Lecture 1 Flashcards
Intro to Pharmacology
Central Concept of Pharmacology
Active drug must reach drug target (receptor) at sufficient levels and for sufficient duration to therapeutically modify biological response
Pharmacology
The study of substances that interact with living systems through
chemical processes, especially by binding to regulatory molecules and activating or
inhibiting normal body processes
Drug
A substance that affects a change in biologic function
Hormone
Bioactive substance synthesized within the body (endogenous)
Xenobiotic
Bioactive substance not synthesized in the body (exogenous). May be
beneficial (medication) or harmful (toxin)
Toxin/Poison
Substance with almost exclusively harmful effects.
Pharmacokinetics (PK)
Process by which bioactive substance is absorbed,
distributed, metabolized and eliminated by the body
Pharmacodynamics (PD)
The action or effects of bioactive substances on living organisms
The Harris-Kefauver Amendments
-Require sufficient pharmacological
and toxicological research in animals before a drug can be tested in human beings.
-The data from such studies must be submitted to the FDA in the form of an application for an investigational new drug (IND) before clinical studies can begin.
-Three phases of clinical testing are required to support a New Drug Application (NDA).
-Proof of efficacy and relative safety in terms of the risk-to-benefit ratio for the disease to be treated are required.
Phase 1 Drug Development
Initial safety and tolerability, determine safe dose range and side effects, <50 patients
Phase 2 Drug Development
Effectiveness (exploratory), dose response, safety evaluation, <100 patients
Phase 3 Drug Development
Effectiveness, side effects, compare to standard of care, safety evaluations, 100s-1000s patients
Phase 4 Drug Development
Post-marketing (therapeutic use), effectiveness in general population, optimization of drug use
Types of Controlled Studies (4)
- Randomized
- Double-blind
- Placebo controlled
- Comparison to standard of care
Not all studies can be conducted using randomized, double-blind, placebo methods due to ethical reasons of not treating ½ the patients (placebo) or due to small population size with certain disease.
Randomized Study
Patient population is equally divided in a random manner.
Double-Blind Study
Neither the patient nor health care provider know whether the patient is receiving the experimental drug or a placebo.
Placebo Controlled Study
Placebo should be used that cannot be differentiated from the experimental drug (size, color, taste etc.)
Comparison to Standard of Care Studies
Validates efficacy
Drug Regulation Points
- Tension between time to drug approval (3-10 years) and needs of patient populations and pharmaceutical companies.
- Streamlining and expedited reviews in 1980s in response to AIDS.
- Once a drug is marketed, the physician is allowed to determine use.
- All marketed drugs must include an insert with basic pharmacological information, as well as essential clinical information in regard to approved indications, contraindications, precautions, warnings, adverse reactions, usual dosage, and available preparations.
Non-prescription Drugs
Over-the-Counter (OTC) which are judged safe
for use without medical supervision
Prescription Drugs
Considered to be unsafe for use except under
supervision and must be dispensed only by the order of practitioners licensed by law to administer them.
Controlled Substances
Prescription drugs with the potential for
abuse. Schedules I, II, III, IV, V. Prescribers must provide a DEA number and the pharmacist must keep precise records of these transactions.
CI
- High potential for abuse, physical and psychological dependence
- No accepted medical use
- Examples: Heroin, LSD
CII
- High potential for abuse, physical and psychological dependence
- Accepted for medical use
- Examples: Morphine, Vicodin
CIII
- Lower potential of abuse than CII
- Moderate to low risk of dependence
- Accepted for medical use
- Examples: Tylenol with Codeine
CIV
- Lower potential of abuse than CIII
- May lead to limited dependence
- Accepted for medical use
- Example: Stadol
CV
- Lower potential of abuse than CIV
- May lead to limited dependence
- Accepted for medical use
- Small amounts are available as OTCs
- Example: codeine in certain cough preparations
a.c.
Before meals
ad lib
As needed
b.i.d.
Twice a day
c
With
h.s.
At bedtime (hour of sleep)
n.p.o. (NPO)
Nothing by mouth
p.c.
After meals
p.r.n.
As needed
q.d.
Every day
q.h.
Every hour
q.h.s.
At bedtime (hour of sleep)
q.i.d.
Four times a day
q.o.d.
Every other day
s
Without
t.i.d.
Three times a day
