global impact of medicine shortages lisa hedman world health organization department of essential...

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.

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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

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Thank you to all