Procurement process of tracer medicines (Amoxicillin and others)

Transcription

1 Procurement process of tracer medicines (Amoxicillin and others) Henrik K.Nielsen Technical Specialist Essential Medicines Unit - Medicines and Nutrition Centre PRELIMINARY CONSULTATION ON THE PRIORITY ESSENTIAL MEDICINES FOR CHILD SURVIVAL 6-7 SEPTEMBER 2010 UNICEF SUPPLY DIVISION - COPENHAGEN, DENMARK

2 UNICEF SD Global procurement of pharmaceuticals supplying UNICEF partner programmes and procurements services partners Approach: Standardize rather than customize What we have done so far is: Bulk Standardized course Customized

3 Customization Customization of pharmaceutical products in UNICEF SD is a considerable investment Strike balance between the gain achieved and the cost of the exercise

4 Cost Impact Additional investment to ensure quality Loss of speed flexibility Regulatory implications Increased treatment compliance Donor/partner visibility Market development

5 Two examples of procurement processes HIV/AIDS Malaria Unit on Artesunate + Mefloquine co-blisters for Cambodia. Essential Medicines Unit on Amoxicillin dispersible tablets for Uganda

6 Resistance to many anti malarial drugs has developed in the western part of Cambodia long before developing elsewhere. In Cambodia, Artesunate-Mefloquine became the first-line treatment of malaria falciparum in 2000

7 Specific requirements for Artesunate 50 mg + Mefloquine 250 mg Tablets to be co-packed in blister strips, following the Cambodian Guideline, per age/weight group: 3+1, 6+2, 9+3, 2+5 tablets Specific packing instructions: Specific dosage instruction on blister Languages on pack and patient leaflet: English and local (Khmer) Pack size and formats

8 ANNEX 1 Indicative outlay A+M blister 1 A+M blister 2 A50mg M250mg A50mg M250mg Day 1 1-5yr kg Day yr kg Day 2 Day 2 Day 3 Day 3 A+M blister 3 A+M blister 4 A50mg M250mg A50mg M250mg Day yr kg Day 1 15yr 35-62kg Day 2 Day 2 Day 3 Day 3 UNICEF RFP

9 Final layout

10 Timeline Specifications Tender exercise Co-operation with partners and project stakeholders Long Term Arrangement ( Contract) Order Planned process time: 29 weeks as of tender exercise Final time it took from A to Z: 15 months

11 Amoxicillin On 15 February 2010 a request was received from Kampala, UNICEF office: 6,957,495 dispersible Amoxicillin 125mg tablets Half of them should be red and other half green. Half of the consignment should be delivered by March 2010 and rest by August 2010

12 Response from EM, UNICEF SD Please consider other ways of marking i.e. coloring the blister instead of tablets Please note that the Bidding process will make delivery in March impossible

13 Progress 1 March mail from UNICEF, Kampala The MOH has agreed to colour code the Blisters/boxes instead of the tablets 10 March received additional information The dispersible tablets should be packed in individual doses.( red 2x10 blister, green 3x10 blister)

14 Further questions Please inform us indication/guideline of prescription/dosage/age. Response: Red 2 months -1 year Green 1 year to 5 years. and provide any regulatory requirements for the products Response: Dispersible tablets is registered However the NDA will need to approve suppliers.

15 Further questions to the coding Response: system It is the Ministry s policy to help improve compliance at community level. The pharmaceutical products will be given out by Village Health team members and community workers

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17 UNICEF SD Specifications Tender exercise Evaluation and identified supplier Approved by NDA, Kampala Order placed in August 2010 Uganda to receive first orders in October 2010

18 Customization - lessons learned Consider production implications: machinery, parts, capacity,... Simplify customization limit to the essential Confirm that there is long term funding Define roles & responsibilities for the product development Consider time lines Assess quality and regulatory implications

19 Thank You