1. Update from the WHO Global Malaria Programme Update from the WHO Global Malaria Programme Silvia Schwarte Diagnosis, Treatment and Vaccines (DTV) Global Malaria Programme (GMP) e-mail: schwartes@who.int Interagency Pharmaceutical Coordination Group Meeting 16-17 December 2014 World Bank, Washington, USA

2. 2 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Outline  Rapid diagnostics tests (RDTs) for malaria - WHO/FIND Malaria RDT Product Testing Programme and WHO Information note on recommended selection criteria for procurement of malaria RDTs  Antimalarial medicines - WHO Prequalification - Stringent Regulatory Authorities  Temporary malaria control measures in ebola- affected countries

3. 3 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 WHO/FIND/CDC Malaria RDT Product Testing Programme Round 1Round 2Round 3Round 4 Round 5 Number of products 4129504842 Number of manufacturers 2113232734 Resubmissions -1231323 Invalid Rate False Positive Rate PDS at 200 parasites/μl PDS at 2000 parasites/μl PDS = 75% Round 5 report published July 2014 http://apps.who.int/iris/bitstream/10665/128678/1/9789241507554_eng.pdf?ua=1&ua=1 WHO Information Note on recommended selection criteria for procurement of malaria RDTs updated September 2014 English: http://www.who.int/entity/malaria/publications/atoz/rdt-selection-criteria-sept2014.pdf?ua=1http://www.who.int/entity/malaria/publications/atoz/rdt-selection-criteria-sept2014.pdf?ua=1 French: http://www.who.int/entity/malaria/publications/atoz/rdt-selection-criteria-sept2014-fr.pdf?ua=1http://www.who.int/entity/malaria/publications/atoz/rdt-selection-criteria-sept2014-fr.pdf?ua=1

4. 4 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 WHO-prequalified medicines (last updated 11 November 2014)  Fixed-dose combinations - AL, 20mg/120mg: Ajanta, Cipla, Ipca, Macleods, Mylan, Novartis, Strides - AL, 20mg/120mg, dispersibles: Ajanta, Novartis - AL, 40mg/240mg: Mylan - ASAQ: Ajanta, Cipla, Guilin, Ipca, Sanofi - ASMQ: DNDi/Cipla  Co-Blisters (Co-B) - AS + AQ: Cipla, Guilin, Ipca, Strides - AS + SP: Guilin  Injectables - AS powder for injection (30mg, 60mg, 120mg): Guilin Full list of WHO- prequalifed medicines available at: http://apps.who.int/prequal/ ----------------------------------------------------------------------------------------------------------------------------- AL: artemether/lumefantrine; AS: artesunate; AQ: amodiaquine; MQ: mefloquine; SP: sulfadoxine / pyrimethamine

5. 5 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 ACT deliveries (2005-2013) by combination

6. 6 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 ACT deliveries (2005-2013) Fixed-dose combinations versus co-blisters

7. 7 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 ACT versus RDT delivery / sales trends (2005-2013)

8. 8 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 European Medicines Agency (EMA) reviewed  EMA approval: Eurartesim (dihydro-artemisinin + piperaquine) Prolonged QTc intervals: max 2 doses / year => further studies are ongoing, results expected soon  EMA Article 58 – Positive Scientific Opinion: Pyramax (artesunate + pyronaridine) Hepatotoxicity: max single dose => further studies on repeated exposure are ongoing, results expected soon

9. 9 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Single-dose primaquine as gametocytocide in Plasmodium falciparum malaria Single dose of primaquine at 0.25mg base/kg:  is effective in transmission blocking  is unlikely to cause serious toxicity in subjects with any of the G6PD variants MPAC recommendation => WHO treatment guidelines, 3 rd Edition, Q1/2015: In low transmission areas, a single 0.25 mg base/kg primaquine dose should be given to all patients with parasitologically-confirmed P. falciparum malaria on the first day of treatment in addition to an ACT, except for pregnant women, breastfeeding women in the first six months and children less than six months of age due to insufficient data on the safety of its use in these categories. G6PD testing is not required. http://www.who.int/malaria/pq_updated_policy_recommendation_en_102012.pdf?ua=1

10. 10 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Primaquine sourcing for procurement LIST OF MALARIA PHARMACEUTICAL PRODUCTS classified according to the Global Fund Quality Assurance Policy, accessible via the following link: http://www.theglobalfund.org/documents/psm/PSM_ProductsMALARIA_List_en/ http://www.theglobalfund.org/documents/psm/PSM_ProductsMALARIA_List_en/

11. 11 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Temporary malaria control measures (I) Diagnosis and treatment Standard precautions at all times for all patients (e.g. hand hygiene, gloves, injection safety, waste disposal) Personal protective equipment (PPE) requirements when performing a malaria RDT:  "dry" patients (without vomiting, bleeding, diarrhoea): Double examination gloves, face shield (or mask and goggle) and disposable gown  "wet" patients (vomiting, bleeding, diarrhoea): Double examination gloves, impermeable gown (or non-impermeable gown and rubber apron), medical mask, face shield or goggles, head cover, boots

12. 12 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Where PPE requirements cannot be met:  Temporary suspension of RDT performance  Presumptive treatment of suspected malaria cases with full ACT dose – clinical response expected within 48hrs – if no fever clearance in this time, this virtually excludes malaria as a cause of fever and strengthens the likelihood of other febrile illnesses, including ebola Integrated community case management (iCCM) programmes:  CHWs should be instructed / trained to diagnose malaria cases only on the basis of history of fever (without performing RDTs)  Presumptive malaria treatment until the epidemic is officially declared over  Pneumonia and diarrhoea: iCCM guidelines – referral of suspected ebola cases Temporary malaria control measures (II) Diagnosis and treatment

13. 13 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Temporary malaria control measures (III) Distribution of long-lasting insecticidal nets (LLINs) Precautions at all times:  personal protective equipement (PPE) is not required  no-touch – avoid hand-shaking; – no touching or providing care to sick people; – no touching of personal items (i.e. plates, cup, utensils) and surfaces in the household, in particular if anyone is sick in the house);  frequent hand hygiene (alcohol-based hand-rub solution or, if not available, with water and soap);  maintaining a 1 meter distance when interacting with people

14. 14 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Temporary malaria control measures (IV) Mass administration of ACTs  Where? Recommended in areas – heavily affected by ebola – with high malaria transmission and – low access to malaria treatment  Why? Expected benefits: – rapid reduction in malaria morbidity and mortality; – decreased incidence of febrile illnesses due to malaria => reduced presentation of febrile patients at ebola evaluation facilities => lower risk of ebola transmission to malaria patients; reduced workload – improve the credibility of health service delivery, including community outreach; – possible delivery in combination with other interventions  How? – Ideally long-lasting ACTs not used as first-line treatment (e.g. DHA-PPQ); – however, ASAQ (first-line treatment in affected countries) may be preferable given its immediate availability and acceptability  Who? Health workers and general population

15. 15 Global Malaria Programme IPC Meeting | 30-31 May 2013 Thank you

16. 16 Global Malaria Programme IPC Meeting | 30-31 May 2013 Backup slides

17. 17 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Temporary malaria control measures Distribution of long-lasting insecticidal nets (LLINs) Further considerations for distribution campaigns  avoid creation of large crowds  communication and social mobilization campaigns  simple recording / pragmatic approach (e.g. standard number of LLINs per household based on average household size if this will ensure universal coverage in target areas)  door-to-door distribution of nets (including nails and strings to limit population movement)  door-to-door distribution of vouchers (reduce logistical requirements; voucher information: (i.) number of LLINs to be given per voucher; (ii.) point of distribution where LLINs can be collected; (iii.) recommended time periods for collecting LLINs and hanging materials; and (iv.) ideally message on appropriate behaviours to prevent malaria and ebola transmission – net no role in ebola transmission blocking)  inclusion of health centres with inpatient facilities including ebola referral and ebola treatment centres to replace used nets (incinerate; PPE!)

18. 18 Global Malaria Programme IPC Meeting – Washington – 16-17 December 2014 Temporary malaria control measures Mass administration of ACTs  Communication and social mobilization campaign (e.g. expected benefits, full adherence to treatment, management of adverse events)  MDA door-to-door; administering health workers: "precautions at all times" (see above). Ideally, 1 st ASAQ dose: directly observed treatment; 2 nd and 3 rd doses self-administered at home.  ASAQ can be given to the entire population (exceptions: pregnant women during the first trimester, infants weighting less than 5 kg, people who received ASAQ during the past month, and patients taking zidovudine, efavirenz or co-trimoxazole)  MDA should be provided at monthly intervals. After 2-3 rounds need for continuing MDA should be assessed.  Ideally, combine MDA with distribution of other commodities (e.g. LLINs, soaps, oral rehydration salts)