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2 The National Antimalarial Drug Policy - Yemen
CONTENTS Page
Abbreviations 3
Introduction 4
What is the “Antimalarial Drug Policy” 5
Purposes of “Antimalarial Drug Policy” 5
Simple (Uncomplicated )Malaria 6
Severe Malaria 9
Management of malaria in pregnancy 12
Treatment of non-falciparum malaria cases 13
Protection against malaria 14
Annexes 16
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3 The National Antimalarial Drug Policy - Yemen
Abbreviations:
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4 The National Antimalarial Drug Policy - Yemen
Introduction
Malaria continues to be one of the major and priority health problems in Yemen. About 78% of
the population living in areas at risk of malaria transmission. The pregnant women and children
under five are the mostly affected groups whereas all age groups are at great risk in the epidemic
prone areas where epidemics may occur following unusual climatic changes, e.g., heavy rainfalls,
unexpected warming and rise in humidity.
Plasmodium falciparum, the life threatening species of malaria, is the dominant species
accounting for more than 90-95% of malaria cases annually. Anopheles arabiensis, the most
effective malaria vector worldwide is the major vector in the mainland and this aggravates the
seriousness of the problem. In Socotra island and Al Mahra governorate, Anopheles culicifacies, a
moderately effective vector, is the main malaria vector.
In the late nineties, the malaria burden in Yemen was estimated to be about 3 million suspected
and confirmed cases with an estimate of 1% related deaths. It has been estimated that families
living in the malaria endemic areas spend a significant proportion of their income on the
management of malaria cases and this proves that an effective and successful NMCP will positively
contribute to the ‘Poverty Reduction’ strategy of the country. In 2005 and early 2006, the results
of the parasite prevalence surveys in Tihama and Socotra island show that the recent estimate of
the malaria burden does not exceed one million suspected and confirmed malaria cases per year.
The main outputs since 2000 were in the form of strategic planning with the formulation of the
National Strategic Plan for malaria control in Yemen 2001-2005 and the National Strategic Plan
2006-2010, organized structure, national capacity building, new qualified and dedicated staff,
improved case management and setting a national anti-malarial treatment policy, monitoring the
efficacy of anti-malarial drugs, quality assurance system, an organized vector control based on
geographical reconnaissance (or GIS) and entomological surveys, health education, national
monitoring and evaluation plan, epidemic preparedness and response in addition to the efforts to
improve surveillance and information system .
The program is still facing several challenges that should be addressed in the coming years. There
is a need to strengthen the information and surveillance system especially that the public health
services’ coverage does not exceed 50% of the population and a plan to involve the private sector
in the information and surveillance system should be developed.
The strategic directions 2006-2010 are as follows:
1. Maintenance and strengthening of the high level political commitment to combat malaria
2. Strengthening the infrastructure of the NMCP at the national, governorate and district levels.
3. Human resource development
4. Early and correct diagnosis followed by prompt and effective treatment of malaria cases
5. Integrated vector management
6. Efficient epidemic preparedness and response
7. Strengthening the information system and surveillance (M&E)
8. Increasing the capability of the community to recognize, prevent and control malaria
9. Developing the capacity to plan and implement operational field research
The above mentioned fourth strategic direction is related to case management and antimalaria drug
policy which should be improved and monitored. In the eighties and nineties of the last century some
studies were conducted to monitor the efficacy of chloroquine, the former first line of treatment of
simple malaria cases and in 2002 a national plan was set to monitor the efficacy of the antimalarial
drugs in sentinel sites established exclusively for this purpose. 8 studies were conducted between
2002 and 2005 in 4 sentinel sites representing different epidemiological strata and the results showed
high level of resistance of P.falciparum to chloroquine, while the sulfadoxine pyrimethamine was still
effective. These results (refer to annex 6) were presented and discussed in the 3rd national seminar of
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the NMCP in November 2005 and the new national antimalarial drug policy was agreed upon.
International and national experts participated in this seminar. The national experts included
professors from the faculties of medicine and pharmacy in Sana’a, Aden, Dhamar, Hodeida universities,
representatives of the private sector and the general directors of the health offices in the governorates.
This manual is mainly to present the updated national policy for antimalaria drugs. Besides it aims at
educating and/or refreshing the knowledge of the medical and paramedical staff by highlighting the
key and important issues in the area of clinical malariology.
It is worth mentioning that the challenge is not only in the area of updating and approving the new
lines of treatment but is mostly in the area of procurement and supply and budgeting systems to
ensure the availability, adequacy, accessibility, acceptability, affordability and sustainability.
2. To provide a guidance for medical practitioners and health workers on the optimal dosage
regimens for different clinical situations of malaria. The dosage regimens should be based on
the patient’s weight, effective concentrations of antimalarial drugs and for sufficient time to
cure the patient and eliminate the infection in all target populations.
3. To ensure the rational use of antimalarial drugs and limit the unnecessary use of antimalarial
drugs. The antimalarial drugs should be administered only to patients who are infected by
malaria.
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Patient with fever or history of fever within the past 48 hours (with or without other symptoms such
as nausea, vomiting and diarrhea, headache, back pain, chills, myalgia) in whom other obvious causes
of fever have been excluded.
Patient with simple or severe malaria with laboratory confirmation of diagnosis by malaria blood film
or other diagnostic test for malaria parasites.
Treatment:
First line treatment of simple falciparum malaria cases:
The addition of a single dose Primaquine (0.25mg/kg) to ACT in the first day as anti gametocyte
medicine, is recommended as component of pre–elimination or an elimination programme. Safety
of use of Primaquine in G6PD deficient individual must always be considered.
Note: Primaquine not used for pregnant women, infants aged < 6 months and women
breastfeeding infants aged < 6 months)
Sulfadoxine-
Artesunate 50 mg tablets Pyrimethamine
Age (years)
(500/25)
Infants ½ ½ ½ ½
≥1 - 6 1 1 1 1
≥7 - 13 2 2 2 2
>13 4 4 4 3
Artesunate is safe and remarkably well tolerated. There have been reports of mild gastrointestinal
disturbances, dizziness, tinnitus, reticulocytopenia, neutropenia, elevated liver enzyme values. The
only potentially serious adverse effect reported with this class of drugs is type 1 hypersensitivity
reactions in approximately 1 in 3000 patients
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Sulfadoxine-
Artesunate 100 mg tablets Pyrimethamine
Age (years)
(500/25)
Infants ¼ ¼ ¼ ½
≥1 - 6 ½ ½ ½ 1
≥7 - 13 1 1 1 2
>13 2 2 2 3
Sulfadoxine/pyrimethamine (SP) shares the adverse effect profile of other sulfonamides, although
allergic reactions can be severe because of its slow elimination. Nausea, vomiting, anorexia and
diarrhoea may occur. Cutaneous manifestations can be severe and include pruritus, photosensitivity
reactions, exfoliative dermatitis, erythema nodosum, toxic epidermal necrolysis and Stevens-Johnson
syndrome. Treatment with SP should be stopped in any patient developing a rash because of the risk
of severe allergic reactions.
Second line treatment of simple falciparum malaria cases
If the patient cannot tolerate artesunate plus SP or had a previous allergic reactions to this medicine,
he or she should be treated with the second line treatment.
If a patient has been treated with artesunate plus SP and is still sick after 72 hours, or if symptoms
recur within one month after treatment, he or she should be referred to a health facility for microscopy
examination of malaria. In case a malaria diagnosis is confirmed, within 14 days of the initial
treatment, he or she should be treated with the second-line treatment, which is artemether-
lumefantrine (each tablets contains artemether 20mg and lumefantrine 120 mg in fixed dose
combination). The treatment regimen consists in six doses, given over three days with twice daily
administration, as shown in the table below.
Content of Artemether
Number of tablets per dose (at 0h,
Weight (kg) Age in years (A) + Lumefantrine (L)
8h, 24h, 36h, 48h and 60h)
per dose
5 – 14 <3 1 20 mg A + 120 mg L
15 – 24 ≥3-8 2 40 mg A + 240 mg L
25 – 34 > 8 - 14 3 60 mg A + 360 mg L
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This medicine is remarkably well tolerated. Despite similarities with halofantrine, lumefantrine does
not significantly prolong the electrocardiographic QT interval. Reported side effects are generally
mild, including nausea, abdominal discomfort, headache and dizziness. Recurrence of fever and
parasitaemia more than 2 weeks after treatment can be retreated with the first-line ACT.
Severe malaria
Case definition:
In a patient with P. falciparum asexual parasitaemia and no other obvious cause of their symptoms,
the presence of one or more of the following clinical or laboratory features classifies the patient as
suffering from severe malaria:
Clinical manifestations:
– Prostration
– Impaired consciousness
– Respiratory distress (acidotic breathing)
– Multiple convulsions
– Circulatory collapse
– Pulmonary oedema (radiological)
– Abnormal bleeding
– Jaundice
– Haemoglobinuria
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8. Blood should be taken for cross-match, and (if possible) full blood count, platelet count,
clotting studies, blood culture and full biochemistry should be conducted. The assessment of
fluid balance is critical in severe malaria.
9. Respiratory distress, in particular with acidotic breathing in severely anaemic children, often
indicates hypovolaemia and requires prompt rehydration and, where indicated, blood
transfusion.
10. Nurse the patient appropriately (e.g. comatose patients on the side, clear airway and turn
frequently).
After rapid clinical assessment and confirmation of the diagnosis, full doses of parenteral antimalarial
treatment should be started as soon as possible without delay
Initial treatment
Parenteral artesunate (IV or IM) is the medicine of choice for severe malaria in all age groups, and in
all trimesters of pregnancy. Artesunate significantly reduces the risk of death, and lowers the risk of
treatment-associated side effects including hypoglycemia.
Follow-on treatment
Once the patient recovers sufficiently and can tolerate oral treatment, or after at least 24 hours of
parenteral treatment, a full course of an effective ACT should be administered to complete the
treatment of the patient.
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- Dose of Quinine for children : 20 mg of salt/kg (loading dose) by IV infusion over 4 hours ,
then 12 hours after the start of the loading dose give a maintenance dose of quinine , 10 mg
salt/kg over 2hours . this repeated every 12 hours ,until the patient can swallow , then quinine
tablets ,10 mg salt /kg ,8 hourly to complete 7- days course , or quinine IV given for at least 3
days and then shift to the first line (AS+S/P) if the patient can swallow .
- If this is not possible to give quinine by intravenous infusion, then it should be given by
intramuscular injection to the anterior thigh, not the buttock (to avoid sciatic nerve injury).
The first dose should be split, 10 mg/kg bw to each thigh. Undiluted quinine dihydrochloride
at a concentration of 300 mg/ml is acidic (pH 2) and painful when given by intramuscular
injection, so it is best either formulated or diluted to concentrations of 60–100 mg/ml for
intramuscular injection
The recommended line of treatment of choice for the management of severe malaria is
Artesunate i.v. (or i.m. if i.v. is not possible and no alternatives are available), artemether i.m.
Or quinine i.v or i.m
Recommendations for use of antimalarial medicines in remote public health units run
by middle level health workers
Rectal artesunate is the drug of choice for pre-referral treatment of severe malaria in the remote health
facilities where health workers do not have access (or cannot practice) safe intramuscular injections
of artesunate or artemether or quinine
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Effects on mother:
- Hyperpyrexia (very high fever)
- Hypoglycemia (low blood sugar)
- Severe haemolytic anemia
- Cerebral malaria
- Pulmonary edema
Follow-on treatment
Once the patient recovers sufficiently and can tolerate oral treatment, or after at least 24 hours of
parenteral treatment, a full course of an effective ACT should be administered to complete the
treatment of the patient.
.
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- Chloroquine as a schizonticidal drug in a dose of 10mg/kg at the first and second days and then
5mg/kg at the third day.
- Primaquine as an anti-relapse measure in a dose of 0.25 mg/kg daily for 14 days or 0.75 mg/kg
weekly for 8 weeks in G6PD deficient patients. Primaquine is contraindicated in children under
1 year and in pregnant women.
½ tablet or
1st day: 1 tablet or 3
1½ 2 tablets 3 tablets 4 tablets
chloroquine teaspoonful
teaspoonful
½ tablet or
1 tablet or 3
2nd day: CQ 1½ 2 tablets 3 tablets 4 tablets
teaspoonful
teaspoonful
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Reference of the above tables is the WHO publication of Travel Medicine, 2005.
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Use of doxycycline:
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Annexes
1) Laboratory Diagnosis
Malaria Microscopy
Detection of malaria parasites using malaria microscopy is done by preparing both thin and thick
blood films on one glass slide. The thin blood film is fixed and both films are then stained by Giemsa
stain. The examination starts by examining 100 fields of the thick blood film using the X100 oil
immersion objective and this may be increased to 200 fields in case of suspicion or for the sake of more
accuracy. This will take 5-10 minutes for each slide. The thin blood film may be examined to confirm
the species. The result written by a lab technician should show the following:
- the parasite species, e.g. Pf, Pv, Po, Pm or mixed infection
- the density of parasitaemia, i.e. the parasite count
- the stages of parasites especially in Pf infections, e.g ring forms, gametocytes or schizonts
Parasite count:
Parasite count per microlitre of blood is calculated as per the following equation assuming that the
average WBC (white blood cell) count is 8000 / microlitre in case the actual WBC count has not been
done. If available, the actual WBC count should be used instead of 8000 (WBC/μl).
Malaria RDTs, sometimes called “dipsticks”, detect specific antigens (proteins) produced by
malaria parasites. These antigens are present in the blood of people with ongoing or recent infection.
The RDT signifies their presence by a colour change on an absorbing nitrocellulose strip.
The development of RDTs over the past decade has offered the potential for the extension of
accurate diagnosis to remote and poorly-resourced areas that are beyond the reach of high quality
microscopy services. Special care must be taken not to expose RDT to high temperatures above 35 °C.
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Acute pulmonary Prevent by avoiding excessive rehydration. Prop patient up; give oxygen. If
oedema pulmonary oedema
is due to over-hydration, stop intravenous fluids, give a diuretic (furosemide
(frusemide) 40 mg
intravenously) and withdraw 3 ml/kg of blood by venesection into a donor bag.
Shock, Suspect Gram-negative septicaemia; take blood samples for culture. Give
parenteral antimicrobials;
correct haemodynamic disturbances.
. Spontaneous bleeding Transfuse screened fresh whole blood or clotting factors; give vitamin K, 10
and coagulopathy mg intravenously.
Hyperpyrexia Give antipyretic (paracetamol 15 mg/kg of body weight) and use tepid sponging
and fanning
Hyperparasitaemia Give initial dose of parenteral antimalarial therapy; consider exchange transfusion
if there are
other signs of severity.
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- heparin,
- prostacyclin,
- epoprostenol (prostacyclin),
- ciclosporin (cyclosporin A),
- deferoxamine (desferrioxamine),
- pentoxifylline,
- phenobarbital.
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