Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

Herder, Matthew; Gibson, Elaine; Graham, Janice E.; Lexchin, Joel; Mintzes, Barbara

doi:10.1503/cmaj.131850

Cited by 10 publications

(5 citation statements)

References 23 publications

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“…This law gives the government a number of powers Canadians likely thought it already had: i.e., the power to initiate mandatory recalls of unsafe drugs, to compel manufacturers (and others) to provide safety information, to impose conditions on market authorizations and to compel companies to revise labels to clearly reflect health risk information (Herder et al 2014; Hohl et al 2015). Despite these improvements, more needs to be done.…”

Section: Specific Objectives and Strategic Actionsmentioning

confidence: 99%

A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada

Morgan

Gagnon

Mintzes

et al. 2016

hcpol

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Canada needs a national strategy to fulfill its obligation to ensure universal access to necessary healthcare, including prescription drugs. A 2004 attempt at a national strategy for pharmaceutical policy failed because it lacked clear vision, logical planning and commitment from federal and provincial governments. The result of uncoordinated pharmaceutical policies in Canada has been more than a decade of poor system performance. In this essay, we present a framework for a renewed national strategy for pharmaceutical policy. Building on published research and international frameworks, we propose that pharmaceutical policies of federal, provincial and territorial HEALTHCARE POLICY Vol.12 No.1, 2016 [19] governments be coordinated around a core health-focused goal. We strongly suggest policy actions be taken on four core objectives that are necessary to support the overarching health goal. If implemented, the proposed strategy would offer clear benefits to all Canadians who use medicines, federal and provincial governments and to the economy as a whole. We therefore argue that political leadership is now needed to articulate and implement such a plan on behalf of Canadians. RésuméLe Canada doit se doter d' une stratégie nationale afin de respecter son obligation d' assurer un accès universel aux services de santé nécessaires, notamment les médicaments sur ordonnance. La tentative de 2004 en ce sens a connu l'échec en raison d' un manque de vision claire, de planification logique et d' engagement de la part des gouvernements provinciaux et fédéral. Le manque de coordination des politiques relatives aux produits pharmaceutiques au Canada a donné lieu à plus d' une décennie de faible rendement pour le système. Dans cet essai, nous proposons un cadre de travail pour le renouvellement de la stratégie nationale relative aux produits pharmaceutiques. À la lumière de recherches publiées et de cadres de travail internationaux, nous proposons que les politiques des gouvernements provinciaux, territoriaux et fédéral s' articulent autour d' un objectif de santé commun. Nous suggérons fortement que l' action politique porte sur quatre objectifs clés, nécessaires pour appuyer l' objectif de santé commun. Si elle était mise en oeuvre, la stratégie proposée se traduirait par de réels avantages pour les Canadiens qui prennent des médicaments, pour les gouvernements provinciaux et fédéral ainsi que pour l' ensemble de l'économie du pays. Nous affirmons donc, pour le bien-être des Canadiens, qu'il est temps de mettre en place le leadership politique nécessaire pour articuler et mettre en oeuvre un tel plan.

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Section: Specific Objectives and Strategic Actionsmentioning

confidence: 99%

A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada

Morgan

Gagnon

Mintzes

et al. 2016

hcpol

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“…In response to this pressing concern, Canada implemented regulations outlined in the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) which came into full effect on December 16, 2019. This federal legislation mandates prompt reporting of serious adverse drug reactions (ADRs; a subtype of ADEs) and medical device incidents from hospitals to Health Canada within 30 days of documentation [5]. These regulations serve as a safeguard to protect patients and improve drug surveillance.…”

Section: Introductionmentioning

confidence: 99%

Characterizing and Comparing Adverse Drug Events Documented in 2 Spontaneous Reporting Systems in the Lower Mainland of British Columbia, Canada: Retrospective Observational Study

Lau,

Cragg,

Small

et al. 2024

JMIR Hum Factors

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Background Robust adverse drug event (ADE) reporting systems are crucial to monitor and identify drug safety signals, but the quantity and type of ADEs captured may vary by system characteristics. Objective We compared ADEs reported in 2 different reporting systems in the same jurisdictions, the Patient Safety and Learning System–Adverse Drug Reaction (PSLS-ADR) and ActionADE, to understand report variation. Methods This retrospective observational study analyzed reports entered into PSLS-ADR and ActionADE systems between December 1, 2019, and December 31, 2022. We conducted a comprehensive analysis including all events from both reporting systems to examine coverage and usage and understand the types of events captured in both systems. We calculated descriptive statistics for reporting facility type, patient demographics, serious events, and most reported drugs. We conducted a subanalysis focused on adverse drug reactions to enable direct comparisons between systems in terms of the volume and events reported. We stratified results by reporting system. Results We performed the comprehensive analysis on 3248 ADE reports, of which 12.4% (375/3035) were reported in PSLS-ADR and 87.6% (2660/3035) were reported in ActionADE. Distribution of all events and serious events varied slightly between the 2 systems. Iohexol, gadobutrol, and empagliflozin were the most common culprit drugs (173/375, 46.2%) in PSLS-ADR, while hydrochlorothiazide, apixaban, and ramipril (308/2660, 11.6%) were common in ActionADE. We included 2728 reports in the subanalysis of adverse drug reactions, of which 12.9% (353/2728) were reported in PSLS-ADR and 86.4% (2357/2728) were reported in ActionADE. ActionADE captured 4- to 6-fold more comparable events than PSLS-ADR over this study’s period. Conclusions User-friendly and robust reporting systems are vital for pharmacovigilance and patient safety. This study highlights substantial differences in ADE data that were generated by different reporting systems. Understanding system factors that lead to varying reporting patterns can enhance ADE monitoring and should be taken into account when evaluating drug safety signals.

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“…When drug safety legislation known as Vanessa’s Law was first introduced in Parliament in 2013, it contained no measures to improve the transparency of the evidence base behind health products, in marked contrast to reforms enacted in the US and elsewhere. 8 Health Canada officials reworked the draft legislation in concert with Members of Parliament, adding several provisions intended to enhance the transparency of evidence generated through clinical trials, as well as the regulatory system as a whole. This legislation later became part of the Food and Drugs Act .…”

mentioning

confidence: 99%

Clinical trial registration and results reporting: a call for transparency, coordination, and meaningful enforcement

Herder,

Murthy

2024

CMAJ

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Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

Cited by 10 publications

References 23 publications

A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada

A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada

Characterizing and Comparing Adverse Drug Events Documented in 2 Spontaneous Reporting Systems in the Lower Mainland of British Columbia, Canada: Retrospective Observational Study

Clinical trial registration and results reporting: a call for transparency, coordination, and meaningful enforcement

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