1. ABSTRACT SELECTING NATURAL INSULIN IMPROVES ACCESS TO COST-EFFECTIVE THERAPY OF DIABETIC PATIENTS IN THE PUBLIC SECTOR OF DAR ES SALAAM, TANZANIA Title: Selecting Natural Animal Insulin Improves Access to Cost-Effective Therapy of Diabetic Patients in the Public Sector of Dar es Salaam, Tanzania Problem Statement: Prevalence of diabetes in urban communities of developing countries is expected to triple within the next 25 years. Rising prevalence and long-term complications will lead to a drastic increase in both the burden of diabetes on health care systems and the need for insulin. Life expectancy of diabetic type 1 patients can be significantly improved with provision of insulin. Access to insulin, however, is limited due to irregular supply and cost. Human synthetic insulin causes more cases of serious hypoglycemia, and frequent glucose monitoring adds to its high cost. Natural animal insulin is cheaper and has lower hypoglycemia rates. In the early 1990s, diabetes care in Dar es Salaam was centralized at the national referral hospital and five-year survival was estimated at 60% for diabetes type 1 patients. Objectives: To improve the quality of life and life expectancy of diabetes patients in Dar es Salaam in a sustainable way by increasing rational drug use based on provision of natural animal insulin, cost sharing, and decentralization of diabetes care. Design: Operational research with baseline data and final evaluation. Data collection from patient interviews, questionnaires for health workers, semi-structured interviews with key informants and record review. Setting and Population: The public health sector of Dar es Salaam: diabetic care clinics integrated at the three municipal hospitals. Population attending the public sector is estimated at approximately 30% of 3 million. As of 1994, a combined 450 type 1 and type 2 diabetic patients attended the three clinics at the ditrict hospitals. Intervention: In 1994, diabetes clinics were decentralized and integrated into three district hospitals; health staff was trained; funding was provided to procure low-cost, good-quality natural animal insulin. Cost sharing was also introduced. Outcome Measures: Availability of natural animal insulin, number of attendances, number of reported serious cases of hypoglycemia, patient satisfaction, ability to pay. Results: Natural animal insulin is generally available. Patients contribute 50% to the cost of natural animal insulin. Financial burden per patient is approximately USD 23 per year (per capita gross national product is USD 280). Eleven percent of patients are unable to pay for drugs. Attendance rates increased from 450 type 1 and 2 diabetic patients combined in 1994 to more than 5,500 patients in 2002 (30% insulin-dependent type 1 diabetics). Serious hypoglycemia was reported in 1.5 patients per month in 2002. 77% of patients were satisfied with the insulin and 97% were satisfied with instructions given. Conclusions: Drug therapy can be optimized by selecting cost-effective natural animal insulin for diabetes patients in a low-income country while also improving access to treatment. Life expectancy and quality of life of diabetic patients can be improved with by strengthening rational drug use, with decentralized provision of natural animal insulin and cost sharing at affordable levels. Increasing workload, supply management, and exemption policy need to be addressed.

2. BACKGROUND AND SETTING + Prevalence of diabetes in urban communities of developing countries is expected to triple within the next 25 years. + Rising prevalence and long-term complications will lead to a drastic increase in both the burden of diabetes on health care systems and the need for insulin. + Life expectancy of diabetic type 1 patients can be significantly improved with provision of insulin. + Access to insulin, however, is limited due to irregular supply and cost. + Human synthetic insulin causes more cases of serious hypoglycemia, and frequent glucose monitoring adds to its high cost. + Natural animal insulin is cheaper and has lower hypoglycemia rates. + In the early 1990s, diabetes care in Dar es Salaam was centralized at the national referral hospital and five-year survival was estimated at 60% for diabetes type 1 patients.

3. STUDY OBJECTIVES. To improve the quality of life and life expectancy of diabetes patients in Dar es Salaam. in a sustainable way. by increasing rational drug use. based on provision of natural animal insulin. cost sharing, and. decentralization of diabetes care.

4. METHODS 1 ? Design: Operational research with baseline data and final evaluation. ? Data collection from patient interviews, questionnaires for health workers, semi-structured interviews with key informants and record review ? Setting: The public health sector of Dar es Salaam: diabetic care clinics integrated at the three municipal hospitals ? Population attending the public sector is estimated at approximately 30% of 3 million. Initially in 1994, a combined 450 type 1 and type 2 diabetic patients attended the three clinics at the district hospitals

5. METHODS 2 Intervention: ? In 1994, diabetes clinics were decentralized and integrated into three district hospitals ? Health staff was trained ? Funding was provided to procure low-cost, good-quality natural animal insulin. ? Cost sharing was also introduced Outcome Measures: ? Availability of natural animal insulin ? Number of attendances ? Number of reported serious cases of hypoglycemia ? Patient satisfaction, ability to pay

6. RESULTS 1 + Natural animal insulin is generally available + Patients contribute 50% to the cost of natural animal insulin + Financial burden per patient is approximately USD 23 per year (per capita gross national product is USD 280) + Eleven percent of patients are unable to pay for drugs + Attendance rates increased from 450 type 1 and 2 diabetic patients combined in 1994 to more than 5,500 patients in 2002 (30% insulin-dependent type 1 diabetics)

7. RESULTS 2 + At district clinics where natural animal insulin is provided, serious hypoglycemia was reported in 1.5 patients per month on average in 2002 + At Muhimbili referral hospital where human synthetic insulin is provided, serious hypoglycemia was reported in 3 patients per month on average in 2002 + 77% of patients were satisfied with the insulin and 97% were satisfied with instructions given.

8. RESULTS 3 Development of attending diabetic patients type 1 and 2

9. DISCUSSION Drug therapy of diabetic patients in Dar es Salaam could be optimized by selecting cost- effective natural animal insulin A combination of elements improved access to insulin: -low cost natural animal insulin -decentralized provision of insulin -cost-sharing at affordable levels In a setting of poverty, access to natural animal insulin with less monitoring expenses is an important advantage Natural animal insulin also added clinical benefit with less cases of serious hypogylcemia

10. CONCLUSION AND RECOMMENDATIONS Drug therapy of diabetic patients can be optimized by selecting cost-effective natural animal insulin for diabetes patients in a low- income country Access to treatment can be improved with selection of low cost natural animal insulin Life expectancy and quality of life of diabetic patients can be improved by improving availability and affordability of insulin Selection of natural animal insulin improves rational drug use Serious hypoglycemia can be reduced with natural animal insulin Increasing workload, supply management, and exemption policy need to be addressed.