25

THE FUTURE OF PHARMACY

VOL 28, NO.1 - JUNE 2012

ot h e r ne c e s s a r y t a sk s . T h e r e fo r e , s et t ing up a s y s t e m to he lp pha r m a c i e s b e n efit fro m au dit s wa s e s t a b li sh e d a s on e of t h e pill a r s of t h e Br a z ili a n Natio n a l Sy s t e m fo r t h e Monit o r ing a n d Imp r o v e m e nt of Comp o un ding Prac t i c e s (Sis t e m a Nacio n a l de Aper fe i ç o a m e nt o e Monit o r a me nt o Magis t r a l , SINAMM), who s e imp l e m e nt a t i o n by t h e Br a z ili a n Natio n a l Asso c i at i o n of Comp o un ding Phar m a c i e s (ANFARMAG) ha d st a r t e d in 20 0 6 . SINAMM result e d fro m a t a sk fo r c e of pha r m a c i s t s wh o gat h - e r e d to de v e l o p to o ls t hat co ul d he lp Br a z ili a n co mp o un ding pha r m a c i e s imp r o v e t h e ir pro c e s s e s a n d t h e qua lit y of t he ir pro du c t s a n d co mp l y wit h le g a l re quir e m e nt s . T h e de v e l o p - m e nt a n d imp l e m e nt a t i o n of t h e fir s t e dit i o n of SINAMM, in 20 0 8 , ha s b e e n de s c r ib e d in det a il els e w h e r e . 3

Ever y ye a r, t r a ining pro g r a mm e s a r e or g a ni ze d fo r pha r m a - c i s t s a n d ot h e r pha r m a c y emp l o y e e s to ad dr e s s t h e ma in ga p s ind e nt ifi e d in t h e pr e v i o u s ye a r. T h e su c c e s s of t h e s e init i a t i v e s w a s mo nit o r e d by t h e p e r fo r m a n c e of p a r t i c i p at ing p h a r m a c i e s in t h e ne x t e dit i o n of t h e pro g r a m . Sp e c ifi c a ll y co n c e r ning t h e au dit s , af t e r s o m e t r i a l s , SINAMM est a b li sh e d a st a n d a r di ze d e x t e r n a l au dit ing s y s t e m , co n du c t e d by a con - sult ing fir m ( Wo r l d Wid e Consult o r i a , S ã o Paulo, Br a z il ) t hat wa s s e l e c t e d by a te c hni c a l b o a r d at ANFARMAG. The con sult - ing fir m wo ul d go t hr o ug h a ch e c k li s t cle a r ing do ubt s on how to int e r p r e t it e m s , a n d a ls o he lp e d pha r m a c i e s id e nt if y a r e a s wit h qua lit y pro b l e m s . V ia t h e SINAMM syst e m , ANFARMAG then he lp e d t h e s e pha r m a c i e s co r r e c t t h e ir defi c i e n c i e s , fo r e x a mp l e by pro v i ding gui d a n c e on wh e r e to fin d info r m a t i o n on a gi v e n to p i c or re quir e m e nt (e . g . , c a lib r a t i o n , s t a n d a r d op - e r a t i o n a l pro c e dur e s , st r u c t ur a l or hygi e n e a sp e c t s , fo r mul a c a l cul a t i o n s) , a n d a ls o by pla nning a n d de v e l o p ing co ur s e s a s p a r t of our co nt inuing e du c a t i o n mo dul e (e . g . wh e n s e v e r a l pha r m a c i e s we r e fo un d to b e e x p e r i e n c ing simil a r pro b l e m s) .

T h e ch e c k li s t us e d in t h e au dit s co mp r i s e s a ll RDC man da - t o r y it e m s , a s foll o w s : hum a n re s o ur c e s , p e r s o nn e l qua lifi c a -

t i o n , fa c ilit i e s , mat e r i a l s , e quip m e nt , c a lib r a t i o n , cle a nn e s s / a s e p si s , r aw mat e r i a l s a n d p a c k a g ing , sup p li e r qua lifi c a t i o n , qua lit y co nt r o l (r aw mat e r i a l s /p a c k a g ing a n d co mp o un ding pr e p a r a t i o n s) , s t o r a ge , wat e r sup p l y, co mp o un ding pro c e s s , la b e ling , t r a n sp o r t a t i o n , disp e n sing , qua lit y a s sur a n c e , s e lf - in sp e c t i o n , a n d co mp l a int ma n a ge m e nt . Dur ing t h e au dit , e a c h sub it e m is e v a lu a t e d a n d cla s sifi e d a s eit h e r co mp li a nt or non c o mp li a nt .

T h e re sult s obt a in e d in t h e au dit s a r e us e d to defin e t h e r isk of non c o mp li a n c e wit h b e s t co mp o un ding pr a c t i c e s of ea c h pha r m a c y. T h e r isk c a n b e : low, wh e n t h e pha r m a c y TIPXT
DPNQMJBODF
XJUI


PG
UIF
JUFNT
BVEJUFE
NPEFSBUF
XIFO
DPNQMJBODF
JT
SFBDIFE
GPS

PG
UIF
JUFNT
PS
IJHI
XIFO
MFTT
UIBO

PG
UIF
JUFNT
BSF
DMBTTJmFE
BT
DPNQMJBOU
Phar m a c i e s sh o w ing a low or mo d e r a t e r isk of non c o mp li a n c e a r e co n si d e r e d to ha v e p a s s e d t h e au dit , wh e r e a s t h o s e sh o w - ing a high r isk a r e co n si d e r e d to ha v e fa il e d . Phar m a c i e s sh o w - ing a high r isk of non c o mp li a n c e a r e t h e n ins t r u c t e d to foll o w SINAMM guide lin e s (e . g . , v ia t r a ining , re v i e w of da il y pr a c t i c e s a n d ro ut in e pro c e dur e s , et c . ) to imp r o v e t h e ir pr a c t i c e a n d me e t t h e st a n d a r d s s et fo r t h by t h e a p p li c a b l e le gisl a t i o n . A new au dit sh o ul d t h e n b e sch e dul e d .

Ta b l e 1 sh o w s co mp li a n c e re sult s obt a in e d fo r pha r m a c i e s audit e d in 2 0 0 9 a n d 2 01 0 . Result s fo r 2 01 1 a r e not av a il a b l e yet , but t h e numb e r s co ll e c t e d s o fa r s e e m to in di c a t e t hat the high le v e l of comp li a n c e ob s e r v e d in 201 0 will b e ma in - UBJOFE

PG

QIBSNBDJFT
BVEJUFE
TP
GBS
IBWF
TIPXO
a mo d e r a t e / l o w r isk of non c o mp li a n c e) .

Alth o ug h t h e s e numb e r s do not a ll o w a n ob j e c t i v e me a s ur e - m e nt of t h e imp a c t s of t h e SINAMM in Br a z il , t h e y cl e a r l y sh o w t h at t h e au dit in g s y s t e m imp l e m e nt e d ha s he lp e d ph a r m a c i e s me e t t h e le g a l re quir e m e nt s a p p li c a b l e to t h e ir pr a c t i c e (a n d co n s e q u e nt l y hig h qua li t y s t a n d a r d s) a n d ha s

Fig. 1. Timeline of introduction of some key concepts and developments in drug discovery

TA BLE 1 . RIS K OF NONCOMPLIANCE WI T H F E D E R AL REG ULAT IONS IN BR A Z ILIAN COMPOUNDING PH A R M A C I E S PA R T I C I PAT ING IN THE NAT IONAL SY S T E M

FOR T H E MONITORING AND IMP ROVEMENT OF COMPOUNDING PR A C T I C E S, 2009 AND 2010

YEAR ( N O . PHARMAC IES AUDITEDA) RISK OF NO N C O M P L I A N CEB %

2 0 0 9 (1 , 4 67 ) L o w/ m o d e r a t e 75 .3 2 High 2 4 . 6 8 2 0 1 0 (1 , 1 6 8 ) c Low/ m o d e r a t e 9 9 . 15 High 0 . 8 5

a Pha r m a c y b r a n c h e s a r e co u nt e d s e p a r a t e l y, r e s u l t i n g in a hig h e r num b e r of p h a r m a c i e s a u d i t e d wh e n co m p a r e d wit h t h e num b e r of p h a r m a c i e s p a r t i c i p a t i n g in t h e SINAMM.

C
)JHI
SJTL
DPNQMJBODF
XJUI


PG
BVEJU
DIFDLMJTU
MPXNPEFSBUF
DPNQMJBODF
XJUI


PG
BVEJU
DIFDLMJTU c S o m e of t h e p h a r m a c i e s a u d i t e d in 2 0 1 0 ha d a lr e a d y b e e n a u d i t e d in 2 0 0 9 , i . e . , h a v e b e e n a u d i t e d m o r e t h a n o n c e .