General Medicine

2. Over-the-counter drugs
 also known as OTC or nonprescription drugs,
and defined as drugs that are safe and effective
to use by the general public without a doctor’s
prescription.
 Play an increasingly vital role in our healthcare
system and are the most prevalent means of
treating the majority of common health problems
in the United States

3. Regulation by countries
 In US, the manufacture and sale is
regulated by Food and Drug
Administration (FDA)
 In UK, medication is governed by
Medicines Regulations 2012

4. What does FDA do with
regard OTC drugs?
 Review OTC products for safety and
effectiveness
 Responsible for establishment of
regulations of OTC drugs labeling
 Responsible for reclassifying process
of OTC drugs from prescription status

5. Outline
Two regulatory pathways which exist for the
legal marketing of such products:
1. Marketing in compliance with an OTC
drug monograph
2. Marketing under the authority of an
approved product-specific new drug
application (NDA) or an abbreviated new
drug application (ANDA)

6. The reasons for a drug to
become OTC:
 Overall risk and potential abuse or dependency low
 Availability for a larger population early in a disease
 The company's way of extending the life of their drug
and reduced price product
 Rx drug cost has increase by 15% per year -financial
relief to consumer
 Increased consumer awareness – increase reliance on
self medication as public awareness on common
ailments goes up

7. What are requirements for
all OTC drug products?
Standards for safety and efficacy
Good manufacturing practices
(inspections)
Labeling under 21 CFR 201.66

8. Safety and Effectiveness
Standards for OTC Products
 Same standards as prescription drugs. Also,
consumers must be able to:
 Self- diagnose
 Self-treat
 Self-manage
Which can be assessed through:
 Label comprehension studies
 Actual use studies

9. Label
According to the law, OTC drug labeling must
include “all of the information that an ordinary
consumer needs for safe and effective use”.
 OTC drugs : the labeling regulated by FDA
but advertising by Federal Trade Commission
(FTC)
 Prescription drugs advertising is strictly
regulated only by FDA

10. OTC Labeling
 “Drug facts”
 Standardized labeling format
 Similar to “Nutrition facts” & “Supplement
Facts”
 21 CFR 201.66
 Required as of May 2005

11. • Over 300,000 marketed OTC drug
products
• The active ingredients and labeling
of over 80 therapeutic classes of
drugs are reviewed by FDA
• For each category, OTC drug
monograph is developed and
published in Federal Register

12. • Once a final monograph is implemented,
companies can make and market an
OTC product without the need for FDA
pre-approval
• New products that conform to a final
monograph may be marketed without
further FDA review
• Those that do not conform must be
reviewed by the New Drug Application
process

13. OTC Monographs
Represent regulatory standards for marketing of
nonprescription drugs not covered by NDA
 “Recipe book” for marketing an OTC drug, a list and
explanation of GRASE conditions -active ingredients,
doses, formulation, labeling and testing , continually
updated
New Drug Application (NDA)
 New ingredients , Rx-OTC switch, generic (ANDA)

14. What is included in an OTC
Drug Monograph?
 GRASE active ingredients
 Dosage strength
 Dosage form
 Labeling requirements
 Indications
 Warning and directions for use
 Final formulation testing

15. NDA Process OTC Monograph Process
Pre-market approval No
Confidential filing Public process
Drug product-specific Active ingredient-specific
• OTC drug category
May require a user fees No user fees
Potential for marketing
exclusivity
No marketing exclusivity
Mandated FDA review
timelines
No mandated timelines
May require clinical studies
• Label comprehension
• Actual use
May require clinical studies
• Label comprehension and
actual use studies not
required

16. OTC Drug Review
 Established to evaluate the safety and effectiveness of
OTC drug products marketed in US before May 11th,
1972
 It is a three-phase public rulemaking process (each
phase requiring Federal Register publication) resulting in
establishment of standards (monographs or non-
monographs) for an OTC therapeutic drug category
1. First phase was accomplished by advisory review
panels

17. Role of advisory review
panels
 Reviewing the ingredients in nonprescription
drugs to determine whether these ingredients
could be generally recognized as safe and
effective for use in self-treatment
 Charged with reviewing claims and
recommending appropriate labeling (tx
indications, dosage instructions, warnings
about side effects and preventing misuse)

18. The panels classified ingredients in
three categories as follows:
Category I: GRASE for the
claimed tx indication
Category II: not GRASE or
unacceptable indications
Category III: cannot
determine if safe and
effective as insufficient data
available to permit final
classification

19. 2. Second phase was the agency’s review of ingredients
in each class of drugs based on panel’s findings, public
comments and new data that may have become
available
 The agency, in turn, publishes its conclusions in the
Federal Register in form of a tentative final monograph
 After publication, a period of time is given for objections
to the agency’s proposal or for requests to be submitted
for a hearing before the Commissioner of FDA

20. 3. Third phase was the publication of
final regulations in form of drug
monographs
 The monographs establish conditions
under which certain OTC drug
products are generally recognized as
safe and effective

21. Characteristics of Eligibility
for OTC Approval
OTC drugs generally have these characteristics:
 their benefits outweigh their risks
 the potential for misuse and abuse is low
 consumer can use them for self-diagnosed
conditions, self treat and self manage
 they can be adequately labeled
 health practitioners are not needed for the
safe and effective use of the product

22. Disadvantages
 Reduced opportunities to receive
counseling about possible lifestyle
therapies (e.g. diet, exercise)
 Poorer compliance
 Misdiagnosis, patients won’t benefit
from the drug but will be exposed to its
risks
 More difficult to study a drug’s effects

23. OTC Drug Labeling (cont.)
 Comprehensibility
 Readability
 Comprehensiveness

24. Comprehensibility:
 FDA regulations require that OTC drug
labeling contain terms likely to be read
and understood by the average
consumers
 Counseling consumers on how to
interpret product labels properly

25. Readability:
 Provision of essential information in
the same orders and area
 Uniformity in print size, pictogram,
icons, colours, numbering, margins
and etc.
 Special population: a threshold print
size of 4.5 has been suggested as
minimum, while not optimum

26. Limitations of package
labeling
A package label can never address the
infinite management issues associated
with drug use, particularly in the
comorbidity or polypharmacy.
Thus, packaging should acknowledge
and encourage dialogue with health
professionals.

27. Expiration date on labeling
 Expiration date: is the date beyond which
product should not be used because the
stability, potency, strength or quality may
have been affected over time
 FDA regulations govern how this date is
determined and tested
 Most OTC drugs are required to include an
expiration date on the labeling

29. Checklist for choosing OTC
drugs

33. OTC DRUGS
-Pregnancy
-Abuse of OTC
DHAMIRAH SAKINAH MAKMON
10-6-75

34. OTC drugs for pregnancy

40. OTC drugs for pregnancy
 Constipation – Colace , Metamucil
 Heart burn - Gaviscon® (aluminum hydroxide, magnesium
carbonate
 Sleep problems- Unisom® SleepTabs® (doxylamine succinate)
 Sinus congestion and cold- loratidine
 Vomiting - Emetrol® Syrup (phosphorated [phosphoric acid]
carbohydrates [dextrose, fructose] syrup), vitamin B6

41. OTC that should be avoided

43. Abuse of the OTC drug
 Dextrometrophan
BRAND/COMMERCIAL NAMES:
Any Cold Medicine with “DM” or “TUSS” in the title
such as: Dimetapp DM®, Nyquil®, Robitussin®,
Theraflu®, Vick’s Formula 44®
SIGNS OF ABUSE:
Nausea, loss of coordination, headache, vomiting,
slurred speech, disassociation
 Pain reliever-Acetaminophen/ibuprofen
 Diet Pills - phenylpropanolamine, ephedrine, and
ephedra

44.  Dimenhydrinate (Dramamine) or diphenhydramine
(Benadryl)
Motion sickness pill
taken in large doses can cause one to feel high and
have hallucinations similar to street drugs
 Pseudoephedrine: This nasal decongestant and
stimulant is found in many cold medicines. Its similarity
to amphetamines has made it sought out to make the
illegal drug methamphetamine. The medicine has also
been taken as a stimulant to cause an excitable,
hyperactive feeling
 Herbal- nutmeg, salvia