Analysis of Prescription Drug to Over

The Counter (Rx to OTC) Switch

Movement:
A Strategic Review With Reference
To Statins.

Presented by: Vipul Dholia

MBA(Pharm)
NIPER
Reason for study
ü The trend for seeking advice from a doctor or medical
practitioner
ü Approximately 800 over-the-counter (OTC) products
currently available use ingredients and dosages available
only by prescription 20 years ago. There are a number of
possible reasons for this trend, including:
• A growing emphasis on individual autonomy and self-help
• Trend toward deregulation in the Health care cost
containment efforts
• Pharmaceutical industry self-interest/profit
ü ZOCOR heart pro is now a days available in UK as OTC
and it is beneficial for patients in primary prevention of
disease.
Research Gaps & Objective
Gaps:
üGiants in UK and USA have entered in market for
This OTC statins and now that’s turn for Indian
Pharma companies to enter in to this lucrative
Market.
üAvailability of statins as lower price in USA and
in UK can it be in India?
üRegulation in India for OTC segment
üStill not any availability of OTC statins in India
but potential for this segments seems to be high
Objective:
ü To identify the market potential for statins in India.
ü Concept testing for OTC Statins
ü Effect of OTC statins in USA,UK
ü Strategies that companies can implement in launching of
this OTC version of statins.
ü Regulatory aspects of OTC statins
Methodology
Research methodology of the project involves
following steps:
ü Research design
ü Sampling plan
ü Data collection
ü Analysis
ü Conclusion and findings
ü Case study method
STATINS
Mechanism of Action
ü Based on the inhibition of the hydroxy-methylglutaryl-
coenzymeA (HMG-CoA) reductase resulting in the
inhibition of cholesterol synthesis in hepatocytes. The
number of LDL receptors on hepatocytes is increased,
and the elimination of LDL from the blood is enhanced.
Part of the action may be through very low-density
lipoprotein (VLDL) or even other mechanisms.
Effectiveness
ü LDL is decreased by 30 to 40%.
ü HDL is increased by 5 to 15%.
ü Triglycerides are decreased by 10 to 30%.
ü Combining statins with resins results in additive effects
Safety profile for STATIN

ATORVASTATIN
ü No evidence of teratogenicity was found in rats at doses
up to 300 mg/kg per day or rabbits at doses up to 100
mg/kg per day
FLUVASTATIN
ü No evidence of teratogenicity was found in rats or
rabbits given doses of up to 36 mg/kg and 10 mg/kg per
day, respectively
CERIVASTATIN
ü No anomalies or malformations were found in rabbits
given 0.75 mg/kg
LOVASTATIN
ü Studies in mice and rats at doses producing plasma
concentrations 40 (mouse fetus) and 80 (rat fetus) times
the human exposure found an increased incidence of
skeletal malformations. No changes occurred in rats or
mice at multiples of 8 and 4 times, respectively, or in
rabbits at exposures up to 3 times the highest tolerated
human exposure.
PRAVASTATIN
ü Studies in rats and rabbits given pravastatin at doses of
1000 mg/kg per day (240 times the human exposure
based on surface area) and 50 mg/kg per day (20 times
the human exposure based on surface area),
respectively, did not reveal teratogenic effects.
SIMVASTATIN
ü No teratogenic effects were observed in rats or rabbits
given simvastatin at doses of 25 mg/kg per day (6 times
the human exposure based on surface area) and 10
,mg/kg per day (4 times the human exposure based on
surface area), respectively.
 Efficacy of Low-Dose STATIN (LOVASTATIN)

ü The statins have a proven track record of safety and

effectiveness in millions of patients around the world. But
for OTC use, the safety and efficacy of a low-dose statin
must be studied in a patient population that includes those
most likely to use the product without consulting a
physician. The recent study by Larouche et al. addressed
this question directly.
ü blinded, placebo-controlled, randomized, parallel-group,
Multicenter, clinic-based study included 210 patients with
characteristics of the anticipated target population for OTC
statins:
– Men were 45 years or older.
– Women were 55 years or older or naturally
postmenopausal.
– Patients had no heart disease (myocardial infarction or
angina).
ü Patients’ low-density lipoprotein (LDL)-cholesterol
values, based on the average of two determinations,
were between 125 and 165 mg/dL.
Several conclusions can be reached based on the results of
the Larouche study

ü Six weeks of dietary therapy and 12 weeks of lovastatin

10 mg/day produced lipid changes from baseline that
were all significantly better than those of placebo.
ü The magnitude of lipid changes from lovastatin 10
mg/day were comparable with a clinic-based, placebo-
controlled study and other open-label studies simulating
the nonprescription use of lovastatin in OTC settings.
ü The beneficial changes to lipid profiles were obtained in
a patient population similar to that likely to use
lovastatin in nonprescription settings.
ü Lovastatin 10 mg/day was well tolerated, with a side
effect profile similar to that of placebo.
Over the Counter Medication
(OTC)
ü Over-the-counter (OTC) pharmaceuticals are medicines
that are available to the consumer for purchase without a
prescription from a physician.OTC pharmaceuticals are
subdivided into two segments
• Those that need to be purchased from a pharmacy under
pharmacist supervision,
• Those that are available freely,
Increase In Self medication

90%
80%
70%
60%
Percent

50%
40%
30%
20%
10%
0%
Take an OTC Wait t i ll c ur e Consul t Tak e Take diet r y Chang e di et
medi cat ion i t sel f physic ian pr escr ipt i on suppl ement s
medi cat i on
Factors
 India OTC Market
India OTC pharmaceutical market
YEAR $BILLION INRBILLION % GROWTH
10 8.6
8.2
2000 1.6 72.5 7.4
8
6.3 6.4

%GROWTH
2001 1.7 77 6.3
6
2002 1.8 82 6.4
4
2003 2 88.7 8.2
2
2004 2.1 96.3 8.6
0
TOTAL 200-2004 CAGR 7.4
YEAR 2000 2001 2002 2003 2004

India OTC Market Forecast

INDIA O T C m a r k e t f o r e c a s t
Year $Billion INR billion % Growth 10
9 8.6 8.7
2004 2.1 96.3 8.6 7.7
8 7.1
6.6
2005 2.3 104.7 8.7 7 6.2
% Growth

6
2006 2.5 112.7 7.7
5
2007 2.7 120.7 7.1 4
3
2008 2.8 128.7 6.6
2
2009 3 136.7 6.2 1
0
CAGR 2004-2009 7.3 2004 2 0 0 5 Y e a r2 0 0 6 2007 2008 2009

Source: data monitor 2005

 Future drivers of OTC Pharmaceutical Market

Dual regulatory
status
Health care Rx to OTC
cost containment switch activity

Future drivers

Emergence
Impact of
of new indication
technology
Increase in
self care medication
What is Rx to OTC switch?
ü This refers only to OTC marketing of a product that was
once a prescription drug product for the same indication,
strength, dose, duration of use, dosage form, population,
and route of administration.

ü Rx-to-OTC switching increases the number of drugs

available OTC and ensures that the drugs are available
for self-medication, without the prescription from a
physician or a pharmacist supervision. Rx-to-OTC
switching has been the dominant factor in the growth of
the OTC market in recent years.
Rational for switches
Reasons why pharmaceutical companies decide to pursue
switches from prescription (Rx) to over-the-counter
(OTC) status for their drugs.
ü Extending revenue generated by a drug (life-cycle
management)
ü Development of a defense strategy against generic
competitors
ü Expansion and growth of an OTC drug portfolio
ü And broadening consumer access to innovative OTC
medication
 Rxo OTC switch activity in USA
10
9
8

No of switches
6

0
Year

Rx to OTC switches in US 1976-2004

Cumulative switches world wide

Drivers for Rx-to-OTC switching

Revenue protection

Patent expiry
Drivers for
Rx to OTC switching

Extension of PLC

Umbrella branding

List of Rx to OTC Switches

Revenue protection
Patent expiry

ü A primary reason for switching a drug to OTC status is to

maintain the revenue stream of the drug even after it
has lost patent protection. Companies incur huge costs
in the drug development process and, when the product
patent expires, generic companies are likely to introduce
cheaper versions of the same molecule and the
discoverer is likely to lose market share, as some
customers switch to the low cost generics.
Extension of product life

ü The entry of a more effective product or technology can

also lead to a decline in the sales value of a prescription
drug, which may also prompt a switch to OTC status as
a possible treatment for less serious conditions

Timing consideration for lifecycle management strategies

Umbrella branding
ü Umbrella branding refers to the process of launching an
OTC brand with the same brand name for a drug that
was previously available through prescription only. This
is also a driver for Rx-to-OTC switches where some
drugs are switched to OTC status in order to
complement a company’s existing product portfolio.
Steady growth for BEPANTHEN
 Differences in Rx to OTC status from country to
country?

ü Different traditions
ü Different situations for initiating a switch
ü Different procedure
ü Different political support
ü Different level of information / education of the patient

Conservative Moderate Progressive

Italy USA Australia
France Germany New Zealand
Japan China UK
Canada
Regulatory Consideration
ü The decision to make a drug available over the counter
and, in particular, to change the status of a drug from
prescription-only to over-the-counter availability raises
questions relevant to the quality of health care, patients'
access to drugs, patients' autonomy, and the cost of
health care. Approval of over-the-counter status for a
drug requires an assessment by the Food and Drug
Administration (FDA) that the drug is safe and effective.

ü The 1951 Durham–Humphrey Amendment provided a

statutory basis and specific criteria for differentiating
prescription from over-the-counter drugs. The
amendment includes three explicit considerations.
ü It specifies that habit-forming drugs must be available
only by prescription
ü Drugs that can be used safely only under the supervision
of a licensed health care practitioner also require a
prescription
ü If a drug has been approved as the result of a new drug
application for use under professional supervision, then
its purchase requires a prescription

The regulatory requirements for drug approval were further

expanded by the Kefauver–Harris Amendments of 1962,
which require the FDA to assess the efficacy as well as
the safety of new drugs
Switching Procedures in the EU

The European Switching Guideline consists of two parts:

ü Part I: addresses criteria for classifying medicinal

product as Rx or Non-Rx (OTC)
ü Part II: outlines data requirements for a switch
application
Part I: Criteria for Product Classification (Rx or not)

Criterion 1: “Medicinal products shall be subject to medical

prescription when they are likely to present a danger
either directly or indirectly, even when used correctly, if
utilized without medical supervision." several factors
should be taken into consideration:
ü The direct danger or safety profile
ü Indirect danger or safety profile
ü self-assessment
ü risk and consequences of incorrect use
ü patient information
Criterion 2: “Medicinal products shall be subject to medical
prescription when they are frequently and to a very wide
extent used incorrectly, and as a result are likely to
present a direct danger to human health.”
Criterion 3: “Medicinal products shall be subject to medical
prescription when they contain substance or
preparations thereof the activity and/or side-effects of
which require further investigation.”
Criterion 4: “Medicinal products shall be subject to
medicinal prescription when they are normally prescribed
by a doctor to be administered parenterally (for
injection)”.
ü Maximum dose
ü Maximum daily dose
ü Strength
ü Pharmaceutical form
ü Certain types of packaging and/or other circumstances of use
Part 2: Data Requirements for Switching Procedures in
EU

In the EU, the main criteria facilitating a switch are

safety and efficacy data. The amount of data needed for
an application is related to the nature of the active
substance.
ü Expert report
ü Safety Information
ü Efficacy
ü Product information
ü Other information such as a change in the packaging
that might have an effect on the product
 Switching Procedures in the US
Exception
ü OTC status and/or switching criteria in the US are similar to
those in the EU. The “switch regulation” in the US was
promulgated by FDA in 1956. As in the EU, if public health is
not at risk, FDA can exempt an NDA drug from prescription
status. Switches can also be achieved via the OTC
monograph process.
Supplements
ü A switch can be made via a NDA or a NDA supplement
submitted to CDER’s new drug review divisions and
reviewed conjointly with the OTC drug division. Three
criteria apply for a switch via a supplement:
• The product should have been on the market for at least three years.
• The product usage was high enough to enable a fair estimation of any
adverse effects.
• Adverse reactions and their frequency have not increased during the
assessment period.
Monographs
ü The third possibility is via the monograph route.
Switches can be made before final monograph
publication if the product is recommended for category I
and there is no objection from the commissioner,
according to the “rush-to-market” regulation. For
category III products or in cases where the
commissioner raises an objection, OTC status is not
allowed.
Rx to OTC switch procedure in us
Sponsor contacts DOTCDP and request meeting

Initial ,meeting ID issues sponsor will need to address

address

Sponsor submits NDA to DOTCDP

DOTCDP notifies division responsible for therapeutic/ pharmacological

pharmacological class

NDA review team is formed within 14 days, generally includes

medical,pharmacotoxilogical,chemistry,biostastical,biopharmacological,project
medical,pharmacotoxilogical,chemistry,biostastical,biopharmacological,project management and
drug safety.

Meetings between FDA and sponsor continue during review process

Advisory committee meetings

Labeling content and format

Switch decision
Yes

Post approval sponsor safety reporting

ü To approve a reclassification to OTC status, FDA
reviewers must find that,
• A drug is safe and effective in its proposed use(s),
• The benefits of the drug outweigh its risks, and
• Consumers will be able to use the drug’s labeling (e.g.,
its package insert) to safely use the medication in an
OTC setting.
NDA drug Monograph Review Process
OTC Drug Monograph Review Process
Potential Benefits & risk
ü Benefits
• Increased Access to Effective Drugs
• Decreased Frequency of Visits to Physicians and Lower Health
Care Costs
• Increases in Patients' Autonomy and Education
• Decrease cost to third party payers
• Improved education of consumers.

ü Risks
• In accurate diagnosis by patients, based on symptoms
• Delay in obtaining need therapy
• Use of sub optimal therapy
• Increases resistance to anti microbial agents as a result of in
appropriate use
• Increased cost to patient
• Failure to follow label instruction and warnings
• Perceived loss of control by physician
 Groups Affected
By Rx to OTC switch
Consumer who uses it
ü Patients may have easy access for the medicine and at
affordable prices
ü cost savings to consumers result from reduced physician
office visits.
ü The benefits to consumers from switching drugs from
prescription to OTC must be weighed against the very
real costs of the switch(es).These costs include
• The costs of inappropriate self-medication, over- or under-
medication, adverse reactions,
• failure to obtain appropriate medical attention,
• The increased costs of medication because the drug is no longer
covered under a health insurance plan.
Pharmaceutical Companies
ü The impact of the Rx-to-OTC switch movement on
Pharmaceutical companies is almost entirely positive.
ü Switch drugs offer greater market opportunities to the
manufacturers for a number of reasons
• Drugs which reach the end of their patent life usually experience a
25 - 40 % drop in sales as Generics enter the market (Winters and
Freeman; 1990). Moving these drugs to OTC offers
• Protected market expansion opportunities;
• Switch drugs often experience significantly expanded markets
• Switching bypasses the intermediary agents of the physician and
pharmacist, removing the “detailing” costs associated with
marketing prescription drugs. These detailing costs can exceed
$5,000 per physician per year for a single company.
• Switching may eliminate some of the pricing constraints created by
third-party reimbursement Programs
We can see how it can be beneficial to pharmaceutical
companies

Source: Data monitor 2004

Physicians
ü The increasing presence of OTCs affects physicians both
professionally and economically. Professionally,
physicians are faced with the challenge of treating
patients who are likely to be self-treating with one or
more OTC medications.
Pharmacist
ü The overall impact of the Rx-to-OTC switch movement
on pharmacists is unclear. While there is strong potential
for the switch movement to enhance the professional
role of the pharmacist, there are so potentially negative
economic implications as well
ü The Rx-to-OTC switch movement could benefit the
pharmacy profession by placing pharmacists in a position
of providing more advice and counseling.

ü The presence of more effective (but also more risky)

OTC medications allows pharmacists to assume a greater
role in the treatment of patients by counseling them
regarding choice of OTC as we be the appropriateness of
seeking further medical attention.
Strategic Perspective by Cases
REVITAL the Re-Vitalizing OTC:
ü Ranbaxy's Revital successfully shifted from prescription
to OTC and became a market leader. There is more to
Revital than just a combination of vitamins, minerals and
ginseng. This is one of the top brands from the Ranbaxy
that made a successful transition from prescription to
OTC markets in India.
ü Ranbaxy chose Grey Worldwide to work on the brand
during the transition of Revital from prescription to OTC.
The challenge was to craft an appeal, which would
successfully launch Revital in the OTC segment, by
moving from a relatively serious image of Revital,
without alienating the already huge base of loyal user
and at the same time energising the sales curve with
new regular users.
ü Grey Worldwide came up with a series of ads for Revital.
First phase of communication had 3 television
commercials called the Wake up ad, the bhangra ad and
the Govind ad. Each sought to demonstrate the pre &
post usage and benefit scenario of Revital, where in
intake of Revital helped reduced all signs of fatigue and
weakness.
ü The second phase of television ad the Husmukhbhai
campaign, wherein the puppet portrayal of an everyday
man named Husmukhbhai is seen able to make the most
out of life even after a hectic day of work which his
friends and colleagues are unable to because
Husmukhbhai is a revital user unlike others
U.K switch study of ZOCOR Heart pro (SIMVASTATIN)

Back ground

ü Third class of BTC drugs exists in UK known as P “Pharmacy”class

ü Patent expired in 2003 on Zocor in the U.K.
ü Cardiovascular disease represents a significant expenditure for the
National Health Service (NHS) in U.K.
ü NHS issues Strategic Plan in 2002 where it seeks more products to
be made available without a prescription to improve patients acc ess
to medicines and decrease spending on Rx drugs
ü Merck Sharp & Dohme(MSD) was granted approval for switch of 10
mg ZOCOR HEART PRO from POM to P status in May 2004
ü First statin in the world available without a prescription
ü The joint venture Johnson & Johnson-MSD launched ZOCOR HEART
PRO in July 2004
ü All doses of ZOCOR higher than 10mg remain POM.
Indication and usage

ü For patients at moderate risk of a major coronary event (those between

10% and 15% in 10 years)
ü Risk factors include age, weight, family history, smoking, lifestyle, etc.
ü For men aged 45 and over and women aged 55 and over
ü The drug is intended to prevent a major coronary event (such as a heart
attack) and coronary heart disease (CHD)deaths in patients at moderate
risk
ü It is positioned as a drug to help reduce risk of CHD and should be used
preventively.

Factors that led to switch

ü UK NHS committed to the switch to increase public awareness about

elevated cholesterol risks and reduce Rx drug expenditures
ü The P class of medicines allows for patient and pharmacist
interaction/consultation
ü MSD had sufficient evidence to support its switch application
ü Cardiovascular drugs one of the most costly Rx drug classes in the U.K.
 Not all stakeholders convinced of ZOCORHEART
PRO’s suitability as an OTC.

ü Physicians are concerned about efficacy at such a low dose

ü Price point is relatively high for British consumers (₤15 to ₤10)
ü Rx statins remain reimbursed so there is incentive for patients to
seek an Rx
ü P status requires patients to complete a risk factor questionnaire
with a pharmacist before medication is dispensed
ü Some sentiment among British consumers that the switch was
driven by purely financial reasons and not necessarily in the interest
of public health.
Conclusion
ü Opportunities for switches in UK fueled by NHS Strategic plan to make
more medications available without a prescription
ü Cost savings for NHS may not be realized in this case since many
patients will continue to seek the advice of physicians and use Rx
medications
ü Actual use data on Zocor Heart Pro and its effects on public cardio
health are anticipated
ü P class of medications creates a “middle ground” for drugs and makes
more switches feasible

Annual cost of cholesterol control

$900
$800
$700
$600
$500
$400
$300
$200
$100
$0
prescription suggested likely eventual
mevacor list price discount generic
price price

Annual cost of cholesterol control

Data Analysis
 Secondary data analysis
COMPONENTS OF TREND

Cost per Prescription 3.9%

Inflation 5.6%
Units per Prescription -0.5%
Brand/Generic Mix 0
Therapeutic Mix -1.1%
Utilization 16.0%
Prevalence 13.0%
Intensity 2.6%
New Drugs 0.4%
TOTAL 20.9%
KEY FACTS

PMPY $81.76
Rx PMPY 0.97
Prevalence of Use 10.3%
Average Cost/Rx $84.62
Rx/User/Year 9.38
 Anti hyperlepidemic market share trend project trend

70 25

% growth projected
60 lipitor
20
% prescription

50 zocor
40 paravachol 15
30 zetia 10
20 generics
5
10 crestor
0 0
2000 2001 2002 2003 2004 2002 2003 2004 2005 5006 2007 2008 2009 2010
year year

Market share trend projected trend

Source: Drug trend report 2004 Source: drug trend report 2004
 FIBRATES
9%
OTHERS
2%

STATIN
89%
FIBRATES OTHERS STATIN

Total market for cholesterol reducers

Source: ORG –Ims 2005

Lipitor (Pfizer) 12
Zocor (MSD) 5.9
Plavix (BMS)
5
Zyprexa (Lilly) 4.8
Norvasc (Pfizer)
4.8
Nexium (AstraZeneca 4.8
Seretide (GSK)
4.7
Erypo (J&J) 4
Ogastro (Abbott)
3.8
Zoloft (Pfizer)
3.7
Efexor (Wyeth) 3.7
Risperdal (J&J)
3.5
Celebrex (Pfizer) 3.3
Fosamax (MSD)
3.2
Neurontin (Pfizer)
0
3 15

sale of STATIN Source: IMSHealth, 2004

Brand Val(L) Gr%(A) TOB BRAND BY VAL OF LOVASTATIN
250
LOSTATIN 200.81 18.0- 200.81
200
ROVACOR 128.49 41.6-
AZTATIN 36.72 29.7-

VALUE(L)
150 128.49
RECOL 35.82 31.7-
100
LOCHOL 23.63 27-
36.72 35.82
LOVAMEG 4.54 61- 50

LOVAMEG 4.45 2.3

0
LOVACARD 1.53 55.1-

ROVACOR

LOVACARD
LOVAMEG

LOVAMEG
RECOL

LOCHOL

SATIN
LOSTATIN

AZTATIN

LIPISTAT
LIPISTAT 0.85 71.0-
SATIN 0.08 17.8- BRAND

LOVASTATIN brands by value and growth

Brand Val(L) Gr%(A)

TOB BRAND BY VAL OF SIMVASTATIN
SIMVOTIN 1281.18 0.1 1400 1274.43
ZOSTA 1274.43 60.5 1200 1281.18
952.59
1000

VALUE(L)
SIMCARD 952.59 11.4
800
SIMVAS 489.85 20.3
600
SIMLO 274.67 6.3
400
SIMVOFIX 155.01 150.1 200
SIM 103.54 59.8 0
VASTATIN 98.9 0.6

RD
IN

IX

AT
L
LO

IN
M
S
A

TO
VA
T

F
ST

SI

AT

ST
CA

M
VO

VO
SIMVASTOL 89.39 18.9-

S
M
ZO

SI

ST

M
VA
M
M

M
SI

SI
SI

VA
SI

SI

M
SIMSTAT 63.71 32.8- BRAND

SI
SIMVASTAIN brands by value and growth
 TOB BRAND BY VAL OF ATROVASTATIN
Brand Val(L) Gr%(A)
STROVAS 2360.01 52.5 2500
ATROVA 2012.92 42.8 2000
ATOCOR 1186.08 54.6

VALUE(L)
1500
AZTOR 1144.41 22.2
TONACT 1063.83 56 1000
TG-TOR 965.52 34.1 500
ATORLIP 909.07 32.3
LIPICOR 766.95 37.3
0

EC
P
TG T
OR
OR

TO R
S

VA

CO

AS
C

LI
VA

TO
AVAS 675.26 22

NA

OR
OR
-T
RO

OC

AV
PI
RO

AZ

AT
LI
AT
AT

AT
ATOREC 281.48 52.7 BRAND

ST
ATROVASTATIN brands by value and growth
 Primary data analysis

1 According to you what is the age when risk to increase in cholesterol

level is greater?

Age when risk to increase in cholesterol level is greater

Age group % response
80
70 70
0-20 0

% RESPONSE
60
20-40 7.5
50
40-60 70 40
30
60-80 22.5
22.5
20
7.5
10 0 0 0
80-100 0
0
AGE
>100 0 0-20 20-40 40-60 60-80 80-100 >100
2. What do you generally prescribe them at first time of visit?

PREFERENCE Total

statin
s Fibrates Others
DOCTOR Cardiologist 16 5 6 27
GP 5 5 3 13
Total 21 10 9 40

Chi square test:

Asymp. Sig. (2-

Value df sided)
Pearson Chi-Square
2.122(a) 2 .346

Likelihood Ratio 2.074 2 .355

Linear-by-Linear Association
.608 1 .436

N of Valid Cases 40
Findings and conclusion
ü There is no any significance difference between the two class of
doctors that is cardiologist and general physician for preference of
statin. So we can say that although statin is most important class
of drug for treatment of hyperlipidemia but their preference is
same in both class of doctors. So for launching OTC statin
company should give emphasize on both general physician as well
as cardiologist

PREFERENC E FOR ST A T IN

16
14
12
10 16
C OUNT 8
6
4 6 5
5 5
2 3
0
C ardiologis t GP
T YPE OF DO C T ORS
 Prefernce for statin

GENERIC NAME % RESPONSE 35

29.03
30
ROSUVASTATIN 14.05 25

%Response
20 17.33 16.62
LOVASTATIN 12.41
15
SIMVASTATIN 17.33 10
5
PARAVASTATIN 16.62 0
1
FLUVASTATIN 10.53 m olecule

ATROVASTATIN 29.03 ROSUVA STA TIN LOVASTATIN SIM VASTATIN PARAVASTATIN FLUVA STA TIN ATROVASTATIN

Prefernce for statins in percentage :

SAMPLE SIZE: 40

Pre fe rnce in cardiologist

Generic Name % Response 30 28.57

25
ROSUVASTATIN 13.66
20 17.70
LOVASTATIN 13.04 % Doctor
15
SIMVASTATIN 17.7 10

PARAVASTATIN 16.45 5
0
FLUVASTATIN 10.55 M ole cule

ROSUV A STA TIN LOV A STA TIN SIM V A STA TIN

ATROVASTATIN 28.57 PA RA V A STA TIN FLUV A STA TIN A TROV A STA TIN

Preference for Statins in Cardiologist:

Sample Size: 27
 Prefernce in general practioner
40
Generic Name % Response
29.25
30
ROSUVASTATIN 14.96

% Doctor
20 17.68
LOVASTATIN 11.56 14.96

SIMVASTATIN 16.32 10
PARAVASTATIN 17.68
0
Molecule
FLUVASTATIN 10.2
ROSUVASTATIN LOVASTATIN SIMVASTATIN
ATROVASTATIN 29.25 PARAVASTATIN FLUVASTATIN ATROVASTATIN

Preference for Statins in General practioner:

Sample Size: 13
 4. Are you aware of Rx to OTC switches?

Respondents Total
General
practioner
Cardiologist s
Awareness yes 19 8 27

no 7 6 13

Total 26 14 40

Asymp. Sig. (2- Exact Sig. (2- Exact Sig. (1-

Value df sided) sided) sided)
Pearson Chi-Square 1.053(b) 1 .305
Continuity Correction(a) .452 1 .501
Likelihood Ratio 1.035 1 .309
Fisher's Exact Test
.480 .249

Linear-by-Linear Association 1.027 1 .311

N of Valid Cases 40

Chi-Square Tests result for Awareness of Rx to OTC switches

 Aw are ne s s for Rx to OTC sw itches

20 19

15

Coun t 10 8
7
6
5

0
Cardiologist GP

There is not any significance difference between the two variables

cardiologist and general practioner about the awareness of Rx to OTC
switch so we can say that both class of doctor are same aware from Rx
to OTC switches. so again for implementing marketing strategies for Rx
to OTC Statin, company should go for more awareness to both class of
respondents; cardiologist as well as general practioners.
 5. Do you think Rx to OTC switch for STATIN will be ..

Advantage of OTC statin

25
22.37 21.67
Factors % Doctor 19.58
20
Company 18.18

% Doctor
15
Consumer 18.18
10
Availability 22.37
5
Product life cycle 21.67
0
Safe and effective 19.58
company consumer availability product lif e cycle saf e and ef f ecit ve

Advantage of OTC statin: for general practioners

Sample size: 6

20.6 20.52 Advantage of OTC statin

Factors % Doctor 20.4

20.2
Company 20.52 20 20

% Doctor
20
Consumer 19.73 19.73
19.8

Availability 20 19.6

19.4
Product life cycle 20
19.2
Safe and effective 19.73 company consumer availability product life cycle safe and effecit ve

Advantage of OTC Statin: for cardiologist

Sample size: 19
6. What do you think for OTC STATIN in the low-
low-to-
to-moderate risk group?
ANOVA TABLE

4 .5
O T C s t a t in in lo w t o m o d e r a t e r is k

3 .5

3
Mean value

2 .5

1.5

0 .5

0
1 2 3 4 5 R e s 6p o n d 7
e n ts 8 9 10 11 12 13
ü From applied statistical tool one way ANOVA and on the
bases of the results obtained there can be seen
significance difference in the opinion of two class of
doctor for the factor like,
ü Risk of inadequate treatment with OTC statins could lead
to accidents
ü The generic versions be better priced than an OTC statin
ü For them significance difference is like .040 and .028
respectively which is less than probability significance
value .05.
 Conclusion&
Recommendation
ü The benefits of OTC statins must be weighed against the
potential side effects. The patient might experience
statin side effects due to taking more than the
recommended dose, their health condition, or because of
drug interactions. These side effects can include
headache, nausea, vomiting, constipation, diarrhea,
rash, muscle pain, and weakness. Statins are commonly
related to muscle problems such as Myopathy, Myalgia,
and Rhabdomyolysis.
ü Patient education is crucial as prescription statins such
as Simvastatin go OTC. The patient should be
adequately educated and informed about the possible
side effects and risks of the medications. Regular
monitoring of lipid levels, avoiding under- or overuse of
statins, correct dosing, monitoring drug interactions, and
health conditions are key factors that can help minimize
the adverse effects of statins.
ü If the company has consumer marketing expertise
(either internally or through a marketing partner), has
adequately built the drug’s brand name among
healthcare professionals and consumers, has and will
continue to invest in significant levels of advertising and
promotional campaigns, and has adequate arrangements
with retailers for widespread distribution and promotion,
the switch is most likely to be carried out and sustained
successfully.
ü Consumer trends will also continue to shape the future
of Rx-to-OTC switches as the baby boomer generation
ages and demands more self-medication options.
Furthermore, some of the financial incentives recently
presented to consumers, such as the use of flexible
spending accounts to pay for OTCs, could increase the
demand for new, innovative OTCs.
ü The success of an Rx-to-OTC switch is dependent on
several factors, the most important of which are timing
of market entry; providing a safe, effective, easy-to use
product that consumers need; having a brand name that
is recognizable; gaining market exclusivity; and providing
a clear, consistent marketing message that
communicates product advantages and sustains repeat
purchases of the product.
ü What will be success ratio in Indian pharma for Rx to
OTC switches?
ü Good for patient in primary prevention. OTC statin will
both increase public awareness about high cholesterol
and encourage people with moderately-elevated
cholesterol levels (who don’t often seek treatment) to do
something about it.
 Product

Efficacy
·Safety
·Ease of use
·Advantages/claims
·Brand awareness

Regulatory Company
·Defines clear strategy for
brand
Sufficient clinical evidence to ·Communicates consistent
·Support approval marketing message
·Lack of political or moral Rx-to- ·Ability to sustain large-scale
issues to Impede approval OTC advertising and promotion
·Clinical evidence to support 3- campaign
year Hatch–Waxman market Switch
·Retail relationships adequate
Exclusivity success for smooth launch and
widespread distribution
·Consumer marketing expertis
Market

·First to market/early to
market
·Reasonable price point
·Consumer need and
demand
·Repeat purchases likely

Rx-to-OTC Switch success

Model for OTC

Questionnaire
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