New drug policy for Malaria 2013

Presented by: Dr. Dawal S Salve (JR-2)Activity Guide: Dr. V.K.Sonkar (Asst. Professor)

Department of Community Medicine,DR.S.C.G.M.C.Nanded.

Content of the presentation Introduction Criteria for change of drug policy Treatment for P. Vivax Treatment of P. Falciparum in NE states Treatment of P. Falciparum in other states Treatment of mixed infection Treatment of P. Ovale and Malaria Resistance to anti malarial drugs Treatment of severe malaria Chemoprophylaxis

Introduction

India has the largest population in the world at risk of malaria, with 85% living in malarious zones.

The combination of Plasmodium falciparum and Plasmodium vivax, six primary malaria vectors, several ecotypes including urban malaria, and various transmission intensities ranging from unstable to hyper endemic create a challenging epidemiological scenario in India.

Introduction In 1953, the National Malaria Control

Programme was launched and protected a population of about 165 million with dichlorodiphenyltrichloroethane (DDT) spraying

The control programme developed into the National Malaria Eradication Programme in 1958

A new strategy, the modified plan of operation,5 was introduced in 1977

Criteria for change in the drug policy

Drug policy is changed for the area/Block PHC reporting 10% or more total treatment failure (ETF+LTF) to the tested drug i.e the currently used antimalarials in a sample of minimum 30 P.falciparum test cases.

To combat the drug resistant in malaria, the National Drug Policy on Malaria recommends the use of combination therapy i.e Artesunate plus Sulfadoxine Pyrimethamine for treatment of P.falcipuram cases in chloroquine resistant areas, surrounding cluster of Blocks and 117 high endemic districts of 7 North Eastern States and state of Andhra Pradesh, Chhatisgarh, Jharkhand, Madhya Pradesh & Orissa.

Chloroquine Resistant Areas (1978-2008 updated to August)

Drug schedule for treatment of P vivax malaria:

1. Chloroquine: 25 mg/kg body weight divided over three

days i.e.

10mg/kg on day 1,

10mg/kg on day 2 &

5mg/kg on day 3.

2. Primaquine: 0.25 mg/kg body weight daily for 14 days.

Age-wise dosage schedule for treatment of P.vivax cases

Age (in years)

Tablet Chloroquine (150 mg base) Tablet Primaquine* (2.5 mg base)

Day – 1 Day – 2 Day -3 Day – 1 to Day – 14

<1 ½ ½ ¼ 0

1-4 1 1 ½ 1

5-8 2 2 1 2

9-14 3 3 1½ 4

15 & above 4 4 2 6

Pregnancy 4 4 2 nil

* Primaquine is contraindicated in infants, pregnant women and individuals with G6PD deficiency. 14 day regimen of Primaquine should be given under supervision.

Treatment of Falciparum Malaria in north east states (NE states)

1. ACT-AL Co-formulated tablet of ARTEMETHER( 20 mg) - LUMEFANTRINE (120 mg)

(Not recommended during the first trimester of pregnancy and for children weighing < 5 kg)

2. Primaquine: 0.75 mg/kg body weight on day 2

Recommended regimen by weight and age groupThe packing size for different age groups based on Kg bodyweight.Co-formulated

tablet ACT-AL5–14 kg

( > 5 months to< 3 years)

15–24 kg(≥ 3 to 8years)

25–34 kg(≥ 9 to14

years)

> 34 kg(> 14 years)

Total Dose ofACT-AL

20 mg/120 mg

twice dailyfor 3 days

40 mg /240mg

twice dailyfor 3 days

60 mg /360mg

twice dailyfor 3 days

80 mg /480mg

twice dailyfor 3 days

Pack size

No. of tabletsin the Packing

6 12 18 24

Give 1 Tablettwice dailyfor 3 days

2 Tabletstwice dailyfor 3 days

3 TabletsTwice dailyfor 3 days

4 TabletsTwice dailyfor 3 days

Colour of thepack

Yellow Green Red White

Treatment of P.falciparum cases in other states

Artemisinin based Combination Therapy (ACT)*

Day 1: Artesunate 4 mg/kg body weight daily for 3 days

Plus Sulfadoxine (25 mg/kg body weight) –

Pyrimethamine (1.25 mg/kg body weight) day 1

Day 2: Primaquine 0.75 mg/Kg body weight

• Caution: 1. ACT is not to be given in 1st trimester of

pregnancy.

2. SP is not to be given to child of age under 5 month

Age-wise dosage schedule for treatment of P.falciparum cases

Age Group (Years)

1st day 2nd day 3rd day

AS SP AS PQ AS

0-1 Pink Blister

1(25 mg)

1 (250 mg +12.5

mg)

1 (25 mg) Nil

1 (25 mg)

1-4 Yellow Blister

1 (50 mg)

1 (500+25 mg

each)

1 (50 mg)

1 (7.5 mg base)

1 (50 mg)

5-8 Green Blister

1 (100 mg)

1 (750+37.5 mg

each)

1 (100 mg)

2 (7.5 mg base

each)

1 (100 mg)

9-14 Red Blister

1 (150 mg)

2 (500+25 mg

each)

1 (150mg)

4 (7.5 mg base

each)

1 (150 mg)

15 & Above White Blister

1 (200 mg)

2 (750+37.5 mg

each)

1 (200 mg)

6 (7.5 mg base

each)

1 (200 mg)

Treatment of P.falciparum cases in pregnancy

1st Trimester : Quinine salt 10mg/kg 3 times daily for 7 days.

2nd and 3rd trimester: Area specific ACT

i.e. ACT-AL in North Eastern States

ACT-SP in Other States

Treatment of mixed infections (P.vivax + P.falciparum) cases

In North-Eastern States: Treat with: Age-specific

ACT-AL for 3 days + Primaquine 0.25 mg per kg

body weight daily for 14 days.

In Other States: SP-ACT 3 days + Primaquine 0.25

mg per kg body wt. daily for 14 days.

Treatment of P. ovale and P. malariae:

In India these species are very rarely found in few places.

P. ovale should be treated as P. vivax and P. malariae should be treated as P. falciparum.

Resistance to anti-malarial drugs.Definition: Resistance can be defined as either the ability of a parasite strain to survive and/or multiply despite the administration and absorption of a drug given in doses equal to or higher than those usually recommended, but within the limits of tolerance of the patient.

Why does malaria parasite become resistant to anti-malarials?

complex phenomenon genetic mutation Insufficient amount of the drug Low prescription dosage Lesser amount of drug dispensed Incomplete treatment taken by the patient Drug vomited out Low absorption due to any reason, for

example, diarrhoea.

Why is it difficult for parasites to develop resistance to ACT?

ACT : combination of 3 drugs, artesunate, sulphadoxine and pyrimethanamine.

All three drugs acts on different parts of parasite

Genetic mutations are very rare

Treatment of severe malaria cases

Initial parenteral treatment for at least 48hours:CHOOSE ONE of following four options

Follow-up treatment, when patient can takeoral medication following parenteraltreatment

Quinine: 20mg quinine salt/kg body weight on admission (IV infusion or divided IMinjection) followed by maintenance dose of10 mg/kg 8 hourly; infusion rate should not exceed 5 mg/kg per hour. Loading dose of 20mg/kg should not be given, if the patient has already received quinine.

Quinine 10 mg/kg three times a daywith:doxycycline 100 mg once a day orclindamycin in pregnant women and childrenunder 8 years of age,- to complete 7 days of treatment.

Artesunate: 2.4 mg/kg i.v. or i.m. given onadmission (time=0), then at 12 h and 24 h, then once a day or Artemether: 3.2 mg/kg i.m. given onadmission then 1.6 mg/kg per day.orArteether: 150 mg daily i.m for 3 days inadults only (not recommended for children).

Full oral course of Area-specific ACT:In NorthEastern states: Age-specific ACT-AL for 3 days + PQ Single dose on secondDayIn other states: Treat with: ACT-SP for 3days + PQ Single dose on second day

Chemoprophylaxis

Short term chemoprophylaxis (up to 6 weeks)

Doxycycline: 100 mg once daily for adults and 1.5 mg/kg once daily for

children (contraindicated in children below 8 years). The drug should be

started 2 days before travel and continued for 4 weeks after leaving the

malarious area.

Note: It is not recommended for pregnant women and children less than 8

years.

Chemoprophylaxis for longer stay (more than 6 weeks)

Mefloquine: 250 mg weekly for adults and should be administered two weeks

before, during and four weeks after exposure.

References

National Drug Policy for Malaria 2010, NVBDCP, MoH&FW, Govt. of India, 2010.

Website of National Vector Borne Disease Control Programmehttp://www.nvbdcp.gov.in/malaria-new.html

Where microscopy result is available within 24 hours

Suspected malaria case Take slide and send for microscopic examination

Result

+ve for P.VivaxTreat with CQ 3 days + PQ 0.25 mg/kg /day for 14 days

+ ve for P. FalciparumNE states: Age specific ACT-AL for 3 days + PQ single dose day 2In other state: ACT-SP 3 days + PQ single dose on day 2

+ ve for mixed infectonNE states: Age sp. ACT-AL 3 D+ PQ 0.25 mg/kg/day 14 DOther states: SP-ACT 3 D + PQ 0.25 mg/kg/d 14 days

- Ve no antimalarial treatment treat as per clinical diagnosis