Clinical Research and Pharmacovigilance
(MPL 204T)
“ History and Progress of Pharmacovigilance ”
Contents :
Introduction
Aim of Pharmacovigilance
History and Progress of Pharmacovigilance
WHO International Drug Monitoring Programme
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Pharmacovigilance
According to WHO pharmacovigilance is defined as
“the science and activities relating to the detection,
assessment, understanding and prevention of adverse
effects or any other medicine-related problem.”
It is derived from two words
pharmacon – “drug”
vigilare – “to keep watch”
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Aim 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.
• Promote understanding, education and clinical training in pharmacovigilance and
its effective communication to the public.
• To identify complications associated with the use of medicines and conveying it in an
appropriate manner.
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History and Progress of Pharmacovigilance
• During the 20th century there were some serious adverse events associated with medical
products and drugs that resulted in development of Pharmacovigilance system.
• 1848 - The history of Pharmacovigilance marked its first milestone
169 years ago, when a young girl Hannah Greener of North
England died after receiving chloroform anesthesia before
removal of an infected toenail.
Sir James Simpson had discovered that chloroform was a
safer and powerful anesthetic, and he had introduced it in
clinical practice.
• 1901 - In USA, 13 children died from contaminated Diphtheria Vaccine.
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Conti….
• 1937 - There were 107 deaths in the USA, because of the use of Sulfanilamide elixir
(Raspberry flavored elixir), containing Diethyl Glycol as solvent.
• 1938 - Due to elixir tragedy, the Federal Food, Drug and Cosmetics Act (FDCA)
was enacted which began to examine the risk-benefit profile of medicinal
products.
• 1938 - Douthwaite suggested that Acetylsalicylic Acid (ASA) is responsible for
causing Melena. In 1955, its toxicity was proved.
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Conti….
• 1950 - Aplastic anemia reported due to chloramphenicol toxicity.
• 1961 - Thalidomide Tragedy made milestone in origin and
development of European Pharmacovigilance. The drug was
tested in 300 patients without any prior toxicity studies.
• Dr. McBride, an Australian doctor suggested a connection between congenital malformation
of babies and thalidomide. Hence, it was discontinued in 1962after it was reported under
pharmacovigilance.
• 1964 - Yellow Card was structured in UK which is a specific form to compile a spontaneous
report of drug toxicity.
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Conti….
• 1965 - The disaster of thalidomide stimulated the development of a European legislation.
• 1966 - A pilot study of Boston Collaborative Drug Surveillance Program started.
• 1968 - The WHO Programme for International Drug Monitoring was instituted and
ten members participated in this program (Australia, UK, USA, Germany, Canada,
Ireland, Sweden, Denmark, New Zealand, and Netherlands).
• 1995 -
European Medicine Agency (EMA) was set up.
EudraVigilance was funded.
• 2001 -
Pharmacovigilance Programme of India was initiated.
• 2010 -
Amendments in the European Pharmacovigilance legislations was done.
• 2012 -
In November, the new Eudravigilance format was launched.
• 2017 -
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Conti….
Pharmacovigilance in India
• Pharmacovigilance in India was introduced in 1986 with formal introduction of ADR
Monitoring System under the guidance of drug controller of India.
• Purpose - to generate data on adverse reactions through spontaneous reporting.
• In 1997, a significant revision took place in program in which India became a part of WHO
Program for International Drug Monitoring controlled by Uppsala Monitoring Centre.
• 1st January, 2005, WHO sponsored and World Bank Funded National PvPI was started in
India and enforced on 23 November, 2004.
• The National Pharmacovigilance Advisory Committee located at the office of CDSCO, the
National Regulatory Authority in India helps in coordinating the reporting of adverse drug
reaction.
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WHO International Drug Monitoring Programme
• The WHO Programme for International Drug Monitoring (PIDM) was established in
1968 to make sure that all the data on adverse reactions on patients was collected from
maximum sources.
• There are more than 150 countries included in this Programme.
• They operate their work as a team –
a) For identification and monitoring the harm caused by medicines
b) To reduce patient’s risks
c) To establish the pharmacovigilance systems and standards globally
• Since 1978, the Uppsala Monitoring Centre (UMC) controls and operates all the technical
and operational aspects of the programme.
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Conti….
Functions of WHO Programme for International Drug Monitoring –
a) Provides forum for Member States of WHO for working together in monitoring drug
safety.
b) Facilitates identifying and analyzing the adverse reaction signals from documented
data handed over to the WHO global individual case safety report (ICSR) database
(Vigibase) by the respective member countries.
c) Provide information to National Centers through ‘Vigimed’ an email information
exchange system.
d) Publication of periodical newspaper, guidelines and books in pharmacovigilance and
risk management area.
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Conti….
Diag. Three-part network of WHO programme
Uppsala Monitoring Centre - a) Collection, assessing and communicating information about drug
b) Collaboration for practice and developing pharmacovigilance
c) Warning National Regulatory Authorities about probable drug
safety problems
WHO Headquarter - manages all the issue related to any type of policy
National Pharmacovigilance Centers - sent all case report to WHO ICSR database
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References
1) A Book of Pharmacovigilance by Dr. Agnimitra Dinda and Monica Saxena, Thakur
Publication, First edition, Pg no. 15-19
2) A Book of Pharmacovigilance by Pramod V. Burakale, Manish Bhise and Vishal
Patond, Pee Vee Publication, Pg no. 1-11
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THANK
YOU
Any question
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