EVIPNet Capacity-Building Workshop Ethiopian Health and Nutrition Research Institute, Addis Ababa, Ethiopia 18 to 22 February 2008

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1 EVIPNet Capacity-Building Wrkshp Ethipian Health and Nutritin Research Institute, Addis Ababa, Ethipia 18 t 22 February 2008 Plicy Brief Terms f Reference (Last updated by Jhn Lavis n 13 February 2008) Title Wrking title (Lnger versin) Hw t supprt the widespread use f artemisinin-based cmbinatin therapies (ACT) t treat uncmplicated falciparum malaria (Shrter versin) Hw t supprt the widespread use f effective treatment fr malaria Authrs List the prpsed authrs and their affiliatins TBA Audience Gvernment fficials and key stakehlders (including civil sciety grups) wh will participate in a deliberative dialgue t discuss wh t supprt the widespread use f artemisinin-based cmbinatin therapies (ACT) t treat uncmplicated falciparum malaria Writing shuld therefre be targeted at an audience that is familiar with many f the issues but nt scientific experts Presentatin shuld ideally fllw a 1:3:25 frmat, with ne-page f take-hme messages utlining: 1) the plicy issue; 2) the magnitude f the prblems r challenges linked t the plicy issue; 3) three ptins fr addressing the plicy issue; and 4) ways t bring abut change, as well as a three-page executive summary and a 25-page reprt Disseminatin will initially be limited t thse participating in the deliberative dialgue but will eventually include bth traditinal disseminatin rutes like the EVIPNet website and mre practivee disseminatin thrugh natinal mechanisms that shuld be identified and planned fr early n Framing the plicy issue(s) State whether and hw the plicy issue relates t prgram / service / drug cverage, prvisin r reimbursement, delivery arrangements, financial arrangements and/r gvernance arrangements Drug cverage, prvisin r reimbursement Shuld ACT be the first-line drug therapy recmmended fr uncmplicated falciparum malaria in natinal treatment guidelines and/r the natinal malaria cntrl plicy and, if s, in what dsage regimes / packaging, fr which ppulatins, and fr areas with which characteristics? Delivery arrangements Wh shuld dispense ACT, when, where and hw? Wh shuld be invlved in surveillance, pharmacvigilance, and in the diagnsis and treatment f atypical cases? Financial arrangements Shuld ACT be subsidized r shuld cnditinal cash transfers be ffered t encurage its use and, if s, at what level and fr which ppulatins (e.g., children under five, pregnant wmen)? Shuld financial incentives be ffered t prescribers, physician-remuneratin arrangements changed r cntracts with the fr-prfit sectr changed t encurage prviders t dispense ACT? Gvernance arrangements Which ACT and ther anti-malarial drugs (i.e., drugs, dsage regimes, and packaging) shuld be registered/licensed fr sale, hw shuld patents fr them and prfits arising frm them be handled, hw shuld they be allwed t be marketed, wh shuld be able t prescribe them and hw, wh shuld be allwed t sell r dispense them and hw, and hw shuld patients be prtected against cunterfeit r substandard drugs? Describe hw the plicy issue has been framed in different ways in the cuntry s health systems (and, if instructive, in ther health systems) ACT shuld be widely ffered as part f a hme-based management strategy (i.e., presumptive treatment f febrile illness with ACT by lay health wrkers) ACT shuld be widely ffered by health prfessinals wh receive nging supprt t prmte their adherence t natinal treatment guidelines ACT shuld be subsidized fr children under five and pregnant wmen Marketing and sale f single drug artemisinin-based drugs, cunterfeit antimalarial drugs, and sub-standard anti-malarial drugs shuld be banned by

2 Magnitude f the prblems r challenges linked t the plicy issue Alternative ways f addressing the plicy issue(s) Plicy Brief - Terms f Reference (Last updated by Jhn Lavis n 13 February 2008) regulatry authrities and the ban strictly enfrced Describe hw the plicy issue has been framed fr the purpses f the plicy brief The widespread use f ACT t treat uncmplicated falciparum malaria shuld be supprted by a cmbinatin f delivery, financial and gvernance arrangements that address unique natinal r sub-natinal cntexts Describe the magnitude f the prblems r challenges linked t the plicy issue within the cuntry s health system (e.g., demgraphic data, healthcare utilizatin data, expenditure data), hw the prblems r challenges have changed ver time, and hw the prblems r challenges have affected particular grups r areas Burden f malaria (Pssible surces include: 1) Glbal Fund-spnsred cmmunity surveys, which typically prvide cmmunity-level data every year and may appear as part f an integrated disease surveillance reprt); and 2) Demgraphic and Health Surveys, which typically prvide detailed cmmunity-level data every 4-5 years) Incidence f (and death rates frm) uncmplicated falciparum malaria, severe falciparum malaria and ther types f malaria by age (including separately fr infants), sex (including separately fr pregnant wmen and lactating wmen), HIV status, malnutritin status, and sciecnmic status Drug cverage, prvisin r reimbursement (Pssible surces include the same tw surces as abve, as well as Health Management Infrmatin Systems, which typically prvide facility-level data every three mnths, and qualitative studies invlving malaria patients) Cure rates fr and drug resistance (r reduced drug sensitivity) t ACT and ther anti-malarial drugs First-line (and secnd-line) drug therapy recmmended fr uncmplicated falciparum malaria in natinal treatment guidelines and/r the natinal malaria cntrl plicy (and in what dsage regimes / packaging, fr which ppulatins, and fr areas with which characteristics) Anti-malarial drugs included n the natinal essential drugs list Patients views abut and experiences with particular anti-malarial drugs Delivery arrangements (Pssible surces include the same fur surces as abve) Access rates fr first-line drug therapy (and fr ACT if this is nt first-line therapy) fr uncmplicated falciparum malaria (i.e., wh has access t smene wh can dispense drug therapy) Cverage rates fr first-line drug therapy (and fr ACT if this is nt first-line therapy) fr uncmplicated falciparum malaria (i.e., wh is dispensed what) Treatment patterns fr uncmplicated falciparum malaria (i.e., wh dispenses what, when, where and hw, including whether treatment is part f the Integrated Management f Childhd Illness r ther hrizntal prgrams) Adherence patterns fr the treatment f uncmplicated falciparum malaria (i.e., wh takes what, when, where and hw) Arrangements fr surveillance, pharmacvigilance and the diagnsis and treatment f atypical cases? Patients views abut and experiences with particular prviders (r delivery arrangements mre generally) Financial arrangements (Pssible surces include healthcare expenditure surveys and qualitative studies invlving malaria patients) Drug and dispensing fees fr first-line drug therapy (and fr ACT if this is nt first-line therapy) fr uncmplicated falciparum malaria, including any subsidies fr particular ppulatins Patients views abut and experiences with fees and/r subsidies Gvernance arrangements Regulatins abut which ACT and ther anti-malarial drugs (i.e., drugs, dsage regimes, and packaging) can be registered/licensed fr sale, hw patents fr them and prfits arising frm them are handled, hw they can be marketed, wh can prescribe them and hw, wh can sell r dispense them and hw (and the degree f their enfrcement) Regulatry safeguards t prtect against cunterfeit r substandard drugs (and the degree f their enfrcement) Benefits and harms/risks f alternative ways f addressing the plicy issue(s) Drug cverage, prvisin r reimbursement (Pssible surces include: 1) WHO cst-effectiveness estimates frm 2005; 2) WHO guidelines frm 2006; 3) the six systematic reviews abut anti-malarial drugs published in 2006 r 2007; and 4) the 2

3 Alternative ways f bringing abut change Plicy Brief - Terms f Reference (Last updated by Jhn Lavis n 13 February 2008) systematic review abut unit-dse packaged antimalarial drugs) Cnfirming / instituting ACT as the first-line drug therapy recmmended fr uncmplicated falciparum malaria in natinal treatment guidelines and/r the natinal malaria cntrl plicy, including the dsage regimes / packaging and any mdificatins required fr specific ppulatins r areas with specific characteristics Delivery arrangements (Pssible surces include: 1) an verview f systematic reviews f the effects f alternative human resurces fr health (HRH) cnfiguratins; 2) five systematic reviews f the effects f specific HRH cnfiguratins, including hme-based management, lay health wrkers, utpatient pharmacists rle expansin, and either nurses r nurse practitiners instead f physicians); and 3) ne systematic review abut the activities f medicine-sellers and hw their practice can be imprved (which is nt a review f effects) Cnfirming/changing wh shuld dispense ACT, when, where and hw and wh shuld be invlved in surveillance, pharmacvigilance and in the diagnsis and treatment f atypical cases Financial arrangements (Pssible surces include: 1) an verview f systematic reviews f the effects f alternative financial arrangements in health systems; 2) six systematic reviews f the effects f specific financial arrangements, including incentives fr patients (i.e., cnditinal cash transfers), incentives fr prescribers, physician-remuneratin arrangements mre generally, cntracting with the fr-prfit sectr t imprve healthcare delivery, and reference pricing, ther pricing and purchasing plicies); and 3) a systematic review abut financial arrangements with the private sectr (which is nt a review f effects) Cnfirming/changing drug and dispensing fees fr first-line drug therapy (and fr ACT if this is nt first-line therapy) fr uncmplicated falciparum malaria, including any subsidies r cnditinal cash transfers fr particular ppulatins Cnfirming/changing financial incentives fr prescribers, physicianremuneratin arrangements mre generally r cntracts with the fr-prfit sectr Gvernance arrangements (Pssible surces include: 1) an verview f systematic reviews f the effects f alternative gvernance arrangements related t pharmaceuticals; 2) a systematic review f the effects f cnsumer invlvement in decisin-making); and 3) a systematic review abut gvernance arrangements related t the private sectr (which is nt a review f effects) Cnfirming/changing which ACT and ther anti-malarial drugs (i.e., drugs, dsage regimes, and packaging) can be registered/licensed fr sale, hw patents fr them and prfits arising frm them are handled, hw they can be marketed, wh can prescribe them and hw, wh can sell r dispense them and hw, and with what safeguards t prtect against cunterfeit r substandard drugs Describe three viable plicy ptins that cmprise different bundles f the afrementined activities, summarize what can reasnably be expected (in terms f bth csts and cnsequences) in the cuntry s health system by pursuing each f the plicy ptins, and pint ut where there are gaps in ur understanding abut what can be expected T be determined by each cuntry team after the abve types f research evidence have been assessed fr their quality and lcal applicability and fr equity and scaling up cnsideratins Benefits and harms/risks f alternative ways f bringing abut change (Pssible surces: 1) an verview f systematic reviews f the effects f different ways f changing prvider behaviur; 2) seven systematic reviews f the effects f different strategies fr achieving desired utcmes, including disseminating and implementing guidelines, implementing guidelines amng allied health prfessinals specifically, influencing prescribing and dispensing, changing medicatin use, imprving antibitic prescribing in ambulatry care and in hspitals, and enhancing medicatin adherence); and 3) seven systematic reviews f the effects f specific strategies fr bringing abut change, including audit and feedback, cmputerized drug-dsage supprt, cntinuing-educatin meetings, educatinal-utreach visits, lcal pinin leaders, mass-media campaigns, and tailred effrts t identify identified barriers t change) Key references List majr plicy dcuments n the tpic that are relevant t the cuntry s health system Wrld Health Organizatin. Guidelines fr the Treatment f Malaria. Geneva, 3

4 Plicy Brief - Terms f Reference (Last updated by Jhn Lavis n 13 February 2008) Switzerland. Wrld Health Organizatin, Wrld Health Organizatin. WHO Briefing n Malaria Treatment Guidelines and Artemisinin Mntherapies. Geneva, Switzerland: Wrld Health Organizatin, Bsman A, Mendis KN, A majr transitin in malaria treatment: The adptin and deplyment f artemisinin-based cmbinatin therapies. American Jurnal f Trpical Medicine and Hygiene 2007; 77 (Suppl 6): Teklehaimant A, McCrd GC, Sachs JD. Scaling up malaria cntrl in Africa: An ecnmic and epidemilgical assessment. American Jurnal f Trpical Medicine and Hygiene 2007; 77 (Suppl 6): Burkina Fas Culibaly SO, Gies S, D Alessandr U. Malaria burden amng pregnant wmen living in the rural district f Brm, Burkina Fas. American Jurnal f Trpical Medicine and Hygiene 2007; 77 (Suppl 6): Tanzania Mbera LEG, Makundi EA, Kitua AY. Uncertainty in malaria cntrl in Tanzania: Crssrads and challenges fr future interventins. American Jurnal f Trpical Medicine and Hygiene 2007; 77 (Suppl 6): Makundi EA, Mbera LEG, Maleb HM, Kituan AY. Pririty setting n malaria interventins in Tanzania: Strategies and challenges t mitigate against the intlerable burden. American Jurnal f Trpical Medicine and Hygiene 2007; 77 (Suppl 6): List systematic reviews f the research literature n the tpic that are relevant t the cuntry s health system Systematic reviews related t the burden f malaria Nne fund Systematic reviews related t the effects r cst-effectiveness f particular antimalarial drugs Select frm separating listing f systematic reviews Systematic reviews related t the effects f alternative delivery arrangements Select frm separating listing f systematic reviews Gdman C, Brieger W, Unwin A, Mills A, Meek S, Greer G. Medicine sellers and malaria treatement in Sub-Saharan Africa: What d they d and hw can their practice be imprved? American Jurnal f Trpical Medicine and Hygiene 2007; 77 (Suppl 6): Systematic reviews related t the effects f alternative financing arrangements Select frm separating listing f systematic reviews Waters H, Hatt L, Peters D. Wrking with the private sectr fr child health. Health Plicy and Planning 2003; 18: Systematic reviews related t the effects f alternative gvernance arrangements Select frm separating listing f systematic reviews Waters H, Hatt L, Peters D. Wrking with the private sectr fr child health. Health Plicy and Planning 2003; 18: Systematic reviews related t the views and experiences f patients (r ther stakehlders) Nne fund Systematic reviews related t alternative ways t bring abut change Select frm separating listing f systematic reviews List majr research studies n the tpic that have nt yet been synthesized Studies related t the burden f malaria T be added Studies related t the effects r cst-effectiveness f particular anti-malarial drugs Mrel CM, Lauer JA, Evans DA. Cst effectiveness analysis f strategies t cmbat malaria in develping cuntries. BMJ 2005;331(7528):1299. Mrel CM, Lauer JA, Evans DB. Crrectins and clarificatins: Achieving the millennium develpment gals fr health: Cst effectiveness analysis f strategies t cmbat malaria in develping cuntries. BMJ 2005;333:86. Ref ID: 7846 Mrel CM, Lauer JA, Evans DB. Crrectins and clarificatins: Achieving the millennium develpment gals fr health: Cst effectiveness analysis f strategies t cmbat malaria in develping cuntries. BMJ 2006;332:151. Studies related t the effects f alternative delivery arrangements T be added Studies related t the effects f alternative financing arrangements 4

5 Plicy Brief - Terms f Reference (Last updated by Jhn Lavis n 13 February 2008) T be added Studies related t the effects f alternative gvernance arrangements T be added Studies related t the views and experiences f patients (r ther stakehlders) T be added Studies related t alternative ways t bring abut change T be added List systematic reviews f the research literature n related tpics that are relevant t the cuntry s health system Tanser FC, Pluess B, Lengeler C, Sharp BL. Indr residual spraying fr preventing malaria (Prtcl). Cchrane Database f Systematic Reviews 2007;Issue 3. Art. N.: CD DOI: / CD Gamble C, Ekwaru PJ, Garner P, ter Kuile FO. Insecticide-treated nets fr the preventin f malaria in pregnancy: A systematic review f randmized cntrlled trials. PLS Medicine 2007;4(3). List studies that have examined whether and hw research evidence has influenced previus effrts t supprt transitins in the treatment f malaria Williams HA, Durrheim D, Shretta R. The prcess f changing natinal malaria treatment plicy: Lessns frm cuntry-level studies. Health Plicy and Planning 2004;19(6): Mubyazi GM, Gnzalez-Blck MA. Research influence n antimalarial drug plicy change in Tanzania: Case study f replacing chlrquine with sulfadxinepyrimethamine as the first-line drug. Malaria Jurnal 2005;4(51). Zurvac D, Ndhlvu M, Rwe AK, Hamer DH, Thea DM, Snw RW. Treatment f paediatric malaria during a perid f drug transitin t artemether-lumefantrine in Zambia: Crss sectinal study. BMJ 2005;331: Amin AA, Zurvac D, Kangwana BB, Greenfield J, Otien DN, Akhwale W et al. The challenges f changing natinal malaria drug plicy t artemisinin-based cmbinatins in Kenya. Malaria Jurnal 2007;6(72). 5

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