Drug-Related Deaths in a Tertiary Hospital: Characteristics of Spontaneously Reported Cases and Comparison to Cases Detected from a Retrospective Study

Drug-related deaths (DRDs) are a common cause of hospital death. Pharmacovigilance, either as spontaneous reporting or active surveillance, plays a key role in the detection and reporting of suspected adverse drug reactions (ADRs). We conducted a retrospective analysis of all DRDs spontaneously reported to a pharmacovigilance program of a tertiary hospital, by health care professionals. We compared these results to those of a previous retrospective study conducted in the same hospital from the hospital’s mortality registry. From 1460 spontaneous reported ADRs in a 10-year period, 73 (5%) were DRDs. The median age of DRD was 75 years (range 1 month–94) and 60.3% were men. The most frequent DRDs were hemorrhages (41.1%), followed by infections (17.8%). The most frequently involved drugs were anticoagulants and/or antithrombotic (30%), and antineoplastics (26.3%). When comparing both studies, spontaneous reporting detected more type B reactions (p < 0.001) and hospital-acquired DRD (p < 0.001); the number of concomitant drugs was higher (p = 0.0035); and the kind of ADR were different. The combination of several methods is mandatory to detect, assess, understand, and design strategies to prevent ADRs in a hospital setting, to ensure patient safety.

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Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital

Journal of Clinical Medicine ◽

10.3390/jcm10235531 ◽

2021 ◽

Vol 10 (23) ◽

pp. 5531

Author(s):

Laura López-Valverde ◽

Èlia Domènech ◽

Marc Roguera ◽

Ignasi Gich ◽

Magí Farré ◽

...

Keyword(s):

Medication Errors ◽

Adverse Drug Reactions ◽

Health Care Professionals ◽

Spontaneous Reporting ◽

Pediatric Population ◽

Hospital Setting ◽

Tertiary Hospital ◽

Drug Reactions ◽

Vulnerable Group ◽

Spontaneous Reports

The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilance Program in a tertiary hospital between 2010 and 2020, and we compared characteristics of ADRs between pediatric age subgroups. From 1787 spontaneously reported ADRs in an 11-year period, 103 (5.85%) were pediatric ADRs. The median age of patients with ADRs was 8.4 years (range 1 day–17 years) and 57.3% were male. The most frequent ADRs reported were nervous system disorders (13.6%) and the most frequently involved drugs were antineoplastics and immunodulators (32.4%). A 59.2% of the ADRs were serious and 55.3% were classified as being type B reactions. Medication errors were involved in 7.8% of the ADRs and 11.9% of the suspected drugs were used off-label. Spontaneous reports of ADRs in newborns, infants, and toddlers were more serious and less often described in the product data sheet than in children and adolescents (p < 0.001 and p = 0.004 respectively). Medication errors were more frequent in patients under two years of age. These results should be interpreted with caution due to under-reporting and biases in spontaneous reporting of ADRs.

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A Retrospective Study of Pediatric Medication Errors in Saudi Arabia

Hospital Pharmacy ◽

10.1177/0018578719882318 ◽

2019 ◽

pp. 001857871988231

Author(s):

Oluwaseun Egunsola ◽

Sheraz Ali ◽

Dalal S. Al-Dossari ◽

Rahsid Hamoud Alnajrani

Keyword(s):

Health Care ◽

Saudi Arabia ◽

Retrospective Study ◽

Medication Errors ◽

Health Care Professionals ◽

Pediatric Population ◽

Tertiary Hospital ◽

Pediatric Care ◽

Common Drug ◽

Transcription Error

Background: The peculiarities of medication errors (MEs) among the pediatric population in the Middle East have not been adequately explored. In this study, we describe the MEs reported at the largest tertiary hospital in Saudi Arabia. Methods: This study is a retrospective analysis of MEs reported by health care professionals at a large tertiary hospital in Saudi Arabia between 2015 and 2016. Results: There were a total of 9123 MEs involving 84 different medications. In total, 109 382 drugs were ordered. Thus, 8.3 MEs per 100 prescriptions were reported during the study period. Thirty-nine errors (0.4%) reached the patient, but did not cause any harm. Transcribing errors accounted for more than half of the MEs (n = 4856, 53.2%). Physicians were the least likely to report an ME (n = 159, 1.7%), whereas pharmacists reported more MEs than any other health care professional (n = 4924, 54%). The most common drug causes of MEs were paracetamol, salbutamol, and amoxicillin, which accounted for 21.0%, 16.6%, and 12.4% of MEs, respectively, over the study period. Conclusions: Medication errors are common in pediatric care, especially for drugs such as paracetamol and amoxicillin that are frequently prescribed. Transcription error was common in this study and is more likely to be reported by pharmacists.

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Analysis of spontaneous reporting of suspected adverse drug reactions for non-analgesic over-the-counter drugs from 2008 to 2017

BMC Pharmacology and Toxicology ◽

10.1186/s40360-019-0338-2 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Josipa Bukic ◽

Doris Rusic ◽

Petar Mas ◽

Deni Karabatic ◽

Josko Bozic ◽

...

Keyword(s):

Health Care ◽

Health Care Professionals ◽

Spontaneous Reporting ◽

Medicinal Products ◽

Over The Counter ◽

Reporting Practices ◽

Adr Reporting ◽

Otc Drugs ◽

Reporting Practice ◽

Suspected Adverse Drug Reactions

Abstract Background Adverse drug reaction (ADR) reporting practices by health care professionals remain poor. Over-the-counter (OTC) drugs are perceived as safe; however, they can also cause ADRs. The objective of this study was to analyze ADR reporting for OTC drugs in a 10-year period, in order to evaluate frequency of ADRs, population that ADRs most affect and reporters of ADRs of OTC drugs in Croatia. Methods Spontaneously reported ADRs of non-analgesic OTC drugs, collected from January 2008 to December 2017 were analyzed. Data was obtained from Agency for Medicinal Products and Medical Devices of Croatia (HALMED). Results There were 547 ADRs of OTC drugs reported in total and an increase in number of reports through the years was observed. Pharmacists reported 45.4% of all ADRs, and were most frequent reporters (p < 0.001). In 2017 majority of reports, 62 (49.2%), were obtained from consumers. ADRs were most frequently observed in patients aged 70 years and older (15% of ADRs). Five percent of all reports were accidental exposures among children. Conclusions Pharmacists most frequently reported ADRs of OTC drugs and consumers’ awareness of ADR reporting has risen. Other health care professionals (e.g., nurses and dentists) must be offered proper education in order to improve reporting practice of ADRs. Health care professionals should address concerns about OTC drug safety in elderly and children.

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Outcomes of Stenotrophomonas maltophilia hospital-acquired pneumonia in intensive care unit: a nationwide retrospective study

Critical Care ◽

10.1186/s13054-019-2649-5 ◽

2019 ◽

Vol 23 (1) ◽

Cited By ~ 1

Author(s):

Philippe Guerci ◽

◽

Hugo Bellut ◽

Mokhtar Mokhtari ◽

Julie Gaudefroy ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Retrospective Study ◽

Primary Endpoint ◽

Antimicrobial Therapy ◽

Stenotrophomonas Maltophilia ◽

Antimicrobial Treatment ◽

Hospital Death ◽

Hospital Acquired Pneumonia ◽

Hospital Acquired

Abstract Background There is little descriptive data on Stenotrophomonas maltophilia hospital-acquired pneumonia (HAP) in critically ill patients. The optimal modalities of antimicrobial therapy remain to be determined. Our objective was to describe the epidemiology and prognostic factors associated with S. maltophilia pneumonia, focusing on antimicrobial therapy. Methods This nationwide retrospective study included all patients admitted to 25 French mixed intensive care units between 2012 and 2017 with hospital-acquired S. maltophilia HAP during intensive care unit stay. Primary endpoint was time to in-hospital death. Secondary endpoints included microbiologic effectiveness and antimicrobial therapeutic modalities such as delay to appropriate antimicrobial treatment, mono versus combination therapy, and duration of antimicrobial therapy. Results Of the 282 patients included, 84% were intubated at S. maltophilia HAP diagnosis for duration of 11 [5–18] days. The Simplified Acute Physiology Score II was 47 [36–63], and the in-hospital mortality was 49.7%. Underlying chronic pulmonary comorbidities were present in 14.1% of cases. Empirical antimicrobial therapy was considered effective on S. maltophilia according to susceptibility patterns in only 30% of cases. Delay to appropriate antimicrobial treatment had, however, no significant impact on the primary endpoint. Survival analysis did not show any benefit from combination antimicrobial therapy (HR = 1.27, 95%CI [0.88; 1.83], p = 0.20) or prolonged antimicrobial therapy for more than 7 days (HR = 1.06, 95%CI [0.6; 1.86], p = 0.84). No differences were noted in in-hospital death irrespective of an appropriate and timely empiric antimicrobial therapy between mono- versus polymicrobial S. maltophilia HAP (p = 0.273). The duration of ventilation prior to S. maltophilia HAP diagnosis and ICU length of stay were shorter in patients with monomicrobial S. maltophilia HAP (p = 0.031 and p = 0.034 respectively). Conclusions S. maltophilia HAP occurred in severe, long-stay intensive care patients who mainly required prolonged invasive ventilation. Empirical antimicrobial therapy was barely effective while antimicrobial treatment modalities had no significant impact on hospital survival. Trial registration clinicaltrials.gov, NCT03506191

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Efficacy of prehospital National Early Warning Score to predict outpatient disposition at an emergency department of a Japanese tertiary hospital: a retrospective study

BMJ Open ◽

10.1136/bmjopen-2019-034602 ◽

2020 ◽

Vol 10 (6) ◽

pp. e034602

Author(s):

Takuro Endo ◽

Toru Yoshida ◽

Tomohiro Shinozaki ◽

Takako Motohashi ◽

Hsiang-Chin Hsu ◽

...

Keyword(s):

Emergency Department ◽

Retrospective Study ◽

Early Warning ◽

Hospital Setting ◽

Tertiary Hospital ◽

Adverse Outcomes ◽

Early Warning Score ◽

Patient Disposition ◽

Hospitalised Patients ◽

National Early Warning Score

ObjectivesThe National Early Warning Score (NEWS) was originally developed to assess hospitalised patients in the UK. We examined whether the NEWS could be applied to patients transported by ambulance in Japan.DesignThis retrospective study assessed patients and calculated the NEWS from paramedic records. Emergency department (ED) disposition data were categorised into the following groups: discharged from the ED, admitted to the ward, admitted to the intensive care unit (ICU) or died in the ED. The predictive performance of NEWS for patient disposition was assessed using receiver operating characteristic curve analysis. Patient dispositions were compared among NEWS-based categories after adjusting for age, sex and presence of traumatic injury.SettingA tertiary hospital in Japan.ParticipantsOverall, 2847 patients transported by ambulance between April 2017 and March 2018 were included.ResultsThe mean (±SD) NEWS differed significantly among patients discharged from the ED (n=1330, 3.7±2.9), admitted to the ward (n=1263, 60.3±3.8), admitted to the ICU (n=232, 9.4±4.0) and died in the ED (n=22, 110.7±2.9) (p<0.001). The prehospital NEWS C-statistics (95% CI) for admission to the ward, admission to the ICU or death in the ED; admission to the ICU or death in the ED; and death in the ED were 0.73 (0.72–0.75), 0.81 (0.78–0.83) and 0.90 (0.87–0.93), respectively. After adjusting for age, sex and trauma, the OR (95% CI) of admission to the ICU or death in the ED for the high-risk (NEWS ≥7) and medium-risk (NEWS 5–6) categories was 13.8 (8.9–21.6) and 4.2 (2.5–7.1), respectively.ConclusionThe findings from this Japanese tertiary hospital setting showed that prehospital NEWS could be used to identify patients at a risk of adverse outcomes. NEWS stratification was strongly correlated with patient disposition.

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