“Medicines Shortages - Industry Perspective” Maura Kinahan, PhD MPSI Toronto

“Medicines Shortages - Industry Perspective”
Maura Kinahan, PhD MPSI
2013 INTERNATIONAL SUMMIT ON MEDICINES SHORTAGE
Toronto
20th-21st June 2013
Overview
1
Setting the Scene
2
Challenges Faced
3
Ideas to Improve Availability
4
Conclusion
Setting the Scene (con’t)
API or Excipient
Shortage
Manufacturing (e.g.
Quality Issue,
Contamination)
Regulatory Action
(e.g. Enforcement)
Why
External Economic
Environment
Shortages
Occur?
Product
Recall
Demand
Increase
Trading of
Medicines
Product
Discontinuation
Lifecycle of a Medicine
Discovery
Innovator
Continues
to Supply
Development
Filing
No New
Market Entrants
Approval
Exclusivity
Period
Loss of
Exclusivity
New Market
Entrants
Innovator’s
Volumes Decrease
Innovator
Decreases Capacity
Commercialisation
Supply Chain Complexity
Product A (Norm Becoming the Exception)
Product B (Becoming the Rule)
DP Mfg
Pack
US
US
DP Mfg
Pack
US
US
DP Mfg
Pack
EU
EU
DP Mfg
Pack
EU
EU
Asia
Canada
US
Mexico
API
Mfg
API
Mfg
US
DP Mfg
Pack
DC’s
US
US
Various
Europe
LA
Asia (1)
API
Mfg
Asia (2)
NA
Pack
ME
Innovator
Site
Spain, France
3rd Party
Site
Pack
Asia
DP Mfg
Pack
EU
EU
ROW
Pakistan
Japan
Turkey
Even Administration Tools
Can Be Complicated
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
Overview
1
Setting the scene
2
Challenges faced
3
Ideas to Improve Availability
4
Conclusion
Supply Disruption Example
Leading to Drug Shortages…
Competitor Supply Disruptions
Started Second Quarter 2011…
And Increased Demand for Pfizer-Outstripping Capacity
16
12.0
13.0
13.5
14.5
15.0
12
8
4
0
2011
Contract site
2012
2013
Perth
Wuxi
2014
2015
Forecast Demand
9
Pfizer’s Response
16
12.0
13.0
13.5
14.5
15.0
12
Managing Constrained Supply
(2011–2012)
• Cross functional Sales and Operations planning
(S&OP) identified supply gaps by market and
potential mitigation
8
4
• Allocation decisions based on medical need and
availability of alternative products
0
2011
2012
Contract site
2013
Perth
Wuxi
2014
2015
Forecast Demand
• Drug Shortage Review Team (DSRT) assessed
shortages and made recommendations
18
14
12.0
13.0
13.5
14.5
15.0
Addressing Long Term Capacity
(2013–2015)
10
6
• Capacity expansion in internal sites
2
-2
2011
Contract site
2012
2013
Perth
Wuxi
2014
2015
• Transfer of manufacturing activities to
leverage additional capacity and re-optimize the
new network
Forecast Demand
10
Drug Shortage Reporting (EU)
Global Logistics & Supply
Global Logistics & Supply
Commercial
Business Unit
Quality Operations or
Regulatory Affairs
Drug Shortage Review Team (DSRT)
Supply Interruption
is identified
(last > 2 weeks)
Drug Shortage Review Team
(DSRT) meeting (GLS lead)
Review Impact e.g.
Is Pfizer
the sole supplier?
•Duration of shortage
•Is this a medically necessary
drug?
•Is this a centrally authorized
product?
•Other information
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
Drug Shortage – When a Drug Product Is Unavailable to Patients
Close the shortage report and
communicates this to the HA
and internally to DSRT
EPBU Executive S&OP Meeting
Dashboard (KPI’s) (Example Only)
Stock (%)
Target
No of Supply Interruptions *
98.0%
Target
0
May
99.2%
May
2
June
98.7%
June
12
July
99.4%
July
2
August
98.0%
August
3
Months on Hand
Target
Forecast Error (FE)
3.2
Target
20.0%
May
3.0
May
25%
June
3.8
June
37%
July
4.0
July
27%
August
3.6
August
20%
* Supply interruption in Pfizer warehouse of greater than 1 day
Local Management
Engage
with
Regulatory
Agency
Local
Response
Team
Communicate
with DoH
Manufacturer
Rework if
Necessary
Update
Customers
Source
Stock from
Other
Markets
Allocations
Overview
1
Setting the Scene
2
Challenges Faced
3
Ideas to Improve Availability
4
Conclusion
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
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?
16
Overview
1
Setting the Scene
2
Challenges Faced
3
Ideas to Improve Availability
4
Conclusion
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