Povezanost potencijalno neprikladnih lijekova i nuspojava lijekova u osoba starije životne dobi

master's thesis

• Title (english): Causal connection between potentially inappropriate medications and spontaneously reported adverse drug reaction in elderly patients
• Author: Magdalena Kovač
• Mentor: Iva Mucalo (mentor)
• Committee member: Iva Mucalo
• Committee member: Maja Ortner Hadžiabdić
• Committee member: Lidija Bach-Rojecky
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2015-09-24, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE

Abstract

Cilj istraživanja bio je ustanoviti broj potencijalno neprikladnih lijekova u bolesnika starije životne dobi iz baze spontano prijavljenih nuspojava Agencije za lijekove i medicinske proizvode pomoću sveobuhvatnog protokola te odrediti uzročno-posljedičnu vezu između utvrđenih potencijalno neprikladnih lijekova i spontano prijavljenih nuspojava. Retrospektivno i opservacijsko istraživanje obuhvatilo je bolesnike od 65 i više godina starosti čije su nuspojave bile prijavljene u razdoblju od 09.01.2013. do 20.12.2013. godine Agenciji za lijekove i medicinske proizvode. Potencijalno neprikladni lijekovi određeni su pomoću sveobuhvatnog protokola hrvatskih autorica, dok je kao referenti izvor za utvrđivanje uzročno-posljedične veze između prijavljenih nuspojava i utvrđenih potencijalno neprikladnih lijekova korišten Sažetak opisa svojstava lijekova, a za utvrđivanje posljedica potencijalno neprikladnih interakcija korišten je Sustav za podršku kliničkom odlučivanju, Lexicomp. Ukupno je bilo uključeno 50 bolesnika prosječne dobi 73,48±6,08 godina čiji je prosječan broj dijagnoza iznosio 2,72 ± 0,99. Ispitanici su u prosjeku koristili 3,82±0,98 lijekova te iskusili 2,42±1,53 nuspojave. Sveobuhvatnim protokolom je utvrđeno da je 36 % bolesnika koristilo barem jedan potencijalno neprikladan lijek, pri čemu su najčešće propisivani potencijalno neprikladni lijekovi bili dugodjelujujući benzodiazepin diazepam te centralno djelujući antihipertenziv moksonidin. Najčešća interakcija bila je kombinacija NSAR s antihipertenzivima. Udio nuspojava za koje smatramo da su uzrokovane potencijalno neprikladnim lijekom iznosi 16,5% te zaključujemo da potencijalno neprikladni lijekovi ne rezultiraju nuspojavama učestalije od lijekova koji nisu tako klasificirani. Nijedna nuspojava klasificirana kao ozbiljna nije bila posljedica primjene potencijalno neprikladnog lijeka Usprkos nižeg postotka utvrđenih potencijalno neprikladnih lijekova na našem uzorku, smatramo da se korištenjem sveobuhvatnog protokola hrvatskih autorica može postići racionalnija primjena lijekova te poboljšana zdravstvena skrb bolesnika što u konačnici može rezultirati boljom suradljivošću bolesnika i većim povjerenjem u zdravstveni sustav.

Abstract (english)

The aim of this study was to determine the number of potentially inappropriate medications (PIMs) among elderly patients in the database of spontaneously reported adverse drug reactions (ADRs) given by the Agency for Medicinal Products and Medical Devices. A comprehensive protocol was used with the aim to determine the causal connection between PIMs and spontaneously reported ADRs. The retrospective observational study included patients aged 65 years and older whose ADRs were reported to the Agency for Medicinal Products and Medical Devices of Croatia during the period from Jan 9, 2013 to Dec 20, 2013. Potentially inappropriate medications were determined by using a comprehensive Croatian protocol. As a reference source for determining the causal connection between the reported ADR and identified PIMs, the Summary of Product Characteristics (SPC) was used, whereas the Clinical Support Decision System, Lexicomp was used for determining the consequences of potentially inappropriate interactions. The study included 50 patients ( age of 73,48 ± 6,08) with an average number of diagnoses of 2,72 ± 0,99. On average, the patients used 3,82 ± 0,98 medications and experienced 2,42 ± 1,53 ADRs. According to the Comprehensive protocol, 36% of patients used at least one potentially inappropriate medication. The most prevalent potentially inappropriate medications were the long-acting benzodiazepine diazepam and the centrally acting antihypertensive moxonidine, while the most prevalent drug interaction was the combination of NSAID with an antihypertensive drug. The analysis of the entire sample shows that 16,5% of total ADRs report were caused by PIMs which leads to the conclusion that the PIM use is not associated with more ADRs reports than any other medication not classified in this way. None of the side effects classified as serious were actually a result of the application of a potentially inappropriate drug. Despite the lower percentage of potentially inappropriate drugs in our sample, we believe that the using a Croatian comprehensive protocol for the detection of potentially inappropriate medication can result in more rational application of medicines and improve the health care of patients which can ultimately result in better compliance of patients and greater confidence in the health system.

• Keywords: osobe starije životne dobi; potencijalno neprikladni lijekovi; nuspojave lijekova
• Keywords (english): elderly; potentially inappropriate medications; adverse drug reactions
• Language: croatian
• URN:NBN: urn:nbn:hr:163:304680
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Access restricted to students and staff of home institution
• Created on: 2016-02-17 16:46:33