1. GROUP PRESENTATION
PHARMACEUTICAL
MANAGEMENT

2. MARKETING OF NON-PRESCRIPTION
DRUGS

3. OTC DRUGS:-
An OTC drug product is a Product marketed
for use by the consumer without the
intervention of a health care professional.

4. PRESCRIPTION DRUGS:-
A prescription drug product is a drug that can only
be obtained with a prescription from an appropriate
health care practitioner.

5. PHASES OF OTC DRUG REVIEW

6. First phase of the OTC drug review?
The first phase was accomplished by
advisory review panels. The panels were
charged with reviewing the ingredients in
nonprescription drug products to determine
whether these ingredients could be generally
recognized as safe and effective for use in
self-treatment. They are also reviewing claims
and recommending appropriate labeling,
including therapeutic indications, dosage
instructions, and warnings about side effects
and preventing misuse.

7. According to the terms of the review, the panels
classified drug product in three categories as follows:
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

8. Second phase of the OTC drug Review?
The second phase of the OTC drug review is the
agency’s 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. After publication of the tentative final
monograph, a period of time is allotted for objections to
the agency’s proposal or for requests to be submitted for
a hearing before the Commissioner of FDA.

9. Third phase of the OTC drug review?
The publication of final regulations in the form of
drug monographs is the third and last phase of the
review process. The monographs establish
conditions under which certain OTC drug products
are generally recognized as safe and effective.

10. FDA’s APPROVAL PROCESS OF OTC
PRODUCTS

11. The Food, Drug, and Cosmetic Act of 1938 was the first piece
of legislation to require that drugs be cleared by the U.S.
Food and Drug Administration before being marketing for
human use. This act required that all new drugs be proved
safe for human use before marketing, prohibited the sale of
dangerous, contaminated or misbranded products, and
mandated labeling specifications.
A new drug application (NDA) has been required for all new
drug entities that have been introduced since the enactment
of the Food, Drug, and Cosmetic Act. After an NDA is
approved by the FDA, the drug product may be marketed only
by the sponsor of the NDA. Additional manufacturers who
wish to market similar products must seek approval to do so
through submission of a separate NDA. In some cases, such
as with generic medications, an abbreviated NDA may be
submitted. NDAs are updated periodically to include post
marketing information and minor label changes.

12. between prescription and OTC drugs. For drugs that could not be
labeled with sufficient instructions to allow safe, unsupervised
use by consumers, these amendments allowed labeling directed
to physicians and pharmacists instead of to consumers. Drugs
with physician- and pharmacist-directed labeling were then
available by prescription only.
In 1962, the Kefauver-Harris amendments to the Food, Drug, and
Cosmetic Act were passed, requiring that drug products be
proved not only safe but also effective for their intended uses.
Enactment of these amendments compelled the FDA to determine
the effectiveness of more than 4,000 newer drug
products, including more than 500 OTC products that had been
marketed before the enactment of the amendments. The OTC
Drug Review was begun in 1972 as an FDA-initiated scientific
review of OTC product ingredients in use at that time to ensure
that appropriate safety, effectiveness and labeling standards are
met. This review process consists of three phases: an advisory
panel review, creation of a tentative monograph and publication
of a final monograph.

13. As a result of the initial OTC drug review
findings, If OTC ingredients determined to be
safe and effective for their intended uses
subsequently the FDA approved these
products for general use.
And if found to be ineffective, these are
considered to be unsafe.
And the some cases required submission of
additional data before safety and
effectiveness could be established by FDA.

14. OTC DRUGS MARKETING

15. Two regulatory pathways exist for the legal
marketing of such products:
NDA process.
OTC Monographs.

16. “NDA PROCESS” “OTC MONOGRAPHS”
 Pre-marketing approval.  No pre-marketing approval.
 Confidential filling.  Public process
 Active ingredient –specific.
 Drug products are specify.
 OTC drug category.
 May require a user fee.
 No user fees.
 Potential for marketing
exclusivity.  No marketing exclusivity
 Mandated FDA review  No mandated time lines.
timelines.
 May require clinical studies.
 May require clinical studies.
 Label comprehension and actual
use studies not required.
 Label comprehension

17. Purchase and use of OTC drugs without full knowledge is not
only a waste of resources for all stakeholders but can be
harmful for consumers. Creating awareness of rational drug
use is only possible through continued public education with
a broad vision of good health and wellbeing of the society. In
developed economies, the four A’s of marketing has been
addressed fairly which is:
Product ------ Appropriateness
Price --------- Affordability
Place ---------- Accessibility, and
Promotion ---- Accountability for the promises made
But in Pakistan the accessibility and awareness is still on a
lower side especially for OTC drugs.

18. ROLE OF SELF-MEDICATION (OTC)

19. health care consumers. The availability of over-the-
counter medications makes it possible for
consumers to treat numerous ailments without the
supervision of a health care professional. Many of
the medications now available without a
prescription were previously classified as
prescription-only products.
The U.S. Food and Drug Administration have
procedures in place that allows prescription
products to be reclassified as over-the-counter
medications if certain criteria are met. Reclassified
products have had clinical and economic effects on
the U.S. health care system and have led to
concerns among health care professionals. Patient
education and counseling are particularly important
to promote safe and effective use of over-the-
counter products.

20. BENEFITS AND RISKS OF OTC

21. POSSIBLE BENEFITS:-
1. Increased access.
2. Decreased frequency of visits to
physicians, leading to lower healthcare costs.
3. Improved education of consumers.
4. Increased autonomy of patients.
5. Decreased cost to third party players.

22. POSSIBLE RISKS:-
1. Inaccurate diagnosis
2. Delay in obtaining needed therapy
3. Use of suboptimal therapy
4. Drug resistance
5. Increased costs to patients
6. Failure to follow label instructions (Adverse
effects, Drug interactions)
7. Perceived loss of control by physicians

23. PHARMACIST’S ROLE IN OTC DRUG
PRODUCTS

24. Over-The-Counter counseling refers to
a pharmacist's full working knowledge of Over-
the-counter (OTC) drugs as well as initiating an
assessment of the patient's self-care concerns
and drug-related needs.
OTC counseling patients about self-care and
non-prescription drugs does not follow the same
format as for prescription drugs. What is also
important is that a pharmacist should assess
whether the patient has any underlying
conditions as to avoid any drug-release
interactions.

25. The pharmacist plays a key role in ensuring that the
balance of OTC use tips toward benefit rather than risk.
Who better to serve as the “learned intermediary” to
help patients understand and apply health information?
The pharmacist is available at the point of purchase to
help the patient select an appropriate OTC
product, suggest non pharmacologic therapy, or refer
the patient to a physician when necessary.
Pharmacists are trained to help patients determine when
and how to treat themselves; when to see a physician;
when diagnostic tests are appropriate; and when to use
emergency health care services. As an extension of
pharmaceutical care, pharmacists can counsel patients
on the appropriate use of OTC products, thereby
maximizing the benefits and reducing the risks.

26. Effective non-prescription drug counseling requires a
thorough description of patient's symptoms. Before
advice can be given, the PHARMACIST will need
knowledge on the nature, severity and extenuating
circumstances surrounding those symptoms. As
well, other aspects of the patient's health e.g. other
diseases, drugs, contraindications, allergies, must be
examined. This information-gathering" stage is most
important.

27. PHARMACIST must be able to give information to the
patient so products are used both safely and effectively.
When providing care to patients involving over the
counter medications, it is necessary to perform an
adequate mini-assessment of the client’s problem,
consisting of:
Properly identifying the person who will be using the
product and determining their approximate age;
Inquiring about any current medical conditions;
Asking about current non-prescription drug use,
including herbal products;
Asking about current prescription drug use;
Inquiring about the symptoms and duration of the
complaint;
Asking about whether the client has any medication
allergies; and,
Asking whether the client has consulted a health care
professional about the problem.

28. You should refer the client for medical attention if:
Their condition is potentially severe,
They are uncertain about their symptoms,
Their self-diagnosis is likely incorrect,
The condition has not responded to previous
appropriate therapy, or
They have other risk factors that should be assessed.
When you have assessed the client and the problem,
and feel that a referral is not necessary, you may
recommend an appropriate product or course of action,
including non-drug measures.

29. If you recommend a non-prescription drug product, you
should discuss:
Directions for use;
Expected outcomes of therapy, including a time-frame
for a response;
Common adverse effects and precautions;
Correct storage; and,
When to seek medical attention.
Ideally, you should document nonprescription drug use
on the client’s medication profile. This is especially
important for clients who have a medical condition
and/or are taking prescription medication.