Mobile apps for quick adverse drug reaction report: A scoping review

Parracha, Edna Ribeiro; Advinha, Ana Margarida; Lopes, Manuel José; Martins, Sofia Oliveira

doi:10.1002/pds.5542

Cited by 12 publications

(4 citation statements)

References 56 publications

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“…According to the Pharmaceutical Society of Australia’s medication safety report (2019), health care expenditure for medication-related problems is estimated at AUD $1.4 billion (US $900,207) per annum [ 14 ]. Despite its limitations, spontaneous reporting remains the most common method for generating safety signals; however, it is estimated that only 6% of all ADRs that occur are reported [ 7 , 15 , 16 ]. The reasons for ADR underreporting have previously been described [ 10 , 17 - 19 ]; these may include limited knowledge and awareness of PV, reluctance to report by consumers or HCPs due to time constraints, and nonsupportive workplace structures.…”

Section: Introductionmentioning

confidence: 99%

Reporting, Monitoring, and Handling of Adverse Drug Reactions in Australia: Scoping Review

Tagne¹,

Yakob²,

Dang³

et al. 2023

JMIR Public Health Surveill

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Background Adverse drug reactions (ADRs) are unintended consequences of medication use and may result in hospitalizations or deaths. Timely reporting of ADRs to regulators is essential for drug monitoring, research, and maintaining patient safety, but it has not been standardized in Australia. Objective We sought to explore the ways that ADRs are monitored or reported in Australia. We reviewed how consumers and health care professionals participate in ADR monitoring and reporting. Methods The Arksey and O’Malley framework provided a methodology to sort the data according to key themes and issues. Web of Science, Scopus, Embase, PubMed, CINAHL, and Computer & Applied Sciences Complete databases were used to extract articles published from 2010 to 2021. Two reviewers screened the papers for eligibility, extracted key data, and provided descriptive analysis of the data. Results Seven articles met the inclusion criteria. The Adverse Medicine Events Line (telephone reporting service) was introduced in 2003 to support consumer reporting of ADRs; however, only 10.4% of consumers were aware of ADR reporting schemes. Consumers who experience side effects were more likely to report ADRs to their doctors or pharmacists than to the drug manufacturer. The documentation of ADR reports in hospital electronic health records showed that nurses and pharmacists were significantly less likely than doctors to omit the description of the drug reaction, and pharmacists were significantly more likely to enter the correct classification of the drug reaction than doctors. Review and analysis of all ADR reports submitted to the Therapeutic Goods Administration highlighted a decline in physician contribution from 28% of ADR reporting in 2003 to 4% in 2016; however, within this same time period, hospital and community pharmacists were a major source of ADR reporting (ie, 16%). In 2014, there was an increase in ADR reporting by community pharmacists following the introduction of the GuildLink ADR web-based reporting system; however, a year later, the reporting levels dropped. In 2018, the Therapeutic Goods Administration introduced a black triangle scheme on the packaging of newly approved medicines, to remind and encourage ADR reporting on new medicines, but this was only marginally successful at increasing the quantity of ADR reports. Conclusions Despite the existence of national and international guidelines for ADR reporting and management, there is substantial interinstitutional variability in the standards of ADR reporting among individual health care facilities. There is room for increased ADR reporting rates among consumers and health care professionals. A thorough assessment of the barriers and enablers to ADR reporting at the primary health care institutional levels is essential. Interventions to increase ADR reporting, for example, the black triangle scheme (alert or awareness) or GuildLink (digital health), have only had marginal effects and may benefit from further improvement revisions and awareness programs.

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Section: Introductionmentioning

confidence: 99%

Reporting, Monitoring, and Handling of Adverse Drug Reactions in Australia: Scoping Review

Tagne¹,

Yakob²,

Dang³

et al. 2023

JMIR Public Health Surveill

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“…Considering the hospitalization rate, close follow-up is necessary. Medical applications that can detect adverse events remotely are increasingly being developed [ 20 ]. However, older patients might encounter challenges in mastering modern applications and media interfaces; therefore, simplifying the system or devising alternative methods becomes necessary [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

Safety of immune checkpoint inhibitors in patients aged over 80 years: a retrospective cohort study

Ikoma,

Matsumoto,

Boku

et al. 2024

Cancer Immunol Immunother

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Background Immuno-oncology (IO) drugs are essential for treating various cancer types; however, safety concerns persist in older patients. Although the incidence of immune-related adverse events (irAEs) is similar among age groups, higher rates of hospitalization or discontinuation of IO therapy have been reported in older patients. Limited research exists on IO drug safety and risk factors in older adults. Our investigation aimed to assess the incidence of irAEs and identify the potential risk factors associated with their development. Methods This retrospective analysis reviewed the clinical data extracted from the medical records of patients aged > 80 years who underwent IO treatment at our institution. Univariate and multivariate analyses were performed to assess the incidence of irAEs. Results Our study included 181 patients (median age: 82 years, range: 80–94), mostly men (73%), with a performance status of 0–1 in 87% of the cases; 64% received IO monotherapy. irAEs occurred in 35% of patients, contributing to IO therapy discontinuation in 19%. Our analysis highlighted increased body mass index, eosinophil counts, and albumin levels in patients with irAEs. Eosinophil count emerged as a significant risk factor for any grade irAEs, particularly Grade 3 or higher, with a cutoff of 118 (/μL). The group with eosinophil counts > 118 had a higher frequency of irAEs, and Grade 3 or higher events than the group with counts ≤ 118. Conclusion IO therapy is a safe treatment option for patients > 80 years old. Furthermore, patients with elevated eosinophil counts at treatment initiation should be cautiously managed.

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“…This way of proceeding can certainly be useful in involving the patient themselves in the care process, also ensuring a more direct dialogue and communication with the clinicians. Thus, the innovation of social and health care processes may be also applied in the context of active pharmacovigilance [ 21 , 22 ].…”

Section: Discussionmentioning

confidence: 99%

Improving Drug Safety in Pediatric and Young Adult Patients with Hemato-Oncological Diseases: A Prospective Study of Active Pharmacovigilance

Parzianello,

Fornasier,

Kiren

et al. 2024

Pharmaceuticals

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The acquisition of relevant pediatric clinical safety data is essential to ensure tolerable drug therapies. Comparing the real number of Adverse Drug Reaction (ADR) reports in clinical practice with the literature, the idea of ADR underreporting emerges. An active pharmacovigilance observational prospective study was conducted to assess the safety of oncology pharmacological prescriptions in patients aged 0–24 years at Institute for Maternal and Child Health IRCCS Burlo Garofolo in Trieste and IRCCS CRO National Cancer Institute in Aviano (Italy) between January 2021 and October 2023. Prescriptions and ADRs were evaluated by a multidisciplinary team. A total of 1218 prescriptions for 38 patients were analyzed, and 190 ADRs of grade 3–5 were collected. As compared to historical data, we registered a significant increase (p < 0.001) in the number of ADRs. The risk of ADR was 3.4 times higher in the case of off-label prescriptions compared to on-label ones (OR 3.4; [1.47; 7.89]; p-value = 0.004). The risks of error and near-miss were reported for 6.3% and 18.2% of total prescriptions, respectively. Of the total of 133 interactions, 47 (35.3%) resulted in ADRs. This study shows the importance of pro-active pharmacovigilance to efficiently highlight ADRs, and the fundamental role of multidisciplinary teams (oncologist, pharmacist, pharmacologist, pediatrician, nurse) in improving patients’ safety during therapy.

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Mobile apps for quick adverse drug reaction report: A scoping review

Cited by 12 publications

References 56 publications

Reporting, Monitoring, and Handling of Adverse Drug Reactions in Australia: Scoping Review

Reporting, Monitoring, and Handling of Adverse Drug Reactions in Australia: Scoping Review

Safety of immune checkpoint inhibitors in patients aged over 80 years: a retrospective cohort study

Improving Drug Safety in Pediatric and Young Adult Patients with Hemato-Oncological Diseases: A Prospective Study of Active Pharmacovigilance

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