The document discusses various aspects of pharmacovigilance, including premarketing safety evaluation, post marketing surveillance, and methodological approaches for assessing adverse drug reactions (ADRs). It outlines different phases of human studies and the importance of reporting and documenting suspected ADRs through spontaneous reports and clinical studies. The document emphasizes training healthcare professionals and using standardized surveys to collect ADR information, alongside various causality assessment methods to determine the relationship between drug treatment and adverse events.

1. By Hema Sri M(M.Pharm,RPh-DHA)
Asst.Professor,
Pharmacy Practice Dept.
AM REDDY COLLEGE OF PHARMACY.

2.  Premarketing safety evaluation
 Post marketing surveillance
 Causality assessment
 Communicating ADR’s
 Postal survey method
 Dechallenge/Rechallenge

3.  Animal studies:
 Carcinogenecity
 Mutagenecity
 Teratogenecity
 Human studies:
Phase 0-Microdosing studies (100mg Max)
Phase 1 –Low dose on low population
Phase 2-Efficacy & safety (more than phase 1)
 Phase 3-Evaluation & Tolerability(Large
number)

4.  Spontaneous report  ADR by health care
 Clinical studies
 Cohort studies –patient exposed to particular
dose & compared to unexposed.
 Case control studies- Person affected ADR’s(
recognised & compared)
 Published case reports-- studies

5.  ADR’s to suspected medicines
 In case of ADR suspected  assessment starts
collection of relevant data:
1. Time of action
2. Duration of action
3. Treatment of reaction
4. Outcome & report

6.  Knowledge about medicines
 Training to healthcare professionals
 Conducting constant education programme
 Counseling the patients

7.  Standardized surveys Questionnaries are
sent by post
 1-2 years after drug has been launched
 Collect information about ADR’s

8.  This refers to the stopping of the drug, usually
after an adverse event(AE)
 Dechallenge may be complete or partial.
 i.e drug is fully stopped or decreased in dose
 And AE may fully disappears or only partially
decreased
 Result of the dechallenge can be confusing
 Rechallenge refers to the restarting of the same
drug after having stopped it usually for an AE

9.  Most important in medical treatment
• Receipt, Data entering, Assessment, Documentation
 Spontaneous reporting of suspected ADR’s possible at
regional & country level web system PV
 Reporting authorities: Healthcare professionals,
Nurses, pharmacist, marketing authority holders
 Reporting data: All serious reactions & interactions
such as poisoning, drug-drug, drug-food interactions
 Sections to validate individual case safety report such
as patient identification, reporter identification,
suspected ADR’s, suspected medicines

10.  Definition: It is the assessment of relationship
between a drug treatment & the occurrence of
an adverse event.
 It is an essential part of ADR report and
important task conducted by ‘National
Pharmacovigilance Programme’.
 Methods:
1.Expert judgements or global introspection
2.Algorithms
3.Probabilistic methods (Bayesian approaches)

11.  These are inividual assessments based on previous
knowledge & experience in the field using no
standardized tool to arrive at conclusions regarding
causality.
 Swedish method of Wilholam
1.The temporal sequence--how time sequence of event
related to the drug administration
2.Previous information on the drug
3.Dose relationship
4.Response pattern to drug
5.Rechallenge
6.Alternative etiological conditions
7.Concomitant drugs

12.  WHO –UMC Causality assessment criteria:
1.Time relationship between drug use & AE
2.Absence of other competing causes
3.Response of drug withdrawal & dose
reduction(Dechallenge)
4.Response of drug re administration(Rechallenge)

14.  Certain: Right timing, no other cause,
withdrawal response possible, rechallenge
“definitive” .
 Probable : Right timing, other cause unlikely,
withdrawal response possible, ,rechallenge not
required.
 Possible: Right timing other causes possible.
 Unlikely: Poor timing other causes more likely.

15.  These are sets of specific questions with
associated scores for calculating the likelihood
of a cause-effect relationship
 Problem specific flow charts step by step
instructions how to arrive at an answer
 Questionnaire probability of causation(when
ADR is suspected)
 No single algorithm accepted as the gold
standard because of the shortcomings &
disagreements that exist between them.