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According to WHO it is the science relating to detection, assessment, understanding and prevention of adverse drug reaction or any drugs related problem.
ADR???
Adverse drug reaction
A response to a drug that is noxious and unintended which occurs at a dose normally used in man for prophylaxis, diagnosis or therapy of disease.
Pharmacovigilance is not only confined to Modern medicine but also includes Herbal medicines, blood products and vaccines too.
Aim of PharmacovigilanceTo improve patient care and safety in relation to use of
medicationTo improve public health and safety in relation to use of
medicineContribute to assessment of benefit, harm, effectivemess and
risk of medicines ,encouraging their safe and rational use.Promote understanding, Educational and clinical Training in
Pharmacovigilance.
Guides regulators on whether the drug should be Guides regulators on whether the drug should be continue in market, continue in market,
be restricted in usages, orbe restricted in usages, or in worst possible in worst possible
scenario,withdrawn from the marketscenario,withdrawn from the market
DRUGS RECENTLY BANNED IN INDIA?Pioglitazone-can cause heart failure and increases risk of
bladder cancer.
Dienxit- Deanxit is a harmful combination
Analgin-causing a sharp fall in white blood cells, a potentially fatal condition, called agranulocytosis
Others-Sibutramin, Gatifloxacin,Nimuslide
History and Evolution1937 –Sulphanilamide +Diethylglycol Disaster
Death of 105 individuals
Diethyleneglycol was incriminated
Drug and Cosmetic Act, 1938 under which pharmaceutical product manufacturers would have to show scientific evidences of the safety of the drugs before releasing them for sale.
1959-1961 –Thalidomide Disaster (Max. Seen in Germany)
Linked to a congenital abnormality phocomelia
In 1962, It was discontinued.
The Kefauver-Harris amendment was approved, under which scientific evidences
of efficacy and safety of drugs required before drug test/trail in humans.
WHO's Programme for International Drug Monitoring was started in 1968 as a means of pooling existing data on adverse drug reactions .
At the end of 2010, 134 countries were part of the WHO Pharmacovigilance Programme.
This Program is coordinated by WHO together with its collaborating centre in Uppsala, Sweden.
The collaborating center is responsible for maintaining the global ADR database, Vigibase. At present the database contains more than four million ADR reports
Till Date -149 countries
Process in Pharmacovigilance
Collect and Record Adverse Event/ Adverse Drug Reaction
Causality Assesment and analysis of ADRCollate and Code in DatabaseCompute Risk benefit and Suggest regulatory actionCommunicate for safe use of drugs among stakeholders.
Pharmacovigilance at JPNATCObjectives:
To Monitor Adverse Drug Reaction seen in JPNATC Patients
To Create awareness among HCP about the importance of ADR Reporting
To monitor Benefit risk profile of Medicines
To Support National Pharmacovigilance Center for formulation of safety related regulatory decision for Medicine.
Pharmacovigilance at JPNATCInitiated along with Patient Safety Program at JPNATC
Feb 10th : Meeting conducted at Pharmacology department Main Hospital AIIMS. The following Stake holders were present at the meeting.
1. HOD,Pharmacology Department,2. Add. MS JPNATC,3. Faculty Incharge IT.4. HOD,Microbiology5. Residents Hospital Administration
Minutes of Meeting
To Initiate Pharmacovigilance program in JPNATC .
1 Phd Student and two Research Assistant to be appointed for Pharmacovigilance program.
Adverse Drug Reaction form to be digitalized in coordination with faculty I/C IT and to be incorporated in E-Hospital
Appropriate Training session to be designed to enhance knowledge of ADR reporting among Health care professionals of JPNATC.
Orientation classes to Health care professional for guidance to Report ADR
KAP SurveyTotal 25 Participants (Nurses , DNS, ANS ,Grade I and
Grade II)
20 set of question
Designation Frequency (n=25) Percentage
ANS 10 25%
DNS 3 12%
Grade I 8 32%
Grade II 7 28%
ConclusionPharmacovigilance program is a helpful tool for protecting
consumers (Patients) from harmful effects of medicines.ADR Should be considered as professional obligationEvery HCP should be aware of existing pharmacovigilance
mechanism in their country .It’s the efficient way to boost the confidence for safety.
Dying from a disease is sometime unavoidable, Dying from a medicine is unacceptable !-Lepakhin V. Geneva