Potentially inappropriate prescribing (PIP) describes medications where risk generally outweighs benefit for older people. Cross-sectional studies suggest an association between PIP and poorer health ...outcomes but there is a paucity of prospective cohort studies. This study investigates the longitudinal association of PIP with adverse drug events (ADEs), health related quality of life, and accident & emergency visits.
Study design: Two-year (2010-2012) prospective cohort study (n = 904, ≥70 years, community-dwelling) with linked pharmacy dispensing data.
Baseline PIP: Screening Tool for Older Persons potentially Inappropriate Prescriptions (STOPP) and Beers 2012 applied 12 months prior.
ADEs (patient interview), health related quality of life (EQ-5D-3L: patient questionnaire), and accident & emergency visits (general practice medical record review).
Descriptive statistics: Poisson (incidence rate ratio 95% confidence interval CI, linear regression models regression coefficient 95% CI, and logistic odds ratio OR 95% CI).
Of 791 participants eligible for follow-up, 673 (85%) returned a questionnaire and 605 (77%) also completed an ADE interview. Baseline STOPP PIP prevalence was 40% and 445 (74%) patients reported ≥1 ADE at follow-up. In multivariable analysis, ≥2 STOPP PIP was associated with ADEs (adjusted incidence rate ratio: 1.29 95% CI 1.03, 1.85; p = .03; poorer health related quality of life adjusted regression coefficient: -0.11 95% CI -0.16, -0.06; p < .001; and, ≥1 accident & emergency visit adjusted OR: 1.85 95% CI 1.06, 3.24; p = .03). Baseline Beers 2012 prevalence was 26% and there was no association with adverse health outcomes in multivariable analysis.
Older community-dwelling people, prescribed ≥2 STOPP PIP are more likely to report ADEs, poorer health related quality of life and attend the accident & emergency department over 2-year follow-up.
Concerns over safety profiles of tumor necrosis factor (TNF)-alfa inhibitors have been raised. The purpose of this study was to clarify the adverse events associated with TNF-alfa inhibitors using a ...spontaneous reporting system database.
A retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report (JADER) database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between 2004 and 2017 were analyzed, and the reporting odds ratio (ROR) and 95% confidence interval (CI) for each adverse event were calculated.
Among the 34,031 reports of adverse events associated with TNF-alfa inhibitors, 65.8% were women, who were frequently in their 60s (28.2%). Signals were detected for pneumonia (ROR, 5.36; 95% CI, 5.14-5.6), interstitial lung disease (ROR, 2.04; 95% CI, 1.95-2.15), pneumocystis jirovecii pneumonia (ROR, 11.8; 95% CI, 11.1-12.5), and herpes zoster (ROR, 6.4; 95% CI, 5.92-6.91) for TNF-alfa inhibitors as a class. There was variability in their signal strength across individual TNF-alfa inhibitors.
The strength of the associations of TNF-alfa inhibitors with adverse events is variable, and further studies are required to evaluate the identified signals.
Background/Objectives
Federally‐mandated consultant pharmacist‐conducted retrospective medication regimen reviews (MRRs) are designed to improve medication safety in nursing homes (NH). However, MRRs ...are potentially ineffective. A new model of care that improves access to and efficiency of consultant pharmacists is needed. The objective of this study was to determine the impact of pharmacist‐led telemedicine services on reducing high‐risk medication adverse drug events (ADEs) for NH residents using medication reconciliation and prospective MRR on admission plus ongoing clinical decision support alerts throughout the residents’ stay.
Design
Quality improvement study using a stepped‐wedge design comparing the novel service to usual care in a one‐year evaluation from November 2016 to October 2017.
Setting
Four NHs (two urban, two suburban) in Southwestern Pennsylvania.
Participants
All residents in the four NHs were screened. There were 2,127 residents admitted having 652 alerts in the active period.
Intervention
Upon admission, pharmacists conducted medication reconciliation and prospective MRR for residents and also used telemedicine for communication with cognitively‐intact residents. Post‐admission, pharmacists received clinical decision support alerts to conduct targeted concurrent MRRs and telemedicine.
Measurement
Main outcome was incidence of high‐risk medication, alert‐specific ADEs. Secondary outcomes included all‐cause hospitalization, 30‐day readmission rates, and consultant pharmacists' recommendations.
Results
Consultant pharmacists provided 769 recommendations. The intervention group had a 92% lower incidence of alert‐specific ADEs than usual care (9 vs 31; 0.14 vs 0.61/1,000‐resident‐days; adjusted incident rate ratio (AIRR) = 0.08 (95% confidence interval (CI) = 0.01–0.40; P = .002). All‐cause hospitalization was similar between groups (149 vs 138; 2.33 vs 2.70/1,000‐resident‐days; AIRR = 1.06 (95% CI = 0.72–1.58); P = .75), as were 30‐day readmissions (110 vs 102; 1.72 vs 2.00/1,000‐resident‐days; AIRR = 1.21 (95% CI = 0.76–1.93); P = .42).
Conclusions
This is the first evaluation of the impact of pharmacist‐led patient‐centered telemedicine services to manage high‐risk medications during transitional care and throughout the resident's NH stay, supporting a new model of patient care.
Adverse drug reactions (ADRs) are an important cause of morbidity and mortality worldwide. They are associated with healthcare costs due to hospital admissions or prolonged length of stay, as well as ...additional interventions. The aim of this study was to conduct a systematic review of observational studies to evaluate the economic impact of preventable ADRs.
Published observational research investigating the cost of preventable ADRs in Western countries (limited to the USA and European countries).
Several reviews have been carried out in the field of the ADR epidemiology but fewer reviews have investigated the economic impact of ADRs, and at the time of writing, none has focused on preventable ADRs. The reason why future research should focus on the costs of preventable ADRs is that both the costs and the negative clinical outcomes are preventable, and as such, are a key point of public health policy action. Nevertheless, the present review highlights an important and sobering limitation of published research on the cost of preventable ADRs, of which the major limitation is the heterogeneity in methods and in reporting which limit what can be known through the summarizing work of a systematic review.
Introduction Drug trials in neonates are scarce, and the neonates may consequently be at risk of adverse drug reactions (ADRs). Spontaneous ADR reporting is an important tool for expanding the ...knowledge on drug safety in neonates. This study explores the quality of current neonatal ADR reports and the ADR reports of the most common drugs used in neonatal departments. Methods An observational cross-sectional study focused on neonates was conducted using data on spontaneous reports extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2014 up to December 2022. Only the primary suspect drugs given to neonates or subjects aged <30 days were included in the analysis. Results Spontaneous reports from 13 million patients of all ages, totaling 50 million ADRs, were evaluated. Information regarding the age was missing in 40% of the reports, and data on 43,737 neonates with 948 different suspected drugs were identified and included in the analysis. We report the frequency of spontaneous ADR reports in the FAERS database for the ten most frequently administered drugs in neonatal intensive care units in the USA. Conclusion Overall, neonatal ADRs are still underreported. The FAERS database in its current form discriminates insufficiently between prenatal and postnatal drug exposures. Hence, improved neonatal pharmacovigilance systems are urgently needed.
Aims
Medication harm has negative clinical and economic consequences, contributing to hospitalisation, morbidity and mortality. The incidence ranges from 4 to 14%, of which up to 50% of events may be ...preventable. A predictive model for identifying high‐risk inpatients can guide a timely and systematic approach to prioritisation. The aim of this study is to develop and internally validate a risk prediction model for prioritisation of hospitalised patients at risk of medication harm.
Methods
A retrospective cohort study was conducted in general medical and geriatric specialties at an Australian hospital over six months. Medication harm was identified using International Classification of Disease (ICD‐10) codes and the hospital's incident database. Sixty‐eight variables, including medications and laboratory results, were extracted from the hospital's databases. Multivariable logistic regression was used to develop the final risk model. Performance was evaluated using area under the receiver operative characteristic curve (AuROC) and clinical utility was determined using decision curve analysis.
Results
The study cohort included 1982 patients with median age 74 years, of which 136 (7%) experienced at least one adverse medication event(s). The model included: length of stay, hospital re‐admission within 12 months, venous or arterial thrombosis and/or embolism, ≥ 8 medications, serum sodium < 126 mmol/L, INR > 3, anti‐psychotic, antiarrhythmic and immunosuppressant medications, and history of medication allergy. Validation gave an AuROC of 0.70 (95% CI: 0.65–0.74). Decision curve analysis identified that the AIME may be clinically useful to help guide decision making in practice.
Conclusion
We have developed a predictive model with reasonable performance. Future steps include external validation and impact evaluation.
Spontaneous reporting of adverse drug events (ADEs) has long been the cornerstone of pharmacovigilance. Medical institutions in China have been a major source of ADE case reports, but the proportion ...of reports from tertiary hospitals is low due to the serious underreporting of case reports. The same problem existed in the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU).
In order to increase the number of ADE reports and promote hospital pharmacovigilance, SAHZU's clinical pharmacists established a pharmacist-led ADE management model. The aim of this paper is to introduce this management model and explore the advantages and disadvantages of the model.
Pharmacist-led ADE management model was gradually formed from 2015 to 2017 in the SAHZU. This "pharmacist-led" model is reflected not only in the fact that clinical pharmacists are the main reporters of SAHZU's ADEs but also in that they are the main groups to analyze and manage ADE and drug errors. The sources of ADEs reported by clinical pharmacists mainly include pharmacy rounds, ADE-related pharmacist consultations, centralized monitoring, ADE warning signal analysis, newly introduced drug evaluations, and drug safety research.
A total of 533 ADEs were reported by SAHZU to China's spontaneous reporting system (SRS) in 2017, while the data in 2012 was 177, with an increase by 201%. In 2012, the proportion of "new" and "serious" reports was 16.4%. The proportions during the period from 2015 to 2017 were 41.4%, 60.8%, and 52.2%, respectively, which were statistically significant compared with the proportion in 2012. The proportion of ADEs reported by clinical pharmacists during the period from 2014 to 2017 were 51.5%, 57.3%, 68.8%, and 90.8%, respectively, which were statistically significant compared with the proportion in 2013 (
<0.05). There was a correlation between the proportions of severe ADEs and the proportion of ADEs reported by clinical pharmacists (
=0.873,
=0.023). Four hundred eighty four ADE cases reported by clinical pharmacists to China's SRS in 2017 were mainly found in rounds of clinical pharmacists (74.17% 359/484).
The pharmacist-led pharmacovigilance working model significantly increased the quantity and quality of ADE reporting in SAHZU and promoted pharmacovigilance. This model is worth developing in Chinese tertiary hospitals and the following hospitals, where the physicians working there spend little time and energy on ADE reporting or the cost of physicians is high, while the clinical pharmacist team has strong professional skills.
Coronavirus disease 2019 (COVID-19) has different clinical manifestations that besides its iatrogenic intervention could affect brain cognitive function. Medication omission has serious effects on a ...patient’s clinical course changing the disease’s mortality and morbidity; herein possible role of the iatrogenic intervention that increased the risk of psychological disturbance including medication omission was reported.
A 40-years-old man with a history of gout treated with allopurinol was admitted due to productive cough and hemoptysis. His physical exam and lung spiral chest CT scan revealed moderate to severe lung infiltrations in favor of COVID-19 which was confirmed with COVID-19 RT-PCR. Due to his clinical course tocilizumab, methylprednisolone pulse, and other conservative therapies were started while allopurinol was omitted. During his hospitalization anxiety and irritability appeared and progressed gradually making him refuse to get oxygen supplementation. Through immediate intervention and controlling his behavioral symptoms with psychotherapy, selective serotonin reuptake inhibitors, benzodiazepines, and initiation of allopurinol, the patient’s psychological disturbance were relieved. In the end, he died due to acute respiratory distress syndrome.
COVID-19 and its iatrogenic interventions could trigger a psychiatric disturbance in patients with a variety of pathways. Corticosteroid therapy, non-hypnotic antihistamines, quarantine stress conditions, hypoxia, and medication omission are underlying factors for it. Reporting this medication omission would help physicians become familiar with this pharmacological phenomenon, its prevention, and the way to respond to it. On the other hand, researchers can study the etiology of this phenomenon to understand the mood-stabilizing role of allopurinol in additional studies.
Aims
This study aimed to determine the association between potentially inappropriate prescribing (PIP) and health related outcomes adverse drug events (ADEs), health related quality of life (HRQOL) ...and hospital accident and emergency (A&E) visits in older community dwelling patients.
Methods
A retrospective cohort study of 931 community dwelling patients aged ≥70 years in 15 general practices in Ireland in 2010. PIP was defined by the Screening Tool of Older Person's Prescriptions (STOPP). ADEs were measured by patient self‐report and medical record for the previous 6 months and reviewed by two independent clinicians. HRQOL was measured by the EQ‐5D. A&E visits were measured by patients’ medical records and self‐report. Multilevel logistic, linear and Poisson regression examined how ADEs, HRQOL and A&E visits varied by PIP after adjusting for patient and practice level covariates: socioeconomic status, co‐morbidity, number of drug classes and adherence.
Results
The overall prevalence of PIP was 42% (n = 377). Patients with ≥2 PIP indicators were twice as likely to have an ADE (adjusted OR 2.21; 95% CI 1.02, 4.83, P < 0.05), have a significantly lower mean HRQOL utility (adjusted coefficient −0.09, SE 0.02, P < 0.001) and nearly a two‐fold increased risk in the expected rate of A&E visits (adjusted IRR 1.85; 95% CI 1.32, 2.58, P < 0.001). The number of drug classes and adherence were also significantly associated with these same adverse health outcomes.
Conclusions
Reducing PIP in primary care may help lower the burden of ADEs, its associated health care use and costs and enhance quality of life in older patients.
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