Otc drugs use & sales

OTC drugs

1. RATIONAL USE OF OTC{OVER THE
COUNTER) DRUGS & ITS SALES
By:-Dr. Manish Pal Singh,
Associate Professor
1Agra Public Pharmacy College, Agra
Source*-https%3A%2F%2Fbusiness.medicaldialogues.in

2. What is OTC-Drugs?
According to FDA-
“OTC drug is safe when it has low incidence of ADR’s & Side effects
under conditions of widespread availability”
➢It’saNon-prescriptionmedicines.
➢Inbroadersenseallnon-prescriptionalmedicinesincludingtraditional
herbalmedicinesornutritionalsupplements(pharmaceuticalcare
meaning).
➢AnSimplysaytoOTC-
“An OTC drug product is a Product marketed for use by the
consumer without the intervention of a health care professional.”
Agra Public Pharmacy College, Agra 2

3. Differences Between Prescription & Non-
prescription Drugs
Agra Public Pharmacy College, Agra 3
•That can only be obtained with a
prescription from an appropriate
health care practitioner.
Prescription
Drugs
•Self Prescribed-we decided what
we need.
Non-prescription
(OTC)-Drugs
But Both are reviewed by healthcare
person & can be interact with each
other

4. Agra Public Pharmacy College, Agra 4
Criteria's of OTC-
Low toxicity
No increase
resistance
First approved as
prescription
Later on Approved
As OTC

5. Agra Public Pharmacy College, Agra 5
OTC-Drugs Can be Classified as-
Category-I
•Generally recognized as safe and effective for the
claimed therapeutic indication
Category-II
•Not generally recognized as safe and effective for
claimed indications
Category-III
•Insufficient data available to permit final classification

6. Significance of OTC Counters:-
✓FDArequiresthatOTClabelsshouldbemoredetailedascomparedto
prescriptiondruglabels.
Agra Public Pharmacy College, Agra 6Source*-https%3A%2F%2Fwww.poison.org

7. Agra Public Pharmacy College, Agra 7
OTC Medication Used by-CATEGORY
OTC
Analgesics
Cough Syrups
Allergy and sinus
Vitamin and Mineral
Supplements

8. Agra Public Pharmacy College, Agra 8
Source*-
https%3A%2F%2Fwww.today.com
https%3A%2F%2Fwww.gartner.com
data:image/jpeg;base64++

9. Agra Public Pharmacy College, Agra 9
Phase’s of OTC Drug Review
•The first phase was accomplished by advisory review
panels.
•In this determine drug ingredients could be generally
recognized as safe and effective for use in self-
treatment.
Ist-Phase
•The second phase of the OTC drug review phase.
•Review of ingredients in each class of drugs, based
on the panel’s findings, on public comment, and on
new data that may have become available.
•The agency, in turn, publishes its conclusions in the
Federal Register in the form of a tentative final
monograph.
•Requests to be submitted for a hearing before the
Commissioner of FDA.
IInd-Phase

10. Agra Public Pharmacy College, Agra 10
The monographs establish
conditions under which certain
OTC drug products are generally
recognized as safe and effective.
The publication of final
regulations in the form of
drug monographs
IIIrd
Phase
FDA approved these products for general
use.

11. Agra Public Pharmacy College, Agra 11
OTC Drugs Marketing
NDA process
OTC Monographs
•Pre-marketing approval
•Confidential filling
•Drug products are specify
•May require a user fee
•Mandated FDA review timelines
•No pre-marketing approval
•Public process
•Active ingredient –specific
•No user fees
•No mandated time lines

12. ➢PurchaseanduseofOTCdrugswithoutfullknowledgeisnotonlyawasteof
resourcesforallstakeholdersbutcanbeharmfulforconsumers.
➢Creatingawarenessofrationaldruguseisonlypossiblethroughcontinued
publiceducationwithabroadvisionofgoodhealthandwellbeingofthe
society.
➢Theavailabilityofover-thecountermedicationsmakesitpossiblefor
consumerstotreatnumerousailmentswithoutthesupervisionofahealth
careprofessional.
➢Patienteducationandcounselingareparticularlyimportanttopromotesafeand
effectiveuseofover-thecounterproducts.
➢Don’tmixRxandOTCsincludingherbals.
➢GiveyourdoctoralistofALLmeds.
Agra Public Pharmacy College, Agra 12

13. Risk/Beneficial Role’s of OTC Drugs
RISK Factors
•Inaccurate diagnosis.
•Delay in obtaining needed
therapy
•Drug resistance
•Failure to follow label
instructions
•Perceived loss of control by
physicians
Benefit Factors
•Increased access
•Decreased frequency of
visits to physicians, leading
to lower healthcare costs.
•Improved education of
consumers.
•Decreased cost to third
party payers
Agra Public Pharmacy College, Agra 13

14. Agra Public Pharmacy College, Agra 14
OTC Medication Use-----“GENRALLY USE 3-R”
OTC
R-Risk
R-Respect
R-Responsibility

15. Agra Public Pharmacy College, Agra 15
Source*-https%3A%2F%2Fwww.slideshare.net%2Fmshubhankar%2Fotc-drug-market-future-growth-driver-for-ipm-