1. Dr. Samiha Baghdadi – Medical officer EMRO –STB ICIUM - Antalya November 2011

2. Introduction TB control is not the duty of MOH only. Several stakeholders are involved in the TB control process in any country. The main bulk (30-80%) of TB patients seek heath care at private sector for respiratory symptoms that could be TB. Efforts are on going to involve all stakeholders in TB control through PPM initiatives noting that there are problems in both access (coverage, financing and availability of TB medicines) and rational use of drugs (Quality of medicines, follow proper treatment regimens, and compliance to full duration of treatment).

3. Medicine regulations exist but not enforced. anti-TB medicines widely available OTC: Pakistan, AFG, Somalia, etc. TB medicines are provided with/without prescriptions (few countries in the region banned the sale of TB medicines OTC such as Oman, Jordan, Syria ) Most of the local pharmaceutical companies in the region are out of WHO pre-qualified list Examples: Wyeth Ph.C Pakistan produces more 140,000 4FDCs treatment courses for the private market (not prequalified). This amount can cover what is equal to 50% of the total TB cases in Pakistan. On the contrary ”Pharma 5 Ph” company in Morocco is working to be enrolled in WHO pre-qualified list producing FDCs.

4. Challenge/issue 2- Medicine formulation 1st line Pediatric medicines are not fully yet implemented in the region. Only 13 countries are using pediatric formulation Other countries in the region still handle the treatment through reconstitution of adult formulations as per the guidelines in Tunisia, Iran, most of the Gulf countries. Local companies do not have the capacity to produce the pediatric formulations. Formulations of TB medicines are not fully in line with the international standards such as (RH 150/100) Mono-therapy of R still represents an issue. Example: Egyptian companies still promote the concept of single formulations regimens due to market considerations.

5. Challenge/issue 3- Information system Proper information system contributes to scale up rational use of medicines. However in the region there is still ineffective DM information system both in public and private such as: – Week feedback on consumption and existing stock levels in most of the countries (only 5 out of 22 countries are submitting DQ-online) – Lack of usage of Indicators to monitor drug management performance in warehouses and treatment clinics (such as lead time, safety stock..etc) which leads to: – Miss communication between customer and provider (NTP and pharmaceutical companies) – Shortage of TB medicines.

6. Initiatives Services of GDF/GLCChallenges in the region 1- uninterrupted supply of 1 st & 2 nd line medicines with (rational use) Not fully implemented. 2- competitive pricing (pooled procurement) 2 nd line medicines still too expensive 3- quality assurance (ensure high standard of quality) The quality control system still need strengthening and improvement 4- New diagnostics particularly for MDR & patient kits, Pediatric formulations Not fully implemented. 5-Technical assistance by closely working with programs Still there is a huge room for improvement in capacity building