Name: Bhagat Rohit Babaso
Sub – pharmacovigilance
Roll no -03
Mrs Reshma V. Pawar
SPM’s College of Pharmacy, Akluj
Patients susceptible to adverse drug reactions must be properly
identified and monitored.
Methods of detection of ADR:-
1. Pre-marketing safety Evaluation
2. Post marketing surveillance
3. Causality assessment
4. Communicating ADR
5. Postal Survey Method
Detection of ADR
Pre-marketing safety Evaluation
> Animal studies -:Specific animal studies for carcinogenicity,
teratogenicity and mutagenicity easily accessible
> Human studies:- Pre-marketing safety Evaluation
> Phase 0: microdosing study (max 100mg)
> Phase 1: in this low dose on low population are study
> Phase 2: in this efficacy and safety of drug study.
Number of patients are more than phase 1
> phase 3: in this phase safety Evaluation and tolerability are
In this patient are in large amounts
> Specific groups are studied 1) elderly patients
. 2) compromised patients
Post marketing surveillance
> Spontaneous Report : reports of ADR by health care
practitioner such as physicians ,nurses, pharmacist
> Clinical study:
> A) cohort studies – Patient exposed to Particular drug
should be monitored and compared to unexposed group.
> B) Case control studies: a)Person affected due to adverse
event being studied should be recognised and Each case
should be compared to Several disease free control patients.
> Meta-analysis of clinical study
> Published case reports : various case reports studies and ADR
> Following knowledge of ADR to suspected medicine or other
> In case of ADR suspected Then assessment starts with Collection
of relevant Data Related to patients demographic such as Time of
action and duration of Action , Treatment of react , outcome and
Communicating of ADR:
Following knowledge About rational and Safe use of medicines
> Basis training of health professionals
> Conducting constant education Programs for health professionals.
> Counselling the patient.
> It is main used for monitoring ADR of new drugs i.e.within1 to
2 years After
> Drug has been launched .
> Drug causing ADR Withdraw, if does not found any ADR then
called positive Dechallenge
> If ADR found , then withdraw the drug ,again given to the drug
to check ADR is called Rechallenge
Postal Survey Method
Reporting of ADR
> Reporting of ADR is One of the most important parameter Of medical
> ADR involves the receipt, Data entering, assessment,adverse event Data
> Spontaneous reporting of suspected ADR, a regional or country wide
system for reporting is currently major source of information in
Who should Report ADR
> Healthcare professionals
> Marketing authorisation holders
What to Report
> All serious reactions and interaction
> Poisoning due to traditional or herbal medicine
> All suspected ADR related to Drug- drug, drug – food Interaction.
> All ADR As a result of Prescription and Non-Prescription medicinal
> All suspected ADR Irrespective to Product information delivered by
Where to Report :
> Peripheral pharmacovigilance centre (city wise )
> Regional pharmacovigilance centre
> Central pharmacovigilance centre
Sections to validate Individual case safety Report
> 1) Patient identification
> 2)Reporter identification
> 3) Suspected ADRs
> 4) suspected medicine
1. patient identification
> The Name, initials or number of the patient in a hospital, name of the
medical institution, dispensary, clinic or pharmacy are to be indicated or
recorded in the report.
> Age at a time of reaction , sex, weight, should be indicated.
2. Reporter identification
> Name of the Reporter
> Contact details And address are indicated .
> Name of the suspected drug (s): Trade name should preferably be used, if trade
name is not available, generic name may be used. Strength of the drug (s)
should also be stated
> Dosage, frequency and route of administration: should be clearly mentioned.
> Therapy date: The dates of starting and end of the administration of each drug
should be stated .
> Batch number and Expiry date: should be mentioned.
> Description of Reaction.
> Seriousness of Reaction.
> Date of start and stop of Reaction.
> Laboratory tests and relevant Data.
> Date of drug withdrawal / continuous of ADR.