Dr. Proton Rahman, MD, FRCPC
I wish to thank Health Canada for providing me with the opportunity to comment on this discussion paper. The paper which highlights why effective regulatory systems are needed is well informed providing a clear summary of the pharmacovigilance systems in place in a number of countries. This information is concisely summarized within table 3; although the inclusion of further information regarding the systems currently in place in Canada would add value to both the body of the text and the summary table. Analysis of this information will provide regulatory bodies with a springboard from which to develop a strategic vision for the implementation of effective pharmacovigilance systems throughout Canada.
The paper helpfully presents two planned developments for enhancing pharmacovigilance in Canada; the development of the Drug Safety Effectiveness Network (DSEN) and the introduction of Progressive Licensing. While the development of both of these initiatives should be applauded it should be noted that the DSEN is still in very early stages of development and a thorough review of the network’s effectiveness should be undertaken following an appropriate period of operation. The development of the DSEN should not lead to the exclusion of other post marketing research. As highlighted in the paper there is some concern regarding the impartiality of industry funded research, however this research should not be disregarded but instead the research environment be managed in such a way as to ensure impartiality in reporting.
The proposed introduction of Progressive Licensing, including conditional licensing (or release) would have a positive impact on “Keeping Canadians Safe” and potentially allow the earlier introduction of new drugs, however unless the introduction is backed with adequate legislation this impact will be severely reduced. The examples given of systems in place in other countries clearly highlight the need for supporting legislation to ensure the success of Progressive Licensing. Only through supporting legislation can it be ensured that pharmaceutical industries will abide by the terms of the license, such as the requirement for monitoring adverse events and the development and implementation of risk management plans. Progressive Licensing should not however be seen as the only answer, as there is benefit in other initiatives such as approvals through surrogate endpoints and mandatory post marketing surveillance of drugs known to have a higher risk of adverse events.
It should be noted that not all clinically relevant situations are assessed by randomized controlled trials. In such circumstances, information from disease registries can make an important contribution to the evidence base. In order for non-randomized prospective disease registries to adequately reflect clinically relevant outcomes it is important to register all relevant patients and capture accurate and comprehensive data through the collection of information on these patients in a defined area in a set time period. For this to occur it is vitally important for funding agencies to provide adequate and sustained resources for national disease registries. In the past, this has often not been a priority of funding agencies as such registries have been considered a “non hypothesis driven” initiative.
Regardless of how effective the pharmacovigilance and post-marketing surveillance systems are they are of limited use without the incorporation of effective methods of communication with prescribing Drs. The discussion paper highlights the need for developing more effective ways of communicating safety messages and this should be seen as one of the priorities of any resulting strategic plan.
The discussion paper also raises a number of issues regarding data collection, with many of the recommendations put forward reflecting the systems currently in place in Newfoundland and Labrador, where partner agencies have developed effective collaborative working arrangements to identify how disparate data sets may be shared and analyzed in a secure environment. Any initiatives to bring about collaboration and data sharing between provinces must give full consideration to the privacy and confidentiality issues that will arise, and as to how these relationships will be impacted by provincial privacy legislation.
On reading the paper it became clear that in order to prevent confusion in the future development of policy there is a need to ensure consistency in terminology when discussing pharmacovigilance and post marketing surveillance.
In order to ensure that any future strategies or policies reflect emerging technologies and future trends it is essential that consideration be given to the role of pharmacogenetics and personalized medicine in the enhancement of drug safety.
In summary this paper provides a good starting point for the development of a strategic vision for the introduction of nationally regulated pharmacovigilance, however if we are to truly “Keep Canadians Safe”, the vision must be developed in concert with all partners and address the broader issues of governance, privacy, data access and drug accessibility.--
Proton Rahman MD, FRCPC a rheumatologist and genetic epidemiologist in the Faculty of Medicine at Memorial University. He is an associate professor of medicine and consultant rheumatologist to Eastern Health at the St. Clare’s site.
- Roy West1 PhD, Don MacDonald2 PhD, Catherine Street1 B.Pharm(Hons), Khokan Sikdar2 MSc, MAS, PhD (candidate), Proton Rahman1 MD1Population Therapeutic Research Group, Memorial University, St. John’s NL
2Newfoundland and Labrador Center for Health Information, St. John’s, NL