Update on selection, the EML, EMLC and implementation Suzanne Hill November 2009 Essential Medicines & Pharmaceutical Policies

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

Essential Medicines & Pharmaceutical Policies 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.

Essential Medicines & Pharmaceutical Policies The ideal…. Treatment guidelines Essential medicines list Procurement and supply systems Prescribing and use measurement and evaluation

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

Essential Medicines & Pharmaceutical Policies

Using evidence….. n Should dihydroartemisin-piperaquine be ä In the WHO treatment guidelines? ä On the Model List? n 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.

Essential Medicines & Pharmaceutical Policies

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

Essential Medicines & Pharmaceutical Policies GRADE example – lamotrigine in children?

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

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

Essential Medicines & Pharmaceutical Policies

The ideal…. treatment guidelines Essential medicines list Procurement and supply systems Prescribing and use measurement and evaluation

Essential Medicines & Pharmaceutical Policies And the problem with guidelines… n Non-communicable diseases, no guidelines (except mental health) n Dermatology – no department n Surgical care – no money to update

Essential Medicines & Pharmaceutical Policies And then there is implementation…

Essential Medicines & Pharmaceutical Policies Implementation…. Comparison with 2009…. n Ethiopia (2002) n Eritrea ? n Ghana (2004) n Kenya (2003) n Nigeria (2003) n Tanzania (2007) n Uganda (2001) n Zambia ? n Cameroun (2007) n Rwanda (2004) n Senegal (2003)

Essential Medicines & Pharmaceutical Policies National processes n Repeated cycles of consultation n No use of evidence (notable exceptions) n Little use of WHO list n Limited linkages with the pharmaceutical sector

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

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

Essential Medicines & Pharmaceutical Policies The ideal…. treatment guidelines Essential medicines list Procurement and supply systems Prescribing and use measurement and evaluation

Essential Medicines & Pharmaceutical Policies Medicines included in survey (n=22) Albendazolechewable tabs 200mg (2), suspension 100mg/5ml 20ml Amoxicillinsuspension 125mg/5ml 100ml Artemether+lumefantrinetablet 20mg + 120mg (16 tabs) Beclometasoneinhaler 50mcg/dose 200doses Ceftriaxone injection 1 gram, 250mg Co-trimoxazolesuspension 200mg + 40mg/5ml 100ml Isoniazidtablets 100mg 1000 tablets Mebendazolechewable tabs 100mg (6), syrup 100mg/5ml 30ml Nevirapinesyrup 50mg/5ml 100ml Nystatindrops 100,000 IU/ml 30mls ORSpacket for 1 litre or 500mls Paracetamolsyrup 120mg/5ml 100ml Rifampicinsyrup 100mg/5ml 200ml Salbutamol inhaler 100mcg/dose 200 doses, spacer device for inhaler Vitamin A100,000IU(30mg) 1000 capsules, liquid 50,000IU/ml 30 Zincdispersible tablets 20mg (100)

Essential Medicines & Pharmaceutical Policies

What to do?

Essential Medicines & Pharmaceutical Policies Fishbone Diagram identifying requirements for the use of Magnesium Sulphate in a health facility Use of MgSO4 MgSO4 is registered in the country Appears in NEDL Licensed for use in pre-eclampsia and eclampsia STGs for MgSO4 exist Health facility has translated STG into suitable local protocol MgSO4 supplied to health facility Suitable procurement procedure is in place Women have access to antenatal care Pre-eclampsia and eclampsia correctly diagnosed Equipment and supplies available to diagnose pre- eclampsia Trained staff available to administer MgSO4 Health professionals aware that MgSO4 is the first line treatment for severe pre- eclampsia and eclampsia Staff are trained to use MgSO4 Equipment and supplies available to administer MgSO4

Essential Medicines & Pharmaceutical Policies

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

Essential Medicines & Pharmaceutical Policies n No product, no program, no system, no outcome

Essential Medicines & Pharmaceutical Policies