A new breakthrough in this field only happened after an episode occurring in 1937. In that year, Sulfanilamide (Prontosil), used since 1932 for treatment of streptococcal infections, was launched as a syrup, containing diethyleneglycol as solvent. Although tested regarding aspect, taste and odor, its safety was not evaluated before launching. It was responsible for the death of 105 individuals (34 children and 71 adults) and diethyleneglycol was incriminated. This tragedy caused the American Congress to approve in 1938 the Food Drug and Cosmetic Act, under which pharmaceutical product manufacturers would have to show scientific evidences of the safety of the drugs before releasing themfor sale.
The thalidomide tragedy is a milestone in the origin and development of pharmacovigilance. Thalidomide was introduced in 1957 and widely prescribed as an allegedly harmless treatment for morning sickness and nausea. It was tested in approximately 300 patients without toxicity. It was soon linked to a congenital abnormality phocomelia, which caused severe birth defects in children of women who had been prescribed this medicine during pregnancy. In 1962, after reports of numerous cases of phocomelia, it was discontinued. In the same year, the Kefauver-Harris amendment was approved, requiring scientific evidences of efficacy and safety before drug tests in humans
. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
The origin of pharmacovigilance in India goes back to 1986, when a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India.  However, nothing much happened until a decade later when in 1997, India joined the WHO Adverse Drug Reaction Monitoring Programme based in Uppsala, Sweden. This attempt was unsuccessful and hence, from 1January 2005, the WHO-sponsored and World Bank-funded National Pharmacovigilance Program for India was made operational.
Pharmacovigilance at Trauma Center, AIIMS
Dr.Sharad H. Gajuryal
Pharmacovigilance: Pillar for Patient
Pharmacovigilance is not only confined to Modern medicine
but also includes Herbal medicines, blood products and
Aim of Pharmacovigilance
To improve patient care and safety in relation to use of
To improve public health and safety in relation to use of
Contribute to assessment of benefit, harm, effectivemess and
risk of medicines ,encouraging their safe and rational use.
Promote understanding, Educational and clinical Training in
Guides regulators on whether the drug should beGuides regulators on whether the drug should be
continue in market,continue in market,
be restricted in usages, orbe restricted in usages, or
in worst possiblein worst possible
scenario,withdrawn from the marketscenario,withdrawn from the market
DRUGS RECENTLY BANNED IN
Pioglitazone-can cause heart failure and increases risk of
Dienxit- Deanxit is a harmful combination
Analgin-causing a sharp fall in white blood cells, a potentially
fatal condition, called agranulocytosis
History and Evolution
1937 –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
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
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
Causality Assesment and analysis of ADR
Collate and Code in Database
Compute Risk benefit and Suggest regulatory action
Communicate for safe use of drugs among stakeholders.
Pharmacovigilance in INDIA
150 Adverse Monitoring Center & NCC (Indian Pharmacopoeia commission)
Patient Safety and Performance
Improvement Program @JPNATC
Pharmacovigilance at JPNATC
To Monitor Adverse Drug Reaction seen in JPNATC
To Create awareness among HCP about the importance of
To monitor Benefit risk profile of Medicines
To Support National Pharmacovigilance Center for
formulation of safety related regulatory decision for
Pharmacovigilance at JPNATC
Initiated along with Patient Safety Program at JPNATC
: Meeting conducted at Pharmacology department Main
Hospital AIIMS. The following Stake holders were present at the
1. HOD,Pharmacology Department,
2. Add. MS JPNATC,
3. Faculty Incharge IT.
5. 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-
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
March,2015 : Orientation class regarding
pharmacovigilance was given to Nursing Staffs .
Total 25 Participants (Nurses , DNS, ANS ,Grade I and
20 set of question
Designation Frequency (n=25) Percentage
ANS 10 25%
DNS 3 12%
Grade I 8 32%
Grade II 7 28%
KNOWELDGE & AWARENESS
Pre-Test Mean Result =5.4
Post-Test Mean Result=9.5
Pharmacovigilance program is a helpful tool for protecting
consumers (Patients) from harmful effects of medicines.
ADR Should be considered as professional obligation
Every 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