scholarly journals Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India

2018 ◽  
Vol 9 (1) ◽  
pp. 51 ◽  
Author(s):  
Prasad Thota ◽  
Anusha Thota ◽  
Bikash Medhi ◽  
Shabir Sidhu ◽  
Pramod Kumar ◽  
...  
Keyword(s):  
Drug Safety ◽  
Spontaneous Reporting

Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection

2014 ◽  
Vol 37 (1) ◽  
pp. 94-104 ◽  
Author(s):  
Vaishali K. Patadia ◽  
Martijn J. Schuemie ◽  
Preciosa Coloma ◽  
Ron Herings ◽  
Johan van der Lei ◽  
...  
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Spontaneous Reporting ◽  
Safety Signal ◽  
Reporting Data

scholarly journals Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

2019 ◽  
Author(s):  
Emanuel Raschi ◽  
Ugo Moretti ◽  
Francesco Salvo ◽  
Antoine Pariente ◽  
Ippazio Cosimo Antonazzo ◽  
...  
Keyword(s):  
Drug Safety ◽  
Spontaneous Reporting ◽  
Reporting Systems

Targeted spontaneous reporting on drug safety alerts issued by pharmacovigilance programme of India: A new origin of pharmacovigilance in India

2019 ◽  
Vol 10 (1) ◽  
pp. 33
Author(s):  
Prasad Thota ◽  
Shabir Sidhu ◽  
Bikash Medhi ◽  
Phulen Sarma ◽  
Ajay Prakash ◽  
...  
Keyword(s):  
Drug Safety ◽  
Spontaneous Reporting

scholarly journals Opportunities Missed, Warnings Ignored: Re-discovering the History of Drug Safety in Great Britain following the Thalidomide Disaster 1961

2016 ◽  
pp. 49-72 ◽  
Author(s):  
Stuart Anderson
Keyword(s):  
Drug Safety ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Spontaneous Reporting System ◽  
Warning Signs ◽  
Regulatory Body ◽  
Missed Opportunities ◽  
History Of ◽  
Suspected Adverse Drug Reactions ◽  
Made In

Following the thalidomide disaster1961 many accounts of pre-thalidomide drug safety history appeared. Some identified events which represented missed opportunities or ignored warning signs. This paper reviews three assertions made in these accounts; that an opportunity to introduce a spontaneous reporting system for suspected adverse drug reactions in 1893 was missed; that concerns about dangers of drugs in pregnancy identified in 1904 were ignored; and that a proposal to establish a drug regulatory body made in 1914 was abandoned. The paper concludes that even if all had been acted upon it is unlikely that the thalidomide disaster could have been entirely avoided.http://dx.doi.org/10.14195/1647-6336_14_3

FDA's New Drug Safety Board Under Scrutiny

2005 ◽  
Vol 39 (3) ◽  
pp. 51
Author(s):  
JENNIFER SILVERMAN
Keyword(s):  
Drug Safety ◽  
New Drug
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