Promoting Drug and Therapeutics Committees in the Developing World

Promoting Drug and Therapeutics Committees in the Developing World Terry Green John Chalker Kathleen Holloway Rational Pharmaceutical Management Plus World Health Organization March 2004 RPM + is supported by the U.S. Agency for International Development

What is a DTC? Drug & Therapeutics Committees The committee designated to ensure the safe & effective use of medicines in health facilities develops policies for managing drug use administers and manages the formulary system evaluates the clinical use of drugs DTCs are important because there is widespread inappropriate use of medicines Polypharmacy, antibiotic overuse, injection overuse and non-sterile injections, non-compliance with guidelines… leading to increased antimicrobial resistance, spread of hepatitis B/C & HIV, waste of resources, increased adverse drug reactions and poor patient outcome

Responsibilities of a DTC Establishing Standards (1) EML & STG development (2) Evaluating drugs (3) Drug Use Evaluation criteria Correcting problems to achieve standards (1) Interventions to promote rational drug use (2) Interventions to prevent medication errors, quality problems, stock-outs & ADRs Regular Assessment (1) ABC/VEN (2) Indicator Studies (3) Drug use evaluation (4) Regular review of reports of medication errors and ADRs DTC’s role to ensure quality of therapeutic care Investigating reported problems (1) Investigation of medication errors, drug quality problems, stock-outs and ADRs (2) Qualitative investigation why a drug use problem exists

Objectives of the MSH/WHO DTC Project To promote DTCs in the developing world DTCs have been shown to be effective in promoting rational drug use in developed countries, but there has been minimal use of these committees in developing countries

Interventions during 2000-3 DTC training materials were developed by MSH and WHO “Drug and Therapeutics Committees: a practical guide” developed by WHO and MSH and published in 2004 4 international and 8 national courses conducted in Asia, Africa, Latin America, E.Europe & aimed at doctors, pharmacists, hospital administrators & MOH officials Follow-up workshop for participants

Structure & content of training course 16 half -day modules and a field trip to hospitals Formulary management Drug Selection Determining efficacy, safety, cost, quality Adding and deleting drugs Identifying drug use problems Qualitative and quantitative methods Strategies to improve drug use Educational, managerial, and regulatory strategies

Training follow-up activities E-mail correspondence with participants DTC Web site Workplans displayed and progress reported Discussion boards Announcements Links to resources Follow-up workshop in Africa

Training results 361 people trained from 56 countries 87 (24%) responded to follow-up e-mail request 57 (16%) participants had undertaken 152 DTC related activities 24 (7%) participants from 10 countries attended the follow-up workshop for active participants

Post-course country DTC activities 29 training courses organized by DTC participants 72 DTCs in 14 countries created/restructured 9 new drug selection processes in 6 countries STGs developed in 12 institutions in 6 countries 7 DUEs undertaken in 4 countries 8 ABC/VEN analyses undertaken in 5 countries 7 ADR reporting systems developed in 5 countries 8 training programmes on rational use of drugs in 6 countries

Major problems identified by participants to implement DTCs Lack resources and institutional support Non-compliance with essential drug list (formularies) Non-compliance with STGs Pharmaceutical company influences Decreasing revenues with improved drug use

Solutions proposed by participants Use locally collected evidence on irrational drug use to convince officials Provide incentives to DTC members e.g. training, recognition by administration for DTC work Develop specific Terms of Reference approved by healthcare administrators Link procurement to STGs and formularies Provide training to DTC members & administrators Build a critical mass of activity to show administration the value of the committee and demonstrate that DTC activities can save money Link procurement to DTC’s formulary/EDL Notes: An RPM Plus partner, ICDDR,B, (International Center for diarrheal disease research, Bagladesh)is responsible for providing technical assistance to the National Public Health Laboratory and 9 sentinel AMR surveillance sites to strengthen the capability of the laboratories for sustainable antimicrobial resistance surveillance.   There was no process in place, however, to utilize these data to guide clinical and policy decision-making at the institutional or national levels. The AMR component of the Infectious Disease program sought to specifically address this gap. RPM Plus activities were planned to provide the link between the surveillance data and clinical decision-making. This would be done through a national level advisory committee within the Ministry of Health, and through the development of a country implementation strategy for containment of antimicrobial resistance, in coordination with the WHO and other RPM Plus programs. Since this was a new undertaking in Nepal, public sector counterparts insisted on the creation and adoption of an antimicrobial use policy in Nepal. A rather small group of motivated individuals, including the local Nepal APUA chapter, drafted an antimicrobial use policy and, with the assistance of the Department of Drug Administration, began shepherding it through the political process. The proposed policy was changed to an amendment to the existing National Drug Policy and took approximately 1-1/2 years for approval. The process was necessary to authorize official government activity on antimicrobial policy, but it also constituted a block to getting anything done on the national level until the policy was adopted. For the first time, veterinarians were included in the process to some extent. There was limited review of the policy, and no evaluation of the implications of implementation of those policies, such as the feasibility of improving enforcement of existing regulations, curriculum development, or developing a new system for monitoring the use of antimicrobials in humans and animals. In the interim, RPM Plus began working with hospitals that provide AMR surveillance data, so that they might be able to use their own data within their institutions to guide prescribing and use of antimicrobials. This will provide some experience with the decision-making process, provide data that will be used to guide decisions, and build support for a common notion of AMR concepts and ways of addressing the problem.

Conclusions Key Lessons Policy Implications Future Research DTCs can be promoted and implemented in developing countries through a combination of training and active follow-up support Increased follow-up support increased the productivity of many DTC course participants Policy Implications Promotion of DTCs is possible in resource poor settings and can result in improved use of medicines but requires institutional support and investment from government and donors Future Research Rigorous evaluation of the impact of DTCs on drug use and costs saved from improved use