Factors associated with underreporting of adverse drug reactions by patients: a systematic review

Costa, Catarina; Abeijon, Patricia; Rodrigues, Daniela A.; Figueiras, Adolfo; Herdeiro, Maria Teresa; Torre, Carla

doi:10.1007/s11096-023-01592-y

Cited by 19 publications

(9 citation statements)

References 71 publications

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“…Regarding educational status, higher educational levels were associated with the presence of ADEs. This association has not been reported in other leprosy studies; however, higher educational levels could lead to a better understanding of the occurrence of drug-related symptoms and, thus, increase the probability of a patient reporting the symptoms, as was described recently by Costa et al (2023) [28]. Other studies have shown that higher educational levels in different diseases could help medication intake and reduce ADEs [32,33].…”

Section: Discussionmentioning

confidence: 73%

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Development of a multivariate predictive model for dapsone adverse drug events in people with leprosy under standard WHO multidrug therapy

de Araujo,

Hacker,

Pinheiro

et al. 2024

PLoS Negl Trop Dis

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Background The occurrence of adverse drug events (ADEs) during dapsone (DDS) treatment in patients with leprosy can constitute a significant barrier to the successful completion of the standardized therapeutic regimen for this disease. Well-known DDS-ADEs are hemolytic anemia, methemoglobinemia, hepatotoxicity, agranulocytosis, and hypersensitivity reactions. Identifying risk factors for ADEs before starting World Health Organization recommended standard multidrug therapy (WHO/MDT) can guide therapeutic planning for the patient. The objective of this study was to develop a predictive model for DDS-ADEs in patients with leprosy receiving standard WHO/MDT. Methodology This is a case-control study that involved the review of medical records of adult (≥18 years) patients registered at a Leprosy Reference Center in Rio de Janeiro, Brazil. The cohort included individuals that received standard WHO/MDT between January 2000 to December 2021. A prediction nomogram was developed by means of multivariable logistic regression (LR) using variables. The Hosmer–Lemeshow test was used to determine the model fit. Odds ratios (ORs) and their respective 95% confidence intervals (CIs) were estimated. The predictive ability of the LRM was assessed by the area under the receiver operating characteristic curve (AUC). Results A total of 329 medical records were assessed, comprising 120 cases and 209 controls. Based on the final LRM analysis, female sex (OR = 3.61; 95% CI: 2.03–6.59), multibacillary classification (OR = 2.5; 95% CI: 1.39–4.66), and higher education level (completed primary education) (OR = 1.97; 95% CI: 1.14–3.47) were considered factors to predict ADEs that caused standard WHO/MDT discontinuation. The prediction model developed had an AUC of 0.7208, that is 72% capable of predicting DDS-ADEs. Conclusion We propose a clinical model that could become a helpful tool for physicians in predicting ADEs in DDS-treated leprosy patients.

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Section: Discussionmentioning

confidence: 73%

“…Previous studies have demonstrated that older age groups are more likely to experience ADEs [ 28 ]. In the present study, we demonstrated that the older participants (>47 years) had more ADEs than younger ones.…”

Section: Discussionmentioning

confidence: 99%

Development of a multivariate predictive model for dapsone adverse drug events in people with leprosy under standard WHO multidrug therapy

de Araujo,

Hacker,

Pinheiro

et al. 2024

PLoS Negl Trop Dis

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“…Uncertainty surrounding causal relationships is a further contributing factor to underreporting in spontaneous systems. Additionally, fear of medicolegal consequences, alongside overall clinician indifference is known to further discourage consistent reporting (85,88,89).…”

Section: Discussionmentioning

confidence: 99%

An overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: A scoping review using a systematic approach

Wang,

Bonomo,

Hallinan

2024

Preprint

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The use of cannabis-based medicines (CBM) as a therapeutic has grown exponentially over the last 5 years in Australia. Prior to this increase, there was significant legislative resistance to the use of CBM for clinical trials, hence pre-clinical data is limited. Safety monitoring systems for CBM are not structured and do not fit easily into the workflow of busy health professionals. Hence, post-marketing surveillance of CBM is patchy. CBM are available in many countries globally and face similar issues in relation to pharmacovigilance. The objective of this review is to answer the following question: What are the systems in place internationally to monitor side effects and adverse events of cannabis use as a medicine? We used the PICO framework to develop keyword elements, which guided two search queries. Each query contained a different combination of keywords to increase sensitivity and specificity of the search. Both queries were entered into Embase and Scopus for retrieval of quality relevant peer-reviewed literature. Only the second search query, was used for the grey literature. Fifty-four full text articles were included in the review, thirty-nine were from the peer-reviewed search, eight were from the grey literature search, and seven were from citations of relevant texts. Our search yielded two main forms of monitoring systems: databases and registries, with databases often created by regulatory authorities. There was great variability within these systems, differing in methods of causality assessment, level of detail collected, terminology, and affiliations. Only one monitoring system captured in our search obligated reporting from patients. VigiBase remains the largest form of centralised monitoring, receiving case reports internationally. Regardless of the scope of VigiBase, there remains heterogeneity of data within the system. As such, our study reaffirms a greater need for a centralised, consistent, and accessible system for the post-marketing surveillance of side effects and adverse events associated with usage of CBM.

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“…Additionally, some healthcare providers do not report because of the fear of legal consequences, which was also seen in several studies. [55][56][57][58]…”

Section: Strength Of the Associationmentioning

confidence: 99%

Exfoliative dermatitis; new safety signal detection regarding Meropenem in VigiBase™: A study based on WHO database

Sami,

Mahmood Mohammed,

M. Younus

2023

F1000Res

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Background Cutaneous adverse drug reactions (CADRs) account for nearly one-third of all adverse drug reactions (ADRs), and severe reactions while they are rare, can dramatically affect patients’ quality of life or even cost them their lives. While clinical trials may prove medicine’s effectiveness, they cannot give a thorough picture of the drug’s safety profile. Spontaneous surveillance and data mining techniques provide a promising complementary technique for post-marketing monitoring to detect safety signals. Objective The objective of this research was to assess the data obtained and uploaded to VigiBase about adverse medication responses affecting the skin and surrounding structures, with a specific focus on identifying any possible signals linked with Meropenem that are not currently indicated on the medicine label. Methods A retrospective study involved clinical review and data mining of patients who suffered cutaneous reactions reported to national Pharmacovigilance centers in Iraq and other countries from January 2010 to December 2021; a total of 4,510 reports were found in Iraq and filtered according to several criteria to obtain a safety signal with the most significant impact on public health. To improve the signal quality, all global cases were included in evaluating the detected signal, excluding duplicate and incomplete reports. Results In a total of 65 cases that contained Meropenem as the suspected cause of exfoliative dermatitis (ED), only 53 cases met the inclusion criteria. Assessment of the included cases proved the detection of a new unlabeled signal that links Meropenem to ED. The mean affected age was 59 years, and males outnumbered females (30:23). The combination showed to be statistically significant (IC025, 2.961; PRR025, 8.227; ROR025, 8.244), and causality assessment showed a possible relation in more than 70% of the cases. Conclusion Spontaneous reporting systems, despite their limitations, are vital to pharmacovigilance systems and the identified signal needs further research.

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Factors associated with underreporting of adverse drug reactions by patients: a systematic review

Cited by 19 publications

References 71 publications

Development of a multivariate predictive model for dapsone adverse drug events in people with leprosy under standard WHO multidrug therapy

Development of a multivariate predictive model for dapsone adverse drug events in people with leprosy under standard WHO multidrug therapy

An overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: A scoping review using a systematic approach

Exfoliative dermatitis; new safety signal detection regarding Meropenem in VigiBase™: A study based on WHO database

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