1. ABSTRACT Progress of Rational Use of Drugs Program in Karnataka, India Srinivas CS*, Sudarshan H, Bilimagga RS Karnataka Society for Promotion of Rational Use of Drugs Karnataka Rational Use of Drugs Program, was initiated in 1999, assisted by the Delhi Society for Promotion of Rational Use of Drugs. The initial phase was utilized for sensitization and advocacy assisted by the Indian Medical Association. The Final report of the Task Force on Health and Family welfare has been used as the guide for action since then. The draft state drug policy was prepared as part of the integrated health policy. A Drug and Therapeutic Committee (DTC) was formed and the first Standard Treatment Guidelines (STGs) and Essential Medicines List (EML) and Formulary for the public sector were prepared. Feedback for the STGs and EML were collected from clinicians in the public sector. Administrative interventions were carried out in pharmaceutical procurement in public sector. Training of doctors and pharmacists in DTCs and rational use of drugs has been carried out. Trained professionals and enlightened bureaucrats have made feasible major changes. The political will and the ability to prevent duplication of work is required to take the system forward. Karnataka Society for Promotion of Rational Drug Use has been formed. These efforts are to initiate debate and discussion to promote Rational use of drugs in Karnataka, India.

2. BACK GROUND AND SETTING The powerful vision of achieving “Health for All” by the year 2000, resulted in countries adopting guiding principles and policies to achieve the same. In 1978, along with 138 other nations, India was a contributor and signatory to the World Health Assembly and Alma Ata declaration. The National Health Policy passed in 1983 was to lead the country towards addressing the health issues. In India, only 50-80% of the population have access to essential drugs. The current status of procurement in Karnataka is decentralised. The Final Report of the Task Force on Health and Family Welfare, Govt of Karnakata, April 2001 has explored the deficiencies in the present system with respect to Infrastructure, Procurement, Distribution, Monitoring and Evaluation ;and Quality Control. Among other issues, the need for Province’s Essential Medicines List, Standard Treatment Guidelines and Formulary were also identified in the Task Force Report.

3. OBJECTIVES The objectives were to: 1.Identify how the concept of Rational Drug Management could be incorporated into an important report in the public sector. 2.Identify how for the first time, the Health Policy of the Province/State could incorporate the drug policy as an integral aspect. 3.Identify the drug use situation in early 2000, by conducting the baseline studies of prescribing indicators in the out patient departments in hospitals. 4.Identify the role of advocacy to involve private medical practitioners in initiating debates on burning issues in rational use of medicines. 5.Identify the means of forming a core group of opinion leaders to initiate the preparation of EML, STG and Formulary for Karnataka. 6.Identify the need for operational research to look into the current procurement practices in the public sector in Karnataka. 7.Identify the resource allocation for procurement of drugs (ABC analysis). 8.Identify the areas in which training should be imparted to health care professionals. 9.Identify the formation of an organization to carry on with these issues.

4. METHODS The timing of the program was crucial in the year 1999, in Karnataka. Operational research and Action Research has been used. It was initiated with the help of Delhi Society for Promotion of Rational Use of Drugs to provide the financial and technical support. Formation of the Rational Use of Drugs Committee in the Karnataka State Pharmacy Council was the first step. It was initiated after training the key personnel in the Drug Policy Issues in Developing Countries conducted by WHO and MSH. The program sustained itself due to the support from the office of Chairman, Task Force on Health and Family Welfare, Government of Karnataka and later on the Vigilance Director (Health, Education and Social Welfare), Lokayukta (Anti Corruption Office) Government of Karnataka. The “early visibility” was evident by incorporating “Rational Drug management” and identifying issues to deal with, in Karnataka, in the Final Report of the Task Force on Health and Family Welfare. The draft Health Policy that had incorporated the Drug policy was a big step in Karnataka.

5. RESULTS 1 The recommendations in the Rational Drug Management in the Task Force report was the GUIDE FOR ACTION. The Indian Medical Association, Karnataka State Branch and the Government conducted “Quality care and ethical practice” workshop and was used as a forum to initiate debate amongst 800 private and public medical practitioners. Special issue of “Rational Use Of Drugs” in the Karnataka Medical Journal of the Indian Medical Association, Karnataka State Branch was published. Formation of the Drug and Therapeutic Committee to work on the first EML, STG and Formulary was a major step. Feedback from the clinicians for STG and EML was collected by sending 06 copies each, to 26 District Health Offices across the province. Responses were obtained from 46 doctors in 08 districts. VED analysis of the Primary Health care EML. Responses were obtained from 22 Medical Officers from 18 districts of the 26 districts of Karnataka during a training program.

6. RESULTS 2 ESI Hospitals9 Public sector 3 Private Hospitals No of prescriptions collected 210727300 Avg no of drugs prescribed 2.533.172.94 % by generic42.2043.943.38 % antibiotics47.656.7343.33 % of injections11.4239.5110.33 Avg Consultation Time 65 sec----- Avg Dispensing Time13 sec----- % of Drugs actually dispensed 92.89----- % of correct knowledge 95.57-----

7. RESULTS 3 FEEDBACK SUMMARY FOR EML and STG FROM 8 District Health Offices (DHO) I Number of Districts to which EDL and ETG were Sent 26 II Number of District that Responded 08 III Total number of doctors who responded 46 IVNames of Districts that responded UDUPI, TUMKUR, BELGAUM, KARWAR, RAICHUR, MYSORE, MANDYA, SHIMOGA 21 drugs were listed under request for addition into the EML 07 drugs were listed under request for deletion from the EML 33 doctors among the 46 who responded felt that no changes were required in the EML and STG

8. RESULTS 4 ABC Analysis of drugs procured by Government Medical Stores, which accounts for 40% of the procurement of the province was performed. Data represented for Nimesulide, a NSAID, not approved in many developed countries and banned in others. YEARABC RANKING VALUE in Rs% VALUE 1999-200012671438010.67 2000-20011289467558.41 2001-20021263844289.26 2002-2003 (Mar 2002- Dec 2002) 33440--

9. RESULTS 5 The Task Force on Health and Welfare recommended for the provision of drugs in the Primary Health Care to be increased by Rs. 25,000- per PHC so that all essential drugs are available at the PHC all the time. The government had responded positively and allotted the same. The procurement of 60% of the budget through the decentralised system of Zilla Panchayat is being examined by the Lokayukta offices. The training program for doctors and pharmacists to sensitize them towards issues like Drug and therapeutic committee, EML, STG, Drug procurement, etc has been carried out. Sporadic approaches to reach out to the community to deal with issues like self medication was attempted. Karnataka has been paying a lot of importance to the rational use of drugs concept. Improvement in monitoring and evaluation of projects needs a greater boost. The issues related to procurement of pharmaceuticals in public sector is shown in the next slide.

10. G M S DRUG CONTROL DEPARTMENT THE CARTEL 60% Drugs Non RC, public sector DHO (ZP) Other Hospitals Directorate RCH, Malaria, Autonomous Hospitals Medical Education RATE CONTRACT PROCUREMENT Distribution (40%of drugs) Need based Indenting Burden of Disease DRUG SCAM DIRECTORATEADMINISTRATION PEOPLE OF KARNATAKA PRIVATE/PUBLIC SECTOR PRIMARY MANUFACTURERS AUTHORISED DEALERS WHOLESALERS RETAILERS EXPoRT PRIVATE HOSPITALS SUBSTANDARD SPURIOUS DRUGS HIGHER RATE STANDARD DRUGS GOOD RATE PERIPHERAL HEALTH INSTITUTIONS Certification Price control Substandard / Spurious Higher Cost Drugs Z P RC Drugs Transparency Act violations BADGOOD 31 March syndro me Public sector Pharmaceutical procurement in Karnataka

11. SUMMARY The department of Health & Family Welfare in Karnataka is implementing Karnataka Drugs Logistics project under the grant from European Commission through Government of India. Rather than spend time and resources from different funding programs in reinventing wheels like starting again with the EML, STG and Formulary, which is available now, it is required to utilise resources in implementing programs. Training of health care professionals is crucial. Capital investment is given more priority in a developing country when compared to Human Resource Development. The process of drug procurement should become transparent, quick and scientific. Constant monitoring and evaluation is required to prevent duplication and creation of more parallel systems. Political support, external financial assistance, existing health system infrastructure and technical capabilities should be made use of, in Karnataka, in reaching the goals of essential drugs accessibility.

12. CONCLUSION AND POLICY IMPLICATIONS The complex issue of Rational Use of Drugs needs integrated action and problem solving oriented research to play an important role. Drug use research that contributes to the development and implementation of effective Rational Drug Use interventions, are important. Trained professionals and enlightened bureaucrats have made possible the steps taken in Karnataka in the right direction to facilitate Rational use of drugs. Educational and administrative interventions have resulted in documented policies and certain changes in processes. The political will to support these documents and decisions are awaited. It is important to initiate debate and discussion amongst policy makers and administrators at the facility level and provincial level to strengthen the system and make it more conducive to promote rational drug use. Accountability, transparency, monitoring and evaluation are absolutely essential to take this concept forward.

13. ACKNOWLEDGEMENT