ADR Reporting, Medication ADR Reporting, Medication Error Reporting System Error Reporting System (MERS) & Cold Chain (MERS) & Cold Chain ManagementManagementUpdates from Bengkel Laporan KesanUpdates from Bengkel Laporan Kesan Advers Ubat-Ubatan dan Vaksin Advers Ubat-Ubatan dan Vaksin18-20 ar!" 200# 18-20 ar!" 200#$rgani%ed B&' Ba"agian (erk"idmatan$rgani%ed B&' Ba"agian (erk"idmatan )armasi* KK )armasi* KK Pharmacovigilance: Pharmacovigilance: Ensring the Sa!e se o! Ensring the Sa!e se o! Medicine and Role o! Medicine and Role o! PharmacistsPharmacists Registration CriteriaRegistration CriteriaEfficacy EfficacyEvaluated from data obtained from clinical trials Evaluated from data obtained from clinical trialsQuality QualityCompliance to established standards,Compliance to established standards, manufacture by GMP licensed premise manufacture by GMP licensed premiseSafety** Safety**Toicolo!y, clinical trials Toicolo!y, clinical trials** "#ery limited information$ ** "#ery limited information$"%urther established throu!h post re!istration studies$ "%urther established throu!h post re!istration studies$"&iscoverin! ne' dan!ers of dru!s after mar(etin! is common$ "&iscoverin! ne' dan!ers of dru!s after mar(etin! is common$ "hat is Pharmacovigilance "hat is Pharmacovigilance (P#)$(P#)$The science and activities The science and activities relatin! to the relatin! to the detection,detection, assessment,assessment, nderstanding nderstanding and preventionand prevention of adverse of adverse effects or any other medicine)effects or any other medicine)related problem ) *+,related problem ) *+, "hy is P# needed$"hy is P# needed$ %&S'(R)%&S'(R)-e!istration of .e' Chemical Entities 'as-e!istration of .e' Chemical Entities 'as very much dependent on the status ofvery much dependent on the status of products in the reference countries products in the reference countriesChan!es to product information 'as mainlyChan!es to product information 'as mainly industry driven industry driven%e' pre)clinical studies conducted in the%e' pre)clinical studies conducted in the re!ion and hardly any Phase /# studies re!ion and hardly any Phase /# studies0dverse dru! reaction reportin! 'as very0dverse dru! reaction reportin! 'as very minimal involved reports submitted byminimal involved reports submitted by health care professionals health care professionals C(*'+,,C(*'+,,Most reports 'ere for (no'n reactionsMost reports 'ere for (no'n reactions involvin! older dru!s 'hich 'ere used ininvolvin! older dru!s 'hich 'ere used in !overnment)run hospitals!overnment)run hospitals Si!nal detection not possible as there 'ereSi!nal detection not possible as there 'ere too fe' reportstoo fe' reports ,nly able to detect some 1uality defects of,nly able to detect some 1uality defects of !enerics 'hich manifested as 0&-s !enerics 'hich manifested as 0&-sPharmacovi!ilance 'as mainly aboutPharmacovi!ilance 'as mainly about !ettin! 0&- reports and submittin! them to!ettin! 0&- reports and submittin! them to *+,*+, .o si!nificant re!ulatory chan!es made.o si!nificant re!ulatory chan!es made based on these reports based on these reports C-RRE*' SCE*AR&(C-RRE*' SCE*AR&(/ncreased a'areness and interest /ncreased a'areness and interest amon!st doctors and pharmacists to amon!st doctors and pharmacists to report 0&-S as they have seen some report 0&-S as they have seen some benefit in reportin!benefit in reportin!/ncreasin! number of clinical trials /ncreasin! number of clinical trials bein! conducted especially in bein! conducted especially in Sin!apore, Thailand and MalaysiaSin!apore, Thailand and MalaysiaGCP trainin! for investi!ators served GCP trainin! for investi!ators served to increase a'areness of S0E and to increase a'areness of S0E and 0&- reportin! amon!st health care 0&- reportin! amon!st health care professionals and the industryprofessionals and the industry C(*'+,C(*'+,More hospitals and companies More hospitals and companies usin! on)line reportin! system usin! on)line reportin! system less hassle than submittin! hard less hassle than submittin! hard copy reportscopy reports/ncreasin! involvement by /ncreasin! involvement by hospital pharmacists in hospital pharmacists in pharmacovi!ilance durin! pharmacovi!ilance durin! clinical 'ard rounds and 'hen clinical 'ard rounds and 'hen counselin! patientscounselin! patients 'he aims o! 'he aims o! PhamacovigilancePhamacovigilanceTo improve patient care and To improve patient care and safetysafetyTo improve public health and To improve public health and safetysafetyTo contribute to the assessment To contribute to the assessment of benefit, harm, effectiveness of benefit, harm, effectiveness and ris( of medicinesand ris( of medicinesTo promote understandin!, To promote understandin!, education and clinical trainin!education and clinical trainin! "ho are the partners$"ho are the partners$.overnment .overnment/ndustry /ndustry+ospitals and academia +ospitals and academiaMedical and pharmaceutical associations Medical and pharmaceutical associationsPoisons information centres Poisons information centres+ealth professionals +ealth professionalsPatients PatientsConsumers ConsumersMedia Media*+, *+, DE/&*&'&(*DE/&*&'&(*0dverse &ru! -eaction 0dverse &ru! -eaction20 response to a dru! 'hich is noious and20 response to a dru! 'hich is noious and unintended, and 'hich occurs at doses normallyunintended, and 'hich occurs at doses normally used in man for the prophylais, dia!nosis, orused in man for the prophylais, dia!nosis, or therapy of disease, or for the modification oftherapy of disease, or for the modification of physiolo!ical function32physiolo!ical function32 0dverse Event 0dverse Event0ny unto'ard medical occurrence that may0ny unto'ard medical occurrence that may present durin! treatment 'ith a pharmaceuticalpresent durin! treatment 'ith a pharmaceutical product but 'hich does not necessarily have aproduct but 'hich does not necessarily have a causal relationship 'ith this treatmentcausal relationship 'ith this treatment Side Effect Side Effect0ny unintended effect of a pharmaceutical product0ny unintended effect of a pharmaceutical product occurrin! at doses normally used in man 'hich isoccurrin! at doses normally used in man 'hich is related to the pharmacolo!ical properties of therelated to the pharmacolo!ical properties of the dru!dru! "%A' '( REP(R'$"%A' '( REP(R'$SER&(-S ADRS SER&(-S ADRS0 serious adverse event "eperience$ or reaction is0 serious adverse event "eperience$ or reaction is any unto'ard medical occurrence that at any dose4 any unto'ard medical occurrence that at any dose4results in death, results in death,is life)threatenin!, is life)threatenin!,re1uires inpatient hospitali5ation of prolon!ationre1uires inpatient hospitali5ation of prolon!ation of eistin! hospitali5ation, of eistin! hospitali5ation,is a con!enital anomaly6birth defect3 is a con!enital anomaly6birth defect3+$,-' ,"e term .life-t"reatening/ in t"e definition+$,-' ,"e term .life-t"reatening/ in t"e definition of .serio0s/ refers to an event in 1"i!" t"eof .serio0s/ refers to an event in 1"i!" t"e patient 1as at risk of deat" at t"e time of t"epatient 1as at risk of deat" at t"e time of t"e event2 it does not refer to an event 1"i!"event2 it does not refer to an event 1"i!" "&pot"eti!all&"&pot"eti!all& mig"t "ave !a0sed deat" if it 1asmig"t "ave !a0sed deat" if it 1as more severe3 more severe3 Adverse Reactions: Possi0le Adverse Reactions: Possi0le CasesCases/ntrinsic factors of the dru!/ntrinsic factors of the dru!Pharmacolo!ical Pharmacolo!ical/diosyncratic /diosyncraticCarcino!enicity, Muta!enicity Carcino!enicity, Muta!enicityTerato!enicity Terato!enicityEtrinsic factorsEtrinsic factors0dulterants 0dulterantsContamination Contamination7nderlyin! medical conditions7nderlyin! medical conditions/nteractions/nteractions*ron! usa!e*ron! usa!e "%A' S%(-1D 2E "%A' S%(-1D 2E REP(R'EDREP(R'ED.e' dru!s.e' dru!s-eport all suspected reactions includin!-eport all suspected reactions includin! minor ones minor ones%or established or 'ell (no'n dru!s%or established or 'ell (no'n dru!s 0ll serious, unepected, unusual 0&-s 0ll serious, unepected, unusual 0&-sChan!e in fre1uency of a !iven Chan!e in fre1uency of a !iven reactionreaction0&-s to !enerics not seen 'ith 0&-s to !enerics not seen 'ith innovator productsinnovator products0&-s to traditional medicines0&-s to traditional medicines "%A' S%(-1D 2E "%A' S%(-1D 2E REP(R'EDREP(R'ED0ll suspected dru!)dru!, dru!)food, 0ll suspected dru!)dru!, dru!)food, dru!)food supplement interactionsdru!)food supplement interactionsStatement hi!hli!htin! marine sourceStatement hi!hli!htin! marine source of supplements such as !lucosamineof supplements such as !lucosamine so that can be avoided by those 'ithso that can be avoided by those 'ith aller!y to sea food aller!y to sea food0&-s associated 'ith dru! 0&-s associated 'ith dru! 'ithdra'als'ithdra'als0&-s due to medication errors0&-s due to medication errorse! vincristine !iven /Te! vincristine !iven /T 0&-s due to lac( of efficacy or 0&-s due to lac( of efficacy or suspected pharmaceutical defectssuspected pharmaceutical defects &**(#A'(R PR(D-C'S&**(#A'(R PR(D-C'S8imited information available at time 8imited information available at time 'hen dru! is first mar(eted'hen dru! is first mar(etedMinimal information on use in 0sian Minimal information on use in 0sian population, interactions 'ith population, interactions 'ith indi!enous medicinesindi!enous medicinesConduct intensive monitorin! to Conduct intensive monitorin! to identify ne', unlabeled adverse identify ne', unlabeled adverse reactions, monitor for 9rare reactions:reactions, monitor for 9rare reactions:Provide updates to prescribers on Provide updates to prescribers on ne' findin!s, labelin! chan!es, ne' findin!s, labelin! chan!es, safety issuessafety issues .E*ER&C PR(D-C'S.E*ER&C PR(D-C'SMonitor efficacy Monitor efficacyMonitor adverseMonitor adverse effect profile toeffect profile to study differencesstudy differences in 0&- patternin 0&- pattern compared 'ithcompared 'ith innovator products innovator products+elp in improvin!+elp in improvin! 1uality of !enerics1uality of !enerics used used&oes the problem&oes the problem arise due to 0&-arise due to 0&- or 1uality defects; or 1uality defects;ProblemsProblems appearin! inappearin! in se1uence se1uence0brupt increase in0brupt increase in fre1uency fre1uencyProblem onlyProblem only arises 'ith certainarises 'ith certain brands brands *(*3PRESCR&P'&(* *(*3PRESCR&P'&(* MED&CA'&(*SMED&CA'&(*SQuality defects can also lead to 0&-s Quality defects can also lead to 0&-s e3!3 Pan Pharmaceuticals "0ustralia$ e3!3 Pan Pharmaceuticals "0ustralia$ casecasePatients can develop 0&-s to food Patients can develop 0&-s to food supplements, 'RAD&'&(*A1 & C(MP1EME*'AR) 'RAD&'&(*A1 & C(MP1EME*'AR) MED&C&*ESMED&C&*ESMinimal information available on traditionalMinimal information available on traditional medicinesmedicines 0&-s 0&-s&ru! interactions &ru! interactions0t ris( !roups e3!3 alfalfa and eacerbation of0t ris( !roups e3!3 alfalfa and eacerbation of S8E S8EMisnomer of eep patient:s record if more information neededinformation needed Recogni5ing, Reporting Recogni5ing, Reporting and Redcing Adverse and Redcing Adverse Drg ReactionsDrg Reactions 1imitations o! Clinical 1imitations o! Clinical 'rials'rialstoo !e6 too !e6 3normally 7 than 89:: 3normally 7 than 89::patients patientstoo simple 3se patients 6ithottoo simple 3se patients 6ithot complications, other medical complications, other medicalconditions conditionstoo narro63limited indicationstoo narro63limited indications too 0rie! 3limited time too 0rie! 3limited timetoo median3very old;very yongtoo median3very old;very yong patients, pregnant 6omen not inclded patients, pregnant 6omen not inclded Classi!ication o! ADRsClassi!ication o! ADRs'ype A ('ype A (AugmentedAugmented ) reactions) reactions-eactions 'hich can be predicted -eactions 'hich can be predicted from the (no'n pharmacolo!y of the from the (no'n pharmacolo!y of the dru!dru!&ose dependent, can be alleviated &ose dependent, can be alleviated by a dose reductionby a dose reductionE3!3 ?leedin! 'ith anticoa!ulants, E3!3 ?leedin! 'ith anticoa!ulants, bradycardia 'ith beta bloc(ers, bradycardia 'ith beta bloc(ers, headache 'ith nitrates, postural headache 'ith nitrates, postural hypotension 'ith pra5osinhypotension 'ith pra5osin Classi!ication o! ADRsClassi!ication o! ADRsType ? "?i5arre$ reactionsType ? "?i5arre$ reactionsCannot be predicted from the Cannot be predicted from the pharmacolo!y of the dru!pharmacolo!y of the dru!.ot dose dependent, host .ot dose dependent, host dependent factors important dependent factors important in pre)dispositionin pre)dispositionE3!3 anaphylais 'ith E3!3 anaphylais 'ith penicillin, anticonvulsant penicillin, anticonvulsant hypersensitivityhypersensitivity Classi!ication o! ADRsClassi!ication o! ADRsType C "Chemical$ reactions Type C "Chemical$ reactions?iolo!ical characteristics can be?iolo!ical characteristics can be predicted from the chemical structure ofpredicted from the chemical structure of the dru!6metabolite the dru!6metaboliteE3!3 paracetamol hepatotoicity E3!3 paracetamol hepatotoicityType & "&elayed$ reactions Type & "&elayed$ reactions,ccur after many years of treatment3,ccur after many years of treatment3 Can be due to accumulation Can be due to accumulationE3!3 Secondary tumours after treatmentE3!3 Secondary tumours after treatment 'ith chemotherapy, terato!enic effects'ith chemotherapy, terato!enic effects of phenytoin ta(en durin! pre!nancy,of phenytoin ta(en durin! pre!nancy, anal!esic nephropathy, tardiveanal!esic nephropathy, tardive dys(inesia 'ith antipsychotic a!ents dys(inesia 'ith antipsychotic a!ents Classi!ication o! ADRsClassi!ication o! ADRsType E " End of treatment$ Type E " End of treatment$ reactionsreactions,ccur on 'ithdra'al ,ccur on 'ithdra'al especially 'hen dru! is especially 'hen dru! is stopped abruptlystopped abruptlyE3!3 'ithdra'al sei5ures on E3!3 'ithdra'al sei5ures on stoppin! phenytoin, stoppin! phenytoin, adrenocortical insufficiency on adrenocortical insufficiency on 'ithdra'al of steroids'ithdra'al of steroids %o6 to recogni5e ADRs$%o6 to recogni5e ADRs$Since 0&-s may act throu!h Since 0&-s may act throu!h the same physiolo!ical and the same physiolo!ical and patholo!ical path'ays as patholo!ical path'ays as different disease, they are different disease, they are difficult and sometimes difficult and sometimes impossible to distin!uishimpossible to distin!uish Drg administeredPt develops a ne6 condition;symptomsDrg sspected$Chec< literatreDocmented $= (!or the prodct or similar class o! prodcts)Highly suggestive of ADR *ot docmented in literatreDrg contined"orsening o! symptomsAny other possi0le cases$H Concomitant therapyH -nderlying conditions Drg discontinedSymptoms improve (>ve dechallenge)Drg restarted Symptoms recr(>ve rechallenge) De!initionsDe!initionsDechallenge Dechallenge 'ithdra'in! the 'ithdra'in! the dru!"s$ and recordin! the dru!"s$ and recordin! the outcome outcome improved or not improved or not improvedimprovedRechallengeRechallenge !ivin! !ivin! oneone dru! dru! a!ain under the same a!ain under the same conditions as before and conditions as before and recordin! the outcome recordin! the outcome re!0rren!e or no re!0rren!e3re!0rren!e or no re!0rren!e3 Preventing, Redcing and Preventing, Redcing and Reporting ADRsReporting ADRsCompletely avoidin! 0&-s may Completely avoidin! 0&-s may be impossiblebe impossibleSome simple approaches to Some simple approaches to prevent the occurrence can be prevent the occurrence can be appliedapplied %("$%("$Chartin! all medications 'hen ordered andChartin! all medications 'hen ordered and refilled dru! aller!ies, types of aller!y refilled dru! aller!ies, types of aller!yClose attention to the 'ritten prescription Close attention to the 'ritten prescription correct dosin!, proper dosa!e form, avoidcorrect dosin!, proper dosa!e form, avoid abbreviations, cautious of dru!s 'ithabbreviations, cautious of dru!s 'ith similar names similar names?ein! familiar 'ith all potential side effects,?ein! familiar 'ith all potential side effects, interactions interactionsChoosin! the oral route 'hen possible Choosin! the oral route 'hen possibleTa(in! careful history of patients esp3Ta(in! careful history of patients esp3 elderly pts elderly pts C(*'+,C(*'+,/nitiate a committee of Post)/nitiate a committee of Post)Mar(etin! &ru! -is( Mana!ement at Mar(etin! &ru! -is( Mana!ement at hospital levelhospital level/nitiate active surveillance "rather /nitiate active surveillance "rather than relyin! on spontaneous than relyin! on spontaneous reportin!$reportin!$0ssess 'hether physicians are 0ssess 'hether physicians are follo'in! recommended &C0 follo'in! recommended &C0 'arnin!s'arnin!s+avin! a hi!h inde of suspicion for +avin! a hi!h inde of suspicion for 0&-s0&-s ADR ReportingADR Reporting&ntensive sa!ety srveillance &ntensive sa!ety srveillance .e' Iealand.e' IealandPrescription event Prescription event monitoringmonitoring7S, 7> 7S, 7> Spontaneos adverse drg Spontaneos adverse drg reaction monitoringreaction monitoring0ustralia, Malaysia0ustralia, Malaysia SP(*'A*E(-S SP(*'A*E(-S REP(R'&*. S)S'EMREP(R'&*. S)S'EMPassive surveillance systemPassive surveillance systemSpontaneous 0&- reportin! Spontaneous 0&- reportin! system has E phases4system has E phases4&ata collection &ata collection most most problematicproblematic&ata processin!&ata processin!&ata analysis and interpretation&ata analysis and interpretation %(" '( REP(R'$%(" '( REP(R'$(*1&*E REP(R'&*.(*1&*E REP(R'&*.'''3bpf(3!ov3my'''3bpf(3!ov3my0&- forms0&- formsREP(R'&*. MEC%A*&SMREP(R'&*. MEC%A*&SM&irectly by the prescribers&irectly by the prescribersThrou!h the pharmacistsThrou!h the pharmacistsThrou!h the dru! companies Throu!h the dru! companies CA-SA1&') CA-SA1&') ASSESSME*' (/ ASSESSME*' (/ S-SPEC'ED AD#ERSE S-SPEC'ED AD#ERSE DR-. REAC'&(*DR-. REAC'&(* &*'R(D-C'&(*&*'R(D-C'&(*Spontaneous reportin! system Spontaneous reportin! system data ac1uisition, assessment, data ac1uisition, assessment, presentation and interpretation3presentation and interpretation3Causality assessment part of Causality assessment part of the Athe Ast st step in case assessment step in case assessment and is based on a !eneral and is based on a !eneral system that is intended for all system that is intended for all reactions and all dru!3reactions and all dru!3 Standardi5ed case causality Standardi5ed case causality assessment has become a routine at assessment has become a routine at pharmacovi!ilance centre around the pharmacovi!ilance centre around the 'orld3'orld3&ecrease the ambi!uity of the data &ecrease the ambi!uity of the data and prevention of erroneous and prevention of erroneous conclusionconclusion/t neither eliminates nor 1uantifies /t neither eliminates nor 1uantifies uncertainty but, at best, cate!ori5es uncertainty but, at best, cate!ori5es it in a semi 1uantitative 'ay it in a semi 1uantitative 'ay ME'%(DS (/ CA-SA1&') ME'%(DS (/ CA-SA1&') ASSESSME*'ASSESSME*''here 6ere several method that can 0e se to'here 6ere several method that can 0e se to ma8 : : : :E) Did the ADR appear a!ter the sspected drgE) Did the ADR appear a!ter the sspected drg 6as administered$6as administered$ >E >E 38 38 : :F) Did the ADR improve 6hen the drg 6asF) Did the ADR improve 6hen the drg 6as discontined$discontined$ >8 >8 : : : :G) Did the ADR appear 6ith re3challenge$G) Did the ADR appear 6ith re3challenge$>E >E 38 38 : :9) Are there alternative cases !or the ADR$9) Are there alternative cases !or the ADR$38 38 >E >E : :H) Did the reaction appear 6hen place0o 6asH) Did the reaction appear 6hen place0o 6as given$given$ 38 38 >8 >8 : :I) "as the drg detected in 0lood at toJicI) "as the drg detected in 0lood at toJic levels$levels$ >8 >8 : : : :@) "as the reaction more severe 6hen the dose@) "as the reaction more severe 6hen the dose 6as increased, or less severe 6hen the dose6as increased, or less severe 6hen the dose 6as decreased$6as decreased$ >8 >8 : : : :?) Did the patient have a similar reaction to the?) Did the patient have a similar reaction to the same or similar drg in any previos eJposre$same or similar drg in any previos eJposre$ >8 >8 : : : :8:) "as the ADR con!irmed 0y any o0Cective8:) "as the ADR con!irmed 0y any o0Cective evidence$evidence$ >8 >8 : : : : 'he *aranCo Pro0a0ility 'he *aranCo Pro0a0ility ScaleScale 'he score :3'he score :3K @ L %ighly pro0a0leK @ L %ighly pro0a0le93@ L pro0a0le93@ L pro0a0le83G L possi0le83G L possi0le: L do0t!l: L do0t!l "%( Casality Categories"%( Casality CategoriesC8 = CertainC8 = CertainCE = Pro0a0leCE = Pro0a0leCF = Possi0leCF = Possi0leCG = -nlive dechallenge, >ve rechallenge dechallenge, >ve rechallenge CECE: Reasona0le time, nlive dechallenge, no rechallengerechallenge CA-SA1&') ASSESSME*'CA-SA1&') ASSESSME*'CFCF:: Reasona0le time, may 0e de Reasona0le time, may 0e de to concrrent disease, other to concrrent disease, other drgs, no in!ormation on drgs, no in!ormation on dechallengedechallengeCGCG: &mpro0a0le temporal : &mpro0a0le temporal relationship, other con!onding relationship, other con!onding !actors sch as drgs, chemicals, !actors sch as drgs, chemicals, nderlying diseasenderlying diseaseC9C9: &ns!!icient in!ormation to : &ns!!icient in!ormation to analyse the reportanalyse the report Case casality Case casality assessmentassessment+o' close is the relationship +o' close is the relationship bet'een dru! and event;bet'een dru! and event;&id the dru! cause the &id the dru! cause the event;event; C(*S-MERS C(*S-MERS MED&C&*ES MED&C&*ES S-R#E&11A*CES-R#E&11A*CE 'he protocol !or the medicines 'he protocol !or the medicines srveillance integrating srveillance integrating consmer reportingconsmer reporting'he srveillance o! medicines'he srveillance o! medicines integrating consmer reporting 6ill 0eintegrating consmer reporting 6ill 0e an eJtension and eJpansion o! thean eJtension and eJpansion o! the eJisting srveillance activities carriedeJisting srveillance activities carried ot 0y *PC2 ot 0y *PC2*PC2 6ill 0e the !ocal point 6hich 6ill*PC2 6ill 0e the !ocal point 6hich 6ill receive, analy5e and investigate thereceive, analy5e and investigate the reports s0mitted 0y the consmers, reports s0mitted 0y the consmers, 'he importance o! involving 'he importance o! involving consmer in medicines srveillanceconsmer in medicines srveillanceThe ultimate !oal is to improve the The ultimate !oal is to improve the 1uality, efficacy and safety of the 1uality, efficacy and safety of the mar(eted productmar(eted productEmpo'er consumers to be a'are ofEmpo'er consumers to be a'are ofQuality QualitySafety SafetyCorrect usa!e of medication Correct usa!e of medication0lleviate the problem of consumers 0lleviate the problem of consumers 'astin! their valuable resources on 'astin! their valuable resources on medicines 'hich may epose their medicines 'hich may epose their health to ris(s3health to ris(s3 Reporting 0y consmers can 0e doneReporting 0y consmers can 0e done throgh throghReporting !orms Reporting !orms(n3line reporting (n3line reporting(ther channels eg: letters, phone calls,(ther channels eg: letters, phone calls, emails and complaints done personally toemails and complaints done personally to Drg Reglatory Agencies (DRA) Drg Reglatory Agencies (DRA)&n!ormation channeled throgh health&n!ormation channeled throgh health pro!essionals, the prodct o6ner, consmerpro!essionals, the prodct o6ner, consmer associations or other trade and indstryassociations or other trade and indstry organi5ations 6hich 6ill then 0e directed toorgani5ations 6hich 6ill then 0e directed to *PC2 *PC2 "hat to report$"hat to report$Quality defectsQuality defects8ac( of efficacy8ac( of efficacy0dverse dru! reactions0dverse dru! reactionsSuspected counterfeit productSuspected counterfeit product7nre!istered product7nre!istered productSuspected adulterated productsSuspected adulterated productsMedication error 6 near missesMedication error 6 near misses%raudulent 6 misleadin! claims%raudulent 6 misleadin! claims "(RD PR(CESSReceive prodct complaint#eri!y registration stats&n!orm reg, holder 6ithot identi!ying complainant3 Mst respond 6ith !indings 6ithin E 6