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Update on selection, the EML, EMLC and implementation

Update on selection, the EML, EMLC and implementation. Suzanne Hill November 2009. Essential Medicines & Pharmaceutical Policies. Quick quiz. What is an essential medicines list? Why bother? How does WHO produce the Model List? What do countries do with it?.

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Update on selection, the EML, EMLC and implementation

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  1. Update on selection, the EML, EMLC and implementation Suzanne Hill November 2009 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

  6. 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.: CD007483. DOI: 10.1002/14651858.CD007483.pub2.

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

  8. GRADE example – lamotrigine in children?

  9. 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

  10. 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

  11. The ideal….

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

  13. And then there is implementation…

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

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

  16. 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

  17. 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 Medicines of note

  18. The ideal….

  19. 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)

  20. What to do?

  21. 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 Equipment and supplies available to administer MgSO4 Suitable procurement procedure is in place

  22. What to do? • Better communication • 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!

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

  24. ?

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