Co esponding au ho : Ashish Jain
Copy igh © 2025 Au ho (s) e ain he copy igh o his a icle. This a icle is published unde he e ms o he C ea i e Commons A ibu ion Liscense 4.0.
Re hinking pha maco igilance: Building inclusi e d ug sa e y sys ems o
ma ginalized popula ions
Ashish Jain 1, * and Zahabia Adenwala 2
1 S . Di ec o , Pha maco igilance, Cu is Inc., Lexing on, MA, US.
2 Di ec o , Pha maco igilance Sciences, Se es The apeu ics, Camb idge, MA, US.
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 21(01), 214-223
Publica ion his o y: Recei ed on 29 No embe 2024; e ised on 08 Janua y 2025; accep ed on 10 Janua y 2025
A icle DOI: h ps://doi.o g/10.30574/wjbphs.2025.21.1.0027
Abs ac
Pha maco igilance is c i ical in acili a ing e o s a ge ed a closing he heal h gap by moni o ing, assessing and
p e en ing he occu ence o ad e se d ug eac ions (ADRs) ac oss di e se popula ions. This e iew aims o e alua e
how pha maco igilance sys ems can help mi iga e heal hca e inequali ies speci ically in low and middle-income
coun ies (LMICs). The ole o pha maco igilance as pa o he mode n d ug sa e y sys em in eg a ed wi hin a
heal hca e sys em became indispensable du ing he COVID-19 pandemic when d ug decision-making equi ed s ong
supe ision sys ems in e ms o accine sa e y. Howe e challenges exis , such as lack o esou ces, aining and
inadequa e in as uc u e ha is pa icula ly appa en in LMICs. The manusc ip conside s he social de e minan s o
heal h; s uc u al inequi ies and o he sys em ac o s ha accoun o he di e ences in he heal h s a us and medica ion
sa e y among di e en ma ginalized g oups. The use o mode n echnology such as elec onic heal h eco ds coupled
wi h da a mining s a egies is an e ec i e way o enhancing pha maco igilance. Communi y engagemen , educa ing
heal hca e p o ide s, and collabo a ing in e na ionally appea o be s ong s a egies o enhancing pha maco igilance
sys ems. Case s udies om Boli ia and Nige ia illus a e such a s a egy e ec i ely. The e iew concludes ha
heal hca e p o essionals and d ug moni o ing sys ems mus be s eng hened, and imp o ed and ecommends a uni ied
app oach in ol ing heal hca e wo ke s, policymake s, and communi ies o build obus , equi able d ug sa e y
moni o ing sys ems.
Keywo ds: Pha maco igilance; D ug Sa e y; Social De e minan s o Heal h; Heal h dispa i ies; Low and middle-
income coun ies (LMICs); S uc u al Inequi ies; Ad e se eac ions
1. In oduc ion
The Wo ld Heal h O ganiza ion (WHO) de ines pha maco igilance as he science and ac i i ies o moni o ing,
e alua ing, and unde s anding how o p e en ad e se e ec s o any o he d ug p oblem[1]. An inc easing ocus on his
a ea has become mo e e iden in ecen yea s, no ably in he con ex o add essing nume ous heal h inequali ies
unde lying di e en popula ions. Heal h inequali ies a e e med as he di e ences in heal h ou comes and heal hca e
access which a e closely associa ed wi h social, economic, o en i onmen al dep i a ion[2]. Such inequali ies could be
disease occu ences, ea men op ions, o ca e se ices. The ole o pha maco igilance in add essing hese inequali ies
a ies as i includes d ug sa e y su eillance, ad e se d ug eac ion moni o ing, and isk managemen o sa e medicines.
These examples indica e ha he scope o pha maco igilance should no be limi ed o d ug sa e y su eillance only as
i can change he cou se o public heal h. Fo example, he e a e o en dispa i ies ega ding he a es o ad e se d ug
eac ions among ma ginalized g oups in socie y, and hese di e ences can o en be a ibu ed o gene ic ac o s o
socioeconomic s a us ha in la e heal h access ba ie s[3]. The e o e, h ough a p oac i e app oach o ga he ing and
s udying da a abou speci ic popula ions, pha maco igilance seeks o be a he o e on o such endea o s so ha heal h
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p ac i ione s as well as egula o s can unde s and how o add ess po en ial issues wi h d ug usage in hese
communi ies[4]. The in eg a ion o pha maco igilance in o heal hca e sys ems can enhance he o e all quali y o ca e,
ensu ing ha all indi iduals, ega dless o hei backg ound, ecei e sa e and e ec i e ea men s. Indeed, he COVID-
19 pandemic has accen ua ed in he ecen pas he need o s eng hen pha maco igilance sys ems, especially in ega d
o accines. The inc ease in demand and supply o COVID-19 accines saw he need o make a ailable adequa e and
e ec i e pha maco igilance sys ems o moni o he sa e y and e icacy o hese accines. Acco ding o he li e a u e,
he e is subs an ial e idence ha indica es ha he e is imp o ed pha maco igilance du ing accina ion campaigns and
his g ea ly dec eases he likelihood o any ad e se e en occu ing ia p o-ac i e isk managemen , which in e u n
enhances he public con idence in u u e accina ions[5]. This is impo an , especially o he mo e ulne able
communi ies ha a e likely o be hesi an o ecei e accines due o ea s o ad e se e ec s.
As a esul o imely in o ma ion abou accine sa e y, he e is an inc ease in he a e o accina ion in hese
communi ies, which means ha pha maco igilance has a undamen al unc ional capaci y o imp o e heal h in hese
communi ies. Also, he suppo and educa ion on pha maco igilance is impo an o heal h equi y. I has been ound
ha heal hca e wo ke s who a e amilia wi h he basic p inciples o pha maco igilance a e mo e willing o epo
ad e se d ug eac ions and p ac ice sa e p esc ibing[6]. This b ings o he o e on he impo ance o egula e eshe
cou ses in majo a eas ela ed o d ug he apy including he epo ing mechanism o ad e se e en s[7]. In a numbe
o LMIC’s (low- and middle-income coun ies) he e a e a numbe o ained s a and a lack o esou ces ha c ea e
bo lenecks o e ec i e pha maco igilance sys ems and u he agg a a e heal h inequi ies[8]. So, he e is a need o
dedica e esou ces o sys ems aining and enhancemen as his would help s eng hen he pha maco igilance sys ems
in such a way ha all socie ies a e able o in eg a e medica ion secu i y. O e and abo e, he impo ance o membe s o
he communi y and he way hey know abou he unc ions o pha maco igilance is equally impo an . I is belie ed ha
public ela ions campaigns o make pa ien s awa e o he impo ance o pha maco igilance can empowe hem o
pa icipa e ac i ely in hei heal hca e[9]. Fo ins ance, p og ams ha p omo e medica ion use among pa ien s p o ide
essen ial in o ma ion o pha maco igilance sys ems, which in u n, lead o be e d ug sa e y and subsequen heal h
ou comes. The ad ancemen o In o ma ion Technology in he p ac ice o pha maco igilance will also help in achie ing
e ec i eness and e iciency in he moni o ing o d ugs. Elec onic heal h eco ds (EHRs) oge he wi h da a mining
s a egies will ease he wo k o de ec ing ADRs and will imp o e he pha maco igilance p ac ice as a whole[10]. In
pa allel, social media si es ha e p o ided cu en eal- ime d ug sa e y in o ma ion which enables ea ly esponse o he
sa e y issue ha is eme ging[11]. Such echnologies could he e o e make pha maco igilance sys ems mo e e ec i e in
add essing heal h inequi ies and o he heal h issues.
2. Unde s anding Heal h Dispa i ies
2.1. Role o Social De e minan s o Heal h
Heal h inequali ies a e in icacies esul ing om a ious causes ha end o be loca ed in he social de e minan s o
heal h. The social de e minan s include he di e se ci cums ances in which people a e bo n, g ow, li e, and wo k as
well as he olde age in which people li e and all o hese con ibu e o he heal h s a us o ce ain popula ions in
di e en ways[12]. Ce ain ac o s such as he indi idual's social class, le el o educa ion, and neighbo hood ha e a
di ec bea ing on whe he one can seek heal h se ices o no , he ype o se ices one ecei es, and he ype o se ices.
P e ious s udies ha e highligh ed ha heal h inequi ies emain an issue and ha people in ma ginalized g oups such
as acial and e hnic g oups and low-income people who li e in u al a eas a e mo e likely o expe ience such
challenges[13]. The in e play o access o heal hy ood op ions, sa e housing, and adequa e medical ca e explains he
highe a es o ch onic illnesses such as diabe es, hype ension, and ca dio ascula diseases in hese popula ions mo e
ho oughly[14]
2.2. S uc u al Inequi ies
Heal h dispa i ies do no only a ise om indi idual ac ions o indi idual unc ioning, bu a he such dispa i ies a e
ein o ced by s uc u al inequi ies in he socie y. Fo example, people esiding in economically disad an aged
neighbo hoods may no ha e easy access o heal hca e cen e s, which may esul in pos poning seeking heal hca e
se ices, hus yielding poo heal h consequences[4]. No is his access aided by c oss-cul u al and linguis ic issues
whe e people om di e en cul u es ha e p oblems wi h na iga ing he heal hca e sys em o e en s a ing hei heal h
o medical needs. Such sys emic p oblems a e ala ming since hey indica e ha he e is a need o he inclusion o heal h
inequali ies in he agenda o public heal h ac ion h ough an explici ocus on he unde lying social de e minan s[15].
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2.3. In eg a ing Pha maco igilance in o Public Heal h Ini ia i es
The ocus o pha maco igilance is indeed an impo an a ea o s a in seeking o ed ess such inequali ies since i
ocuses on e alua ing ADRs in a mo e popula ion-ad e se way. Pha maco igilance sys ems a e able o iden i y he
p esence o speci ic disc epancies among ma ginalized popula ions because hey a e able o disce n and assess da a on
Ad e se D ug Reac ions (ADRs). Fo example, speci ic g oups may possess a highe isk o he ad e se e ec s o ce ain
medica ions due o gene ics, en i onmen al, and o he social de e minan s o heal h[16]. These ac o s ha e signi ican
implica ions o clinicians and policy ad oca es when seeking a ge ed in e en ions o indi iduals who a e acing
heigh ened isks o medica ion- ela ed ad e se e ec s and will be able o explain why a nuanced app oach is desi ed.
They wan o augmen he sa e y o medica ion and i s e ec i eness o all people, especially hose a g ea e isk.
Mo eo e , pha maco igilance can s eng hen exis ing na ional public heal h s a egies and coun e ac he e ec s o
sa e y e en s on people al eady ecei ing heal hca e in e en ions. Toge he wi h local o ganiza ions, communi ies, and
o he ele an s akeholde s, hose in cha ge o moni o ing ad e se d ug e en s can be e pinpoin he speci ic needs
o a di e se popula ion[17]. Such clinical ca e in eg a ion helps o build con idence wi hin he a ge popula ion and
makes hem mo e willing o be esponsible o hei ea men choices[18]. As an example, i can be a gued ha i
pa ien s a e augh o ecognize he impo ance o ADRs, hen pa ien s a e mos likely o show mo e ac i i y and epo
speci ic occu ences, hus assis ing medical p o essionals and ul ima ely con ibu ing o imp o ed heal h ou comes.
3. Impo ance o Pha maco igilance sys ems
Pha maco igilance main ains a c i ical ole in heal hca e sys ems as i is designed o ack he sa e y and e ec i eness
o p oduc s a e hey ha e been comme cialized. These sys ems p o ec he popula ion by ac i ely o ganizing and
e alua ing in o ma ion on ad e se d ug eac ions (ADRs) and o he d ug- ela ed p oblems du ing he pos -ma ke ing
s age o a d ug li e cycle[19] . The ole o pha maco igilance goes u he han simply epo ing da a; i p o ides an
oppo uni y o ge a be e g asp on he my iad o issues ela ed o d ug sa e y, as well as he isks b ough on by d ug
ea men s among di e en g oups.
3.1. Iden i ying and Cha ac e izing ADRs
One o he p ima y unc ions o pha maco igilance sys ems is o iden i y and cha ac e ize ADRs ha may no ha e been
e iden du ing clinical ials. The esul s o clinical ials, hough impo an in de e mining he i s le el o d ug sa e y
and e icacy, a e no mally conduc ed on a selec ed and limi ed popula ion g oup, which may no ully ep esen he
b oade pa ien demog aphics ha will ul ima ely use he medica ion[20]. As a esul , some o he ad e se d ug
eac ions may only be de ec ed when he d ug is gi en o a mo e a ied and b oade g oup o people, como bid
popula ions, polypha macy, and di e en e hnici y g oups[21]. Such eac ions moni o ed in he pos -ma ke ing s age
a e ele an since hey make i possible o e alua e he d ug sa e y in eal-wo ld condi ions and ecommend o he
possible uses in pa ien managemen . These sys ems may also assis heal hca e p o essionals and policymake s in
iden i ying medica ion sa e y issues o conce ns, which in u n may aid he de elopmen o s eng hen exis ing isk
managemen amewo ks. As an example, whene e he e is a signi ican numbe o epo s o ADRs o a pa icula
medica ion, egula o s end o ini ia e o eassess he sa e y o he d ug[4]. This ype o ac ion can esul in quick ac ions
such as e ising he d ug label in o ma ion; gi ing wa nings o he public ega ding sa e y issues, o e en suspending
he d ug om comme cializa ion. P e en ion and mi iga ion measu es o his ype a e c ucial o sa egua ding he
heal h s a us o he popula ion and o he e ec i e managemen o he ea men o pa ien s.
3.2. Sa egua ding Vulne able Popula ions and In eg a ing Technology
E ec i e pha maco igilance is pa icula ly essen ial when dealing wi h ADRs in ulne able popula ions. Gene ic,
en i onmen al, and e en socioeconomic ac o s play a ole in how indi iduals espond o medica ion[10]. Fo example,
d ug me abolism may be impai ed in ce ain e hnic subpopula ions o he ex en ha hey a e a isk o ADR.
Addi ionally, indi iduals om lowe socioeconomic backg ounds may ace ba ie s o u iliza ion o he heal h se ices
ha may esul in delayed epo ing o ADRs o seeking ca e[22]. By ocusing on hese a - isk popula ions,
pha maco igilance sys ems can help iden i y speci ic sa e y conce ns and ailo in e en ions o mi iga e isks
e ec i ely. Mo eo e , echnology nowadays can be emb aced in pha maco igilance ac i i ies hus inc easing he
moni o ing e ec i eness o d ug sa e y. The in oduc ion o EHRs and da a mining echniques acili a es he quick
analysis o la ge quan i ies o da a, and his inc eased access o in o ma ion helps in he iden i ica ion o ADRs ha a e
di icul o see wi h he use o adi ional epo ing echniques[10]. Social ne wo ks ha e also become impo an sou ces
o cap u ing d ug sa e y e en s, allowing pha maco igilance sys ems o add ess sa e y issues ha a ise in a imely
ashion. U iliza ion o hese echnological ends can b ing abou mo e esponsi e and lexible pha maco igilance and
hus imp o e pa ien sa e y and ul ima ely leading o be e pa ien sa e y ou comes[23].
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4. Pha maco igilance in Low- and Middle-Income Coun ies (LMICs):
4.1. Inadequa e pha maco igilance in LMICs
The e a e many issues associa ed wi h he pha maco igilance sys em in low- middle-income coun ies which in u n
does no allow d ug sa e y moni o ing sys em o be e ec i e. The issues basically a ise ou o esou ce cons ain s, lack
o app op ia e s a aining and inadequa e p ima y heal h ca e sys em[24]. Because o hese de iciencies he e a e
di e consequences due o magni ica ion o heal h inequali ies. The majo i y o people in low and middle income
coun ies lack p ope access o medica ion sa e y supe ision which pu hem a a mo e dange ous isk han hose in
high income coun ies[8]. Fo example, a su ey conduc ed in Nepal e ealed ha medical ca e p o ide s ha e poo
unde s anding and p ac ice o pha maco igilance which makes hem ine ec i e in epo ing and moni o ing ad e se
d ug eac ions (ADRs). This ba ie o epo ing ad e se d ug eac ions can be insu icien educa ion and aining in
hese a eas which can be c i ical in sa egua ding he use o d ugs in such egions[25].
4.2. Financial and human esou ce cons ain s
The inancial limi a ions encoun e ed by he LMICs wo sen he al eady exis ing cos s associa ed wi h es ablishing and
e en keeping unc ioning pha maco igilance sys ems. Nume ous coun ies in his g oup ha e p oblems wi h budge a y
alloca ions which do no enable hem o unde ake ac i e pha maco igilance ac i i ies. As an example, compa ison o
na ional pha maco igilance sys ems in Eas e n A ica highligh ed ha e en when some budge s a e p o ided, hose
ela i ely do no mee he po en ial alloca ion needed o e ec i e unde s anding o he pha maco igilance egula ion
and guidelines[26]. This inancial de iciency can gi e ise o unde esou cing o d ug sa e y moni o ing including he
lack o epo ing ADRs da abases and he sa e y da a analysis sys ems[27]. Besides budge a y issues, he human
esou ce pa o he pha maco igilance in LMIC is also insu icien . The e is a lack o quali ied pe sonnel capable o
pe o ming pha maco igilance unc ions such as collec ion and analysis o ADR epo s. Mos o he ime, wi h he
excessi e wo kload hey ha e, he medical s a ha e no chance o pe o m he ac i i ies o d ug sa e y. Also, he
absence o such specialized aining p og ams ende s a mo e o less unp epa ed d ug sa e y wo k o ce who a e no
able o de ec and epo ADRs p ope ly[26,27]. Fu he mo e, his ac is agg a a ed by he ac ha many heal hca e
wo ke s a e no likely o iew pha maco igilance ac i i ies as highly impo an and a e he e o e less likely o epo
abuse, which c ea es an en i onmen esis an o good pha maco igilance p ac ices[28].
4.3. Oppo uni ies o Imp o emen : Technology and Collabo a ion
One o he ways o add ess some o hese issues is o conside he applica ion o echnology in pha maco igilance
p ac ices. Fo example, mobile heal h apps and elec onic epo ing sys ems can make he p ocess o epo ing e en
ad e se d ug eac ion in cases whe e he esou ces a e sca ce qui e easy[8]. In a s udy ha was conduc ed in Namibia,
heal hca e p ac i ione s exp essed a desi e o employ mobile heal h apps in epo ing ADRs which indica es ha
pha maco igilance could be ad anced by echnology in he case o LMIC[29]. Howe e , he success ul implemen a ion
o such echnologies equi es adequa e in as uc u e and aining, which a e o en lacking in hese egions. The
e ec i e use o a ailable da a and sha ing o in o ma ion be ween coun ies may enhance he pha maco igilance sys em
in de eloping coun ies. Tha is, he c ea ion o egional pha maco igilance ne wo ks can acili a e he sha ing o bes
p ac ices, exis ing esou ces and da a on ADRs[30]. Such collabo a i e endea o s help coun ies o be mo e igilan and
he e o e sa e in e ms o d ug use and can also p o ide imely answe s o sa e y ma e s ha a ise[31]. In addi ion,
he local popula ion’s in ol emen in pha maco igilance may aise he knowledge le el conce ning epo ing ad e se
d ug e ec s and in he end imp o e pa ien s’ sa e y and lead o be e ou comes.
5. O e coming dispa i ies in Pha maco igilance awa eness
5.1. Educa ion and T aining in Pha maco igilance:
Educa ion and aining o heal hca e p o essionals a e p e equisi es o he success o pha maco igilance p og ams.
The s udies indica ed ha heal hca e s a wi h a sound unde s anding o pha maco igilance a e p edisposed o
epo ing ADRs[32]. Pha maco igilance educa ion p og ams a e capable o imp o ing he knowledge and
unde s anding o hese esponsibili ies among heal hca e p o ide s he eby enhancing he a e o epo ing and
be e ing pa ien sa e y. Fo example, he addi ion o pha maco igilance aining in o cou ses such as medical and
pha macy educa ion can p epa e u u e heal hca e wo ke s o iden i y and epo on ADRs[32,33].
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5.2. Communi y Engagemen and Public Awa eness
I is impo an o in ol e he communi y and c ea e public awa eness on pha maco igilance so as o imp o e he ADRs
epo ing le els. Many o he pa ien s who ecei e hese medica ions do no unde s and he need o epo ing o ADRs,
which leads o low epo ing and loss o da a on d ug sa e y. Campaigns on heal h issues aimed a pa ien s by educa ing
hem abou pha maco igilance can ensu e ha hey ake pa in hei heal h ca e ac i ely. Fo ins ance, campaigns
aimed a pa ien s o epo hei expe ience wi h use o medica ions can be bene icial o pha maco igilance sys ems
[34].
6. Challenges in Pha maco igilance Implemen a ion and Fu u e Di ec ions
6.1. Challenges in implemen a ion
The e a e a numbe o ba ie s p e en ing he es ablishmen o sys ems o pha maco igilance despi e ha ing he
po en ial o be bene icial especially in LMICs. These ba ie s include he lack o unds, egula o y en o cemen , absence
o s akeholde coope a ion, and a gene al lack o willingness o inco po a e pha maco igilance in he la ge heal hca e
sys em[35]. Such excep ions do no ake in o conside a ion he exis ing egula o y amewo ks wi hin he LMIC, whe e
adap abili y plays a key ole in seamless d ug moni o ing. Fo example, heal hca e wo ke s may be eluc an o epo
ADRs due o he need o excessi e documen a ion and bu eauc a ic p ocedu es can de e heal hca e p o essionals
om epo ing ADRs, leading o signi ican unde epo ing. Fo ins ance, du ing ou b eaks o in ec ious diseases,
esou ces may be di e ed away om pha maco igilance e o s, u he weakening he sys em's capaci y o moni o
d ug sa e y[8].
E ec i e pha maco igilance equi es coo dina ion be ween heal h p o essionals, he go e nmen , he communi y, and
pha maceu ical companies. Ye in many LMICs, hese s akeholde s a e known o ope a e in silos, leading o agmen ed
e o s o imp o e d ug sa e y. Fo ins ance, poo communica ion among heal hca e p o essionals and egula o s can
lead o pe sis en sa e y issues and conce ns, po en ially pu ing pa ien s a isk. The absence o a uni ied app oach o
pha maco igilance does no allow o s anda diza ion o p ac ices such as he epo ing o ad e se d ug eac ions and
da a collec ion ac i i ies, which is pi o al in examining pa e ns and de e mining sa e y signals ha may be p esen [36].
6.2. Dispa i ies in Pha maco igilance Awa eness
The challenge o inco po a ing pha maco igilance in o he b oade con ex o he heal h sys em is ano he issue. In
se e al coun ies, pha maco igilance is ega ded as an independen sys em a he han an essen ial componen o
pa ien sa e y and quali y o ca e. This sepa a ion could acili a e a lack o knowledge among heal hca e wo ke s wi h
espec o he signi icance o ADR epo ing and he ole o pha maco igilance in pa ien ca e[16]. Mo eo e , his lack
o coo dina ion is compounded by he absence o s anda dized aining p og ams o heal hca e p ac i ione s ega ding
pha maco igilance, c ea es a gene al knowledge gap, and hinde s e ec i e epo ing o ad e se d ug eac ions (ADRs)
o epo ing and moni o ing[32]. S udies ha e demons a ed ha , heal hca e p o essionals do no unde s and he
exis ing pha maco igilance sys ems as well as epo ing p ocesses, his could cause u he incidences o
unde epo ing[31].
6.3. Fu u e Di ec ions
Solu ions o he challenge o unde - epo ing should be mul i-s a egic in na u e. Fi s , he egula o y amewo ks o
he pha maco igilance sys ems ha e o be e ised o simpli y he epo ing o ADRs and acili a e pa icipa ion o he
heal hca e p o essionals in su eillance ac i i ies. This may in ol e s eamlining documen a ion equi emen s and
p o iding clea guidelines on how o epo ADRs app op ia ely. Fu he mo e, inc easing he alloca ion o esou ces o
pha maco igilance sys ems equi es also an inc ease in unding in exis ing sys ems. In e na ional o ganiza ions and
go e nmen s should conside pha maco igilance and hese budge a y esponsibili ies in hei heal h expendi u e
s a egies and sea ch o s ong esou ces o supplemen hem.
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Figu e 1 Pha maco igilance amewo k o inclusi eness
7. Case S udies
The e a e many case s udies ha demons a e he ole o pha maco igilance in educing heal h dispa i ies, pa icula ly
in LMICs ha ha e ulne able popula ions ha a e a inc eased isk when i comes o he use o medica ions.
• One such case is Boli ia, whe e sus ained e o s owa ds imp o emen o he pha maco igilance sys em ha e
helped in add essing he p oblem o low moni o ing o ad e se d ug eac ions (ADRs) ela ing o Chagas disease
and ube culosis medicines. These diseases ha e a s ong incidence in low-income popula ions and hus
e ec i e pha maco igilance is c ucial o ensu e pa ien sa e y and ea men e ec i eness[37]. In Boli ia,
in e na ional heal h o ganiza ions eamed up wi h he go e nmen o design an elabo a e educa ional package
on he ecogni ion and epo ing o ADRs o heal h p ac i ione s. This p ojec no only imp o ed he
compe ence o he heal h p o ide s bu also nu u ed he sa e y cul u e in he heal h sys em. Consequen ly,
he e was a huge inc ease in he epo ing o ADRs which made i possible o adminis e imely changes in
allowing o imely in e en ions and adjus men s o ea men p o ocols he eby p omo ing he sa e y and
heal h o he popula ions in he a ge ed egions[37]
• In Nige ia, Communi y heal h wo ke s ha e been c ucial in p e en ing heal h dispa i ies in ega d o mala ia
h ough he use o pha maco igilance. In mala ia con ol ini ia i es, communi y heal h wo ke s we e ec ui ed
o collec da a on ad e se e en s associa ed wi h he d ugs used— his con e ged wi h he idea o g ass oo s
pha maco igilance o encou age local in ol emen in hese e o s as communi y heal h wo ke s se e as i al
links be ween heal hca e sys ems and he popula ions hey se e[38]. This ini ia i e empowe ed hese wo ke s
wi h he abili y o cap u e ADRs and helped he Nige ian heal h au ho i ies complemen hei d ug sa e y
su eillance e o s. Namely, his in o ma ion was use ul no jus o showcase o he heal hca e p o ide s he
isks associa ed wi h a ious ea men op ions, bu also o ealize ce ain isk g oups, which would be
inhe en ly a mo e isk o being a ec ed so ha esou ces could be e icien ly u ilized o educe he isk[38]
These case s udies collec i ely demons a e ha i is possible o add ess speci ic public heal h issues a ec ing
ma ginalized g oups h ough a ge ed pha maco igilance policies. By s eng hening local pa icipa ion, imp o ing
educa ion and aining o p ac i ione s as well as embedding pha maco igilance in o he public heal h ac i i ies,
coun ies will be able o s eng hen d ug sa e y p ac ices and ul ima ely imp o e heal h ou comes o he whole
popula ion, wi h a pa icula ocus on hose popula ions mos likely o su e om ad e se d ug e en s.
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8. Conclusion
In add essing heal h dispa i ies, pha maco igilance is essen ial as i makes ce ain ha medica ions used by di e se
popula ions a e sa e and e ec i e. This has become e en mo e appa en looking a how he wo ld heal hca e sys em is
s uggling wi h issues su ounding he sa e y o d ugs as obus pha maco igilance amewo ks a e becoming
necessa y and no op ional. These sys ems no only moni o ADRs bu also se e as impo an mechanism o educing
he ad e se d ug eac ions ha could be su e ed by a popula ion wi h high heal h bu den. Howe e , o maximize he
impac o pha maco igilance, he e is need o educa ion o he s akeholde s such as heal hca e p o ide s on how o
use hese sys ems by p o iding hem wi h ele an in o ma ion, his change could os e a cul u e o sa e y wi hin
heal hca e sys ems. This is especially he case in LIMC whe e he p o ide s lack awa eness on how and why epo ing
ad e se d ug eac ions is necessa y. Addi ionally, engaging in he communi y in pha maco igilance ends o empowe
pa ien s o a ca egi e o ensu e sa e y and pa icipa e in d ug sa e y moni o ing hus leading o collec ing da a ha
would be use ul in de e mining he isks in ol ed wi h he medica ion. In eg a ion o echnology is ano he way ha
g ea ly con ibu es o he imp o emen o he o e all sa e y moni o ing o d ugs.
The in eg a ion o ad anced da a analy ics, machine lea ning, and a i icial in elligence can enhance he pe o mance o
signal de ec ion and isk assessmen , acili a ing imely and e ec i e esponses o new and e ol ing sa e y issues.
Au oma ed epo ing sys ems will p o ide help o heal hca e p o ide s and pa ien s o he easie submission o ADRs.
Mo eo e , social ne wo k ools and online heal h o ums p o ide insigh s in o how pa ien s eel abou he sa e use o
medica ions. Fo a pha maco igilance sys em o be e ec i e, he challenges o implemen a ion mus be well me . The
absence o app op ia e egula o y amewo ks, inadequa e unding and poo engagemen can hinde he de elopmen
o obus pha maco igilance amewo ks. Such sys ems equi e he in eg a ion o go e nmen agencies, medical
p ac i ione s and he non-go e nmen al sec o s is necessa y o c ea e a suppo i e en i onmen o pha maco igilance
ac i i ies. In u n, his collabo a ion can enable he in eg a ion and sha ing o esou ces, skills and expe iences o
s eng hen d ug sa e y moni o ing and enhance he o e all heal h s a us o he popula ion. Wi h he ad ancemen o
science and unde s anding o he ole o pha maco igilance in public heal h, hese sys ems ha e o be inco po a ed in
la ge heal h policies encompassing he wide spec um o social well-being. This will no only inc ease he e iciency
o pha maco igilance bu also os e he achie emen o he o e a ching aim o heal h equali y.
By p io i izing he sa e y o medica ions and add essing he unique needs o ulne able popula ions, we can s i e o
he de elopmen o a heal hca e sys em ha is app op ia e o he di e se needs o he pa ien popula ion. To conclude,
i can be s a ed ha s eng hening he exis ing pha maco igilance sys ems is an in eg al pa o he s a egy o assu ing
he sa e y o public heal h and ensu ing ha all g oups can ecei e sa e and e ec i e medica ions. By os e ing a cul u e
o sa e y, he use o new echnologies, and elimina ing o some sys emic challenges, i will be possible o imp o e
pha maco igilance measu es and ul ima ely heal h ou comes o he en i e popula ion, especially he ulne able ones.
A uni ied app oach is needed om all heal hca e wo ke s o ensu e ha pha maco igilance suppo sys ems a e
accep able om he onse and a e buil in o pa ien ca e and public heal h ini ia i es.
Compliance wi h e hical s anda ds
Disclosu e o con lic o in e es
The au ho s ha e no con lic s o in e es ha a e di ec ly ele an o he con en o his a icle. The iews exp essed in
his a icle a e he pe sonal iews o he au ho s and may no be unde s ood o quo ed as being made on behal o o
e lec ing he posi ion o hei ins i u ions.
Funding
The au ho s did no ecei e inancial suppo om any o ganiza ion o he submi ed wo k
Code a ailabili y
No applicable, as no cus om code o so wa e applica ion was de eloped o used in his s udy.
Au ho s’ Con ibu ion
Ashish Jain and Zahabia Adenwala con ibu ed o he concep ion and design o he manusc ip . Ashish Jain d a ed he
manusc ip . Zahabia Adenwala p o ided c i ical e iews and key inpu s o he manusc ip . All au ho s ead, e iewed,
and app o ed he inal manusc ip .
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 21(01), 214-223
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Highligh s
• The pape highligh s how pha maco igilance sys ems a e c ucial o moni o ing d ug sa e y bu ace signi ican
challenges in low and middle-income coun ies due o esou ce cons ain s and inadequa e in as uc u e.
• Technology in eg a ion h ough elec onic heal h eco ds and mobile apps o e s p omising solu ions o
imp o ing ad e se d ug eac ion epo ing and moni o ing.
• Success cases om Boli ia and Nige ia demons a e how communi y engagemen and heal hca e wo ke
aining can s eng hen pha maco igilance sys ems in esou ce-limi ed se ings.
• The COVID-19 pandemic emphasized he c i ical need o obus pha maco igilance sys ems, pa icula ly o
accine sa e y moni o ing, while showcasing he impo ance o add essing heal h dispa i ies h ough inclusi e
d ug sa e y moni o ing app oaches.
Re e ences
[1] WHO. The Impo ance o Pha maco igilance: Sa e y Moni o ing o Medicinal P oduc s 2002.
h ps://www.who.in / eams/ egula ion-p equali ica ion/ egula ion-and-sa e y/pha maco igilance (accessed
Decembe 24, 2024).
[2] Osadolo OO, Osadolo AJ, Osadolo OO, Enabulele E, Akaji EA, Odiowaya DE. Access o heal h se ices and heal h
inequali ies in emo e and u al a eas. Janaki Med Coll J Med Sci 2022;10:70–4.
h ps://doi.o g/10.3126/jmcjms. 10i2.47868.
[3] Baeh A, Peña JC, Hu DJ. Racial and E hnic Dispa i ies in Ad e se D ug E en s: A Sys ema ic Re iew o he
Li e a u e. J Racial and E hnic Heal h Dispa i ies 2015;2:527–36. h ps://doi.o g/10.1007/s40615-015-0101-3.
[4] Co es-Se a N, Sa a ia R, G ágeda RM, Apaza A, González-Ga cía J, Ríos B, e al. S eng hening he Boli ian
Pha maco igilance Sys em: New Su eillance S a egies o Imp o e Ca e o Chagas Disease and Tube culosis.
Plos Neglec ed T opical Diseases 2020. h ps://doi.o g/10.1371/jou nal.pn d.0008370.
[5] Sh es ha S, Kha i J, Shakya S, Danekhu K, Kha iwada AP, Sah R, e al. Ad e se e en s ela ed o COVID-19
accines: he need o s eng hen pha maco igilance moni o ing sys ems. D ugs The Pe spec 2021;37:376–82.
h ps://doi.o g/10.1007/s40267-021-00852-z.
[6] Siddiqua A, Alshah ani N, Iqbal JM, Ali AM, Abdul ahman R, alqa ni S ahmad, e al. E alua ion and Assessmen o
he Knowledge, A i ude and P ac ice o Pha macy S uden s Wi h Respec o Pha maco igilance in a Saudi
Pha macy School: A C oss-Sec ional S udy. 2019. h ps://doi.o g/10.21203/ s.2.13367/ 2.
[7] Rajesh G, Binnal A, Chhab a C, Chhab a KG, Sha ma A, Goyal A. Pha maco igilance: The Leas Unde s ood and
Leas P ac iced Science in Den is y. Wo ld Jou nal o Den is y 2019. h ps://doi.o g/10.5005/jp-jou nals-
10015-1661.
[8] Kiguba R, Olsson S, Wai C. Pha maco igilance in low- and middle-income coun ies: A e iew wi h pa icula
ocus on A ica. B i J Clinical Pha ma 2023;89:491–509. h ps://doi.o g/10.1111/bcp.15193.
[9] Aiden J, Dabes C, Maduka K, Oguche D, I iola AJ, O esanya O. Pha maco igilance Repo ing Du ing Seasonal
Mala ia Chemop e en ion in Nige ia: Findings F om he 2020 Campaign 2022. h ps://doi.o g/10.21203/ s.3. s-
1327256/ 1.
[10] Ed ees H, Song W, Sy owa ka A, Simona A, Ama o MG, Ba es DW. In elligen Teleheal h in Pha maco igilance: A
Fu u e Pe spec i e. D ug Sa e y 2022. h ps://doi.o g/10.1007/s40264-022-01172-5.
[11] Sa R, Xu Y, Pan X, Wang Y, Lin Z, Zhang X, e al. A Bibliome ic Analysis o Resea ch P og ess on Pha maco igilance
and Cance F om 2002 o 2021. F on ie s in Oncology 2023. h ps://doi.o g/10.3389/ onc.2023.1078254.
[12] WHO. Social de e minan s o heal h n.d. h ps://www.who.in /heal h- opics/social-de e minan s-o -
heal h# ab= ab_1 (accessed Decembe 24, 2024).
[13] Williams DR, Mohammed SA, Lea ell J, Collins C. Race, socioeconomic s a us, and heal h: Complexi ies, ongoing
challenges, and esea ch oppo uni ies. Annals o he New Yo k Academy o Sciences 2010;1186:69–101.
h ps://doi.o g/10.1111/j.1749-6632.2009.05339.x.
[14] S upplebeen DA. Housing and Food Insecu i y and Ch onic Disease Among Th ee Racial G oups in Hawai’i. P e
Ch onic Dis 2019;16:180311. h ps://doi.o g/10.5888/pcd16.180311.
[15] Al Shamsi H, Almu ai i AG, Al Mash a i S, Al Kalbani T. Implica ions o Language Ba ie s o Heal hca e: A
Sys ema ic Re iew. Oman Med J 2020;35:e122–e122. h ps://doi.o g/10.5001/omj.2020.40.
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 21(01), 214-223
222
[16] Jee u G, Anusha G. Pha maco igilance: A Wo ldwide Mas e Key o D ug Sa e y Moni o ing. Jou nal o Young
Pha macis s 2010;2:315–20. h ps://doi.o g/10.4103/0975-1483.66802.
[17] Sama a C, Ga cia A, Hen y C, Vallo on L, Ca iola o L, Desmeules J, e al. Sa e y Su eillance Du ing D ug
De elopmen : Compa a i e E alua ion o Exis ing Regula ions. Ad The 2023;40:2147–85.
h ps://doi.o g/10.1007/s12325-023-02492-3.
[18] C oss AJ, Ellio RA, Pe ie K, Ku u illa L, Geo ge J. In e en ions o imp o ing medica ion- aking abili y and
adhe ence in olde adul s p esc ibed mul iple medica ions. Coch ane Da abase o Sys ema ic Re iews
2020;2020. h ps://doi.o g/10.1002/14651858.CD012419.pub2.
[19] San o o A, Geno G, Spoone A, Raine J, A le P. P omo ing and P o ec ing Public Heal h: How he Eu opean
Union Pha maco igilance Sys em Wo ks. D ug Sa e y 2017. h ps://doi.o g/10.1007/s40264-017-0572-8.
[20] La e u A, Vo a B, Giacomini KM, Al man R, Rensi S. A New E a in Pha maco igilance: Towa d Real-Wo ld Da a
and Digi al Moni o ing. Clin Pha ma and The apeu ics 2021;109:1197–202. h ps://doi.o g/10.1002/cp .2172.
[21] Downing J, Taylo R, Moun ain R, Ba B, Da as K, Come o d T, e al. Socioeconomic and heal h ac o s ela ed o
polypha macy and medica ion managemen : analysis o a Household Heal h Su ey in No h Wes Coas England.
BMJ Open 2022;12:e054584. h ps://doi.o g/10.1136/bmjopen-2021-054584.
[22] Aloma MJ. Fac o s a ec ing he de elopmen o ad e se d ug eac ions (Re iew a icle). Saudi Pha maceu ical
Jou nal 2014;22:83–94. h ps://doi.o g/10.1016/j.jsps.2013.02.003.
[23] Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pi mohamed M. Social media and pha maco igilance: A
e iew o he oppo uni ies and challenges. B i J Clinical Pha ma 2015;80:910–20.
h ps://doi.o g/10.1111/bcp.12717.
[24] Menang O, Kuemme le A, Maige e K, Bu i C. S a egies and in e en ions o s eng hen pha maco igilance
sys ems in low-income and middle-income coun ies: a scoping e iew. BMJ Open 2023;13:e071079.
h ps://doi.o g/10.1136/bmjopen-2022-071079.
[25] Jha N. Need o in ol ing consume s in Nepal’s pha maco igilance sys em. AMJ 2014;7:191–5.
h ps://doi.o g/10.4066/AMJ.2014.2011.
[26] Ba y A, Olsson S, Minzi O, Bien enu E, Makonnen E, Kamuhabwa A, e al. Compa a i e Assessmen o he Na ional
Pha maco igilance Sys ems in Eas A ica: E hiopia, Kenya, Rwanda and Tanzania. D ug Sa 2020;43:339–50.
h ps://doi.o g/10.1007/s40264-019-00898-z.
[27] Ndagije HB, Walusimbi D, A uhai e J, Ampai e S. D ug sa e y in A ica: a e iew o sys ems and esou ces o
pha maco igilance. Expe Opinion on D ug Sa e y 2023;22:891–5.
h ps://doi.o g/10.1080/14740338.2023.2251375.
[28] Adisa R, Omi ogun TI. Awa eness, knowledge, a i ude and p ac ice o ad e se d ug eac ion epo ing among
heal h wo ke s and pa ien s in selec ed p ima y heal hca e cen es in Ibadan, sou hwes e n Nige ia. BMC Heal h
Se Res 2019;19:926. h ps://doi.o g/10.1186/s12913-019-4775-9.
[29] Adenuga BA, Kibuule D, Rennie TW. Op imizing spon aneous ad e se d ug eac ion epo ing in public heal hca e
se ing in Namibia. Basic Clin Pha ma Tox 2020;126:247–53. h ps://doi.o g/10.1111/bcp .13325.
[30] Ga ashi HY, S einke DT, Scha heu le EI. A Sys ema ic Re iew o Pha maco igilance Sys ems in De eloping
Coun ies Using he WHO Pha maco igilance Indica o s. The Inno Regul Sci 2022;56:717–43.
h ps://doi.o g/10.1007/s43441-022-00415-y.
[31] Vu al F, Ci ci S, Vu al B. The Knowledge, A i ude and Beha iou s o Nu ses Abou Pha maco igilance, Ad e se
D ug Reac ion and Ad e se E en Repo ing in a S a e Hospi al. No he n Clinics o Is anbul 2015.
h ps://doi.o g/10.14744/nci.2014.41636.
[32] Shenoy AK, Kama h A, Chow a MN, Boloo A, A a ind A, Thaku PB, e al. Knowledge o pha maco igilance among
heal hca e p o essionals and he impac o an educa ional in e en ion. Medicine and Pha macy Repo s
2023;96:406–12. h ps://doi.o g/10.15386/mp -2076.
[33] Reume man M, Tichelaa J, Pie sma B, Richi MC, Van Ag mael MA. U gen need o mode nize pha maco igilance
educa ion in heal hca e cu icula: e iew o he li e a u e. Eu J Clin Pha macol 2018;74:1235–48.
h ps://doi.o g/10.1007/s00228-018-2500-y.
