Robert J. Spiegel, M.D. Sr. V. P. Medicinal Issues Boss Therapeutic Officer Schering Furrow.


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For some patients, sensitivities are not fittingly treated without doctor administration ... For some patients, sensitivities are not fittingly treated without ...
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FDA ADVISORY COMMITTEE 5/11/01 Robert J. Spiegel, M.D. Sr. V. P. Therapeutic Affairs Chief Medical Officer Schering Plow

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OVERVIEW For some patients, sensitivities are not properly treated without doctor administration More information are important to bolster this OTC switch in light of one of a kind issues of utilization OTC status will diminish access for some patients, and may not diminish utilization of original against histamines

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OVERVIEW For some patients, hypersensitivities are not fittingly treated without doctor administration Different sorts of antihistamine clients Short-term versus incessant Comorbid infections Cold Use versus Sensitivity Disease Management

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OVERVIEW For some patients, hypersensitivities are not fittingly treated without doctor administration More information are important to bolster this OTC switch in view of novel issues of utilization OTC status will diminish access for some patients, and may not diminish utilization of original antihistamines

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"Information to bolster the OTC change for the most part originates from the accompanying sources: viability trials, wellbeing information, real utilize trials, and name understanding trials … these last two trials could possibly be required relying on whether there are any one of a kind issues identified with use, notices, or bearings that should be tried before promoting ." "The switch of a professionally prescribed medication to OTC advertising requires an audit of the post-showcasing security information and a determination that a customer can enough utilize the item in an OTC setting " FDA OTC Antihistamine Review Team 4/5/01

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OVERVIEW For some patients, sensitivities are not suitably treated without doctor administration More information are important to bolster this OTC switch in light of one of a kind issues of utilization OTC status will diminish access for some patients, and may not diminish utilization of original antihistamines

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For some patients, hypersensitivities are not properly treated without Physician Management 1. Solution status might be important to protect and improve general wellbeing

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U.S. Social insurance System - 2001 - Evidence-based prescription - Guideline-driven practice - Disease administration approach

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U.S. Medicinal services System Allergy Management - 2001 Diagnostic Evaluation Differentiate unfavorably susceptible clutters from different illnesses Uncover beforehand unsuspected allergens Assess comorbid conditions Environmental Assessment – Antigen Testing Pharmacologic Therapy Antihistamines +Rx for Comorbid Conditions Decongestants Nasal Steroids Immunotherapy Follow-up, Reassessment, Compliance Management

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For some patients hypersensitivities are not suitably treated without Physician Management 1. Prescription status might be important to ensure and improve general wellbeing 2. The security profiles of the second- generation antihistamines in an OTC setting are not completely known

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2. The security profiles of the second- era antihistamines in an OTC setting are not completely known How frequently will they be utilized to treat colds? How frequently will patients measurement inaccurately? What number of patients will encounter fuel of untreated or unrecognized co-morbidities? How regularly will patients have antagonistic results as an aftereffect of postponements in looking for restorative consideration?

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For some patients sensitivities are not fittingly treated without Physician Management 1. Prescription status might be important to secure and enhance general wellbeing 2. The wellbeing profiles of the second- generation antihistamines in an OTC setting are not completely known 3. Allergies are habitually constant, complex illnesses with genuine co-morbidities

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Allergies are much of the time perpetual, complex infections with Serious Comorbidities Co-dismal conditions connected with unfavorably susceptible rhinitis Asthma Sinusitis Otitis Media Children are truly influenced by hypersensitive rhinitis 10-40% of school youngsters Under treatment is identified with learning and behavioral issues

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Allergies: >50 million Americans Asthma: 15 million Americans 4.8 million kids Asthma Prevalence  75% 1980- - > 1994 Asthma Deaths 1980 - 11.5/1 million 1995 - 18.0/1 million (5,500 passings)

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Allergic Rhinitis and Asthma Often Co-exist 78% of asthma patients have nasal manifestations 38% of hypersensitive rhinitis patients have asthma 3 million Claritin® Rx\'s are co-recommended with R x \'s for asthma medicines (for around 1.2M patients with asthma)

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Allergy-Asthma Link Treating hypersensitive aggravation in the nose can lessen asthma indications and lower aviation route hyper-responsiveness. 1,2 Asthmatic patients with Allergic Rhinitis have higher therapeutic expenses In a longitudinal investigation of 783 understudies: 3 Resolution of Allergic Rhinitis side effects corresponded with change in asthma (p=.0078) Worsening of Allergic Rhinitis was connected with industriousness of asthma 1 Allergy Clin Immonol 1995;95:923-32 2 Allergy Clin Immonol 1996;98:274-82 3 Allergy Proc 1994;15:21-25 .

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FIRST-GENERATION ANTIHISTAMINES Short-term/verbose use Simple Sx help for straightforward sensitivity patients ?co-horribleness Frequent use in colds SECOND-GENERATION ANTIHISTAMINES Long-Term/endless use Disease administration for Complex patients Frequent co-dismalness Not viable for colds CHANGES IN ALLERGY MANAGEMENT

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OTC status may diminish get to and not diminish utilization of original antihistamines Medicaid and poor patients will be not able bear the cost of second Generation items as OTC\'s Patients as of now with protection scope will settle on choices taking into account out-of-pocket costs Use of calming antihistamines may well increment

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US and Canadian Antihistamine Market Share Source: IMS Health NPA Plus and A.C. Nielsen Note: Calculated utilizing most extreme dosage every day .

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CONCLUSION Loratadine is most properly utilized as a Rx item There are extraordinary issues identified with utilize first Generation  second Generation FDA Switch Principles -Labeling must be created and tried -Actual Use Trials are essential

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CONCLUSION Loratadine is most suitably utilized as a Rx item There are novel issues identified with utilize first Generation  second Generation FDA Switch Principles -Labeling must be produced and tried -Actual Use Trials are vital

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CONCLUSION Loratadine is most fittingly utilized as a Rx item There are one of a kind issues identified with utilize first Generation  second Generation FDA Switch Principles -Labeling must be produced and tried -Actual Use Trials are fundamental

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CONCLUSION Loratadine is most fittingly utilized as a Rx item There are special issues identified with utilize first Generation  second Generation FDA Switch Principles - Labeling must be produced and tried -Actual Use Trials are important

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ISSUES REQUIRING ASSESSMENT FOR OTC SWITCH Ability to self-analyze the condition Assessment of danger of starting misdiagnosis Assessment of danger of ensuing misdiagnosis of malady intensification or basic co-dismal conditions Assessment of danger of off base dosing (willful and/or unintentional) Assessment of security in at-danger populaces Label improvement and cognizance

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CONCLUSION Loratadine is most suitably utilized as a Rx item There are one of a kind issues identified with utilize first Generation  second Generation FDA Switch Principles -Labeling must be produced and tried -Actual Use Trials are vital

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? Advantage/Risk Benefit/Risk + R OTC x

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Benefit/Risk Benefit/Risk + R OTC x

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QUESTIONS