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Definition of pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Pharmaco = medicineVigilare = to watch
alert watchfulnessforbearance of sleep; wakefulnesswatchfulness in respect of danger; care;
caution; circumspectionthe process of paying close and continuous
attention
Need of pharmacovigilance in society
1.To prevent the deaths by using medicines due to adverse drug reactions.
2.To monitor the clinical trials data whether the drug is safe or nor.
3.To determine any adverse drug reaction of particular drug through the world.
4.Safety data of drugs used in clinical trails5. Promoting rational use of medicines and
adherence.
6. Ensuring public confidence.
The scope of pharmacovigilance
Improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions,
Improve public health and safety in relation to the use of medicines,
Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and
Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
Opportunities in pharmacovigilance
1.Ther are many companies providing jobs for pharmacovigilance graduates (cognizant, oracle, mahindra sathyam...)
2.Any science graduate, Pharma graduate and Medical graduate is eligible to do study pharmacovigilance .
3.There are used in management of clinical trails data.
4.Many companies are coming into this field (Pharma, CRO, IT, BPO and KPO orgs).
What is an ADR "Any untoward medical occurrence that
may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment." WHO).
A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
DefinationsExpected ADR : An ADR to a drug that has
been previously observed and documented, if the ADR is already listed in the official prescribing information, it is an expected ADR
Unexpected ADR : the nature or severity of which is not consistent with the applicable product information.
Major Aims Of Pharmacovigilance
Early detection of unknown reactions & interactions
Detection of increases in frequency of known ADR
Identification of risk factors & Quantifying risks
Preventing drug induced illness
Rational & safe use of medicines
Major Aims Of Pharmacovigilance
Assessment and communication of benefits /risks of drugs
Educating and informing patients
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Why pharmacovigilance?Humanitarian concernsEconomical concerns
check if drugs on the market fulfill their intended role in society i.e. if resources spent on drugs produce optimal results in terms ofalleviating human sufferingreduce disease related economical lossProtection of rights and well being of research
subjectsConduct an ongoing assessments of risks vs benefits
Clinical DevelopmentPhases of Clinical DevelopmentPhase IPhase IIPhase IIIPhase IVAll these phases focus on monitoring the
efficacy and the safety of the investigational product and most of these phases last for 2-3 yrs
Limitations of premarketing clinical trialsShort duration : Effects that develop with
chronic use or those that have a long latency period are difficult to detect in preclinical trials
Relatively small number of patients exposed to the drug
Rare ADR are difficult detect in these trials
Limitations of clinical trials continued….Narrow populationThose trials where efficacy is studied
don’t cover actual evolving usePremarketing trials generally don’t
include special groups (eg children, elderly, coexisting disease)
Not always representative of the population that may be exposed to the drug after approval.
Required sample size for detecting a rare adverse drug reaction
Incidence Incidence of ADRof ADR
Number of patients to be observed Number of patients to be observed in order to detect 1,2 or 3 cases of in order to detect 1,2 or 3 cases of ADRADR
1 2 31 2 3
1 in 1001 in 100
1 in 2001 in 200
1 in 1,0001 in 1,000
1 in 2,0001 in 2,000
1 in 10,0001 in 10,000
300300
600600
3,6003,600
6,0006,000
30,00030,000
480480
960960
4,8004,800
9,6009,600
48,00048,000
650650
1,3001,300
6,5006,500
13,00013,000
65,00065,000
Some of the drugs withdrwn post marketing
Drug Drug Date Date approved approved
Date Date withdrawnwithdrawn
Reason for Reason for withdrawlwithdrawl
Fenfuramine Fenfuramine 19731973 19971997 Valvular Valvular heart heart deffectdeffect
Bromfenac Bromfenac 19971997 19981998 Liver Liver failurefailure
MibafradilMibafradil 19971997 19981998 Interaction Interaction with other with other drugsdrugs
Minimum reportable information for ADR’An identifiable patientAn identifiable reporterA suspect productAn adverse event.
Safety data management becomes an important part of pharmacovigilance.
How can data help a product/patient
Defend a product from false safety claims Influence labelAllow practitioners to feel more comfortable
using a drug Enables better decision making around risk
management
What is the end goalThe data helps in detecting the signal –
something that draws attentionPattern of the ADR’s Trend How frequently is the signal or pattern
observed What is the severity.
US FDA definition of signalsNew unlabeled event, especially if seriousAn apparent increase in the severity of a
labeled eventNew drug interactionMore than a small number of serious events
thought to be extremely rare.Identification of previously unrecognized at risk
populationProduct confusionMisuseConcerns that risk management plan is
inadequateOther
What is the worst that can happen if reportedIf the drug is blatantly unsafe and the
risk/benefit ratio is not favorable its always better to withdraw that drug from the market ( this will not happen unless it really should happen
Label changeRegulatory agencies may request
additional information ( more studies, risk management program etc.)
Pharmacovigilance reportingExpedited reportingPeriodic safety update reports Both these can be from the following sourceSpontaneous reports, clinical trial reports,
literature reports, registries, regulatory authorities, PMSS
The pharmacovigilance process
Case reports
Case database
Signal detection
Signal analysis
Action
Follow up
Communication
Reporting processAll serious adverse events should be
reported immediately to the sponsor/ regulatory
For reported deaths, the investigator should supply the sponsor IRB/IEC with any additional requested information( eg Autopsy report, terminal medical report)
Notify IRBS and independent EC’s of all serious adverse events
What to report (both Serious and non serious) • All adverse events suspected to have been caused by
new drugs and ‘drugs of current interest‘• If drug is ineffective • All suspected drug interactions• Reactions to any other drugs which are suspected of significantly affecting a patient's management, including reactions suspected of causing:
• Death • Life-threatening (real risk of dying)• Hospitalization (initial or prolonged) • Disability (significant, persistent or permanent)• Congenital anomaly • Required intervention to prevent permanent impairment or damage.
Pharmacovigilance in practise. Continued……Data entered in the databaseAssessment of the event (expected or
unexpected).Medical confirmation of the event.Expedited reporting of the event.Source country where the event occurred.Submission to regulatory authorities.