Adverse drug reactions in the ambulatory internal patients at the emergency department : focus on causality assessment and drug-drug interactions

Dobravc Verbič, Matej (author), Brvar, Miran (author), Kerec Kos, Mojca (author)

A non-interventional retrospective study in ambulatory patients was conducted at the emergency department of the Division of internal medicine. In 2 months, 266 suspected adverse drug reactions (ADRs) were identified in 224/3453 patients (6.5 %). In 158/3453 patients (4.6 %), an ADR was the reason for emergency department visit and in 49 patients (1.4 %), ADRs led to hospitalisation. A causality assessment algorithm was developed, which included Naranjo algorithm and levels of ADR recognition by the treating physician and the investigators. Using this algorithm, 63/266 ADRs (23.7 %) were classified as “certain”, whereas using solely the Naranjo score calculation, only 19/266 ADRs (7.1 %) were assessed as “probable” or “certain”, and the rest of ADRs (namely, 247/266 = 92.9 %) were assessed as “possible”. There were 116/266 (43.6 %) ADRs related to potential drug-drug interactions (DDIs), stated in at least one of the literature sources used. Based on the causality relationship, the rate of the clinically expressed DDIs was 19.0 %, or 12/63 “certain” ADR cases. Of these, 10 cases presented serious DDI-related ADRs. In summary, ADR causality assessment based exclusively on Naranjo algorithm demonstrated low sensitivity at an ambulatory emergency setting. Additional clinical judgment, including the opinion of the treating physician, proved necessary to avoid under-rating of the causality relationship, and enabled the determination of clinically expressed DDIs.

• Language: English
• Keywords: adverse drug reactions, drug interactions, causality assessment, emergency department, ambulatory patients
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine; FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2023
• Number of pages: Str. 195-210
• Numbering: Vol. 73, iss. 2
• PID: 20.500.12556/RUL-148362
• UDC: 615.065:616-08-056.24
• ISSN on article: 1846-9558
• DOI: 10.2478/acph-2023-0013
• COBISS.SI-ID: 139850755

Copyright

Licenca Creative Commons (CC BY-NC-ND) je z ikono navedena na pristajalni strani članka (glej izvorni URL). Ta licenca je navedena tudi v zapisu za revijo Acta pharmaceutica v DOAJ (https://doaj.org/toc/1846-9558). (Datum opombe 25. 8. 2023)

• Publication date in RUL: 18.08.2023

Record is a part of a journal

• Title: Acta pharmaceutica
• Shortened title: Acta pharm.
• Publisher: Sciendo, Croatian Pharmaceutical Society
• ISSN: 1846-9558
• COBISS.SI-ID: 3817585

Licences

• License: CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
• Link: http://creativecommons.org/licenses/by-nc-nd/4.0/
• Description: The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.

Secondary language

• Language: Slovenian
• Keywords: neželeni učinki zdravil, interakcije zdravil, ocena vzročnosti, urgentni oddelek, ambulantni bolniki, zdravila, neželeni učinki, ambulantno zdravljenje

Projects

• Funder: ARRS - Slovenian Research Agency
• Project number: P3-0019
• Name: Aplikativna in bazična fiziologija in patofiziologija v medicini

• Funder: ARRS - Slovenian Research Agency
• Project number: P1-0189
• Name: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih