History of pharmacovigilance

The formal pharmacovigilance began in the sixties of the last century after the so called ‘Softenon®-affair’. This medicine was used to treat nausea in pregnant women. After their mother had used Softenon® or Distaval®, more than 10.000 children were born with severe birth defects. It took (too) long before the causal relationship with the use of this medicine was made. Therefore, two global measures were taken:

  • Before medicines may be prescribed, medicines must meet requirements for efficacy, quality and safety. The Dutch Medicines Evaluation Board was established in the Netherlands in 1963.
  • A system for reporting adverse drug reactions by healthcare professionals was introduced in order to detect new signals at an early stage. In the Netherlands, all reports are collected by the Dutch Pharmacovigilance Centre Lareb.    

Pharmacovigilance is necessary because not all adverse effects of drugs and vaccines are known at the time they are admitted to the market. Only when large numbers of people use these medicines or vaccines, (rare) side effects, interactions with other drugs, or vaccines and effects on specific groups of users can be discovered.

Many articles and books on the history of pharmacovigilance have been written. All of the sources mentioned below are available at Lareb and can be provided on request. If you have additional information, please contact by sending an e-mail to: info@lareb.nl  

Title Authoress  Journal or book Year Volume 
Adverse drug reactions, a global perspective on signal generation and analysis   WHO anniverary symposium, proceedings  1988   
Adverse Reactions to drugs  Wade O.L.  Boek: Willimam Heinermann Medical Books Ltd., Londen  1970  1e druk, 163 pag. 
Bijwerkingen van geneesmiddelen; een historisch perspectief  Egberts, A.C.G.  Pharmaceutisch Weekblad  1993  128(36):1058-1061 
Drugs in our society  Talalay P., Murnaghan J,H,  Boek: The Johns Hopkins Press, Baltimore  1964  1e druk, 303 pag. 
Drugs, doctors and disease  Inglis B.  Boek: Mayflower Book Ltd., Londen  1965  1e druk, 232 pag. 
Erkrankungen durch Arzneimittel  Heintz D.R.  Boek: Georg Thieme -Verlag, Stuttgart  1966  1e druk 544 pag. 
Klinik und Therapie der Nebenwirkung C.en  Kuemmerle H.P., Senn A., Rentchnick P., Goossens N.  Boek: Georg Thieme -Verlag, Stuttgart  1960  1e druk, 1255 pag. 
Le risque thérapeutique  Duchesnay G.  Boek: G. Doin & Cie., Parijs  1954  1e druk, 587 pag. 
Leopold Meyler (1903-1973): een pionier op het gebied van bijwerkingen en geneesmiddelen  van Grootheest A.C., Dukes M.N.G.  Pharmaceutisch Weekblad  2003  138(51/52):1816-1819 
Leopold Meyler (1903-1973): een pionier op het gebied van bijwerkingen en geneesmiddelen  van Grootheest A.C., Dukes M.N.G.  Nederlands Tijdschrift voor Geneeskunde  2003  147(51):2526-2529 
Maladies Médicamenteuses dórdre thèrapeutique et accidental  Albahary C.  Boek: Masson & Cie., Parijs  1953  1e druk, 729 pag. 
Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994  Rawlins M.D.  Journal of the Royal College of Londen  1995  29(1):41-49 
Reactions with drug therapy  Alexander H.L.  Boeke: W.B. Saunders Comp., Philidelphia-Londen  1955  1e druk, 284 pag. 
Signal Detection, historical background  Egberts A.C.G.  Drug Safety  2007  29(7):607-609 
The Dawn of pharmacovigilance: an historical perspective  van Grootheest A.C.  Int. J. Pharm. Med.  2003  17(5-6): 195-200 
The history of DES, lessons to be learned  Veurink M., Koster M., De Jong-van den Berg L.T.W.  Pharm. World Science  2005  27:139-143 
The therapeutic nightmare  Mintz M.  Boek: Houghton Mifflin Comp., Boston  1965  1e druk, 576 pag.