Notification Tactics for ImprovedNotification Tactics for Improved Field Action Communications

L. TussingJune 2013

Disclaimer

• The information in this presentation is representative of the Author’s experience and opinion and does not necessarilyAuthor s experience and opinion and does not necessarily that of Hospira, Inc.

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Objectives

This presentation will cover the key elements of:Wh t d t b d i fi ld ti i tiWhat needs to be covered in your field action communicationStrategies for obtaining and documenting informationCommunication strategies

o Internallyo Externally

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References and Guidance Documents

• 21 CFR part 7)

• 21 CFR 314.81(b)(1)

• 21CFR 806

I d t G id I f ti R ll f FDA• Industry Guidance - Information on Recalls of FDA Regulated Products

– FDA Guidance for Industry: Product Recalls Including– FDA Guidance for Industry: Product Recalls Including Removals and Corrections

– Model press releases and letters

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Contents of Communication• Heading / Type of communication• Identification of productp• Issue / Description of problem / Reason for action• Product description / Use

Hazard / Risk to user patient caregiver etc• Hazard / Risk to user, patient, caregiver etc.• Level of action if known• User actions• Distribution information• Alternate product

Company actions• Company actions• Timing• Communication / contact information

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Methods of Communication• Press Release• Traceable DeliveryTraceable Delivery

– mail / delivery service (FedEx, UPS) / telegram / email• Phone callo e ca• Rep visits• Website• Safety Organizations

Customer base will help determine how to best communication

Document delivery/receipt of the communication

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Document delivery/receipt of the communicationL. TussingJune 2013

Internal Notifications

• Public Affairs• Customer Care• Customer Care• Medical• Investor Relations• Insurance• Marketing/Sales/Reps• International• Production• Website• Finance

Oth

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• Others

External Notifications

• Customers (direct and indirect)•HospitalHospital•Pharmacy•Wholesaler/Distributor/Buying Groups•Kitpacker•Compounder

• Service Providers• Service Providers• Safety Organizations• FDA/Regulatory AgenciesFDA/Regulatory Agencies• Others

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Thank YouThank You

L. TussingJune 2013