Analysis of Prescription Drug to Over Analysis of Prescription Drug to Over The Counter (Rx to OTC) Switch The Counter (Rx to OTC) Switch

Movement:Movement:A Strategic Review With Reference A Strategic Review With Reference

To Statins.To Statins.

Presented by: Vipul DholiaMBA(Pharm)NIPER

Reason for studyReason for study

üü The trend for seeking advice from a doctor or medical The trend for seeking advice from a doctor or medical practitionerpractitioner

üü Approximately 800 overApproximately 800 over--thethe--counter (OTC) products counter (OTC) products currently available use ingredients and dosages available currently available use ingredients and dosages available only by prescription 20 years ago. There are a number of only by prescription 20 years ago. There are a number of possible reasons for this trend, including:possible reasons for this trend, including:

•• A growing emphasis on individual autonomy and selfA growing emphasis on individual autonomy and self--help help

•• Trend toward deregulation in the Health care cost Trend toward deregulation in the Health care cost containment efforts containment efforts

•• Pharmaceutical industry selfPharmaceutical industry self--interest/profit interest/profit

üü ZOCOR heart pro is now a days available in UK as OTC ZOCOR heart pro is now a days available in UK as OTC and it is beneficial for patients in primary prevention of and it is beneficial for patients in primary prevention of disease.disease.

Research Gaps & ObjectiveResearch Gaps & Objective

Gaps: Gaps: üüGiants in UK and USA have entered in market for Giants in UK and USA have entered in market for

This OTC statins and now that’s turn for Indian This OTC statins and now that’s turn for Indian Pharma companies to enter in to this lucrative Pharma companies to enter in to this lucrative Market.Market.üüAvailability of statins as lower price in USA and Availability of statins as lower price in USA and

in UK can it be in India?in UK can it be in India?üüRegulation in India for OTC segmentRegulation in India for OTC segmentüüStill not any availability of OTC statins in India Still not any availability of OTC statins in India

but potential for this segments seems to be highbut potential for this segments seems to be high

Objective:Objective:üü To identify the market potential for statins in India.To identify the market potential for statins in India.üü Concept testing for OTC StatinsConcept testing for OTC Statinsüü Effect of OTC statins in USA,UKEffect of OTC statins in USA,UKüü Strategies that companies can implement in launching of Strategies that companies can implement in launching of

this OTC version of statins.this OTC version of statins.üü Regulatory aspects of OTC statinsRegulatory aspects of OTC statins

MethodologyMethodology

Research methodology of the project involves Research methodology of the project involves following stepsfollowing steps::üü Research design Research design üü Sampling planSampling planüü Data collectionData collectionüü AnalysisAnalysisüü Conclusion and findingsConclusion and findingsüü Case study methodCase study method

STATINSSTATINS

Mechanism of ActionMechanism of Action

üü Based on the inhibition of the hydroxyBased on the inhibition of the hydroxy--methylglutarylmethylglutaryl--coenzymeA (HMGcoenzymeA (HMG--CoA) reductase resulting in the CoA) reductase resulting in the inhibition of cholesterol synthesis in hepatocytes. The inhibition of cholesterol synthesis in hepatocytes. The number of LDL receptors on hepatocytes is increased, number of LDL receptors on hepatocytes is increased, and the elimination of LDL from the blood is enhanced. and the elimination of LDL from the blood is enhanced. Part of the action may be through very lowPart of the action may be through very low--density density lipoprotein (VLDL) or even other mechanismslipoprotein (VLDL) or even other mechanisms..

EffectivenessEffectiveness

üü LDL is decreased by 30 to 40%. LDL is decreased by 30 to 40%. üü HDL is increased by 5 to 15%. HDL is increased by 5 to 15%. üü Triglycerides are decreased by 10 to 30%. Triglycerides are decreased by 10 to 30%. üü Combining statins with resins results in additive effects Combining statins with resins results in additive effects

Safety profile for STATINSafety profile for STATIN

ATORVASTATINATORVASTATIN

üü No evidence of teratogenicity was found in rats at doses No evidence of teratogenicity was found in rats at doses up to 300 mg/kg per day or rabbits at doses up to 100 up to 300 mg/kg per day or rabbits at doses up to 100 mg/kg per daymg/kg per day

FLUVASTATINFLUVASTATIN

üü No evidence of teratogenicity was found in rats or No evidence of teratogenicity was found in rats or rabbits given doses of up to 36 mg/kg and 10 mg/kg per rabbits given doses of up to 36 mg/kg and 10 mg/kg per day, respectively day, respectively

CERIVASTATINCERIVASTATIN

üü No anomalies or malformations were found in rabbits No anomalies or malformations were found in rabbits given 0.75 mg/kg given 0.75 mg/kg

LOVASTATINLOVASTATINüü Studies in mice and rats at doses producing plasma Studies in mice and rats at doses producing plasma

concentrations 40 (mouse fetus) and 80 (rat fetus) times concentrations 40 (mouse fetus) and 80 (rat fetus) times the human exposure found an increased incidence of the human exposure found an increased incidence of skeletal malformations. No changes occurred in rats or skeletal malformations. No changes occurred in rats or mice at multiples of 8 and 4 times, respectively, or in mice at multiples of 8 and 4 times, respectively, or in rabbits at exposures up to 3 times the highest tolerated rabbits at exposures up to 3 times the highest tolerated human exposure. human exposure.

PRAVASTATINPRAVASTATINüü Studies in rats and rabbits given Studies in rats and rabbits given pravastatinpravastatin at doses of at doses of

1000 mg/kg per day (240 times the human exposure 1000 mg/kg per day (240 times the human exposure based on surface area) and 50 mg/kg per day (20 times based on surface area) and 50 mg/kg per day (20 times the human exposure based on surface area), the human exposure based on surface area), respectively, did not reveal respectively, did not reveal teratogenicteratogenic effects.effects.

SIMVASTATINSIMVASTATINüü No No teratogenicteratogenic effects were observed in rats or rabbits effects were observed in rats or rabbits

given given simvastatinsimvastatin at doses of 25 mg/kg per day (6 times at doses of 25 mg/kg per day (6 times the human exposure based on surface area) and 10 the human exposure based on surface area) and 10 ,mg/kg per day (4 times the human exposure based on ,mg/kg per day (4 times the human exposure based on surface area), respectively.surface area), respectively.

Efficacy of LowEfficacy of Low--Dose STATIN (LOVASTATIN)Dose STATIN (LOVASTATIN)

üü The statins have a proven track record of safety and The statins have a proven track record of safety and effectiveness in millions of patients around the world. But effectiveness in millions of patients around the world. But for OTC use, the safety and efficacy of a lowfor OTC use, the safety and efficacy of a low--dose statin dose statin must be studied in a patient population that includes those must be studied in a patient population that includes those most likely to use the product without consulting a most likely to use the product without consulting a physician. The recent study by physician. The recent study by LaroucheLarouche et al. addressed et al. addressed this question directly.this question directly.üü blinded, placeboblinded, placebo--controlled, randomized, parallelcontrolled, randomized, parallel--group, group,

Multicenter, clinicMulticenter, clinic--based study included 210 patients with based study included 210 patients with characteristics of the anticipated target population for OTC characteristics of the anticipated target population for OTC statins:statins:–– Men were 45 years or older.Men were 45 years or older.–– Women were 55 years or older or naturally Women were 55 years or older or naturally

postmenopausal.postmenopausal.–– Patients had no heart disease (myocardial infarction or Patients had no heart disease (myocardial infarction or

angina).angina).

üü Patients’ lowPatients’ low--density lipoprotein (LDL)density lipoprotein (LDL)--cholesterol cholesterol values, based on the average of two determinations, values, based on the average of two determinations, were between 125 and 165 mg/were between 125 and 165 mg/dLdL..

Several conclusions can be reached based on the results of Several conclusions can be reached based on the results of the the LaroucheLarouche studystudy

üü Six weeks of dietary therapy and 12 weeks of Six weeks of dietary therapy and 12 weeks of lovastatinlovastatin10 mg/day produced lipid changes from baseline that 10 mg/day produced lipid changes from baseline that were all significantly better than those of placebo.were all significantly better than those of placebo.üü The magnitude of lipid changes from The magnitude of lipid changes from lovastatinlovastatin 10 10

mg/day were comparable with a clinicmg/day were comparable with a clinic--based, placebobased, placebo--controlled study and other opencontrolled study and other open--label studies simulating label studies simulating the nonprescription use of the nonprescription use of lovastatinlovastatin in OTC settings.in OTC settings.üü The beneficial changes to lipid profiles were obtained in The beneficial changes to lipid profiles were obtained in

a patient population similar to that likely to use a patient population similar to that likely to use lovastatinlovastatin in nonprescription settings.in nonprescription settings.üü LovastatinLovastatin 10 mg/day was well tolerated, with a side 10 mg/day was well tolerated, with a side

effect profile similar to that of placebo.effect profile similar to that of placebo.

Over the Counter Medication Over the Counter Medication (OTC)(OTC)

üü OverOver--thethe--counter (OTC) pharmaceuticals are medicines counter (OTC) pharmaceuticals are medicines that are available to the consumer for purchase without a that are available to the consumer for purchase without a prescription from a prescription from a physician.OTCphysician.OTC pharmaceuticals are pharmaceuticals are subdivided into two segmentssubdivided into two segments

•• Those that need to be purchased from a pharmacy under Those that need to be purchased from a pharmacy under pharmacist supervision,pharmacist supervision,

•• Those that are available freely, Those that are available freely,

Increase In Self medication

0%10%20%30%40%50%60%70%80%90%

Take an OTCmedicat ion

Wait t i ll cureit self

Consultphysic ian

Takeprescr ipt ionmedicat ion

Take diet rysupplement s

Change diet

Factors

Perc

ent

7.4TOTAL 200-2004 CAGR

8.696.32.12004

8.288.722003

6.4821.82002

6.3771.72001

72.51.62000

% GROWTHINRBILLION $BILLIONYEAR

INDIA OT C m ar k e t fo r e cas t

7.16 .6 6.2

8 .67 .7

8 .7

0123456789

10

2004 20 05 2006 2007 2008 200 9Ye a r

% G

row

th

India OTC pharmaceutical market

6.3 6.4

8.2 8.67.4

0

2

4

6

8

10

2000 2001 2002 2003 2004YEAR

%G

RO

WTH

India OTC Market

India OTC Market Forecast

Source: data monitor 2005

7.3CAGR 2004-2009

6.2136.732009

6.6128.72.82008

7.1120.72.72007

7.7112.72.52006

8.7104.72.32005

8.696.32.12004

% GrowthINR billion$BillionYear

Future drivers of OTC Pharmaceutical MarketFuture drivers of OTC Pharmaceutical Market

Future drivers

Increase in self care medication

Dual regulatory status

Impact oftechnology

Rx to OTCswitch activity

Health carecost containment

Emergenceof new indication

What is Rx to OTC switch?

üü This refers only to OTC marketing of a product that was This refers only to OTC marketing of a product that was once a prescription drug product for the same indication, once a prescription drug product for the same indication, strength, dose, duration of use, dosage form, population, strength, dose, duration of use, dosage form, population, and route of administration.and route of administration.

üü RxRx--toto--OTC switching increases the number of drugs OTC switching increases the number of drugs available OTC and ensures that the drugs are available available OTC and ensures that the drugs are available for selffor self--medication, without the prescription from a medication, without the prescription from a physician or a pharmacist supervision. Rxphysician or a pharmacist supervision. Rx--toto--OTC OTC switching has been the dominant factor in the growth of switching has been the dominant factor in the growth of the OTC market in recent years.the OTC market in recent years.

Rational for switchesRational for switches

Reasons why pharmaceutical companies decide to pursue Reasons why pharmaceutical companies decide to pursue switches from prescription (Rx) to overswitches from prescription (Rx) to over--thethe--counter counter (OTC) status for their drugs. (OTC) status for their drugs. üü Extending revenue generated by a drug (lifeExtending revenue generated by a drug (life--cycle cycle

management)management)üü Development of a defense strategy against generic Development of a defense strategy against generic

competitorscompetitorsüü Expansion and growth of an OTC drug portfolioExpansion and growth of an OTC drug portfolioüü And broadening consumer access to innovative OTC And broadening consumer access to innovative OTC

medication medication

Rxo OTC switch activity in USA

9

0

2

4

6

8

10

Year

No o

f swi

tches

Rx to OTC switches in US 1976-2004

Cumulative switches world wide

Drivers for RxDrivers for Rx--toto--OTC switchingOTC switching

List of Rx to OTC Switches

Drivers forRx to OTC switching

Revenue protection

Patent expiry

Extension of PLC

Umbrella branding

Revenue protectionRevenue protection

Patent expiryPatent expiry

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

Extension of product lifeExtension of product life

üü The entry of a more effective product or technology can The entry of a more effective product or technology can also lead to a decline in the sales value of a prescription also lead to a decline in the sales value of a prescription drug, which may also prompt a switch to OTC status as drug, which may also prompt a switch to OTC status as a possible treatment for less serious conditions a possible treatment for less serious conditions

Timing consideration for lifecycle management strategies

Umbrella brandingUmbrella branding

üü Umbrella branding refers to the process of launching an Umbrella branding refers to the process of launching an OTC brand with the same brand name for a drug that OTC brand with the same brand name for a drug that was previously available through prescription only. This was previously available through prescription only. This is also a driver for Rxis also a driver for Rx--toto--OTC switches where some OTC switches where some drugs are switched to OTC status in order to drugs are switched to OTC status in order to complement a companycomplement a company’’s existing product portfolio.s existing product portfolio.

Steady growth for BEPANTHEN

Differences in Rx to OTC status from country to Differences in Rx to OTC status from country to country?country?

üü Different traditionsDifferent traditionsüü Different situations for initiating a switchDifferent situations for initiating a switchüü Different procedureDifferent procedureüü Different political supportDifferent political supportüü Different level of information / education of the patientDifferent level of information / education of the patient

Conservative

Italy

France

Japan

Moderate

USA

Germany

China

Progressive

Australia

New ZealandUK

Canada

Regulatory ConsiderationRegulatory Consideration

üü The decision to make a drug available over the counter The decision to make a drug available over the counter and, in particular, to change the status of a drug from and, in particular, to change the status of a drug from prescriptionprescription--only to overonly to over--thethe--counter availability raises counter availability raises questions relevant to the quality of health care, patients' questions relevant to the quality of health care, patients' access to drugs, patients' autonomy, and the cost of access to drugs, patients' autonomy, and the cost of health care. Approval of overhealth care. Approval of over--thethe--counter status for a counter status for a drug requires an assessment by the Food and Drug drug requires an assessment by the Food and Drug Administration (FDA) that the drug is safe and effective.Administration (FDA) that the drug is safe and effective.

üü The 1951 DurhamThe 1951 Durham––Humphrey Amendment provided a Humphrey Amendment provided a statutory basis and specific criteria for differentiating statutory basis and specific criteria for differentiating prescription from overprescription from over--thethe--counter drugs. The counter drugs. The amendment includes three explicit considerations. amendment includes three explicit considerations.

üü It specifies that habitIt specifies that habit--forming drugs must be available forming drugs must be available only by prescriptiononly by prescriptionüü Drugs that can be used safely only under the supervision Drugs that can be used safely only under the supervision

of a licensed health care practitioner also require a of a licensed health care practitioner also require a prescriptionprescriptionüü If a drug has been approved as the result of a new drug If a drug has been approved as the result of a new drug

application for use under professional supervision, then application for use under professional supervision, then its purchase requires a prescriptionits purchase requires a prescription

The regulatory requirements for drug approval were further The regulatory requirements for drug approval were further expanded by the expanded by the KefauverKefauver––Harris Amendments of 1962, Harris Amendments of 1962, which require the FDA to assess the efficacy as well as which require the FDA to assess the efficacy as well as the safety of new drugs the safety of new drugs

Switching Procedures in the EUSwitching Procedures in the EU

The European Switching Guideline consists of two parts:The European Switching Guideline consists of two parts:

üü Part I: addresses criteria for classifying medicinal Part I: addresses criteria for classifying medicinal product as Rx or Nonproduct as Rx or Non--Rx (OTC) Rx (OTC) üü Part II: outlines data requirements for a switch Part II: outlines data requirements for a switch

applicationapplication

Part I: Criteria for Product Classification (Rx or not)Part I: Criteria for Product Classification (Rx or not)

Criterion 1: Criterion 1: “Medicinal products shall be subject to medical “Medicinal products shall be subject to medical prescription when they are likely to present a danger prescription when they are likely to present a danger either directly or indirectly, even when used correctly, if either directly or indirectly, even when used correctly, if utilized without medical supervision." several factors utilized without medical supervision." several factors should be taken into consideration:should be taken into consideration:

üü The direct danger or safety profileThe direct danger or safety profileüü Indirect danger or safety profileIndirect danger or safety profileüü selfself--assessmentassessmentüü risk and consequences of incorrect userisk and consequences of incorrect useüü patient informationpatient information

Criterion 2: “Medicinal products shall be subject to medical Criterion 2: “Medicinal products shall be subject to medical prescription when they are frequently and to a very wide prescription when they are frequently and to a very wide extent used incorrectly, and as a result are likely to extent used incorrectly, and as a result are likely to present a direct danger to human health.”present a direct danger to human health.”

Criterion 3: Criterion 3: “Medicinal products shall be subject to medical “Medicinal products shall be subject to medical prescription when they contain substance or prescription when they contain substance or preparations thereof the activity and/or sidepreparations thereof the activity and/or side--effects of effects of

which require further investigationwhich require further investigation.” .” Criterion 4: “Medicinal products shall be subject to Criterion 4: “Medicinal products shall be subject to

medicinal prescription when they are normally prescribed medicinal prescription when they are normally prescribed by a doctor to be administered by a doctor to be administered parenterallyparenterally (for (for injection)”.injection)”.

üü Maximum dose Maximum dose üü Maximum daily dose Maximum daily dose üü Strength Strength üü Pharmaceutical form Pharmaceutical form üü Certain types of packaging and/or other circumstances of useCertain types of packaging and/or other circumstances of use

Part 2: Data Requirements for Switching Procedures in Part 2: Data Requirements for Switching Procedures in EUEU

In the EU, the main criteria facilitating a switch are In the EU, the main criteria facilitating a switch are safety and efficacy data. The amount of data needed for safety and efficacy data. The amount of data needed for an application is related to the nature of the active an application is related to the nature of the active substance.substance.üü Expert reportExpert reportüü Safety InformationSafety Informationüü EfficacyEfficacyüü Product informationProduct informationüü Other information such as a change in the packaging Other information such as a change in the packaging

that might have an effect on the productthat might have an effect on the product

Switching Procedures in the USSwitching Procedures in the USExceptionExceptionüü OTC status and/or switching criteria in the US are similar to OTC status and/or switching criteria in the US are similar to

those in the EU. The “switch regulation” in the US was those in the EU. The “switch regulation” in the US was promulgated by FDA in 1956. As in the EU, if public health is promulgated by FDA in 1956. As in the EU, if public health is not at risk, FDA can exempt an NDA drug from prescription not at risk, FDA can exempt an NDA drug from prescription status. Switches can also be achieved via the OTC status. Switches can also be achieved via the OTC monograph process.monograph process.

SupplementsSupplementsüü A switch can be made via a NDA or a NDA supplement A switch can be made via a NDA or a NDA supplement

submitted to submitted to CDER’sCDER’s new drug review divisions and new drug review divisions and reviewed conjointly with the OTC drug division. Three reviewed conjointly with the OTC drug division. Three criteria apply for a switch via a supplement: criteria apply for a switch via a supplement:

•• The product should have been on the market for at least three yeThe product should have been on the market for at least three years. ars. •• The product usage was high enough to enable a fair estimation ofThe product usage was high enough to enable a fair estimation of any any

adverse effects. adverse effects. •• Adverse reactions and their frequency have not increased during Adverse reactions and their frequency have not increased during the the

assessment period.assessment period.

MonographsMonographsüü The third possibility is via the monograph route. The third possibility is via the monograph route.

Switches can be made before final monograph Switches can be made before final monograph publication if the product is recommended for category I publication if the product is recommended for category I and there is no objection from the commissioner, and there is no objection from the commissioner, according to the “rushaccording to the “rush--toto--market” regulation. For market” regulation. For category III products or in cases where the category III products or in cases where the commissioner raises an objection, OTC status is not commissioner raises an objection, OTC status is not allowed.allowed.

Rx to OTC switch procedure in usRx to OTC switch procedure in us

Sponsor contacts DOTCDP and request meeting Sponsor contacts DOTCDP and request meeting

Initial ,meeting ID issues sponsor will need to addrInitial ,meeting ID issues sponsor will need to address ess

Sponsor submits NDA to DOTCDPSponsor submits NDA to DOTCDP

DOTCDP notifies division responsible for therapeutic/ pharmacoloDOTCDP notifies division responsible for therapeutic/ pharmacological classgical class

NDA review team is formed within 14 days, generally includes NDA review team is formed within 14 days, generally includes medical,pharmacotoxilogical,chemistry,biostastical,biopharmacolomedical,pharmacotoxilogical,chemistry,biostastical,biopharmacological,projectgical,project management and management and

drug safety.drug safety.

Meetings between FDA and sponsor continue during review processMeetings between FDA and sponsor continue during review process

Advisory committee meetings Advisory committee meetings

Labeling content and format Labeling content and format

Switch decision Switch decision YesYes

Post approval sponsor safety reportingPost approval sponsor safety reporting

üü To approve a reclassification to OTC status, FDA To approve a reclassification to OTC status, FDA reviewers must find that, reviewers must find that,

•• A drug is safe and effective in its proposed use(s),A drug is safe and effective in its proposed use(s),•• The benefits of the drug outweigh its risks, and The benefits of the drug outweigh its risks, and •• Consumers will be able to use the drug’s labeling (e.g., Consumers will be able to use the drug’s labeling (e.g.,

its package insert) to safely use the medication in an its package insert) to safely use the medication in an OTC setting. OTC setting.

NDA drug Monograph Review Process

OTC Drug Monograph Review Process

Potential Benefits & riskPotential Benefits & risk

üü BenefitsBenefits•• Increased Access to Effective DrugsIncreased Access to Effective Drugs•• Decreased Frequency of Visits to Physicians and Lower Health Decreased Frequency of Visits to Physicians and Lower Health

Care Costs Care Costs •• Increases in Patients' Autonomy and Education Increases in Patients' Autonomy and Education •• Decrease cost to third party payers Decrease cost to third party payers •• Improved education of consumers.Improved education of consumers.

üü RisksRisks•• In accurate diagnosis by patients, based on symptomsIn accurate diagnosis by patients, based on symptoms•• Delay in obtaining need therapy Delay in obtaining need therapy •• Use of sub optimal therapy Use of sub optimal therapy •• Increases resistance to anti microbial agents as a result of in Increases resistance to anti microbial agents as a result of in

appropriate use appropriate use •• Increased cost to patientIncreased cost to patient•• Failure to follow label instruction and warnings Failure to follow label instruction and warnings •• Perceived loss of control by physicianPerceived loss of control by physician

Groups Affected Groups Affected By Rx to OTC switchBy Rx to OTC switch

Consumer who uses itConsumer who uses itüü Patients may have easy access for the medicine and at Patients may have easy access for the medicine and at

affordable pricesaffordable pricesüü cost savings to consumers result from reduced physician cost savings to consumers result from reduced physician

office visits. office visits. üü The benefits to consumers from switching drugs from The benefits to consumers from switching drugs from

prescription to OTC must be weighed against the very prescription to OTC must be weighed against the very real costs of the switch(es).These costs includereal costs of the switch(es).These costs include

•• The costs of inappropriate selfThe costs of inappropriate self--medication, overmedication, over-- or underor under--medication, adverse reactions, medication, adverse reactions,

•• failure to obtain appropriate medical attention,failure to obtain appropriate medical attention,•• The increased costs of medication because the drug is no longer The increased costs of medication because the drug is no longer

covered under a health insurance plan. covered under a health insurance plan.

PharmaceuticalPharmaceutical CompaniesCompanies

üü The impact of the RxThe impact of the Rx--toto--OTC switch movement onOTC switch movement onPharmaceutical companies is almost entirely positive. Pharmaceutical companies is almost entirely positive.

üü Switch drugs offer greater market opportunities to theSwitch drugs offer greater market opportunities to themanufacturers for a number of reasonsmanufacturers for a number of reasons

•• Drugs which reach the end of their patent life usually experiencDrugs which reach the end of their patent life usually experience a e a 25 25 -- 40 % drop in sales as Generics enter the market (Winters and 40 % drop in sales as Generics enter the market (Winters and Freeman; 1990). Moving these drugs to OTC offersFreeman; 1990). Moving these drugs to OTC offers

•• Protected market expansion opportunities;Protected market expansion opportunities;•• Switch drugs often experience significantly expanded markets Switch drugs often experience significantly expanded markets •• Switching bypasses the intermediary agents of the physician and Switching bypasses the intermediary agents of the physician and

pharmacist, removing the pharmacist, removing the ““detailingdetailing”” costs associated with costs associated with marketing prescription drugs. These detailing costs can exceed marketing prescription drugs. These detailing costs can exceed $5,000 per physician per year for a single company.$5,000 per physician per year for a single company.

•• Switching may eliminate some of the pricing constraints created Switching may eliminate some of the pricing constraints created by by thirdthird--party reimbursement Programsparty reimbursement Programs

We can see how it can be beneficial to pharmaceutical We can see how it can be beneficial to pharmaceutical companiescompanies

Source: Data monitor 2004

PhysiciansPhysiciansüü The increasing presence of OTCs affects physicians both The increasing presence of OTCs affects physicians both

professionally and economically. Professionally, professionally and economically. Professionally, physicians are faced with the challenge of treating physicians are faced with the challenge of treating patients who are likely to be selfpatients who are likely to be self--treating with one or treating with one or more OTC medications.more OTC medications.

PharmacistPharmacistüü The overall impact of the RxThe overall impact of the Rx--toto--OTC switch movement OTC switch movement

on pharmacists is unclear. While there is strong potential on pharmacists is unclear. While there is strong potential for the switch movement to enhance the professional for the switch movement to enhance the professional role of the pharmacist, there are so potentially negative role of the pharmacist, there are so potentially negative economic implications as welleconomic implications as well

üü The RxThe Rx--toto--OTC switch movement could benefit the OTC switch movement could benefit the pharmacy profession by placing pharmacists in a position pharmacy profession by placing pharmacists in a position of providing more advice and counseling.of providing more advice and counseling.

üü The presence of more effective (but also more risky) The presence of more effective (but also more risky) OTC medications allows pharmacists to assume a greater OTC medications allows pharmacists to assume a greater role in the treatment of patients by counseling them role in the treatment of patients by counseling them regarding choice of OTC as we be the appropriateness of regarding choice of OTC as we be the appropriateness of seeking further medical attention. seeking further medical attention.

Strategic Perspective by CasesStrategic Perspective by Cases

REVITAL the ReREVITAL the Re--Vitalizing OTC:Vitalizing OTC:

üü Ranbaxy'sRanbaxy's Revital successfully shifted from prescription Revital successfully shifted from prescription to OTC and became a market leader. There is more to to OTC and became a market leader. There is more to Revital than just a combination of vitamins, minerals and Revital than just a combination of vitamins, minerals and ginseng. This is one of the top brands from the Ranbaxy ginseng. This is one of the top brands from the Ranbaxy that made a successful transition from prescription to that made a successful transition from prescription to OTC markets in India. OTC markets in India. üü Ranbaxy chose Grey Worldwide to work on the brand Ranbaxy chose Grey Worldwide to work on the brand

during the transition of Revital from prescription to OTC. during the transition of Revital from prescription to OTC. The challenge was to craft an appeal, which would The challenge was to craft an appeal, which would successfully launch Revital in the OTC segment, by successfully launch Revital in the OTC segment, by moving from a relatively serious image of Revital, moving from a relatively serious image of Revital, without alienating the already huge base of loyal user without alienating the already huge base of loyal user and at the same time energising the sales curve with and at the same time energising the sales curve with new regular users.new regular users.

üü Grey Worldwide came up with a series of ads for Revital. Grey Worldwide came up with a series of ads for Revital. First phase of communication had 3 television First phase of communication had 3 television commercials called the Wake up ad, the commercials called the Wake up ad, the bhangrabhangra ad and ad and the the GovindGovind ad. Each sought to demonstrate the pre & ad. Each sought to demonstrate the pre & post usage and benefit scenario of Revital, where in post usage and benefit scenario of Revital, where in intake of Revital helped reduced all signs of fatigue and intake of Revital helped reduced all signs of fatigue and weakness. weakness. üü The second phase of television ad the Husmukhbhai The second phase of television ad the Husmukhbhai

campaign, wherein the puppet portrayal of an everyday campaign, wherein the puppet portrayal of an everyday man named Husmukhbhai is seen able to make the most man named Husmukhbhai is seen able to make the most out of life even after a hectic day of work which his out of life even after a hectic day of work which his friends and colleagues are unable to because friends and colleagues are unable to because Husmukhbhai is a revital user unlike othersHusmukhbhai is a revital user unlike others

U.K switch study of ZOCOR Heart pro (SIMVASTATIN)U.K switch study of ZOCOR Heart pro (SIMVASTATIN)

Back groundBack ground

üü Third class of BTC drugs exists in UK known as P Third class of BTC drugs exists in UK known as P ““PharmacyPharmacy””classclassüü Patent expired in 2003 on Zocor in the U.K.Patent expired in 2003 on Zocor in the U.K.üü Cardiovascular disease represents a significant expenditure for Cardiovascular disease represents a significant expenditure for the the

National Health Service (NHS) in U.K.National Health Service (NHS) in U.K.üü NHS issues Strategic Plan in 2002 where it seeks more products tNHS issues Strategic Plan in 2002 where it seeks more products to o

be made available without a prescription to improve patients accbe made available without a prescription to improve patients access ess to medicines and decrease spending on Rx drugs to medicines and decrease spending on Rx drugs

üü Merck Sharp & Dohme(MSD) was granted approval for switch of 10 Merck Sharp & Dohme(MSD) was granted approval for switch of 10 mg ZOCOR HEART PRO from POM to P status in May 2004mg ZOCOR HEART PRO from POM to P status in May 2004

üü First statin in the world available without a prescriptionFirst statin in the world available without a prescriptionüü The joint venture Johnson & JohnsonThe joint venture Johnson & Johnson--MSD launched ZOCOR HEART MSD launched ZOCOR HEART

PRO in July 2004PRO in July 2004üü All doses of ZOCOR higher than 10mg remain POM.All doses of ZOCOR higher than 10mg remain POM.

Indication and usageIndication and usage

üü For patients at moderate risk of a major coronary event (those bFor patients at moderate risk of a major coronary event (those between etween 10% and 15% in 10 years)10% and 15% in 10 years)

üü Risk factors include age, weight, family history, smoking, lifesRisk factors include age, weight, family history, smoking, lifestyle, etc.tyle, etc.üü For men aged 45 and over and women aged 55 and overFor men aged 45 and over and women aged 55 and overüü The drug is intended to prevent a major coronary event (such as The drug is intended to prevent a major coronary event (such as a heart a heart

attack) and coronary heart disease (attack) and coronary heart disease (CHD)deathsCHD)deaths in patients at moderate in patients at moderate riskrisk

üü It is positioned as a drug to help reduce risk of CHD and shouldIt is positioned as a drug to help reduce risk of CHD and should be used be used preventively.preventively.

Factors that led to switchFactors that led to switch

üü UK NHS committed to the switch to increase public awareness abouUK NHS committed to the switch to increase public awareness about t elevated cholesterol risks and reduce Rx drug expenditureselevated cholesterol risks and reduce Rx drug expenditures

üü The P class of medicines allows for patient and pharmacist The P class of medicines allows for patient and pharmacist interaction/consultation interaction/consultation

üü MSD had sufficient evidence to support its switch applicationMSD had sufficient evidence to support its switch applicationüü Cardiovascular drugs one of the most costly Rx drug classes in tCardiovascular drugs one of the most costly Rx drug classes in the U.K.he U.K.

Not all stakeholders convinced of ZOCORHEART Not all stakeholders convinced of ZOCORHEART PROPRO’’ss suitability as an OTC.suitability as an OTC.

üü Physicians are concerned about efficacy at such a low dose Physicians are concerned about efficacy at such a low dose üü Price point is relatively high for British consumers (Price point is relatively high for British consumers (₤₤15 to 15 to ₤₤10)10)üü Rx statins remain reimbursed so there is incentive for patients Rx statins remain reimbursed so there is incentive for patients to to

seek an Rxseek an Rxüü P status requires patients to complete a risk factor questionnaiP status requires patients to complete a risk factor questionnaire re

with a pharmacist before medication is dispensedwith a pharmacist before medication is dispensedüü Some sentiment among British consumers that the switch was Some sentiment among British consumers that the switch was

driven by purely financial reasons and not necessarily in the indriven by purely financial reasons and not necessarily in the interest terest of public healthof public health..

ConclusionConclusionüü Opportunities for switches in UK fueled by NHS Strategic plan toOpportunities for switches in UK fueled by NHS Strategic plan to make make

more medications available without a prescriptionmore medications available without a prescription

üü Cost savings for NHS may not be realized in this case since manyCost savings for NHS may not be realized in this case since manypatients will continue to seek the advice of physicians and use patients will continue to seek the advice of physicians and use Rx Rx medicationsmedications

üü Actual use data on Zocor Heart Pro and its effects on public carActual use data on Zocor Heart Pro and its effects on public cardio dio health are anticipatedhealth are anticipated

üü P class of medications creates a P class of medications creates a ““middle groundmiddle ground”” for drugs and makes for drugs and makes more switches feasible more switches feasible

Annual cost of cholesterol control

$0$100$200$300$400$500$600$700$800$900

prescriptionmevacor

suggestedlist price

likelydiscount

price

eventualgenericprice

Annual cost of cholesterol control

Data AnalysisData Analysis

Secondary data analysisSecondary data analysisCOMPONENTS OF TRENDCOMPONENTS OF TREND

Cost per Prescription 3.9%Cost per Prescription 3.9%Inflation 5.6%Inflation 5.6%Units per Prescription Units per Prescription --0.5%0.5%Brand/Generic Mix 0Brand/Generic Mix 0Therapeutic Mix Therapeutic Mix --1.1%1.1%Utilization 16.0%Utilization 16.0%Prevalence 13.0%Prevalence 13.0%Intensity 2.6%Intensity 2.6%New Drugs 0.4%New Drugs 0.4%TOTAL 20.9%TOTAL 20.9%KEY FACTSKEY FACTS

PMPY $81.76PMPY $81.76Rx PMPY 0.97Rx PMPY 0.97Prevalence of Use 10.3%Prevalence of Use 10.3%Average Cost/Rx $84.62Average Cost/Rx $84.62Rx/User/Year 9.38Rx/User/Year 9.38

Anti hyperlepidemic market share trend

010203040506070

2000 2001 2002 2003 2004

year

% p

resc

ript

ion

lipitorzocorparavacholzetiagenericscrestor

project trend

0

5

10

15

20

25

2002 2003 2004 2005 5006 2007 2008 2009 2010

year

% g

row

th p

roje

cted

projected trendSource: drug trend report 2004

Market share trendSource: Drug trend report 2004

Lipitor (Pfizer)

Plavix (BMS)

Zyprexa (Lilly)

Seretide (GSK)

Erypo (J&J)

Ogastro (Abbott)

Zoloft (Pfizer)

Efexor (Wyeth)

Risperdal (J&J)

Celebrex (Pfizer)

Fosamax (MSD)

Neurontin (Pfizer)

Zocor (MSD)

33.23.3

3.53.73.73.8

44.74.84.84.8

55.9

Norvasc (Pfizer)

12

0 15

Nexium (AstraZeneca

sale of STATIN Source: IMSHealth, 2004

STATIN89%

FIBRATES9%

OTHERS2%

FIBRATES OTHERS STATIN

Total market for cholesterol reducersSource: ORG –Ims 2005

TOB BRAND BY VAL OF LOVASTATIN

200.81

128.49

35.8236.72

0

50

100

150

200

250

LOST

ATI

N

RO

VA

CO

R

AZT

ATI

N

REC

OL

LOC

HO

L

LOV

AM

EG

LOV

AM

EG

LOV

AC

AR

D

LIPI

STA

T

SATI

N

BRAND

VA

LUE

(L)

17.8-0.08SATIN

71.0-0.85LIPISTAT

55.1-1.53LOVACARD

2.34.45LOVAMEG

61-4.54LOVAMEG

27-23.63LOCHOL

31.7-35.82RECOL

29.7-36.72AZTATIN

41.6-128.49ROVACOR

18.0-200.81LOSTATIN

Gr%(A)Val(L)Brand

LOVASTATIN brands by value and growth

32.8-63.71SIMSTAT

18.9-89.39SIMVASTOL

0.698.9VASTATIN

59.8103.54SIM

150.1155.01SIMVOFIX

6.3274.67SIMLO

20.3489.85SIMVAS

11.4952.59SIMCARD

60.51274.43ZOSTA

0.11281.18SIMVOTIN

Gr%(A)Val(L)Brand TOB BRAND BY VAL OF SIMVASTATIN

952.59

1274.431281.18

0200400600800

100012001400

SIMVOTI

N

ZOSTA

SIMCARD

SIMVAS

SIMLO

SIMVOFI

XSIM

VASTATI

N

SIMVASTO

L

SIMSTA

T

BRAND

VA

LU

E(L

)

SIMVASTAIN brands by value and growth

52.7281.48ATOREC

22675.26AVAS

37.3766.95LIPICOR

32.3909.07ATORLIP

34.1965.52TG-TOR

561063.83TONACT

22.21144.41AZTOR

54.61186.08ATOCOR

42.82012.92ATROVA

52.52360.01STROVAS

Gr%(A)Val(L)BrandTOB BRAND BY VAL OF ATROVASTATIN

0500

1000150020002500

STROVA

S

ATROVA

ATOCOR

AZTO

R

TONAC

T

TG-T

OR

ATORLIP

LIPIC

OR

AVAS

ATOREC

BRAND

VA

LU

E(L

)

ATROVASTATIN brands by value and growth

Primary data analysisPrimary data analysis

1 According to you what is the age when risk to increase in chol1 According to you what is the age when risk to increase in cholesterol esterol level is greater?level is greater?

Age when risk to increase in cholesterol level is greater

07.5

0 0

22.5

70

01020304050607080

0-20 20-40 40-60 60-80 80-100 >100AGE

% R

ES

PO

NS

E0>100

080-100

22.560-80

7040-60

7.520-40

00-20

% responseAge group

2. What do you generally prescribe them at first time of visit?2. What do you generally prescribe them at first time of visit?

4091021Total

13355GP

276516CardiologistDOCTOR

Others Fibratesstatin

s

TotalPREFERENCE

40N of Valid Cases

.4361.608Linear-by-Linear Association

.35522.074Likelihood Ratio

.34622.122(a)Pearson Chi-Square

Asymp. Sig. (2-sided)dfValue

Chi square test:

Findings and conclusionFindings and conclusionüü There is no any significance difference between the two class ofThere is no any significance difference between the two class of

doctors that is cardiologist and general physician for preferencdoctors that is cardiologist and general physician for preference of e of statin. So we can say that although statin is most important clastatin. So we can say that although statin is most important class ss of drug for treatment of of drug for treatment of hyperlipidemiahyperlipidemia but their preference is but their preference is same in both class of doctors. So for launching OTC statin same in both class of doctors. So for launching OTC statin company should give emphasize on both general physician as well company should give emphasize on both general physician as well as cardiologist as cardiologist

16

5 6 5 53

02468

10121416

C OUNT

Cardiologis t G PT YPE OF DOC T ORS

PREFERENC E FOR ST A T IN

29.03ATROVASTATIN

10.53FLUVASTATIN

16.62PARAVASTATIN

17.33SIMVASTATIN

12.41LOVASTATIN

14.05ROSUVASTATIN

% RESPONSEGENERIC NAME

Prefernce in cardiologist

17.70

28.57

0

5

10

15

20

25

30

Molecule

% D

octo

r

ROSUV ASTA TIN LOVA STATIN SIM VASTA TINPARAV ASTA TIN FLUVA STATIN ATROVA STATIN28.57ATROVASTATIN

10.55FLUVASTATIN

16.45PARAVASTATIN

17.7SIMVASTATIN

13.04LOVASTATIN

13.66ROSUVASTATIN

% ResponseGeneric Name

Prefernce for statins in percentage :SAMPLE SIZE: 40

Preference for Statins in Cardiologist:Sample Size: 27

Prefernce for statin

17.33 16.62

29.03

05

101520253035

1molecule

%R

espo

nse

ROSUVASTATIN LOVASTATIN SIM VASTATIN PARAVASTATIN FLUVASTATIN ATROVASTATIN

Prefernce in general practioner

14.96 17.68

29.25

0

10

20

30

40

Molecule

% D

octo

r

ROSUVASTATIN LOVASTATIN SIMVASTATINPARAVASTATIN FLUVASTATIN ATROVASTATIN29.25ATROVASTATIN

10.2FLUVASTATIN

17.68PARAVASTATIN

16.32SIMVASTATIN

11.56LOVASTATIN

14.96ROSUVASTATIN

% ResponseGeneric Name

Preference for Statins in General practioner:Sample Size: 13

4. Are you aware of Rx to OTC switches?4. Are you aware of Rx to OTC switches?

401426Total

1367no

27819yesAwareness

General practioner

sCardiologist

TotalRespondents

40N of Valid Cases

.31111.027Linear-by-Linear Association

.249.480Fisher's Exact Test

.30911.035Likelihood Ratio

.5011.452Continuity Correction(a)

.30511.053(b)Pearson Chi-Square

Exact Sig. (1-sided)

Exact Sig. (2-sided)

Asymp. Sig. (2-sided)dfValue

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

There is not any significance difference between the two variablThere is not any significance difference between the two variables es cardiologist and general cardiologist and general practionerpractioner about the awareness of Rx to OTC about the awareness of Rx to OTC switch so we can say that both class of doctor are same aware frswitch so we can say that both class of doctor are same aware from Rx om Rx to OTC switches. so again for implementing marketing strategies to OTC switches. so again for implementing marketing strategies for Rx for Rx to OTC Statin, company should go for more awareness to both clasto OTC Statin, company should go for more awareness to both class of s of respondents; cardiologist as well as general respondents; cardiologist as well as general practionerspractioners..

19

8 7 6

0

5

10

15

20

Count

Cardiologist GP

Awareness for Rx to OTC switches

5. Do you think Rx to OTC switch for STATIN will be ..5. Do you think Rx to OTC switch for STATIN will be ..

19.58Safe and effective

21.67Product life cycle

22.37Availability

18.18Consumer

18.18Company

% DoctorFactors

Advantage of OTC statin

22.37 21.67 19.58

0

5

10

15

20

25

% D

octo

r

company consumer availability product life cycle safe and ef fecitve

Advantage of OTC statin: for general practionersSample size: 6

19.73Safe and effective

20Product life cycle

20Availability

19.73Consumer

20.52Company

% DoctorFactorsAdvantage of OTC statin

20 20

20.52

19.73

19.2

19.4

19.6

19.8

20

20.2

20.4

20.6

% D

octo

r

company consumer availability product life cycle safe and effecitve

Advantage of OTC Statin: for cardiologistSample size: 19

6. What do you think for OTC STATIN in the low6. What do you think for OTC STATIN in the low--toto--moderate risk group?moderate risk group?ANOVA TABLEANOVA TABLE

O T C s ta t in in lo w to m o d e r a te r is k

0

0 .5

1

1.5

2

2 .5

3

3 .5

4

4 .5

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3R e s p o n d e n ts

Mea

n va

lue

üü From applied statistical tool one way ANOVA and on the From applied statistical tool one way ANOVA and on the bases of the results obtained there can be seen bases of the results obtained there can be seen significance difference in the opinion of two class of significance difference in the opinion of two class of doctor for the factor like, doctor for the factor like, üü Risk of inadequate treatment with OTC statins could lead Risk of inadequate treatment with OTC statins could lead

to accidents to accidents üü The generic versions be better priced than an OTC statin The generic versions be better priced than an OTC statin üü For them significance difference is like .040 and .028 For them significance difference is like .040 and .028

respectively which is less than probability significance respectively which is less than probability significance value .05.value .05.

Conclusion& Conclusion& RecommendationRecommendation

üü The benefits of OTC statins must be weighed against the The benefits of OTC statins must be weighed against the potential side effects. The patient might experience potential side effects. The patient might experience statin side effects due to taking more than the statin side effects due to taking more than the recommended dose, their health condition, or because of recommended dose, their health condition, or because of drug interactions. These side effects can include drug interactions. These side effects can include headache, nausea, vomiting, constipation, diarrhea, headache, nausea, vomiting, constipation, diarrhea, rash, muscle pain, and weakness. Statins are commonly rash, muscle pain, and weakness. Statins are commonly related to muscle problems such as related to muscle problems such as MyopathyMyopathy, , MyalgiaMyalgia, , and and RhabdomyolysisRhabdomyolysis. . üü Patient education is crucial as prescription statins such Patient education is crucial as prescription statins such

as as SimvastatinSimvastatin go OTC. The patient should be go OTC. The patient should be adequately educated and informed about the possible adequately educated and informed about the possible side effects and risks of the medications. Regular side effects and risks of the medications. Regular monitoring of lipid levels, avoiding undermonitoring of lipid levels, avoiding under-- or overuse of or overuse of statins, correct dosing, monitoring drug interactions, and statins, correct dosing, monitoring drug interactions, and health conditions are key factors that can help minimize health conditions are key factors that can help minimize the adverse effects of statins.the adverse effects of statins.

üü If the company has consumer marketing expertise If the company has consumer marketing expertise (either internally or through a marketing partner), has (either internally or through a marketing partner), has adequately built the drug’s brand name among adequately built the drug’s brand name among healthcare professionals and consumers, has and will healthcare professionals and consumers, has and will continue to invest in significant levels of advertising and continue to invest in significant levels of advertising and promotional campaigns, and has adequate arrangements promotional campaigns, and has adequate arrangements with retailers for widespread distribution and promotion, with retailers for widespread distribution and promotion, the switch is most likely to be carried out and sustained the switch is most likely to be carried out and sustained successfully.successfully.üü Consumer trends will also continue to shape the future Consumer trends will also continue to shape the future

of Rxof Rx--toto--OTC switches as the baby boomer generation OTC switches as the baby boomer generation ages and demands more selfages and demands more self--medication options. medication options. Furthermore, some of the financial incentives recently Furthermore, some of the financial incentives recently presented to consumers, such as the use of flexible presented to consumers, such as the use of flexible spending accounts to pay for OTCs, could increase the spending accounts to pay for OTCs, could increase the demand for new, innovative OTCs.demand for new, innovative OTCs.

üü The success of an RxThe success of an Rx--toto--OTC switch is dependent on OTC switch is dependent on several factors, the most important of which are timing several factors, the most important of which are timing of market entry; providing a safe, effective, easyof market entry; providing a safe, effective, easy--to use to use product that consumers need; having a brand name that product that consumers need; having a brand name that is recognizable; gaining market exclusivity; and providing is recognizable; gaining market exclusivity; and providing a clear, consistent marketing message that a clear, consistent marketing message that communicates product advantages and sustains repeat communicates product advantages and sustains repeat purchases of the product. purchases of the product. üüWhat will be success ratio in Indian pharma for Rx to What will be success ratio in Indian pharma for Rx to

OTC switches?OTC switches?üü Good for patient in primary prevention. OTC statin will Good for patient in primary prevention. OTC statin will

both increase public awareness about high cholesterol both increase public awareness about high cholesterol and encourage people with moderatelyand encourage people with moderately--elevated elevated cholesterol levels (who don’t often seek treatment) to do cholesterol levels (who don’t often seek treatment) to do something about it.something about it.

Regulatory

Sufficient clinical evidence to•Support approval•Lack of political or moral issues to Impede approval•Clinical evidence to support 3-year Hatch–Waxman market Exclusivity

Rx-to-OTC

Switch success

Product

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

Market

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

Company•Defines clear strategy for brand•Communicates consistent marketing message•Ability to sustain large-scale advertising and promotion campaign•Retail relationships adequate for smooth launch and widespread distribution

•Consumer marketing expertis

Rx-to-OTC Switch success

Model for OTCModel for OTC

QuestionnaireQuestionnaire

References:References:üü www.fda.gov/cder/handbook/otcdata.htmlwww.fda.gov/cder/handbook/otcdata.htmlüü www.dietwww.diet--andand--health.net/glossary.htmlhealth.net/glossary.htmlüü www.seekwellness.com/heart/cholesterol/glossary.htmwww.seekwellness.com/heart/cholesterol/glossary.htmüü www.floraglolutein.com/resources_glossarywww.floraglolutein.com/resources_glossaryüü www.drugdigest.org/dd/comparision/new comparision.htmlwww.drugdigest.org/dd/comparision/new comparision.htmlüü Micromedex.uspMicromedex.usp drug information drug information HmgHmg co A.HTMco A.HTMüü Snyder K. Market and consumer trends driving switchSnyder K. Market and consumer trends driving switch--hitters: prescription drugs changing to overhitters: prescription drugs changing to over--thethe--counter status. Drug Topics 1 counter status. Drug Topics 1

l( 141).l( 141).üü LaroucheLarouche SJ, SJ, StrubleStruble WE, Tipping RW. WE, Tipping RW. LovastatinLovastatin 10 mg efficacy in nonprescription studies. Paper presented at: 10 mg efficacy in nonprescription studies. Paper presented at: 2001 Annual 2001 Annual

Meeting of the American Society for Clinical Pharmacology and ThMeeting of the American Society for Clinical Pharmacology and Therapeutics; March 7, 2001; Orlando, erapeutics; March 7, 2001; Orlando, FlaFlaüü http://http://www.chpainfo.org/statistics/otc_sales_by_category.aspwww.chpainfo.org/statistics/otc_sales_by_category.asp..üü OTC sales by category. Washington, D.C.: Consumer Healthcare ProOTC sales by category. Washington, D.C.: Consumer Healthcare Products Association, 2001. (Accessed August 20, 2001, at ducts Association, 2001. (Accessed August 20, 2001, at üü JuhlJuhl RP. Prescription to overRP. Prescription to over--thethe--counter switch: a regulatory perspective. counter switch: a regulatory perspective. ClinClin TherTher 1998;20:Suppl C:C1111998;20:Suppl C:C111--C117C117üü Brewer T, Brewer T, ColditzColditz GA. GA. PostmarketingPostmarketing surveillance and adverse drug reactions: current perspectives asurveillance and adverse drug reactions: current perspectives and future needs. JAMA nd future needs. JAMA

1999;281:8241999;281:824--829829üü RosenauRosenau PV. RxPV. Rx--toto--OTC switch movement. Med Care Rev 1994;51:429OTC switch movement. Med Care Rev 1994;51:429--466466üü Brass EP (2004) Consumer behavior in the setting of overBrass EP (2004) Consumer behavior in the setting of over--thethe--counter statin availability: lesson from the consumer use study counter statin availability: lesson from the consumer use study of of

OTC OTC MevacorMevacor. Am J . Am J CardiolCardiol 94: 22F94: 22F--29F29Füü The International Journal of Pharmacy EducationThe International Journal of Pharmacy Educationüü Fall 2003, Issue 2Fall 2003, Issue 2üü http://apnews.myway.com/article/20040804/D84831AG0.htmlhttp://apnews.myway.com/article/20040804/D84831AG0.htmlüü www.lelava.org/eng/2004www.lelava.org/eng/2004--05.html05.html1. 1. üü Soller RW. OTCness. Drug Inf J. 1997;32:555Soller RW. OTCness. Drug Inf J. 1997;32:555--560.560.üü www.fda.gov US Food and Drug Administration. OTC Treatment of Hywww.fda.gov US Food and Drug Administration. OTC Treatment of Hypercholesterolemia Guidance for Industry. September 1997.percholesterolemia Guidance for Industry. September 1997.üü maximising the drug life cycle business insightmaximising the drug life cycle business insightüü www.mhra.gov.ukwww.mhra.gov.uküü www.pjonlie.com otc statin may change pharmacy for ever.htmlwww.pjonlie.com otc statin may change pharmacy for ever.htmlüü BachrachBachrach, Eve E., The FDA's New Over, Eve E., The FDA's New Over--thethe--Counter Drug OfficeCounter Drug Officeüü and Advisory and Advisory ComitteeComittee: An Industry Perspective, 48 Food & Drug Law Journal: An Industry Perspective, 48 Food & Drug Law Journalüü http://http://www.rpsgb.orgwww.rpsgb.org. . uk/pdfs/otcsimvastatincardguid.pdfuk/pdfs/otcsimvastatincardguid.pdfüü Royal Pharmaceutical Society of Great Britain. Concise version oRoyal Pharmaceutical Society of Great Britain. Concise version of practice guidance on the sale of OTC f practice guidance on the sale of OTC simvastatinsimvastatin. July 2004. . July 2004. üü www.pharmabiz.comwww.pharmabiz.com Does India need more OTC drugs Does India need more OTC drugs -- An IDMA view An IDMA view -- Chronicle Specials.htmChronicle Specials.htmüü Cohen JP, Paquette C, Cairns CP. Switching prescription drugs toCohen JP, Paquette C, Cairns CP. Switching prescription drugs to over the counter. BMJ 2005;330: 39over the counter. BMJ 2005;330: 39--4141üü http://http://www.medicalnewstoday.com/medicalnews.php?newsidwww.medicalnewstoday.com/medicalnews.php?newsid=18471=18471üü www.RXsolutions.com/c/pbi/pbi_Drugwww.RXsolutions.com/c/pbi/pbi_Drug Cost Management Report (online 28 May 2004) UK approval reviewsCost Management Report (online 28 May 2004) UK approval reviews debate on OTC debate on OTC

cholesterol drugs in US cholesterol drugs in US üü http://www.cbsnews.com/stories/2005/01/13/health/main666618.shtmhttp://www.cbsnews.com/stories/2005/01/13/health/main666618.shtmll