Silvia Schwarte Diagnosis Treatment and Vaccines DTV Global Malaria Programme GMP email schwarteswhoint Interagency Pharmaceutical Coordination Group Meeting 1617 December 2014 ID: 736297
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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 Meeting16-17 December 2014World Bank, Washington, USASlide2
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
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WHO/FIND/CDC Malaria RDT Product Testing ProgrammeRound 1
Round 2
Round 3
Round 4 Round 5Number of products
412950 48
42
Number of manufacturers
21
13
23
27
34
Resubmissions
-
1
231323
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 fo
r procurement of malaria
RDTs
updated September 2014
English
:
http://
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=1Slide4
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): GuilinFull list of WHO-prequalifed medicines available at: http://apps.who.int/prequal/-----------------------------------------------------------------------------------------------------------------------------AL: artemether/lumefantrine; AS: artesunate; AQ: amodiaquine; MQ: mefloquine; SP: sulfadoxine /
pyrimethamineSlide5
ACT deliveries (2005-2013) by combinationSlide6
ACT deliveries (2005-2013) Fixed-dose combinations versus co-blistersSlide7
ACT versus RDT delivery / sales trends (2005-2013)Slide8
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 soonSlide9
Single-dose primaquine as gametocytocide in Plasmodium falciparum malariaSingle 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 , 3rd 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 Slide10
Primaquine sourcing for procurementLIST 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/ Slide11
Temporary malaria control measures (I) Diagnosis and treatmentStandard 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 Slide12
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 overPneumonia and diarrhoea: iCCM guidelines – referral of suspected ebola cases
Temporary malaria control
measures (II)
Diagnosis and treatmentSlide13
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 Slide14
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 populationSlide15
Thank youSlide16
Backup slidesSlide17
Temporary malaria control measuresDistribution 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!) Slide18
Temporary malaria control measuresMass 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, 1st ASAQ dose: directly observed treatment; 2nd and 3rd 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)