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Adverse Drug Reactions
Corticosteroidsaremostefficientdrugstoreduceinflammationbuttheirlong-
termuse is notrecommended due torisk ofadrenalsuppression,which means
bodyownadrenalglandsstopmakingcortisol.Addison’sdisease(acuteadrenal
insufficiency)occurs onsudden withdrawal of corticosteroids. In this disease,
thepatientbecomes,hypotensiveandthencollapsed.Gradual reductionindose
corticosteroidoveraperiodofweeksisaremedytoavoidthisoutcome.Thistime
perioddependsuponlengthofperiodofcorticosteroidtherapy.
7. Drug interactions: Nowadays most of the drugs are used in combination to get fast
relief. Sometimes, these may interact together and cause adverse reactions due to
drug interaction.
In drug interaction phenomenon, drug action is either increased or decreased,
caused by co-administered drug. Most of cases of drug interactions are not
intentional. These become visible, when there is either therapeutic failure or
occurrence of undesirable adverse drug reactions. The response of main drug
of therapy is either enhanced or lowered by a precipitant (or perpetrator) drug
in drug–drug interactions. Response of drug is altered via pharmaceutical, or
pharmacokinetic, or pharmacodynamic mechanism which are illustrated here.
Pharmaceutical type of interaction occurswhen two or more drugs reactwith
each,when they areadministered together.Physical orchemical incompatibility is
responsiblefor this typeof interaction.This typeof interactionis usually observed
duringintravenousdruginfusion,inwhichtwoormoredrugsaremixed.Forexample,
inactivationof cisplatin (antineoplastic drug) occurs by theaddition of the sodium
2-mercaptoethanesulfonate(detoxifying drug), which canbe avoidableby infusing
individualdrugseparately.
Pharmacokinetic type of interactions results in change in rate of absorption, protein
binding, cellular distribution, metabolism, or excretion of an object drug, caused by
co-administered drug.
Pharmacodynamic type of interactions occurs due to either direct antagonistic or
synergistic actions when both co-administered drug act on the same receptor or site of
action or similar effects at different sites) or indirect, when an outcome of main drug is
altered by the co-administered drug.
Drug–drug interactions may have negative or positive effects. Positive effects are
beneficial to the patients, while negative effects are associated with toxicities or adverse
reactions. Beneficial drug–drug interactions are employed deliberately in clinical practice
while adverse drug–drug interactions are unintended and adverse in nature, which are
avoided.
BENEFICIAL DRUG INTERACTION
Some examples are given here:
1. Probenecid and penicillin: Coadministrationofprobenecidrepresentsanexampleof
beneficialdrug–drug interaction. Probenecid lowers down the renal clearance
ofpenicillinand otherbeta-lactamantibiotics. Thus, plasmahalf-life and serum
concentrationsofpenicillinareincreasedwhichresultinincreaseeffectofpenicillin.
2. Sulphamethoxazole and trimethoprim: Sulphamethoxazoleissulphadrug,whichis
bacteriostaticinnature.Itactsbyinterferinginthefolicacidsynthesisinsusceptible
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Textbook of Pharmacy Practice
bacteria.Trimethoprim, when co-administeredwithsulphamethoxazole,inhibits
asequentialstepinbacterialfolicacidsynthesis.Folicacidisanessentialnutrient
requiredforbacterialmultiplication.Thymidine,purines,andbacterialDNAare
biosynthesizedfrom folicacid, which acts as a cofactor.Thesetwo drugs work
synergisticallytoinhibitenzymesystemsinvolvedinthebacterialsynthesisoffolic
acid.Usingtogetheralsodecreasesthedevelopmentofbacterialresistance.
3. Levodopa and carbidopa: This co-administrationofcarbidopawithlevodopa is
beneficialinthetreatmentofParkinson'sdisease,whichoccursduetodeficiency
ofdopamine,naturallyoccurringbiologicalamineinthebrain.Levodopaismain
drug,convertedintodopamineinthebrain,soclinicallyuseful.Co-administrationof
carbidopapreventsthedegradationoflevodopainthebloodstream,thusincreased
concentrationoflevodopaenteringinthebrain.Itisalsohelpfulinreducingsome
oflevodopa'ssideeffectssuchasnauseaandvomiting.
4. Atenolol and Amlodipine: Atenololandamlodipinemayproduceadditiveeffects
tolowerdownthebloodpressureandheartrate.Bothactbydifferentmechanisms.
Amlodipineisacalciumchannelblocker,andsorelaxesanddilatestheconstricted
bloodvessels.Dilatoryeffectultimatelyimprovespumpingofbloodthroughout
thebodybyheartanddecreasestheheart'sworkload.Atenololisabeta-blocker,
actsbyblockingthe actionofneurotransmitterslikeadrenalineandepinephrine
throughreceptormechanism.Itresultsinreductionintheincreasedheartrate.
5. Sitagliptin and metformin: Thereis better control of sugar in peoplewith
type2 diabetes, whenmetformin is combined with sitagliptin. Sitagliptin acts
byincreasing levelsof naturallyoccurring substances,called incretins,which
increasestheinsulinrelease,especiallyafteramealtocontrolbloodsugar.Theyalso
decreasethesugarformationinliver.Metforminrestoresthebody'sproperresponse
totheinsulinforantidiabeticaction.Itlowersdowntheproductionofbloodsugar
byliveraswellasabsorptionofsugarinstomach/intestines.
6. Combination of different antibiotics(e.g.ampicillinandcloxacillin)isinpractice
forbetterresult.Amoxicillinisfrequentlycombinedwithbetalactamaseinhibitor
(e.g.clavulanicacid)forbetterefficacy.
7. Varioustypesofcytotoxicdrugsareusedincombinationincancertherapytoget
thebeneficialdesiredclinicaloutcome.Thecytotoxicdrugsincombinationtherapy
actby differentmechanisms to produce cytotoxic effect to cancerous cells, thus
decreasesthedevelopmentofresistantcancerouscells.Doseofeachdrugusedin
combinationisreducedwhichresultsinlessersideeffects.
ADVERSE DRUG–DRUG INTERACTIONS
Some examples of drug interaction causing adverse reactions are illustrated here:
1. ACE (Angiotensin Converting Enzyme) inhibitors and Potassium Supplements:
Benazepril,lisinopril,enalapril,etc.areexamplesofACEinhibitors,implicatedin
treatmentof highblood pressure,heart failure and preliminary kidney disease.
Potassium supplements such aspotassium citrate, potassiumbicarbonate and
potassiumchloride,etc.areusedtoprevent/treathypokalemia.
Interaction: ThecombinationofACEinhibitorsandpotassiumsupplement,when
administeredmayproducehyperkalemia,whichisapotentialriskforrenalfailure.
Hyperkalemiaisduetoincreaseinthelevelsofpotassium,causedbyACEinhibitors.
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Adverse Drug Reactions
2. ACE (angiotensin converting enzyme) inhibitors and spironolactone:ACE
inhibitorsare implicatedin the treatment of hypertension. Spironolactone is a
diureticagent,usedtoremoveexcessbodyfluidfromthebodythroughurine.
Interaction: The combination causes hyperkalemiadue to additive effect.
Spironolactone,potassiumsparingdiureticdrug,elevatespotassiumlevelinblood.
ThereisadditiveeffectbecauseACEinhibitorsalsoincreasethebloodpotassium
level.Increasedpotassiumlevelmaycauserenalfailure.
3. Digoxin and amiodarone: Digoxinisclinicallyusedinthetreatmentofcongestive
heartfailureduetoitspositiveinotropiceffect.Amiodaroneisanantiarrhythmic
medicine,usedinatrialfibrillation.
Interaction: Amiodaroneincreasesserumconcentrationofdigoxinbyinhibiting
P-glycoproteinsystem.Thus,thereisariskofintoxication,whenusedincombination
withdigoxin.
4. Digoxin and verapamil: Digoxinduetoitspositiveinotropiceffect,drugofchoicefor
themanagementofcongestiveheartfailure.Verapamil,prototypecalcium-channel
isusedasantihypertensivedrug.
Interaction: Verapamilincreasestheserumconcentrationofdigoxinbydecreasing
itsrenalandnon-renalclearance.Itmayresultindigoxinintoxication,whichmay
leadtoexcessiveslowingdownoftheheartrhythm.
5. Warfarin and nonsteroidal anti-inflammatory drugs: Warfarin,anticoagulantdrug,
isusedtomaintaintheflowofbloodbypreventingbloodcoagulation.NSAIDslike
diclofenac,aspirin,ibuprofen,etc.areusedtotreatinflammation.Someofthese,
especiallyaspirin,mayinterfereinbloodclottingprocess.
Interaction: Severegastrointestinalbleedingmayoccurduetoco-administration
ofwarfarinwithNSAIDs,hencecombinationisdiscouraged.
6. Warfarin and phenytoin: Warfarinandphenytoinareanoralanticoagulant and
antiepilepticdrugrespectively.
Interaction: Phenytoin may potentiate the action ofwarfarin, presumablyby
inhibitingitsmetabolisminsomeindividuals.Itresultsinbleedingwhilewarfarin
isthoughttoinhibitthemetabolismofphenytoin,whichresultinincreasedlevel
ofphenytoininblood.
Signs and Symptoms of Adverse Drug Reactions
Patients who are administered relatively new drugs are more vulnerable to unexpected
complications. There is greater risk of adverse reactions of unknown nature with the
newer drugs, the. However, adverse reactions may occur due to alteration in enzymatic
system to metabolize the drug or alteration in excretion ability of drugs that have been
well tolerated for extended periods of time. The identification of common reactions
to a specific drug often requires 10 to 20 years of experience in therapeutic use. Even
then some problems may not be recognized as being drug related. For example, aspirin
was widely used for decades before its detrimental effects were acknowledged. The
importance of careful observation and complete documentation of patient response to
medication cannot be overemphasized.
Side effects are those actions of a drug that are specifically manifested in a treatment
situation. None of drug exerts a single effect on the body; rather, a spectrum of multiple
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Textbook of Pharmacy Practice
effects occurs. A substance administered in one instance for a particular purpose may
be used in another for a different effect. Which of the actions are termed therapeutic
and which are deemed side effects depend upon the situation. Side effects are not all
detrimental; many drugs are chosen for prescription in order to exploit their desirable
side effects. For example, diazepam (Valium) is both a tranquilizer and a skeletal
muscle relaxant. When administered to reduce anxiety, its relaxant properties are
considered side effects. When used to treat low-back pain, tranquilization is considered
a side effect. In the latter instance, the side effect is usually considered helpful, because
the client often has difficulty adjusting to the immobility and pain associated with
the disorder.
Among common undesirable side effects from drugs are nausea, vomiting, skin rashes,
electrolyte imbalance, and changes in the level of consciousness or emotional effect.
Side effects may be mild, or they may be severe and life-threatening. The less serious
ones are often undiagnosed, and in long-term drug therapy may persist as troublesome
and distressing conditions that are refractory to treatment. Table 3.2 illustrates some
common signs and symptoms of some ADRs.
Table 3.2: Signs and symptoms of adverse drug reactions
Types of ADRs Indication
Allergy Any organ can be affected, including the CNS, gastrointestinal system,
bone marrow and liver, with signs and symptoms similar to those
listed below for these systems
Anaphylaxis Itching of palms, chin, throat, a sensation of swelling in the throat,
lacrimation, wheezing, dyspnea, hypotension and circulatory collapse
Arthralgia skin eruption Joint pain, difficulty in ambulation, physical disability, superficial
reddening of the skin, usually in patches
Bone marrow Weakness, dyspnea, headaches, anemia, tiredness
Leukopenia Fever, chills, sore throat, dry non-productive cough, malaise, redness
or pain in area of body
Thrombocytopenia Unusual bleeding following minor trauma or from mucous
membranes, hemorrhage
Confusion Forgetfulness, confused, inappropriate verbal responses, anxiety
Excitation Restlessness, talkativeness, irritability, insomnia, anxiety
Sedation Restlessness, talkativeness, irritability, insomnia, anxiety
Gastrointestinal irrigation and/
or bleeding
Dysphagia, anorexia, stomatitis (dryness or cracking of lips, swelling
and redness of mouth tissues, soreness to burning pain of mouth
tissues, mouth odour), nausea, vomiting, abdominal pain, bloody or
black tarry stools, diarrhea
Hepatotoxicity Anorexia, malaise, fatigue, nausea, jaundice, fever, hepatic tenderness,
elevated serum glutamic oxaloacetic transaminase, alkaline
phosphatase, and/or bilirubin, bile in urine
Nephrotoxicity Decrease in urination (oliguria to anuria), edema, unusual weight gain,
hematuria, albuminuria, and/or crystalluria, progressive azotemia
Ototoxicity Abnormal ringing or other noises in the ear (tinnitus), increased
sensitivity to noise, difficulty in understanding speech, audiograms
showing loss of perception, particularly of high tones
27
Adverse Drug Reactions
Monitoring of Adverse Drug Reactions
Drug regulatory authority in any country is tasked to make certain about the availability
of safe and efficacious drug and nutraceutical of standard quality for human use. The two
criteria—safety and efficacy are established through animal studies and clinical trials
involving human volunteers to ensure compliance with acceptable standards. It is
noted that premarketing clinical studies although can confirm the safety and efficacy
of the drugs along with common adverse reactions but these studies cannot identify the
occurrence of neither rare adverse reaction nor adverse reaction which appears after
significant latency on long-term use. For this, monitoring of marketed products is done
to confirm the safety profile under the umbrella of pharmacovigilance (PV) program.
PV, also referred to as drug safety, is a branch of pharmaceutical science, which
includes the "detection, assessment, understanding and prevention of adverse effects
of pharmaceutical products or any other drug related problems”.
Goals of ADRs Management
1. Tosend orguidethedrug regulatory authority totakeappropriatemeasuresto
minimizetherisksofadverseeventsincommunityafterperiodicre-evaluationof
pharmaceuticalsavailableinthemarket.Itisdoneby:
i. Deliveringup-to-datesafetyprofileofdrugtomedicalpractitionersinhospital
settingand othercontributors including ADRs MonitoringCentre’s working
underpharmacovigilanceprogramofIndia.
ii.Advising for providingmore effectiveand purposefulpackage insert and
publishingthedatawhichmaysuggestthediscontinuationofproductforhuman
useorputsomelimitations.
iii. Providingthedatarelatedtosafetytoultimateconsumerviamedia.
2. Toidentifytheconsequenceforprevalenceofadverseeventswhichinclude:
i. Patientfactors:Theseincludeinherited,racialdifferences,diets,diseases,etc.
ii. Pharmaceuticalfactors:Useofdrug,includingindications,dose,bioavailability,
interactionwithco-administereddrug,storage,etc.
METHODS OF DETECTION OF ADVERSE DRUGS REACTIONS
Uncontrolled pharmacological action may result in drug-induced disease, manifested
by unintended effect, which is predictable. The unpredictable adverse drug reactions
are not identified unless it becomes more common. To detect unpredictable ADRs, the
following techniques are used:
a. Spontaneous case reports: Spontaneous reportingis aninexpensive, and very
effectivemethodofcollectinginformationregardingADRsviahealthprofessionals,
whovoluntarilysubmitcasereportsofADRs.Inrecentyears,nationalregistershave
beenestablishedinseveralcountrieswiththeobjectivetoprovideanearlywarning
aboutdrug that is capable ofcausing adverse effects. Intentionalspontaneous
reportingofsuspectedadversereactionsbydoctorsareenteredintheseregisters.
Forexample, in 1964, Medicines andHealthcare Products RegulatoryAgency
(MHRA)andtheCommissiononHumanMedicines(CHM)introducedYellowCard
SchemeintheUK,inviewtopreventthethalidomidelikedisaster,whichoccurred
inthelate1950s,resultingindeathof2,000childrenandseriousbirthdefects.Data
onsuspected ADRs of licensed/unlicensed medicines issuedon prescriptionor
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Textbook of Pharmacy Practice
purchasedover the counter are recorded throughspontaneous reportingin the
register.SomephysiciansdonotfavorthereportingofADRsduetothefollowing
reasons:
i. MisconceptionthatADRsreflectpoortherapeuticagentselection.
ii. Lackofinterest.
iii. Lackofunderstandingofwhattoreport.
iv.Beliefthat reactionis unimportant or has been previously reported in the
literature.
b. Cohort studies: ‘Cohort’meansgroupof people.Groupofparticipantsisselected
alongwithparticularadministereddrug.Then,observationstudyisdone,means,
alloftheserecipientsareobservedforvarying period oftimeforidentificationof
ADRsbasedonappearanceofsymptomsorclinicaldata.Then,ADRsarecompared
tounexposedcontrolpopulation.Itisused,whendetectionofeventsoccurswitha
frequencyofmorethan1in500exposedtodrug.Therearetwotypesofcohortstudies:
Prospective cohort studies: Thisincludescollectionofdataoveraperiodoftime.
Datarelatedtohealthoutcome,obtainedfromdrugrecipient,iscomparedwith
those,whoarenotgivendrug.
Retrospective cohort studies:Inthis,participatingvolunteersmustalreadyhave
thediseaseorhealthcondition,forwhichstudyistobedonepriortojoining.
Due to its longevity, cohort studiesare beneficial for investigatingand for
studyingrareadverse events,suchasexposuretoanewdrugoranenvironmental
toxin.
Cohortstudieshavemorechancestocontrolthepotentialsurprising variable
suchasage,gender,orsocioeconomicstatusbecauseresultreliesoninclusionofa
largenumberofparticipants.
c. Review of vital statistics and record linkage studies:Routinereviewofnationaland
regionalstatisticscouldindicateanunexpectedincreaseinadverseevents,which
mightbedruginduced.Municipalityandhospitalrecordsareroutinelycollected
andanalyzedtocheckthedeathcertificateanddischargesliptoknowthereason
fordiseaseordeath.Earlywarningforanepidemicofdrug-relateddiseasecanbe
obtainedfromthesestatistics.Forexample,occurrenceofuterinecanceronlong
termuseofestrogen.Drug-induceddiseasescaneasilybeidentifiedwithrecord
linkagestudies.
d. Case control studies: It,alsocalledretrospectivestudy,includesthecomparisonof
twogroupsofparticipants.Onegroupofparticipantshasthediseaseorcondition
whichistobestudied(cases)andtheothersimilargroupofpeople(controlgroup)
whodonothavethediseaseorcondition.Thiscasecontrolapproachisusefulfor
investigationof diseases, whichare rare inoccurrence.Some of theprecautions
shouldbetakenwhileconductingcasecontrolstudies.Theseare:
i. Carefulselectionofthecaseswithwell-defineddiseasewhichistobestudied.
ii. Casecontrolandcontrolgroupsshouldbeselectedfromthesimilarpopulation.
iii. Interpretationofresultmustbeaccurate.
Casecontrolstudiescancorrelatetheexposureswithoutcomes,butcannotprovide
thereasonforcausation.Thesestudiessimplycancorrelatethepasteventsandthe
currentstate.
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Adverse Drug Reactions
PROCEDURE FOR REPORTING ADVERSE DRUG REACTIONS
1. Reporting of ADRs
Report the unintended adverseevent,appearedwiththeuseof drugs,biological
productsincludingbloodproducts,etc.Reportshouldinclude.
(a)EntireADRswhichmanifestedwiththeuseofprescriptionaswellasOTCdrugs.
Itisimmaterial,whetherthesewereadministeredasperrecommendeddirection
ornot.
(b) Unintendedreaction,whichisnotasperinformationprovidedonlabel.
(c) IncreaseinfrequencyofADR,whichismanifested.
(d)ADRofseriousnature,whichwaseitheranticipatedornot.
(e)Drug–drug,drug–foodor drug–food supplements interactions,leadingto
ADRs.
(f)Drugabuse,druguseinpregnancyandduringlactationrelatedADRs.
(g) OverdoseormedicationerrorrelatedADRs.
(h) Unusuallackofefficacyorwhensuspectedpharmaceuticaldefectsareobserved.
2. Particulars necessary for an ADR case report
FormattedfortheADRcasereportincludes:
i. Identified patient data(includesname,ageat the time ofADRs, sex, weight,
etc.).
ii. Adversereactionsspecification(includesillustrationofthereaction,expectedas
perproductinformationornot,severityofunintendedreaction,timeanddate
ofstartofthereaction,fordurationoftime,ultimateresultofADRs,relevant
tests/laboratorydata,ifavailable,etc.).
iii.Particulars about the suspected druginclude name (INNand brand name),
strength(concentration),dose,frequency,dosageform,routeofadministration,
indicationforuse,durationofuse,datewhenstartedandstopped,batchnumber
(especiallyforvaccines).
iv. CommentsrelatedtomanagementoftheADRs(includeconfirmationofADRs,it
isconfirmedifsymptomsofADRsdisappearafterstoppingthedrugoradjusting
thedoseoraftertakingthenecessarytreatment).
v. Particularsofthereporter(includesnamewithinitials,address,contactdetails,
qualificationifreporterishealthcareprofessional).
3. Person responsible for reporting. Theundermentionedpersonscanreportanycase
ofsuspectedADRs:
i.Healthcare professionals, such as physicians, family practitioners,
medicalspecialists, and dentists are the preferredsource of information in
pharmacovigilance.Nurses,whoadministermedicines,shouldreportrelevant
adversedrugreactionsexperienced bythepatients. Pharmacists canplay an
importantroleinreportingandprovidingadditionalinformation(forexample,
onco-medicationandpreviousmedicineuse).
ii.Patients and their relatives can also reporttheir experienced adverse drug
reactionsdirectly,orthroughtheirhealthcareprofessionals.
iii. Manufacturersorproductregistrantsareprimarilyresponsibleforthesafetyof
theirproducts.
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Textbook of Pharmacy Practice
4. When to provide information about ADRs. Report the suspected ADR, if any, to
monitoring centre as soon as possible.
5. Method to report. Use the prescribed form to send the report. Form for reporting
ADRs is illustrated in Appendix 3.1.
Basic Principles of Efficient Reporting
1. Once adverse reaction occurs, report to the monitoring centre immediately.
2. Take prompt action as it is convenient the fill the data in adverse reporting form, if
the patient is still with you, so that the details can be filled in at once on the reporting
form.
3. Consider the other possible factors, such as type of co-administered drug, use of
OTC products, smoking, etc. which affect the severity of adverse event.
4. Send the supplement data in a supplementary note if reporting person further
information related to adverse event mentioning the name of identified patient.
5. Efficiently recorded data have the following:
i. Patient, who is identified
ii. Specification of suspected adverse event
iii. Suspected drugs related information
iv. Details of identified reporting person along with contact details
6. Adverse events should be providing in a neat and understandable handwriting.
Management of Adverse Drug Reactions
It is general practice to alter a dosage regimen or withdraw a suspected medicine,
which is responsible for adverse events. However, the approach followed to manage
an adverse event is likely to vary from clinician to clinician.
Suspected adverse drug event of serious nature, such as anaphylactic shock, whether
due to immunoglobulin (Ig)E- or non-IgE-mediated release mechanisms, need prompt
attention for appropriate treatment. Treating with oxygen (oxygenation) and maintenance
of normotension is a necessary step in acute therapy along with other measures. Other
measures, which may require, include the use of epinephrine, and adequate fluid
replacement. In some conditions, administration of vasopressors or corticosteroids may
be needed. It is advisable to keep the airway free, free from any obstruction. Although
the administration of suspected offending drug is usually stopped, it is better to start
the necessary drug to keep the continuation of therapy without interruption.
Physician may face problems, if several drugs are involved in the therapy. In this
condition, it is difficult to identify the culprit, which is responsible for adverse event.
Alternate drug can be given easily if culprit is identified. If several medicines are
suspected culprit, then at the initial level, the non-essential medicines should be
withdrawn, preferably one by one, depending on the severity of the ADR. Dose of the
drug should be minimized, if the reaction is related to dose-related. Many physicians
stop the drug unnecessarily, when interactions are suspected, rather than doing dose
adjustment. During withdrawal or stopping the drug, the patient should be observed.
Rate of elimination of the drug from the body system and the type of pathology are
deciding factor for period of waiting or observation. For example, in urticaria, on
elimination of drug, symptoms disappear readily, whereas waiting period goes up to
a week in the case of fixed psoriatic skin reactions. If the patient condition is getting
31
Adverse Drug Reactions
Appendix 3.1: Report of suspected adverse drug reaction
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Textbook of Pharmacy Practice
ADVICE ABOUT REPORTING
A. What to report
Report serious adverse drug reactions. A reaction is serious when the patient outcome is:
Death
Life-threatening
Hospitalization (initial or prolonged)
Disability (significant, persistent or permanent)
Congenital anomaly
Required intervention to prevent permanent impairment or damage
Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines,
Vaccines and Herbal products.
B. Who can report
All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurses) can report adverse drug
reactions
C. Where to report
Duly filled Suspected Adverse Drug Reaction Reporting Form can be send to the nearest Adverse
Drug Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC).
Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.
Or can directly mail this filled form to pvpi@ipcindia.net or pvpi.ipcindia@gmail.com
A list of nationwide AMCs is available at: http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.
html
D. What happens to the submitted information
Information provided in this form is handled in strict confidence. The causality assessment is carried
out at AMCs by using WHO-UMC scale. The analyzed forms are forwarded to the NCC through ADR
database. Finally the data is analyzed and forwarded to the Global Pharmacovigilance Database
managed by WHO Uppsala Monitoring Centre in Sweden.
The reports are periodically reviewed by the NCC-PvPI. The information generated on the basis of
these reports helps in continuous assessment of the benefit-risk ratio of medicines.
The information is submitted to the Steering committee of PvPI (Pharmacovigilance Programme of
India) constituted by the Ministry of Health & Family Welfare. The Committee is entrusted with the
responsibility to review the data and suggest any interventions that may be required.
E. Mandatory field for suspected ADR reporting form
Patient initials, age at onset of reaction, reaction term(s), date of onset of reaction, suspected
medication(s) and reporter information
National Coordination Centre
Pharmacovigilance Programme of India
Ministry of Health & Family Welfare,
Government of India
Sector-23, Raj Nagar, Ghaziabad-201002
Tel.: 0120-2783400, 2783401, 2783392
Fax: 0120-2783311
www.ipc.nic.in
Pharmacovigilance
Programme of India for
Assuring Drug Safety
For ADRs Reporting Call on PvPI Helpline (Toll Free)
1800 180 3024
(9:00 AM to 5:30 PM, Working Days)