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Global impact of medicine shortages
Global impact of medicine shortages
Lisa Hedman
World Health Organization
Department of Essential Medicines and Health Products
Toronto, Canada 20-21 June 2013Photos courtesy of Lisa Hedman unless otherwise noted.
Medicine shortages 2 |
Outline:
Vulnerabilities in low- and middle-income countries
Case study: anti-tuberculosis medicines
Financing
Trade trends in BRICS countries
Unanswered issues
Shortage of essential medicines is a global problem…and there is insufficient information to determine the magnitude and specifics characteristics of the problem
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Bulletin of the World Health Organization 2012;90:158-158A. doi: 10.2471/BLT.11.101303
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Access to public sector medicinesAccess to public sector medicines
Policy environment
Market environment
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Vulnerabilities in low- and middle-income countries
Vulnerabilities in low- and middle-income countries
AreaProblem leading to stock outs
PolicyInconsistent policies lead to fragmentation of markets and limited demand
RegulationWeak pharmacovigilance and surveillance
FinancingDependency on donor financing can disrupt demand
ManufacturingLack of production capacity that meet basic quality standards
SupplyVulnerable forecasting and supply systems, open to influences of spurious, falsely labelled, falsified, counterfeit (SFFC)
EmergenciesLack of purchasing power, locked out of international markets
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Case study: anti-tuberculosis medicines
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2009 daily dosing guidelines, based on 0.5 to 2 tablets per day
Comparison to available PQS approved products (in mg)
Individual tablets Combination tablets
Dispersible combination
tablets
Individual components
Guideline Recommended
dose
Recommended format(in mg)T1T2CT1CT2CT3CT4
DT 1
DT 2
DT 3
Ethambutol20mg/kg/day100 or 50400 400 275275
Isoniazid10mg/kg/day50300100150757575306030
Pyrazinamide35mg/kg/day150400500 400 1506060
Rifampicin15mg/kg/day75 15015015060
Scale of current products is different and too complex to use within treatment guidelines
Case study: anti-TB medicines and policy change
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Case study: anti-TB medicines financing
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Slide detail excepted from Clinton Health Access Initiative data, 2012
Cycloserine
Case study: anti-TB medicines demand
Demand estimated to drop below sustainable production levels when donor funding in India
expires
Case study: anti-TB medicines quality study
10
Failure rateTotal = 11.3%
88.7%
10.3%
1.0%Compliant
Non-extremedeviations
Extremedeviations
No sample suspected to be of spurious, falsely-labelled, falsified or counterfeit product
Extreme deviation:
API content of more than 20% from the declared content
average dissolution of tested units lower than 25% below pharmacopoeia Q value
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The 17% of the world's population that live in low income countries accounted for only 1% of global pharmaceutical expenditure.
Relative to GDP, low income countries spent more than 30% of total health budgets on medicines, compared with 17% in high income countries.
Source: The World Medicines Situation, 2011 .
Higher costs as a causeHigher costs as a cause
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Higher costs as a causeHigher costs as a cause
The World Medicine Situation 2011, Cameron et al, WHO
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Public sector prices paid for the lowest-priced generic medicines, range from 1.9 times to 3.7 times the international reference price (IRP) and from 5.3 times to 20.5 times for originator brands.
Private sector prices of originator brand medicines were at least 10 times higher than the corresponding international reference prices, and were as much as 20 and 30 times higher in Africa.
Higher costs as a causeHigher costs as a cause
The World Medicine Situation 2011, Cameron et al, WHO
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www.the.lancet.com ,December 1, 2008, Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis; Cameron et al
Example: Cost of CiprofloxacinExample: Cost of Ciprofloxacin
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Example: Cost of CiprofloxacinExample: Cost of Ciprofloxacin
Median price ratios of public sector procurement prices for lowest-cost generics
www.the.lancet.com ,December 1, 2008, Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary, analysis; Cameron et al
4.32 2.55
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Example: Availability of CirpofloxacinExample: Availability of Cirpofloxacin
www.the.lancet.com ,December 1, 2008, Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary, analysis; Cameron et al
Average country-level mean percentage of availability by WHO region
49% 24%
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Higher costs can be measured
Challenges: lack of research and research approaches to determine the contribution of stock outs to the cost and burdens of:
– Antimicrobial resistance (where alternative treatments can increase costs by 10-fold)
– Irrational use– Contribution to increased mortality and morbidity
Making the cost-benefit caseMaking the cost-benefit case
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Making the cost-benefit case:
Supply Chain Costs It is clear that additional investment would improve stock
outs caused by national or local supply chain failures
Challenge: looking at the inverse, we do not know how much global shortages cost supply chains annually
Challenge: stock out prevalence reports vary widely, but what is the cost in terms of under-treatment?
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Are the BRICS making a difference?Are the BRICS making a difference?
Unpublished WHO report: Pharmaceutical Trade Expenditures in BRICS Countries, based on data from WTO 2012
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What is missing?What is missing?
– Quantification of the global problem – Evaluation of the effectiveness of reporting
systems (e.g., SMS for life et al)– Evaluation of the effectiveness of legislation and
financing in preventing stock outs– Agreed approaches to quantify costs and impact
on disease burden e.g., antimicrobial resistance– Criteria for escalating problems– Logical framework for managing shortages
Medicine shortages 21 |
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Thank you to all