Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study
Background: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction repor...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Pensoft Publishers
2018-09-01
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| Series: | Folia Medica |
| Subjects: | |
| Online Access: | http://www.degruyter.com/view/j/folmed.2018.60.issue-3/folmed-2018-0016/folmed-2018-0016.xml?format=INT |
| _version_ | 1818085136177037312 |
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| author | Getova Violeta I. Georgiev Stanislav R. Stoimenova Assena H. Petkova-Georgieva Elina S. |
| author_facet | Getova Violeta I. Georgiev Stanislav R. Stoimenova Assena H. Petkova-Georgieva Elina S. |
| author_sort | Getova Violeta I. |
| collection | DOAJ |
| description | Background: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction reports from patients and consumers have different characteristics from those sent by healthcare professionals. Moreover, they may require specific algorithm and assessment methods in order to be informative and beneficial to the pharmacovigilance system. |
| first_indexed | 2024-12-10T20:04:59Z |
| format | Article |
| id | doaj.art-7f6be912f8cc4fc5b8c511a024bc5487 |
| institution | Directory Open Access Journal |
| issn | 1314-2143 |
| language | English |
| last_indexed | 2024-12-10T20:04:59Z |
| publishDate | 2018-09-01 |
| publisher | Pensoft Publishers |
| record_format | Article |
| series | Folia Medica |
| spelling | doaj.art-7f6be912f8cc4fc5b8c511a024bc54872022-12-22T01:35:24ZengPensoft PublishersFolia Medica1314-21432018-09-0160344745310.2478/folmed-2018-0016folmed-2018-0016Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base StudyGetova Violeta I.0Georgiev Stanislav R.1Stoimenova Assena H.2Petkova-Georgieva Elina S.3Bulgarian Drug Agency, Sofia, BulgariaFaculty of Pharmacy, Medical University of Plovdiv, Plovdiv, BulgariaBulgarian Drug Agency, Sofia, BulgariaFaculty of Pharmacy, Medical University of Plovdiv, Plovdiv, BulgariaBackground: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction reports from patients and consumers have different characteristics from those sent by healthcare professionals. Moreover, they may require specific algorithm and assessment methods in order to be informative and beneficial to the pharmacovigilance system.http://www.degruyter.com/view/j/folmed.2018.60.issue-3/folmed-2018-0016/folmed-2018-0016.xml?format=INTadverse drug reaction reportspatients and consumersreporting levelseriousness criteriapharmacovigilance |
| spellingShingle | Getova Violeta I. Georgiev Stanislav R. Stoimenova Assena H. Petkova-Georgieva Elina S. Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study Folia Medica adverse drug reaction reports patients and consumers reporting level seriousness criteria pharmacovigilance |
| title | Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study |
| title_full | Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study |
| title_fullStr | Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study |
| title_full_unstemmed | Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study |
| title_short | Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers – Retrospective Data-base Study |
| title_sort | bulgarian experience with adverse drug reaction reports from patients and consumers retrospective data base study |
| topic | adverse drug reaction reports patients and consumers reporting level seriousness criteria pharmacovigilance |
| url | http://www.degruyter.com/view/j/folmed.2018.60.issue-3/folmed-2018-0016/folmed-2018-0016.xml?format=INT |
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