Essentials, OTC and controlled

drugs
Essential medicines
OTC-drugs
They are products that consumers can purchase them in pharmacies,
supermarkets and other retail stores as well as online without a
.prescription

OTC medicines are considered safe and effective treatments by the

Food and Drug Administration(FDA) and other health authorities
.around the world

These medicines treat common, self-treatable health conditions and

:symptoms such as
,Common cold-
,Minor pain-
,Allergies-
.Other conditions that impact large segments of the population-
 General Characteristics of OTC Drugs

.Safe (acceptable safety margin) and efficacious-

.Low abuse potential-

.Condition to be treated is self-diagnosable-

.Does not require a health care practitioner for safe and appropriate use-

:Have adequate labeling so that consumers can-

Self-diagnose–
Self-select–
Self-administer–
Know when to stop using–
 Examples of OTC Drug Categories
Antacids -Antidiarrheal products-

Antiemetics -Antiperspirants-

Cough and cold products -Wart removers-

Sleep aids -Ophthalmic products-

Hemorrhoidal products -Dandruff products-

Anticaries products -Otic products-

Analgesics-
 Compare between prescription and OTC drugs?

Prescription medicines Non-prescription drugs (OTC)

• High risk • Minimum risk

• Low safety
• Treated conditions are
usually more difficult to
self-assess
• Safe use requires
prescription
• Less detailed label
• Higher safety
• Treat complaints for which
users recognize their own
symptoms
• Used on the basis of their
labelling alone, then drug
must be safe and effective
• More detailed label

OTC safety > prescription drugs

 OTC labels
• In addition to:
-the name,
-active ingredients,
-inactive ingredients,
-manufacturer name,
-net quantity,
-indications for use
-dosages,
-warning and cautionary statements,
-expiration date and batch number,............................................

There are certain requirements for the OTC label

 Requirements for the OTC drug label

• Should be free from complex-medical terminology

• Terms used should accurately reflex the symptoms which is relieved

by the drug (e.g., Heart burn in antacid labelling)

• Should be informative and related to product effectiveness

• Warnings against misuse (e.g.. Stop taking this product if ringing in

the ear occurs ........for toxic over-dose of salicylates)
 ?Why it is essential for clinicians to be familiar with the OTC-drugs
First, many OTC medications are effective in treating common
ailments, and it is important to help the patient select a safe and effective
.product

Second, many of the active ingredients contained in OTC drugs may

worsen existing medical conditions or interact with prescription
.medications

Finally, the misuse or abuse of OTC products may actually produce

.significant medical complications
For example, Phenylpropanolamine, a sympathomimetic previously
found in many cold drugs, was withdrawn by the FDA based on reports
.that the drug increased the risk of hemorrhagic stroke
Cases in which OTC are primary therapy:
• Acne
• Constipation
• Dysmenorrhea
• Vaginal candidiasis
• Head lice
Most frequently used OTC drugs:
• Analgesics
• Laxatives
• Vitamins
• Antacids
• Cough and cold preparations
 Selection of OTC drugs approaches
• Select a product that contains a therapeutically effective dose.

• Single ingredient products are preferred.

• Select a product with completely informative label

• Carefully read the product label

• Be wary of "gimmicks" or advertising claims of specific superiority

over similar products

• For children, dose, dosage form and palatability are important

A controlled substance is a drug or chemical whose manufacture,
.possession and use are regulated by a government

The drugs with the highest abuse potential are placed in Schedule I, and
.those with the lowest abuse potential are in Schedule V

.These schedules are commonly shown as I, II, III, IV, and V

:Types of controlled substances

Hallucinogens –
Stimulants –
Narcotics –
Depressants –
Controlled Substance: A drug included in a schedule I, II, III, IV or V .
The term dose not includes distilled spirits, wine, malt beverages or
.tobacco
:Schedules of Controlled Substances

: Schedule I*

.The drug or other substance has a high potential for abuse ]A[

The drug or other substance has no currently accepted medical use in ]B[
.treatment

There is a lack of accepted safety for use of the drug or other substance ]C[
.under medical supervision
e.g., Heroin, Cannabis, ecstasy and Lysergic acid diethylamide(LSD)
: Schedule II*

.The drug or other substance has a high potential for abuse ]A[

The drug or other substance has recurrently accepted medical use in ]B[
.treatment or a currently accepted medical use with severe restrictions

Abuse of the drug or other substances may lead to severe ]C[

.psychological or physical dependence

e.g., Cocaine, morphine, Methadone & fentanyl

: Schedule III*

The drug or other substance has a potential for abuse less than the ]A[
.drug or other substances in schedules I and II

The drug or other substance has a currently accepted medical use in ]B[
.treatment

Abuse of the drug or other substances may lead to moderate or low ]C[
.physical dependence or high psychological dependence

e.g., Ketamine & Anabolic steroids

: Schedule IV*

The drug or other substance has a low potential for abuse relative to ]A[
.the drug or other substances in schedules III

The drug or other substance has a currently accepted medical use in ]B[
.treatment

Abuse of the drug or other substances may lead to limited physical ]C[
dependence or psychological dependence relative to the drugs or other
.substances in schedule III

e.g., Diazepam, lorazepam, Tramadol & Alprazolam and phenobarbitone

: Schedule V*

The drug or other substance has a low potential for abuse relative to ]A[
.the drugs or other substances in schedules IV

The drug or other substance has a currently accepted medical use in ]B[
.treatment

Abuse of the drug or other substances may lead to limited physical ]C[
dependence or psychological dependence relative to the drugs or other
.substances in schedule IV

e.g., Lomotil, Imodium & codeine containing cough preparations