Guidelines on the use of ACT (Artesunate plus sulpha pyrimethamine) combination in chloroquine resistant areas.

Preamble

It has been observed that Chloroquine (CQ) resistance in malaria is increasing in some high endemic PHCs/districts in the country. Till 2006 261 Blocks/PHCs of 71 districts spread over 20 states have been declared as CQ resistant and revised Drug Policy is being followed in all these areas using ACT (Artesunate plus Sulpha Pyrimethamine) combination therapy. The ACT combination (second line drugs) for treatment of P falciparum malaria has been supplied to CQ resistant areas by Govt. of India. As per the National Drug Policy on malaria ACT should be given only to confirmed P faliciparum cases found positive by microscopy or Rapid Diagnostic Kits in CQ resistant pockets or may also be given on clinical diagnosis of malaria by a trained Medical Officer or trained paramedical Personnel after excluding other common caused of fever in areas with high diseases burden, High proportion of Pf, inadequate facilities for laboratory diagnosis and the inaccessibility and relatively poor communication facilities and the Pf Chloroquine resistant pockets.

Requirements for implementation of ACT

1. List the areas placed under second line treatment based on the results of therapeutic efficacy studies.
2. The chance of drug from Chloroquine (first line of treatment ) to ACT combination should be implemented in the area / PHC showing a treatment failure more than 10%. Further the change of drug to second line of treatment may also be implemented in a cluster of PHCs around the resistant foci after taking into consideration the epidemiological trend of P falciparum (Pf > 30%) and clinical response in these areas.
3. All the areas placed under ACT combination should be strengthened in terms of diagnosis. Wherever, laboratory testing (microscopy diagnosis) is not possible. Rapid Diagnostic Kits should be supplied so that patient testing positive for Pf can be immediately given treatment.
4. Treatment with ACT on the basis of clinical diagnosis may be given by a Medical Officer or rained Paramedical Personnel. In case diagnostic facilities are not available and in a special circumstances community volunteers can dispense with ACT on confirmation by RDK.
5. Availability of ACT (including Blister Pack to be used for adults) to Health facilities (Hospital, Health Centers & Sub Centers) should be ensured depending upon the estimated number of patients.
6. Sensitization to use ACT to all the users (i.e. Medical Officer or Para Medical Personnel or Community Volunteers) before supplying the drugs.
7. Training in use of SP-ACT be imparted to all community volunteers including ASHA and AWW.
8. Enlisting the NGOs/CBOs/PRIs and private Sector Organizations having diagnostic facilities and who can dispense SP-ACT for treatment of Pf cases.
9. Regular Field supervision for tracking utilization of ACT and stock position at Field Level.
10. Epidemiological monitoring of the PHCs / areas for the trend of Pf malaria wherever ACT is being used.
11. Artesunate Tablets should not be administered as monotherapy. It should invariably be combined with Sulpha Pyrimethamine tablets in prescribed dosages.

Supply of SP- ACT

It depends upon the requirement of the Blocks /Districts and has to be worked out based on the number of Pf cases in CQ resistant areas estimated to be detected through Health System and other Organizations like NGOs, CBOs etc. Under the Programme the Drug Artesunate and SP are being supplied separately as well as in combi-blister Pack to be used for adults. The estimated requirement of drug should be sent to SPO for making arrangements for the supply at one year in advance.

Note : Blister Packs are to be used for adult patients only and should not be used in Children under 14 years.

Age wise dose schedule of SP-ACT

Dose of Artisunate is 4 mg / Kg of BW in single dose for three days. Strength of each Artisunate Tablet is 50 mg.
Dose of SP is 25 mg / Kg BW of Sulphadoxine / Sulphalene plus 1.25 mg/kg BW Pyremethamine single dose. Strength of each Pyremethamine (SP) tablet is 500 mg of Sulphadoxine / Sulphalene and 25 mg Pyremethamine.

Note : Artemisinin group of drugs in not recommended in pregnancy

* Primaquine should not be given with ACT combination as Artisunate reduces gametocyte carriage.

Monitoring the use of ACT combination
It is essential to monitor the use of SP-ACT to obtain optimum benefits. For this following activities need to be done :
1. Regular field visit by Supervisory Officer to monitor and replenish the drugs.
2. Monthly report to include information on ACT drugs used for Pf cases.
3. Monitoring of fever cases and confirmed cases of malaria.
4. Reporting of adverse / Toxic reactions to ACT Therapy.