Rx to OTC switch by Dr. Zubair Ali

1. Dr. Zubair Ali
The art of Rx to OTC switch

2. Introduction
Rx to OTC switch stakeholders.
Rx-to-OTC switch process.
Factors contributing to successful switches
Rx to OTC Switch considerations
literature review and input on switch
success
Value-tree framework
Incorporating the Pharmacist as a Key
Customer in Planning
Road Map

3. 1.What is “Rx-to-OTC switch?”
The process of transferring FDA-
approved prescription medications to
non-prescription, over-the-counter
(OTC) status is known as “Rx-to-OTC
switch.”
The process provides consumers with
convenient, cost-effective access to
safe and effective medicines without
the required assistance of a
healthcare provider.

4. How does the switch
process impact the
healthcare system
OTC medicines are cost-effective first-line
therapies for many ailments.
The Rx-to-OTC switch process has a
positive impact on healthcare system
process by driving down overall healthcare
costs.

5. How many medicines
available today have made
the switch from Rx to OTC
status?
106 ingredients, indications, or dosage
strengths have made the switch from Rx
to OTC status or have been newly
approved since 1976. That translates to
more than 700 OTC products on the
market today

6. What is a third class or
behind the counter (BTC)
class of drugs?
A third class or BTC class of drugs are
referring to a category of medicines
available without a prescription, but only
in pharmacies or through a pharmacist.
Under this system, some OTC medicines
would not be available in other convenient
retail outlets, such as grocery stores
without a pharmacy.

7. INTRODUCTION

8. Rx-to-OTC switch
The term Rx-to-OTC switch" relates to the process of
transferring proven prescription drugs (Rx) to
nonprescription, so-called over-the-counter (OTC)
status.
FDA definition of an Rx-to-OTC switch is marketing of
a drug product that was once a prescription (Rx)
drug for the same indication, with the same strength,
dose, duration of use, dosage form, population, and
route of administration"

9. The Rx-to-OTC switch
movement
Back ground
The early reclassification movement dates back to
the 1950s
When paracetamol was switched from prescription to
nonprescription status
Brompheniramine meleate (antihistamine) was known
to be the first OTC switch approved on 9th
September
1976
The modern era of switch was set out in 1984 with
the switch of ibuprofen in the US, challenging aspirin

10. Patients' increasing empowerment in managing their own health
Enhanced knowledge about their disease status
Aging population
Growing middle class in developing markets / increased purchasing
power
Consumers increasingly are taking charge of their own healthcare
needs
Increased consumer interest in lifestyle and wellness products
Movement towards self-selection
Opening of non-pharmacy channels in pharmacy-only markets
Favorable Regulatory environment for Rx-to-OTC switches
Global Trends for OTC

20. IMPACT OF RX TO OTC
SWITCH ON STAKEHOLDERS

22. (+)
•Accelerated treatment access to a broader
range of OTC drugs
•Increased convenience
(-)
•Abuse/Misuse
•Masking of underlying serious diseases
(delayed diagnosis)
Consumers/Patients

23. (+)
•Less patients with minor complaints
•More time for seriously ill patients
(-)
•Concerns regarding risks of OTC use
•OTC drugs difficult to track
•Perceived loss of control
Physicians

24. Physicians
Recommendations

26. (+)
•Less Rx drug reimbursements (at least short-term)
•Less doctor visits for minor illnesses
(-)
•Increased and more intense medical care based
on serious safety problems by reason of
inappropriate use
(long-term)
Third Party Payers

27. (+)
•Switching as lifecycle instrument
•Expanded target patient group
•Increased brand awareness
•Increased disease awareness
(-)
•Stricter regulations on OTC drugs
•Increasing demand for improved safety and
efficacy studies
Industry

28. (+)
•Gain in scope of action (new research tools to
evaluate complex switches)
•Application of best practices
(+)/(-)
•Careful benefit-risk analysis of new complex
switches
•Multiple stakeholder involvement
•Industry cooperation
Regulatory Authorities

29. (+)
•Increased competence (counseling and
educational role)
(+)/(-)
•Cultural dependency/variation of pharmacists
national role in switches
Pharmacists

30. THE RX-TO-OTC SWITCH
PROCESS

31. The Rx-to-OTC switch process
Peck’s “Switch Principles”
1. Does the switch candidate have special toxicity in its
class?
2. Does the candidate have a large margin of safety?
3. Does the candidate’s frequency of dosing affect its safe
use?
4. Has the candidate’s safety profile been defined at high
dose?
5. Has the candidate been used for a sufficiently long time
on the prescription market to enable a full characterization
of its safety profile?
6. What is the worldwide marketing experience of the switch
candidate?
7. What foreign countries market the candidate OTC? What
is its experience in those countries?
Switch principles elaborated by CDER Director Carl Peck, MD, at
the 1990 Annual CHPA Research and Scientific Development Conference

32. 8. What do the “use data” show?
9. Has a vigorous risk analysis been performed?
10. Has the efficacy literature been reviewed in a way
to support the expected usage and labeling of the
switch candidate?
11. Is there a full understanding of the pharmacy-
dynamics of the switch candidate?
12. Is the minimally effective dose for the proposed
OTC indication known?
13. Have possible drug interactions for the switch
candidate been characterized?

33. Switch principles elaborated by Robert DeLap,
MD and Director of the Office of Drug Evaluation
V, at the 2002 CHPA Research and Scientific
Development Conference (from Soller 2007)

34. Fundamentals:
1. Can the condition be adequately self-diagnosed?
2. Can the condition be successfully self-treated?
Points to consider:
1. Is there a need for physician evaluation of the condition?
2. What is the nature and severity of adverse effects of
consumer misdiagnosis and delay in correct diagnosis?
3. Regarding effective product use, what is the nature of
consumer understanding of product use?
4. What is the consumer understanding of the expected
benefit?
5. Does the consumer have the ability to assess treatment
effect?
DeLap’s “Switch Principles”

35. Safe product use:
1.What is the consumer understanding of
product directions for safe use?
2. What is the consumer understanding of what
to do if the product isn’t working?
3. What is the consumer ability to identify
adverse effects and the consumer ability to
determine when adverse events may require
professional care?
4. What is the consumer expectation of safety?

36. FACTORS CONTRIBUTING TO
SUCCESSFUL AND
SUSTAINABLE RX-TO-OTC
SWITCHES

37. Factors contributing to
successful and sustainable Rx-
to-OTC switches

38. Product
• Efficacy
• Safety
• Ease of use
• Advantages/Claims
• Brand awareness
Company
• Consumer marketing expertise
• Clear strategy for brand
• Consistent marketing message
• Ability to sustain large-scale advertising and promotion
campaign
• Retail relationships adequate for smooth launch and
widespread distribution
Rx-to-OTC switch
success

39. Market
• First to market/Early to market
• Reasonable price point
• Consumer need and demand
• Repeat purchases likely
Scientific affairs/Regulatory
• Sufficient clinical evidence to support approval
• Lack of political or moral issues to impede approval
• Clinical evidence to support data/market exclusivity

40. Central role of OTC label,
product information, and
communication
to minimize individual patient
risk

41. Central role of OTC label
HCP: Doctors/Medical staff
• Encouragement and support of self- care after initial medical
diagnosis
HCP: Pharmacists/Pharmacy staff
• Product recommendation based on treatment protocol/
guidance for patient consultation
• Identification of at risk population
• Improved communication skills
Patients/Consumers
• Disease and brand awareness
• Appropriate self-selection
• Effective and safe use of OTC drug
• Effort regarding behavioral change

42. LITERATURE REVIEW AND
INPUT ON SWITCH
SUCCESS

43. The development of “test market“ concepts as a general
form of behavioral research has been suggested elsewhere
to address case-specific (switch-related) questions as well
as to affirm the identified target population and exclude
potential risk populations, respectively (White and Beall
2001).
Test Marketing in Rx to OTC
Switch

44. Adequate information and
support of HCPs
Pharmacists should not only receive
comprehensive information and training on the
product in advance and continuously during
marketing phase, but should also acquire some
practically relevant communication techniques
(Stitching AESGP Foundation 2002).

45. In light complex switches being more often seen today,
accompanying educational programs, most suitably
personalized, have emerged as useful information and
training tools.
Prominent examples of recent switches using this kind of
information kits are the aforesaid Prilosec OTC®
and alli®.
They provide assistance via mail, toll free phone lines,
and/or internet.
Apart from information and training on indication and
medication use, such campaigns are designed to create
disease awareness, on the one hand, and consumers'
action towards tackling their health problems, on the
other.

46. VALUE-TREE
FRAMEWORK FOR RX
TO OTC SWITCH

47. Value-tree framework of benefit
and risk domains for
nonprescription drugs

48. Differentiation of
pharmacoeconomic evaluations
based on health gain
measurement

49. RX TO OTC
SWITCH
CONSIDERATIONS

50. Rx to OTC Switch Considerations
• Cherish your equity
• Know the “new” consumer
• Self-Selecting “Consumer” vs. a Physician’s “Patient”
• Study the “new” environment
• “Open Retail Shelves” vs. “Physician as Gatekeeper”
• Leverage the importance of the pharmacist
• Surround the target consumer with consistent imagery
and messaging that reinforces product efficacy and
safety
• Prepare for success

51. Rx to OTC Switch Considerations
First-to-market
Unique product offering
Advantages over existing therapies
Meets an unmet consumer need
Own able and protectable elements

52. Implications of an Rx To OTC
Switch
Can represent a step-change in the
portfolio...
...But does not guarantee success
Difficult to execute
Requires multi-disciplinary analysis and
constant reiteration and refinement
Begins with Regulatory, but after dossier
approval...
...The “switch” ends and the “Brand” begins

53. Your Brand is an Asset
Strong Brand Equity is a Competitive Advantage
Continue to build on your Rx brand equity with
the physician and the pharmacist
In many cases, the physician and the pharmacist
play critical roles in advocating OTC treatment
and even specific OTC brands.
Ensure that your Rx brand has a well-defined,
consistent, sustainable consumer positioning

55. Equity Building
Starts Before the
Switch
Most prescribed allergy medicine
Strong consumer awareness
Popular with patients
Over $500 million invested in DTC TV advertising
as an Rx
U.S Example: Rx Claritin

56. As You Move From Rx to OTC Evolve
From Functional Benefits to Higher
Order Emotional Benefits
Rx Claritin
Non-drowsy
Relieves allergy symptoms
24-hour
OTC Claritin
Claritin is the only brand
that provides powerful,
long-lasting relief
without unwanted side
effects, so that allergy
sufferers can live as if
they are condition-free

57. Strong Brand Equity is a Competitive
Advantage
Determine whether or not your present positioning
for is “ownable” and is sufficiently differentiating
from your key competitors.
Determine how to make your brand’s positioning
ownable and unique
Imagery
Colors
Claims
Taglines

58. Strong Brand Equity is a
Competitive Advantage
Help your patients develop a relationship with and an
affinity for Rx brand
Does your Rx brand have a clear and compelling
consumer positioning?
Do the package graphics embody this consumer
positioning?
What do the graphics communicate?
What imagery do they conjure?

59. Claims Matter!
In the arena of self-selection, product claims are
important
Product claims separate your brand from the
competition
Claims make your product ownable and unique
Conduct marketing research to determine the
optimal bundle of claims
Work with Regulatory to determine whether or not
you can support the optimal bundle of claims