Cantú-Quintanilla G, Alberú J, Reyes-Acevedo R, Gracida-Juárez C, Medeiros M, Mendoza-Sánchez F, Silva-García CG, Ramírez-Carreón J

Language: Spanish
References: 14
Page: 60-66
PDF size: 256.60 Kb.

ABSTRACT

Background: The use of generic drugs with a narrow therapeutic window is controversial. Objective: Identifying bioethical perceptions and implications of use of generic immunosuppressants. Methodology: A poll was applied to determine perception about the use of generic immunosuppressants. Answers were grouped in three categories: monitoring, immunosuppressants and information handling. In order to determine the impact of variables, a one-way variance analysis (ANOVA) was applied for three-variable cases, and a t test was applied for two-variable cases. Critical value of p ‹ 0.05 was considered statistically significant. Results: 30 replies were obtained. Out of pollees, 83% were physicians, 10% nurses and 7% in other fields. Perception when comparing the incidence of adverse effects of the generic immunosuppressant to those of the patent medications was that the effect with a higher incidence was organ rejection, with a lower incidence for toxicity. The p value for the immunosuppressant category was 0.0100. This shows that the sector where work is carried out affects the immunosuppressant use, monitoring and scheme for the patient. The sector with the highest average value was the private sector, with 1.512, which suggests that immunosuppressants are handled with a greater care in this sector. Conclusions: Results show a serious fault against bioethical principles of distributive justice and non-maleficence.

REFERENCES

1. Obrador-Vera G. Guías latinoamericanas de práctica clínica sobre la prevención, diagnóstico y tratamiento de los estadios 1-5 de la enfermedad renal crónica. 2012.

2. Ansari MJ, Sayegh MH. Switching immunosuppressive drugs in kidney transplant recipients: “show me the evidence”. Saudi J Kidney Dis Transpl. 2006; 17 (2): 149-152.

3. Historia de trasplantes un largo camino que tiene historia [Internet]. Secretaría de Salud del Estado de México, 2014. Disponible en: http://salud.edomex.gob.mx/cetraem/doc/SIC_TEMA%20DEL%20MES.pdf

4. Puig JM. Historia del trasplante renal. BISEDEN [Internet]. 1992 [Consultado 15 de junio de 2013]; 1992 (1): 10-17. Disponible en: http://revistaseden.org/files/art655_1.pdf

5. Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, Goodman GA, editores. Goodman & Gilman. Las bases farmacológicas de la terapéutica. 9a edición. Ciudad de México, México: Editorial McGraw-Hill Interamericana; 1996.

6. Rojas-Espinosa O. Inmunología (de memoria). 3a edición. Ciudad de México, México: Editorial Médica Panamericana; 2006.

7. Pope ND. Generic substitution of narrow therapeutic index drugs. US Pharm. 2009; 34 (6) (Generic Drug Review suppl): 12-19.

8. Tichy E, Morris G. Generic immunosuppresant use at major transplant center. Pharmacy, Purchasing and Products Magazine. Generic Drugs. 2012; 9 (9).

9. van Gelder T, Gabardi S. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs. Transpl Int. 2013; 26 (8): 771-777.

10. Domínguez-Pérez DA, Pérez-Raul MN, Reséndiz-Romero JG. Los medicamentos genéricos intercambiables: su origen e impacto en México durante el periodo 1998-2005. Mundo Siglo XXI [Internet]. 2007-2008 [Consultado 18 de junio de 2013]; 11: 91-99. Disponible en: http://www.mundosigloxxi.ciecas.ipn.mx/pdf/v03/11/07.pdf

11. Simoens S. The Portuguese generic medicines market: a policy analysis. Pharmacy Practice. 2009; 7 (2): 74-80.

12. Norma Oficial Mexicana NOM-177-SSA1-1998, Que establece las pruebas y procedimientos para demostrar que un medicamento es intercambiable. Requisitos a que deben sujetarse los terceros autorizados que realicen las pruebas. 1998.

13. Mendoza-Sánchez F, Tanús R, Gracida-Juárez C, Alberú-Gómez J, Pérez-Gómez HR, Rivas-Carrillo JD et al. Foro de bioética en trasplante de órganos y tejidos. «Declaratoria Guadalajara» 77 Sociedad Mexicana de Trasplantes, A.C. Septiembre 29 de 2012 Paraninfo Universidad de Guadalajara, Guadalajara, Jalisco, México. Rev Mex Traspl. 2013; 2 (2): 77-84.

14. Esquivel A, González-Ramírez R, Alberú J, Gracida C, Medeiros M, Castañeda-Hernández G. Comparison of dissolution properties of 2 enteric-coated formulations containing mycophenolate sodium: Myfortic vs Femulan. Transplant Proc. 2010; 42 (1): 353-356.