Promotion of Digitalized Pharmacovigilance Technologies ... ·...

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%!

!

!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$Sta>s>cs$


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$


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$$


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$it……..$


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.!!


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!


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$$


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$authori>es$


Terms,$Condi>ons$and$Prac>ces$of$

Pharmacovigilance$in$UAE$$

UAE$RADR$Smart$Phone$Applica>on$


"  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!

Promotion of Digitalized Pharmacovigilance Technologies ... ·...

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