Diseño de un plan de gestión del riesgo del servicio farmacéutico de la Fundación Oftalmológica de Santander; según los requisitos de la norma ISO 31000:2018 y la Resolución 1403:2007

Abstract

Problem. The pharmaceutical service of the Santander Ophthalmological Foundation Foscal is likely to materialize an event related to its processes, since it lacks the design of a risk management plan as a mechanism to create and protect value in organizations through the management of risks, according to the guidelines of ISO 31000: 2018; harmonized with the requirements of Resolution 1403: 2007, which dictates the management model of the pharmaceutical service in Colombia. The objective was design a risk management plan for a highly complicated pharmaceutical service, under harmonization of the ISO 31000: 2018 and Resolution 1403: 2007 standards. Methodology. Transversal study. Results. A checklist was designed with 312 criteria and 16 were excluded; according to the level of complexity of the pharmaceutical service. The 296 criteria applied were evaluated as follows: (0%), (25%), (50%), (75%), (100%); 36 findings (12.2%) were obtained for the ISO31000: 2018 standard and 11 findings (3.7%) for Resolution 1403: 2007. 10 characteristics of the risk management plan and 45 activities were established for a pharmaceutical service action plan. Discussion. Establishing the characteristics of the risk management plan allows consolidating risk management without excluding the guidelines of the ISO 31000: 2018 Standard, it will also help define the aspects to be strengthened within risk management and maintain compliance with the aspects that are contemplated during the qualification of the pharmaceutical service; as well as, harmonize the ISO 31000: 2018 and Resolution 1403: 2007 standards to standardize the risk management system of the pharmaceutical service.