Capacity building and access to essential medicines in the resource-limited settings: Policy tool of risk scoring of the WHO essential medicines

This presentation aims to propose a pharmaceutical policy tool to categorize medicines based on safety. Burden of disease and information on essential medicines provide policy makers with basic ideas about priority medicines in each setting. However, some medicines require an appropriate capacity to distribute them safely and efficiently. Information on comparative risk of medicines can be utilized to distinguish medicines which can be distribute in a less-restrictive manner, and ones which should be used properly by trained personnel. Time for training pharmacists and task-shifting programs would be shortened by focusing an educational curriculum on riskier priority medicines. Procurement and distribution of safer medicines can be properly managed by semi-health care workers with a short training course, which result in cost saving as well as capacity building regarding with medicines' supply chain. As supplemental information about risk of medicines in the WHO model list of essential medicines, risk scoring is proposed in this study. This study's method was based on the idea that risks of medicines can be categorized objectively based on the regulatory information, even though drug classes are different. Prescribing information (PI) of each essential medicine in the WHO model list was examined based on the drug information available in the U.S. regulatory agency (US FDA). Risks and safety were assessed based on the information about contraindication, boxed warnings, pregnancy risk factor, thermo-stability and controlled substances. To quantify the risks, the number of aforementioned risk information is counted. Physiological data and adverse reactions were divided into smaller categories to reflect the diversities of monitoring points. Medicines listed in High-Alert Medications from the Institute for Safe Medication Practices and complementary medicines in the WHO model list were used to justify the risk scoring. Out of 359 medicines, drug information on 310 medicines was collected for this study. Among 310 medicines, 291 medicines' PI was accessible. Risk scores were calculated based on the descriptions in each medicine's drug information. Medicines with high score included medicines which more frequently require health care workers to know their risk profiles and to monitor them. Although some of these medicines were not in the High-Alert Medications or complementary medicines in the WHO model list, the reasons for being in a high score were pharmacologically justifiable. This risk scoring can differentiate the safety of essential medicines, and can assist pharmaceutical policy making in terms of capacity building and cost-effective training in various settings.