DRUG

CLASSIFICATIONS
DRUG CLASSIFICATIONS
• Drugs are classified according to their effects
on particular body systems, their therapeutic
uses.
• E.g. GI SYSTEM: PPI, are used to
DECREASE the amount of acid the stomach
makes.
• Example: OMEPRAZOLE (PRILOSEC)
A.PRESCRIPTION DRUGS
 Are those that have on their labels the
prescription legend.
 May be prescribed by the physicians,
dentists, veterinarians, or other legally
authorized health practitioner as part
of their specific practice.
A.NON-PRESCRIPTION DRUGS
 The drugs that may be legally
acquired by the client without
the prescription order.
 Also known as over the counter
drugs (OTC)
A.INVESTIGATIONAL DRUGS
 A new drug which a
manufacturer wishes to market.
Must fulfil the requirements of
FDA.
 
A.ORPHAN DRUG
• Are drugs that have been
discovered but are not
financially viable and therefore
have not been “adopted” by any
drug company
 
A.ELLICIT DRUG
• a.k.a. “street’ drugs are those
which are used and/or
distributed illegally.
DRUGS ARE ALSO CLASSIFIED ACCORDING TO
THEIR CLINICAL INDICATION

CARDIOVASCULAR DRUGS:
Used for treating congestive heart failure, cardiac arrhythmias
and hypertension.
• ANTIHYPERTENSIVE MEDICATIONS, are used to
treat hypertension.
• E.g. Amlodipine (Norvasc)
DRUGS ARE ALSO CLASSIFIED
ACCORDING TO THEIR CHEMICAL
ACTION

•Signal transduction systems

(neurotransmitters)
•E.g. opiate painkillers
• Intracellularly
• Extracellularly
• Invasive agents
DRUG STANDARDS
AND DRUG
INFORMATION
LEGAL REGULATION OF DRUGS
 

A. FDA Pregnancy Categories

Category A
• Adequate studies in pregnant women have
NOT demonstrated a risk in the fetus in the
first trimester of pregnancy and there is no
evidence of risk in later trimester.
Category B
• Animal studies have NOT demonstrated a
risk for 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, and there is no evidence of risk on
later trimester.
 
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 the potential risks, or there are no
animal reproduction studies and no
adequate studies in humans.
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 of
its potential risks.
 
 CONTROLLED SUBSTANCES

1. Schedule I
• Drugs that are not approved for medical use and
have high abuse potentials: heroin, lysergic acid
diethylamide (LSD), peyote, mescaline,
tetrahydrocannabinol, marijuana.
2. Schedule II
• Drugs that are used medically and have high
abuse potentials: opioid analgesics (eg,
codeine, hydromorphone, methadone,
meperidine, morphine, oxycodone,
oxymorphone), central nervous system (CNS)
stimulants (eg, cocaine, methamphetamine,
methylphenidate), and barbiturate sedative-
hypnotics (amobarbital, pentobarbital,
secobarbital).
3. Schedule III
• Drugs with less potential for abuse than those in
Schedules I and II, but abuse may lead to
psychological or physical dependence: an-
drogens and anabolic steroids, some CNS
stimulants (eg, benzphetamine), and mixtures
containing small amounts of controlled
substances (eg, codeine, barbiturates not listed
in other schedules).
 
1.Schedule IV
• Drugs with some potential for abuse:
benzodiazepines (eg, diazepam,
lorazepam, temazepam), other
sedative-hypnotics (eg, phenobarbital,
chloral hydrate), and some prescription
appetite suppressants (eg, mazindol,
phentermine).
1.Schedule V
• Products containing moderate amounts of
controlled substances. They may be dispensed
by the pharmacist without a physician’s
prescription but with some restrictions
regarding amount, record keeping, and other
safeguards. Included are antidiarrheal drugs,
such as diphenoxylate and atropine
(Lomotil).
PRESCRIPTION AND NONPRESCRIPTION
DRUGS
• Legally, consumers have two routes of access
to therapeutic drugs.
• One route is by PRESCRIPTION or order from
a licensed health care provider, such as a
physician, dentist, or nurse practitioner.
• The other route is by OVER-THE-COUNTER
(OTC) purchase of drugs that do not require a
prescription.
 DRUG APPROVAL PROCESSES
 
• The FDA (Food and Drug
Administration) is responsible for
assuring that new drugs are safe
and effective before approving the
drugs and allowing them to be
marketed.
 
TESTING AND CLINICAL TRIALS
• The testing process begins with
animal studies to determine
potential uses and effects.
• In Phase I, a few doses are given to a
few healthy volunteers to determine
safe dosages, routes of
administration, absorption,
metabolism, excretion, and toxicity.
• In Phase II, a few doses are
given to a few subjects with the
disease or symptom for which
the drug is being studied, and
responses are compared with
those of healthy subjects.
• In Phase III, the drug is given to a
larger and more representative
group of subjects.
• In phase IV, after a drug is
approved for marketing, it enters a
phase of continual evaluation.
 
TERMS INDICATING DRUG ACTION
 
INDICATIONS
• A list of medical conditions or diseases for which
the drug is meant to be used.
 
ACTIONS
• A description of the cellular changes that occur
as a result of the drug.
CONTRAINDICATIONS
A list of conditions for which the drug should not be given.
 
SIDE EFFECTS and ADVERSE REACTIONS
• A list of possible unpleasant or dangerous
effects, other than the desired effects.
 
INTERACTIONS
• A list of other drugs or foods that may alter
the effects of the drug and usually should
not be given during the same course of
therapy.