Post Marketing SurveillancePosted by Ahmed on February 25, 2021 at 6:46 pm
What is the difference/relationship/scope of work of the following bodies/programs/platform in the field of post market surveillance? (who is who)
ADR report portal
Canada Vigilance database
- 3 Replies
- MemberFebruary 25, 2021 at 10:04 pm
This is Omar Aimer, Pharmacovigilance Specialist and instructor of the drug safety and pharmacovigilance course developed and hosted by InnoVigilance and RxCourse.
– Medeffect : The MedEffect program has been developed by Health Canada’s (HC) Marketed Health Products Directorate (MHPD), with the following goals in mind:
– To provide centralized access to relevant health product safety information
– To make it as simple and efficient as possible for health professionals and consumers to complete and file adverse reaction reports via web, phone, fax or mail
– To build awareness about the importance of reporting adverse reaction reports to HC, and how this information is used to identify and communicate potential risks. (similar to : Medwatch in the US, Yellow Card in UK…)
– Canadavigilance : HC’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada
– ADR report Portal : never heard of this program here in Canada
– Canadavigilance Database : is HC’s database of reported adverse events (occurred in Canada) reported from: Manufacturers, HCPs, and Pts. (FAERS for FDA, Eudravigilance for EMA Europe and Vigibase for the WHO)
– Sentinel e-system: Canada’s first multi-disease electronic medical record surveillance system. Engages with clinicians, researchers, and policy makers to better understand primary care efficiencies and gaps to improve health care for Canadians.
– MHPD: on of multiple HC’s directrorates, leads an evidence-based program that works collaboratively with other organizations to assess health product risks and makes regulatory decisions to manage those risks (Drug Safety and Pharmacovigilance). It also leads the development of regulations for reporting adverse reactions and works closely with international organizations (FDA, EMA, PMDA, WHO, ICH…) in the harmonization of regulatory systems to facilitate the sharing of information.
– Canadian Adverse Drug Reaction Information System (CADRIS): is the ancestor of Canadavigilance database. It was established in 1965 after thalidomide was discovered to cause disabilities in children in utero. The computer database was designed to provide an early-warning system to flag problems with drugs and replaced in 2007.
– Canadian Adverse Drug Reaction Monitoring Program (CADRMP) : is the Canadian adverse drug reaction monitoring program (CADRMP) online query and data extract strengthened by Medeffect program.
Hope this helps!
- MemberFebruary 26, 2021 at 1:44 pm
Dear Dr @omar-aimer ,
Thank you very much. that was so informative and comperhensive.
- MemberFebruary 27, 2021 at 2:51 pm
You’re most welcomed @ahmed
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