Assessment of a New Instrument for Detecting Preventable Adverse Drug Reactions

Benkirane, R.; Soulaymani-Bencheikh, Rachida; Khattabi, Asmae; Benabdallah, Ghita; Alj, Loubna; Sefiani, Houda; Hedna, Khedidja; Ouammi, Lahcen; Olsson, Sten; Pal, Shanti N.

doi:10.1007/s40264-014-0257-5

Cited by 25 publications

(21 citation statements)

References 19 publications

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“…The case is categorized as 'not assessable' if there are no data or insufficient data for assessment (e.g. an anaphylactic reaction due to penicillin is deemed 'not assessable' if the patient's previous history of drug allergy is not documented) or if the situation is controversial [13,14].…”

Section: Study Instruments and Data Collection Approachmentioning

confidence: 99%

Adverse Drug Reactions among Patients Admitted to Eritrean Hospitals: Prevalence Causes and Risk Factors a prospective analysis of 5848 patients

Russom¹,

Tesfai²,

Elias³

et al. 2017

IJP

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Background: Eritrea is one of the developing countries which has shortage of physicians at all levels. As a result, lower health cadres are authorized to prescribe medicines. In addition, due to shortages of laboratory setups, lab-based therapeutic monitoring is a challenge. The Eritrean society is also highly involved in self-medication; all these could have contributions to ADRs. Thus, the objective of the study is to investigate and analyze the prevalence, causes, and risk factors of Adverse Drug Reactions (ADRs) among patients admitted to Eritrean hospitals.

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Section: Study Instruments and Data Collection Approachmentioning

confidence: 99%

Adverse Drug Reactions among Patients Admitted to Eritrean Hospitals: Prevalence Causes and Risk Factors a prospective analysis of 5848 patients

Russom¹,

Tesfai²,

Elias³

et al. 2017

IJP

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“…In our study, for all the ICSRs that reported NSAIDs as suspected, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by the P-method as described elsewhere (Benkirane et al, 2015; Sessa et al, 2016a,d). The “P-method,” is an algorithm that was developed to assess the preventability of ICSRs sent through spontaneous reporting system and that was validated by several Pharmacovigilance centers in the program for International Drug Monitoring coordinated by the World Health Organization (Benkirane et al, 2015; Pal et al, 2015).…”

Section: Methodsmentioning

confidence: 99%

“…The “P-method,” is an algorithm that was developed to assess the preventability of ICSRs sent through spontaneous reporting system and that was validated by several Pharmacovigilance centers in the program for International Drug Monitoring coordinated by the World Health Organization (Benkirane et al, 2015; Pal et al, 2015). …”

Section: Methodsmentioning

confidence: 99%

“…The first step is the causality assessment evaluation that in our study was performed by using the Naranjo algorithm (Naranjo et al, 1981) as in accordance with the standard national procedure suggested by Italian Medicine Agency (AIFA). The second and third steps are the determination of the potential mechanism for the ADRs, and screening of the critical criteria listed in the P-Methods (Benkirane et al, 2015), respectively. Evaluation of the critical criteria consists in answering a questionnaire (Supplementary Table 1), at which the multidisciplinary team could answer positively, negatively or that the question was “not applicable” or “unknown.” A positive answer (each question represent a critical criterion) made the case eligible to be classified as preventable.…”

Section: Methodsmentioning

confidence: 99%

“…Summary of Product Characteristics (SmPCs) published by AIFA were used for all evaluations that required information provided in SmPCs. ICSRs were classified as “documented” and “non-documented” based on the procedure described by Benkirane et al (2015). …”

Section: Methodsmentioning

confidence: 99%

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Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions

et al. 2017

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Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016.Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method.Results: In all 19,039 ICSRs were sent to Campania Pharmacovigilance Regional Centre, of which 550 reported NSAIDs as suspected drug. In total, 94 cases (17.1%) out of 550 ICSRs were preventable. In the 94 preventable cases, 201 critical criteria were detected of which 182/201 (90.5%) related to healthcare professionals' practices, 0/201 (0.0%) to drug quality, and 19/201 (9.5%) to patient behavior. The most detected critical criteria were the necessary medication not given (52/182; 28.6%), labeled drug–drug interaction (36/182; 19.7%), incorrect drug administration duration (31/182; 16.9%), wrong indication (26/182; 14.2%), therapeutic duplication (18/182; 10.0%), and documented hypersensitivity to administered drug or drug class (10/182; 5.6%). In seventeen (18.1%) preventable cases, there were 19 critical criteria involving non-compliance (15/19 critical criteria; 78.9%) and self-medication with the non-over-the-counter drugs (4/19 critical criteria; 21.1%). In all, 17 out 94 (18.1%) preventable cases involved over-the-counter drugs.Conclusion: A call for action for Campania Pharmacovigilance Regional Centre is necessary in order to promote initiatives to increase the awareness of healthcare professionals and citizens on the risk associated with inappropriate use of NSAIDs.

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Serious adverse drug reactions in sub‐Saharan Africa in the era of antiretroviral treatment: A systematic review

Mouton

Jobanputra

Tatz

et al. 2021

Pharmacology Res & Perspec

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The burden of adverse drug reactions (ADRs) in low-and middle-income countries (LMICs) may differ from that in high-income settings for a variety of reasons, including differences in disease burden, differences in drug utilization patterns, a potential lack of effective drug quality control, and the high risk for prescribing and dispensing errors that occur in overburdened healthcare systems. Previous systematic reviews summarizing the global burden of ADRs 1-6 included only a few surveys from LMICs, which limits the generalizability of their results to LMIC settings.In sub-Saharan Africa (SSA), an epidemiological transition is taking place, with high prevalence of both non-communicable

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Assessment of a New Instrument for Detecting Preventable Adverse Drug Reactions

Cited by 25 publications

References 19 publications

Adverse Drug Reactions among Patients Admitted to Eritrean Hospitals: Prevalence Causes and Risk Factors a prospective analysis of 5848 patients

Adverse Drug Reactions among Patients Admitted to Eritrean Hospitals: Prevalence Causes and Risk Factors a prospective analysis of 5848 patients

Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions

Serious adverse drug reactions in sub‐Saharan Africa in the era of antiretroviral treatment: A systematic review

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