promotion of digitalized pharmacovigilance technologies ... ·...
TRANSCRIPT
Promotion of Digitalized Pharmacovigilance Technologies
towards Protection of Public Health: UAE Insights
Dr.$Amin$Hussain$AlAmiri,$M.Sc.,$PhD.!!!!Asst.!Undersecretary!of!Public!Health!Policy!and!Licensing!Sector!!
MOHAP<2018!
1!ISOP!<!18TH!ANNUAL!MEETING!<!2018!
IntroducFon!about!the!United!Arab!Emirates!
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 2!
Country!Establishment!date!
Dec.!2nd!1971!
PopulaFon!size!
9.8!M!
Per!Capita!Healthcare!expenditure!
1,875!USD!
Per!Capita!PharmaceuFcal!expenditure!
322!USD!
Healthcare!expenditure!
4.4%!of!GDP!
Registered!medical!products!
14,000!
Life!Expectancy!at!birth!
78!years!
PopulaFon!25!–!45!years!
53.2%!
Internet!users!staFsFcs!
98.4%!
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 3!
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 4!
!
!PV:$Widening$Horizons!
!
!
!
Globaliza>on,!consumerism,!!
and!the!explosion!in!free!
trade!and!communicaFon!across$borders,!
Illegal!sale!of!medicines!and!drugs!of!abuse!
over!the!Internet$
Increasing!selfB
medica>on$pracFces!
Global!widespread!
manufacture!and!sale!of!
counterfeit!and!substandard!medicines!
increasing!use!of!tradi>onal$and$herbal$medicines$
outside!the!confines!of!the!tradiFonal!culture!of!use!!with!potenFal!adverse!interacFons.!
ISOP!<!18TH!ANNUAL!MEETING!<!2018!
! Within$the$last$decade,$there$has$been$a$growing$awareness$that$the$scope$of$pharmacovigilance$should$be$extended.$$
! Many$changes$have$given$rise$to$new$kinds$of$safety$concerns$such$as:$$
5!
EBControl$Medicine$Prescrip>on$System$
ISOP!<!18TH!ANNUAL!MEETING!<!
2018!6!
EBSystem$Sta>s>cs$
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 7!
Pharmacist$Registered$ Pa>ent$Registered$
Healthcare$Providers$Registered$
Regula>ons$
Electronic$Names$of$Facility$
Electronic$pa>ent$data$$
Pharmacy$Role$" Daily$Repor>ng$of$$Narco>cs$
Dispensing$" Monthly$Electronic$Reports$
Prescrip>on$Dispensed$2017$
Licensed$Medical$Stores$
Ac>ons$Controlled$M$
Dispense$of$Controlled$Medicines$
in$emergency$
Dura>on$of$Days$a$
Specialist$Can$Prescribe$controlled$M$
Dura>on$of$Days$a$
Psychiatrist$$Can$Prescribe$controlled$M$
Ac>ons$Semi$Controlled$M$
Dura>on$of$Days$a$GP$
Can$Prescribe$semi$
controlled$M$
Dura>on$of$Days$a$
Prescrip>on$can$be$renewed$$
Cycle$of$Audi>ng$
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 8!
Controlled$and$Semi$Controlled$Medicines$
Shipment$Received$$ Electronic$Data$Base$
Electronic$Transfer$to$Healthcare$Facility$
Pa>ent$goes$to$Pharmacy$to$Receive$Medicine$
Data$saved$to$Database$
In$case$Pa>ents$returns$for$another$prescrip>on$from$
Healthcare$Provider$against$rules$the$system$
denies$the$order$automa>cally$
Healthcare$Providers$
Data$of$eBcontrol$System$$
9!
Lyrica,$300mg$$
ISOP!<!18TH!ANNUAL!MEETING!<!2018!
Data$of$eBcontrol$System$(cont.)!
10!
$! EBcontrol$System$is$a$very$
intelligent$Program$developed$within$the$Health$Compliance$and$Empowerment$Department$$aiming$to$Inves>gate$any$viola>ons.$$
! By$Poin>ng$to$any$Bar$on$the$Chart$with$the$arrow$it$instantly$shows$the$Rank$and$$Intensity$of$Viola>on,$$
! It$Moreover$further$clarifies$the$details$required:$such$as$the$name$of$the$pa>ent$abusing$the$drug,$name$of$Physician$prescribing$the$drug,$name$of$Health$Facility$as$well$as$the$pharmacy$dispensing$it……..$
ISOP!<!18TH!ANNUAL!MEETING!<!2018!
Global Facts about ADRs
Adverse!Drug!ReacFons!(ADRs)!are!among!the!top!ten!causes!of!mortality!
Approximately!5%!of!hospitalized!paFents!are!admi\ed!into!hospital!as!a!result!of!an!ADR!and!6<10%!of!in<paFents!will!experience!a!serious!ADR!during!hospitalizaFon.!
ADRs!are!unwanted!drug!effects!that!have!considerable!economic!as!well!as!clinical!costs!!
ADRs!may!cost!up!to!!$136!billion!annually!(FDA:!Preventable!Adverse!Drug!ReacFons:!A!Focus!on!Drug!InteracFons!2017)!
ADRs!may!increase!costs!due!to!increased!hospitalizaFon,!prolongaFon!of!hospital!stay,!addiFonal!clinical!invesFgaFons!and!may!trigger!prescripFon!cascades.!!
The!good!news:!About!50%!of!ADRs!are!preventable.!!
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 11!
Health!Care!Professionnels:!Physiciens!,!Pharmacists,!
nurses!!
Publics!
ReporFng!Adverse!Drug!ReacFon!
EvaluaFon!of!ADR!causing!factors!
PV in UAE
# Analysis!&!EvaluaFon!of!ADR!causing!factors,!!
# Issuing!Circulars!&!publicaFons!related!to!ADR!
Local PV centers (MOHAP& Health Authorities in UAE)
Pharmaceutical Companies
Uppsala Center for Assessing ADR & WHO
Local Health Authorities
Ministry of Health And Prevention
ISOP!<!18TH!ANNUAL!MEETING!<!2018!12!
UAE$PV$Figures:$From$Passive$to$Ac>ve$Pharmacovigilance$
45$ 59$388$
721$ 825$
1999$
0!
1000!
2000!
3000!
2012! 2013! 2014! 2015! 2016! 2017!
ADR$
ADR!
ReporFng!
ISOP!<!18TH!ANNUAL!MEETING!<!2018!
25$ 95$ 253$ 136$352$
966$
0!
1000!
2000!
2013% 2014% 2015% 2016% 2017% 2018%
PV$reports$sent$to$Uppsala$
PV!reports!
NUMBER!OF!PV!
OFFICERS!IN!
MOHAP!DISTRICTS!
$305$
13!
The!number!of!warnings!and!noFces!issued!by!the!Higher!Commi\ee!for!
pharmacovigilance!is!47!warnings!since!the!beginning!of!the!current!year,!including!21!
warning!of!products!registered!by!Drug!Department!and!10!circulars!for!counterfeit!and!
26!circulars!on!safety!reports!and!warnings!for!products!not!registered!with!the!Ministry.!
Alerts$in$Social$Media$$
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 14!
Pharmacovigilance$Achievements$in$UAE:$$Innova>ve$Example$
Achievements$of$Beginning$of$$2018$
Developing$a$Smartphone$Applica>on$$$$$$$$$$! Directly$linked$to$Uppsala$! Any$individual$is$allowed$to$report$side$or$
adverse$effects$$! The$Ministry$is$allowed$to$send$no>ces$and$
data$to$users$of$the$applica>on$
Full$subscrip>on$to$the$Uppsala$Center$$$$$$$$$
! Ministry$of$Health$and$Preven>on$is$the$na>onal$center$$
! Ac>va>on$of$4$regional$centers$represen>ng$local$health$authori>es$
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 15!
Terms,$Condi>ons$and$Prac>ces$of$
Pharmacovigilance$in$UAE$$
UAE$RADR$Smart$Phone$Applica>on$
ISOP!<!18TH!ANNUAL!MEETING!<!2018! 16!
" UAE$RADR$Scheme$is$vital$in$helping$MOHAP$monitor$the$safety$of$all$healthcare$products$in$the$UAE$to$ensure$they$are$acceptably$safe$for$pa>ents$and$those$that$use$them.$$
" Reports$can$be$made$for$all$medicines$including$vaccines,$blood$factors$and$immunoglobulin,$herbal$medicines$and$homeopathic$remedies$available$on$the$UAE$market.$
$$$$$$$$$
From$Play$store$for$android$hcps://play.google.com/store/apps/details?id=com.mhra.mohap$
from$App$Store$from$ios$hcps://itunes.apple.com/gb/app/uaeBradr/id1374384487?mt=8$
$
17!
With our Citizens at the Heart of Development, We Strive to become one of the most Competitive
Countries in the World”ISOP!<!18TH!ANNUAL!MEETING!<!2018!