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Transcript of 6916984-vipul-dholia-Rx-to-OTC
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