Characteristics and quality of adverse drug reaction reports by pharmacists in Norway

Gedde-Dahl, Ane; Harg, Pernille; Stenberg-Nilsen, Hanne; Buajordet, Marit; Granås, Anne Gerd; Horn, Anne Marie

doi:10.1002/pds.1400

Cited by 32 publications

(30 citation statements)

References 16 publications

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“…So, our results did not show any site‐specific issue nor did they show any type of CT issue as we used data from different types of CT. Moreover, this issue of completeness or accuracy in SAE case reports has been identified as an important factor hampering the usefulness of SAE case reports not only in CT but also in post‐marketing pharmacovigilance . Direct comparison between our results and other published data is not easy because criteria used are different, nethertheless; results go in the same way.…”

Section: Discussionmentioning

confidence: 83%

See 1 more Smart Citation

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

Crépin

Villeneuve

Merle

2016

Pharmacoepidemiology and Drug

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Section: Discussionmentioning

confidence: 83%

“…Although SAE case reports are the main way of monitoring safety in CTs, there is little information available about their quality . On the contrary, in post‐marketing pharmacovigilance, lack of quality of AE case reports is a known problem …”

Section: Introductionmentioning

confidence: 99%

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

Crépin

Villeneuve

Merle

2016

Pharmacoepidemiology and Drug

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“…In the study of Gedde-Dahl et al [16], the characteristics and the quality of ADR reports of the pharmacists were evaluated in comparison to the reports of the physicians. The spectrums of the reported drugs were especially different from the ones in our study.…”

Section: Discussionmentioning

confidence: 99%

The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul

2008

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“…However, in this study we found about 50% of the adverse events identified in RCTs such as nausea and diarrhoea could be detected from the FDA spontaneous reporting database. Other studies have also found that non-serious adverse events are commonly reported to spontaneous reporting databases [40][41][42]. Similarly, in administrative claims data, medicines used to treat adverse events may not always be recorded.…”

Section: Discussionmentioning

confidence: 99%

Sequence Symmetry Analysis and Disproportionality Analyses: What Percentage of Adverse Drug Reaction do they Signal?

Pratt¹

2013

Adv Pharmacoepidem Drug Safety

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Background: Sequence Symmetry Analysis (SSA) is a method to detect Adverse Event (AE) signals using administrative claims data. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) are methods to detect AE signals using spontaneous reporting data. The proportion of AEs detected by all four methods is unknown.Objective: To determine sensitivity, specificity and predictive values of SSA, PRR, ROR and BCPNN for a set of medicine-AE pairs.Methods: All AEs identified in published Randomised Controlled Trials (RCTs) and Product Information (PI) were extracted for 19 medicines. Gold standard positive AEs were events identified in powered RCTs and gold standard negative AEs were events not listed in the PI for that medicine or any other medicines in the class. SSA was performed for each medicine-AE pairs using Australian Goverrnment Department of Veterans Affairs' data, while the PRR, ROR and BCPNN, was calculated using the Food and Drug Administration Adverse Events Reporting System data.Results: A total of 157 medicine-AE pairs (43 positive and 114 negative) were identified and tested. SSA, PRR, ROR and BCPNN had a sensitivity of 65%, 19%, 49% and 51% respectively. Specificities across all methods were similar; 89%-97%. Thirty percent of true positive pairs were detected by all methods. SSA detected an additional 35% different true positive pairs while PRR, ROR and BCPNN methods detected an additional 21% different true positive pairs. Conclusions:Using the combination of signalling methods and data sources, more adverse drug reactions can be detected and could potentially strengthen the safety surveillance of post-marketing medicine.

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Characteristics and quality of adverse drug reaction reports by pharmacists in Norway

Abstract: Pharmacists submit valuable ADR reports which provide information complimentary to physicians' reports. This emphasises that pharmacist ADR reporting might constitute an important addition to the spontaneous reporting system.

Cited by 32 publications

References 16 publications

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul

Sequence Symmetry Analysis and Disproportionality Analyses: What Percentage of Adverse Drug Reaction do they Signal?

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