Dataset Information

Factors associated with adverse drug reaction occurrence and prognosis, and their economic impacts in older inpatients in Taiwan: a nested case-control study.

ABSTRACT:

Objective

Older patients are likely to have higher disease complexity and more drug prescriptions of which are associated with a higher incidence of adverse drug reactions (ADR). This study aimed to investigate factors associated with ADR occurrence, prognosis and medical expenses in older inpatients.

Design

A nested case-control study.

Setting

A medical centre located in north Taiwan.

Participants

539 reported ADR cases from a patient cohort containing 108?548 older inpatients were collected from 2006 to 2012. There were 1854 non-ADR matched controls; a maximum of 1:5 matched by age, sex and principal diagnosis were collected.

Exposure

Polypharmacy, the number of drugs prescribed, comorbidities and the admission department were factors associated with ADRs, as well as subsequent poor prognosis, length of stay and medical expenses.

Primary and secondary outcome measures

ADR occurrence and poor prognosis (mortality, discharge against medical advice in critical conditions, or admitted to intensive care unit) were the primary outcomes. Additional medical expenses and the length of hospital stay were the secondary outcomes.

Results

The admission department, number of comorbidities and number of drug prescriptions before ADRs were associated with ADR occurrence among older inpatients. ADR severity was a significant prognostic factor among ADR cases. The multivariate-adjusted OR of 1.63 (95% CI 1.36 to 1.95) for poor prognosis was found as the number of comorbidities increased. Patients prescribed ?11 drugs including psychoactive drugs showed 2.45-fold (95%?CI 1.40 to 4.28) poorer prognosis than other patients. ADRs caused the addition of US$1803.8, US$360.8 and 5.6 days in total medical expenses, drug expenses and length of stay among affected older inpatients, respectively.

Conclusions

The number of comorbidities and polypharmacy including the use of psychoactive drugs has significant impacts on ADR occurrence and prognosis among older inpatients. The findings provide clues for future prescription modification and patient's safety improvement in geriatric care.

SUBMITTER: Liao PJ

PROVIDER: S-EPMC6530431 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Factors associated with adverse drug reaction occurrence and prognosis, and their economic impacts in older inpatients in Taiwan: a nested case-control study.

Liao Pei-Ju PJ Mao Chien-Tai CT Chen Tun-Liang TL Deng Shin-Tarng ST Hsu Kuang-Hung KH

BMJ open 20190510 5

<h4>Objective</h4>Older patients are likely to have higher disease complexity and more drug prescriptions of which are associated with a higher incidence of adverse drug reactions (ADR). This study aimed to investigate factors associated with ADR occurrence, prognosis and medical expenses in older inpatients.<h4>Design</h4>A nested case-control study.<h4>Setting</h4>A medical centre located in north Taiwan.<h4>Participants</h4>539 reported ADR cases from a patient cohort containing 108 548 older ...[more]

PMID: 31079084

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Project description:BackgroundBased on data of clinical trials, new agents are receiving approval to the pharmaceutical market, for which information concerning safety issues under real-life conditions is not yet available.ObjectivesThe aim was to evaluate the tolerability of newer antiepileptic drugs (AEDs), such as topiramate, levetiracetam, zonisamide, pregabalin, extended-release oxcarbazepine, lacosamide and eslicarbazepine, under real-life conditions by means of an assessment of routine clinical data of inpatients.MethodOver 2.75 years data of all inpatients receiving one of the newer AEDs were documented. Occurring adverse drug reactions (ADRs) were classified according to the WHO-UMC Causality Assessment concerning their likely relationship to the prescribed AEDs. For each AED, the total number of patients without and with ADRs, assessed as at least possibly related to the particular drug, was calculated and corresponding incidences compared with reference data provided in the Summary of Product Characteristics (SmPC). For statistical evaluation Spearman correlation (rs), estimated relative risk and logistic regression analysis were used.ResultsIn total, the data of 562 patients were assessed, of which 90 % received up to six different AEDs. The proportion of off-label use with regard to dosage varied between 6.4 and 64.7 %. Levetiracetam and oxcarbazepine as an extended-release formulation were most commonly used, and levetiracetam showed the best tolerance. By using logistic regression, the occurrence of ADRs was significantly associated with the number of AEDs (p < 0.001) as well as the defined daily doses (p = 0.003). In total, ADRs of AEDs were documented for 318 patients (56.6 %). The most common referred to electrolyte imbalance, e.g., low sodium (n = 79, 14.1 %) and potassium (n = 25, 4.4 %) levels, the central nervous system, including dizziness (n = 61, 10.9 %), disturbed vision (n = 47, 8.4 %), fatigue (n = 40, 7.1 %), nystagmus (n = 36, 6.4 %) and ataxia (n = 29, 5.2 %), or cognitive deficits, especially disturbance of speech (n = 37, 6.6 %), memory impairment (n = 36, 6.4 %) and mental slowing (n = 32, 5.7 %). By comparing the assessed ADR incidences with specification data, for some ADRs, a probable underestimation by the SmPC of respective risk could be assumed.ConclusionDuring inpatient treatment, valuable data are generated, which are currently rarely utilized for pharmacoepidemiologic or pharmacovigilance purposes. A systematic evaluation of these data can increase the probability of detecting ADRs and can promote real-life-related drug surveillance.

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Dataset Information

Factors associated with adverse drug reaction occurrence and prognosis, and their economic impacts in older inpatients in Taiwan: a nested case-control study.

Objective

Design

Setting

Participants

Exposure

Primary and secondary outcome measures

Results

Conclusions

Publications

Factors associated with adverse drug reaction occurrence and prognosis, and their economic impacts in older inpatients in Taiwan: a nested case-control study.

Similar Datasets

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