Díaz-Roa KA, Montaña-Chaparro WF, Otálvaro-Cifuentes EH

Language: Spanish
References: 6
Page: 233-244
PDF size: 766.96 Kb.

ABSTRACT

Introduction. The National Reagent Surveillance Program is a pioneering program in the Americas of post-marketing surveillance of in vitro diagnostic reagents in Colombia. The objective of this study was to analyze the results of the implementation of the program between January 2014 and January 2018. Methods. In the archives and databases of the Epidemiological Surveillance Group of the Office of Devices and Other Technologies of the Invima, a data search was carried out to characterize the different program variables, which were analyzed descriptively, depending on their qualitative or quantitative nature. Results. A total of 4,191 new registrations were recorded in the network; 76.7% of them from private entities or independent providers, with a 66% coverage of the Colombian institutions. There were 78 trainings, 93 technical assistance sessions, and 133 people were certified online. 96% of the reports were incidents, 95.8% were made by Health Services Provider Institutions (IPS), 17.2% due to false positives and 44.3% corresponded to products in category II, according to the Invima classification for health risk. 74% of the products analyzed belonged to category II. 516 international monitoring reports were included. Conclusion. The PNR is a unique program in the region of the Americas, and after four years of starting its implementation process, significant coverage has been achieved with trained personnel among those enrolled in the network, and in the report of safety alerts.

REFERENCES

1. Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). Resolución 2013038979 de 2013. «Por medio de la cual se implementa el Programa Nacional de Reactivovigilancia ». Diario Oficial No. 49.048 de 29 de enero de 2014. Acceso 14 de julio de 2018. Disponible en https://www.icbf.gov.co/cargues/avance/ docs/resolucion_invima_38979_2013.htm.

2. U.S. Food and Drug Administration. Code of Federal Regulations, Title 21. Maryland: U.S. Department of Health and Human Services; 2019. Volume 8: Part 809. Acceso 23 de julio de 2018. Disponible en https://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch. cfm?CFRPart=809.

3. Montaña-Chaparro WF, Díaz-Roa KA, Otalvaro- Cifuentes EH. Estudio descriptivo del Programa Nacional de Reactivovigilancia. Bogotá D. C.: INVIMA; 2018. p. 33. Acceso 3 de septiembre de 2018. Disponible en https://www. invima.gov.co/documents/20143/442961/ ESTUDIO-DESCRIPTIVO-PROGRAMA-DEREACTIVOVIGILANCIA- EN-COLOMBIA-SEPTIEMBRE- 2018.pdf/f48dc56f-4624-82f0-d35be4b935fc0d66? t=1560457322234.

4. Ministerio de la Protección Social. Decreto número 3770 de 2004. Por el cual se reglamentan el régimen de registros sanitarios y la vigilancia sanitaria de los reactivos de diagnóstico in vitro para exámenes de especímenes de origen humano. Bogotá D. C., 12 de noviembre del 2004. Acceso 5 de agosto de 2018. Disponible en https://www.minsalud.gov.co/Normatividad_ Nuevo/DECRETO%203770%20DE%20 2004.PDF.

5. Ministerio de Salud y Protección Social. Resolución número 1229 de 2013. Por la cual se establece el modelo de inspección, vigilancia y control sanitario para los productos de uso y consumo humano. Bogotá D. C. 23 de abril del 2013. Acceso 18 de junio de 2018. https://www. minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/ RIDE/DE/DIJ/resolucion-1229-de-2013.pdf.

6. Ministerio de Salud y Protección Social. Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). ABC de Reactivovigilancia. Bogotá D. C: Imprenta Nacional de Colombia; 2014. p. 39. Acceso 1 de julio del 2018. Disponible en https:// es.scribd.com/document/375066271/ABCReactivovigilancia.