Dataset Information

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding.

ABSTRACT: One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detecting safety signals for OTC medicines in National ADR spontaneous reporting data, using OTC non-steroidal anti-inflammatory drugs (NSAIDs) and gastrointestinal bleeding as an example. Data from the Australian Adverse Drug Reactions System (ADRS) dataset (1971-2008) and the Canadian Vigilance Adverse Reaction Online Database (VAROD) (1965-2013) were used to explore the feasibility of using spontaneous reporting data, exploring the association between gastrointestinal bleeding and the use of OTC NSAIDs. Safety signals were examined using disproportionality analyses and reporting odds ratios calculated. After adjusting for age, gender, medications known to increase the risk of bleeding, and medications used for the management of conditions associated with an increased risk of bleeding, a two-fold increase in the risk of gastrointestinal (GI) bleeding with OTC NSAID was observed within each dataset. This study demonstrates that spontaneous ADR reporting data can be used in pharmacovigilance to monitor the safety of OTC medicines.

SUBMITTER: Amatya E

PROVIDER: S-EPMC7558367 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding.

Amatya Elina E Fois Romano R Williams Kylie A KA Pont Lisa G LG

Pharmacy (Basel, Switzerland) 20200917 3

One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detec ...[more]

PMID: 32957485

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Project description:BackgroundOver-the-counter (OTC) medicines are typically safe. However, there is evidence that OTC medicines can sometimes cause harm as a result of their misuse, abuse and dependence.Aim of the reviewTo review the literature on OTC medicines misuse, abuse and dependence in adults and identify the implicated medicines, contributing factors, associated harms and risk-mitigating interventions.MethodsFollowing PRISMA guidelines, electronic databases including Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, MEDLINE, PsycINFO Web of Science and Google Scholar were searched for peer-reviewed journal articles published in English between January 2011 and March 2019. Quantitative, qualitative and mixed-methods studies assessing aspects of misuse, abuse and dependence of OTC medicines in individuals aged 18 years or more were included. Studies that solely focused on adolescents only, doping in sports or abuse of OTC medicines in people who are substance abusers were excluded. The random effect meta-analysis model was used to pool the prevalence among the population-based studies.ResultsOf 2355 peer-reviewed studies initially identified, 53 were included in this review. According to the study design, the prevalence varied, but the overall pooled prevalence in the population-based studies was: 16.2% for misuse, 2.0% for abuse, and 7.2% for dependence. The common OTC medicines groups involved in the problematic use were analgesics (with or without codeine), sedative antihistamines, cough mixtures containing dextromethorphan. Physical, psychological, social and financial harms were associated with problematic use of OTC medicines in addition to hospitalisation and death. Interventions for the affected individuals were provided mainly through the community pharmacies, general practices and specialised addiction centres.ConclusionThe problematic use of OTC medicines is quite prevalent in adults, necessitating raising public awareness about their safe use. In addition, innovative harm minimisation models need to be developed, evaluated and implemented across health care settings.

Project description:Background/Objective: Spontaneous reporting systems (SRS) such as the Korea Adverse Event Reporting System (KAERS) are limited in their ability to detect adverse drug reaction (ADR) signals due to their limited data on drug use. Conversely, the national health insurance claim (NHIC) data include drug use information for all qualifying residents. This study aimed to compare ADR signal profiles for antidepressants between KAERS and NHIC, evaluating the extent to which detected signals belong to common ADRs and labeling information. Materials and Methods: ADR signal detection in KAERS and NHIC databases, spanning January to December 2017, employed disproportionality analysis. Signal classes were determined based on System Organ Class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA). Also, Common ADR Coverage (CAC), the proportion of detected signals deemed common ADRs, and labeling information coverage (LIC) represented by mean average precision (mAP) were calculated. Additionally, protopathic bias and relative risk (RR) evaluation were performed to check for signal robustness. Results: Signal detection revealed 51 and 62 signals in KAERS and NHIC databases, respectively. Both systems predominantly captured signals related to nervous system disorders, comprising 33.3% (N = 17) in KAERS and 50.8% (N = 31) in NHIC. Regarding the type of antidepressants, KAERS predominantly reported signals associated with tricyclic antidepressants (TCAs) (N = 21, 41.2%), while NHIC produced most signals linked to selective serotonin reuptake inhibitors (SSRIs) (N = 22, 35.5%). KAERS exhibited higher CAC (68.63% vs. 29.03%) than NHIC. LIC was also higher in KAERS than in NHIC (mAP for EB05: 1.00 vs. 0.983); i.e., NHIC identified 5 signals not documented in drug labeling information, while KAERS found none. Among the unlabeled signals, one (Duloxetine-Myelopathy) was from protopathic bias, and two (duloxetine-myelopathy and tianeptine-osteomalacia) were statistically significant in RR. Conclusion: NHIC exhibited greater capability in detecting ADR signals associated with antidepressant use, encompassing unlabeled ADR signals, compared to KAERS. NHIC also demonstrated greater potential for identifying less common ADRs. Further investigation is needed for signals detected exclusively in NHIC but not covered by labeling information. This study underscores the value of integrating different sources of data, offering substantial regulatory insights and enriching the scope of pharmacovigilance.

Project description:IntroductionSpontaneous reporting systems (SRSs) are pivotal for signal detection, especially for rare events with a high drug-attributable component, such as torsade de pointes (TdP). Use of different national SRSs is rarely attempted because of inherent difficulties, but should be considered on the assumption that rare events are diluted in international databases.ObjectiveThe aim was to describe TdP-related events associated with antipsychotics, H1-antihistamines and anti-infectives in three national SRSs (in Italy, Germany and France) and highlight potential signals of torsadogenicity through a combined literature evaluation.MethodsA common search strategy was applied to extract TdP-related events: (1) TdP, (2) QT interval abnormalities, (3) ventricular fibrillation/tachycardia, and (4) sudden cardiac death. Signals of disproportionate reporting (SDRs) were calculated for TdP + QT interval abnormalities and defined by a lower limit of the 95 % confidence interval of the reporting odds ratio (ROR) >1. Among SDRs with at least three cases without concomitant pro-arrhythmic drugs, we defined potential new signal of torsadogenicity as drugs with no published evidence from (a) the crediblemeds(®) website ( http://www.crediblemeds.com , as of November 1st, 2014); (b) studies on the FDA Adverse Event Reporting System (FAERS); and (c) safety trials or pharmaco-epidemiological studies (as of December 16th, 2014).ResultsOverall, 3505 cases were retrieved (1372, 1468, and 801 for France, Germany and Italy, respectively). Antipsychotics were mainly recorded in Germany (792 cases), whereas antibiotics peaked at 515 and 491 (France and Italy, respectively). Forty-one drugs met criteria for SDRs in at least one single source, of which 31 were detected only from one single SRS: 18, ten and three (French, German and Italian SRS, respectively). By contrast, only five SDRs were detected in all national data sources (amisulpride, aripiprazole, haloperidol, olanzapine, risperidone). Overall, five potential new signals of torsadogenicity were identified: flupentixol, ganciclovir, levocetirizine, oxatomide and tiapride.ConclusionsWe found differences across and within national SRSs in the reporting of drug-induced TdP, which finally resulted in five potential new signals of torsadogenicity. These findings warrant targeted pharmacovigilance studies to formally assess the existence of actual drug-event associations.

Dataset Information

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding.

Publications

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding.

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