2. DRUG EVALUATION
Process of classifying drugs as either
therapeutic or non-therapeutic and are
approved by a governing agency
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3. DRUG APPROVAL PROCESS
1. Food and Drug Administration (FDA) - US
Agency in-charge of monitoring the use of drugs as well
as its development.
2. Bureau of Food and Drug Administration (BFAD)
– Philippines
Concerns of these agencies are 2-fold:
Whether the drugs are effective
Whether the drug is safe for human use
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4. Drugs for approval should pass
through
4 Stages of New Drug
Development.
4
5. Stages of New Drug Development
1. Preclinical Study
2. Clinical Study
1. Phase I
2. Phase II
3. Phase III
3. New Drug Application (NDA) review
4. Post Clinical Study
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6. Stages of New Drug Development
1. Preclinical Study
Starts with the discovery, synthesis and
purification of drug
Functions:
To know if with therapeutic value
Safe in animals
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7. Stages of New Drug Development
2. Clinical Study
“testing in humans” stage.
3 phases:
Phase I
○ Tested in small # of healthy volunteers.
○ Initial info on the effects in humans
Phase II
○ Tested in small, selected population (10-150 subjects)
○ To evaluate the therapeutic effect in treating specific disease/pathologic condition.
Phase III
○ More cients (several hundredths-thousands)
○ Provides info on proper dosing and safety.
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8. Stages of New Drug Development
3. New Drug Application (NDA) Review
the drug is submitted to FDA for new drug
application.
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9. Stages of New Drug Development
4. Post Clinical Study
Known as “postmarketing surveilance”
Final stage of drug approval process
It surveys the drug’s harmful effects.
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13. Drug Classifications
2. Physiologic/ Chemical Action
Examples:
1. Beta-adrenergic blockers
○ management of cardiac arrhythmias
○ block the action of epinephrine and norepinephrine
○ Ex. propanolol
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14. Drug Classifications
2. Physiologic/ Chemical Action
Examples:
2. Anticholinergics
○ inhibit parasympathetic nerve impulses
responsible for the involuntary movements of smooth (GI, urinary, etc)
○ Ex. Atropine sulfate
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15. Drug Classifications
2. Physiologic/ Chemical Action
Examples:
3.Cholinergics
○ drug that functions to enhance the effects mediated
by acetylcholine
4. Calcium channel blockers
○ to decrease blood pressure
○ Antiepileptics
○ Ex. Dihydropyridine
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17. Drug Classifications
4. Non-prescription (Non-Ethical) Drugs
Drugs available over the counter
Not requiring any prescription for use
Can be purchased directly by consumer
Used to treat relatively minor problems and conditions
Judged to be safe for used by the consumer without direct medical
supervision
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18. Drug Classifications
5. Illegal Drugs
Use for non-therapeutic purposes.
Also referred as “recreational drugs”
Drugs not approved by FDA/BFAD
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25. #5
Amphetamines
affecting the amount of dopamine and serotonin in the brain
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26. #4
Ecstasy
Psycho therapeutic drug
produces euphoria and a feeling of well being, decreased levels of fear
and anxiety and a physical stimulant and sensational effect in users.
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31. Drug Standards and Legislation
Drug Standards
The United Pharmacopoeia National Formulary (USP NF)
○ the current authoritative source for drug standards (revised every 5 years by a
group of experts in nursing: pharmaceutics, pharmacology, chemistry, and
microbiology)
○ Drugs included in the USP-NF have the standards for:
therapeutic use
client safety
quality
purity
strength
packaging
dosage form
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32. Drug Standards
International Pharmacopoeia – first published in 1951
by WHO
○ provides basis for standards in strength and
composition of drugs worldwide
○ published in English, Spanish, and French (revised
every 5 years)
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33. FEDERAL LEGISLATION
Purpose – to ensure safety (drugs that are impure, toxic, ineffective, or not
tested before public sale)
do not include drug effectiveness and drug safety
1938: Food, Drug, and Cosmetic Act
empowered a governing body—the Food and Drug Administration (FDA) and
Cosmetic Act of 1938
Purpose: to monitor and regulate the manufacture and marketing of drugs
FDA’s responsibility is to ensure that all drugs are tested for harmful effects,
have labels with accurate information, drug literature that explains adverse
effects
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34. FEDERAL LEGISLATION
1952: Durham-Humphrey Amendment
amendment to the FDA and Cosmetic Act of 1938
distinguished between drugs that be sold with or without
prescription and those that should not be refilled without a new
prescription (ex. Narcotics, hypnotics, or tranquilizers; must be
labeled)
It also specified that all other drugs are approved for use to be
considered non-prescription drugs
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35. 1962: Kefauver-Harris Amendment
tightened controls on drug safety, especially experimental drugs, and required
that adverse reactions and contraindications must be labeled and included in
the literature
it added requirements that both prescription and non-prescription drugs be
shown to be effective as well as safe
thalidomide tragedy1950 – pregnant European women who took the
sedative-hypnotic thalidomide during their first trimester of pregnancy gave
birth to infants with extreme limb deformities.
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36. A German pharmaceutical company, Chemie Grünenthal at Stolberg,synthesized thalidomide in
West Germany in 1953.
It had accidentally been discovered during a search for cheap antibiotics, but was soon marketed
with little evidence as a sedative.
In 1961 the drug was found to be harmful to the unborn children of pregnant women
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37. 1978: Drug Regulation Reform Act
This reform act shortened the time in which new drugs could be
developed and marketed.
1992: Drug Relations Act
The regulations were changed to increase the approval rates of drugs
used to treat AIDS and cancer
The pharmaceuticals pay a users fee at the time they file the
application for the new drugs (for FDA approval process).
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38. 1997: The Food and Drug Administration Modernization Act
5 Provisions included in this act:
Review and use of new drugs is accelerated.
Drugs can be tested in children before marketing.
Clinical trial data is necessary for experimental drug for serious or life-
threatening health conditions.
Drug companies are required to give information on “off-label” drugs (non-
FDA approved drugs) and their uses and costs
Drug companies that plan to discontinue drug must inform health
professionals and clients at least 6 months before stopping drug production
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39. LEGAL REGULATIONS OF DRUGS
1. Pregnancy Categories
Reviews drug labeling information on
pregnancy and risk effects to the fetus
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40. Drug Pregnancy Categories
CATEGORY A: No risk to fetus. Studies have not shown evidence for fetal harm.
CATEGORY B: No risk in animal studies, and well-controlled studies in pregnant
women are not available. It is assumed there is little to no risk in pregnant
women.
CATEGORY C: Animal studies indicate a risk to the fetus. Controlled studies on
pregnant women are not available. Risk versus benefit of the drug must be
determined.
CATEGORY D: A risk to the human fetus has been proven. Risk versus benefit
of the drug must be determined. It could be used in life-threatening conditions.
CATEGORY X: A risk to the human fetus has been proven. Risk outweighs the
benefits and drug should be avoided during pregnancy.
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41. LEGAL REGULATIONS OF DRUGS
2. Controlled Substances
Comprehensive Drug Abuse Prevention and Control Act of 1970 known
as “Controlled Substance Act”
○ To improve the administration and regulation of manufacturing,
distribution, and dispensing of drugs found necessary to be controlled
○ Consist of 5 classifications or schedules of controlled substance
○ The degree of control, the condition of record keeping, and the particular
order form required, and other regulation depends on these
classifications.
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42. LEGAL REGULATIONS OF DRUGS
2. Controlled Substances
Drug Enforcement Administration (DEA)
Organize to enforce the Controlled Substance Act
To gather intelligence, train and conduct research in the
area of dangerous drug and drug abuse
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43. LEGAL REGULATIONS OF DRUGS
3. Generic Drugs
Drug which is produced and distributed without patent
protection.
Drugs which may still have a patent on the formulation but not
on the active ingredient
It must contain the same active ingredients as the original
formulation
Identical/bioequivalent to the brand name counterpart since
these drugs should be identical in dose, strength, route of
administration, safety, efficacy and intended use.
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44. LEGAL REGULATIONS OF DRUGS
4. Orphan Drugs
Drugs that have been discovered but not
financially viable and therefore have not
been “adopted” by any drug company.
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45. Drug Nomenclature
Chemical Name
describes the drug’s chemical structure
Chemical constitution of the drug & the exact placing of its atoms or molecular
groupings.
Generic Name (nonpropriety names)
Common name or non-proprietary name for the drug
○ this name is not owned by any pharmaceutical (drug) company and is
universally accepted
Brand Name or Trade Name (proprietary name)
○ also chosen by the drug company and is usually a registered trademark owned
by that specific manufacturer
○ Uses the symbol ®
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46. Drug Name
Chemical Name:
0-[(2S)-3-mercapto-2-
methylpropionyl]-L-
proline[MW217.29]
Generic Name:
captopril
Trade Name:
Capoten
Official Name:
captopril
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47. Drug Uses
1. Symptomatic treatment.
ANTI-EMETIC DRUGS
2. Preventive drug
helps the body avoid disease.
VACCINES & TOXOIDS
3. Diagnostic drugs
help the physician determine whether a disease is present
4. Curative drugs
eliminate the disease.
ANTICANCER AGENT & ANTIBIOTICS
5. Health maintenance drugs
help the body to function normally.
VITAMINS & MINERALS
6. Contraceptive drugs
prevent pregnancy.
ORAL CONTRACEPTIVES/SPERMICIDAL AGENTS
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48. Properties of Ideal Drug
1. Effectiveness:
A drug that elicits the response it was meant to.
It is the most important property.
No effect=no justification of use (FDA approved with
appropriate experiments).
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49. Properties of Ideal Drug
2. Safety:
Pharmakon = poison in Greek
Safe even at high concentrations and for long periods of administration
(no such thing as a safe drug)
○ Reduced by proper administration (iv, im, sc, etc…)
○ No habit forming aspects
○ No side effects
( excessive dosage of opoid analgesics carries a risk of respiratory failure, cancer
drugs increase infections, aspirin causes gastric ulcer etc…)
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50. Properties of Ideal Drug
3. Selectivity:
One that elicits only the response for which it is given
Selective for specific reaction with no side effects (there is no such thing)
○ Drowsiness can be caused by antihistamines
○ Morning sickness, cramps, and depression can be caused by oral
contraceptives
○ Constipation, urinary hesitance, and respiratory depression can be
caused by morphine
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51. Additional Properties of Ideal Drug (no drug is ideal!)
1. Reversible action
Effects be reversible, i.e., removal/subside w/i
specific time (1/2 life is short but potent during that
time)
Example: General Anesthetic; Contraceptives
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52. Additional Properties of Ideal Drug (no drug is
ideal!)
2. Predictability
Know how patient will respond
3. Ease of Administration
Number of doses should be low and easy to administer
increase compliance & decrease errors
○ Diabetic patient: Multiple daily injection of insulin
○ Intravenous infusion
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53. Additional Properties of Ideal Drug (Continued)
4. Freedom from drug interactions
Should not augment or decrease action of other drugs or have
adverse combined effects
○ Respiratory depression caused by diazepam (Valium), which
is normally minimal, can greatly be intensified by alcohol.
○ Antibacterial effects of Tetracycline can be greatly reduced
by taking iron or calcium supplements
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54. Additional Properties of Ideal Drug (Continued)
5. Low Cost
Easy to afford (especially with chronic illness)
○ Growth hormone (somatrem) costs between $10,000
and $20,000
○ Lifelong medication: hypertension, arthritis, diabetes
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55. Additional Properties of Ideal Drug (Continued)
6. Chemical Stability
No lose of effectiveness with storage
7. Possession of a simple generic name
Easy to remember and pronounce
○ Example: Viagra (sildenafil); Tylenol (acetaminophen)
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56. Because No Drug is Ideal……..
Because no drug is ideal…….
No medications are ideal
No drug is safe
All drugs produce side effects
Drug responses may be difficult to predict
Drugs may be expensive
Drugs may be hard to administer
All members of health care team must exercise care to
promote therapeutic effects and minimize drug induced
harm
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57. Therapeutic Objective
To provide maximum benefit
with minimum harm
Factors that determine Intensity of Response
Administration- dosage size and route
Pharmacokinetic processes
Pharmacodynamics
Individual Variations
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58. Therapeutic Objective
1. Administration- dosage size and route
- Because of errors in administration routes and dosage and at wrong time
there are many discrepancies in what patient gets and could cause more
harm than good
- Errors could be made by pharmacists, physicians, or nurses
- Should give patients complete instruction about their medication and how
to take it
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59. Therapeutic Objective
2. Pharmacokinetic processes
- Determines how much of an administered dose
gets to its sites of action
○ 1) drug absorption
○ 2) drug distribution
○ 3) drug metabolism
○ 4) drug excretion
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61. Therapeutic Objective
(continued)
3. Pharmacodynamics
pharmacodynamic processes determine the type of response and
intensity
Once a drug has reached its site of action, it must first bind to its specific
target site at (RECEPTOR)
Receptor
may be a chemical, a protein on a cell or in blood or tissue spaces, or on a
bacteria or virus
Ex. heparin, antibody, leukotriene receptor (new), penicillin, etc
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62. Therapeutic Objective
(continued)
3. Pharmacodynamics
Series of events that result in response such as inhibition of:
1. Clotting
2. Peptidoglycan synthesis
3. Inflammation
4. Blocking of virus
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63. Therapeutic Objective
(continued)
4. Sources of individual variation
Each patient is unique in ability to respond and to how they each
respond, but formation of “IDEAL DRUG” will lessen this variation
○ Age- very important factor
○ Sex- due to hormonal differences
○ Weight
less effective and longer lasting in obese individuals (storage in fat)
○ Kidney & liver functions - elimination of drug
○ Genetic variables- tolerance, allergy (though not always genetic)
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65. Summary
To promote desired effects and minimize adverse
effects, we need to understand
Pharmakokinetics
Pharmacodynamics
In addition
○ Sources of individual variation in drug response
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66. Key Points
The most important properties of an ideal drug are:
effectiveness, safety, and selectivity.
If the drug is not effective, it should not be used.
There is no such drug as safe drug: all drugs can cause harm.
There is no such thing as selective drug: all drugs can cause
side effects.
The objective of drug therapy is to provide maximum benefit
within minimum harm.
Because all patients are unique, drug therapy must be tailored
to each individual.
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67. ASSIGNMENT
GIVE 5 EXISTING LAWS (INTERNATIONAL & LOCAL)
REGARDING FOOD AND DRUG
REGULATION/ADMINISTRATION. THEN, MAKE A REACTION
(AT LEAST 200 WORDS).
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68. ASSIGNMENT
RA 9165
THE COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002
FURNISH A COPY OF THE LAW
ANSWER THE FOLLOWING QUESTIONS:
1. WHAT IS THE IMPORTANCE OF SUCH LAW AS A NURSING STUDENT AND
AS A CITIZEN OF THE COUNTRY?
2. HOW CAN YOU CONTRIBUTE TO THE IMPLEMENTATION OF THE LAW AS A
HEALTH CARE PROVIDER? CITE EXAMPLES IN THE COMMUNITY AND
HOSPITAL SETTING
3. HOW CAN YOU APPLY THIS REPUBLIC ACT TO YOUR SELF AS A CITIZEN?
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