispensing of drugs that are known to have abuse
potential.
• classified drugs as to their potential for abuse;
provided strict controls over the distribution, storage,
and use of these drugs.
The Controlled Substance Act of 1970.

- Designed to improve the administration and regulation of

manufacturing, distributing, and dispensing of drugs that have
been found necessary to be controlled.
Who is responsible for the enforcement of these regulations?
- The Drug Enforcement Administration (DEA) was organized to
enforce the Controlled Substances Act, gather intelligence, and
train and conduct research in the area of dangerous drugs and
drug abuse.
• The DEA implements the CSA and may prosecute violators of these
laws at both the domestic and international level.
The Controlled Substance Act of 1970.

Why Act of 1970?

• The CSA was signed into law by President Richard Nixon on October
27, 1970.
Controlled Substance Act
5 Schedules and their Criteria
I. Schedule I (C-1)
1. A high potential for abuse
2. No currently accepted medical use in the United States
3. A lack of accepted safety for use under medical supervision
Examples: lysergic acid diethylamide (LSD)
marijuana, STP, heroin, hashish
Controlled Substance Act
5 Schedules and their Criteria
2. Schedule II (C-2)
1. A high potential for abuse
2. A currently accepted medical use in the United States.
3. An abuse potential that may lead to severe psychological or
physical dependence. (no refill)
Examples: secobarbital, pentobarbital, amphetamines,
morphine, meperidine, methadone, methyphenidate
Controlled Substance Act
5 Schedules and their Criteria
3. Schedule III (C3)
1. A high potential for abuse, but less so than drugs in
Schedules I and II
1. A high potential for abuse, but less so than drugs in
Schedules I and II
3. An abuse potential that may lead to moderate or low
physical dependence or high psychological dependence
Examples: Empirin with codeine, Lortab, Fiorenal, Tylenol with
codeine
Controlled Substance Act
5 Schedules and their Criteria
4. Schedule IV (C-4)
1. A low potential for abuse, compared with those on Schedule III
2. A currently accepted medical use in the United States
3. An abuse potential that ay lead to limited physical or
psychological dependence, compared with drugs in Schedule III
Examples: phenobarbital propoxyphene, chloral hydrate,
paraldehyde, chlordiazepoxide, diazepam, flurazepam, temazepam
Controlled Substance Act
5 Schedules and their Criteria
5. Schedule V (C-5)
1. A low potential for abuse, compared wit those on
Schedule IV
2. A currently accepted medical use in the United States
3. An abuse of limited physical or psychological dependence
liability, compared with drugs in Schedule IV. Because abuse
potential is low, a prescription may not be required.
Examples: Lomotil, Robitussin A-C
Schedule I Schedule II Schedule III Schedule IV Schedule V
1. A high potential for 1. A high potential for 1. A high potential for 1. A low potential for 1. A low potential for
abuse abuse abuse, but less so abuse, compared with abuse, compared wit
than drugs in those on those on
Schedules I and II Schedule III Schedule IV

2. No currently 2. A currently 2. A currently 2. A currently 2. A currently

accepted medical use accepted medical use accepted medical use accepted medical use accepted medical use
in the United States in the United States. in the United States in the United States in the United States

3. A lack of accepted 3. An abuse potential 3. An abuse potential 3. An abuse potential 3. An abuse of limited
safety for use under that may lead to that may lead to that ay lead to limited physical or
medical supervision severe psychological moderate or low physical or psychological
Examples: lysergic or physical physical dependence psychological dependence
acid diethylamide dependence or high psychological dependence, liability, compared
(LSD), marijuana, Examples: dependence compared with drugs with drugs in
STP, heroin, hashish secobarbital, Examples: Empirin in Schedule III Schedule IV. Because
pentobarbital, with codeine, Lortab, Examples: abuse potential is low,
amphetamines, Fiorenal, Tylenol with phenobarbital a prescription may
morphine, codeine propoxyphene, chloral not be required.
meperidine, hydrate, paraldehyde, Examples: Lomotil,
methadone, chlordiazepoxide, Robitussin A-C
Percodan, diazepam,
C. Generic Drugs
• When a drug receives approval for marketing from the FDA, the drug
formula is given a time-limited patent, in much the same way as an
invention is patented.
• The length of time for which the patent is good depends on the type
of chemical involved.
• When the patent runs out on a brand-name drug, the drug can be
produced by other manufacturers.
• Generic drugs are chemicals that are produced by companies
involved solely in the manufacturing of drugs.
• The Philippine government passed the Generics Act of 1988 to
ensure that inexpensive and effective drugs are made available to all
Filipinos. (REPUBLIC ACT NO. 6675)
• UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT
OF 2008 (REPUBLIC ACT NO. 9502)
D. Orphan Drugs
• are drugs that have been discovered but are not
financially viable and therefore have not been
“adopted” by any drug company. Orphan drugs may
be useful in treating a rare disease, or they may
have potentially dangerous adverse effects.
• are often abandoned after preclinical trials or phase
I studies.
The Orphan Drug Act of 1983

• Provided tremendous financial incentives to drug companies to

adopt these drugs and develop them.
• These incentives help the drug company put the drug through
the rest of the testing process.
• These incentives help the drug company put the drug through
the rest of the testing process, even though the market for the
drug in the long run maybe very small.
• According to the US Food and Drug Administration (FDA), an
orphan drug is defined as one "intended for the treatment,
prevention or diagnosis of a rare disease or condition, which is
one that affects less than 200,000 persons in the United States."
E. Over-the-Counter Drugs
• OTC drugs are products that are available without prescription for self-
treatment of a variety of complaints.
• Some of these agents were approved as prescription drugs but later were
found to be very safe and useful for patients without the need of a
prescription.
• Some were not rigorously screened and tested by the current drug
evaluation protocols because they were developed and marketed before
the current laws were put into effect.
• Many of these drugs were “grandfathered” into use because they had been
used for so long. The FDA is currently testing the effectiveness of many of
these products and, in time, will evaluate all of them. Karch, 2013.
 Warning for OTC drug use
Although OTC drugs have been found to be safe when taken as directed,
nurses should consider several problems related to OTC drug use:
• Taking these drugs could mask the signs and symptoms of underlying disease, making
diagnosis difficult.
• Taking these drugs with prescription medications could result in drug interactions and
interfere with drug therapy.
• Not taking these drugs as directed could result in serious overdoses.
SCRIPT: Many patients do not consider OTC drugs to be medications
and therefore do not report their use. Nurses must always include
specific questions about OTC drug use when taking a drug history and
should provide information in all drug-teaching protocols about
avoiding OTC use while taking prescription drugs or checking with the
health care provider first if the patient feels a need for one of these
drugs.
DRUG NOMENCLATURE
Chemical name of a drug
• The chemical name is the most meaningful to the chemist. By means of the
chemical name, the chemists understands exactly the chemical constitution of the
drug and the exact placing of its atoms or molecular groupings.
• Names that reflect the chemical structure of a drug.
Generic name (nonproprietary name of a drug)
- The generic name, or common name is named to a drug before it becomes
official.
- Is the original designation that the drug was given when the drug company applied
for the approval process.
- The first letter of the generic name is not capitalized.
- It is provided by an official body— ex. the United States Adopted Names (USAN)
Council, which is an organization sponsored by the US Pharmacopeial Convention,
the American Medical Association, and the American Pharmaceutical Association.
Brand name/ Trademark/ Proprietary name/ Registered name
- Developed by the company requesting approval for the drug and identifies it as its’
exclusive property.
- This is followed by the symbol ®. This indicates that the name is approved and
registered and that use is restricted to the owner of the drug, who is usually the
manufacturer or the pharmaceutical company that develop it.
- The first letter is capitalized. The word is Italicized.
Generic name BRAND NAME Chemical Name

metformin GLUCOPHAGE N-dimethylimidodicarbonimidic diamide

hydrochloride
glipizide GLUCOTROL 1-cyclohexyl-3-[[p-[2-(5-
methylpyrazinecarboxamido)
ethyl]phenyl]sulfonyl]urea
paracetamol acetaminophen Tylenol N-acetyl-p-aminophenol
ibuprofen Motrin (RS)-2-(4-(2-
methylpropyl)phenyl)propanoic acid
Acetylsalicylic acid Aspirin 2-acetoxybenzoic acid
azithromycin Zithromax (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-
13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-
α-L-ribo-hexopyranosyl)oxy]-2-ethyl-
3,4,10-trihydroxy-3,5,6,8,10,12,14-
heptamethyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-β-D-xylo-
hexopyranosyl]oxy]-1-oxa-6-
azacyclopentadecan-15-one
 Property of Drugs:
• A. Purity – Completely pure drugs are rarely attainable. Pure drugs contain
only one chemical agent, but additives may be needed to facilitate
formulation or manipulate absorption. Environmental and extraneous
substances may be present in certain quantities and types.
• B. Potency – The drug’s potency, or strength, depends on the
concentration of active drug in the medicinal preparation.
• C. Bioavailability – The drug’s bioavailability is measure of the rate and
extent of drug transfer from its administration site to the systemic
circulation.
• D. efficacy – a drug’s efficacy is its effectiveness in promoting desirable
clinical changes. Objective measures are rarely available, and data are
interpreted subjectively. Efficacy of therapeutics is rated by the National
Council of the National Academy of Sciences for the FDA using the
following scale:
• Ineffective- no substantial evidence of effectiveness
 Property of Drugs:
• Ineffective as a fixed combination- not effective in fixed dosage combinations
for reasons of safety or because one or more components lack substantial evidence
of effectiveness.
• Possibly effective- effectiveness might be shown eventually, but at the present
time shows little evidence of effectiveness.
• Effective- substantial evidence of effectiveness
• Effective but- effective with qualification or restriction until completion of further
studies.
E. Safety/Toxicity
1. All chemicals are toxic to some degree.
2. The safety of the drug is measured by the incidence and severity of adverse reactions.
3. Safety is determined by the degree between therapeutic and toxic dosages.
4. Complete safety cannot be determined regardless of testing before release of a drug.
DRUG CLASSIFICATIONS
1. According to the BODY SYSTEM they affect (ei. drugs affecting the
CNS, Cardiovascular, G.I.)
2. THERAPEUTIC USE or CLINICAL INDICATIONS (ei. antacids,
antibiotics, antihypertensive, diuretics, laxatives).
3. PHYSIOLOGIC or CHEMICAL ACTION (ei. cholinergic, anticholinergics,
beta adrenergic blockers, calcium channel blockers).
4. PRESCRIPTION or NONPRESCRIPTION/OTC drugs
“Rx only or “Caution: Federal Law Prohibits Dispensing Without a
Prescription”
5. Illegal drugs/Recreational Drugs- non therapeutic purposes, have not
received approval for use by the FDA.
SOURCES OF DRUG INFORMATION
1. Drug Labels
• Drug labels have specific information that identifies a specific drug.
• Ex., the brand and generic names for the drug, the drug dosage, the
expiration date, and special drug warnings. Some labels also indicate
the route and dose for administration.
2. Package Inserts
• The package insert contains all of the chemical and study information that led to
the drug’s approval. Package inserts sometimes are difficult to understand and
are almost always in very small print, making them difficult to read. The FDA Web
site, www.fda.gov, is a good resource for finding the prescribing information or
package insert for most drugs.
3. Reference Books
• A wide variety of reference books are available for drug information.
• Ex. The Physician’s Desk Reference (PDR)
• American Medical Association (AMA) Drug Evaluations
• Lippincott Nursing Drug Guide (LNDG)
• North American Nursing Diagnosis Association (NANDA) Handbook
4. Journals
• - The Medical Letter - is a monthly review of new drugs, drug classes,
and specific treatment protocols.
• - The American Journal of Nursing offers information on new drugs,
drug errors, and nursing implications.
5. Internet Information
Government Sites
• Agency for Health Care Research and Quality: http://www.ahcpr.gov
• CancerNet (National Cancer Institute): http://www.cancer.gov
• Centers for Disease Control: http://www.cdc.gov
• Drug Formulary: http://www.intmed.mcw.edu/drug.html
• Food and Drug Administration: http://www.fda.gov
PHARMACOPEIA
( Book, Repertoire of Drugs)
1. The United States Pharmacopeia (USP)/National Formulary (NF)
2. European Phamacopeia
3. The International Pharmacopeia
4. The British Pharmacopeia
5. The British Pharmaceutical Codex
6. The Canadian Formulary
 Executive Order No. 302: Declaring and Adopting the
Philippine Pharmacopeia as the Official Book of Standards
and Reference for Pharmaceutical Products and Crude
Plant Drugs in the Philippines
• WHEREAS, it is State Policy under Article II, Section 15 of the 1987
Constitution to "protect and promote the right to health of the people and
instill health consciousness among them";
• WHEREAS, the 1987 Constitution also provides in Article XIII, Section 12,
that: "The State shall establish and maintain an effective food and drug
regulatory system and undertake appropriate health manpower
development and research, responsive to the country’s health needs and
problems";
Declaring and Adopting the Philippine
Pharmacopeia as the Official Book of Standards
and Reference for Pharmaceutical Products and
Crude Plant Drugs in the Philippines

• WHEREAS, a national pharmacopeia that adequately

establishes standards for drug/drug products and crude
drugs available for commerce in the Philippines is
essential to the attainment of an effective regulatory and
health care delivery systems and addresses the
foregoing constitutional mandates;
• NOW, THEREFORE, I GLORIA MACAPAGAL-ARROYO,
President of the Philippines, do hereby order:
• SECTION 1. The Philippine Pharmacopea (PP) 1st edition
April 2004 and any supplement thereto, is hereby
declared and adopted as the official book of the
standards and references for the determination of the
identity, purity, and quality of pharmaceutical products
and crude plant drugs in the Philippines.
 Declaring and Adopting the Philippine
Pharmacopeia as the Official Book of Standards
and Reference for Pharmaceutical Products and
Crude Plant Drugs in the Philippines
• SECTION 2. For pharmaceutical products and crude plant drugs that are
not listed in the PP, reference maybe made to the latest editions of United
States Pharmacopeia/National Formulary (USP/NF), Japanese
Pharmacopeia (JP), British Pharmacopeia (BP) European Pharmacopeia
(EP), and International Pharmacopeia (IP) and other books of standards
and references as maybe recognized and adopted by the Bureau of Food
and Drugs from time to time.
 Declaring and Adopting the Philippine
Pharmacopeia as the Official Book of Standards
and Reference for Pharmaceutical Products and
Crude Plant Drugs in the Philippines
• SECTION 3. All orders, issuances, rules and regulations, or parts thereof
inconsistent with this Executive Order are hereby repealed or modified
accordingly.

• SECTION 4. This Executive Order shall take effect fifteen (15) days after
publication in the Official Gazette.
 Declaring and Adopting the Philippine
Pharmacopeia as the Official Book of Standards
and Reference for Pharmaceutical Products and
Crude Plant Drugs in the Philippines
Done in the City Manila this 29th day of March, in the year
of Our Lord, two thousand and four.

(Sgd.) GLORIA MACAPAGAL-ARROYO

By the President:

(Sgd.) ALBERTO G. ROMULO

Executive Secretary
DRUG LEGISLATION

Protects the consumer and the patient from

unfounded claims of the manufacturers and
advertisers claims about the benefits of their
products.
LEGAL REGULATION OF DRUGS

• In the 1930’s, the drug “elixir of sulfanilamide”

was distributed in a vehicle of ethylene glycol
that had never been tested in humans and
hundreds of people died and many others
became very ill. This led to the Federal Food,
Drug and Cosmetic Act of 1938, which gave the
FDA power to enforce standards for testing drug
toxicity and monitoring labeling.
1938 Federal Food, Drug and Cosmetic Act

• Mandated tests for drug toxicity and provided means for recall
of drugs; established procedures for introducing new drugs;
gave Food and Drug Administration (FDA) the power of
enforcement
KEFAUVER- HARRIS ACT OF 1962
• In 1962, a drug Thalidomide used as a sleeping aid by pregnant women
resulted in limb deformities to newborns.
• 1962 Kefauver Harris Act
• Tightened control over the quality of drugs; gave FDA regulatory power
over the procedure of drug investigations; stated that efficacy as well as
safety of drugs had to be established.
SUMMARY

• ■ Drugs are chemicals that are introduced into the body to bring about
some sort of change.
• ■ Drugs can come from many sources: plants, animals, inorganic
elements, and synthetic preparations.
• ■ The FDA regulates the development and marketing of drugs to
ensure safety and efficacy.
SUMMARY: STAGES OF DRUG DEVELOPMENT
1. Preclinical trials: initial trial of a chemical thought to have therapeutic
potential; uses laboratory animals, not human subjects.
2. Phase I study: a pilot study of a potential drug done with a small
number of selected, healthy human volunteers.
3. Phase II study: a clinical study of a proposed drug by selected
physicians using actual patients who have the disorder the drug is
designed to treat; patients must provide informed consent.
4. Phase III study: use of a proposed drug on a wide scale in the clinical
setting with patients who have the disease the drug is thought to treat.
5. Phase IV study: continual evaluation of a drug after it has been
released for marketing.
SUMMARY
• ■ FDA pregnancy categories indicate the potential or actual
teratogenic effects of a drug.
• ■ DEA controlled-substance categories indicate the abuse potential
and associated regulation of a drug.
• ■ Generic drugs are sold under their generic names, not brand
names; they may be cheaper but in some situations are not
necessarily as safe as brand-name drugs.
SUMMARY
• ■ Orphan drugs are chemicals that have been discovered to have
some therapeutic effect but that are not financially advantageous to
develop into drugs.
• ■ OTC drugs are available without prescription for the self-treatment
of various complaints.
• ■ Information about drugs can be obtained from a variety of
sources, including the drug label, reference books, journals, and
Internet sites.
■ Drugs are chemicals that are introduced into the body to bring about some sort of change.
■ Drugs can come from many sources: plants, animals, inorganic elements, and synthetic
preparations.
■ The FDA regulates the development and marketing of drugs to ensure safety and efficacy.
■ Preclinical trials involve testing of potential drugs on laboratory animals to determine their
therapeutic and adverse effects.
■ Phase I studies test potential drugs on healthy human subjects.
■ Phase II studies test potential drugs on patients who have the disease the drugs are designed
to treat.
■ Phase III studies test drugs in the clinical setting to determine any unanticipated effects or
lack of effectiveness.
■ FDA pregnancy categories indicate the potential or actual teratogenic effects of a drug.
■ DEA controlled-substance categories indicate the abuse potential and associated regulation
of a drug.
■ Generic drugs are sold under their generic names, not brand names; they may be cheaper
but in some situations are not necessarily as safe as brand-name drugs.
■ Orphan drugs are chemicals that have been discovered to have some therapeutic effect but
that are not financially advantageous to develop into drugs.
■ OTC drugs are available without prescription for the self-treatment of various complaints.
■ Information about drugs can be obtained from a variety of sources, including the drug label,
reference books, journals, and Internet sites.
 Activity 4
Instruction:
1. Kindly do research on the following
2. Handwritten, DO NOT ENCODE, may use a notebook, coupon bond or pad paper
3. to be submitted before the end of the day (11:59PM)
4. take a picture/scan the output and send to my email: mmmaspil@uc-bcf.edu.ph
subject: Family Name and Activity Number
5. write your name (Family Name, First Name, MI) and ID number in every page of your work

1. Give 10 example of medications of each pregnancy category and include its

classification and use.
2. Give 5 example of medications of each category of controlled substance and
include its classification and use.
3. Give 10 example of generic medications and include its classification and
use.
4. Research and discuss/summarize on the executive order on the generic drug
signed by President Duterte
5. Give 10 example of orphan medication and include its classification and use.
6. Research and discuss/summarize the law that tackles orphan drugs here in
the Philippines