Anti- alaria

DRUG POLICY
for Ghana
January 2014
Ministry of Health
 16
20
22
24
26
30
31
33
35
36

2
 Immunization

3
 Anti-Malaria Drug Policy for Ghana

Governmental

4
This revised edition of the Anti-Malaria Drug Policy is based on
current evidence on malaria treatment and lessons learnt in the
implementation of the previous policy of 2004.

The revision is borne out of consultative meetings of all relevant

stakeholders involved in malaria case management in the country.
This document is written in very simple and precise language to
make it easy for everyone to read and understand.

I implore all stakeholders and health professionals to ensure that the

guidelines contained in this document are complied with both in the
Private and Public sectors in order to ensure effective treatment of
malaria and reduce the malaria burden in our country.

It is my hope that the New Malaria Treatment Policy will form the
basis for the standardization of the management of all types of
malaria throughout the country as it supports the new paradigm of
creating wealth through health.

5
6
 Anti-Malaria Drug Policy for Ghana

7
Malaria is a major cause of illness and death in Ghana, particularly
among children and pregnant women. In 2012, malaria accounted
for 38.9% of all out-patient illnesses and 38.8% of all admissions. The
average Malaria parasite prevalence among children aged 6-59
months as recorded in the 2011 MICS 4 report shows a 27.5% with
regional variations from as low as 4% in the Greater Accra region to as
high as 51% in the Upper West region (Fig. 1).

Upper East
Upper 44%
West
51%
Northern
48%

Brong Ahafo
37% Volta
17%
Ashanti
22% Eastern
22%

Western
36% Central Greater
36% Accra 4%
Figure 1: Malaria Parasite prevalence among
under five children in Ghana (MICS 2011)2

8
 Anti-Malaria Drug Policy for Ghana

Malaria infection during pregnancy causes maternal anaemia and

placental parasitaemia both of which are responsible for
miscarriages and low birth weight babies among pregnant women.
As much as 16.8% of all admissions of pregnant women in 2011, were
attributable to malaria whilst 3.4% of death among pregnant women
were due to malaria.

Globally, malaria is estimated to impose a growth penalty of over 1.2

% of GDP on endemic countries. Malaria related-illnesses and
mortality cost Africa's economy alone USD 12 billion per year.

In Ghana, Malaria is estimated to cause the loss of about 10.6%

Disability Adjusted Life Years (DALYs) costing an equivalent of up
to 6% of GDP annually in economic burden. It is a major cause of
under-development and inflicts serious socio-economic burden on
the entire citizens.

The Ministry of Health in its Mid-Term Strategic Plan document,

considers malaria as a priority disease which has to be tackled in
order to achieve the Millennium Development Goals 4,5,6.

Case Management has been and continues to be one of the main

strategic interventions for the control of malaria in the country.
Diagnosis and treatment has previously been largely presumptive
but current global trend recommends the T3 initiative, that is Test,
Treat and Track, and Ghana is currently promoting that option.
However, the effectiveness of this intervention is highly dependent
on anti-malarials, which should not only be safe and effective, but
also available, affordable and acceptable to the entire population
who are at risk. To achieve this objective, up-to-date evidence- based
Anti-Malaria Drug Policy for the country is a critical requirement.

9
 Anti-Malaria Drug Policy for Ghana

The drug policy will also contribute to:

Preventing progression of uncomplicated malaria to

severe disease and death

Shortening clinical episodes of malaria and reduce the

occurrence of malaria-associated complications such as
anaemia in populations residing in areas of high malaria
transmission

Reducing consequences of placental malaria infection

and maternal malaria-associated anaemia through
chemoprophy-laxis or preventive intermittent treatment
during pregnancy.

Delaying the development and spread of resistance to

anti-malaria medicines.

An anti-malaria drug policy is therefore a fundamental and dynamic

document that needs to be regularly reviewed against the
background of global trends and the country context.

10
In Ghana, as well as globally, the emergence and spread of P.
falciparum resistance to commonly used anti-malaria, poses a serious
challenge to the benefits of early diagnosis and prompt treatment as a
priority within the current strategy for malaria control.

In November 2000, an informal consultation on the use of anti-

malaria drugs was convened by W.H.O. in Geneva. The meeting
reviewed and updated recommendations on the use of artemisinin
based combination medicines for chemoprophylaxis and treatment,
based on the information available. The potential value of malaria
therapy using combinations of drugs was identified as a strategic and
viable option in improving efficacy and delaying development and
selection of resistant parasites.

Consequently, the Ministry of Health through the National Malaria

Control Programme in collaboration with the Noguchi Memorial
Institute for Medical Research studied the efficacy of chloroquine
country wide in 2002 and found that treatment failure following
chloroquine was in the range between 6% and 25% and parasite
clearance rates were low and in some cases below 50% as shown in
figure 2.

11
 Anti-Malaria Drug Policy for Ghana

Fig.2

KND
37.2%

Sunyani
46.2%

Hohoe
32.1%

La
/Accra
21.7%
Tarkwa
49.0 % Figure 2: Levels of chloroquine resistance in sentinel
sites across the country.
The evidence culminated in the change of Ghana's
Anti-malaria

12
 Anti-Malaria Drug Policy for Ghana

These results prompted the search for alternative treatment for

uncomplicated malaria.

A comparative study conducted subsequent to the chloroquine

efficacy tests showed that the efficacies of Artemether - Lumefantrine
and Artesunate +Amodiaquine were similar. This shown in the
figure 3 below.

Fig.3 Comparisons of Drug Efficacies

100 CHQ
90 SP
Proportion with Parasites (%)

AS–AQ
80
AL
70
60
50
40
30
20
10
0
Day 0 Day 1 Day 2 Day 3 Day 7 Day 14
Days post treatment

Drug Policy changed from the use of Chloroquine to the adoption of

Artesunate-Amodiaquine combination as the first line drug for the
management of uncomplicated malaria in 2004.

The introduction of Artesunate-Amodiaquine combination

encountered a number of challenges resulting from reported
adverse events and subsequent negative publications in some
sections of the mass media and hence loss of confidence in the policy
by some health cares providers and clients alike.

13
 Anti-Malaria Drug Policy for Ghana

Following these unfortunate events, the policy was recommended

for revision by the then Minister of Health upon expert advice in
2007. The revised policy made provision for alternatives to arte-
sunate-amodiaquine for the management of uncomplicated malaria,
while recommending injection quinine and injection artemether for
the treatment of severe malaria and sulphadoxine-pyrimethamine
for intermittent preventive treatment in pregnancy. The revised
policy has been in force since 2007.

Taking into account the dynamic nature of drug research and

development and the growing volume of evidence that could
influence the choice of a particular medicine in preference to others,
and also drawing lessons from local researchers and practitioners,
the Minister of Health reconstituted the Anti-Malaria Drug Policy
Working Group which was inaugurated on the 23rd August 2012 to
review the existing drug policy. Concerns prompting the setting up
of the working group to review the anti-malaria drug policy include
the following:

Fresh evidence that injection artesunate is superior to

injection quinine in managing severe malaria and WHO's
recommendation for its use in preference to quinine.

Conflicting reports on preference of practitioners bet-

ween Artesunate-Amodiaquine and Artemether-Lume-
fantrine as first line treatment choice for uncomplicated
malaria. Concern about the use of three ACTs (A-A, AL,
DHAP) for uncomplicated malaria in the Malaria Policy,
and implications for logistics management (quantifica-
tion, procurement, storage etc)

14
 Anti-Malaria Drug Policy for Ghana

15
2.0 POLICY OBJECTIVE

To provide prompt, safe, effective and appropriate anti malaria

treatment to the entire population.

2.1 MANAGEMENT OF UNCOMPLICATED MALARIA

Studies conducted on drug efficacies and safety did not show marked
difference between tablet Artesunate-Amodiaquine and
Arthemether –Lumefantrine. The efficacy of DHAP in most cases
was found to be higher than AS-AQ or AL. The three Artemisinin
combination therapies therefore still remain the medicines of choice
for managing uncomplicated malaria. Adherence to testing before
treatment using the appropriate dosing is essential to ensure prompt
effective treatment.

2.1.1. Artesunate-Amodiaquine Combination

Artesunate-Amodiaquine Combination shall be the medi-

cine/drug of choice for the treatment of uncomplicated
malaria.

2.1.2 Alternative combination therapies

The Alternative combination medicines for the treatment of

uncomplicated malaria shall be the recommended strengths
and dosage forms of:
i. Artemether-Lumefantrine
ii. Dihydroartemisinin Piperaquine

16
 Anti-Malaria Drug Policy for Ghana

These additional ACTs shall be used for patients who cannot tolerate
the Artesunate –Amodiaquine.

2.2. MANAGEMENT OF UNCOMPLICATED MALARIA

IN PREGNANCY

2.2.1 First Trimester

Oral Quinine or a combination of oral quinine and clinda-

mycin shall be used. This shall remain the drug of choice for
managing malaria in the first trimester of pregnancy.

2.2.2 Second and Third Trimesters

Oral Quinine or the combination of Quinine and Clindamycin

or the combination of Artesunate-Amodiaquine or Arte-
mether-Lumefantrine shall be used

Pregnant women with co-morbidities of HIV and sickle cell

anaemia shall be treated as above for malaria.

2.3 HOME MANAGEMENT OF UNCOMPLICATED

MALARIA

Artesunate-Amodiaquine shall be the medicine of choice for treating

uncomplicated malaria in the community or near-home setting for
children below five (5) years of age.

The Ministry of Health and other stakeholders involved in home

management of malaria in the context of the High Impact Rapid
Delivery Approach and Community Integrated Management of
Childhood Illness shall ensure that community based agents
involved in home management of malaria are adequately supported,

17
 Anti-Malaria Drug Policy for Ghana

supervised and provided with essential skills in behaviour change

communication.

2.4 TREATMENT FAILURE

2.4.1 Treatment Failure of Uncomplicated Malaria

For the management of treatment failures, the following
options are recommended:

an alternative ACT; Artesunate-Amodiaquine, Arteme-

ther-Lumefantrine or Dihydroartemisinin-Piperaquine
which has not been administered as first-line of treatment.

if for any reason ACT cannot be administered, then oral

quinine could be used.

(oral quinine 10mg/kg body weight 8 hourly plus tetra-

cycline 250mg 6 hourly or doxycycline 100mg twice daily
or clindamycin 5mg/kg body weight (maximum 300mg)
8 hourly must all be given for a total of 7 days).

Treatment Failure should be distinguished from Inadequate

Treatment.

Inadequate treatment can be defined as failure to complete the

initial course of treatment for whatever reason (e.g. vomiting,
non-compliance, etc.) . In case of inadequate treatment a full
course of the initial drug used should be repeated.

18
 Anti-Malaria Drug Policy for Ghana

2.4.2 Treatment Failure of Uncomplicated Malaria in

Pregnant Women

2.4.2.1 First Trimester

ACTs are not recommended for use in the first trimester,

however their use shall not be with-held in cases where they
are considered to be life-saving and other anti-malarials are
deemed to be unsuitable.

2.4.2.2 Second and Third Trimesters:

Quinine or Artesunate-Amodiaquine or Artemether–Lume-

fantrine combination therapies shall be given depending on
which medicine was used first. A treatment option other than
what was first used shall be given where treatment failure is
established.

19
Complicated/ Severe Malaria is caused by Plasmodium falciparum and
confirmed by the presence of the asexual parasite forms in the blood.

Management of severe/complicated malaria requires parenteral

treatment to provide adequate blood-serum concentrations as quic-
kly as possible initially; subsequently reverting to oral treatment as
soon as the patient's condition permits.

3.0 PRE-REFERRAL TREATMENT OF MALARIA IN

HOMES AND COMMUNITIES

All children who do not respond to treatment with Artesunate-

Amodiaquine or Artemether-Lumefantrine within 24 hours shall be
referred immediately to the nearest health facility after tepid spon-
ging. Such children shall be given an initial dose of an artemisinin-
based suppository prior to referral to the nearest health facility.

3.2 MANAGEMENT OF COMPLICATED

(SEVERE) MALARIA

Following new evidence showing the superiority of parenteral

artesunate over parenteral quinine and the recommendation by
WHO, parenteral artesunate shall be used as the medicine of choice
for managing severe malaria, to be followed by full course of ACT
when patient is able to take in oral preparations.

In the event of injection artesunate not being readily available,

injection quinine should be used as an alternative to save lives.

20
 Anti-Malaria Drug Policy for Ghana

The necessary support therapy shall be provided as and when

appropriate.

3.2 MANAGEMENT OF COMPLICATED (SEVERE)

MALARIA IN PREGNANCY

3.2.1 First Trimester

In the first trimester of pregnancy, perenteral quinine remains the

medicine of choice for the treatment of severe malaria until patient is
able to take oral preparations.

3.2.2 Second and Third Trimesters

Parenteral Artesunate is the recommended medicine of choice for

managing severe malaria in the second and third trimesters of
pregnancy.

Pregnant women with co-morbidities of HIV and sickle cell anaemia

shall be treated as above.

21
4.0 PREAMBLE

Currently, apart from ITNs the most preferred intervention to

prevent malaria in pregnancy is Intermittent Preventive Treatment
(IPT) using SP. This shall be administered in predefined intervals
after quickening (16 gestational weeks).

IPT is preferably provided as part of a comprehensive antenatal

package with other products like haematinics and anthelmintics. The
medicine shall be administered under the supervision of a qualified
healthworker – “Directly Observed Therapy (DOT)”.

4.1 DRUG OF CHOICE FOR INTERMITTENT PREVENTIVE

TREATMENT (IPT)

Sulphadoxine-Pyrimethamine (Sulphadoxine 500mg + Pyrimetha-

mine 25mg) shall be reserved for Intermittent Preventive Treatment
(IPT) given under DOT.

4.1.1 Conditions for use of Sulphadoxine-Pyrimethamine

All pregnant women shall undergo screening before the

commencement of IPT in order to exclude those who are
either G-6PD deficient or allergic to sulphonamides.

22
 Anti-Malaria Drug Policy for Ghana

Pregnant women who cannot take the Sulphadoxine-

Pyrimethamine shall be encouraged to sleep under Insecti-
cide Treated Nets.

Pregnant women, especially those who are non-immune,

may be put on Proguanil beginning in the first trimester
of pregnancy.

Folic acid at a daily dose equal or above 5mg should not

be given concomitantly with SP as this counteracts its
efficacy as an anti-malaria.

Pregnant women with HIV shall receive monthly doses

of Sulphadoxine-Pyrimethamine, except when they are
receiving co-trimoxazole.

23
5.0 PREAMBLE

Seasonal Malaria Chemoprevention (SMC) is defined as the

intermittent administration of full treatment courses using the
recommended anti-malarial medicine during peak malaria trans-
mission season to prevent malaria illness with the objective of main-
taining therapeutic anit-malarial drug concentrations in the blood
throughout the period of greatest malaria risk.

A complete treatment course of anti-malarial is given to children

aged between 3 and 59 months at monthly intervals, at the beginning
of the transmission season, to a maximum of four doses during the
malaria transmission season.

5.1 DRUG OF CHOICE FOR SEASONAL MALARIA

CHEMOPREVENTION

The recommended anti-malarial for this intervention is Sulfadoxine-

Pyrimetahmine plus Amodiaquine (SP-AQ).

Target Area for Seasonal Malaria Chemoprevention

Target area for implementation is the Sahel sub-region where:

24
 Anti-Malaria Drug Policy for Ghana

25
 STEPS INVOLVED IN THE CHANGE
PROCESS /IMPLEMENTATION FRAMEWORK

6.0 PREAMBLE

The local pharmaceutical manufacturing industry has been engaged

throughout the policy development process to facilitate a smooth
process with minimal cost to both industry and public health.

A lot of public and private sector investments in equipment and

infrastructure have already gone into the production and dist-
ribution of Artesunate-Amodiaquine combination therapy. The
introduction of the more expensive Artemisinin-based Combination
Therapies (ACTs) has further cost implications. To reduce the inc-
reased cost burden of ACTs on the most vulnerable populations and
ensure their availability and affordability to the population, the
recommended ACTs have been incorporated into the National
Health Insurance Medicines List .

Government also has the task of ensuring access to medicines and

product safety to forestall implementation challenges. It is critical
that all anti-malarials deployed are of good quality, safe and
efficacious. To this end, the pharmaceutical inspection programmes
of the national drug regulatory authority have been intensified and
national drug quality control laboratories further equipped and
resourced.

Improved patient acceptance of Artemisinin-based Combination

Therapies (ACTs) shall be promoted by appropriate agencies of the
Ministry of Health to ensure compliance. This will entail extensive
public education on the new management of malaria using multiple

26
 Anti-Malaria Drug Policy for Ghana

approaches, through print, mass media, and community-based

information, education and communication strategies. The FDA
shall ensure the quality and safety of ACTs to increase public
confidence in the implementation of this policy.

6.1 RE-LAUNCHING OF NEW ANTI-MALARIA POLICY

The New Anti-Malaria Treatment Policy for Ghana shall be re-

launched after ratification. The existing malaria treatment guidelines
shall be reviewed accordingly.

6.2 RE-CLASSIFYING ANTI-MALARIA COMBINATION

THERAPIES

Artemisinin-based combination therapies were initially classified as

'prescription only' drugs. This means that they have to be prescribed
by a clinician and dispensed by a pharmacist.

The recommended ACTs shall now be re-classified as Over-the-

Counter (OTC) medicines permissible to be dispensed at all levels to
ensure ready availability to the general public.

6.3 SUPPLY OF ANTI-MALARIALS

6.3.1 The Ministry of Health shall support the local pharmaceutical

manufacturing industry to build capacity to meet interna-
tionally accepted requirements of Good Manufacturing
Practices in the production of ACTs. This will facilitate
sustainability of this policy especially the provision of
facilities for conducting bioavailability and bioequivalence

27
 Anti-Malaria Drug Policy for Ghana

studies among others so as to enhance the manufacture and

supply of the ACTs to both the public and the private sectors.

6.3.2 The Ministry of Health and other relevant agencies shall

ensure the availability of all recommended anti-malarials for
the treatment of uncomplicated and severe malaria.

6.3.3 The FDA shall monitor the quality as well as any reported
Adverse Drug Reactions(ADRs) resulting from the use of all
anti-malarials in accordance with the provisions of the Ghana
National Drug Policy.

6.3.4 Sulphadoxine-pyrimethamine reserved solely for use in

Intermittent Preventive Treatment of malaria in pregnancy is
produced locally and therefore readily available. The FDA
shall continue to monitor the quality of these products
whether locally produced or imported as well as the Adverse
Drug Reactions (ADRs) associated with their use.

6.3.5 Access to drugs under this policy

To ensure smooth implementation of this policy, the Ministry

of Health and its agencies shall ensure access and availability
of the recommended anti-malarials under this policy in all
facilities.

6.3.6 Operational Considerations

6.3.6.1 Nationwide Implementation Program

This revised policy shall be implemented through an

immediate nationwide rollout. This shall entail the rollout of
the new policy in the entire country at the same time.

28
 Anti-Malaria Drug Policy for Ghana

6.3.6.2 Procurement

Mechanisms will be put in place to ensure minimal price

disparities between products from the public and private
sectors.

6.3.6.3 Revision of the STGs, EDL and NHIDL

Sections of the Standard Treatment Guidelines (STGs),

Essential Medicines List (EML), National Health Insurance
Drug List (NHIDL), and other guidelines for health workers,
curricula or documents recommending treatment for malaria
shall be revised. The revision shall be harmonised with the
development of the Behavioural Change Communication to
ensure that the same messages are communicated to health
care workers and members of the public.

29
 CAPACITY BUILDING

The Ministry of Health shall ensure appropriate activities are

conducted to facilitate the smooth implementation of the policy.

7.0 SERVICE PROVIDERS

Health professionals, policy makers, manufacturers, other service

providers, relevant training institutions (including medical schools,
nurses' training colleges and pharmacy schools etc), health managers
in the public and private sector as well as the general public shall be
well informed about the new policy.

7.1 TRAINING

Training needs shall be assessed and training manual developed and

updated to ensure every target group is catered for. The health
industry shall be re-oriented to become responsive to local needs and
not compromise on quality and value for money. A comprehensive
training programme shall be conducted for all relevant healthcare
providers prior to the roll-out of public education programmes.

7.2 PUBLIC EDUCATION

Public education shall be directed at all target groups including

health professionals, community-based service providers and the
general public using the appropriate tools and media.

30
 MONITORING AND EVALUATION

A framework for monitoring this policy shall include the following:

8.0 PRESCRIBING AND DISPENSING

Prescribing and dispensing practices at all service delivery points

shall be monitored to enhance rational use of the Antimalarials.

8.1 PATIENT COMPLIANCE AND ACCEPTANCE

The Ministry of Health and its agencies shall conduct regular surveys
to assess patient compliance and acceptance of the drugs under this
new policy.

8.2 QUALITY AND EFFICACY OF PRODUCTS

Post marketing surveillance and laboratory testing shall be

conducted by the FDA to ensure that both imported products and
locally manufactured products meet the relevant pharmacopoeia
and manufacturing standards of quality and efficacy.

The FDA shall also be required to furnish the Ministry of Health with
periodic updates of the quality of products on the market. GMP audit
inspections of manufacturing facilities both local and overseas shall
be rigorously enforced by the FDA. The programme shall monitor
anti-malaria drug efficacy through the use of Sentinel Surveillance.

31
 Anti-Malaria Drug Policy for Ghana

8.3 SAFETY MONITORING

The FDA, health agencies and research institutions shall develop and
outline procedures for efficient Safety Monitoring countrywide.

8.4 AVAILABILITY AND ACCESSIBILITY

Relevant indicators shall be developed to measure and monitor the

availability and accessibility of the products under this policy to the
general public.

32
 REGULATION

9.0 REGISTRATION OF PRODUCTS

Only anti-malarials recommended by the policy and duly registered

by the Food and Drugs Authority shall be authorised for supply and
use by the general public. This will involve going through a drug
registration process that includes information on efficacy and safety.
New fixed-dose combinations and new pre-packaged products must
be registered even if the individual components of the combination
are already registered.

9.1 DRUG DE-REGULATION

9.1.1 Artemisinin-based derivatives and Amodiaquine as

Monotherapies

The use of Artemisinin-based derivatives and Amodiaquine

as monotherapies for the treatment of any type of malaria
outside the provisions of the new treatment policy shall be
discontinued in all health institutions.

9.1.2 Re-classification of Artemisinin Combination

Therapies

The recommended ACTs shall now be re-classified as Over-

the-Counter (OTC) medicines permissible to be dispensed at
all levels to ensure ready availability to the general public.

33
Anti- alaria
DRUG POLICY
for Ghana
January 2014
 Anti-Malaria Drug Policy for Ghana

Use of Sulphadoxine-Pyrimethamine

Sulphadoxine-Pyrimethamine shall be reserved only for use in the

prevention of malaria during pregnancy under observation (IPT) and
Seasonal Malaria Chemoprevention SMC. The use of Sulphadoxine-
Pyrimethamine as monotherapy for uncomplicated malaria shall be
discontinued.

34
 PUBLIC PRIVATE PARTNERSHIPS
The current policy shall build on the earlier work of capacity building
in the private sector and other providers of care. The emphasis
would be to promote the adoption of standards and regulation of the
industry in collaboration with the Ministry of Trade and Industry, the
Ghana Standards Authority, Association of Ghana Industries, and
other relevant regulatory agencies.

The Ministry of Health shall encourage collaboration with all

stakeholders in the industry to understand the components,
structure, conduct, performance and contribution to the national
economy.

The local industry shall be supported to develop and market

products and services for the health care market, establish and
strengthen intra-sectoral policy dialogue, coordination, plan-ning
and accountability.

The Ministry shall provide a framework of relevant incentives and

sanctions that enhance performance promote accountability and
continuously refine the role of Government in the delivery of health.

The Ministry of Health shall provide the platform for local

pharmaceutical manufacturers to re-engineer their technologies and
systems for the local production of ACTs. Government shall actively
facilitate the process to ensure a successful change particularly in
view of the current additions. Innovative research within the local
industry shall be promoted by Government to aim at the
development of co-formulated ACTs for enhanced compliance.

35
 REFERENCES
1
National Malaria Control Annual Report 2011

2
Multiple Indicator Cluster Survey 4, 2011

3
Economic Burden of Malaria in Ghana, November 2003

36