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THE FUTURE OF PHARMACY
INTERNATIONAL PHARMACY JOURNAL
COMPOUNDING IN BRAZIL LEGAL COMPLIANCE FOR FUTURE PROGRESS
Compounding pharmacies in Bra zil are subject to heavy and extensive legislation. This article describes the implementation of an auditing system by the Bra zilian National System for the Monitoring and Improvement of Compounding Practices (Sistema Nacional de Aperfeiçoamento e Monitoramento Magistral, SINAMM) to help pharmacies comply with legal requirements and thus improve compounding practices. The results obtained in two years of audits are presen- ted and discussed, with a focus on the volun - tary commitment of Bra zilian compounding pharmacies to achieving excellence.
B r a z il sha r e s wit h co unt r i e s su c h a s t he Unite d St at e s , Sp a in , It a l y, a n d B e lg ium a st r o ng t r a dit i o n in comp o un ding , wit h dat a fro m 2 0 0 8 in di c a t ing 7, 4 0 2 pha r m a c i e s de di c a t e d to all o p a t hi c c o mp o un ding a n d 1 , 0 7 3 pha r m a c i e s de di c a t e d to hom e o p a t hi c co mp o un ding . 1 It als o sha r e s wit h ot h e r co un - t r i e s t h e bur d e n of at le a s t s o m e de gr e e of susp i c i o n co n c e r n - ing re g ul a t i o n – how a n d how mu c h co mp o un d e d me di c in e s a r e re g ul a t e d – a n d qua lit y – how a n d how mu c h is qua lit y, s afe t y, a n d ef fi c a c y re a ll y co nt r o ll e d in suc h pha r m a c i e s . 2 D e sp it e a st r o ng t r a dit i o n , la c k of st a n d a r di z a t i o n a n d do ubt s a b o ut t h e re a l qua lit y of t h e fina l pro du c t a r e st ill a s s o c i a t e d wit h co mp o un ding pha r m a c i e s in Br a z il . 3
Also not e w o r t hy is t h e le g a l fr a m e w o r k re g ul a t ing co mp o un d - ing in Br a z il . 4 In 20 0 7, t h e Natio n a l S a nit a r y Sur v e ill a n c e Agenc y (Agênc i a Nacio n a l de V igil â n c i a S a nit á r i a , ANVISA) int r o du c e d Resolut i o n RDC 67, a ne w s et of Go o d Comp o un d - ing Prac t i c e s b a s e d on con c e pt s fro m t h e Go o d Manuf a c- t ur ing Prac t i c e s gui ding t h e pha r m a c e ut i c a l in du s t r y in Br a z il . 5 To ensur e co mp li a n c e wit h t h e Resolut i o n , e v e r y ye a r pha r m a c i e s a r e visit e d a n d insp e c t e d fo ll o w ing a lis t of 20 it e m s a n d ov e r 3 0 0 sub it e m s cla s sifi e d a s ma n d a t o r y, ne c e s - s a r y, info r m a t i v e , or re c o mm e n d e d , s e l e c t e d acc o r ding to t he ac t i v it i e s c a r r i e d out at ea c h pha r m a c y. Nonco mp li a nt pha r- m a c i e s ha v e to fa c e t h e p e n a lt i e s imp o s e d by ANVISA, whic h may r a nge fro m not i c e s or fin e s unt il t h e clo sur e of sel e c t e d de p a r t m e nt s or of t h e pha r m a c y a s a who l e . Accor ding to RDC 67/ 2 0 0 7, t his s a m e e x t e n si v e ch e c k li s t sh o ul d b e us e d by pha r m a c i e s in se lf - in sp e c t i o n s , to en c o ur a ge imp r o v e m e nt a n d qua lit y co nt r o l .
Howe v e r, it so o n b e c a m e cle a r t hat co mp o un ding pha r m a c i e s we r e of t e n unp r e p a r e d to do se lf - in sp e c t i o n s a n d to ac t u a ll y a p p l y t h e re sult s of se lf - in sp e c t i o n to gen e r a t e imp r o v e m e nt using a pla n - d o - c h e c k - a c t pro c e s s . The t a sk wa s vie w e d a s a tim e - a n d mo n e y - c o n s uming ac t i v it y t hat to o k away fro m
Hugo Guedes de Souza1 , Álvaro Favaro Jr.,2 , , Alba Lívia Andrade3 , Lenir Yago Gomes4 , Maria do Carmo Garcez5 ,
Vagner Miguel6 , Lúcia Helena Gonzaga Pinto7