Biology and Medicine

Impact analysis of mandatory reporting of serious adverse drug reactions and medical device incidents on healthcare institutions following the 2014 amendment to the Food and Drug Regulations (Vanessas Law) in Canada

Annual Congress on Medicine

November 05-06, 2018 Bangkok, Thailand

Shereen Aly

Pharmacovigilance Manager, Canada

Posters & Accepted Abstracts: Biol Med

Abstract:

Over the past 50 years, minimal updates were done to the Canadian Food and Drugs Act, yet there was significant progress internationally within the pharmacovigilance environment. This changed in the year 2000, when a 15-year-old girl Vanessa was a victim of a serious and fatal adverse drug reaction (long QT) and eventually death from a prescription drug cisapride. Vanessa???s father ???Terrence Young??? initiated and proposed the Bill C-17 on December 6th, 2013; Protecting Canadian from unsafe drugs act known as Vanessa???s Law that received final approval on November 6th, 2014. To measure the national readiness of the healthcare institutions for the adoption and implementation of the SAE and MDI mandatory reporting process to meet the new drug law; Protecting Canadian from Unsafe Drug Act Vanessa???s Law set by Health Canada. An online survey questionnaire was designed to gain institutional insights on policy awareness, preparedness, systems and processes, resourcing and training measures taken for ADR reporting and the potential challenges and benefits that would be faced when the law becomes implemented in December 2019. Result analysis indicated, 96.4% of the respondents were unaware of the Law and its reporting requirements, 50% confirmed the preparedness of their respective institutions to implement the new requirement. Their information management systems, 75% of respondents indicated they have a well-established reporting system in place to support the new regulation. Currently, ARD reporting within the hospitals is an encouraged voluntary process. The study has identified that awareness of the new law is very less and there is no clear supporting guidance in place yet. Hospitals need a formal guidance from Health Canada upon which to base their operational procedures. Health Canada needs to consider immediately implementing educational strategies to address the issues and provide a clear and descriptive supporting guidance before the law goes into full force.

Biography :

E-mail: shereenali@hotmail.com