Postmarketing Drug Surveillance Research Articles

Timely, Granular, and Actionable: Designing a Social Listening Platform for Public Health 3.0

Every day, patients access and generate online health content through a variety of channels, creating an ever-expanding sea of digital data. At the same time, proponents of public health have recently called for timely, granular, and actionable data to address a range of public health issues, stressing the need for social listening platforms that can identify and compile this valuable data. Yet previous attempts at social listening in healthcare have yielded mixed results, largely because they have failed to incorporate sufficient context to understand the communications they seek to analyze. Guided by activity theory to design HealthSense, we propose a platform for efficiently sensing and gathering data across the web for real-time analysis to support public health outcomes. HealthSense couples theory-guided content analysis and graph propagation with graph neural networks (GNNs) to assess the relevance and credibility of information, as well as intelligently navigate the complex online channel landscape, leading to significant improvements over existing social listening tools. We demonstrate the value of our artifact in gathering information to support two exemplar public health tasks: (1) performing postmarket drug surveillance for adverse reactions and (2) addressing the opioid crisis by monitoring for potent synthetic opioids released into communities. Our results across data, user, and event experiments show that effective design artifacts can enable better outcomes across both automated and human decision-making contexts, making social listening for public health possible, practical, and valuable. Through our design process, we extend activity theory to address the complexities of modern online communication platforms, where information resides not only in the collection of individual communication activities but also in the complex network of interactions among them.

Model driven method for exploring individual and confounding effects in spontaneous adverse event reporting databases

ABSTRACT Background Spontaneous Adverse Event Reporting (SAER) databases play a crucial role in post-marketing drug surveillance. However, the traditional model-free disproportionality analysis has been challenged by the insufficiency in investigating subgroup and confounders. These issues result in significant low-precision and biases in data mining for SAER. Methods The Model-Driven Reporting Odds Ratio (MD-ROR) was proposed to bridge the gap between SAER database and explainable models for exploring individual and confounding effects. MD-ROR is grounded in a well-designed model, rather than a 2 × 2 cross table, for estimating AE-drug signals. Consequently, individual and confounding effects can be parameterized based on these models. We employed simulation data and the FDA Adverse Event Reporting System (FAERS) database. Result The simulated data indicated the subgroup effects estimated by MD-ROR were unbiased and efficient. Moreover, the adjusted-MD-ROR demonstrated greater robustness against confounding biases than the crude ROR. Applying our method to the FAERS database suggested higher occurrences of drug interactions and cardiac adverse events induced by Midazolam in females compared to males. Conclusion The study underscored that MD-ROR holds promise as a method for investigating individual and confounding effects in SAER databases.

Overview and Lifecycle Management of Generic Pharmaceutical Drugs in Mexico, Guatemala and Brazil

Objective: The generic pharmaceutical markets in Mexico, Guatemala, and Brazil are influenced by distinct regulatory frameworks, production and distribution dynamics, and marketing strategies, which shape lifecycle management. Regulatory policies, market competition, and healthcare initiatives impact accessibility, affordability, and quality, presenting both challenges and opportunities for enhancement in these areas. Summary: This thesis offers an in-depth examination of lifecycle management strategies in the generic pharmaceutical markets of Mexico, Guatemala, and Brazil. Generic drugs are crucial for increasing access to affordable healthcare, especially in emerging economies. Through comparative analysis, this research explores the regulatory frameworks, market dynamics, and key challenges in the development, approval, marketing, and post-marketing surveillance of generic drugs in these three Latin American countries. The study starts with an overview of the regulatory landscape for generic pharmaceuticals in Mexico, Guatemala, and Brazil, highlighting similarities and differences in registration requirements, approval processes, and post-approval obligations. It investigates the roles of regulatory agencies like COFEPRIS, DIGEMID, and ANVISA in ensuring the quality, safety, and efficacy of generic drugs throughout their lifecycle. Additionally, the research delves into the strategies used by pharmaceutical companies for lifecycle management of generic drugs, including variations, biowaivers, and labeling changes. Real-world case studies illustrate post-approval changes and their regulatory implications in each country, providing insights into the complexities of managing generic drug portfolios in different regulatory environments. The thesis also examines the market dynamics affecting the availability, pricing, and accessibility of generic drugs in Mexico, Guatemala, and Brazil. Factors such as patent expirations, competition, healthcare policies, and public procurement practices are analysed to understand their impact on market entry, competition, and the affordability of generic drugs. Furthermore, the study addresses the challenges and opportunities in pharmacovigilance and post-marketing surveillance of generic drugs, emphasizing the need for robust systems to detect and manage adverse drug reactions and ensure patient safety. Conclusion: The key findings highlight regulatory frameworks, market dynamics, and lifecycle management strategies in the generic pharmaceutical markets, identifying challenges and opportunities. The study reflects on implications for stakeholders and suggests areas for future research to enhance accessibility, affordability, and quality.

Depression Events Associated with Proton-Pump Inhibitors in Postmarketing Drug Surveillance Data

Proton-pump inhibitors, PPIs, are widely prescribed and are available over the counter for prolonged reduction of stomach acid production and related disorders. PPIs irreversibly inhibit the hydrogen/potassium ATPase in gastric parietal cells. Recent retrospective studies have described an association between PPI use and depression. However, there is conflicting evidence that PPI therapy improves depressive symptoms. Considering the widespread use and over-the-counter availability of these drugs, further investigation into depression adverse event was warranted with a larger-scale postmarketing set of reports. Here we analyzed over 125,923 reports from the FDA Adverse Event Reporting System consisting of PPI and histamine-2 receptor antagonist monotherapy records and found a statistically significant association between use of PPIs and depression. Additionally, we analyzed each of the six currently marketed PPIs individually and observed the association with the depression adverse reaction for all of them.

Global Postmarket Pharmacovigilance: A Generic Drug Perspective.

Despite the recognized need for generic drug pharmacovigilance harmonization efforts, only a few studies compared generic drug postmarket safety and surveillance methods adopted by regulatory agencies in different countries. The purpose of this research is to collect available information from a sample of international regulators with the overall goal of providing a general overview of each agency's decision-making processes for postmarket generic drug safety and surveillance. A structured four-part questionnaire of open-ended and multiple-choice questions along with a semi-structured interview were designed to elicit detailed information. Swissmedic, Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, and the U.S. Food and Drug Administration (FDA) provided information. Detailed information from participating regulatory agencies demonstrated some similarities and differences in their postmarket generic drug pharmacovigilance approaches. This study examines each agency's scientific perspective to address generic drug safety issues, as well as to identify common barriers within decision-making processes, such as legislative restrictions and limited resources. Most agencies do not have specific processes that are unique to generic drug products. This exploratory study, through documenting common and unique approaches intends to create a greater awareness and to promote cross-collaboration between global regulatory agencies.

Patterns of adverse drug reactions in Jordan: a retrospective analysis of the National Pharmacovigilance Data Registry (2015–2021)

ABSTRACT Background Post-marketing surveillance of drugs is a cornerstone of pharmacovigilance. This study was conducted to characterize patterns of adverse drug reactions (ADRs) reported in Jordan. Research design and methods ADR reports submitted to the pharmacovigilance database of the Jordan Food and Drug Administration during 2015–2021 were retrospectively analyzed. The most commonly reported drugs, drug classes, ADRs, and ADRs consequences were explored. Logistic regression identified possible predictors of reporting serious ADRs. Results A total of 2744 ADR reports were included, among which 28.4% were classified as serious. An annual increase in ADR reporting was observed. The most commonly implicated drug classes were antineoplastic and immunomodulating agents (24.0%), anti-infectives for systemic use (14.2%), and alimentary tract and metabolism (12.1%). Covid−19 vaccination was the most reported drug (22.8%). Fatigue (6.3%), injection site pain (6.1%), and headache (6.0%) were the top three common ADRs. Among ADRs with outcome information, 4.7% were fatal. Patient’s age and intravenous medication use largely predicted reporting serious ADRs. Conclusions This study provides contemporary insights into the post-marketing surveillance of drugs in Jordan. The findings are foundational for future studies exploring drug-ADRs causality relationships. Efforts that promote pharmacovigilance concepts should be sustained and enhanced at the national level.

The person-time ratio distribution for the exact monitoring of adverse events: Historical vs surveillance Poisson data.

In the postmarket drug and vaccine safety surveillance, when the number of adverse events follows a Poisson distribution, the ratio between the exposed and the unexposed person-time information is the random variable that governs the decision rule about the safety of the drug or vaccine. The probability distribution function of such a ratio is derived in this paper. Exact point and interval estimators for the relative risk are discussed as well as statistical hypothesis testing. To the best of our knowledge, this is the first paper that provides an unbiased estimator for the relative risk based on the person-time ratio. The applicability of this new distribution is illustrated through a real data analysis aimed to detect increased risk of occurrence of Myocarditis/Pericarditis following mRNA COVID-19 vaccination in Manitoba, Canada.

Data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries: developing and piloting an assessment tool (VPASS)

BackgroundThere is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to pilot this tool in sites using MNCH data collection systems through virtual informant interviews.MethodsWe conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to pilot domains included in the assessment tool.ResultsWe developed and piloted the “VPASS (Vaccines during Pregnancy – sites supporting Active Safety Surveillance) assessment tool” through interviews with nine stakeholders, including central-level systems key informants and site-level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). The tool includes different domains such as the system’s purpose, the scale of implementation, data capture and confidentiality, type of data collected, the capability of integration with other platforms, data management policies and data quality monitoring. Similarities among sites were found regarding some domains, such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy, such as a routine collection of MNCH individual data and the capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR).ConclusionThis study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by identifying and using active individual MNCH data collection systems in LMICs.

Testing of Coding Algorithms for Inflammatory Bowel Disease Identification, as Indication for Use of Biological Drugs, Using a Claims Database from Southern Italy.

Inflammatory bowel diseases (IBDs), Crohn's disease (CD) and ulcerative colitis (UC), are chronic diseases that have been increasingly treated with biological drugs in recent years. Newly developed coding algorithms for IBD identification using claims databases are needed to improve post-marketing surveillance of biological drugs. To test algorithms to identify CD and UC, as indication for use of biological drugs approved for IBD treatment, using a claims database. Data were extracted from the Caserta Local Health Unit database between 2015 and 2018. CD/UC diagnoses reported by specialists in electronic therapeutic plans (ETPs) were considered as gold standard. Five algorithms were developed based on ICD-9-CM codes as primary cause of hospital admissions, exemption from healthcare service co-payment codes and drugs dispensing with only indication for CD/UC. The accuracy was assessed by sensitivity (Se), specificity (Sp), positive (PPV) and negative predicted values (NPV) along with computation of the Youden Index and F-score. In the study period, 1205 subjects received at least one biological drug dispensing approved for IBD and 134 (11.1%) received ≥1 ETP with IBD as use indication. Patients with CD and CU were 83 (61.9%) and 51 (38.1%), respectively. Sensitivity of the different algorithms ranged from 71.1% (95% CI: 60.1-80.5) to 98.8 (95% CI: 93.5-100.0) for CD and from 64.7% (95% CI: 50.1-77.6) to 94.1 (95% CI: 83.8-98.8) for UC, while specificity was always higher than 91%. The best CD algorithm was "Algorithm 3", based on hospital CD diagnosis code OR CD exemption code OR [IBD exemption code AND dispensing of non-biological drugs with only CD indication] (Se: 98.8%; Sp: 97.2%; PPV: 84.5%, NPV: 99.8%), achieving the highest diagnostic accuracy (Youden Index=0.960). The best UC algorithm was "Algorithm 3", based on specific hospital UC diagnosis code OR UC exemption code OR [IBD exemption code AND golimumab dispensing] OR dispensing of non-biological drugs with only UC indication (Se: 94.1%; Sp: 91.6%; PPV: 50.0%; NPV: 99.4%), and achieving the highest diagnostic accuracy (Youden Index=0.857). In a population-based claims database, newly coding algorithms including diagnostic and exemption codes plus specific drug dispensing yielded highly accurate identification of CD and UC as distinct indication for biological drug use.

Risk-Based Post-Marketing Surveillance (RB-PMS2) of Antimalarial and MNCH drugs in Mali (PY2)

Background and Objectives: The advent of multi-source generic drugs has exacerbated the prevalence of drugs and the spread of counterfeit and sub-standard drugs requiring increased vigilance and collaboration from drug regulatory authorities. Post-marketing surveillance (PMS) of medicines therefore plays an important role in detecting poor quality products on the market. Risk-Based Post-Market Surveillance (RB-PMS) RB-PMS helps optimize resource utilization and create sustainable post-market surveillance programs that are integrated and implemented as a key regulatory function. Methods: The survey concerned points of sale identified by a Technical Working Group in certain geographical areas according to risk-based approaches applied in the selection of the type of drugs to be targeted. It took place from September to December 2021 and aimed to assess the quality of antimalarial and MNCH medicines. Results: A total of 320 samples were taken and analyzed according to a risk-based protocol, of which 306 were compliant with a rate of 96% against 14 were non-compliant or 4% (P≤0,05). Non-compliant drugs were from both the public and private sectors. We found that 84% of drugs were unregistered among which antimalarials were the least registered drugs with a rate of 66% against 34% for MNCH drugs and came mainly from India and China. Conclusion: The RB-PMS allows the optimization of health resources in LMIC. In view of its scientific nature, this sampling and analysis technique must be made permanent to ensure health and guarantee access to quality medicines for the health and well-being of populations.

Risk-Based Post-Marketing Surveillance (RB-PMS2) of Antimalarial and MNCH drugs in Mali (PY2)

Risk-Based Post-Marketing Surveillance (RB-PMS2) of Antimalarial and MNCH drugs in Mali (PY2)

Bounded-width confidence interval following optimal sequential analysis of adverse events with binary data.

In sequential testing with binary data, sample size and time to detect a signal are the key performance measures to optimize. While the former should be optimized in Phase III clinical trials, minimizing the latter is of major importance in post-market drug and vaccine safety surveillance of adverse events. The precision of the relative risk estimator on termination of the analysis is a meaningful design criterion as well. This paper presents a linear programming framework to find the optimal alpha spending that minimizes expected time to signal, or expected sample size as needed. The solution enables (a) to bound the width of the confidence interval following the end of the analysis, (b) designs with outer signaling thresholds and inner non-signaling thresholds, and (c) sequential designs with variable Bernoulli probabilities. To illustrate, we use real data on the monitoring of adverse events following the H1N1 vaccination. The numerical results are obtained using the R Sequential package.

Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer.

AimUtilization of signal detection methods in longitudinal claims data can improve post-marketing drug surveillance, but to date there has been limited application. The aim of this study is to use 3 approaches, the proportional reporting ratio, Gamma Poisson Shrinker, and tree-based scan statistic in detecting adverse drug events (ADEs) attributed to trastuzumab using an administrative claims dataset.MethodsUsing data from the Texas Cancer Registry and SEER linked to Medicare from 2010 to 2013, we conducted 1:2 propensity score matching. Breast cancer HER2+ patients treated with trastuzumab in addition to standard chemotherapy were matched to HER2– patients treated with standard chemotherapy. Inpatient and outpatient encounters up to 6 months from start of therapy were used to identify adverse events.ResultsA total of 4191 patients were included in the study. Across all methods, use of trastuzumab generated signals on 9 distinct body systems. Cardiomyopathy and heart valve disease were the most consistently detected signals. Clinical review determined that most signals represented known ADEs.ConclusionsWe showed that claims data can be used to complement current ADE monitoring using common data mining methods with propensity score matching. Our analysis identified all expected ADEs associated with trastuzumab, and additional signals of valvular heart disorders.

Risk-Based Post-Marketing Surveillance (RB-PMS) of antimalarial drugs and maternal, neonatal and reproductive health (MNCH) in Mali

Objectives: In a world marked by the increase in chemoresistance leading to the adoption of therapeutic combinations, the advent of generic multi-source drugs, the spread of counterfeiting and substandard drugs, often without active ingredients or falsified active ingredients, a Greater vigilance by pharmaceutical regulatory authorities is needed. Drug Post-Marketing Surveillance (PMS) therefore plays an important role in detecting poor quality products on the market. Risk-Based Post-Marketing Surveillance (RB-PMS) is a new form of PMS that is emerging and was the subject of a recent WHO publication.
 Methods: The survey covered certain regions and certain points of sale identified by a Technical Working Group. It aimed to assess the quality of antimalarial and MNCRH drugs available at certain risk distribution levels based on priority sites. The selection of drugs and geographic areas was made using risk-based sampling using the Drug Risk Assessment Tool (MedRS) developed by USP / PQM +.
 Results: A total of 242 samples were taken and analyzed according to a risk-based protocol, of which 233 were compliant with a rate of 96% against 9 were non-compliant or 4% (P≤0,05). Non-compliant drugs were mainly from the public sector. We found 69% of the unregistered drugs that consisted mainly of antimalarial drugs and which came from India and China.
 Conclusion: In view of the scarcity of resources and its scientific nature, this risk-based sampling and analysis technique (RB-PMS) must be pursued, optimized and made sustainable to ensure health and guarantee access to quality medicines for the health and well-being of populations.
 Keywords: Antimalarials, MNCH, Quality Control, RB-PMS.

Spontaneous reporting of adverse drug reaction among health professionals in Ghana

BackgroundSpontaneous reporting of adverse drug reactions (ADR) is an effective means of ensuring postmarketing surveillance of drugs, and health professionals play a cardinal role through voluntary reporting of ADR. However, the pharmacovigilance system in Ghana is plagued with under-reporting issues, which is of public health concern.MethodA questionnaire-based cross-sectional study involving 268 health professionals at Kpone-Katamanso District was carried out. Data on spontaneous reporting of ADR, demographics of participants, knowledge, and attitudes of professionals towards reporting and factors that may influence ADR reporting were collected. Logistic regression models were used to examine the association of the independent variables with spontaneous reporting of ADR.ResultOverall, 77.6% (208) of the 268 respondents had observed ADR; however, only 17.3% of the respondents had ever reported an ADR to the Ghana FDA. Health professionals who had average knowledge on spontaneous reporting of ADR were 51.9%, while 30.3% had good knowledge of spontaneous reporting of ADR. After adjustment on potential confounding variables (Knowledge, Feedback from FDA, Uncertainty about cause of ADR, Severity of ADR), Age (AOR = 2.26, 95%CI = 1.25–4.10), Fear of Legal Consequences (AOR = 0.15, 95%CI = 0.41–0.51), Time Constraint (AOR = 0.3, 95%CI = 0.10–0.91), Pharmacovigilance training (AOR = 18.78, 95%CI = 5.46–64.59) and Unavailability of Reporting form (AOR = 0.28, 95%CI = 0.09–0.88) were found to be significantly associated spontaneous reporting of ADR.ConclusionThe proportion of health professionals in the Kpone- Katamanso District who spontaneously reported observed ADR was low though they had average knowledge about ADR reporting. This underscores the need for a policy to be implemented that makes spontaneous reporting of adverse drug reaction mandatory for health professionals.

Pharmacovigilance in Pakistan: A Peek into the Future Prospects

Pharmacovigilance in Pakistan: A Peek into the Future Prospects

Pharmacoepidemiology for oncology clinical practice: Foundations, state of the art and perspectives

Since the early 2000s, the arrival of the so-called targeted therapies and immunotherapies have prolonged survival rates in many cancers. In parallel, post-marketing surveillance of anticancer drugs through pharmacoepidemiology has gradually developed. This paper provides (i) a detailed argumentation of the foundations for pharmacoepidemiology of anticancer drugs, (ii) an overview of pharmacoepidemiological studies currently available in this field, and (iii) some perspectives to improve pharmacoepidemiology for oncology practice. First of all, according to the existing literature, the development of pharmacoepidemiological studies for the clinical evaluation of anticancer drugs appears particularly justified based on common limitations of clinical trials in oncology regarding essential methodological principles such as adequate control groups, randomisation or double blinding. Many descriptive field cohort studies have investigated together treatment patterns, effectiveness, and safety to compare results from clinical trials with those of everyday practice. The utilisation of anticancer drugs has also been extensively described through cross-sectional or cohort studies by often using medico-administrative or medical databases. Such studies are useful to quantify and characterise use over time in the population, including clinically unvalidated use, and to evaluate adherence and persistence to increasingly available oral anticancer drugs. Despite their importance to increase knowledge, comparative effectiveness or safety studies remain uncommon. In a context of rapidly emerging therapies and personalised treatments, this may be due to methodological challenges especially related to the choice of a comparator or the consideration of confounding by indication. In the future, efforts must be pursued to provide real-time access to high-quality, large-scale clinical, biological and treatment data, and to improve record-linkage between hospital and outpatient databases. More research is also needed to better evaluate all medications, not only anticancer, as part of an overall cancer care pathway and to bring the evaluation of anticancer drugs closer to patients and society (social pharmacology).

Augmenting aer2vec: Enriching distributed representations of adverse event report data with orthographic and lexical information

Adverse Drug Events (ADEs) are prevalent, costly, and sometimes preventable. Post-marketing drug surveillance aims to monitor ADEs that occur after a drug is released to market. Reports of such ADEs are aggregated by reporting systems, such as the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In this paper, we consider the topic of how best to represent data derived from reports in FAERS for the purpose of detecting post-marketing surveillance signals, in order to inform regulatory decision making. In our previous work, we developed aer2vec, a method for deriving distributed representations (concept embeddings) of drugs and side effects from ADE reports, establishing the utility of distributional information for pharmacovigilance signal detection. In this paper, we advance this line of research further by evaluating the utility of encoding orthographic and lexical information. We do so by adapting two Natural Language Processing methods, subword embedding and vector retrofitting, which were developed to encode such information into word embeddings. Models were compared for their ability to distinguish between positive and negative examples in a set of manually curated drug/ADE relationships, with both aer2vec enhancements offering advantages in performances over baseline models, and best performance obtained when retrofitting and subword embeddings were applied in concert. In addition, this work demonstrates that models leveraging distributed representations do not require extensive manual preprocessing to perform well on this pharmacovigilance signal detection task, and may even benefit from information that would otherwise be lost during the normalization and standardization process.

Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders in children and although stimulant medications remain first line to treat the disorder, some families prefer nonstimulants. The goal is to analyze the adverse events (AE) associated with nonstimulant medications using post-marketing drug surveillance data. We aim to increase awareness and aide patient education. A retrospective study of adverse drug events with atomoxetine, clonidine, and guanfacine was performed using the Federal Drug Administration Adverse Event Reporting System (FAERS) Database. Results show that the most commonly reported AEs, as defined by FAERS, were ineffectiveness (9.91–14.15%) fatigue (8.93%), and somnolence (8.8–10.16%). Of those taking atomoxetine, suicidal and self-injurious ideation was reported to a similar degree amongst all age groups. Suicidal ideation was listed within the top 20 most reported AEs for all three medications. It is more likely that some patients will experience milder side effects. We suggest providing these data to patients to help overcome the stigma of starting medication, especially if they prefer nonstimulants. Serious AEs are still reported to a small degree, thus monitoring and consistent patient education remains important. We also recommend educating a wider demographic of patients about recognizing potential development of suicidal thoughts.

Deploying the Precautionary Principle to Protect Vulnerable Populations in Canadian Post-Market Drug Surveillance

Drug regulatory bodies aim to ensure that patients have access to safe and effective drugs; however, no matter the quality of pre-licensure studies, uncertainty will remain regarding the safety and effectiveness of newly approved drugs until a large and diverse population uses those drugs. Recent analyses of Canada’s post-market drug surveillance (PMDS) system have found that Canada’s PMDS system requires strengthening and that efforts must be improved to monitor and address the safety and effectiveness of approved drugs among vulnerable populations. Given the uncertainty that exists when drugs enter the market, some have suggested that the precautionary principle is relevant to guiding decision-making in this context. This paper responds to recommendations that the Canadian PMDS system should be responsive to the health needs of vulnerable populations by assessing the utility of deploying the precautionary principle to guide a post-market strategy for vulnerable populations.