INTRODUCTION TO DRUGS

Introduction to Drugs
• Pharmacology
– Pharmakon – “drug”
– Logia – “study of” or “knowledge of”
– study of the biological effects of chemicals.
• Drugs – are chemicals that are introduced into
the body to cause some sort of change.
• Pharmacotherapeutics – or clinical
pharmacology, is the branch of pharmacology
that uses drugs to treat, prevent, and
diagnose disease.
Clinical Pharmacology
• Addresses two key concerns:
1. The drug effects on the body
2. The body’s response to the drug
Sources of Drugs
• Natural
– Plants
– Animals
– Inorganic compounds
• Synthetic
Drug Evaluation
• Food and Drug Administration (FDA)
– an agency of the U.S. that regulates the
development and sale of drugs.
– For every 100,000 chemicals that are identified as
being potential drugs, only about 5 end up being
marketed.
– Before receiving the final FDA approval, drugs
must undergo stages of development.
Preclinical Trials
- Refers to the testing of chemicals with
therapeutic value on laboratory animals.
- 2 purposes: (1.) to determine whether they have
the presumed effects in living tissue; (2.) to
evaluate any adverse effects.
- Reasons for discarding some chemicals:
1. It lacks therapeutic activity
2. Is too toxic
3. Is highly teratogenic
4. Safety margins are so small
Phase I
• Uses human volunteers to test the drugs.
• Are performed by trained clinical investigators.
• Volunteers are fully informed of the risks and
may be paid.
• Volunteers are healthy, young men.
• Reasons for dropping the chemical include:
– Lack of therapeutic effect in humans
– Cause unacceptable adverse effects
– Are highly teratogenic
– Are too toxic
Phase II
• 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 effects of
the drug and are informed about the risks if
consent to participate is given.
• Can be performed in hospitals, clinics, and
doctor’s offices
• Reasons for removal of chemical from further
investigation include:
– Is less effective than anticipated
– Is too toxic
– Produces unacceptable adverse effects
– Has a low benefit-to-risk ratio
– Is no more effective than other drugs already in
market
Phase III
• Involves the use of the drug in a vast clinical
market.
• Prescribers are well informed of the known
reactions to the drug and precautions
required; observe the patient closely
• Reasons for dropping the drug include:
– Produces unacceptable adverse effects
– Produce unexpected responses especially when
used widely
FDA Approval
• NOTE! Only those drugs that receive FDA
approval may be marketed. (Figure 1.3/p9)
• Brand name – or trade name, refers to an
approved drug develop by the pharmaceutical
company. Ex. Levothroid, Synthroid
• Generic name – is the original designation
that a drug is given when the drug company
that developed it applies for the approval
process Ex. Levothyroxine sodium
• Chemical name – reflect the chemical
structure of the drug
– Ex. L-thyroxine, T4
– Acetaminophen (Tylenol)
• N-Acetyl P- Aminophenol
NOTE! Generic and chemical names always
appear straight print. While, brand name is
always italicized.
NOTE! Entire drug development and approval
process may take 5 to 6 years. Some may be
accelerated. Ex. Delavirdine (Rescriptor)- for
AIDS
Phase IV
• Refers to continual evaluation after a drug was
approved for marketing.
• Example: dexfenfluramine (Redux), a diet drug
• Rofecoxib (Vioxx)
Legal Regulation of Drugs
• Safety during pregnancy: Category A-D & X
• Controlled drugs – are drugs with abused
potential.
• Generic drugs – drugs sold by their generic
names
• Orphan drugs – are drugs that have been
discovered but that are not financially viable.
• Over-the-counter drugs – are available
without prescription for self-treatment.