MEDLINE INDIA - NATIONAL DRUG POLICY OF MALARIA

Malaria is one of the major public health problem of the country. Around 2 million laboratory confirmed cases of malaria are reported in the country annually. Out of the total malaria cases, 40-50% is P.falciparum. The P.falciparum species is spreading wider due to migration of population from endemic to non endemic areas and vice versa has increased tremendously.

One of the reasons attributed to rise in P.falciparum is resistance to drug chloroquine, which is being used as a first line of treatment for malaria cases. During recent years it has been observed that chloroquine resistance is widely spread as per the results of the drug sensitivity studies conducted in the country. This is a serious concern to the programme as this species is responsible for mortality. It is observed that P.falciparum infection may lead to complications in 0.5% to 2% of cases. Mortality may result in about 30% of such cases if timely treatment is not given. Use of an appropriate anti malaria drug is very important not only to save the life of patients suffering from P.falciparum cases but also to contain the spread of this species.

At present the main thrust in the programme is on early diagnosis and prompt treatment which are the key components of malaria control. Malaria diagnosis is carried out by microscopic examination of blood films collected by active and passive surveillance. In the new drug policy it has been stressed that all fever cases clinically suspected of malaria should preferably be investigated for confirmation of malaria by Microscopy or Rapid Diagnostic Kit (RDK) so as to ensure full therapeutic dose with appropriate drug to all confirmed cases. Presumptive treatment with incomplete dose of chloroquine has been stopped and it has been stressed to treat patients on the basis of clinically suspected cases rather than only fever. If a patient is suspected of having malaria i.e showing signs and symptoms of malaria without any other obvious causes (listed in drug policy) which cannot be immediately confirmed, full treatment with chloroquine should be given. Health agencies and volunteers running Fever Treatment Depots like ASHAs in inaccessible areas are being provided with rapid diagnostic kits for diagnosis of P.falciparum cases and to ensure full radical treatment to all confirmed malaria cases. Further, the National Malaria Treatment Guidelines also recommend that change of drug should be considered when treatment failure proportion exceeds 10%.

According to WHO: An antimalarial treatment policy is a set of recommendations and regulations concerning the availability and rational use of antimalarial drugs in a country.
It should be the part of the national essential drug policy and the national malaria control policy and in line with the overall national health policy.
The main purpose of the national anti-malaria drug policy is to provide a framework for the safe and effective treatment of uncomplicated and severe malaria as well as prevention of malaria in travellers and vulnerable groups, such as pregnant women and young children. All health care providers in both the public and private sectors must be aware of the rationale for implementing the National Malaria Drug Policy. An effective treatment policy should aim to:
 Reduce morbidity by prompt and complete treatment of suspected/confirmed malaria cases.
 Prevent the progression of uncomplicated disease into severe and potentially fatal disease and thereby reduce malaria mortality
 Prevent transmission of malaria.
 Prevent or minimize the development of antimalarial drug resistance by correct diagnosis and rational treatment of all malaria positive cases.
The National Drug Policy on Malaria was first devised in 1982. Thereafter the policy is being reviewed periodically by the expert committee on chemotherapy of malaria constituted by Director General of Health Services. The recommendations of this committee are ratified by the Technical Advisory Committee constituted by the MOH&FW under the Chairmanship of Director General of Health Services. The present National Drug Policy for Malaria has been framed keeping in view of proper deployment of effective anti malarial drugs in full therapeutic dose for the treatment of clinically suspected and confirmed malaria cases.

Management of malaria cases
 Clinically diagnosis of malaria on the basis of sign and symptoms
 Confirmation of malaria by blood smear examination/RDT;
 Referral to secondary/tertiary level of care, if necessary;

 Dispensing the correct drugs of assured quality,( first dose be given preferably by dispenser);
 Education of patient or family on :
                   i. administration of the drugs
                   ii. when to report to health facility
                   iii. danger symptoms
                   iv. prevention of malaria
 Patient compliance as per instructions;

Typical: Sudden onset of high fever with rigors and sensation of extreme cold followed by feeling of burning, leading to profuse sweating and remission of fever by crisis thereafter. The febrile paroxysms may occur every alternate day. Headache, body ache, nausea, etc. may be the associated features.
Atypical: In atypical cases, classical presentation as mentioned above may not manifest.
Hence, any fever case without any other obvious cause in the endemic areas during transmission season may be considered as malaria. For ruling out other obvious causes of fever, the following should be looked for:
1. Cough and other signs of respiratory infection
2. Running nose and other signs of cold
3. Diarrhoea
4. Pelvic inflammation indicated by severe low back ache, with or without vaginal discharge and urinary symptoms
5. Skin rash suggestive of eruptive illness
6. Burning micturition
7. Skin infections e.g. boils, abscesses, infected wounds
8. Painful swelling of joints
9. Ear discharge
However, none of these symptoms exclude malaria with certainty therefore a trained clinician has to judge and ensure whether they constitute an “other obvious cause”.

1) Schizonticidal drugs for clinical and parasitological cure
 Chloroquine, Amodiaquine, Quinine, Quinidine, Pyrimethamine, Trimethoprim, Proguanil, sulfonamides in combination with Pyrimethamine, Mefloquine, Halofantrine, Artemisinine and its derivatives like Artesunate, Artemether, Arteether.
2) Gametocytocidal and anti-relapse drugs.
 Primaquine (8-Aminoquinolines groups)
The main features of the National Drug Policy on malaria are given below along with the flow chart. Treatment schedule followed for different drugs under the programme is given in Annexure1.

1. All clinical suspected cases should preferably be investigated for malaria by Microscopy or Rapid Diagnostic Kit (RDK).
2. Chloroquine is recommended for treatment of all P.vivax and P.falciparum only in areas at low risk of Pf and considered sensitive to chloroquine. ACT (Artesunate+Sulpha Pyrimethamine) combination is recommended for the treatment of Pf cases in qualified areas like chloroquine-resistant areas, cluster of Blocks surrounding resistant areas and identified high endemic districts.
3. Microscopically positive P.vivax cases should be treated with chloroquine in full therapeutic dose of 25 mg/kg body weight divided over three days. This practice is to be followed at all levels including community volunteers like ASHAs, etc. Primaquine should be given in dose of 0.25 mg/kg body weight daily for 14 days as per prescribed guidelines only to prevent relapse except in contraindicated patients.
4. In areas at low-risk of Pf and considered sensitive to chloroquine, Pf cases should be treated with chloroquine in full therapeutic dose of 25 mg/kg body weight divided over three days plus single dose of Primaquine 0.75 mg/kg body weight on day 1. This practice is to be followed at all levels including community volunteers like ASHAs.
5. ACT combination is recommended for treatment of P.falciparum in chloroquine resistant areas, identified cluster of Blocks surrounding resistant foci, high Pf endemic districts in selected 50 districts of 5 states namely Andhra Pradesh, Chhattisgarh, Jharkhand, Madhya Pradesh and Orissa and 67 districts of N.E states. The dose is 4 mg/kg bw of Artesunate daily for 3 days + 25 mg/ kg bw of sulphadoxine/sulphalene and 1.25 mg per kg bw of pyrimethamine on the first day. ACT should be given only to confirmed P. falciparum cases, found positive by microscopy or Rapid Diagnostic Test (RDT). Compliance and full intake are to be ensured. Single dose of Primaquine i.e 0.75 mg/kg body weight, may be given with ACT combination as it will be beneficial for gametocyte clearance in P.falcipaum and will facilitate effective interruption of transmission.
6. ACT tablets are not to be used in pregnant women.
7. Artesunate tablets should not be administered as mono therapy. It should invariably be combined with sulpha pyrimethamine tablets in prescribed dosages.

8. Wherever microscopy results are not available within 24 hours or the patient is at high risk of Pf both RDT and slide should be taken. Cases positive for Pf by RDK should be treated with full therapeutic dose of chloroquine or ACT combination as per prescribed drug in that area.
However negative cases showing sign and symptom of malaria without any other obvious causes should be considered as ‘clinical malaria’ and treated with chloroquine in full therapeutic dose of 25 mg/kg body weight over three days. Such cases if later found positive may be treated accordingly
9. The area/PHC showing a treatment failure more than 10% (both Early and Late Treatment Failures) to the chloroquine drug in the minimum sample of 30 cases, should be switched over to the alternate antimalarial drug e.g. Artesunate-Sulpha-Pyrimethamine (ACT) combination.
10. Change of drug to second line of treatment may also be implemented in a cluster of Blocks around the resistant foci after taking into consideration the epidemiological trend of P.falciparum and approval of Directorate of NVBDCP.
11. Resistance should also be suspected if in spite of full treatment with no history of vomiting, diarrhea, patient does not respond within 72 hours parasitologically. Such individual patients should be reported to concerned District Malaria /State Malaria Officer/ROHFW Pf monitoring teams for monitoring of drug sensitivity status.
12. In cases resistant to chloroquine and ACT (AS-SP) combination, oral quinine with tetracycline or doxycline can be prescribed.
13. Mefloquine should only be given to chloroquine/multi resistant uncomplicated P.falciparum cases only in standard doses as prescribed by WHO against the prescription of medical practitioners supported by laboratory report showing asexual stage of P.falciparum parasite and not gametocyte alone and other species.
14. Primaquine is contra indicated in pregnant woman and infants.
15. Chemoprophylaxis should be administered only in selective groups in high P.falciparum endemic areas. Use of personal protection measures including insecticide treated bed nets should be encouraged for pregnant women and other vulnerable population including travellers for longer stay. However for longer stay in high Pf endemic districts by the Military & Para-military forces, the practice of chemoprophylaxis should be followed wherever appropriate e.g. troops on night patrol duty etc and decisions of their Medical Administrative Authority should be followed. For short term chemoprophylaxis (less than 6 weeks), daily doxycycline is the drug of choice (if not contraindicated). However, it is not recommended for pregnant women and children less than 8 years. Mefloquine is the drug of choice for chemoprophylaxis involving longer stay. It is contraindicated in cases with history of convulsions, neuropsychiatric problems and cardiac diseases. Hence, necessary precautions should be taken and all individuals should undergo screening before prescription of the drug.
16. In severe and complicated P.falciparum malaria cases intra-venous Quinine/ parenteral Artemisinine derivatives are to be given irrespective of chloroquine resistance status. This treatment may continue till such time oral Quinine/Artemesinine derivatives become available.
17. Migratory labour/project population: Since these groups belong to high risk category they need to be screened on weekly basis and treated accordingly.
18. All the medical, paramedical and village level health volunteers should be adequately trained before their involvement in the programme.

National Drug Policy on Malaria 2008