Authors’ Reply to Ahmad SR: “Adverse Drug Reaction Reporting by Patients: An Overview of Fifty Countries”

Experiences with adverse drug reaction reporting by patients: an 11-country survey.

BACKGROUND Patients are important stakeholders in pharmacovigilance; however, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe. If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted. OBJECTIVE This study aims to rev...

Canada proposes amendments to adverse drug reaction reporting.

On June 13, 2009, proposed regulations amending the Food and Drug Regulations1 with respect to adverse drug reaction reporting (“Proposed Regulations”) were published in the Canada Gazette. The Proposed Regulations permit more rigorous monitoring of drug safety by the Minister of Health and bolster the Minister’s ability to enforce Canada’s reporting requirements for adverse drug reactions.2 Un...

The Authors’ Reply

Quality check of spontaneous adverse drug reaction reporting forms of different countries.

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establ...

The Authors’ Reply