Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study
Abstract:AimTo analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence.MethodsIn this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them.ResultsHALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential d… Show more
“…Original observational studies were included if they met the following criteria: (a) the identification of DDIs was performed by using a DDI electronic database; (b) clinically manifested DDI was confirmed by laboratory tests and/or signs and symptoms were documented in the medical records and analyzed by specialists [ 25 ]; (c) data for the calculation of the prevalence of clinically manifested DDIs among patients, prescriptions, or DDI adverse reaction reports were available; and (d) the study was published in English, Portuguese, or Spanish. In this systematic review, we excluded: (a) duplicate records; (b) studies with unavailable abstract or full-text, even after authors were contacted; and (c) studies focusing only on specific diseases/pharmacotherapies (for example: patients receiving oncological, HIV, or diabetes treatment) or specific drugs.…”
This review aims to determine the prevalence of clinically manifested drug-drug interactions (DDIs) in hospitalized patients. Methods PubMed, Scopus, Embase, Web of Science, and Lilacs databases were used to identify articles published before June 2019 that met specific inclusion criteria. The search strategy was developed using both controlled and uncontrolled vocabulary related to the following domains: "drug interactions," "clinically relevant," and "hospital." In this review, we discuss original observational studies that detected DDIs in the hospital setting, studies that provided enough data to allow us to calculate the prevalence of clinically manifested DDIs, and studies that described the drugs prescribed or provided DDI adverse reaction reports, published in either English, Portuguese, or Spanish. Results From the initial 5,999 articles identified, 10 met the inclusion criteria. The pooled prevalence of clinically manifested DDIs was 9.2% (CI 95% 4.0-19.7). The mean number of medications per patient reported in six studies ranged from 4.0 to 9.0, with an overall average of 5.47 ± 1.77 drugs per patient. The quality of the included studies was moderate. The main methods used to identify clinically manifested DDIs were evaluating medical records and ward visits (n = 7). Micromedex® (27.7%) and Lexi-Comp® (27.7%) online reference databases were commonly used to detect DDIs and none of the studies evaluated used more than one database for this purpose.
“…Original observational studies were included if they met the following criteria: (a) the identification of DDIs was performed by using a DDI electronic database; (b) clinically manifested DDI was confirmed by laboratory tests and/or signs and symptoms were documented in the medical records and analyzed by specialists [ 25 ]; (c) data for the calculation of the prevalence of clinically manifested DDIs among patients, prescriptions, or DDI adverse reaction reports were available; and (d) the study was published in English, Portuguese, or Spanish. In this systematic review, we excluded: (a) duplicate records; (b) studies with unavailable abstract or full-text, even after authors were contacted; and (c) studies focusing only on specific diseases/pharmacotherapies (for example: patients receiving oncological, HIV, or diabetes treatment) or specific drugs.…”
This review aims to determine the prevalence of clinically manifested drug-drug interactions (DDIs) in hospitalized patients. Methods PubMed, Scopus, Embase, Web of Science, and Lilacs databases were used to identify articles published before June 2019 that met specific inclusion criteria. The search strategy was developed using both controlled and uncontrolled vocabulary related to the following domains: "drug interactions," "clinically relevant," and "hospital." In this review, we discuss original observational studies that detected DDIs in the hospital setting, studies that provided enough data to allow us to calculate the prevalence of clinically manifested DDIs, and studies that described the drugs prescribed or provided DDI adverse reaction reports, published in either English, Portuguese, or Spanish. Results From the initial 5,999 articles identified, 10 met the inclusion criteria. The pooled prevalence of clinically manifested DDIs was 9.2% (CI 95% 4.0-19.7). The mean number of medications per patient reported in six studies ranged from 4.0 to 9.0, with an overall average of 5.47 ± 1.77 drugs per patient. The quality of the included studies was moderate. The main methods used to identify clinically manifested DDIs were evaluating medical records and ward visits (n = 7). Micromedex® (27.7%) and Lexi-Comp® (27.7%) online reference databases were commonly used to detect DDIs and none of the studies evaluated used more than one database for this purpose.
“…Observational studies examining actual DDIs were included if they were prospective or retrospective; the patients were of any age, admitted to hospital wards, or visited outpatients/emergency department due to DDIs; and studies were published in any language and provided sufficient data for calculating the prevalence rates. The actual DIs were defined on the basis of clinical evidence; that is, they were confirmed by laboratory tests or by symptoms . Potential DIs can be defined as documented interactions that may either enhance or antagonize the pharmacological activity of the drugs, resulting in potential adverse effects …”
Drug-drug interactions are a significant cause of hospital admissions and hospital visits. Improved DDI information gathering could help to reduce such adverse effects from DDIs, especially for patients using non-steroidal anti-inflammatory drugs and warfarin.
“…Number and percent of the evaluated studies that failed to meet each of the methodological criteria tested, the number of the evaluated criteria not satisfied per country, and the number of studies that satisfied more than 4 criteria per country is presented in Table 2 . References of the analyzed studies from Bosnia and Herzegovina could be found in our previous publication ( 12 ), while the references of the studies analyzed from Croatian ( 17 - 59 ), Slovenian ( 60 - 92 ) and Serbian medical journals ( 93 - 135 ) are given on the list at the end of this article.…”
Introduction:
Certain methodological principles should be inexcusably followed when designing clinical or observational research to avoid bias and presentation of results that do not reflect the truth about the phenomenon that is the object of the study.
Aim:
The aim of this study was to compare the methodological quality of clinical trials and observational studies published in medical journals from ex-Yugoslav countries indexed in Pubmed/MEDLINE.
Methods:
Clinical studies published in medical journals of ex-Yugoslav countries were retrieved from the Pubmed/MEDLINE database, and the sample for analysis was randomly chosen from the retrieved publications. The rate of the most common errors in the design of clinical/observational studies was established by a careful reading of the sampled publications and their checking against predefined criteria.
Results:
The studies published in two countries that are now member states of the European Union (Slovenia and Croatia) have significantly higher citation rates, impact factor, and methodological quality scores than studies from other ex-Yugoslav countries. While publications from Croatia show clear improvement trend throughout the last two decades, which is visible also in the last 10 years in Slovenia and Bosnia and Herzegovina, quality of clinical research published in journals from Serbia was stagnating in the same period.
Conclusions:
There are significant differences in methodological quality and scientometric characteristics of clinical research published in medical journals of ex-Yugoslav countries that could be mitigated by more intensive training of clinical researchers in statistics and research design, as well as by more rigorous editorial practices.
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