Download the Applications form for Inclusions and Exclusions of

Criteria for additions and deletions to the STG and EML v1.2
Criteria for Addition and Deletion to the National Standard Treatment Guidelines and Essential
Medicines List
Ghana’s medicines selection system is governed by the principles of rational use of
medicines, evidence-based selection and multi-stakeholder consultation. These processes
promote acceptability by health care practitioners and consumers alike as well as value for
money. The central policy tools used by the Ministry of Health to drive the rational use
processes are the Standard Treatment Guidelines and Essential Medicines List. Whereas the
Standard Treatment Guidelines guide health professionals in the diagnosis and treatment of
most common disease conditions in the population, the Essential Medicines List directs the
procurement and reimbursement of medicines.
To be continuously relevant, these documents require regular updating. Their review, which
could include addition, deletion or modification of their content, is led by the Ministry of
Health, through the Ghana National Drugs Programme (GNDP), in collaboration with local
health experts. Health professionals and other stakeholders are encouraged to submit
proposals for such changes to the National Medicines Selection Committee of Experts
through the GNDP, utilizing the criteria below and the attached form [FORM A] provided.
GUIDE FOR APPLICANTS
1. What is the purpose of your filling this form?
2. What is/are the Name(s) of the Person(s)/Company(ies)/Agency(ies) or Entity(ies)
submitting the application
3. What is/are Names and Contacts of Focal Person(s) in charge of this application.
i.e. Who is submitting the application; including Focal Persons and contacts, [Name(s),
Phone(s), Email(s)]. May be a person, agency, team or group of persons.
4. Any other organizations and or any policies in favour of the application e.g. A Health
Policy, a WHO recommendation etc.
5. Which medication [indicate International Non-proprietary Name] are you requesting for
inclusion or exclusion in the EML?
a. Indicate the formulation(s) proposed for inclusion or exclusion [e.g. Tablet, Syrup
etc.]
b. Indicate the strength(s) for the proposed formulations above [e.g. 100 mg,
125mg/5ml etc.]
6. What disease/clinical condition is this medication indicated for?
[e.g. Medication X is being recommended for Y condition]
7. What is the target treatment group for this medication
[e.g. In adults, In children, In pregnant women etc.]
8. How should this medication be listed in the EML?
[e.g. Medicine X to be listed as Anti-hypertensive to be used in All Health Facilities with
a Doctor1]
Items 2, 3 and 4 must be stated clearly with no ambiguity.
9. What are the reasons and justification for the recommended inclusion or exclusion?
This must be supported by solid evidence e.g. Randomized Control Trials, Systematic
Reviews etc. [Please indicate the appropriate medical literature reference]
It is recommended that the submission include evidence on:
 Comparative Efficacy, Effectiveness and Clinical Benefits
 Comparative Cost and Cost-Effectiveness
1
This corresponds to the levels of care; A-Community, M-Midwifery; B1-Health Centre without Doctor; B2-Health
Centre with Doctor; C-District Hospital; D-Regional/Teaching; SD-Specialist Drug; PD-Programme Drug
1
Criteria for additions and deletions to the STG and EML v1.2
 Comparative Safety and Quality
 Supply Chain and Storage Issues
 Use (dosing) and Administration
10. Availability of the product in Ghana; specifically,
 Manufacturers
 Country of Manufacture
 Suppliers in Ghana
 Brand Names and their corresponding Ghana FDA registration status
[e.g. Registered, Not Registered, In the process of being registered]
11. For the inclusion or exclusion of disease conditions to the treatment guidelines, data on
prevalence may be added.
12. For exclusion of medicines, suitable alternatives may be recommended with justification.
All recommendations submitted based on this document, is in recognition of the fact that
this evidence does not guarantee decisions for or against the recommendation. The
submission would go through reviews by the Nation Selection Committee of Experts and
also reviews by the body of stakeholders within the pharmaceutical sector. Please provide
the information in the specified order above.
Soft copies of the completed application should be sent via email to [email protected] or
could be posted online at www.ghndp.org/medicineselection
APPLICATION FORM
Variable
Responses
1. Tick the purpose of your filling this form
Proposal for inclusion of medication
Proposal for exclusion of medication
Proposal for inclusion of disease condition
Proposal for exclusion of disease condition
2.
3.
Indicate the Name of the
Person/Company/Agency or Entity
submitting the application
[NB Could also be the Name of a team or
group of persons.]
Indicate the Names and Contacts of Focal
Persons in charge of this application.




[Name(s)]:
[Phone(s)]:
[Email(s)]:
4.
Indicate the Name(s) of any other
organizations and/or any policies in favour of
the application
[e.g. A Health Policy, a WHO
recommendation etc.]
1.
2.
3.
4.
5.
etc.
5. Indicate International Non-proprietary Name
[INN] of the medication you are requesting
for inclusion or exclusion in the EML?
2
Criteria for additions and deletions to the STG and EML v1.2
a. Indicate the formulation(s) proposed for
inclusion or exclusion
[e.g. Tablet, Syrup etc.]
Tablet
Syrup
Capsule
Suspension
Suppository
Injection
Other(s)…
b. Indicate the strength(s) for the proposed
formulations above
[e.g. 100 mg, 125mg/5ml,
10000 units/ml etc.]
1.
2.
3.
4.
5.
6.
7.
8.

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









Drops
Ointment
Cream
Inhaler
Pessary
Infusion
What disease/clinical condition is this
medication indicated for?
[e.g. Medication X is being recommended for
Y condition]
What is the target treatment group for this
medication
[e.g. In adults, In children, In pregnant
women etc.]
How should this medication be listed in the
EML?
[e.g. Medicine X to be listed as Antihypertensive to be used in All Health
Facilities with a Doctor2]
Items 2, 3 and 4 must be stated clearly with
no ambiguity.
9. What are the reasons and justification for the recommended inclusion or exclusion?
This must be supported by the appropriate evidence e.g. Randomized Control Trials, Systematic Reviews etc.
[Please indicate the references to the evidence/ literature reference included. Also attach copies of the underlisted documents to this application]
It is recommended that the submission include evidence on the following:
a. Summarize the evidence for Comparative
Efficacy, Effectiveness and Clinical
Benefits or otherwise
[Also state the References in support of the
above]
b. Summarize the evidence for Comparative
Cost and Cost-Effectiveness
[Also state the References in support of the
above]
c. Summarize the evidence for Comparative
Safety and Quality
[Also state the References in support of the
above]
d. Summarize the evidence for Supply Chain
and Storage Issues
[Also state the References in support of the
above]
e. Summarize the evidence for Use (dosing)
and Administration
2
This corresponds to the levels of care; A-Community, M-Midwifery; B1-Health Centre without Doctor; B2-Health
Centre with Doctor; C-District Hospital; D-Regional/Teaching; SD-Specialist Drug; PD-Programme Drug
3
Criteria for additions and deletions to the STG and EML v1.2
[Also state the References in support of the
above]
10. Provide information on the Availability of the
product in Ghana; specifically:
a. Name(s) of any Manufacturers of the
product in Ghana if any
b. Name(s) of the Country of Manufacture of
the product
c. Name(s) of Suppliers of the product in
Ghana
d. Brand Names and their corresponding
Ghana FDA registration status
1.
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















Registered
Not Registered
Being registered
Registered
Not Registered
Being registered
Registered
Not Registered
Being registered
Registered
Not Registered
Being registered
Registered
Not Registered
Being registered
Registered
Not Registered
Being registered
2.
3.
4.
5.
6.
11. For the inclusion or exclusion of disease
conditions to the treatment guidelines,
please indicate data on prevalence
12. For exclusion of medicines, you may
indicate/recommend alternatives with
justification.
Submitted by
Submitted by
Name: ______________________________
Name: ______________________________
Sign:
Sign:
Designation:
Designation:
Date:
Date:
Please do not write/type in this box
AID:
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