1. Update on selection, the EML, EMLC and implementation
Suzanne Hill
Essential Medicines & Pharmaceutical Policies

2. Quick quiz What is an essential medicines list? Why bother?
How does WHO produce the Model List?
What do countries do with it?

3. The essential drugs concept is nearly universal
Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists.

4. The ideal….

5. Currently…WHO Model List
16th EML – now lists all medicines that are OK for adults AND children, age restrictions, formulations
2nd EMLc – children's medicines, age restrictions, neonates
Evidence based
Transparent
Declarations of interest

7. Using evidence….. Should dihydroartemisin-piperaquine be
In the WHO treatment guidelines?
On the Model List?
Sinclair D, Zani B, Donegan S, Olliaro P, Garner P. Artemisinin-based combination therapy for treating uncomplicated malaria. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD DOI: / CD pub2.

11. Should lamotrigine be added to the Model List for the treatment of epilepsy , particularly in children?

12. GRADE example – lamotrigine in children?

13. The tyranny of evidence…
Using GRADE – not easy for observational studies (eg safety)
Getting evidence -
Palliative care – GOBSAT paper from 2007, no advance
Neonates – comprehensive review, we know what doesn't exist
Data on doses, especially in small children - regulatory approval as proxy?
Getting applications
Artesunate+amodiquine
Cytotoxics for children
Cost-effectiveness

14. Discrepancies…and difficulties to explain…
Section 8.4, palliative care
No medicines listed for grown-ups
Long list for children
Section 28 – ENT medicines, children only
Salts/actives – still need to be sorted
Probably too many liquids

16. The ideal….

17. And the problem with guidelines…
Non-communicable diseases, no guidelines (except mental health)
Dermatology – no department
Surgical care – no money to update

18. And then there is implementation…

19. Implementation…. Comparison with 2009….
Ethiopia (2002)
Eritrea ?
Ghana  (2004)
Kenya  (2003)
Nigeria  (2003)
Tanzania (2007)
Uganda  (2001)
Zambia ?
Cameroun (2007)
Rwanda  (2004)
Senegal  (2003)

20. National processes Repeated cycles of consultation
No use of evidence (notable exceptions)
Little use of WHO list
Limited linkages with the pharmaceutical sector

21. Content of national lists
Model EML changes not reflected -
Chronic disease
Analgesics
Deletion of symptomatic treatments (eg cough syrups)
Harmonisation with treatment guidelines – eg HIV, malaria, TB
Psychotherapeutic medicines (eg substance abuse)
Age appropriate dosage forms
Medicines for neonates

22. Medicines of note Adult/general ether Pethidine/fentanyl/ pentazocine
Ipecacuanha
Clonidine, hydralazine, methyldopa, reserpine
Antitussives
Ergotamine (migraine)
Pralidoxime
antimalarials
Maternal & Child
Zinc sulphate
Salbutamol (oral, tocolytic)
Various contraceptives
Caffeine citrate
Oral ergometrine
Aminophylline/ theophylline

23. The ideal….

24. Medicines included in survey (n=22)
Albendazole chewable tabs 200mg (2), suspension 100mg/5ml 20ml
Amoxicillin suspension 125mg/5ml 100ml
Artemether+lumefantrine tablet 20mg + 120mg (16 tabs)
Beclometasone inhaler 50mcg/dose 200doses
Ceftriaxone injection 1 gram, 250mg
Co-trimoxazole suspension 200mg + 40mg/5ml 100ml
Isoniazid tablets 100mg 1000 tablets
Mebendazole chewable tabs 100mg (6), syrup 100mg/5ml 30ml
Nevirapine syrup 50mg/5ml 100ml
Nystatin drops 100,000 IU/ml 30mls
ORS packet for 1 litre or 500mls
Paracetamol syrup 120mg/5ml 100ml
Rifampicin syrup 100mg/5ml 200ml
Salbutamol inhaler 100mcg/dose 200 doses, spacer device for inhaler
Vitamin A 100,000IU(30mg) 1000 capsules, liquid 50,000IU/ml 30
Zinc dispersible tablets 20mg (100)

28. What to do?

29. Fishbone Diagram identifying requirements for the use of Magnesium Sulphate in a health facility
MgSO4 is registered in the country
Women have access to antenatal care
Equipment and supplies available to diagnose pre-eclampsia
Licensed for use in pre-eclampsia and eclampsia
Appears in NEDL
Pre-eclampsia and eclampsia correctly diagnosed
Trained staff available to administer MgSO4
Use of MgSO4
STGs for MgSO4 exist
MgSO4 supplied to health facility
Health professionals aware that MgSO4 is the first line treatment for severe pre-eclampsia and eclampsia
Health facility has translated STG into suitable local protocol
Staff are trained to use MgSO4
Apologize for busy slide!
From previously published studies key requirements were identified as facilitators for the availability and use of magnesium sulphate for the treatment of severe pre-eclampsia and eclampsia. These were then used to develop a checklist to identify different levels in a health system where barriers to the availability and use may exist.
Equipment and supplies available to administer MgSO4
Suitable procurement procedure is in place 29

31. What to do? Better communication Better dissemination
Can the web site be content based rather than function?
Better dissemination
Needs money
Problem-based approach to implementation
work with disease/condition groups
Think about the pharmaceutical sector, not technical skills
Not just selection!

32. No product, no program, no system, no outcome

33. ?