How to Develop Internal Monitoring How to Develop Internal Monitoring ProgramsPrograms

SEVENTHSEVENTH ANNUAL PHARMACEUTICAL ANNUAL PHARMACEUTICAL REGULATORYREGULATORY

AND COMPLIANCE CONGRESS AND BEST AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUMPRACTICES FORUM

Stephen F. MohrStephen F. MohrGlobal Compliance Officer Global Compliance Officer

AstraZeneca AstraZeneca Stanhope GateStanhope Gate

London, United KingdomLondon, United Kingdom44 (0)2044 (0)20--73047304--51205120

Steve.Mohr@astrazeneca.comSteve.Mohr@astrazeneca.com

Keith M. KorenchukCovington & Burling LLP1201 Pennsylvania Avenue, N.W.Washington, D.C. 20004(202) 662-5385

kkorenchuk@cov.com

The views of the presenters are their own and do not necessarily reflect the positions or actions of their respective organizations.

An Overview of the Issues in An Overview of the Issues in DDevelopment of Internal Monitoring evelopment of Internal Monitoring

ProgramsPrograms

Stephen F. MohrStephen F. MohrGlobal Compliance Officer Global Compliance Officer

AstraZeneca AstraZeneca

33

The Roadmap to an EffectiveThe Roadmap to an EffectiveMonitoring Program Monitoring Program

Identify areas for potential monitoringIdentify areas for potential monitoringDevelopment of areas of focus Development of areas of focus Budget supportBudget supportWritten protocolsWritten protocolsDevelopment and use of metrics Development and use of metrics Deployment of resourcesDeployment of resourcesUtilization of technologyUtilization of technologyEffectively communicating resultsEffectively communicating results

44

Potential Challenges to Developing Potential Challenges to Developing an Effective Monitoring Function an Effective Monitoring Function Data qualityData qualitySystems integrationSystems integrationUnderUnder--developed key performance developed key performance indicatorsindicatorsFinancial resourcesFinancial resourcesHuman resources/staffingHuman resources/staffing

55

Potential Challenges in Potential Challenges in Deployment of ResourcesDeployment of Resources

• Personnel issues in performing monitoring

• Training of personnel• Communicating event indicators• Collaboration with HR/Legal• Follow-on investigations• Corrective Action

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Potential Challenges in Utilization Potential Challenges in Utilization of Technologyof Technology

• Real time monitoring• Transition issues• Dash Board Metrics• System Development and

Integration• Vendor Performance

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Potential Challenges in Potential Challenges in Communicating Results to Communicating Results to

ManagementManagementEffective lines of communication between the Effective lines of communication between the compliance officer and senior management to compliance officer and senior management to communicate monitoring metrics and program communicate monitoring metrics and program performanceperformanceFocus on key performance indicatorsFocus on key performance indicatorsMetrics and nature of the reporting will evolve Metrics and nature of the reporting will evolve over time based upon the evolution of the over time based upon the evolution of the program in general and the sophistication of the program in general and the sophistication of the monitoring functionmonitoring function

A Closer Look: Developing Metrics A Closer Look: Developing Metrics and Approaches in Internal and Approaches in Internal

Monitoring ProgramsMonitoring Programs

Keith M. KorenchukCovington & Burling LLP

99

Part 1: Potential Areas to be Part 1: Potential Areas to be Considered for Monitoring Considered for Monitoring

Government Price ReportingGovernment Price ReportingEngagement of Physicians (Consulting, Speaking Engagement of Physicians (Consulting, Speaking Honoraria, Honoraria, PreceptorshipsPreceptorships))Clinical & Research Grants/StudiesClinical & Research Grants/StudiesContinuing Medical EducationContinuing Medical EducationMedical Affairs GuidelinesMedical Affairs GuidelinesSamplesSamplesFree GoodsFree GoodsPatient Assistance Program/Indigent Patient Patient Assistance Program/Indigent Patient ProgramsProgramsDebt Forgiveness/ReductionDebt Forgiveness/ReductionContractual Payments (Discounts, Rebates, Admin. Contractual Payments (Discounts, Rebates, Admin. Fees)Fees)

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Potential Areas to be Considered Potential Areas to be Considered for Monitoring (continued)for Monitoring (continued)

Conventions/Symposia/FoundationsConventions/Symposia/FoundationsData PurchasesData PurchasesNonNon--clinical Grantsclinical GrantsValueValue--Added ProgramsAdded ProgramsGifts, Meals, And EntertainmentGifts, Meals, And EntertainmentPromotional Materials/Sales AidsPromotional Materials/Sales AidsOffOff--Label PromotionLabel PromotionPrivacyPrivacyData IntegrityData IntegrityGXPGXP/FDA Related Issues/FDA Related IssuesPublication of Clinical DataPublication of Clinical Data

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Part 2: Development of Areas of Part 2: Development of Areas of FocusFocus

Risk matrix Risk matrix Use of surveysUse of surveysInternal assessmentsInternal assessmentsGovernment enforcement effortsGovernment enforcement effortsAbility to monitorAbility to monitor--technology and technology and resourcesresources

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Part 3: Budget Support and Part 3: Budget Support and Allocation of ResourcesAllocation of Resources

Priority of monitoring in the Priority of monitoring in the compliance contextcompliance contextAllocation of resources Allocation of resources Funding supportFunding supportCapital and operating commitmentsCapital and operating commitments

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Part 4: Written ProtocolsPart 4: Written Protocols

Develop written protocols for the Develop written protocols for the monitor function.monitor function.Training of staff on monitoring functionTraining of staff on monitoring functionEstablish framework for assessment Establish framework for assessment of monitor program operationof monitor program operation

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Part 5: Development of MetricsPart 5: Development of Metrics

Within areas of focus identify key data Within areas of focus identify key data needsneedsFashion approach based upon Fashion approach based upon measurement capabilitiesmeasurement capabilitiesDevelopment of metrics is context specificDevelopment of metrics is context specificUtilize metrics that can provide notice of the Utilize metrics that can provide notice of the need for further reviewneed for further reviewUtilize results to achieve compliance Utilize results to achieve compliance program goals program goals Use results to communicate program Use results to communicate program activityactivity

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Possible Metrics to be Considered Possible Metrics to be Considered for Monitoring Dissemination of for Monitoring Dissemination of

Scientific Information Scientific Information Requests or inquires related to offRequests or inquires related to off--label uses of label uses of productsproductsSales call notesSales call notesVerbatimsVerbatimsDrug sampling recordsDrug sampling recordsApproved promotional materialsApproved promotional materialsBusiness/strategic plansBusiness/strategic plans

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Possible Metrics to be Considered Possible Metrics to be Considered for Monitoring Engagement of for Monitoring Engagement of

Physicians Physicians Number of consultants retained per productNumber of consultants retained per productNumber of speakers retained per productNumber of speakers retained per productUtilization of speakers who attend speaker Utilization of speakers who attend speaker trainingtrainingDirect payments to physiciansDirect payments to physiciansIndirect (via vendor) payments to physiciansIndirect (via vendor) payments to physiciansProgram design and content of advisory boardsProgram design and content of advisory boards

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Possible Metrics to be Considered Possible Metrics to be Considered for Sales Representative/for Sales Representative/MSLMSL

Monitoring Monitoring Identifying potential offIdentifying potential off--label label promotional activity by sales promotional activity by sales representatives/MSLs through representatives/MSLs through observations of the interactions with observations of the interactions with Health Care Professionals.Health Care Professionals.Conduct fullConduct full--day, potentially random, day, potentially random, direct inspections and observations of direct inspections and observations of the messages and materials delivered the messages and materials delivered by sales representatives/by sales representatives/MSLsMSLs. .

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Possible Metrics to be Considered Possible Metrics to be Considered for Sales Representative/for Sales Representative/MSLMSL

Monitoring (contMonitoring (cont’’d)d)Number of inspections conducted Number of inspections conducted proportional in number to the size of the proportional in number to the size of the sales force/MSLs sales force/MSLs Inspections conducted across all regions Inspections conducted across all regions where the company operates.where the company operates.Inspection report prepared by compliance Inspection report prepared by compliance personnel to include: personnel to include: –– the identify of the sales reps/the identify of the sales reps/MSLsMSLs; ; –– the identity of the monitor; the identity of the monitor; –– the date and duration of the inspection; the date and duration of the inspection; –– the topics discussed during the inspection; and the topics discussed during the inspection; and –– identification of any potential offidentification of any potential off--label label

promotional activity by the sales rep/promotional activity by the sales rep/MSLMSL..

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Possible Metrics to be Considered Possible Metrics to be Considered for Monitoring and Review of for Monitoring and Review of

Requests for OffRequests for Off--Label InformationLabel InformationAnalyze sales representative/Analyze sales representative/MSLMSLsubmitted offsubmitted off--label inquiries.label inquiries.Compile and provide information about all Compile and provide information about all requests submitted to the Medical requests submitted to the Medical Information Unit by sales Information Unit by sales representatives/representatives/MSLsMSLs about products.about products.Request information should be separated Request information should be separated by therapy area and/or productby therapy area and/or productData analyzed to identify those sales Data analyzed to identify those sales representatives/MSLs associated with the representatives/MSLs associated with the highest number of requests for information.highest number of requests for information.

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Possible Metrics for Monitoring and Possible Metrics for Monitoring and Review of Requests for OffReview of Requests for Off--Label Label

Information (contInformation (cont’’d)d)For each therapy area, review further the requests For each therapy area, review further the requests and resulting responses from a certain number of and resulting responses from a certain number of sales rep/MSLs with the largest number of sales rep/MSLs with the largest number of requests.requests.Information related to the Medical Information Information related to the Medical Information requests for the top number of requestors in the requests for the top number of requestors in the therapy area is reviewed.therapy area is reviewed.A formal investigation is conducted and disciplinary A formal investigation is conducted and disciplinary action undertaken where appropriate in the event action undertaken where appropriate in the event that the analysis and review indicates that an MSL that the analysis and review indicates that an MSL may have inappropriately caused the dissemination may have inappropriately caused the dissemination of offof off--label information or engaged in offlabel information or engaged in off--label label promotion.promotion.

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Possible Metrics: Message Recall Possible Metrics: Message Recall Monitoring ProgramMonitoring Program

Message Recall Monitoring Program designed to Message Recall Monitoring Program designed to identify potential offidentify potential off--label promotional activities by label promotional activities by sales representatives /MSLs through the analysis sales representatives /MSLs through the analysis of commercially available, nonof commercially available, non--company messages company messages delivered by sales representatives/MSLs (Message delivered by sales representatives/MSLs (Message Recall Studies)Recall Studies)Obtain Message Recall Studies relating to several Obtain Message Recall Studies relating to several products products Analyze the results of all Message Recall Studies Analyze the results of all Message Recall Studies to determine whether they reveal any indicators of to determine whether they reveal any indicators of potential offpotential off--label promotional activitieslabel promotional activities

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Total Spend Monitoring: the Holy Total Spend Monitoring: the Holy Grail?Grail?

Total spend requirements under State Total spend requirements under State law evolvinglaw evolvingChanging standards and calculationsChanging standards and calculationsCapturing data across the enterpriseCapturing data across the enterpriseQuality of dataQuality of dataReporting timelinessReporting timeliness

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Other Metrics to be ConsideredOther Metrics to be Considered

• Government Price Reporting • Clinical & Research Grants/Studies• Continuing Medical Education• Samples• Free Goods• Patient Assistance Program/Indigent Patient

Programs• Debt Forgiveness/Reduction• Contractual Payments (Discounts, Rebates, Admin.

Fees)• Conventions/Symposia/Foundations

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Other Metrics to be Considered Other Metrics to be Considered (continued)(continued)

• Data Purchases• Non-clinical Grants• Value-Added Programs• Gifts, Meals, And Entertainment• Promotional Materials/Sales Aids• Privacy• Data Integrity• Publication of Clinical Data

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Questions/DiscussionQuestions/Discussion