Quality of the record of drug-related problems in a database for voluntary adverse event reporting
Objective: To determine the number and type of errors found in the record of drug-related problems in the SINEA database, an electronic system for voluntary reporting of adverse events in healthcare, in order to quantify the differences between the raw and refined databases, suggest improvements, an...
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| Format: | Article |
| Language: | English |
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Elsevier
2017-07-01
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| Series: | Farmacia Hospitalaria |
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| Online Access: | http://www.aulamedica.es/fh/pdf/10747.pdf |
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| author | Maria Teresa Aznar-Saliente Laura Roca-Aznar Amparo Talens-Bolós Paola Herraiz-Robles Manuel Bonete-Sánchez Laia Pons-Martínez Borja Marcos-Ribes |
| author_facet | Maria Teresa Aznar-Saliente Laura Roca-Aznar Amparo Talens-Bolós Paola Herraiz-Robles Manuel Bonete-Sánchez Laia Pons-Martínez Borja Marcos-Ribes |
| author_sort | Maria Teresa Aznar-Saliente |
| collection | DOAJ |
| description | Objective: To determine the number and type of errors found in the record of drug-related problems in the SINEA database, an electronic system for voluntary reporting of adverse events in healthcare, in order to quantify the differences between the raw and refined databases, suggest improvements, and determine the need for refining said databases. Methods: A Pharmacist reviewed the database and refined the adverse events reported from January to August, 2014, considering the “describe_what_happened” field as the gold standard. There was a comparison of the rates of medication errors, both potential and real, adverse reactions, impact on the patient, impact on healthcare, and medications more frequently involved in the raw and refined databases. Agreement was calculated through Cohen’s Kappa Coefficient.
Results: 364 adverse events were reported: 66.7% were medication errors, 2.7% adverse reactions to the medication (2 were wrongly classified as both, showing a total percentage >100%) and 31% were other events. After refinement, the percentages were 69.5%, 5.8% and 24.7%, respectively (κ=0.85; CI95% [0.80-0.90]). Before refinement, 73.6% of medication errors were considered potential vs. 82.3% after refinement (κ=0.65; CI95% [0.54- 0.76]). The medication most frequently involved was trastuzumab (20.9%). The “molecule” field was blank in 133 entries. A mean of 1.8±1.9 errors per entry were detected.
Conclusions: Although agreement is good, the refinement process cannot be avoided, as it provides valuable information to improve pharmacotherapy. Data quality could be improved by reducing the number of type-in text fields, using drop-down lists, and by increasing the training of the reporters. |
| format | Article |
| id | doaj-art-5c33e30bf96c414da1476547f2b00839 |
| institution | OA Journals |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2017-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-5c33e30bf96c414da1476547f2b008392025-08-20T02:18:03ZengElsevierFarmacia Hospitalaria1130-63432171-86952017-07-0141450851710.7399/fh.2017.41.4.10747Quality of the record of drug-related problems in a database for voluntary adverse event reportingMaria Teresa Aznar-Saliente0Laura Roca-Aznar1Amparo Talens-Bolós2Paola Herraiz-Robles3Manuel Bonete-Sánchez4Laia Pons-Martínez5Borja Marcos-Ribes6Hospital Universitario de Sant Joan, Pharmacy Unit, Alicante.Hospital Universitario de Sant Joan, Pharmacy Unit, AlicanteHospital Universitario de Sant Joan, Pharmacy Unit, AlicanteHospital Universitario de Sant Joan, Pharmacy Unit, AlicanteHospital Universitario de Sant Joan, Pharmacy Unit, AlicanteHospital Universitario de Sant Joan, Pharmacy Unit, AlicanteHospital Universitario de Sant Joan, Pharmacy Unit, AlicanteObjective: To determine the number and type of errors found in the record of drug-related problems in the SINEA database, an electronic system for voluntary reporting of adverse events in healthcare, in order to quantify the differences between the raw and refined databases, suggest improvements, and determine the need for refining said databases. Methods: A Pharmacist reviewed the database and refined the adverse events reported from January to August, 2014, considering the “describe_what_happened” field as the gold standard. There was a comparison of the rates of medication errors, both potential and real, adverse reactions, impact on the patient, impact on healthcare, and medications more frequently involved in the raw and refined databases. Agreement was calculated through Cohen’s Kappa Coefficient. Results: 364 adverse events were reported: 66.7% were medication errors, 2.7% adverse reactions to the medication (2 were wrongly classified as both, showing a total percentage >100%) and 31% were other events. After refinement, the percentages were 69.5%, 5.8% and 24.7%, respectively (κ=0.85; CI95% [0.80-0.90]). Before refinement, 73.6% of medication errors were considered potential vs. 82.3% after refinement (κ=0.65; CI95% [0.54- 0.76]). The medication most frequently involved was trastuzumab (20.9%). The “molecule” field was blank in 133 entries. A mean of 1.8±1.9 errors per entry were detected. Conclusions: Although agreement is good, the refinement process cannot be avoided, as it provides valuable information to improve pharmacotherapy. Data quality could be improved by reducing the number of type-in text fields, using drop-down lists, and by increasing the training of the reporters.http://www.aulamedica.es/fh/pdf/10747.pdfAdverse event reporting systemDrug-related problems; Quality; Medication errorPatient safety. |
| spellingShingle | Maria Teresa Aznar-Saliente Laura Roca-Aznar Amparo Talens-Bolós Paola Herraiz-Robles Manuel Bonete-Sánchez Laia Pons-Martínez Borja Marcos-Ribes Quality of the record of drug-related problems in a database for voluntary adverse event reporting Farmacia Hospitalaria Adverse event reporting system Drug-related problems ; Quality; Medication error Patient safety. |
| title | Quality of the record of drug-related problems in a database for voluntary adverse event reporting |
| title_full | Quality of the record of drug-related problems in a database for voluntary adverse event reporting |
| title_fullStr | Quality of the record of drug-related problems in a database for voluntary adverse event reporting |
| title_full_unstemmed | Quality of the record of drug-related problems in a database for voluntary adverse event reporting |
| title_short | Quality of the record of drug-related problems in a database for voluntary adverse event reporting |
| title_sort | quality of the record of drug related problems in a database for voluntary adverse event reporting |
| topic | Adverse event reporting system Drug-related problems ; Quality; Medication error Patient safety. |
| url | http://www.aulamedica.es/fh/pdf/10747.pdf |
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