A Pharmacovigilance Program From Laboratory Signals for the Detection and Reporting of Serious Adverse Drug Reactions in Hospitalized Patients

Ramı́rez, Elena; Carcas, Antonio J.; Borobia, Alberto M.; Lei, S. H.; Piñana, Enrique; Fudio, Salvador; Frías, Jesús

doi:10.1038/clpt.2009.185

Cited by 71 publications

(77 citation statements)

References 36 publications

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“…The widely differing estimates of ADR percentage in various studies may be explained by differences in data collection methods, in definitions of ADR, characteristics of patients, typology of wards involved, and duration of hospital stay. In our study the occurrence of an ADR during hospital stay increased the median length of that stay by 50%, in line with the literature 12,13,18,19…”

Section: Discussionsupporting

confidence: 93%

Adverse drug reactions in older patients: an Italian observational prospective hospital study

Conforti

Costantini²,

Zanetti³

et al. 2012

DHPS

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BackgroundIn adults over 65 years of age, the frequency of adverse drug reaction (ADRs) related hospital admissions is higher than in younger adults, and the frequency of ADRs occurring during hospital stay highly ranges. The review was designed to evaluate the frequency of ADRs, both resulting in hospital admission and occurring during the hospital stay of older patients, while identifying the types of reactions and the associated drugs.MethodsAge, sex, date, and diagnosis of admission of all patients aged 65 and over admitted in three geriatric wards of University Hospital of Verona, Italy, from February to July 2009 were registered by nurses on a special form. In the specific cases of admissions caused by an ADR as well as in the cases of an ADR occurring during the hospital stay, the type of reactions and the suspected drugs were also registered by nurses and physicians involved in the study.ResultsDuring the six months of the study, 1023 patients matched the inclusion criteria and were included in the study. One hundred fourteen hospital admissions (11.1%) were caused by ADRs, while 256 patients (25.0%) had an ADR during their hospital stay. The duration of hospital stay was significantly longer in patients who developed an ADR during their time in hospital, 18.7 (95% CI: 17.2–20.1) days versus 12.6 (95% CI: 11.9–13.3) days. Electrolyte disorders, gastrointestinal disorders, anemia, and International Normalized Ratio increase were the more frequent observed ADRs, with diuretics, antithrombotic agents, and antibacterials as the main involved drugs. Our study confirms that ADRs are an important cause of hospitalization in older patients. In addition, the frequency of ADRs occurring during hospital stay is high and causes prolonged hospitalization.

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Section: Discussionsupporting

confidence: 93%

Adverse drug reactions in older patients: an Italian observational prospective hospital study

Conforti

Costantini²,

Zanetti³

et al. 2012

DHPS

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“…Serious events usually have an increased public health importance compared with non‐serious ones . The events were classified as serious if they were included in the EMA's important medical events list.…”

Section: Methodsmentioning

confidence: 99%

Characteristics of drugs safety signals that predict safety related product information update

Insani

Păcurariu

Mantel‐Teeuwisse

et al. 2018

Pharmacoepidemiology and Drug

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PurposeInvestigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signal characteristics that might predict PI update following signal evaluation. The objective of this study was to identify signal characteristics associated with PI updates following signal evaluation by the European Medicines Agency Pharmacovigilance Risk Assessment Committee during 2012 to 2016.MethodsA comparative study was performed based on data from 172 safety signals. Characteristics of signals were extracted from the European Pharmacovigilance Issues Tracking Tool database. Multivariable logistic regression analysis was used to assess the relationship between signal characteristics and the decision to update the PI.ResultsMultivariable logistic regression analysis showed that the presence of evidence in multiple types of data sources (adjusted odds ratio [OR] 7.8 95% CI [1.5, 40.1]); mechanistic plausibility of the drug‐event association (adjusted OR 3.9 95% CI [1.9, 8.0]); seriousness of the event (adjusted OR 4.2 95% CI [1.3, 13.9]); and age of drugs ≤5 years (adjusted OR 3.9 95% CI [1.2, 12.7]) were associated with the decision to change the PI (P < 0.05).ConclusionsThis study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.

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“…Adverse drug reactions (ADRs) are an important cause of morbidity and mortality (Ramirez et al, 2009). Current studies reveal that ADRs occur in 6.5% to more than 20% of hospitalized patients.…”

Section: Introductionmentioning

confidence: 99%

Cardiovascular drug adverse reactions in hospitalized patients in cardiac care unit

Karimzadeh¹,

Namazi²,

Shalviri³

et al. 2011

Afr. J. Pharm. Pharmacol.

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The aim of the present survey was to evaluate different aspects of cardiovascular drug adverse reactions in a cardiac care unit (CCU). All patients admitted to CCU during a 16 months period were recruited into this study. Detection of adverse drug reactions (ADRs) was based on daily chart review and face to face interview with patients. Causality assessment was performed by the World Health Organization (WHO) probability criteria. Seriousness of ADRs was determined by WHO definition. Schumock and Thornton scale was applied to assess preventability of ADRs. Statistical analysis was performed. Among 740 cardiovascular patients admitted to CCU, 70 ADRs were recorded from 44 patients. Headache (15.71%) was the most frequent ADR. The highest ADR rates were attributed to digoxin (44.29%) and atenolol (12.86%). Fifty five (78.57%) of ADRs were serious. The rate of preventable ADRs was 62.86%. Regarding outcome, one (1.43%) ADR led to death. Multivariate logistic regression showed that length of CCU stay (OR = 1.09, 95%CI = 1.02-1.17) and non-ischemic heart diseases (OR = 3.26, 95% CI = 1.57-6.78) were risk factors for ADR occurrence. Cardiovascular drugs could develop fatal adverse reactions in CCU patients. Primary admission diagnosis and duration of CCU stay were risk factors for ADR development.

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A Pharmacovigilance Program From Laboratory Signals for the Detection and Reporting of Serious Adverse Drug Reactions in Hospitalized Patients

Cited by 71 publications

References 36 publications

Adverse drug reactions in older patients: an Italian observational prospective hospital study

Adverse drug reactions in older patients: an Italian observational prospective hospital study

Characteristics of drugs safety signals that predict safety related product information update

Cardiovascular drug adverse reactions in hospitalized patients in cardiac care unit

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