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“Medicines Shortages - Industry Perspective”

“Medicines Shortages - Industry Perspective”. Maura Kinahan, PhD MPSI. 2013 INTERNATIONAL SUMMIT ON MEDICINES SHORTAGE Toronto 20 th -21 st June 2013. Overview. 1. Setting the Scene. 2. Challenges Faced. 3. Ideas to Improve Availability. 4. Conclusion.

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“Medicines Shortages - Industry Perspective”

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  1. “Medicines Shortages - Industry Perspective”

    Maura Kinahan, PhD MPSI 2013 INTERNATIONAL SUMMIT ON MEDICINES SHORTAGE Toronto 20th-21st June 2013
  2. Overview 1 Setting the Scene 2 Challenges Faced 3 Ideas to Improve Availability 4 Conclusion
  3. Setting the Scene (con’t) API or Excipient Shortage Regulatory Action (e.g. Enforcement) Manufacturing (e.g. Quality Issue, Contamination) Why Shortages Occur? Product Recall External Economic Environment Demand Increase Trading of Medicines Product Discontinuation
  4. Lifecycle of a Medicine Discovery Development Filing Approval Innovator Continuesto Supply No New Market Entrants Exclusivity Period Loss of Exclusivity Commercialisation New Market Entrants Innovator’s Volumes Decrease Innovator Decreases Capacity
  5. Supply Chain Complexity Product A (Norm Becoming the Exception) Product B (Becoming the Rule) DP Mfg US Pack US Canada US DP Mfg US Pack US Mexico Asia API Mfg Asia (1) DP Mfg EU Pack EU Europe Spain, France API Mfg US DP Mfg US Pack US DC’s Various API Mfg Asia (2) LA DP Mfg EU Pack EU ROW NA Pack ME Pakistan Innovator Site 3rd Party Site Pack Asia Japan DP Mfg EU Pack EU Turkey
  6. Even Administration ToolsCan Be Complicated 7
  7. Global Supply Chain Network Ireland Belgium Michigan France China 35K SKUs supplied globally 150 markets 89 Pfizer manufacturing sites > 500 external suppliers 175 logistic centres
  8. Overview 1 Setting the scene 2 Challenges faced 3 Ideas to Improve Availability 4 Conclusion
  9. Supply Disruption Example Leading to Drug Shortages… Competitor Supply DisruptionsStarted Second Quarter 2011… And Increased Demand for Pfizer-Outstripping Capacity
  10. Pfizer’s Response Managing Constrained Supply(2011–2012) Cross functional Sales and Operations planning(S&OP) identified supply gaps by market andpotential mitigation Allocation decisions based on medical need and availability of alternative products Drug Shortage Review Team (DSRT) assessedshortages and made recommendations Addressing Long Term Capacity(2013–2015) Capacity expansion in internal sites Transfer of manufacturing activities toleverage additional capacity and re-optimize the new network
  11. Drug Shortage Reporting (EU) Drug Shortage Review Team (DSRT) Drug Shortage Review Team (DSRT) meeting (GLS lead) Review Impact e.g. Duration of shortage Is this a medically necessary drug? Is this a centrally authorizedproduct? Other information Supply Interruption is identified (last > 2 weeks) Is Pfizerthe sole supplier? Local mkt reporting requirements? Yes Report the drug shortage to the HA Shares results, recommendations & comments from the HA with DSRT GLS closes DSRT report Close the shortage report and communicates this to the HA and internally to DSRT Drug Shortage – When a Drug Product Is Unavailable to Patients
  12. EPBU Executive S&OP Meeting Dashboard (KPI’s) (Example Only) Stock (%) No of Supply Interruptions * Months on Hand Forecast Error (FE) * Supply interruption in Pfizer warehouse of greater than 1 day
  13. Local Management Engage with Regulatory Agency LocalResponse Team Communicatewith DoH Manufacturer Rework if Necessary UpdateCustomers Source Stock from Other Markets Allocations
  14. Overview 1 Setting the Scene 2 Challenges Faced 3 Ideas to Improve Availability 4 Conclusion
  15. Ideas to Improve Availability Culture of quality and compliance embedded in manufacturing and distribution network and with supply partners In Pfizer, we are continuously investing to ensure our sites and partners meet contemporary regulatory standards Assess risks in supply chain and put plans in place to minimize Streamline communication between manufacturing and markets from global perspective to quickly identify and mitigate potential supply issues Critical care products prioritised Address manufacturing complexity to improve overall efficiencies Sales & Operational Planning (S&OP) and end-to-end supply chain teams in place
  16. Ideas to Improve Availability (con’t) Industry-Regulator collaboration As we build early warning and contingency planning, we need to work closely together to maintain supply in a pragmatic and flexible way: Opportunity to simplify processes? Fast-track variations? Derogation from regulatory process?
  17. Overview 1 Setting the Scene 2 Challenges Faced 3 Ideas to Improve Availability 4 Conclusion
  18. Conclusion Medicines supply chain is highly complex Many challenges to maintaining supply Each out of stock situation is unique and needs to be dealt with on a case by case basis All stakeholders need to work together to streamline processes and procedures to enable the safe and secure supply of medicines We must all remember the impact on the patient However, in spite of these challenges, Pfizer is committed to maintaining supply
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