WHO EMP MAR 2012.3 Eng PDF

WHO/EMP/MAR/
/2012.3
Th
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Sha
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Th
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WHO/EMP/MAR/2012.3
The Pursuit of
Responsible Use of
Medicines:
Sharing and Learning from
Country Experiences
Technical Report prepared for the Ministers Summit
on
The benefits of responsible use of medicines:

Setting policies for better and cost-effective health care

The Pursuit of Responsible Use of Medicines:
Sharing and Learning from Country Experiences
WorldHealthOrganization2012
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Table of contents
Acknowledgements .......................................................................................................... v
Acronyms and abbreviations .......................................................................................... vii
Summary of recommendations ....................................................................................... ix
Chapter I The case for better use of medicines ............................................................. 1
Chapter II Structure of the report ................................................................................. 6
Chapter III Implementing a list of prioritized medicines .............................................. 8
CASE STUDY 1 Essential medicines list (OMAN) ........................................................... 9
CASE STUDY 2 Popular pharmacy programme (BRAZIL) ............................................. 13
Chapter IV Treating the right patient at the right time ............................................... 17
CASE STUDY 3 Medicines supply reform (BHUTAN) .................................................... 18
CASE STUDY 4 Malaria rapid diagnostic test (SENEGAL) ............................................. 21
CASE STUDY 5 HIV antenatal screening (SWAZILAND) ............................................... 27
CASE STUDY 6 Antibiotics smart use (THAILAND) ...................................................... 31
CASE STUDY 7 Medical use of opioids (INDIA)........................................................... 34
CASE STUDY 8 Upscaling zinc in diarrhoea treatment (BANGLADESH) .......................... 40
Chapter V Focusing on adherence ............................................................................... 45
CASE STUDY 9 Community interventions (ETHIOPIA) ................................................. 46
Chapter VI Health system capabilities ......................................................................... 50
CASE STUDY 10 Antiretroviral supply and adherence monitoring (NAMIBIA) ................. 51
Chapter VII The importance of leadership commitment .............................................. 55
CASE STUDY 11 Polio eradication (INDIA) ................................................................ 56
Conclusions .................................................................................................................... 60
References ..................................................................................................................... 61

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iv

Acknowledgements
Dr Krisantha Weerasuriya, Medical Officer, Medicines Access and Rational Use in the
DepartmentofEssentialMedicinesandHealthProducts,WHO,coordinatedthewritingof
thisdocumentandwasinvolvedinthetechnicalconcept,writingandreview.
Dr Clive Ondari, Coordinator, Medicines Access and Rational Use, WHO, reviewed the
document.
Thanks are also due to Mr Sander van den Bogert and Mr Michele Mestrinaro for study
design,reviewofcasehistories,datacollection,dataanalysis,writingandreviewaspartof
theirinternshipinWHOheadquartersfromMarch2012toJune2012.
DrPieterStolk,DrH.R.(Hugo)HurtsandDrH.J.J.(Harrie)SeeverensfromtheMinistryof
Health,WelfareandSportsintheNetherlandsreviewedthedraftsofthedocument.
The document was produced by WHO under an Agreement for Performance of Work for
the Ministry of Health in the Netherlands, for the Ministerial Summit to be held on
3October2012inAmsterdam.

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vi


Acronyms and abbreviations
3TC Lamivudine
ACT Artemisininbasedcombinationtherapy
AIDS acquiredimmunodeficiencysyndrome
ART antiretroviraltreatment
ASU AntibioticsSmartUse
AZT Zidovudine
BHU basichealthunits
EDP EssentialDrugsProgramme
EDT electronicdispensingtool
EGPAF ElizabethGlaserPediatricAIDSFoundation
FPB PopularPharmacyProgramme
FPBE PopularPharmacyProgrammeExpansion
Fiocruz OswaldoCruzFoundation
GOI GovernmentofIndia
HIV humanimmunodeficiencyvirus
INCB InternationalNarcoticsControlBoard
INN internationalnonproprietaryname
MoHSS MinistryofHealthandSocialServices
MTC MobileTelecommunicationsLimited
NDPSA NarcoticDrugsandPsychotropicSubstancesAct
NGO nongovernmentalorganization
NID NationalImmunizationDay
NMCP NationalMalariaControlProgramme
NPSP NationalPolioSurveillanceProject
NVP nevirapine
OPV oralpoliovaccine
OTC overthecounter
P.falciparum/vivax Plasmodiumfalciparum/vivax
PMTCT preventionofmothertochildtransmission
RDT rapiddiagnostictest
RDU rationaldruguse
RMI RecognizedMedicalInstitution
sdNVP singledosenevirapine
SNID subnationalimmunizationday
SOP StandardOperatingProcedure
SUS UnifiedHealthSystem
SUZY ScalingUPZincforYoungChildren
TB tuberculosis
UNAIDS JointUnitedNationsProgrammeonHIV/AIDS
UNICEF UnitedNationsChildrensFund
USAID UnitedStatesAgencyforInternationalDevelopment
vs versus
WHA WorldHealthAssembly
WHO WorldHealthOrganization

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Summary of recommendations
Strategic recommendation 1: Develop and mandate a List of Essential Medicines

at the national level to inform reimbursement decisions and ensure access to
essential medicines.
Alistofmedicinestobeused in publichealthcarefacilities and/orprovidedtopatientsfreeof
charge is a powerful tool in the development of a national medicines policy, aimed at ensuring
access to these medicines. Furthermore, identifying these medicines by international non
proprietary name provides the basis for efficient procurement and institutionalization of the
conceptofgenericsandincreasestheiruse.Ifafullmedicinesassessmentandprioritizationeffort
cannot be done at the national level because of resource constraints, the World Health
Organization Model List of Essential Medicines can be used to develop a national essential
medicineslist.

Tacticalrecommendation1.1:Alistofessentialmedicinesshouldbeidentifiedatthenational
leveltoregulateaccesstomedicinesinpublichealthcarefacilitiesandtoensureabroader,more
efficientuseofthesemedicines.
Tacticalrecommendation1.2:Partialtofullreimbursementshouldbegrantedatthenational
leveltomedicinesincludedintheessentialmedicineslistinordertoincreaseaccessandpromote
theiruseinthehealthcaresystem.

Strategic recommendation 2: Invest to ensure national medicines procurement
and supply systems are efficient and reliable to support the responsible use of
medicines.
A robust healthcare system needs to be able to support the responsible use of medicines by
assuringthatessentialmedicinesareprocuredefficientlythroughcentralizedtenders,delivered
effectively to health providers and patients without stockouts, and routinely checked to assure
quality. The reliability and effectiveness of the system is necessary for the right medicine to be
availabletotherightpatientattherighttime;theefficiencyofmedicinesprocurementisofthe
essencetoensurepublicspendingprovidesthebestvalueformoney.

Tacticalrecommendation2.1:Establishcentralized,tenderbasedprocurementofessential
medicines.Fundsformedicinesprovidedbyinternationalaidorganizationsshouldpreferablybe
usedthroughthesamesystem,andcomplywithnationalpriorities.
Tacticalrecommendation2.2:Establishroutinequalitytestingprocedurestoverifythat
medicinesprocuredthroughthenationaltenderingsystemareofassuredquality.Resultsof
qualitytestsshouldinformtheselectionofmedicinesuppliers.
Tacticalrecommendation2.3:Establisharoutineperformancefeedbacksystemtoensurethat
supplierswhocannotdelivermedicinesofassuredqualityintimeareinformed,andexcluded
fromfuturetenders.

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Strategic recommendation 3: Promote a shift in focus to early screening and
accurate diagnosis to guide/inform medicines prescription and avoid overuse,
underuse and misuse of medicines.
Medicinesprescribedonthebasisofaninaccuratediagnosisareawasteofresources,andalate
diagnosis can adversely affect the health outcomes of an otherwise effective treatment. The
consequences of a late or inaccurate diagnosis range from unnecessary side effects to
hospitalization and inefficient use of resources. Early screening of atrisk patients, and
diagnostics,arepowerfultoolsinthepursuitofaresponsibleuseofmedicines.Whilediagnostics
dohaveacost,thepotentialbenefits(bothinhealthandsavings)areconsiderableandoutweigh
theinitialinvestment.

Tacticalrecommendation3.1:Promotefocusonaccuratediagnosis,withtheaidofdiagnostics
wherepossible,inordertoguidetheappropriateprescriptionofmedicines.
Tacticalrecommendation3.2:Mandateearlyscreeninginatrisksegmentsofthepopulation
toensurepatientsarediagnosedintimetomaximizethebenefitsoftreatment.
Strategic recommendation 4: Facilitate the implementation of evidence-based

treatment guidelines; where they exist, remove regulatory or administrative
barriers and directly target all key stakeholders: prescribers, dispensers and
patients.
The underuse, overuse and misuse of medicines can have adverse consequences on health
outcomesandexpenditure,andareoftenduetoalackofstakeholderawarenessorengagement.
Evidencebased treatment guidelines can be effective in avoiding this, and governments should
facilitate their implementation by realigning regulatory/ administrative incentives to improve
medicine useandtopromoteacultureinwhichprescribers,dispensersand patients valueand
advocatetheresponsibleuseofmedicines.

Tacticalrecommendation4.1:Sensitizeandpromotetheengagementofprescribers,dispensers
andpatientsthroughmultistakeholderworkshops,determiningeducationalrequirementsfor
healthcareprofessionals,andpublicinformationcampaigns.
Tacticalrecommendation4.2:Reassessregulatoryrequirementsonthedispensingofselected
medicinestoensuretheirwideravailabilityandaccessibility.Regulationsshouldpermitover
thecounteravailabilityofmedicinesofappropriateriskbenefit.
Tacticalrecommendation4.3:Reduceredundantpaperworkandtheadministrativeburdenof
prescribing/dispensingparticularessentialmedicinestoensureappropriatepatientaccess.
Strategic recommendation 5: Promote initiatives that put patients at the centre

of treatment in order to maximize adherence to therapy.
Poor adherence can impair the efficacy and safety of medicines, reduce the full benefits of
treatment,andleadtounnecessaryadverseeventsandhospitalization.Governmentsshouldtake
the lead in promoting, through national health policy, comprehensive initiatives to improve
adherencetomedicinetreatment.Toachievethiscomplexgoal,communitybasedinterventions
should be explored to bring healthcare professionals and the treatment as close as possible to
patientsandtheirlifestyles.

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Tacticalrecommendation5.1:Promotethecreationof,andprovidetechnicalsupportto
communitybasedinitiativesaimedatimprovingpatientengagementandadherenceto
treatment.
Tacticalrecommendation5.2:Facilitatehealthcareprofessionalsinprovidingclosertherapy
supporttopatients,tomotivatetheirhealthseekingbehaviour.
Strategic recommendation 6: Monitor medicine use, from purchase to health

outcome, to evaluate the real-world efficacy of treatment and guide evidence-
based policy-making.
Policymaking aimed at improving the responsible use of medicines is only effective if it is
monitored.Recordsofmedicineexpenditureprovideagoodpictureofmedicineuse.Ultimately,
patient use and health outcomes should be longitudinally monitored to evaluate adherence and
therealworldeffectivenessofmedicines.Thevalueofmonitoringtoimproveresourceallocation
hasbeenrepeatedlydemonstratedinhospitals;suchmonitoringshouldbecomeroutineinhealth
careinstitutionsatalllevels.
Tacticalrecommendation6.1:Instituteasystemofcentralizedmonitoringofthepurchaseof
medicinestoinformbudgetingandensureoptimalfundingallocationtoessentialmedicines.
Tacticalrecommendation6.2:Collectdataonmedicineuseatthenationalleveltoidentifyand
evaluateprescribingtrendsandexpenditure.
Tacticalrecommendation6.3:Designasystemtomeasurepatientuseofmedicines,preferably
atthepointofdispensing,toassesspatientadherencetotherapy.
Tacticalrecommendation6.4:Designasystemtocollectandaggregateinformationonpatient
healthoutcomestomeasurerealworldefficacyandsafetyofmedicineuse.
Strategic recommendation 7: Ensure sustained, top-down commitment of

national authorities and promote active, bottom-up engagement of prescribers,
patients and dispensers to the principles and policies fostering the responsible
use of medicines.
Government commitment is essential for a more responsible use of medicines. Commitment
shouldbemanifestedbyprovidingresourcestoupscaleeffectiveinterventionstoachievetheirfull
potential,sustainedsupporttosuccessfulinterventionsforaslongasneededtoensuresustained
results, and by directly engaging national and regional stakeholders to promote topdown
commitmentcoupledwithbottomupengagementofprescribers,dispensersandpatients.

Tacticalrecommendation7.1:Nationalauthoritiesshouldprovidesustained,topdownpolicy
andfinancialcommitmenttoinitiativesfosteringaresponsibleuseofmedicines.
Tacticalrecommendation7.2:Buildconsensusonmedicineuseamongnationalandlocal
stakeholdersbystimulatingtheactiveengagementofprescribers,dispensersandpatients.

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xii

Chapter I The case for better use of medicines
Background and rationale for the report
Inthelastdecades,medicineshavehadanunprecedentedpositiveeffectonhealth,leading
toreduced mortality anddisease burden, and consequently toanimprovedqualityof life.
Atthesametime,thereisampleevidencethatalargemissedpotentialexistsbecauseofthe
wayinwhichmedicinesareused:therightmedicinedoesnotalwaysreachtherightpatient;
approximately50%ofallpatientsfailtotaketheirmedicinecorrectly(1);andinmanycases,
thecapabilityofthesystemisnotsufficienttosupporttheoptimaluseofmedicines.Thereis
muchtobegainedbyusingmedicinesmoreresponsibly,primarilyintermsofhealthgains;
conversely,lostvaluehassignificantcostimplications.

Given the importance of medicine use, the Ministry of Health of the Netherlands, in the
context of the International Pharmaceutical Federation World Centennial Congress of
Pharmacy and Pharmaceutical Sciences, is organizing a Ministers Summit in October 2012
withthethemeThebenefitsofresponsibleuseofmedicines.ThepurposeofthisSummitis
toexploresolutionstoimprovepatientoutcomesandsupportsustainableandcosteffective
healthcare.

From analyses conducted for the Summit, significant healthcare costs can be avoided by
using available medicines in a more appropriate way. For example, estimates that focus
uniquely on reducing direct healthcare costs such as hospitalization do not take into
accountother,indirectandavoidablecoststosociety,includinglossofproductivity.

ThisWorldHealthOrganization(WHO)reportisoneoftwocommissionedbytheMinistry
of Health of the Netherlands to fuel discussions at the Summit; the other is from the IMS
InstituteforHealthcareInformatics.WhileWHOusescasehistoriestogleanpolicylessons
from experiences in low and middleincome countries, the IMS Institute focuses on cost
quantification, case studies, and supporting evidence from low, middle and highincome
countries. A briefing paper further describes the context of the Summit, summarizes the
findings of both reports, and identifies a potential way forward for improved use of
medicines.
What is meant by the responsible use of medicines?
Thetermresponsibleuseofmedicinesimpliesthattheactivities,capabilitiesandexisting
resources of health system stakeholders are aligned to ensure patients receive the right
medicines at the right time, use them appropriately, and benefit from them. This
incorporates the importance of stakeholder responsibility and recognizes the challenge of
finiteresources.Conversely,suboptimaluseistheoppositeofwhatismeantbyresponsible
usethroughoutthisreport.

1


This description complements and is not intended to substitute the WHO definition of
rationalmedicineuse:Medicineuseisrational(appropriate,proper,correct)whenpatientsreceive
the appropriate medicines, in doses that meet their own individual requirements, for an adequate
period of time, and at the lowest cost both to them and the community. Irrational (inappropriate,
improper,incorrect)useofmedicinesiswhenoneormoreoftheseconditionsisnotmet.(2)
The framework for the Summit
The focus of the Summit is on how to recapture the lost value of medicines due to
suboptimaluse.Thevalueofmedicinescanbeassurediftheyare:
1. matchedtotherightpatientattherighttime
2. takenappropriatelybythepatient
3. usedwiththerightcapabilities.
Figure1illustratesthesevalueswithinthebroadercontextofuniversalaccesstomedicines,
and although the Summit framework does not explicitly cover topics such as innovation
policies, pricing, or financing challenges, they are described in World Health Assembly
resolutionWHA58.331.
Table 1. The value of medicines
Value of medicines is
lost if these Requirement
Drug innova on should align with health care
are not developed needs and address pharmacotherapeu c gaps. Addressed
General availability , affordability and access to where relevant,
are not available/
affordable
medical care and medicines are a precondi on for but not in scope
responsible use.
When pa ents present themselves to health care
are not matched to the right professionals, a medicine has to prescribed and
pa ent at the right me dispensed that ideally fits treatment requirements,
including appropriate ming.
When a medicine has been dispensed or sold to a
are not appropriately taken by pa ent, he/she has to be supported and
the pa ent empowered to use the medicine in such a way to Focus for the
ensure it improves his/her wellbeing. summit
Health system capabili es such as human capital
are not used with the right and data analy cs should op mally support the
capabili es in place prescriber, dispenser and pa ent to enable
evalua on of interven ons at the pa ent and
system level.
Source:MinistryofHealth,theNetherlands
1 https://apps.who.int/gb/ebwha/pdf_files/.../WHA58_33-en.pdf

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The medicines challenge in the broader health system
Healthsystemsaimtobringhighqualityhealthcaretotheircitizensatanacceptablecost.
Thedecisionsofhealthsystemleaderstooptimizescarceresourcesareoftenmadeinlightof
politicalandeconomicinterests.Insomecountries,highdebtandfiscaldeficitshaveplaced
healthcare reform high on policy agendas, with medicines as a specific priority. In other
countries, health technology assessments have been introduced to assist with
implementationofuniversalhealthcarecoverage.
Useofmedicinesisacriticalfactorinhealthsystemefficiency.Ontheonehand,medicine
spendingaccountsforuptoafifthofallhealthspending,orevenmoreinsomecountries.
On the other, medicines contribute indirectly to efficient health systems as they can avert
more costly interventions for severe conditions (e.g. vaccines and statins). However,
medicinesareoftenoverused(e.g.antibiotics)orunderused(e.g.nonadherence),resulting
inavoidableadverseeventsandpoorhealthoutcomes.
Revisiting medicine use in light of health-care costs is timely
Totalhealthexpenditureisrisingmorerapidlythanincomeacrosshigh,middleandlow
income countries. Across high and middleincome countries of the Organisation for
Economic Cooperation and Development, health spending per capita has surpassed
economic growth since 2000 (Figure 1). There is little reason to think this might change as
emerging markets accumulate wealth and access to healthcare increases. However, the
growthrateofthemedicinesmarketwillslowdown:whileglobalspendingonmedicinesis
predictedtonearUS$1trillionby2015,thisis36%lower(in20122017)thantheannual
growthrateof6.1%overthelast5years(in20072012)(3).
A closer look at health spending over the last decade reveals this trend. The rise in health
spending combined with the inherent link between medicine use and overall health care
(bothcostsandoutcomes),itisextremelyimportanttoexaminewhethermedicineusecan
beimprovedforthebenefitoftheentirehealthsystem.
This is particularly relevant as medicine access increases in lowincome countries and the
trend of the last 10 years continues (Figure 2). In fact, emerging markets are expected to
surpass the EU 5 (France, Germany, United Kingdom, Italy and Spain) in terms of global
medicines spending, and will account for 30% of global spending in 2016 (vs. 13% for the
EU5)(3).

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Figure 1. Total health vs medicine expenditure in high- and middle-income
countries
Across middle and high income countries, medicine spending is less than a third
of total health spending while growth rates are comparable
Revisiting medicine use is timely given rising healthcare costs and

the impact the use of medicines can have to control health Nonmedicine spending per capita*
system costs and improve health outcomes
Medicine spending per capita
Nonmedicine spending vs. medicine spending per capita in high income
countries, Average, US$ CAGR
2,796 2,987 3,357 3,647 3,531

100% 6.2%
83% 83% 83% 84% 84%

5.0%
17% 17% 17% 16% 16%
Nonmedicine spending vs. medicine spending per capita in middle

income countries, Average, US$
CAGR
275 309 373 443 433
100%
12.1%
76% 76% 76% 76% 76%
24% 24% 24% 24% 24% 12%
2005 2006 2007 2008 2009

*Nonmedicine spending is calculated by subtracting pharmaceutical expenditure from total health expenditure per
capita
Sources: IMS Institute for Healthcare Informatics, 2012; World Bank; WHO (latest available data for a subset of countries representing over 50%
Of each income group based on World Bank income groupings)
CAGR, compound annual growth rate
Figure 2. Total health vs medicine expenditure in low-income countries
In low income countries, although medicine spending is a larger share of total

health spending nonmedicine spending has been outpacing medicine spending
Nonmedicine spending per capita*

Medicine spending per capita
Nonmedicine spending vs. medicine spending per capita in low income countries,
Average, US$
CAGR
28 34 39 48 48 15.2%
100%
70% 73% 71% 71% 71% 13.7%
30% 27% 29% 29% 29%
2005 2006 2007 2008 2009
*Nonmedicine spending is calculated by subtracting pharmaceutical expenditure from total health expenditure per
capita
Sources: IMS Institute for Healthcare Informatics, 2012; World Bank; WHO (latest available data for a subset of countries representing over 50%
Of each income group based on World Bank income groupings)

4


Arangeoffactorsdrivesthesetrends:demographicshifts,changesindiseaseepidemiology,
innovation,andhealthsystemcomponentssuchasstakeholderincentivealignment.
Health system leaders are confronting new challenges in light of an ageing population,
increasingnoncommunicablediseaseburden,andrapidlyevolvingscienceandtechnology.
These challenges also present opportunities. Today, countries have much greater access to
informationandevidencefordecisionmakingandcanlearnfromoneanotheronarangeof
issues, from innovative payment schemes to human resource changes. At the core of the
discussionisthepatient,seenasapartnerinthetreatmentofthediseaseorcondition.This
approach allows the patient to participate in the selection of, and therefore the best use of
medicines.
These dynamics offer an ideal opportunity for all healthcare stakeholders, particularly
ministersofhealth,toexploitthefullvalueofmedicinesformaximumhealthoutcomes.

5


Chapter II Structure of the report
The aim of this report
As noted above, the responsible use of medicines means that patients receive the right
medicines at the righttime, use them appropriately, and benefit from them. This technical
report illustrates sound examples of nationallevel policies implemented to promote the
responsible use of medicines. Each case study is accompanied by strategic and tactical
recommendations could be implemented by ministers of health in other countries and
regionsoftheworld.
Scope of the report
Great emphasis is placed on medicine prescribers, dispensers and patients as key

stakeholders. This downstream focus on the delivery of medicines recognizes that a
functioning delivery system is a prerequisite to being able to implement the
recommendationsofthisreport.Here,dispensersarenotlimitedtopharmacists:although
qualified pharmacists are best positioned to guide medicine management by supporting
physicians in their prescription choices, and patients in their healthseeking behaviour,
policymakers should not underestimate the role authorized nonpharmacist medicines
distributors play in the use of medicines in the short term. The adequate training and
supply of qualified healthcare professionals, and pharmacists in particular, is essential in
the pursuit of a more responsible use of medicines and should be a priority in healthcare
systemsstrengthening.
Beyondhumanresources,thecapabilitiesthatneedtobeinplaceinahealthcaresystemto
ensure the successful implementation of the recommendations of this report range from a
reliable and resilient supply system to robust quality controls and appropriate healthcare
financing.Althoughthesecapabilitiesarenottakenforgrantedinthisanalysis,theyfallat
the margin of the downstream delivery and stakeholder focus. Other fundamental
challenges within the healthcare system are high outofpocket spending and the
fragmentationofcaredelivery.
It is not necessary for the Ministry of Health to own every step of the process. Good
regulation of the market along with publicprivate partnerships and private contributions
underpin the attainment of responsible use of medicines. On the other hand, unregulated,
profitdrivenhealthcareprovision,fromindividualsorinstitutions,canseverelyjeopardize
public health policy efforts. The importance placed by this report on universal health
coverageunderstronggovernmentstewardshipisinlinewiththe2005FiftyeighthWorld
Health Assembly resolution WHA 58.33, which promotes sustainable health financing,
universalcoverageandsocialhealthinsuranceforthehighestattainablestandardofhealth.

6


Structure and methodology
Thefollowingchaptersofthisreportconsiderinturnthekeyareasof:therightmedicines
(ChapterIII)matchedtotherightpatientattherighttime(ChapterIV)takenappropriately
by the patient (Chapter V) with the right support capabilities (Chapter VI). Chapter VII
centres on the benefits of broad, sustained stakeholder commitment to a more responsible
use of medicines. Through 11 exemplary country case studies, policy options are explored
foreachofthesekeyareas, highlightingthebenefitsofeachintervention.Thecasestudies
selected by WHO for this analysis largely showcase national policies that have been
implemented over a period of 35 years in developing countries, although examples from
developedcountriesandlongertermpoliciesarealsoillustratedwhereappropriate.
Each case study highlights how stakeholders have been engaged to secure the successful
implementation of the national policy. Prescribers need to understand the benefits of
responsible use, and practice it to avoid inappropriate use of medicines. Furthermore,
dispensers need to be engaged to ensure that only prescribed/appropriate medicines are
issued/dispensed to the patient. Finally, patients need to be sensitized to the value of
adherenceandproactivehealthseekingbehaviour.Althoughcasestudiesillustratedinthis
reporttouchontheissueofanappropriatesupplychainofmedicines,thescopeprecludesa
moreextensiveevaluationofthisissue.
Policy recommendations
Therecommendationsofthisreportaimtoguidenationalpolicymakingattwolevels:high
levelstrategicrecommendationsdesignedtocreatethe policyframework foraresponsible
use of medicines; and more concrete, pointofimplementation recommendations. Strategic
recommendations are listed at the beginning of each chapter, while tactical
recommendationsarelinkedtotherelevantcasestudy.
Thesevenstrategicrecommendationsofthisreportarethebackboneofamultistakeholder
policyroadmapthat,ifimplemented,willensureamoreresponsibleuseofmedicines.

7

The Pursuit of Responsible
R U
Use of Medicines:
Sharin
ng and Learnning from Co
ountry Experriences

Chap
pter III Impllementing a lis
st of prrioritize
ed
mediicines
Strattegic rec commendation 1: Develop and man ndate a List L of Es ssential

Medic cines at th he nationa al level to inform re eimbursem ment decis sions and ensure
acces ss to essen ntial medic cines.
The WHO concep pt of essen ntial medicines was established

e over 35 years
y ago and
a has
develop ped since then
t into a
a powerful tool to prromote heaalth equity on a globaal scale.
Essentiaal medicinees are thosee that satisffy the priority healthcare needss of the pop pulation
andareeselectedw withduereg gardtopub blichealthreelevance,ev videnceofeefficacyand dsafety,
and whenever
w p
possible cossteffectiven ness. Furthhermore, essential
e m
medicines m
must be
availablleatalltimmesinadequ uatequantiities,inthe appropriattedosagefo orms,with assured
quality and adequ uate inform mation, and at a price the individ dual and thhe commun nity can
afford.
ThelateestWHOM ModelListo ofEssential Medicines ispublicly availablea andcomprissesover

350 meedicines. Th he list is reg
gularly upd dated and is used tod day by man ny governm ments in
develop ping countrries as the basis (thro ough their National Essential
E M
Medicines Lists) for
procureement,supp plyanduseeofmedicin nesforthe healthcareesystem.A Althoughheealthcare
professiionalsinhighincomecountriesm mightnotbeefamiliarw withtheterm mWHOMo odelList
of Esseential Medicines, the vast v majoriity of deveeloped countries use lists of priioritized
medicin nesthatemu ulatethisW WHOModellList.
This ch hapter addresses the ro ole of goveernments inn identifying g, procurinng and supp plying a
list of prioritized
p medicines at the natio onal level, with
w particcular emphaasis on dev veloping
countriees.Theiden ntificationaandpromottionofalim mitedlistoffprioritym medicinesstiimulates
evidenccebased meedicalpractticeandop ptimizestheeefficiency ofexpendiitureonmeedicines.
Moreov ver, govern nment com mmitment to o providing g access to o, and reimmbursing essential
e
medicin nesnaturalllydecreasesstheuseof obsoleteorrsuboptimaalmedicines,andcaniimprove
the heaalth outcom mes of treaatment and d avoid unn necessary expenditure
e e on mediccines of
unprov ven efficacy y. Therefore, govern nments sho ould comm mit to priioritizing essential
e
medicin nes,fosterinngandimpllementingttargetedacccessandreim mbursemen ntpolicies.
Nationaal medicinee policy sho ould be bassed on the concept of essential medicines.
m T case
The
historiees in this Chapter illlustrate ho ow the go overnmentss of two countries
c o
obtained
remarkableresultssbyprioritiizingaccessstomedicin nesandreim mbursemen nt:Omanim mproved
medicin ne use by liimiting access in publlic healthcaare facilitiess to a speciified list of priority
(later teermed essential) meedicines. Sim milarly, Braazil strived to increasee access to priority
medicin nes (which h were a partp of Esssential Meedicines) by y establishhing a natiionwide
pharmaacy program mme that provided
p th
hese medicin nes for seleected indicaations at low w or no
cost.

8


CASE STUDY 1 Essential medicines list (OMAN)
Tactical recommendation 1.1: A list of essential medicines should be identified at the

national level to regulate access to medicines in public health-care facilities and to
ensure a broader, more efficient use of these medicines.
Executive summary
Inordertoensurethequality,safetyandeffectivenessofessentialmedicinesatan
affordablepriceinOman,theSultanateenactedanationalmedicinesinterventionin
2000focusingontheprioritizationofmedicinesprescribedthroughthepublichealth
channel.
TheCentralDrugCommitteewasstrengthenedinitsroleofselectingthemedicines
availableforuseinpublicsectorfacilitiesthroughtheMinistryofHealthApproved
DrugList.Thisstrengtheningwasbasedonasharperfocusonevidencebased
medicalneedsandcosteffectivenessofthemedicines.
Themoreresponsibleapproachtomedicinesuseiscalculatedtohavesaved1020%
oftheforecastedmedicineexpenditureeveryyearbetween2003and2009withno
evidentnegativeimpactontheburdenofdiseaseinOman.
Background
The Sultanate of Oman has experienced a remarkable improvement in the quality and
availability of health care in the last 40 years. Through sustained commitment and
investment, Oman has progressed from limited healthcare provision in the 1970s to the
present comprehensive universal healthcare model which has been internationally
acclaimedforitsperformanceandcosteffectiveness(4).
Initially, Oman had no clear national policy to ensure the availability of safe and effective
medicines to its population, nor a functioning healthcare infrastructure, since healthcare
providers were limited and predominantly trained outside the country (5). Due to this
diverse background and training, the quality of care provided as well as the medicines
prescribed were inconsistent. Thus, ensuring that appropriate medicines were made
availableandthenusedproperlywasaproblem.
Inordertoensurethequality,safetyandeffectivenessofessentialmedicinesatanaffordable
price in Oman, the Sultanate enacted a national medicine intervention in 2000 focusing on
theprioritizationofessentialmedicinesprescribedthroughthepublicchannel(6).
Intervention
FollowingaWHOassessmentin1996(7),theCentralDrugCommitteewasstrengthenedin
2000initsroleofselectingthemedicinesavailableforuseinpublicsectorfacilitiesthrough
theMinistryofHealthApprovedDrugList(7).Thisstrengtheningwasbasedonasharper
focus on evidencebased medical needs and costeffectiveness of the medicines.
Furthermore,allmedicinesweretobeincludedintheApprovedDrugListbyinternational

9


nonproprietary name (INN) in order to encourage generic prescription. A system for the
regularupdateoftheApprovedDrugListwasestablishedtotakeintoaccountthefeedback
of prescribers and other sources of information related to the appropriate procurement of
medicines. These concerted efforts culminated in 2003 in the publication of the Oman
NationalFormularyforMinistryofHealthInstitutions(5).
This intervention was enacted in the context of increased and sustained focus of the
Sultanateonthedevelopmentofacomprehensivehealthcaresysteminwhichpatientsare
treated free of charge, mainly through the public sector and by an appropriate number of
trained professionals. Separate policies were enacted to ensure the appropriate supply of
medicines to the treating centres and the appropriate quality monitoring of the medicines
distributed(5).
Inordertoensurethecooperationandsupportofallkeystakeholdersinthisnationaleffort,
the Sultanate engaged physicians, pharmacists and patients separately (5). In 2002 Oman
sponsored a series of courses promoting rational drug use (RDU), which consisted of an
intensive twoweek curriculum encompassing all aspects of how to improve the use of
medicines. These courses were designed to train key prescribers on the importance of the
newNationalDrugPolicyandtheimpendingOmanNationalFormulary,toallowthemin
turntoinfluencetheirpeersonresponsibleprescribing.Furthermore,since2001therational
useofmedicinesbecamearequirementinthefinalexaminationofMedicalOfficerGeneral
Practitioners.
Renewedattention wasalso placedonthe training of pharmacists.Atrainingmanual was

developed to provide them with practical examples and suggestions in order to support
prescribers to be more responsible in the use of medicines. This manual was published in
2004 and its implementation followed up through a series of workshops throughout the
country. The recommendations were specifically tailored to the needs and nuances of the
healthcaresituationinOman.
A public education campaign was launched in 2011 to sensitize the general public to the
benefitsofamoreresponsibleuseofmedicinesintheirhomeswiththetitleMyhealthlies
in the appropriate use of medicines. The campaign consisted of a series of mass media
advertisements and public events to raise awareness of the benefits of the new national
medicinespolicy.Thefirstphaseofthepubliceducationcampaignhasbeenconcluded,and
aMinistryofHealthreportonthesuccessoftheinitiativeiscurrentlybeingcompiled.
Health outcomes
Figure 3 shows that a more responsible use of medicines had no negative effect on the
burden of disease, since outpatient morbidity for communicable diseases (the proxy
indicatorformorbiditypreventablebymedicines)didnotsignificantlychangeafter2003(8).

10


Figure 3. Outpatient morbidity, communicable diseases, 20002009
7000
Registered cases/10000 people
6500
6000
5500
5000
4500
4000
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Communicable diseases

Source:Annualhealthreports,MinistryofHealthoftheSultanateofOman
Financial outcomes
The economic benefits of an increased focus on essential medicines are clear from
expenditure on medicines after 2003, when the Oman National Formulary was published
and most stakeholder engagement programmes were under way. Figure 4 shows a
comparisonofactualmedicineexpenditureasapercentageoftotalhealthcareexpenditure
between 2000 and 2009 with its forecasted value based on mean medicine expenditure
between 1995 and 2003: a more responsible approach to the use of medicines consistently
saved1020%oftheforecastedmedicinesexpenditurebetween2003and2009(8).

11


Figure 4. Measured vs forecasted medicines expenditure, 20002009
12%
Percentage of total health-care
10%
8%
expenditure
6%
4%
2%
0%
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Measured Medicines Expenditure
Forecasted Medicines Expenditure (Mean % 1995-2003)
Success factors
Themedicinepolicyreform,andimplementationoftheNationalEssentialMedicinesListin
Omanwentsmoothlybecauseofthepredominantlypublichealthcaresystemthathadbeen
built during the previous decades. The Oman National Formulary was updated and
expanded in 2009. Uptake of essential medicines was not as great in the private sector;
however,thisrepresentslessthan10%oftotalhealthcareservices.
Afurtherfactorinthesuccessofthisinterventionwastheengagementofkeystakeholders.
Without a strong and sustained educational effort targeting physicians, prescribers and
patients,theinterventionmayhavebeenseenasamerecostcuttingprocedure.
Conclusions
The establishment of a welldeveloped and implemented essential medicines list has

allowed the Sultanate to ensure the availability of safe and effective medicines, and at the
same time secure significant economic benefits from better medicine expenditure control.
Furthermore,itisclearthatthesegainswerenotmadeattheexpenseofanincreasedburden
of disease. The experience in Oman shows how the prioritization of medicines at the
nationallevelcanbeinstrumentalinsupportingamoreresponsibleuseofmedicines.

12


CASE STUDY 2 Popular pharmacy programme (BRAZIL)
Tactical recommendation 1.2: Partial to full reimbursement should be granted at the

national level to medicines included in the essential medicines list in order to increase
access and promote their use in the health-care system.
Executive summary
InBrazil,equalaccesstomedicinesisapriorityfortheGovernment.However,a
significantpartofthepopulationisnotcoveredbythenationalhealthcaresystem.
Toimproveaccesstoessentialmedicines,theBrazilianGovernmentintroducedthe
PopularPharmacyProgrammeBrazil(FPBP)in2004,creatingGovernmentowned
pharmaciesthroughoutthecountrywherepatientscouldobtain107medicinesat
lowcost.
Theprogrammewasexpandedin2006totheprivatesector(FPBE),makingmore
lowcostmedicinesavailableatmorelocations.
Forallmedicines,theGovernmentreimburses90%ofeitherthereferencevalueor
thepharmacyretailpriceofgenericmedicines.
Since2011,selectedmedicinesfordiabetesandhypertensionhavebecomeavailable
freeofchargeatthepharmaciesparticipatingintheFPBE.
Asaresult,accessto,anduseofessentialmedicineshasincreased.
Thisimpliesthatbyprioritizingnationalreimbursementpolicies,agovernmentcan
improvetheaffordabilityandaccessibilityofessentialmedicines.
Background
In Brazil, access to essential medicines became a constitutional right for its population of
over 190 million and an obligation for the State in 1988. To ensure equal, universal and
integral access to health care for all citizens, the Brazilian Government introduced the
Unified Health System (SUS), covering all Brazilian citizens. However, 30% of the
population57millionpeopleremainedoutsidethereachofthepublichealthcaresystem
in 2008 for several reasons, including their residence in remote locations and/or far from
pharmaceutical services. For these persons, health care and medicines had to be obtained
through private insurance or through outofpocket payments, meaning that essential
medicineswereunaffordableandinaccessibleforasubstantial,andthepoorest,partofthe
population(9).
Responsible use of medicines requires that the patient take them appropriately. Based on
WHOstrategiestominimizenonadherence,aholisticapproachwasadoptedtoenhancethe
privatesectorreimbursementofessentialmedicinesthroughapolicyintervention:in2004,
theBrazilianGovernmentinitiatedtheProgramaFarmciaPopulardoBrasil(FPBP,Brazilian
PopularPharmacyProgramme).In2006theprojectwasextendedbyapublicprivatesector
initiative called Aqui tem Farmcia Popular (Here there is a Popular Pharmacy). This
extension, also known as FPBE, is a privatesector managed, copaying system that offers

13


essentialmedicinesatlowpricesforanumberofconditionssuchashypertension,diabetes,
asthmaandglaucomaamongothers.(9).
Theoverallobjectiveofthesetwoprojectswastooptimizetheuseofessentialmedicinesfor
peopleinBrazilwhohadnoaccesstoSUSbenefits,ofwhohadprivatehealthcareinsurance
butnofinancialresourcestopurchasemedicines(privatehealthplansinBrazilrarelycover
medicines).Brazilachievedthisobjectivebyincreasingtheavailabilityandaffordabilityof
essential medicines through publicprivate partnerships, since patients clearly cannot
adheretotreatmenttheycannotafford.Althoughsocioeconomicpolicyinterventionsarenot
within the boundaries of this report, this case study is a good example of how the
responsible use of medicines can be improved by facilitating access for the whole
population,i.e.aholisticapproachtominimizenonadherence(9).
Intervention
ThetwopartsoftheFPBcanbedescribedasdriversoftheBrazilianhealthcaresystemto
servethosenotcoveredbytheSUS.Theinitial,publicsectorproject(FPBP)wasintroduced
in 2004 and extended to the private sector managed project (FPBE) in 2006. The FPBP is
managedbytheBrazilianMinistryofHealthandtheOswaldoCruzFoundation(Fiocruz),
cooperating with nonprofit organizations in the public and private sectors. For the
introduction of the FPBP in 2004, 27 new pharmacies the Popular Pharmacies were
createdtodispensemedicinesfromalistof107items,comprising96medicines.1
RecentdatashowthatthenumberofGovernmentownedPopularPharmacieshasreached
556,covering440municipalities(80%).All107medicinesdispensedatthesepharmaciesare
centrallypurchasedbyauctionbidsfromofficialpublicandprivatelaboratories,andmade
availableatthesamepriceacrossthecountry.Pricesaresetatanaffordablelevel,ranging
from R$ 110 (=US$ 0.505.00) per single dose for incidental treatment medicines to R$
0.010.50 (US$ 0.010.25) for single units for chronic treatment medicines, including
antibioticsandhormonalpreparations.
The extension of the project in 2006 is managed by the private sector and includes 20373
registered retail pharmacies nationwide. This extension includes medicines for
hypertension, diabetes, dyslipidaemia, asthma and rhinitis, glaucoma, Parkinson disease,
osteoporosis, influenza H1N1 and contraceptives, as a subset of the medicine list of the
initial programme. For all medicines, a reference value (RV) was established by the
Government. When the pharmacy retail price is equal to or higher than the RV, the
Government reimburses 90% of the RV; when the pharmacy retail price is lower than the
RV,theGovernmentreimburses90%ofthepharmacyretailprice.TheRVsoftheFPBEare
basedongenericmedicines.
1 ThecompletelistofmedicinesavailablethroughthePopularPharmaciescanbeconsultedonthe
BrazilianMinistryofHealthwebsite:
http://portal.saude.gov.br/portal/arquivos/pdf/tabela_farmaciapopular_abril08.pdf.

14


The extension model was expanded in early 2011, making diabetic and antihypertensive
medicinesavailableforfreetoeligiblepatientsattheenrolledpharmacies.Fourconditions
applyforthispartoftheprogramme:
1. Themedicinesareonlydispensedmonthly;
2. Themedicinesmustbedispensedtotheuserofthemedicinesoraproxywhocan
justifyobtainingthemedicines;
3. Thepharmacymustkeeparecordofthemedicalprescription;
4. Theusermustsignforthemedicines.
TheMinistryofHealthbuysthemedicinesfromprivateandpublicindustrywhicharethen
sold by the governmental pharmacies (FPBP) and private retail stores (FPBE) at the
predefinedprices.
In summary, the policy interventions undertaken by the Federal Government for the first
part of the programme included the creation and management of Popular Pharmacies to
deliver selected essential medicines. The policy interventions for the second part included
registration of participating pharmacies and implementing a nationwide reimbursement
policyforadefinedlistofgenerics.
Since the aim of the FPB project was to optimize pharmaceutical care and adherence to
medicinetreatment,thefirststakeholdersengagedwerepharmacists.However,prescription
practice had to be in line with the available medicines at the Popular Pharmacy and the
participating private sector pharmacies. Therefore, although prescribers were not the
principal stakeholders in this case study, their commitment to responsible prescribing of
medicineswasessential.
Health outcomes
Althoughnomortality data wereavailable,improved utilization of essentialmedicinesfor

chronic conditions should lead to improved health outcomes, both on the individual and
population scale. According to government data, the introduction of the FBP has allowed
patientstocontinuetakingtheir medicines withoutabreak intreatment.Furthermore,the
programmehasdecreasedthefinancialburdenonfamilies(10).
Financial outcomes
ThefinancialoutcomesoftheFPBcanbederivedfrompharmaceuticalsalesdataobtained
fromIMSHealthBrazil.Datanotincludedinthisreportshowtheexampleofinsulinafterit
was made available free of charge, as part of the second expansion of the FPB in 2011.
Consumption of insulin derivatives not covered in the private sector remained stable,
whereastherewasatwofoldincreaseinsalesofinsulinprovidedforfreethroughtheFBP
P. Figure 5 shows how increased access to insulin medicines in Brazil encouraged people
whowerenotusingthembefore2011tostartusingthemwhentheybecameavailablefreeof
charge. Data from IMS Health Brazil show that the volume of insulin provided free

15


accountedfor51%ofthetotalmarketvolume,whiletheircostaccountedforonly26%ofthe
totalmarketcostsofinsulininBrazil(9).
Figure 5. Insulin sales before and after extension of the Popular Pharmacy
Programme in Brazil
Insulin sales in Brazil

200%
February2011: Announcementoffull
Retail sales (%, indexed at January
reimbursementofinsulinincludedin
180% theprogramme
160%
140%
120%
2010)
100%
80%
May-10
Aug-10
Sep-10
Jan-10
Apr-10
Nov-10
May-11
Jul-10
Dec-10
Jan-11
Apr-11
Jul-11
Feb-10
Feb-11
Jun-10
Jun-11
Mar-10
Mar-11
Oct-10
Non-reimbursed (Insulin Aspart, Detemir, Glargine et al.)

Reimbursed (Intermediate and short-acting human insulin)

Source:IMSHealthBrazil
Success factors
ThekeysuccessfactorofthisprogrammewasthecommitmentoftheBrazilianGovernment
to improve access to essential medicines for all its citizens. Furthermore, the approach of
engagingpublicandprivatesectors,includingmunicipalities,aphilanthropicorganization
and retail pharmacies, made possible the nationwide outreach of the programme.
Expanding the programme to the private sector created a winwin situation: participating
retail pharmacies could increase revenue; patients could afford their medicines; and the
Governmentcouldmaximizetheimpactonhealthofitsreimbursementpolicy.
Conclusions
Brazil is a large, highly populated country, and so achieving nationwide results from a
centrallymanagedprojectwasarealchallenge.Asthecasestudyshows,thischallengewas
successfully addressed through the introduction, evaluation and continuation of the FPB.
Theoutcomesofthiscasestudymayserveasrecommendationsforothercountrieswishing
to improve affordability of medicines and thereby adherence to treatment schedules and
theirhealthoutcomes.

16

R U
Use of Medicines:
Sharin
ountry Experriences

Chap
pter IV Treatting the
e right patient
p at the right tiime
Strategic re ecommend dation 2: 2 Investt to ens sure natio onal med dicine
procu urement and a supply systems s are effic cient and reliable to t supporrt the
respo onsible use of medic cines.
Strategic rec commendation 3: Promote a shift in focus to early e scree ening

and accurate diagnosis to inform m medicine prescrip ption and thereby avoid a
overu use, underuse and misuse m of medicines s.
Strategic rec commend dation 4: Facilitate the imple ementation of evide ence-
based treatm ment guide elines; where
w the
ey exist, remove regulatorry or
admiinistrative barriers and a directtly target all key sttakeholderrs: prescriibers,
dispe ensers and d patients. .
The effficient proccurement anda reliablee supply of

o medicinees of assurred quality remain
concern nsinmany developing ganddevellopedcoun ntriesalike. Referringm morespecifficallyto
essentiaal medicinees, a robustt healthcarre system needs
n to su
upport the responsiblee use of
medicin nes by asssuring thatt they are procured efficiently through tenders, delivered
effectiv
velytohealtthcareprov vidersandp patientswitthoutstocko outs,andch heckedrouttinelyto
assureqquality.Asseenincaseestudy3on nthemediccinessupply ysystemrefforminBhu utan,the
reliabiliity and efffectiveness of the sysstem is neccessary to ensure
e the right med dicine is
availablle to the right
r patiennt at the right
r time. Therefore,, the efficieency of medicines
procureementisofttheessencetoensuretthatfundssspentprovid dethebestv valueformmoney.
Theavaailabilityof effectivem medicinesallone,howev ver,isnotssufficienttooguarantee thatthe

patientreceivestheappropriaatetreatmen ntforthem
maximumheealthoutcom me;theresp ponsible
useofmmedicinesreequiresaco orrectandttimelydiagn nosis,andp prescription nanddispensingof
the righht medicines in correect quantities. An accurate diagn nosis is needed to av void the
misuseofmedicinees,andalatediagnosiscanannih hilatetheheealthoutcom mesofanottherwise
vetreatmentt.Theconseequencesofthesubopttimaluseoffmedicinesduetoanyofthese
effectiv
causes can be diree, ranging from
f unnecessary suffeering from sideeffectss to hospitaalization
duetoccomplicatio onsandthewasteofscarceresources.
Asinth hemalaria casestudy 4below,th heimpacto ofdiagnostiicsisincreaasing asph hysicians

rely on them to taarget therappy and avo oid the misu
use of med dicines. Thee value of aa correct
diagnossis is eviden nt, especiallly in instan
nces where the diseasee progressio on is very rapid
r or
themed dicinesare expensive. Furthermorre,earlyscrreeningofp patientgrou upsthatareeknown
to be at
a heighten ned risk of a specific disease caan greatly increase th he effectiveeness of
availablletherapy. Casestudy y5onHIVaantenatalsccreeningbeestillustrateesthevalueeofsuch
proactiv ve,earlyscrreeninginccriticalpatieentgroups.
Diagnosisneedsto obefolloweedbytheco orrectprescrriptionanddispensing goftheapp propriate

quantity y of mediccines: evideencebased treatment guidelines are fundaamental in guiding
prescripption,andrregulatory/aadministrattiveincentiv vesplayassignificantrroleindetermining

17


prescribing behaviour. The case studies on Antibiotics Smart Use in Thailand (see Case
StudyfromThailand);medicaluseofopioidsinIndia(seeCaseStudyfromIndia)andzinc
indiarrhoeatreatment(seeCaseStudyfromBangladesh)areexamplesofactionsthatcanbe
takentoavoidunderuse,overuseandmisuseofmedicines.
The six case studies included in this Chapter offer concrete, practical suggestions on how
efficient supply management, correct and timely diagnosis, and evidencebased guidelines
canbeleveragedtopromotetheresponsibleuseofmedicines.
CASE STUDY 3 Medicines supply reform (BHUTAN)
Tactical recommendation 2.1: Establish centralized, tender-based procurement of

essential medicines. Funds for medicines provided by international aid organizations
should preferably be used through the same system, and comply with national priorities.
Tactical recommendation 2.2: Establish routine quality testing procedures to verify

that medicines procured through the national tendering system are of assured quality.
Results of quality tests should inform the selection of medicines suppliers.
Tactical recommendation 2.3: Establish a routine performance feedback system to

ensure that suppliers who cannot deliver medicines of assured quality in time are
informed, and excluded from future tenders.
Executive summary
AnEssentialDrugsProgrammewasinitiatedinBhutanin1986,whichincludedthe
creationofanEssentialMedicinesList,newtreatmentguidelinesandthemonitoring
ofmedicinesuse.Onekeyaspectoftheprogrammehasbeenthefocusonimproving
theprocurementanddeliveryofmedicines.
ThefirstkeyactionundertakenbytheMinistryofHealthwastocentralizethe
procurementofallmedicinestobeprescribedinpublichealthcarefacilitiesthrough
asystembasedonsuppliercompetitioninyearlytendering,asopposedtosingle
manufactureremergencypurchase.Thequalityofmedicinesprocuredwas
monitoredthroughamixofrandomsampletestingandstaffreportsofsuspected
poorquality.
Theavailabilityofessentialmedicinesinbasichealthunits(BHU),thechief
providersofprimaryhealthcareservicesforalargeportionofthepopulationin
remoteareas,increasedfrom6%beforetheEssentialDrugsProgramme(EDP)to
66%in1989.
Theincreaseincompetitionamongsuppliersresultedina6%dropinaverage
medicinepricesbeforeinflationbetween1985(beforeEDPimplementation)and
1990.Only3%ofrandomlysampledessentialmedicinesfailedlaboratoryquality
controlsbetween1988and1992;thefailurerateofallprocuredproductsinthe
period19881997was1.5%.Themajorityofrecordedqualityfailureswereminor.

18


Background
WhentheGovernmentofBhutansetouttoimprovethequalityofitshealthcaresystem,it
becameevidentthattheprocurement,storageandsupplysystemformedicineswasneither
resilient nor reliable enough to support the responsible use of medicines. The overall
availabilityofmedicineswasheavilyinfluencedbydecentralizeddirectprocurement,alack
ofGovernmentorothercontroloveraccountingofdonatedsupplies,andfrequentstockouts
duetoacombinationofshortmedicineshelflifeandpoortransportationroutesduringthe
monsoonmonths.

An Essential Drugs Programme was initiated in 1986 in partnership with WHO and
international healthcare professionals, and has been run with increasing independence by
local staff since the early 1990s. The programme includes interventions ranging from the
creation of an Essential Medicines List to new treatment guidelines and the monitoring of
medicinesuse.Theprogrammehasparticularlyfocusedonimprovingtheprocurementand
delivery of supplies. Sixmonthly drug consumption reports were introduced, along with
annualindentformsformedicalsuppliesotherthandrugs(11).
Intervention
Inordertosecuremorereliableandefficientprocurement,thefirstkeyactionundertakenby
theMinistryofHealthwastocentralizetheprocurementofallmedicinestobeprescribedin
public healthcare facilities. This centralization allowed economies of scale and laid the
foundation for a procurement system based on supplier competition in yearly tendering,
rather than emergency purchase from a single manufacturer. A new list of suppliers was
draftedfornationalprocurementpurposes,includingatleastthreemanufacturersforeach
medicineintheessentiallisttoensureappropriatecompetition.Thetenderprocesswasthen
opened to both local and international manufacturers. This centralization included the
procurementofdonatedmedicines(27%ofthetotalmedicineexpenditurebetween1987and
1997)whosebidpriceswerecomparedwiththoseproposedbymanufacturersinthetender
list.Thispolicywasdesignedtoobtainthebestvalueformoneyinprocurement,andfocus
donatedfundssolelyonessentialmedicines(11).

Through the use of centralized tenders, it became possible to lay down more specific
conditions on the medicines procured and the timeliness of their delivery. Purchase order
termswere revised tospecify thatthemedicinesprocured hadto have aminimumoftwo
yearsshelflifewhenreceivedbyministerialfacilities,splittingdeliveriesforproductswith
shorter shelflives. Furthermore, given the narrow window of opportunity of medicine
distribution throughout the country due to the constraints imposed by the monsoons,
supply deadlines were firmly enforced. The enforcement of these conditions was
particularly influential as late deliveries or those not meeting ministerial specifications
wouldeventuallyresultinexclusionfromthenationaltendersupplierslist.

The quality of medicines procured was ensured through a twopronged approach. First,
only manufacturers that had secured a WHO Good Manufacturing Practices Certificate
(issued by the manufacturers national authorities according to WHO Guidelines) were
admitted to the tendering list. The quality of the medicines delivered was then assured

19


through a mix of random sample testing and staff reports of suspected poor quality. All
failures in quality control tests were reported, which influenced supplier selection in
subsequent tenders. Because Bhutan did not have a national institution in charge of
verifying medicine quality through laboratory tests, two WHO collaborating centres (in
ThailandandIndia)wereidentifiedtoassessalimitednumberofmedicinesamplesonan
ongoing basis. The availability of these laboratories allowed a sharing of the quantity of
medicines tested in any one centre, and the Ministry of Health to doublecheck test
results(11).
Although these policies were essential to support the responsible use of medicines in the
downstream area of healthcare delivery, the interventions focused on shifting the
procurementpowerfrommanufacturerstotheMinistryofHealth.Inordertobroadenthe
key targets of the interventions beyond medicine manufacturers and suppliers to include
prescribersanddispensers,thefollowingactivitieswereregularlyconducted:workshopson
good prescribing practices; good store and inventory management for all health workers,
especiallypharmacytechniciansresponsibleformedicalstoreinthehospitals;andtraining
forprescribersontherationaluseofdrugs.
Health outcomes
NotallthepositiveresultsofthebroadEssentialDrugsProgrammecanbeattributedtothe
interventions on procurement. However, key outcomes reflect the success of the policies
implementedtosupporttheresponsibleuseofmedicinesviasupplyreforms.Asitwasnot
possible to carry out a robust comparison of key outcome indicators before and after
implementationoftheEssentialDrugsProgramme,theresultsareclearlylimited.

Thesignificantincreaseinaccessandpricereductionswerenotobtainedattheexpenseof
quality.Only3%ofrandomlysampledessentialmedicinesfailedlaboratoryqualitycontrols
between1988and1992(1.5%failureofallprocuredproductsintheperiod19881997).The
majority of recorded quality failures were minor, underlying the importance of supplier
screeningviaWHOCertification(11).
Financial outcomes
TheEDPshowedanimpressiveimpactontheavailabilityofessentialmedicinesinremote
areasofBhutan.BHUs,chiefprovidersofprimaryhealthservicesforalargeportionofthe
population in remote areas, increased from 6% to 66% in 1989. The essential medicines
pertainingtoBHUsandhospitalswereavailableinover80%ofauditsperformedbetween
1990 and 1997. In addition, over 90% of 27 basic medicines were available in all health
facilitiesthroughouttheyearduringthe1989and1997audits.Thewastageofmedicinesdue
toexpiryalsodeclinedtoanaverage0.73%ofthetotalmedicinesbudgetbetween1993and
1996(11).
The increase in competition among suppliers resulted in a 6% drop in average medicine

prices before inflation between 1985 (before EDP implementation) and 1990. This price
reductionslowedinthefollowingyears,withinflationadjustedaveragepricesin1997being
only 10% less than those of 1990. Due to strict adherence to the new procurement policies

20


aimed at fostering price competition, the average medicine prices paid in Bhutan in 1997
were50%lowerthanaverageinternationalprices(11).
The legislation for regulation of medicines was enforced only when the medical supply
system was well instituted and fully functioning: in 2003, the Bhutan Medicines Act was
passed by Parliament and effective enforcement of medicinal product registration was
initiated in 2005. Today, only medicinal products that are registered with the Drug
Regulatory Authority, independent of the Ministry of Health, are allowed in the country.
Theprovisionsaredraftedtobemorefacilitative,tofocusonthebestpracticesofdeveloped
countries,andtoensureavailabilityoftheessentialdrugsneededinthecountry.
Success factors
The clear focus on quality and timeliness of delivery, coupled with yearly performance
assessmentssharedwiththesupplier,placedpressureonallstakeholderstoworktothebest
oftheirabilityinordertoremainonthenationaltenderinglist.Theinclusionintendersof
three or more suppliers for each essential medicine ensured that both the cost and the
qualityofmedicinesprocuredwerealwayscontrolled.
Conclusions
The reform of both medicine supply and delivery were fundamental in supporting the
ministerialcampaignforresponsibleuseofessentialmedicines.Thisexperienceunderlines
the importance of ensuring robust and resilient supply systems to support prescribers,
dispensersandpatientsinthedownstreamdeliveryofhealthcare.
CASE STUDY 4 Malaria rapid diagnostic test (SENEGAL)
Tactical recommendation 3.1: Promote focus on accurate diagnosis, with the aid of
diagnostics where necessary, in order to guide the appropriate prescription of medicines.
Executive summary
Duetosuboptimalavailabilityandaffordabilityofadequatediagnostics,febrile
patientsareofteninappropriatelytreatedwithantimalarialartemisinincombination
therapy(ACT)medicines.
Rapiddiagnostictests(RDTs)areimportanttoolsintheaccurateandspecific
diagnosisof,forexample,Plasmodiumfalciparummalaria.
InSenegal,theGovernmentprioritizedaccuratediagnosisbyintroducingRDTsas
thefirstchoicediagnosticformalariasuspectedpatients.
Asaresult,presumptivetreatmentbasedonclinicalsymptomsdecreasedandACT
medicinescorrectlytargetedpatientswithconfirmedmalaria.
Thisinterventionisverylikelytohavecontributedtothesignificantdecreasein
malariathatoccurred.

21


Background
The parasitic disease malaria is a significant cause of death, mainly for children in sub
Saharan Africa under five years of age (12). To help countries to manage the burden of
malaria,WHOhaspublishedtreatmentguidelinesthatencourageearlydiagnosis,builton
solid scientific evidence. Prompt parasitological confirmation by microscopy or by RDT is
recommendedinallpatientssuspectedofmalariabeforetreatmentisstarted(13).Treatment
based solely on clinical suspicion should only be considered when a parasitological
diagnosis is not accessible (i.e. within 2 hours of the patient presenting); symptomatic
diagnosis has very poor specificity, as the first symptoms of the disease can also be
attributedtominorviralinfections(13).
Presumptive treatment of febrile illnesses without parasitological confirmation has led to

overuse of medicines, which is one of the contributing factors to the development of
resistance. Oral artemisininbased monotherapy medicines also play a major role in the
developmentofresistance.Toavoidanddelaythedevelopmentofresistance,combination
therapiesaregiven(13).Therefore,promptandaccuratediagnosisofmalariaisessentialto
providethecorrectmedicaltreatmentforbothconfirmedmalariacasesandthemanagement
ofotherfebrilediseases.
Following a parasitological confirmation, artemisininbased combination therapy (ACT) is

the evidencebased and costeffective firstchoice treatment for uncomplicated falciparum
malaria recommended by the WHO malaria treatment guideline. Increasing accurate
diagnoses reduces the frequency of falsepositive results, which in turn reduces drug
wastage,overuseandpressuretowardsresistance(13,14).
ThedecisionondiagnostictestingbymicroscopyorRDTlargelydependsonthesetting.In
remoteareas,forexample,qualitymicroscopyisnotasavailableasinmainhospitals.Thus,
when an outpatient onthespot diagnosis is required, RDTs are the preferred diagnostic.
RDTsareeasytouseandeffectiveinearlydiagnosisofmalaria.Importantly,theydelivera
rapidandpointofcarediagnosiswithoutthedelaysassociatedwithcentralizedlaboratory
diagnostics. Since their introduction in 1993, the accuracy, availability and affordability of
quality products have progressively improved, although this remains suboptimal in many
countries(12).
This case study shows the successful introduction of malaria RDTs in Senegal, a lower
middleincomecountrywithamalariaincidenceofmorethan10%ofthetotalpopulation,
dependingonthearea.ThepotentiallyfatalP.falciparumparasiteisresponsibleforvirtually
all reported cases and the relatively benign P. vivax parasite is a small fraction. Before the
introductionofRDTsin2007,malariadiagnosisdependedprimarilyonclinicalassessment,
withmicroscopyconfirmationlimitedtothelargerhospitals.
The impact of RDTs on treatment exposure and health outcomes is poorly documented in
manycountries.TheresultsoftheSenegalintervention,however,werecarefullyevaluated
inthepeerreviewedacademicjournalPloSOne(14),providingageneralizablerationalefor
implementationofRDTsinmalariaendemiccountries,inlinewithWHOguidelines(13).

22


Intervention
Since1995,theNationalMalariaControlProgramme(NMCP),affiliatedtotheGovernment,
has been the overarching institute in Senegal responsible for the development and
implementationofmalariapolicy.Overtheyears,theNMCPhasattractedseveralgrantsto
fund their projects from international organizations including the Global Fund to Fight
AIDS, Tuberculosis and Malaria, the United Nations Childrens Fund (UNICEF) and the
WorldBank.TheprogrammesoughttoscaleuptheuseofRDTsanddecreasetheoveruseof
ACTs,andhenceincreaseeffectiveandresponsibleuse.Thisisintegraltothemissionofthe
NMCPandWHOtocontrolandultimatelyeliminatemalaria.
TheprojectstartedinSeptember2007withincorporationoftheuseofRDTsinthenational
guidelinesforthemanagementoffebrileillness.Allpresentedcaseswithsuspectedmalaria
in the community were subjected to an RDT, restricting ACT to positive cases. Figure 6
showsthetreatmentalgorithmtobefollowedwhenacasewaspresentedatthecommunity
pointofcare(14,15).Thisguidelinechangereachedallhospitals,publicsectorhealthcentres
and community health huts in 2008, making RDTs accessible to all patients presenting at
healthcare settings in Senegal with febrile disease. This shows that this intervention had
goodshorttermfeasibility.
Figure 6. Febrile illness case management algorithm recommended in Senegal,

2007
Fever
(High body temperature in last 2 days or axillary
temperature equal or greater than 37.5C)
Presence of other symptoms than malaria?

(cough, sputum, sore throat, skin rash, ...)
NO YES
Treat cause
YES Fever
Fever persists
persists NO
after
after 48
48 hours?
hours?
Perform
Perform
malaria
malaria
RDT
RDT
Negative RDT results Positive RDT results
Administration
Administration of
of antibiotic
antibiotic
(broad
(broad spectrum)
spectrum) and
and antipyretic
antipyretic Treat
Treat malaria
malaria
Follow
Follow up
up visit
visit after
after 48
48 hours
hours
Condition
Condition
Condition
Condition not
not improving
improving improving
improving
Continue
Continue
Refer
Refer patient
patient to
to reference
reference centre
centre management
management
Source:MalariacasemanagementalgorithmoftheSenegalNMCP,2007

23

R U
Use of Medicines:
Sharin
ountry Experriences

Stakeho older engaggement wass ensured by
b the widee scope of the
t project. Although it was a
topdow wnpolicy(ffromnation naltocommmunityleveel),allmalarriafacilitiesswereenro olled.To
trainheealthcarew
workersintthefield,th heprojectwwaspiloted onasmall scaleintheecapital
Dakar. Duringthisspilotperio od,educationalmateriialsweredevelopedsu upportedb byWHO
traininggmanuals.T TheNMCP PcollaborateedwiththeUniversityofCheikhAntaDiop(Dakar)
to estab
blish distriict and reg
gional train
ning teams to educatee healthcaare workerss in the
manageement of th he new treaatment guid deline. Thee University y also activ
vely contrib
buted to
commu unity engaggement by disseminatin
d ng data to nongovern nmental org ganizations (NGOs)
and commmunity organization ns showing the reliabiility of the RDTs and the new treatment
guidelinne.Asaressult,keyopiinionleaderrsadvocateedrelianceo onRDTsinthemedia.
Health outcom
mes
Thepriimaryresultsoftheintterventionccanbeseen ninthreem majoroutcom mes(Figuree7&8):
1. Fromthein ntroductionnin2007tottheendof22009,theuseeofRDTsrrosefromzeeroto
virtually1000%ofallprresentedfeb brilecases.
2. Increasedd diagnosticsp pecificity:ssincethebeg ginningof22008,theprroportionoff
patientstreeatedwithAACTdroppeedfrom6080%ofallp presentedfeebrilecasessto15
50%(followwingtheacttualmalaria aseasoninS Senegal),in
nlinewiththheRDTresults.
3. TotalACTexposurein nthepopulaationdecreaased,which hledtodecrreasedpresssure
towardsressistance.
Figure
e 7. Perce
entage of febrile
f pattients testted, diagno
osed posittive and trreated
w
with artem
misinin-ba
ased comb bination thherapy in Senegal,
S 2
20072009 9

Sou
urce:Majorred
ductioninanttimalarialdrrugconsumptiioninSenegal(14)

24

R U
Use of Medicines:
Sharin
ountry Experriences

Figu
ure 8. Nummber of febbrile patie
ents presenting, sus
spected to have malaria,
teste
ed, diagno
osed posittive, and treated witth artemis
sinin-base
ed combina
ation
th
herapy in Senegal, 2007200 09

Sou
urce:Majorred
ductioninanttimalarialdrrugconsumptiioninSenegal(14)
Finan
ncial outc
comes
No oveerall costbeenefit analy

yses have been publish hed on the RDT interv vention in Senegal.
S
The purchase of thhe tests putt an extra burden
b on financial
f resources, wh hereas the reduced
r
numberr of procurred ACTs probably
p offfset these extra costss. Furtherm more, RDTn negative
patientsscouldbep prescribedaantibiotics,w whichinSeenegalarem moreexpenssivethanACTs.
Longitu udinalstatissticsofantiibioticpresccriptionsw werenotava ailable,but someunpu ublished

reports indicate thhat many of
o the RDTnegative patients did not receiv ve antibioticcs. Cost
benefit models bassedonsituationselsew where impllythat ano overall cost avoidance may be
expecteed for the improved
i m
managemen nt of febrilee illness (booth malariaa and nonm malaria)
(15,16,117). Patientts are receeiving earliier and more accuraate diagnosses and m medicinal
treatmeentsandareethereforeaabletomaximizethebenefitofan ntimalarialmmedicines.
An imp portant ecoonomic issu ue for resou urcelimited d countries such as Seenegal is access
a to
ACTs m medicines for the lesss wellsub bsidized po opulations. This accesss may be limited
becausee, while thee Government contrib buted to thee cost of ACTs, patien nts still had
d to pay
some of
o the cost. Thus, Goveernment savings could d be reinveested in thee developm ment of a

25


system in which everyone has access to both appropriate diagnostics and medicine
treatments (13). Malaria control can only be achieved when the whole population receives
thetreatmentitneeds.
Success factors
ThesuccessoftheinterventioninSenegalcanbeattributedtothefollowingfactors:
1. CommitmentbytheMinistryofHealthtotheprogramme,includingadequate
fundingforthescaleupandclearpolicychange.
2. Welldevelopedtrainingofhealthcareworkersatalllevelsofsociety.
3. MultistakeholderadvocacyofanationwideuseofRDTs.
4. Closemonitoringoftheincidenceofmalariaratesatdistrictlevel:astandardized
evaluationstrategyperformedbyalldistrictswassubmittedtothecentralmonitor
point.
5. Provisionofmedicineornonmedicinebasedtherapyforpatientswithnegative
RDTresults.
6. Engagementofacademia(theUniversityinDakar)andseniorphysicians.
7. PresenceofaqualityassurancesystembasedonlottestingshowingthattheRDTs
wereworking,tomitigateconcernsoffalsenegativeresults.ThechoiceofRDTwas
basedonWHOrecommendationsandresultsofthevalidationwerepublishedin
peerreviewedacademicjournals(18,19).
Conclusions
Inconclusion,theSenegalcasestudyhasshownthatnationwideimplementationofmalaria
RDTs is feasible in a relatively short period of time. Scaling up the availability of reliable,
quality diagnostics such as RDTs helps to discriminate parasitological confirmed malaria
casesagainstotherfebrileillnesses,forwhichappropriatealternativediseasemanagementis
required.
Prioritization of early and accurate diagnosis is essential to improve health outcomes of

medicinetreatmentandcanalsobecosteffectivewhenmoreexpensivemedicalhealthcare
canbeavoidedbytreatingtherightpatientwiththerightmedicineat therighttime.This
case study proves that this can be achieved by scaling up the availability of the right
diagnostics.

26


CASE STUDY 5 HIV antenatal screening (SWAZILAND)
Practical recommendation 3.2: Mandate early screening in at-risk segments of the

population to ensure patients are diagnosed in time to maximize the benefits of
treatment.
Executive summary
Swazilandisthecountrywiththehighesthumanimmunodeficiencyvirus(HIV)
infectionprevalenceamongpregnantwomenintheworld.
Effectivemedicinesforthepreventionofmothertochildtransmission(PMTCT)and
treatmentofHIVareavailable.However,duetolackofscreening,manypregnant
womenarenotreceivingthem.
TheGovernmentofSwazilandprioritizedHIVscreeninginmaternityunitsby
introducinganationwidetraininginterventionformaternitynurses,thereby
increasingtheproportionofHIVpositivemothersreceivingantiretroviraltreatment
(ART)anddecreasingHIVinfectionamongyoungchildren.
Background
Although remarkable progress has been achieved in the battle against the HIV pandemic,
many challenges remain, especially for countries in the developing world. One of the key
achievements in the last decade has been the provision of ART to infected mothers, to
prevent mothertochildtransmission of HIV. In June 2001, the United Nations General
Assembly adopted the Declaration of Commitment on HIV/AIDS. A focus of this
Declaration was improved PMTCT and the reduction of infant HIV infections (20). Since
then, WHO has led the process of updating technical PMTCT guidelines to support
countriesinthismajorhealthissue.Withotherpartners,WHOhasalsosupportedcountries
todevelopandimplementPMTCThealthcareservices(21,22).
Swaziland has the highest prevalence of HIV in pregnant women in the world, increasing
from 3.2% in 1992 to 42% in 2008. WHO data from 20002003 show that 47% of neonatal
deathsinSwazilandwereattributedtoHIV/AIDS,incontrastto7%intherestoftheAfrican
Region(23,24).
The Swaziland Government acknowledged the urgency of reducing childhood HIV

infections and prioritized the availability of appropriate medicines to do so. As a result,
significantimprovementshavebeenachievedinaccesstothesemedicines,andintegration
of PMTCT in 80% of antenatal care facilities throughout the country by 2007. The Joint
UnitedNationsProgrammeonHIV/AIDS(UNAIDS)estimatedthatin2007,67%ofallHIV
positive pregnant women in Swaziland received ART. However, given the extremely high
HIV prevalence in Swaziland, a large number of HIVpositive pregnant women still
remained untreated, leading to many newly infected infants every year, as well as illness
anddeathoftheirmothers.

27


TheElizabethGlaserPediatricAIDSFoundation(EGPAF)performedananalysisofPMTCT
programme data in 2007, revealing several potential improvements in the management of
theprotocolforwomenpresentingatmaternityunitsinSwaziland(24).EGPAFsupported
theSwazilandGovernmenttoidentifyandaddressthese missedopportunities.Thisledto
improveddetectionofHIVinfectioninpregnantwomen,andadministrationofappropriate
ART drugs before delivery, and thus decreased the infant HIV infection rate and neonatal
deaths attributed to HIV/AIDS. This case study describes the intervention, why it was
successful,andwhatrecommendationscanbeextrapolatedtoothercountries.
Intervention
Thematernityunit(i.e.inthelabourward)wasthemainfocusofthePMTCTintervention
as this is where pregnant women have the last opportunity to receive ART before the
deliveryprocessstarts.Itisessentialthatthemedicinesare giventothewomeninlabour,
becausethehighestriskoftransmissionoccursduringandfollowingdelivery.
According to national guidelines of Swaziland at the time of the pilot study, the firstline
regimenforARTwaslamivudine(3TC),zidovudine(AZT)andnevirapine(NVP)andany
pregnantwomantreatedwouldreceivethesedrugs,whichalsoareeffectiveinpreventing
transmission to their infants (25). HIVpositive women not eligible for ART received a
regimenofAZTfrom28weeksofpregnancy,andduringlabourtheyreceivedasingledose
of NVP (sdNVP) with a tail of AZT/3TC for one week (25). For maternity sites with
minimal capacity, sdNVP was also the minimal required ART in Swaziland. Thus, since
every HIVpositive pregnant woman in Swaziland should have had at least NVP in their
blood plasma, NVP detection was a good measurement to screen for provision of
appropriateART.
Assessment of the management of PMTCT at maternity units included an evaluation of

compliance with the national PMTCT guidelines. Maternity nurses in Swaziland receive
nationaltrainingtolearnaboutPMTCTpractice.Inadditionto provisionofARTforHIV
positive women, those with unknown HIV status or who tested negative more than 3
months prior to their presentation at the clinic were to be tested before delivery. The 2007
assessmentrevealedthatthistestingguidelinewasoftennotfollowedbythematernitystaff.
To improve compliance to the recommended testing policy and performance of the

maternitystaff,theEGPAFdevelopedanadditional,targetedtrainingsessioninPMTCT,as
infant infections were expected to decrease by improving the nurses skills in this service
delivery.TheEGPAFteamformedapartnershipwiththeSexualandReproductiveHealth
Unit of the Swaziland Ministry of Health to integrate the training intervention into the
national maternity nurse training programme in 20082009. First, the intervention was
pilotedinaquasiexperimentalsettingtoevaluateitsimpact.
TheEGPAFonedaycourseincludedthefollowingkeytargets:
1. IdentifytheHIVstatusofthepresentingmotheratthetimeofarrival(positive,
negativeorunknown).

28


2. TestorretestifneededtoconfirmtheHIVstatusofthemother.
3. ProvidethecorrectART.
4. Increasetheconfidenceandskillsofmaternitynursestocounselmothersinoptimal
PMTCT.
The Ministry of Health was engaged at the national and regional levels in the design and
conductofthepilot,targetingprimarilymaternitynurses.EGPAFworkedcloselywiththe
maternity clinics to enrol women at the clinic sites and collect the umbilical cord blood
samples.Forthepilotstudy,thematernityclinicsacrossSwazilandwereselectedfromthose
that received support from EGPAF, and included over 60% of deliveries in the country
duringthestudyperiod.
Based on the results of the pilot, the policies on retesting women before delivery were
strengthened.The2010SwazilandguidelinesforPMTCTincludedanewclausespecifying
thatanHIVretestshouldbedoneafter32weeksgestationoratdeliveryforallwomenwho
testedHIVnegativeearlierinpregnancy.
Theobservationthatnearly5%ofHIVnegativepregnantwomenbecameinfectedwithHIV
during pregnancy resulted in implementation of a combination prevention policy
nationwideinallclinicsprovidingantenatalcare.Combinationpreventionincludes:
Retesting8weeksafterinitialtestingandevery6monthsthereafter.
Preventivecounseling.
Partnertesting/counselling.
Identificationofserodiscordanceandreferralfortreatment.
Condomdemonstrationanddistribution.
Infantfeedingcounselling.
This policy is also a key component of the Swaziland National Strategic Framework for
Accelerated Action for Elimination of New HIV Infections among Children by 2015 and
KeepingTheirMothersAliveinitiative,adoptedbytheMinistryofHealthin2012.
Health outcomes
Data from the first pilot study were analysed and showed promising results that were
publishedinapeerreviewedjournal.DataclearlyshowedhigherratesofNVPpresencein
the umbilical cord blood of mothers who delivered at the intervention maternity sites
comparedwithcontrolsites(Figure9).

29


Figure 9. Rate of NPV detection in cord blood of HIV-positive mothers
presenting at the maternity clinic sites, grouped by their situation at arrival,
20082009
90%
80%
70%
60%
50%
84% Intervention
40% 77%
Control
30% 58%
54%
20%
26%
10% 20%
0%
KnownPositiveonArrival, NegativeonArrival,HIV UnknownonArrival,HIV
n=796 PositiveCordBlood,n=58 PositiveCordBlood,n=83

Source:SwazilandHealthProfile,2006
Financial outcomes
Noofficialpublisheddataareavailableonthecostofthisintervention.Thepilotstudywas
performed by a privatefunded organization and required no financial resources from the
Government. When the pilot data were available, no further investment was needed to
implement the new screening policy. Using the pilot data from Swaziland, other countries
mayalsointensifytheirHIVscreeningpolicywithoutplacingasignificantburdenontheir
budget.
Success factors
The key success factor of this intervention was the comprehensive pilot study carried out
before the training became national policy. The pilot study conducted a quantitative
statisticalanalysisoftheeffectofthetraininginterventionandwasperformedin60%ofthe
countrys maternity clinics, covering over 70% of births in the country. This was possible
giventhesmallsizeofSwaziland.
Conclusions
ThiscasestudyshowstheclearbenefitsofatargetedtrainingeffortinSwazilandtoincrease
proper screening of pregnant women presenting at maternity care facilities. Although the
concept applied in this case to HIV testing and consequent provision of ART, well
developedtrainingofmedicalstaffisimportantforotherdiseasesandmedicinetreatments.
Toobtainthemaximalbenefitfrommedicinetreatment,providingtherightmedicinestothe
rightpatientmustgohandinhandwitheducatinghealthworkersinaccuratescreening.

30


CASE STUDY 6 Antibiotics smart use (THAILAND)
Practical recommendation 4.1: Sensitize and promote the engagement of prescribers,

dispensers and patients through multi-stakeholder workshops, determining educational
requirements for health-care professionals, and public information campaigns.
Executive summary
InthepastfiveyearsThailandhasbeenattheforefrontamongdevelopingcountries
initsactiveengagementtocontrolantimicrobialresistancethroughtheAntibiotics
SmartUseprogram.TheAntibioticsSmartUse(ASU)isavoluntaryprogram
deployedinselectedprovincesinThailandbetween2007and2012tofosteramore
responsibleuseofantibioticsbydirectlyengagingprescribers,dispensersand
patients.
Phase1oftheprojectwasintendedasapilotforthebroaderinitiativeanditwas
deployedin200708showingencouragingresults.Phase2wasdesignedtobea
scalabilitytestoftheAntibioticSmartUseinitiative,anditwasdeployedover13
months(200809)inthreeprovincesandtwohospitalnetworks,ultimatelyinvolving
44hospitalsand627primaryhealthcentres.Phase3,currentlyongoing,isintended
toachievesustainabilityfortheAntibioticsSmartUseprogrambystimulatingpolicy
advocacy,resourcemobilizationandpubliceducationthroughout.
InPhase1,theoverallamountofantibioticsprescribedinthecommunityhospitals
targetedbytheinitiativedeclinedbetween18%and23%,whilethedeclinein
primaryhealthcentresdeclinedevenfurtherbetween39%and46%.Theoutcomeof
phase2confirmedtheoutstandingresultsofthepilotphaseoftheprogram,and
phase3iscurrentlyunderwaytoensurethebenefitsoftheAntibioticSmartUse
programaremaintained.TheNationalHealthSecurityOffice(NHSO)hasadopted
ASUasakeyindicatorofqualityofserviceinpayforperformanceagreementswith
communityhospitals.
Background
Antimicrobial resistanceisincreasingly recognized as akey public healthconcernforboth

developed and developing countries due to its potentially alarming socioeconomic impact
onhealth.Bacterianaturallydevelopresistanceduetotheselectivepressureappliedbyboth
responsible andirresponsibleuseofantibiotics,which effectively limitsthe efficacyof any
one antibiotic over time. This realization, coupled with negligible innovation in antibiotics
over the last decades, highlights the critical need for responsible use of antibiotics to slow
downthedevelopmentofantimicrobialresistance.
InthepastfiveyearsThailandhasbeenattheforefrontamongdevelopingcountriesinits
active engagement to control antimicrobial resistance. Antibiotic consumption alone
represented1622%ofnationalmedicinesexpenditure,andbothinappropriateprescription
andcasesofantimicrobialresistantinfectionsweresteadilyincreasing(26).Toaddressthese
concerns,theAntibioticsSmartUse(ASU)programmewasdevelopedinpartnershipwith

31


keynationalandinternationalstakeholderstofosteramoreresponsibleuseofantibioticsin
primarycareandhospitalsettings.
ASU is a voluntary programme that has been deployed in selected provinces in Thailand
since 2007 with the engagement of prescribers, dispensers and patients. The intervention
seekstochangetheperceptionandbehaviourofprescribersandpatientsregardingtheuse
of antibiotics to treat three common conditions in primary health care: upper respiratory
tract infections, acute diarrhoea and simple wounds. The threephase intervention used
multiple tools to raise awareness and affect behaviour, ranging from training group
discussionstolocalpoliciesandtargetedreminders.
Intervention
Phase1oftheprojectwasintendedasapilotforthebroaderinitiativeandwasdeployedin
20072008bytheThaiFoodandDrugAdministration(FDA)inpartnershipwithWHO.The
scope for the pilot was 10 community hospitals and 87 primary health centres in the
SaraburiProvince(27),targetedwithinformationmaterialspreparedbytheThaiFDAand
activitiestosensitizepatientsandprescriberstotheimportanceofamoreresponsibleuseof
antibiotics. Training was offered to medical personnel, while informative brochures were
provided to patients in order to gain their active support. The success of the intervention
wastobemeasuredthroughfourkeymetrics:changeinknowledgeandawareness;change
inquantityofantibioticsprescribed;changeinnumberofpatientsreceivingantibiotics;and
levelofpatienttreatmentsatisfaction(28).
Phase 2, designed as a scalability test, was deployed over 13 months (20082009) in three
provinces and two hospital networks, ultimately involving 44 hospitals and 627 primary
healthcentres(27).Thethreeprovinceswereofdifferentsizesinordertotestscalability,and
bothprivateandpublichospitalswereinvolved.Onceagain,prescribersandpatientswere
engagedthroughinformationmaterialandactivities,andprivatepharmacieswereincluded
inthetargetaudience.Inthissecondpartoftheinitiative,over10000healthprofessionals
and patients were trained, and 22 ASU projects initiated in 15 provinces. This formed the
decentralizedASUnetworkofpeopleandcentresthatwereleveragedinPhase3(26).The
successofthesecondphasewastobemeasuredthroughsimilarmetricsasthosechosenfor
thepilotphase:antibioticsuse;percentageofpatientsreceivingantibiotics;patienttreatment
satisfaction;andknowledgeandawareness(28).
Phase 3, ongoing, aims to achieve sustainability for the ASU programme by stimulating
policyadvocacy,resourcemobilizationandpubliceducation(27).One ofthekeyexpected
outcomes of the second phase was the creation of a decentralized ASU network of health
care professionals andinstitutions,sothattheinitiative couldnaturallyspreadbeyondthe
targethospitalsifsuccessful.
The sensitization of all key stakeholders prescribers, dispensers and patients to the
benefitsofaresponsibleuseofantibiotics,andtheiractiveinvolvementinpromotingsuch
practices,are the cornerstonesof thisinitiative.Theinitiativeitself was structuredin three
progressively larger phases which achieved widespread and grassroots involvement of
patientsandprescribersandfacilitatedmeasurementoftheefficacyoftheapproach.

32


Health outcomes
Todate,allfourkeymetricsdemonstratedtheefficacyoftheintervention(25,27).Asaproxy
measurement of increased sensitization, the response rate of healthcare professionals
invited to take part in the training sessions exceeded 60%, with the highest percentage of
participantsbeingnurses.Thisisveryencouragingasitshowsthattheeducationcampaign
toraiseawarenessandchangeperceptionsontheresponsibleuseofantibioticsreachedboth
prescribersanddispensers.
The overall amount of antibiotics prescribed in the targeted community hospitals declined
by 1823%, while the decline in primary health centres was even greater at 3946%.
Prescription reduction alone is a success, and is supported by a similar reduction in the
percentageofpatientsreceivingantibioticsforupperrespiratorytractinfection,diarrhoeaor
simple wounds, from54.5% to25.4%.Thereduction inantibioticsusewasnot achievedat
the expense of reduced positive clinical outcomes: 97.199.3% of patients fully recovered
aftertheirhealthvisit,withsmallvariationsdependingonthetreatmentsetting.Finally,up
to90%ofpatientsweresatisfiedwiththetreatmentoutcomeandintendedtoreturntothe
samehealthcaresettingforthenextmedicalvisit.
An explicit evaluation of the outcomes of the initiative will be published by the relevant
authoritiesinThailandassoonasPhase3iscompleted.
Financial outcomes
TheoutcomeofPhase2confirmedtheoutstandingresultsofthepilotphase(27).Inthefirst
four months of the second phase, the use of antibiotics declined sharply, delivering
estimated savings of Thai Bhat 6.6 million (approximately US$ 220 000 per year). For
example, the percentage of patients treated with antibiotics for upper respiratory tract
infections declined from 50.4% to 37.5% within months of the beginning of the initiative.
Furthermore, 9699% of patients treated without antibiotics in the participating centres
recoveredfromtheirillness.
A key positive outcome of Phase 2 has been the public support of the National Health
Security Office for the initiative, which has adopted ASU as a key indicator of quality of
service in payforperformance agreements with community hospitals (26). This
acknowledgement opened the door to nationwide policy support, and highlights how
nationalguidelinesandpoliciesontheresponsibleuseofmedicinesdonotnecessarilyhave
to be promoted through a topdown approach by the Ministry of Health; rather, this
initiative was tested using a bottomup approach that was eventually supported through
nationalpolicy.
Success factors
The key success factors of the Antibiotics Smart Use program are its multidisciplinary
approach,aclearfocusonstakeholderengagement,anddemonstratedresultsateachstepof
the way. The ASU approach has been successful in creating a decentralized network of
participating centres and professionals who can claim ownership for the quality and

33


outcome of their contribution. Furthermore, the measurement of the health and economic
outcomes of each phase have been key factors in promoting expansion of the initiative.
Finally, the policy support granted by the National Health Security Office guaranteed the
legitimacy needed to spread the project nationwide in Phase 3 and ensure that all citizens
canenjoythebenefitsofamoreresponsibleuseofantibiotics.
Conclusions
The Antibiotics Smart Use programme is a clear example of how the responsible use of
medicinescanbetestedandupscaled,ifsuccessful,viaabottomupapproachthroughthe
supportofkeystakeholders,andleadtoeffectivenationalguidelinesandpolicies.
CASE STUDY 7 Medical use of opioids (INDIA)
Tactical recommendation 4.2: Reassess regulatory requirements on the dispensing of

selected medicines to ensure their wider availability and accessibility. Sensitise and
promote engagement of prescribers, dispensers and patients through multi-stakeholder
workshops, educational requirements for health-care professionals and information
campaigns.
Tactical recommendation 4.3: Reduce redundant paperwork and the administrative

burden of prescribing/dispensing particular essential medicines to ensure appropriate
patient access.
Executive summary
Useofmedicinesproducedfromsubstancescontrolledundertheinternationaldrug
controlconventions,suchasstrongopioidanalgesicsandlongactingopioidsfor
treatmentofopioiddependence,issuboptimalinmostdevelopingcountries.
Improvingmedicalaccesstoopioidanalgesics(painrelievers)willimprove
treatmentofmoderateandseverepainandthequalityoflifeforpatientsinIndia
andintherestoftheworld.
TheIndianStateofKeralaorganizedasymposiumtosimplifytheregulationsof
opioidprocurementanduse.Thisresultedinalargeincreaseintheprescribingand
useofopioidsintheState.
Alongwithsimplificationoftheregulations,Keraladevelopedasystemtomonitor
theuseofopioidswhichgeneratedacomprehensivepictureofopioiduse.This
showedtherewasminimalmisuse.
Anessentialpartoftheinitiativetoimproveaccesswaspalliativecareeducationof
physicians,pharmacistsandnurses.
TheexperienceinKerala(whichhadpoliticalcommitmentandmultistakeholder
involvement)demonstratesthatitispossibletoimprovetheuseofmedicinesand
hasimportantlessonsforotherstatesinIndiaaswellothercountries.

34


Background
Various medicines produced from substances controlled under international drug control
conventionsarenotreadilyavailableformedicaluseinmostcountries,evenwhentheyare
considered to be essential medicines. One such group is strong opioid analgesics (pain
relievers). They are essential in the treatment of moderate and severe pain, including in
palliative care. However, in many developing countries, lack of access to effective pain
medicines is due to excessive regulatory and policy restrictions, the lack of knowledge on
treatment among healthcare professionals, attitudes among healthcare professionals,
patientsandtheirfamilies,andeconomicissues.
The International Narcotics Control Board (INCB) Annual Report demonstrates significant
disparities in morphine use in the world (Figure 10) (29). WHO data from 2006 estimates
that 5.5 billion people (83% of the worlds population) live in countries with low to non
existent access to controlled medicines and have inadequate access to treatment for
moderatetoseverepain.Thesedataalsoshowastrongpositivecorrelationbetweenranking
ontheHumanDevelopmentIndexandtheconsumptionofstrongopioidanalgesics(30).In
thesecountries,tensofmillionsofpainpatientssuffereachyearfrominadequatetreatment
(31)forconditionssuchas:
endstageHIV/AIDS(1millionpatients)
terminalcancer(5.5millionpatients)
injuriescausedbyaccidentsandviolence(0.8millionpatients)
chronicillnesses
recoveryfromsurgery
labourpain(110millionbirthseachyear)
paediatricillness.

Other conditions where controlled medicines are essential for treatment include epilepsy,
postpartum bleeding (cause of maternal mortality), opioid dependence (including the
prevention of HIV and hepatitis C transmission) and psychiatric conditions (30). The
particularmedicinesneededintheseconditionsarederivedfromcontrolledsubstances.

35


Figure 10. Global distribution of morphine consumption, 2010
Europe (12%),
26.9%
Canada (0.5%),
4.2%
Australia and New
Zealand (0.4%),
2.8%
Japan (2.2%),
0.8%
Other countries
(79.9%), 9.9%
United States
(5.2%), 55.4%

Thepercentageswithinparenthesesaretheproportionoftheworldspopulationinthecountry;thepercentageswithoutparenthesesarethe
proportionofthetotalavailablemorphineconsumedbythecountry.
Source:ReportoftheInternationalNarcoticsControlBoard(29)
Allcountrieshaveadualobligationwithregardtothesemedicinesbasedonlegal,political,
public health and moral grounds. The dual obligation is to ensure adequate availability of
controlledsubstancesformedicalandscientificpurposes,whilesimultaneouslymaintaining
a system to monitor potential dependence (e.g. methadone and buprenorphine), abuse,
diversion and trafficking. In order to develop a policy that incorporates both access to
rational medical use and the prevention of dependence, governments should carefully
reviewexistingregulationsandlaws.Althoughopioidabuseanddependenceisharmfulfor
theindividual,itsuseformedicalandscientificpurposesisevidentandessential:morphine,
forexample,isoneoftheonlyeffectivemedicinesforpatientssufferingfrommoderateand
severepainandshouldthereforebeavailabletothoseinneed(32).
Inthiscasestudy,Indiashowshowsuccessfulpolicieseventuallyresultedinrestoringthe
balance in the regulation of opioid use, particularly for the treatment of pain in palliative
care.In1998,toreduceoverandunderuseinpalliativecare,theGovernmentofIndia(GOI)
proposed an amendment to State law aimed at simplifying opioid regulations. This
amendmentwouldhaveauthorizedtheStatesMedicineControllertolicensepalliativecare
programmeswithinRecognizedMedicalInstitutions(RMIs),requiringnofurtherlicencesto
purchase,importand/orpossessopioids(33,34).
InKerala,asymposiumwasorganizedin1998toimproveopioidpracticeinpalliativecare
pain management services, chaired by the State Minister of Health. His commitment to
engagebothlocalstakeholdersandrepresentativesofotherdepartmentswasessential.The
symposiummadeimportantdecisionsonopioidpolicyandpalliativecaredevelopment.
However,in other statesof India opioidsremainedunderused.Theunsuccessfuleffortsof

theGOIwerearesultofanumberoffactorsdescribedbelow(35).

36


ThethreeobjectivesofthiscasestudyaretoanalysethepolicychangeinKerala,todescribe
reasons why the intended policy change could not be replicated in other parts of the
country, and to identify more universal and generalizable recommendations on how other
governments,workingwithinthehealthcaresystem,couldimprovetheresponsibleuseof
controlledmedicinessuchasopioids.
While this case history describes the specific situation of opioid access in palliative care, it
must be clear that palliative care is only one of many medical applications of opioid
medicines.Toaddresstheissueofopioidaccessibilityonalarger,nationwidescale,theGOI
adoptedin2012anewcontrolledsubstancespolicythatcoversimprovedaccesstoadequate
palliativecare,extrapolatingthisaccesstootherconditionswhereopioidpainmanagement
isessential,andaccesstotreatmentofopioiddependence(36).
Intervention
Thefirstdecisionofthesymposiumwastosimplifyopioidlicensingrulesasrecommended
bytheGOI.Thesecondstepwasthecreationofavoluntaryadvisorypanelofpalliativecare
physicians.Thesewereselectedbecauseoftheirexperienceinthefieldandcommitmentto
treat pain in terminal diseases such as cancer. To ascertain whether the minimum
mandatory requirements were met by a potential institute to be licensed, a member of the
panelperformedanonsitevisit.Minimummandatoryrequirementsincludedthepresence
ofaphysicianwithatleastonemonthofpalliativecaretraininginanapprovedinstitution,
safestoragefacilitiesandanopioiddocumentationsystemthatmonitorsdispensinganduse
(35,37).
Abasic principleofthe Keralasymposium was toengage allkeystakeholdersfor abroad

consensusontheuseofopioids.Thereforealocalchampion,appointedbytheGovernment,
was given the responsibility to invite all involved stakeholders to maximize attendance.
Invited stakeholders included palliative care physicians, a state Medicine Controller
representative, a Health Department officer, an Excise Department representative, and
representatives of the collaborators. The collaborator group comprised the Pain Policy
StudiesGroupatUniversityofWisconsin,Madison,WI,UnitedStatesofAmerica(aWHO
Collaborating Centre for Pain Policy and Palliative Care), the Indian Association for
Palliative Care and the Pain and Palliative Care Society of Calicut. All these organizations
werecommittedtothesimplificationandimprovementofopioidrulesinKerala.
Health outcomes
Followinglowopioidconsumptionfrom1985duetotheintroductionoftheNarcoticDrugs
andPsychotropicSubstancesAct,manufacture(asanindicatorofconsumption)roseagain
in 2007 (Figure 11). The rise in 2000 and 2001 were due to efforts of the GOI aiming at a
nationwide scaleup of opioid accessibility, following introduction of the amendment.
However, for reasons described below, these policies did not result in an actual
improvementofopioidaccessibility.

37


AsaresultofthesymposiuminKerala,over140palliativecareservicesbecamelicensedto
prescribe and dispense oral morphine in the State. This contrasts with the rest of Indian
states where no or few clinics provide palliative care. Thus, by expanding palliative care
facilities where opioids were allowed, availability of opioids medicine was improved.
Governmental data show that institutes in Kerala procured 75 kg of morphine sulphate in
2010,33%ofthetotalamountofmorphinesulphateprocurednationwide.Thepopulationof
Keralaisonly2.5%ofIndia,clearlyindicatingthatopioidavailabilityinKeralaissuperiorto
thenationalaverage.
OtherstatesthathaveadoptedtheKeralamodelhavenotshownclearimprovementsinthe
shortterm.However,somesmallbutsignificantregulationchangesmayeventuallyleadto
an improvement in morphine use. In addition, official data show a steady increase
nationwideinmorphinemanufacturesince2007,implyingsustainedimprovementinopium
accesssincetheinterventionwasimplemented(Figure11).
Regardingmisuse,noincreaseddependenceprevalencehasbeenreportedsince2001,anda
surveydetectednodiversionofopioidanalgesics(33).
Financial outcomes
Opioidsareingeneralaffordablemedicines,relativelyeasytoproduce,transportandstore.
ThesuccessoftheKeralainterventionisthereforenotexpressedintermsoffinancialgains.
On the other hand, there are no financial barriers for increasing access to opioids,
underliningthehighrelevanceofthiscasehistoryforalllowandmiddleincomecountries
aswellasfortherestoftheworld.
Figure 11. Quantity of morphine manufactured in India, 19982009
300
261.00 264.67 259.24
237.50
250
Morphine in kg
200
178.11
150
116.10 121.11
109.40
87.00
100
76.10 73.10
45.74
50
0
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Year
Source:
GovernmentofIndia.NationalPolicyonNarcoticDrugsandPsychotropicSubstances,NewDelhi,2012(36)

38


Success factors
Incontrasttootherstates,Keralahasachievedsomeremarkableresultsthatcouldserveasa
template for other states or countries. Using the WHO guidelines and its checklist (32), a
policy for medical use of controlled substances should be developed through a multi
stakeholder approach. The policy should then be implemented through negotiations and
advocacy by committed professionals at national and local levels. Based on the Kerala
recommendations,aworkshopshouldincludeatleastthefollowingsixkeyelements(35):
1. Alocalchampioncommittedtothecase.
2. Seniorgovernmentalofficialssensitizedtotheneedforpalliativecareandoral
morphine.
3. Developmentandimplementationofpalliativecareeducationprogrammesfor
doctorsandnurses.
4. Interactionofthelocalchampion,governmentalofficialsandcollaboratorstoensure
adoptionofoptimalopioiduse,developStandardOperatingProcedures(SOPs)and
establishafollowupmonitoringschedule.
5. CollaborationwithorganizationssuchasWHOtobenefitfromtheirexperience.
6. StrongcommitmentofpalliativecarepioneersandNGOstodevelopanetworkof
facilitiesandeducationprogrammes,andcreateconsensusonappropriateopioid
prescribingpractice.
Key failure factors
TheGOIexperiencedanumberofhurdlesintheireffortstoimprovetheresponsibleuseof
morphinenationwide.Eightofthesearedescribedbelow.(35)
1. In20002001,theGOIdistributedlargequantitiesofmorphinefreeofchargetoits
states.However,themorphinecouldnotbeusedbecauseessentialsupportat
regulatorylevelandtheengagementofmedicalprofessionalswerenotinplace.The
wholeconsignmentwasthereforewastedandmorphineconsumptiondropped.
2. Thefollowupscheduletothesymposiumwasinadequate.Governmental
organizationsneedtoinitiateincentivesandactivitiesearlytomaintaintheprocess.
Theabsenceofasolidtimeframecreatedcriticalbottlenecksinsomestates.
3. Sociogeographicalfactorscreatedbarrierstoincreasedmorphineconsumption,for
exampleintheborderstatesinnorthernIndia,whichsufferhighersubstanceabuse
thanotherstates.
4. Thetransferofcommittedkeyofficialstootherdepartmentswasdetrimentalto
expansionoftheinitiative.
5. InstatessuchasSikkim,TripuraandJammuKashmir,althoughtheamendmentwas
adopted,morphineuseremainedsuboptimalbecauseofalackoftrainedpalliative
carephysicians.
6. Aneffectivesystemwasnotinplacetoupdatetheregulations.

39


7. Thescopeoftheamendmentwaslimitedtoeasingrestrictionsinpalliativecare;pain
clinicsandpostoperativepaintreatmentwerenotservedbythepolicychange.
8. Thepolicytoallowcancerpatientsaccesstopainmanagementwithopioid
analgesicswasclearbutotherpatients,suchasthosewithendstageAIDS,were
deniedaccess.
Conclusions
Prioritizingtheremovalofregulatorybarrierstoaccesscanbeachievedwhilemaintaininga
necessary level of regulation; the Kerala example has demonstrated this. However, the
suboptimal use of opioid analgesics in India shows that simplifying regulations and
purchasinglargequantitiesarenotsufficient.Otheractivitiessuchaseducation/information
onpalliativecareforallstakeholdersareneeded.InKerala,opioidconsumptionimproved
by strongly embracing a national initiative, coupled with commitment from the local
government,academia,educationaleffortsandstrongadvocacy.
CASE STUDY 8 Upscaling zinc in diarrhoea treatment (BANGLADESH)
Tactical recommendation 4.1: Sensitize and promote the engagement of prescribers,

dispensers and patients through multi-stakeholder workshops, determining educational
requirements for health-care professionals, and public information campaigns.
Tactical recommendation 4.2: Reassess regulatory requirements on the dispensing of

selected medicines to ensure their wider availability and accessibility. Regulations should
permit over-the-counter availability of medicines of appropriate risk/benefit.
Executive summary
Diarrhoeaisamajorcauseofdeathinmanydevelopingcountries.
Zinctreatmentinadditiontooralrehydrationsolution(ORS)reducesmortalityand
morbidityfromdiarrhoea.
InBangladesh,theGovernmentscaleduptheprocurementanduseoforalzinc
tabletsfrom2006to2009.
Asaresult,awarenessontheneedforzincsupplementationincreasedamonghealth
careprovidersandcaregivers,andtheuseofzincincreased.
Consistentwiththelongtermtrend,theunderfivemortalityratedroppedin
Bangladeshbelowtheregionallevel.
TheGovernmentwasnotresponsibleforthefullproject,butitsenablingfunction
wasessentialforitssuccess.
TheScalingUpZincforYoungchildren(SUZY)projectisanexcellentexampleof
effectiveguidelineimplementationandremovingbarrierstoincreasetheresponsible
useofmedicines.

40


Background
Childhood diarrhoeal disease is a major problem in developing countries, contributing

significantly to childhood morbidity and mortality (38). Zinc treatment during a diarrhoea
episode has been proven to reduce this disease burden in lowincome countries. It is
estimated that the lives of nearly 400000 children under five years of age could be saved
eachyearthroughadequatezinctreatment.Inturn,thiswouldsupporttheMDG4toreduce
mortality in children of this age group by two thirds by 2015. According to a joint
WHO/UNICEF statement in 2004, increasing the use of zinc in childhood diarrhoea
treatmentisoneofthebestwaystoachievearapidimpact(39).
Indeed,findingsofacommunityrandomizedtrialinBangladeshclearlyindicatereductions
indiarrhoeaincidence(15%),diarrhoeacausedhospitalizations(24%)andnoninjurydeath
rates(51%)intheinterventiongroup(40).Inaddition,acutelowerrespiratoryinfectionsand
causal hospitalizations decreased among zinc users. The efficacy of zinc addition in
diarrhoea treatment is supported by other studies conducted in lowincome countries in
AsiaandAfrica,includingIndia,Mali,PakistanandtheUnitedRepublicofTanzania(41).
At the start of the project in 2006, only 515% of children <5 years old suffering from
diarrhoeawerereceivingzinctreatmentinBangladesh,dependingonwheretheylived(42).
Hence,theBangladeshGovernmentdecidedtoinitiateaprojecttoimproveoverallzincuse
against childhood diarrhoea. The goal of the project was to implement zinc treatment in
addition to oral rehydration therapy (ORT) as the standard therapy for all young children
sufferingfromdiarrhoeainBangladesh.
Intervention
ThepolicyinterventionscarriedoutbytheBangladeshGovernmentin2006toscaleupthe
useofzinccomprisedfivefundamentalactions(42):
1. DevelopmentoftwocommitteesbytheMinistryofHealthandFamilyWelfarein
collaborationwiththeSUZYteam:
a. NationalAdvisoryCommittee,headedbytheHealthSecretary
b. PlanningandImplementationCommittee,headedbytheJointSecretary,
PublicHealth,andsupportedbytheWHOCountryOffice.
2. RevisionoftheNationalDiarrhoeaTreatmentGuidelineandapprovalofa20mg
dispersiblezinctabletformulationforchildren<5yearssufferingfromdiarrhoea.
3. ApprovaltobrandtheproductasBabyZinc.Thisapproval,leveragingthe
intellectualpropertyandmarketingofthiszincformulation,becameattractivefor
thepharmaceuticalmanufacturer.
4. Obtaininganoverthecountersaleswaiver:20mgoralzincformulationbecame
availableinpharmacyretailstoreswithoutprescription,socaregiversdidnothave
toseeaprescriberfirsttoobtainzinctablets.ThestandardORSwasalready
availableoverthecounter.
5. PermissiontoproceedwithapublicpromotionalcampaigntopromoteBabyZinc.

41


The governmental policy changes engaged the private sector in areas including
manufacture, promotion and education. A Project Performance Framework was created to
describeallpreparatoryactivitiesincluding atimelinetomonitorand evaluatetheproject,
policy interventions, laboratory research and development of the formulation, and the
promotionalcampaigntoengagestakeholders.Thisprocesswastobecompletedwithin18
months(42).
The three primary endpoints of the SUZY project were (1) changes over time in carer
awarenessofzincasatreatmentforchildhooddiarrhoea,(2)theactualuseofzinctotreat
childdiarrhoea,and(3)theuseofORS.Thisinformationwasobtainedbyrepeatedimpact
surveyscarriedoutinhouseholdscomprisingapproximately3200childrenwithanactiveor
recentcaseofdiarrhoea.Between2006and2008,sevenofthesesurveyswereconductedand
stratifiedbysocioeconomic/geographicarea(43).
AnessentialpartoftheSUZYprojectwastoensurethatallkeystakeholderswereengaged
in and supported the scaling up of zinc use for diarrhoea. To achieve full support of the
stakeholders, nearly one third of the projects overall budget was reserved for the
promotional campaign (42). Governmental and professional organizations, including the
Ministry of Health and Family Welfare and the Bangladesh Paediatric Association, fully
supportedthemessagesdeliveredthroughthecampaign.
Health-care providers (physicians and pharmacists)

Thegoalsofthezinccampaignweretocreateawarenessofzincasatreatmentofchildhood
diarrhoea andits protective effectsagainstrecurrence;toincludetheuseof zincinclinical
practices;andtoreachallhealthcareprovidersinallregions.Therefore,approximately2000
representatives working in all geographic areas were trained to educate healthcare
providers. In addition, information pamphlets were developed and sent out to all parts of
thecountrybytheGovernment.
Caregivers (parents)
Newspaper and television commercials, billboards, posters, a catchphrase, as well as
educational efforts such as a drama series, talk shows and health education programmes,
were developed to reach the caregivers. Marketing specialists and social scientists worked
togethertodevelopthecontentofthecommercials.
Health outcomes
The results indicate a rapid increase in caregiver awareness of zinc as a treatment of

diarrhoea and anincrease inthe actualuseofzincfor childhooddiarrhoea (Figure12). At
theendofthescaleupproject,theuseofzinchadclearlyincreasedforallregionalstratain
Bangladesh.
Addingzinctochildhooddiarrhoeatreatmentreducedmortality,morbidityandmorbidity
associatedhospitalization.WHOhealthstatisticsindicatethattheunderfivemortalityrate
inBangladeshdroppedbelowtheregionalaveragein2008forthefirsttime(WHOcountry
profile Bangladesh). Specifically, a 2004 WHO report showed that diarrhoea mortality
represented 21.1% of mortality from communicable, maternal, perinatal and nutritional

42

R U
Use of Medicines:
Sharin
ountry Experriences

conditio ons among Bangladesshi children n aged 0144 years. In 2008, whenn the SUZYY project
hadbeeenrunning fortwoyeears,thispeercentagew wasreduced dto12.4%.T Thisriskreeduction
cannot becomplettelyattributtedtothesccaleupofzzincuse,sin nceotherm majorimprov vements
in the h
health secto
or and geneeral living conditions had also been
b made during thiss period
(41,42). Nevertheleess, the risk
k reductionn in combinnation with h the scientific evidencce show
thattheescaleupoofzinctreatmmentfordiiarrhoeaisllikelytohav vehadapoositivecontribution
toreducingchildm mortality.
Figure
e 12. Trends in zinc use in Bangladesh categorize
ed by household loc
cation,
2
2006200 9

Source:L
Larsonetal.,2011(42)
Zinc suupplementa ation also im

mproved overall
o quallity of life in a borderline zincd
deficient
populattion includding Banglaadesh (44). Appetite, physical activity and d the happiness of
childrenn also imp
proved, as did
d that off their careegivers. An necdotal wittness reporrts have
describeed motherss saying m
my son is sh
hining agaiin after sta
arting zinc treatment for
f their
child.
Finan
ncial outc
comes
Random mized studiies in counttries such as

a India and the Uniteed Republicc of Tanzan nia have
shown that hospittalizations are reduceed as a resu ult of an in
ncreased usse of zinc, thereby
making g diarrhoea treatment cheaper wh hen ORS iss complemeented with zinc. Careg givers in
Banglad deshpurchasethezincctherapyo overthe cou unter. AtUUS$ 0.25fortherecomm mended
10day treatment,, this purcchase signiificantly reeduces the likelihood d of an ex xpensive
hospitaalization. A costeffectiiveness stu
udy conduccted in the United Rep public of Tanzania
T
(40) sho
owed that the cost to
o avert onee child deatth due to diarrhoea
d was
w approx ximately
US$32000, comparred with US$ 2100 to provide ziinc to all children
c su
uffering from m acute
diarrhooea.Thus,thhecostofav vertingoneechilddeath hfromdiarrrhoeaisreducedbyU US$1100
whenzincisadded dtothetreaatment(40).Althoughtheseresultswereobttainedinad different

43


region, it is believed that zinc treatment for childhood diarrhoea can be considered highly
costeffective.
Success factors
Several factors that made this project successful were identified. Firstly, the approval of a
20mg oral zinc tablet formulation and its introduction into the National Diarrhoea
Guideline were essential in making the medicine available on the market. Secondly, the
preparation and use of a Project Performance Framework provided a good structure to
monitor andevaluatethe project. Thirdly, a promotional campaign wasdesignedwiththe
support of all key stakeholders including the Ministry of Health and the Bangladesh
Paediatric Association. Nearly one third of the overall project budget was allocated to the
campaign to maximize stakeholder engagement. Finally, the Bangladesh Government
createdthecircumstancesnecessaryforthescaleupofzinctreatmentandthustheultimate
successoftheproject.
Conclusions
Important lessons on successful guideline implementation can be extracted from the

Bangladeshzincproject.Anumberofprocessesneededtobecompletedinordertoproduce,
promote and scale up the use of zinc in clinical practice. The Project Performance
Framework enabled these processes to be completed in only 18 months and, thanks to a
multistakeholder approach, improvements were made within a relatively short period of
timeinalowincomecountry.Adequateresourcesshouldbespentonpromotiontoengage
allstakeholdersandmaintaintheirengagement.Inaddition,regulatoryburdensshouldbe
removedwherepossible,forexamplebyallowingoverthecounteraccess.

44

R U
Use of Medicines:
Sharin
ountry Experriences

Chap
pter V Focusing on adhere
a nce
Strattegic recommendation 5: Promote initiatives s that putt patients at the

centrre of treatm ment in orrder to ma aximize ad dherence to therapy.
Adhereencetotreattmentfocussesonindiv vidualpatieentbehaviou urinthecoontextoftheeproper

use of medicines. The term adherence is used in this reportt as the ov verarching term
t for
compliaance and persistence.
p Compliancce refers to o the mediccine being taken at th he time,
frequen ncy, dose and
a circummstances ad dvised by the
t prescribber. Persisttence referss to the
patientscontinued duseoftheeprescribed dmedicineaslongas neededwiithoutinterruption.
Reasonss for poor adherence
a i
include lackk of perceivved suscepptibility to, and
a severitty of the
disease,, adverse reactions
r a
associated with
w the medicine,
m laack of finaancial resouurces to
continu ue the treattment, incoonvenience of taking the mediccines as dirrected and simply
forgettingtotaketthem.

Poorad dherencecanimpairth heefficacya andsafetyo ofmedicinesssothatnotonlythein ntended
treatmeent outcom me may no ot be fully y achieved, but unneecessary ad dverse even nts and
hospitaalizationmaayoccur.Th henegativeeffectsofn nonadheren nceonhealtthoutcome andthe
cost annd efficienccy of treatm
ment are of o great con ncern, espeecially in thherapy areeas with
worryin nglylowlon ngtermadh herencerateessuchascchronic,non ncommuniccablediseases.
Nonad dherenceis anacknow wledgedand ddocumenttedproblem mintheuseeofmedicin nes,and

the commpetence to o tackle thee issue is in
ncreasingly y integrated
d in the edu ucation of medical
professiionals in booth develop ped and deeveloping countries. However,
H th
here is only
y limited
evidencce availablee on interv ventions efffective in improving
i adherence in the reaalworld
setting.Changingthebehavio ourofindiv vidualsisacomplexso ocialprocesssandmany yfactors
may pllay a role. This chap pter showcaases a com mmunityba ased interveention in Ethiopia
E
targetinng tubercullosis patien nts to miniimize nonadherence by provid ding closer patient
supporttduringtheerapy.
Govern nments sho ould take the lead in promo oting, throu ugh nation nal health policy,
compreehensiveiniitiativesto improvead dherenceto omedicinettreatment.IInorderto achieve
this com
mplex goal,, partnershiips with th he private sector shoulld be explo ored so thatt health
care proofessionals and the treeatment aree brought as a close as possible too patients annd their
lifestylees. Furthermmore, to close the cu urrent know wledge gap p on how to minimiize non
adheren nce, governnments sho ould supporrt and prom mote acadeemic researrch to identtify risk
factors anddeterm minantsofn nonadheren nce,theressultsofwhiichcanbeu usedtostraatifythe
risksannddevelopinnovativeinterventio ons.

45


CASE STUDY 9 Community interventions (ETHIOPIA)
Tactical recommendation 5.1: Promote the creation of, and provide technical support
to community-based initiatives aimed at improving patient engagement and adherence
to treatment.
Tactical recommendation 5.2: Facilitate health-care professionals in providing closer

therapy support to patients to motivate their health-seeking behaviour.
Executive summary
Tuberculosis(TB)isamajorproblemforpublichealthandsocietyinmanylow
incomecountries.
Formanyreasons,includingfrequentHIVcomorbidityandrelatedmultiple
medicinetreatments,adherencetoTBtreatmentmedicinesissuboptimal.
InEstieDistrict,Ethiopia,agrassrootspatientcentredinitiativewasimplemented
byandforTBpatients,supportedbythelocalgovernment.
TheGovernmentenabledthesuccessoftheinterventionbyprovidingeducation,
organizingTBclubeventsandmonitoringtheimpact.
ThecaseofEstieDistrictdemonstrateshowgovernmentscanfacilitatepatient
empowermenttoimprovetreatmentadherenceinaveryresourcelimitedsetting.
Background
AsreportedbyWHOin2010,TBisamajorcommunicablediseasewithaglobalincidenceof
8.8million1.1milliondeathsfromTBamongHIVnegativepatientsandanadditional0.35
million associated with HIV (45). Effective medicine treatments are available; however,
suboptimal adherence to the treatment is a major problem. Reasons for this may include
HIV comorbidity and therefore the high pill burden for the patient, and medicine
interactions (46). WHO recommends the empowerment of patients in TB treatment to
increase their engagement and treatment adherence. The concept of patient empowerment
to improve treatment adherence has been discussed for other diseases such HIV/AIDS
(47,48). Several studies have identified patient empowerment and community engagement
aseffectivemeanstoimproveadherencetoTBtreatment(49).Nevertheless,althoughsuch
empowermentisawellknownconcept,itremainsunderdevelopedinmanycountries(48).
TBhashighprevalence,incidenceandmortalityratesinEthiopia,placingaseriousburden
on the public sector. This case history describes a patientcentred initiative in 1996,
introducedintheEthiopianEstieDistrict(population290000)wherepatientempowerment
wasconcretizedbytheformationofTBclubs.Thedistrictisinaremoteareawithnoaccess
to electricity and poor communication and transportation infrastructure. Health care was
providedinverybasicconditions,withonehealthcentreandtenclinics(healthstations)in
thewholedistrictandnoindividualdoctorTBpatientcounsellingbefore1996.Asaresult,
adherence to TB treatment was suboptimal; patients were frequently and inappropriately
extendingorstoppingtheirantibioticcourses.Thesmallestadministrativesubdivisioninthe

46


districtwherepeoplelivetogetheriscalledakebele.TheformationofTBclubswithinthese
kebeles was promoted by the governmental District Medical Officer, providing a strong
endorsement of this approach, supported by research in other countries and WHO
guidelines(47,48,50).
Intervention
Theinterventionstartedwithagrassrootsinitiativefromthecommunitylivingtogetherin
a kebele. In 1996, the Estie District public health administration decided to improve the TB
patient followup procedure at the sole health centre in the district. At that time, no
individual patientdoctor interaction took place during these followup visits: 500 patients
had an appointment on the same day and were seen by the doctor in large groups. In the
new approach, more days were reserved for TB patients and appointments could be
distributedoverseveralweeks.AllappointmentsforallTBpatientslivingwithinonekebele
were scheduled on the same day. As a result, intrakebele relationships were established
among TB patients since they had to travel and be at the health centre together. These
patientsthenformedTBclubs,usuallyof310persons.ThepurposeoftheTBclubwasfor
members to stimulate each other to adhere to treatment, help identify new TB cases and
share experiences of the course of the disease, the progress of the treatment and adverse
drugreactions(50).
The TB clubs received support from the local District Medical Officer, which included
educationalmaterialspreparedbytheMinistryofHealthandtheRegionalHealthBureau,
written in the regional language Amharic. Further public sector support was provided by
localhealthworkersandcommunityhealthagentswhosupervisedmeetingsandeducated
the TB clubs in identifying new cases. The TB clubs elected a leader who was literate and
functioned as the contact person for the health workers and the district government,
coordinatedtheclubmeetingsandwasresponsiblefordistributingtheeducationmaterials
to the club members. The task of the leader was also to report any treatment failures or
adversedrugreactionstothelocalhealthfacility.
Thisinitiativewasaclearexampleofapatientcentredapproachinimprovingadherenceto
medicine treatment; there was no primary involvement of any prescribers or dispensers.
However,theirroleinsupportingtheTBclubswasessentialthroughfollowupwiththeTB
club leaders and provision of materials. In addition, health workers monitored TB club
attendanceandinitiatedfollowupwithcuredpatients.
InruralareassuchasEstieDistrictinEthiopia,communityleaders(e.g.Copticpriestsand
mullahs) areimportantstakeholders inthe healthseeking behaviourof the population.TB
clubleaderssoughtthereforetocollaboratewiththemtoencourageTBpatientstoattendthe
clubmeetings.

47


Health outcomes
Adherencewasmeasuredbycalculatingtheproportionofactualvsexpectedattendanceata
followupTB appointmentatthedistrict healthcentre.TB patientsfrom a particular kebele
absent at a followup appointment were defined as nonadherent. The District Medical
Officertrackedthe attendance per kebeleand couldtherefore monitortheimpactofthe TB
clubs on attendance, before and after TB clubs were introduced. Table 2 shows that
adherence increased after the introduction of the TB clubs in 1996. As a result, health
outcomes from TB medicine treatment improved. Although no published results on
mortalityareavailable,datafromtheWHOGlobalTuberculosisProgrammeshowthatTB
mortalityinEthiopiadecreasedbymorethanonethirdbetween1996and2008,implyinga
contributionfromtheTBclubstothispositivetrend(50).
Table 2. Adherence to treatment, before and after the introduction of the TB

club approach in Estie District, Ethiopia
Actual/Expected attendances
1996 1997
January 195/286 (68.2%) 224/240 (93.3%)
February 215/291 (73.9%) 239/247 (96.8%)
March 230/306 (75.2%) 251/259 (96.9%)
April 230/296 (77.7%) 278/281 (98.9%)
May 225/290 (77.6%) 297/299 (99.3%)
June 219/287 (76.3%) 302/308 (98.1%)
Source:GetahunH&Maher,D.,2000(50)
Financial outcomes
The TB clubs were costeffective because they were a grassroots and voluntary initiative
requiringnoexpensiveinterventions.TheexistingDistrictMedicalOfficerwasresponsible
forthefollowupmeetingswiththeTBclubleadersandmonitoringwasperformedbythe
districthealthcentre.Theeconomicoutcomeoftheinitiativewasthereforecharacterizedby
theuseofexistingresourcesratherthananinvestmentinnewapproaches.
Success factors
This case history shows that patient empowerment is an effective concept in improving
treatment adherence. By making the community selfresponsible for health, capacities to
contributetoindividualandcommunityTBtreatmentweredevelopedinaremoteandlow
incomeareainEthiopia.ThefollowingkeyfactorscontributedtotheimpactofTBclubs:
TherationalreorganizationofTBfollowupvisitsatthedistricthealthcentrethat
includedthekebelegroupedappointmentschedules.
Theintroductionofindividualpatientdoctorinteraction,creatinganincentivefor
patientstoattendtheTBappointments.
TheidentificationofacommittedleaderoftheTBclub,whoisliterateandhas
organizationalcapacities.

48


TheTBclubactivitiesweretailoredtothelocalcommunity:meetingswerescheduled
duringweekendsorholidays,takingculturalandreligiouseventsintoaccount,and
materialswereprovidedinthelocallanguage.
Theengagementoflocalinfluentialcommunityleaders,includingpriestsand
mullahs.
Thevoluntarynatureoftheintervention:commitmentcameprimarilyfromthe
patients,withtheGovernmentfunctioningasthefacilitator.
Conclusion
The introduction of TB clubs in Estie District in Ethiopia is an excellent example of how

adherencetomedicinetreatmentcanbeimprovedinabasic,resourceandincomelimited
area.Thismodelhasbeenproveneffectiveinothercountriesandregionsoftheworld(49).
AlthoughtheGovernmentwasnotthelead,itprovidedessentialsupportandfunctionedas
the primary enabler of the intervention. While the initiative in Estie District was a
spontaneous event, governments in other TBburdened countries may follow the example
andcreateTBclubswithintheircommunities.Addressingadherencetomedicinetreatment
is a complicated process, especially for settings with few resources, financing capabilities
and infrastructure. Nevertheless, governments can prioritize treatment adherence by
supportingpatientempowermentandstimulatingselfresponsibilityofthepopulation.

49

R U
Use of Medicines:
Sharin
ountry Experriences

Chap
pter VI Healtth syste
em capa
abilities
s

Strattegic recoommenda ation 6: Monitor
M me edicine usee, from pu
urchase to health
outco
ome, to ev valuate the
e real-worrld efficacy
y of treatm
ment and guide eviidence-
basedd policy-making.

Healthcaresystem msrelyonaabroadran ngeofcapab bilitiesino
ordertofulffiltheirpurrposeof
providiingeffectivee,accessibleeandafford dablecare. According toWHO,siixbuilding gblocks
are neeeded for a fully functtional healtthcare systtem: service delivery, health wo orkforce,
healthiinformation n,medicalttechnologies,healthfin nancing,an ndleadershiipandgoveernance.
Althoug gh this rep
port focusees on the responsiblee use of medical
m techhnologies, and on
medicin nesinparticcular,itisw
worthhighliightingtheimportanceeoftheserv vicedeliveryaspect
ofarespponsibleusseofmediciines.
Policymmaking aim med at improving the efficacy an nd efficienccy of the prrocurementt system
can be crippled by
b the inability to mo onitor mediicines use. Electronic records of specific
medicin nes expenditure and waste
w due to
t expiry before use, provide
p a clear
c picturre of the
leveloffimplementtationoftheessentialm medicinesllistandoftthequalityo oftheprocu urement
system.. Furtherm more, mediccines expen nditure datta can be compared with presscription
recordss to identiify prescrib bing trend ds, e.g. th
he average number of medicin nes per
prescripption, and the amoun nt of mediicines dispeensed with hout prescrription. Ulttimately,
expend diture and prescription
p n records shhould be m
matched wiith patient use and measured
m
healthooutcomesto obeabletomonitorlongitudinalllythecosta andrealwo orldeffectivvenessof
medicin nes.Althou ughthisisn notyetpractisedattheenationalleevel,ithasb beendemon nstrated
attheh
hospitalleveeltoimprov veresourceallocation, andwillbeecometheg goldstandarrdinthe
nearfuttureduetoitsunmatch hedabilityttoinformtaargeted,eviidencebaseedpolicym making.
ThefolllowingcaseestudyinN Namibiaillu ustrateshowwacentralizedmonito oringsystem mcanbe

successfullyimpleementedeveeninsparseelypopulattedcountrieeswithlimitedresources.The
benefitssofcloserccontrolofthhesupplyo ofmedicinesandthem measuremen ntoftheiru
usefrom
pointofpurchasetohealthou utcomesareegreat,and dallowheallthcarepro ofessionalsttotarget
betterthheirinterveentionstoimmprove,forexample,aadherencera ates.

50


CASE STUDY 10 Antiretroviral supply and adherence monitoring
(NAMIBIA)
Tactical recommendation 6.1: Institute a system of centralized monitoring of

medicines purchasing to inform budgeting and ensure optimal funding allocation to
essential medicines.
Tactical recommendation 6.2: Collect medicines utilisation data at the national level
to identify and evaluate prescribing trends and expenditure.
Tactical recommendation 6.3: Design a system to measure patient use of medicines,

preferably at the point of dispensing, to assess patient adherence to therapy.
Tactical recommendation 6.4: Design a system to collect and aggregate information

on patient health outcomes to measure real-world efficacy and safety of medicines use.
Executive summary
HIV/AIDSisamajorprobleminNamibia(51).Effortstoscaleupantiretroviral
(ARV)coveragehighlightedtheneedforbettercontrolofmedicinessupplyand
dispensingtoavoidstockoutsandmeasuretheeffectivenessoftheprogramme
throughpopulationcoverageandpatientcompliance.
In2005,theNamibianMinistryofHealthandSocialServices,supportedbythe
RationalPharmaceuticalManagementPlusprogramme,introducedanelectronic
dispensingtool(EDT)tofacilitatethemonitoringofmedicineusenationwide.
TheEDTsoftware,computersandusertrainingwereprovidedtoallfacilities
offeringantiretroviraltherapy(ART)services.AsatMarch2012,49ARVdispensing
pharmaciesthroughoutNamibiawereusingtheEDT.
Thecentralizednationaldatabasewasusedtogeneratenationalandregionalreports
onARTpatientnumbersandstatusaswellasARVstockconsumptionandstock
levels.ThisinformationisusedbytheMinistryforplanningandbudgeting
purposes.
TheEDTallowspharmaciststomonitortheadherencerateofeachpatientandan
averageforthefacilitythroughpillcountandpillcoverage.Moresupportcan
thereforebeprovidedtopatientsathigherriskofdevelopingcomplicationsand
ultimatelyfailingtreatmentduetononadherence.TheEDTisalsousedtogenerate
HIVDrugResistanceEarlyWarningIndicatorsthatcanidentifyfacilitieswhose
patientsareathighestriskofdevelopingdrugresistance(52).

51


Background
Income inequality and the very low population density in Namibia are challenges for the
healthcare system to reach the 2.3 million people living in ~800 000km2. Since gaining
independence in 1990, the Namibian Government has focused on the crippling HIV/AIDS
epidemicaffectingthecountrythroughtheNationalAIDSControlProgrammeandseveral
short and mediumterm interventions (53). In 2003, Namibia secured funds from the US
PresidentsEmergencyPlanforAIDSRelieftoscaleupthecoverageofARTinthecountry
(54),withthegoalofprovidingARVtreatmenttoover80%oftheaffectedpopulation(55):
theefforthascontinuedthrough2010andisyieldingencouragingresults(53).
TheinitiativetoscaleupARVcoveragehighlightedtheneedforbettercontrolofmedicines
supplyanddispensinginordertoavoidstockouts,andtomeasuretheeffectivenessofthe
programmenotonlythroughpopulationcoveragebutalsopatientcompliance.Thelargely
paperbased tracking system used in the country was deemed insufficient to collect and
centralize data on the use of medicines, especially due to the challenges of implementing
suchsysteminasparselypopulatedcountry.
In 2005, The Namibian Ministry of Health and Social Services, with support from the US
Agency for International Development (USAID), introduced an electronic dispensing tool
(EDT) that had been developed by Management Sciences for Health, to facilitate the
monitoringofmedicineusethroughoutthecountry.
Intervention
USAIDfundedtheStrengtheningPharmaceuticalSystemsprogramme(55)tocustomizeand
enhancetheEDT.ThetoolwasthusabletoimprovethetraceabilityofARVsupply,better
assess consumption rates at each facility, and track patients. For example, the system was
able to identify which patients were not achieving optimal adherence levels, to identify
provinces/regions where consumption was higher, and consequently to budget medicines
supplyaccordinglytoreducestockouts.
Throughout Namibia, 35 ARVdispensing pharmacies (49 as of April 2012) were provided

with computers, training and specialized tools to record and match ARV dispensing to
specific patients. A clear picture was available of when patients has their prescriptions
dispensed,andwhichfacilitiesweredispensingtowhichpatients.Furthermore,allfacility
andpatientleveldatawereaggregatedinanationaldatabasesothattrendsandkeymetrics
couldbeeasilyevaluatedatthedistrict,regionalandnationallevels(56).Finally,handheld
scanners were provided to dispensers as part of the programme to extend the coverage of
the EDT to more remote areas of the country; the data collected were sent to the national
database via 3G cell phone technology with support from Namibia Mobile
TelecommunicationsLimited(56).
TheEDTinterventiontargetedmainlythemedicinedispensersastheywerethegateway
betweenpatientsandtheirtherapy.Theengagementofkeypharmacieswasfundamental,as
thesystemwasintendedtomonitortheuseofmedicineswhilereducingtheadministrative
burdenofdispensingARVs.TheEDTwaswelcomedbypharmacistsasitallowedthemto

52


focusmoreonpatientcaretoimprovehealthcaredeliveryratherthanfillinginpaperwork
manually.
Health outcomes
ThenewsystemwassuccessfullyimplementedinallARVdispensingpharmacies,andthe
projectandfacilitieswerehandedovertotheMinistryofHealthin2010(55).Thecentralized
nationaldatabasecanbeusedtomonitorprescriptiondatacollectedatthepharmacylevelto
predict more easily pharmacies that needs to be resupplied to avoid stockouts, and this
informationisfedbackintothebudgeting processtoensurebetteraccuracy.Furthermore,
usagedatacanbeaggregatedatthedistrict,regionalandnationallevelstomonitorareasof
the country that dispense the highest amount of ARVs, and that can be targeted
appropriatelytoensurethatmedicinesareusedresponsibly.
The EDT allows health workers to monitor the adherence rate of each patient through pill
countandtimeofprescriptionrefill:thisinformationisusedtoprovidemoresupportand
attention to patients at higher risk of developing complications and ultimately failing
treatmentduetononadherence.PatientleveldatacanthenbeusedtomonitorWHOEarly
Warning Indicators (55) to identify areas at heightened risk of developing ARV resistance
andinformpolicytoaddresstheissue.
Finally, it is easy to see how the output of the EDT can be used to better inform
pharmacovigilance. Heterogeneous information sources have been successfully used in
Namibiatoconnectadverseeventswiththeirpotentialmedicinalcause.Agoodexampleof
this practiceis assessmentoftheconnectionbetween anaemia andZidovudinebasedART
(56,57)toinformtreatmentchoices.Suchmonitoringwouldhavebeenvirtuallyimpossible
with the previous paperbased system. The longitudinal monitoring of medicines
dispensing,useandhealthoutcomeatthepatientlevelisinvaluableinprovidingrealworld
evidenceontheefficacyandsafetyofmedicines.DatafromtheEDThavealsobeenusedin
the quarterly ART reports and the nationwide ART adherence baseline survey currently
underway.
Financial outcomes
Although no official published data are available on the costeffectiveness of the

implementation of the EDT, or on the shortterm financial investment required, such
investment will be effective in the long term. By monitoring dispensing, procurement of
medicines is more accurate and wastage of expired medicines is reduced. In addition, it
enables pharmacists to monitor and evaluate adherence and target education to non
adheringpatients,reducingmedicationerrorsandavoidablehospitalizations.
Success factors
The EDT implementation has been widely successful in Namibia due to several factors,
including the design of the tool. Pharmacists readily accepted the system as it reduces the
administrative burden of dispensing ARVs, increasing therefore their ability to support
patientsintheirtherapybyprovidingmoreadviceandbetterinformationontheimportance
ofadheringtotreatment.Furthermore,pharmacistsmaybeabletospendthetimesavedby

53


identifying and following up patients with the lowest adherence rates. This form of risk
stratificationhasthepotentialtogreatlyimprovetreatmentoutcomes,asitmakesthemost
efficientuseofhumanresourcesintargetingnonadherence.Theinterventiontrulybrought
thepharmaciststothecoreofthemedicinesuseevaluationeffort,andthisisoneofthetwo
maindriversofthesuccessoftheinitiativeinsuchashortperiodoftime.
The ability to operate the system through handheld devices allowed the reach of the
initiativetobeextendedtoremotecommunitieswheretheuseofmedicineswasprohibitive
totrackinaconsistentandreliablefashion.Thisgreaterreachallowedforbetterbudgeting
of supplies in remote communities where stockouts might have jeopardized patients
adherence.Atthesametimesupportedamoreaccuratemonitoringofadherenceevenwhen
pharmacistsordoctors were not in close proximitytothe patient.In acountry as sparsely
populatedasNamibia,theabilitytoreachsuchremotecommunitieseffectivelyisessential
tothesuccessofanyintervention.Thefactthattheprojectandfacilitieswerehandedoverto
the Ministry of Health in 2010 and that the number of clinics participating has increased
demonstratethatitissustainableandlocallyowned.
Conclusions
The introduction of EDT has proved effective in Namibia in monitoring medicine use to
improvepolicymaking,andtheabilitytooperateitthroughhandhelddevicesensuredits
efficacyeveninremotecommunitiesthataretraditionallyhardtoreachwithpolicymaking.
Namibia provides a clear example of how longitudinal medicine use monitoring can be
implemented and scaled up not only in highincome countries, and how the information
collectedthroughsuchasystemcanprovideinvaluabledirectioninpolicymaking.
EDT is also a good example of how developing countries can leverage technology to
overcome physical barriers to the provision of health care, such as in sparsely populated
lands. The efficacy of these systems is of course not limited to ARVs but can be used to
monitor medicine use more generally at the point of prescription and dispensing. In
Namibia, the Ministry of Health is currently piloting a broader ehealth system in two
referralhospitalsinWindhoek,whichisintendedultimatelytomonitor,amongmanyother
functionalities,allmedicineuseineverypublicfacilityinthecountry.Theabilitytomonitor
medicines use and adherence will be an invaluable tool in informing policymaking to
promotetheresponsibleuseofmedicines.

54

R U
Use of Medicines:
Sharin
ountry Experriences

Chap
pter VII
I The importtance off leader
rship co
ommitm
ment
Strattegic recommendation 7: Ensure su ustained, top-down commitm ment of

natio nal author rities and promote a
active, botttom-up engagemen
e nt of presc cribers,
patie nts and d ispensers to the pr inciples annd policiess fosteringg the respponsible
use o of medicines.
Govern nment com mmitment through

t po
olicymakin ng and susstained fin nancial sup pport is
essentiaalinthepu ursuitofam morerespon nsibleuseo ofmedicinees.Commitm mentdoesn notstop
at the wwill to imp
prove health h care: goodwill is ratther the verry beginnin ng of comm mitment.
Govern nment comm mitment co omprises th hree key elements:
e p
provide ressources to upscale
effectiv veinterventiionstoachiievetheirfu ullpotentiall;providesu ustainedsu upporttosu uccessful
interven ntions for as
a long as needed
n to ensure the permanencce of the reesults; and directly
engage nationalan ndregionalstakeholdeerstoprom motetopdow wncommitmentcouplledwith
bottomupengagementofpreescribers,diispensersan ndpatients..

As illusstrated by case studiees througho out this repport, and paarticularly by
b the casee in this
Chapterr, the scalee of the inteervention can
c often bee a key detterminant of o success. In large
countriees,governm mentsshoulldmakesurrethateven nthemorerremoteregiionsarereaached.In
countriees with sev veral ethnic or religio ous groupss, the goveernment sho ould addreess their
respectiive concern ns and neeeds. Finally y, the goveernment sh hould makee sure thatt people
obtainin ng health care outsiide the reach of thee public sector also benefit frrom the
interven ntion.
In addiition, the efffort underrtaken shou uld be supp ported as loong as neeeded to susstain the
positivee impact off a project.. A frequen nt mistake is that whhen the goaals of a pro oject are
accomp plished,theeffortsand dinvestmen ntsaregradu uallytermin natedandttherebythebenefits
reduced d. The casee history of polio elim
mination in India is a clear
c examp ple of the n
need for
sustaineed commitm ment to immmunization n: if immuunization cooverage had decreased, polio
wouldh havehadth hechanceto ospreadagaainandthebenefitsachievedwou uldhavebeenlost.
Govern nment comm mitment sh hould entaill provision of the neeeded financial supportt for the
interven ntion. Goveernments frrom low an nd middleincome cou untries with h limited reesources
should collaborateewithdevelopmentorrganizationsstoacquireesufficientffundingto support
their prrojects. Inteerventions improving the respon nsible use of
o medicinees may neeed more
intensiv veshortterm minvestmeent,whichiinthelongttermcanbeeexpectedtobecostefffective.
Finally,,the govern nmentshou uldbe readyto translaate itscomm mitment intto strong ad dvocacy
foraniintervention natallleveelsofthepu ublicandprrivatesecto ors.Thegoaalofsuchad dvocacy
is to create and coonsolidate broad
b conssensus among stakeho olders to su
ustain comm mitment.
Thetop pdownapp proachofin ntegratingp policiesfrom mthenatio onalgovern nmentmusttalways
be supp ported by a bottomu up responsse from graassroots in nstitutions, profession nals and
patientss.

55


CASE STUDY 11 Polio eradication (INDIA)
Tactical recommendation 7.1: National authorities should provide sustained, top-

down policy and financial commitment to initiatives fostering a responsible use of
medicines.
Tactical recommendation 7.2: Build consensus on medicine use among national and
local stakeholders by stimulating the active engagement of prescribers, dispensers and
patients.
Executive summary
Despitetheavailabilityofeffectivevaccines,polioremainedendemicinIndiauntil
January2011.
TheGovernmentofIndia(GOI)madeasustainedeffortover17yearstoachieve
polioeradicationthroughimmunizationcampaigns.
Thesuccessoftheimmunizationcampaignwasattributedtothesustained
commitmentoftheGOIandthelocalgovernmentinstitutions.
Thegovernmentsatnational,state,regionalanddistrictlevelswereallengagedin
thepolioeradicationprogrammeregardlessofpoliticalbackground.
Background
In1988,theWorldHealthAssembly(WHA)adoptedaresolutioncallingfortheworldwide
eradication of the poliovirus by the year 2000 (resolution WHA41.28). At that point, polio
was endemic on a global scale. Figures 13 and 14 show the effect of the immunization on
globalpolioepidemiology.Althoughthiswasamajorsuccess,thegoaloftheresolutionwas
not achieved. Figure 14 shows that in 2012, polio remains endemic in three countries:
Afghanistan,NigeriaandPakistan,whereasAngola,ChadandtheDemocraticRepublicof
theCongohaveimportedthevirusafterinitialeradication.Othercountriesalsoexperienced
outbreaks during 2011 from imported poliovirus. This indicates the critical need for
sustained efforts in the fight against this devastating, lifeimpairing and immobilizing
disease(58).
OneofthemostrecentpoliofreedeclaredcountriesisIndia.InJanuary2012,oneyearhad
passed since the last case of wild poliovirus had been reported. India was one of the
Member States that ratified the 1988 WHA resolution, but did not start the eradication
programme until 1995. In 1997 the National Polio Surveillance Project (NPSP) was
establishedasacollaborationbetweenWHOandtheMinistryofHealthandFamilyWelfare
to centralize, monitor and coordinate the campaign. The strong incentive of the GOI for a
comprehensive multistakeholder intervention to eradicate polio definitively in India was
fuelledbythreemotivations:theburdenofdisease,theinternationalobligationtoeradicate
polio as India was the main global source of the virus, and belief in the feasibility of
eradication.Althoughthepolioviruswaseradicatedinmostpartsofthecountry,twostates
remained endemic: Uttar Pradesh and Bihar. This last pool of polio virus was finally
targeted in 2010 and 2011, resulting in the official eradication in January 2012. This case

56


studydescribesthecommitmentoftheGOItoeradicatepolioandhowthetargetedpolicies
wereintegratedonalargescaletoaccomplishthisgoal(58,59).
Because there is little research on the political commitment for eradication, the facts
mentioned in this case history are based on information from WHO experts and GOI
publications.
Figure 13. Global polio epidemiology, 1988

Source:GlobalPolioEradicationInitiative(58)
Figure 14 Wild poliovirus epidemiology, 2012

Source:GlobalPolioEradicationInitiative(58)

57


Intervention
AllIndianpoliticalpartiesdecidedtocommittopolioeradicationatthenational,stateand
district level. This was essential, because the states of India can independently decide
whether to implement health policies. By achieving unanimous political commitment,
betweenstate barriers were removed, as all state governments were committed to
implement the necessary policies. Because polio immunization is an ongoing process,
continuous action was essential and administrations of different political backgrounds
workedontheprogramme.
Normally, the states of India are responsible for the implementation of policies in their
healthcaresystems,andthusallocatingGOIfundingforhealthintheirstate.Forthepolio
eradication programme, however, the GOI established an exclusive budget. To sustain the
commitmentofthestategovernments,theGOIfundedover80%ofthetotalprojectcosts.
The Government collaborated with several partners that could contribute to the local
implementation of polio immunization. These partners included WHO, UNICEF, the US
CentresforDiseaseControlandPrevention,andRotaryInternational.
Startingin1995,twonationwidepulsepolioimmunizationdays(NIDs)wereorganizedby
the GOIon an annualbasis.Thetargeted agegroupof these extensive vaccination rounds
was05years.Allinfantsinthatgroupweregiventwodosesoforalpoliovaccine(OPV).In
addition, the GOI performed several subnational immunization days (SNIDs) and
eradicationroundsinlocallyinfectedareas.
SincethefoundationoftheNPSPin1997,regularimmunizationroundshavebeencarried
out, mobilizing increasing proportions of the population. In 2010, the GOI Central Drugs
StandardControlOrganisationapprovedtheuseofbivalentOPV,targetingtype1and3of
the poliovirus (type 2 was eradicated by 1999). In 2011, the GOI collaborated with the
privatesector,NGOs,healthagenciesandotherprofessionalbodiestoscaleuptheSNIDs,
leading to seven small SNIDs focused on the specific cores of polio outbreaks in Uttar
Pradesh and Bihar. During these immunization days, approximately 2 million community
healthcare workers were raising awareness, providing information and mobilizing the
population to be immunized. The SNIDs were centrally planned and funded by the GOI.
HealthcareworkersweresentouttoallregionsofUttarPradeshandBiharwiththevaccine
toreacheveryremotelocation.
TheinterventionsweremonitoredbyUNICEFandtheNPSP,whichtrackedallimmunized
infants and documented all new polio cases. The GOI was able to evaluate the status of
immunizationanderadicationbyreliabledataprovidedbytheseorganizations.
TheGOI establisheda partnershipwithallkeystakeholdersinthehealthcaresystemthat

could contribute to maximize the scope of the SNIDs. In addition, key figures in the
communitywereengagedtourgeparentstoobtainthevaccinesfortheirchildren,reducing
the number ofparents who wererefusing vaccination on groundsof principle. Duringthe
whole intervention, the stakeholders engaged included public healthcare workers,

58


physicians, clerics, imams and teachers. These were engaged in order to mobilize parents
whoareresponsibleforobtainingthevaccinationfortheirchild.
Health outcomes
Asaresultoftheintervention,IndiahasbeenfreeofanynewpoliocasesinceJanuary2011.
Thismeansthatthecountryhasaccomplishedpolioeradicationastheminimumperiodfor
officialeradicationisoneyear.Tomaintaineradication,continuouseffortsarededicatedin
Indiatotheuniversalcoverage of immunization against polio.Immunization activities are
stillperformed,andtheNPSPcontinuestomonitoranddetectpoliooutbreaks.
Financial outcomes
There was no financial incentive for the polio eradication interventions performed by the
GOI.Poliovaccinesareinexpensiveandcanbeprocuredonalarge,nationalscale.TheGOI
showed its commitment by sustaining investment in the procurement of vaccines and
ensuring that sufficient health workers distributed the vaccines to all areas of the country
over 17 years. Governments can prioritize universal immunization against viral diseases
suchaspoliobyprovidingthevaccineforfree,becausethehealthbenefitsclearlyoutweigh
thefinancialburden.
Success factors
Seveninnovativeapproachescontributedtothesuccessoftheimmunizationcampaign(58).
Theseapproachesevolvedoverthe17yearexperienceofthepolioeradicationprogramme
inIndia.
1. Commitmenttopolioimmunizationofallstategovernmentsregardlessofpolitical
background:allpoliticalpartiessupportedtheeradicationprogrammetoensurethat
theeffortcontinuedifonegovernmentwassucceededbyadifferentpoliticalparty.
2. Highqualitystandardsandresponsibilityforhealthcareworkersatdistrictlevelin
thepolioprogramme:localprojectleaderswerepersonallyresponsibleforthe
requiredoptimaldeliveryofvaccines,withseriousconsequencesforanylaxity.
3. Access:healthcareworkersweresentouttobusstations,constructionsitesandused
motorbikesandtrainstoreachthemobilepopulationinIndia.Theyalsotravelledby
foottovaccinatechildreninthemostremoteregions.
4. StakeholdersinMuslimcommunities:keyfacilitatorssuchasclerics,imams,
madrasateachersandphysicianswereengagedtopersuadereluctantparentsto
obtaintheimmunization.
5. Monitoring:sewagesampleswerecollectedinhighriskareastotrackthespreadof
thepoliovirus.
6. Specifictargets:107highriskblocksintheStatesofUttarPradeshandBiharwere
targetedbyfocusingonhygiene,sanitationandtheavailabilityofcleanwater
besidestheroutineimmunizationpractice.

59


7. Combinationinterventions:thecombineduseofoperational(mobilizationof
populationslivingintheremainingpoliopools)andtechnical(introductionof
bivalentOPVasmosteffectiveforIndia)innovations.
All seven success factors testify to the strong and sustained commitment of the GOI to
accomplishpolioeradication.
Conclusions
This case study provides a clear example of successful polio eradication for the remaining
polioendemiccountries.Itshowsthatthroughthestrongandsustainedcommitmentofthe
government, eradication can be achieved even in a large country such as India. However,
thebattleagainstpolioiscertainlynotfinished.Allstakeholdersatthegovernmental,state
and district levels must maintain immunization coverage, polio surveillance and
preparednesstocontainoutbreaks.
Overall,thiscasestudyshowshowacommittedGovernmentimprovedtheresponsibleuse
ofmedicinesandasaresultobtainedthemaximumbenefitsofthemedicineforitspeople.
Sustained leadership commitment was important for achieving polio eradication. This
message is not limited to India; it applies to governments and policymakers in India and
therestoftheworld,whetheritconcernspolioeradicationorotherissuesaffectinghealth.If
leaderscan standtogetherbehindaspecificinterventionforaslong asit takestoimprove
the responsible use of medicines, setting aside their opposing political backgrounds and
ideologies,itwillbetheircitizenshealth(includingthepoliticians)andthecountrythatwill
bethewinners.

60


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WHO/EMP/MAR/

Technical Report prepared for the Ministers Summit

The benefits of responsible use of medicines:

Strategic recommendation 1: Develop and mandate a List of Essential Medicines

Strategic recommendation 4: Facilitate the implementation of evidence-based

Strategic recommendation 5: Promote initiatives that put patients at the centre

Strategic recommendation 6: Monitor medicine use, from purchase to health

Strategic recommendation 7: Ensure sustained, top-down commitment of

Chapter I The case for better use of medicines

Background and rationale for the report

What is meant by the responsible use of medicines?

The framework for the Summit

Table 1. The value of medicines

Revisiting medicine use in light of health-care costs is timely

Revisiting medicine use is timely given rising healthcare costs and

2,796 2,987 3,357 3,647 3,531

83% 83% 83% 84% 84%

Nonmedicine spending vs. medicine spending per capita in middle

24% 24% 24% 24% 24% 12%

2005 2006 2007 2008 2009

CAGR, compound annual growth rate

Figure 2. Total health vs medicine expenditure in low-income countries

In low income countries, although medicine spending is a larger share of total

Nonmedicine spending per capita*

70% 73% 71% 71% 71% 13.7%

30% 27% 29% 29% 29%

2005 2006 2007 2008 2009

The aim of this report

Scope of the report

Great emphasis is placed on medicine prescribers, dispensers and patients as key

Strattegic rec commendation 1: Develop and man ndate a List L of Es ssential

acces ss to essen ntial medic cines.

The WHO concep pt of essen ntial medicines was established

ThelateestWHOM ModelListo ofEssential Medicines ispublicly availablea andcomprissesover

Tactical recommendation 1.1: A list of essential medicines should be identified at the

Renewedattention wasalso placedonthe training of pharmacists.Atrainingmanual was

The establishment of a welldeveloped and implemented essential medicines list has

Tactical recommendation 1.2: Partial to full reimbursement should be granted at the

Althoughnomortality data wereavailable,improved utilization of essentialmedicinesfor

Insulin sales in Brazil

Non-reimbursed (Insulin Aspart, Detemir, Glargine et al.)

Strategic rec commendation 3: Promote a shift in focus to early e scree ening

The effficient proccurement anda reliablee supply of

Theavaailabilityof effectivem medicinesallone,howev ver,isnotssufficienttooguarantee thatthe

Asinth hemalaria casestudy 4below,th heimpacto ofdiagnostiicsisincreaasing asph hysicians

Diagnosisneedsto obefolloweedbytheco orrectprescrriptionanddispensing goftheapp propriate

CASE STUDY 3 Medicines supply reform (BHUTAN)

Tactical recommendation 2.1: Establish centralized, tender-based procurement of

Tactical recommendation 2.2: Establish routine quality testing procedures to verify

Tactical recommendation 2.3: Establish a routine performance feedback system to

The increase in competition among suppliers resulted in a 6% drop in average medicine

CASE STUDY 4 Malaria rapid diagnostic test (SENEGAL)

Presumptive treatment of febrile illnesses without parasitological confirmation has led to

Following a parasitological confirmation, artemisininbased combination therapy (ACT) is

Figure 6. Febrile illness case management algorithm recommended in Senegal,

Presence of other symptoms than malaria?

Negative RDT results Positive RDT results

Thepriimaryresultsoftheintterventionccanbeseen ninthreem majoroutcom mes(Figuree7&8):

No oveerall costbeenefit analy

Longitu udinalstatissticsofantiibioticpresccriptionsw werenotava ailable,but someunpu ublished

Prioritization of early and accurate diagnosis is essential to improve health outcomes of

Practical recommendation 3.2: Mandate early screening in at-risk segments of the

The Swaziland Government acknowledged the urgency of reducing childhood HIV