History and Development of Pharmacovigilance

Pharmacovigilance

WHO defines Pharmacovigilance as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems.

Aims of Pharmacovigilance

Improve patient care and safety in relation to use of medicines

Improve public health and safety

Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective use

Promote understanding, education and clinical training in Pharmacovigilance and its effective communication to the public.

 

History and Development of Pharmacovigilance

   

History

During the 20th century there were some serious adverse events associated with the medical products and drugs that resulted in pressure on governments, businesses to produce legalization and guidance, as well as the evolution of the regulatory bodies to protect the safety of patients.


Chloroform Anesthetic

The history of pharmacovigilance started 169 years ago, on Jan 29, 1848, a young girl (Hannah greener) from the north of England died after receiving chloroform anesthetic before removal of infected toenail.

The cause of Hannah's death was investigated to understand what happened to Hannah, but it was impossible to identify what killed her.


Sulfanilamide Elixir

In 1937, there were 107 deaths in the USA, because of the use of sulfanilamide elixir, containing diethyl glycol as the solvent. 

This solvent was considered the cause of deaths, but the manufacturing companies were not aware about its toxicity at that time.

Consequently, the Federal Food, Drug and Cosmetic Act was established in 1938. Its aim was to renovate the public health system. It introduced a new system that the safety of drugs should be demonstrated before their market approval and introduced the possibility of conducting factory inspections.


Thalidomide Tragedy

The greatest of all drug disasters was the 'Thalidomide tragedy' of 1961-1962 in Europe.

Thalidomide had been introduced as a safe and effective hypnotic and anti-emetic. It rapidly became popular for the treatment of nausea and vomiting in early pregnancy.

Tragically, the drug proved to be a potent human teratogen that caused major birth defects in an estimated 10,000 children in the countries, where it was widely used in pregnant women.

Dr. M.C. Bride, an Australian doctor suggested a connection between congenital malformation of babies and thalidomide.

He observed that the incidence of congenital malformations of babies (1.5%) had increased up to 20% in the women who had taken thalidomide during pregnancy.

Also in Germany Dr. Lenz suggested a correlation between malformations and thalidomide and his suspect was published in a German journal.

Later in 1973, a retrospective study showed the correlation between the congenital malformations of babies and ingestion of thalidomide during pregnancy.

 

Development

Thalidomide tragedy, led in Europe and other countries to the establishment of the drug regulatory authorities. FDA started systemic collection of reports on all types of ADRs.

In many other countries, along with efficacy, safety of drugs was emphasized and standards were set which the new drugs were required to meet before getting authorization for marketing. Government organizations were instructed to set up post marketing surveillance systems so as to pick up any ADR as early as possible and prevent similar tragedies in future.

 

Important Years to Remember

In 1962 USA revised the law required to prove safety and efficacy before issuing marketing authorization.

In 1963 British Committee on Safety of Drug Monitoring was established.

In1964 the UK started a “yellow cards” system.

In 1964-65 National ADR reporting system was established in the UK, Australia, New Zealand, Canada, West Germany, and Sweden.

In 1968, a collaborative effort was made by 10 countries to cooperate with WHO for international drug safety monitoring.

In 1978 WHO center moved from Geneva to Uppsala.

In 1986 ADR monitoring system for India was proposed (12 regional centers).

In 1997 India joined WHO-ADR monitoring programme (3 centers: AIIMS, KEM hospital, JLN the Joint Learning Network for Universal Health Coverage).

In 2004 – 2008 National Pharmacovigilance programme by ICH (2 Zonal, 5 Regional, and 24 Peripheral centers) was founded.

In 2010 The Pharmacovigilance Programme of India was implemented.


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