Frequency, Characteristics, and Preventability of Adverse Drug Reactions in Perioperative Neurosurgery: Analysis Over 11 Years.

OBJECTIVE: Despite the importance of adverse drug reactions (ADRs), little is known about their role in perioperative neurosurgery. This study aimed to determine the prevalence of ADRs in perioperative neurosurgery and clarify the characteristics, severity, preventability, and risk factors of ADRs. METHODS: Data for all patients who underwent neurosurgical procedures over an 11-year period were analyzed. During the study period, 3648 surgical procedures were performed for 2695 patients. Demographic and clinical information documented included medical history, allergic history, diagnosis, surgical method, suspected drugs, concomitant medications, and drug details. Multivariate logistic regression analyses were performed to identify independent parameters that were correlated with ADRs. RESULTS: In total, 467 ADRs (18.3% ADRs/all neurosurgical procedures) were experienced by 401 patients. Anticonvulsants were associated with the highest number of ADRs (16.0%), followed by antibiotics (14.7%). Patients with ADRs were older than patients without ADRs (P<0.01). The total number of drugs in patients with ADRs was 8.8±3.6, compared to 5.2±2.4 for patients without ADRs (P<0.01). There were no significant differences in sex, allergic history, severe renal dysfunction (eGFR<30 ml/min/1.73 m2), hypertension, diabetes, urgency of surgery, and type of surgery. Multivariate analysis showed that a high total number of drugs (odds=3.2; 95%CI 1.9-5.1) and older age (odds=2.1; 95%CI 1.3-3.8) were independent risk factors for ADRs. CONCLUSIONS: The frequency of suspected and severe ADRs was higher than expected. Polypharmacy and older age were independent risk factors for ADRs in perioperative neurosurgery. To decrease ADRs during perioperative neurosurgery, polypharmacy must be discouraged, especially among older adult patients.

Characteristics and preventability of medication-related admissions for acute kidney injury and dehydration in elderly patients.

PURPOSE: Patients with impaired renal function using medication that affects glomerular filtration rate are at increased risk of developing acute kidney injury (AKI) leading to hospital admissions. The risk increases during periods of dehydration due to diarrhoea, vomiting or fever (so-called "sick days"), or high environmental temperatures (heat wave). This study aims to gain insight into the characteristics and preventability of medication-related admissions for AKI and dehydration in elderly patients. METHODS: Retrospective case series study in patients aged ≥ 65 years with admission for acute kidney injury, dehydration or electrolyte imbalance related to dehydration that was defined as medication-related. General practitioner's (GP) patient records including medication history and hospital discharge letters were available. For each admission, patient and admission characteristics were collected to review the patient journey. A case-by-case assessment of preventability of hospital admissions was performed. RESULTS: In total, 75 admissions were included. Most prevalent comorbidities were hypertension, diabetes, and known impaired renal function. Diuretics and RAS-inhibitors were the most prevalent medication combination. Eighty percent of patients experienced non-acute onset of symptoms and 60% had contacted their GP within 2 weeks prior to admission. Around 40% (n = 29) of admissions were considered potentially preventable if pharmacotherapy had been timely and adequately adjusted. CONCLUSION: A substantial proportion of patients admitted with AKI or dehydration experience non-acute onset of symptoms and had contacted their GP within 2 weeks prior to admission. Timely adjusting of medication in these patients could have potentially prevented a considerable number of admissions.

Causality, Severity, Preventability and Predictability Assessments Scales for Adverse Drug Reactions: A Review.

The pharmacovigilance program of India (PvPI), after its inception, has been reliably acquiring force in bringing issues to light among the masses, healthcare professionals, the pharma industry, and clinical staff at hospitals. Adverse drug reactions are unintended events that occur after exposure to a drug, biological product, or medical device, and they may result in morbidity and mortality. It is critical to monitor the safety of drugs during the post-marketing phase to find long-term and rare ADRs, as well as ADRs in special populations and patients with co-morbidities that are not usually included during clinical trials. The definitive objective of pharmacovigilance is to collate data and analyze it. Assessing the causality between ADRs and drugs is necessary to decrease the occurrence of ADRs and to reduce the risk of drug-related ADRs. ADRs may lead to increased morbidity, increased hospital stays, and increased cost of treatment, resulting in compromised patient safety. Causality assessment is the evaluation of the likelihood that a particular treatment is the cause of an observed adverse event and establishing a causal association between a drug and a drug reaction is necessary to prevent further recurrences. Numerous methods available for establishing a causal association between the drug and adverse events have been broadly classified into clinical judgment or global introspection, algorithms, and probabilistic methods. These include the Swedish method, World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, Naranjo's algorithm, Kramer algorithm, Jones algorithm, Karch algorithm, Bégaud algorithm, Adverse Drug Reactions Advisory Committee guidelines, Bayesian Adverse Reaction Diagnostic Instrument, and so on. Despite various methods available, none of the causality assessment tools have been universally accepted as the gold standard. Naranjo's algorithm and WHO-UMC scales are, however, the most commonly used. Similarly, for preventability and severity assessment of ADRs, the Schumock and Thornton scale and Hartwig and Siegel's scale are most commonly used. Hence, we reviewed different tools and methods available to assess the causality, preventability, and severity of ADRs.

[Maternal mortality, adequation of care and preventability, France 2016-2018]. / Mortalité maternelle, adéquation des soins et évitabilité, France 2016­2018.

OBJECTIVE: To describe, for the 2016-2018 period, the adequacy of care provided to women who died of maternal death in France, as well as the possible preventability of these deaths. METHOD: National data from the Enquête Nationale Confidentielle sur les Morts Maternelles for 2016-2018. For each maternal death identified, the National Expert Committee on Maternal Mortality (CNEMM) assesses the adequacy of the care provided and whether the death was probably, possibly or not preventable. RESULTS: For 2016-2018, 272 maternal deaths (considered up to 1 year after the end of pregnancy) occurred in France. Of these, 265 had sufficient information collected by the confidential survey and could be assessed by the CNEMM. In total, care was judged to be "sub-optimal" for 66% of deaths assessed for all causes, a proportion similar to that for previous periods. In addition to the obstetric and anaesthetic care provided at the time of the acute complication, which was judged to be sub-optimal for 45% (obstetric care) and 38% (anaesthetic care) of maternal deaths, this report highlights the scope for improvement in other types of care, more related to prevention and screening: "sub-optimal" preconception care for 51% of the women who died for whom it was justified, particularly notable for deaths linked to a preexisting condition (52%) and for suicides (67%); prenatal surveillance judged to be "sub-optimal" in 30% of cases, a sub-optimality also more frequent among deaths linked to a preexisting condition (35%) and suicides (34%). In all, 59.7% of maternal deaths assessed were judged to be "probably" (17%) or "possibly" (42.7%) preventable, a profile that remained stable. Suicide and other psychiatric causes, the leading cause of maternal death, were considered to be potentially preventable in 79% of cases. Deaths from haemorrhage remained largely preventable (95%, the highest proportion by cause). The factor most often implicated was inadequate care, and preventability linked to this factor was identified in 53% of deaths, all causes combined. Gap in organization of care was a preventability factor identified in 24% of deaths, and poor interaction between the woman and the healthcare system in 22% of deaths. CONCLUSION: This proportion of more than half of potentially preventable maternal deaths shows that a reduction in maternal mortality in France is still possible and must be achieved, the objective being to prevent all preventable deaths. Analysis of the factors involved, overall and by cause of death, suggests areas for improvement.

Preventable deaths in hospitalized trauma patients.

AIM: To study the preventable trauma deaths of hospitalized patients in the United Arab Emirates and to identify opportunities for improvement. METHODS: We analyzed the Abu Dhabi Emirate Trauma Registry data of admitted patients who died in the emergency department or in hospital from 2014 to 2019. A panel of experts categorize the deaths into not preventable (NP), potentially preventable (PP), and definitely preventable (DP). RESULTS: A total of 405 deaths were included, and 82.7% were males. The majority (89.1%) were NP, occurring mainly in the emergency department (40.4%) and the intensive care unit (49.9%). The combined potentially preventable and preventable death rate was 10.9%. The median (Interquartile range) age of the DP was 57.5 (37-76) years, compared with 32 (24-42) and 34 (25-55) years for NP and PP, respectively (p = 0.008). Most of the PP deaths occurred in the intensive care unit (55.6%), while the DP occurred mainly in the ward (50%). Falls accounted for 25% of PP and DP. Deficiencies in airway care, hemorrhage control, and fluid management were identified in 25%, 43.2% and 29.5% of the DP/PP deaths, respectively. Seventy-two percent of the Airway deficiencies occurred in the prehospital, while 34.1% of hemorrhage control deficiencies were in the emergency department. Fluid management deficiencies occurred in the emergency department and the operation theater. CONCLUSIONS: DP and PP deaths comprised 10.9% of the deaths. Most of the DP occurred in the emergency department and ward. Prehospital Airway and in-hospital hemorrhage and excessive fluid were the main areas for opportunities for improvement.

Lessons learned from a cluster of immunization errors in newborns.

Background: Vaccines are safe and effective, but adverse reactions can occur. Immunization errors (IEs) are one of the types of adverse events following immunization. The Moroccan Pharmacovigilance Centre (MPC) received a cluster of IEs from a maternity university hospital (MUH) regarding six newborns who were inadvertently administered rocuronium instead of hepatitis B (HepB) vaccine. The newborns experienced respiratory distress and one had a fatal outcome. Objectives: The study aimed to describe the investigation findings, the underlying causes, and contributing factors of the IEs cluster, and proposed risk minimization actions. Design: We carried out a descriptive analysis of the cluster of IEs related to the HepB vaccine reported to the MPC. Methods: An investigation was conducted by the Ministry of Health according to the World Health Organization guidance. The root cause analysis was performed to identify underlying causes and contributing factors that lead to IE occurrence. Results: The cluster analysis showed that the main contributing factors were the look-alike rocuronium and HepB vaccine packaging, the first-time running HepB vaccination for newborns in the MUH, the lack of a full-time pharmacist, and the unsafe storage of rocuronium and vaccines. The administration of Sugammadex to the newborns followed by their transfer to the neonatal care unit resulted in the recovery of five of the six newborns. Proposed recommendations included (1) raising awareness of healthcare professionals to the risk related to look-alike medications, (2) training nurses to ensure vaccination to implement procedures related to immunization practices, (3) nomination of a full-time pharmacist, (4) reassessment of the safety of drug storage and dispensing at the hospital pharmacy, particularly for high-alert medications. Conclusion: Reporting IEs, particularly serious ones, allows us to identify causes and contributing factors that led to their occurrence. Lessons learned from errors are key to take risk minimization actions to improve vaccine safety worldwide.

Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System.

BACKGROUND: Antibiotics are commonly used in both outpatient and inpatient settings and are responsible for the majority of adverse drug reaction (ADR) reports. We aimed to characterize spontaneously reported ADRs associated with antibiotics and assessing the preventability of these ADRs in a Vietnamese setting. MATERIALS AND METHODS: We conducted a retrospective descriptive study based on ADRs related to antibiotics spontaneously reported by healthcare workers to the National Pharmacovigilance Database of Vietnam (NPDV) between June 2018 and May 2019. The characteristics of included reports were descriptively analyzed. The preventability of reported ADRs was assessed using a standardized preventability scale. We identified the leading causes and described the characteristics associated with preventable ADRs (pADRs). RESULTS: We included 6385 antibiotic-related reports from a total of 12,056 reports submitted to the NPDV during the study period. Beta-lactam antibiotics, mostly broad-spectrum with parenteral route, were suspected in the majority cases. The most commonly reported pADRs were allergic reactions, mostly classified under skin and subcutaneous tissue disorders. Of all included cases, 537 cases (8.4%) were deemed as associated with pADRs. Major causes of pADRs include potentially inappropriate prescribing (352/537, 65.5%) and re-administration of antibiotics causing prior allergy/allergies (99/537, 18.4%). The majority of pADRs involved the use of beta-lactam antibiotics with inappropriate indications. CONCLUSION: ADRs related to antibiotic use represent more than half of ADRs spontaneously reported in Vietnam. Approximately one in every ten reported cases is associated with pADRs. The majority pADRs can be prevented through simple improvement in antibiotic prescribing practices.

Influence of analytic methods, data sources, and repeated measurements on the population attributable fraction of lifestyle risk factors.

Population attributable risk (PAR%) reflects the preventable fraction of disease. However, PAR% estimates of cancer have shown large variation across populations, methods, data sources, and timing of measurements. Three statistical methods to estimate PAR% were identified from a systematic literature review: the Levin's formula, the comparative incidence rate method, and the comparative risk assessment method. We compared the variations in PAR% of postmenopausal breast cancer in the Nurses' Health Study to evaluate the influence by method choice, source of prevalence data, use of single vs repeated exposure measurements, and potential joint effects of obesity, alcohol, physical activity, fruit and vegetable intake. Across models of the three methods, the estimated PAR% using repeated measurements were higher than that using baseline measurement; overall PAR% for the baseline, simple update, and cumulative average models were 13.8%, 21.1%, 18.6% by Levin's formula; 13.7%, 28.0%, 31.2% by comparative risk assessment; and 17.4%, 25.2%, 29.3% by comparative incidence rate method. The estimated PAR% of the combination of multiple risk factors was higher than the product of the individual PAR%: 18.9% when assuming independence and 31.2% when considering the risk factors jointly. The three methods provided similar PAR% based on the same data source, timing of measurements, and target populations. However, sizable increases in the PAR% were observed for repeated measures over a single measure and for calculations based on achieving all recommendations jointly rather than individually.

Incidence and preventability of hospital admissions for adverse drug reactions in France: A prospective observational study (IATROSTAT).

AIMS: In the last French study in 2007, the incidence of hospital admissions (HAs) related to adverse drug reactions (ADRs) was 3.6%. The objective was to assess the current ADR-HA incidence in France and to describe both its characteristics and preventability. METHODS: A prospective multicentre study was conducted among randomly selected French public hospital medical wards (April-July 2018). Patients admitted during a week period were included. ADR-HA cases were collected by the French Regional Pharmacovigilance Centres network. An independent committee validated potential cases and ADR preventability. RESULTS: ADR-HA incidence was 8.5% (95% confidence interval [CI]: 7.6-9.4%), increasing with age (3.3% [95%CI: 1.8-5.5%] ≤16 y vs. 10.6% [95%CI: 9.3-12.0%] ≥65 y). The most common ADRs were haemorrhagic events (8.8%), haematological disorders (6.5%), acute renal failure (6.3%), fluid and electrolyte disorders (6.0%), and falls (5.2%). New drugs were involved: targeted therapies (22.8% of antineoplastics), direct oral anticoagulants (29.6% of antithrombotics) and incretin-based drugs (20.0% of antidiabetics). ADRs were preventable in 16.1% of cases because the drugs involved had not been used in accordance with monographies, package leaflets or other therapeutic guidelines. The main situations of noncompliance addressed either dose or duration of use (27.9%), warning (23.2%), use precaution (18.6%) and inappropriate self-medication or misuse by patients (11.6%). CONCLUSION: In France, ADR-HA incidence dramatically increased over the last decade. A significant proportion was related to new pharmacological classes and considered as preventable. These findings should lead to in-depth thought on preventive actions on at-risk drug classes.

Close to zero preventable in-hospital deaths in pediatric trauma patients - An observational study from a major Scandinavian trauma center.

BACKGROUND: In line with international trends, initial treatment of trauma patients has changed substantially over the last two decades. Although trauma is the leading cause of death and disability in children globally, in-hospital pediatric trauma related mortality is expected to be low in a mature trauma system. To evaluate the performance of a major Scandinavian trauma center we assessed treatment strategies and outcomes in all pediatric trauma patients over a 16-year period. METHODS: A retrospective cohort study of all trauma patients under the age of 18 years admitted to a single institution from 1st of January 2003 to 31st of December 2018. Outcomes for two time periods were compared, 2003-2009 (Period 1; P1) and 2010-2018 (Period 2; P2). Deaths were further analyzed for preventability by the institutional trauma Mortality and Morbidity panel. RESULTS: The study cohort consisted of 3939 patients. A total of 57 patients died resulting in a crude mortality of 1.4%, nearly one quarter of the study cohort (22.6%) was severely injured (Injury Severity Score > 15) and mortality in this group decreased from 9.7% in P1 to 4.1% in P2 (p<0.001). The main cause of death was brain injury in both periods, and 55 of 57 deaths were deemed non-preventable. The rate of emergency surgical procedures performed in the emergency department (ED) decreased during the study period. None of the 11 ED thoracotomies in non-survivors were performed after 2013. CONCLUSION: A dedicated multidisciplinary trauma service with ongoing quality improvement efforts secured a low in-hospital mortality among severely injured children and a decrease in futile care. Deaths were shown to be almost exclusively non-preventable, pointing to the necessity of prioritizing prevention strategies to further decrease pediatric trauma related mortality.

Readmission rates and predictors of avoidable readmissions in older adults in a tertiary care centre.

Context: Thirty-day readmissions are used to gauge health care accountability, which occurs as part of the natural course of the illness or due to avoidable fallacies during the index admission. The utility of this metric is unknown in older adults from developing countries. Aim: To ascertain the unplanned 30-day readmission rate and enumerate predictors of avoidable hospital readmission among early (0-7 days) and late (8-30 days) readmissions. Settings and Design: A retrospective chart audit of 140 older adults who were readmitted to a premier tertiary care teaching hospital under Geriatrics from the neighboring states of Tamil Nadu, Andhra Pradesh, and Kerala were undertaken. Methods and Materials: Data from health records were collected from the hospital electronic database from May 2015 to May 2020. The data was reviewed to determine the 30-day readmission rate and to ascertain the predictors of avoidable readmissions among both early and late readmissions. Results: Out of 2698 older adults admitted to the geriatric wards from the catchment areas, the calculated 30-day hospital readmission rate was 5.18%, and 41.4% of these readmissions were potentially avoidable. The median duration from discharge to the first readmission was ten days (Interquartile range: 5-18 days). Patients had to spend INR 44,000 (approximately 602 USD) towards avoidable readmission. The most common causes for readmission included an exacerbation, reactivation, or progression of a previously existing disease (55.7%), followed by the emergence of a new disease unrelated to index admission (43.2%). Fifty-eight patients (41.4%) were readmitted within seven days following discharge. Early readmissions were seen in patients with malignancies [8 (13.5%) vs. 4 (4.8%); P = 0.017], on insulin (P = 0.04) or on antidepressants (P = 0.01). Advanced age was found to be an independent predictor of avoidable early readmission (OR 2.99 95%CI 1.34-6.62, P = 0.007), and admission to a general ward (as compared to those admitted in a private ward) was an independent predictor of early readmissions (OR 2.99 95%CI 1.34-6.62, P = 0.007). Conclusion: The 30-day readmission rate in a geriatric unit in a tertiary care hospital was 5.2%. Advanced age was considered to be an independent predictor of avoidable early readmission. Future prospective research on avoidable readmissions should be undertaken to delineate factors affecting 30-day avoidable hospital readmissions in developing nations.

Prevalence and factors associated with adverse drug reactions among heart failure patients hospitalized at Mbarara Regional Referral Hospital, Uganda.

BACKGROUND: Adverse drug reaction (ADR) of medications remains an obstacle to achieving optimal disease outcomes. This study aimed to assess the prevalence and associated factors of ADR among Heart failure (HF) patients hospitalized at Mbarara Regional and Referral Hospital. METHOD: A prospective observational study was conducted among hospitalized HF patients from November 2021 to January 2022. Univariate and multivariate logistic regression was employed to determine factors associated with the ADR. RESULT: Overall, 118 HF patients were included in the study with a median age of 43 years. A total of 164 ADRs were identified during the follow-up period of 1011 days. The incidence of new ADRs was 106 ADRs/1000 person-days. The prevalence of ADR was 59.3%. Of the 164 ADRs, 118(71.9%) were probable. The gastrointestinal system was the most frequently (27.5%) affected system. Over half (86, 52.4%) of the ADRs were mild and 96(58.5%) were preventable. Age group 19-59(AOR 0.15[0.03-0.35] at 95%CI, p = 0.013), herbal use (AOR 3.07[1.01-9.32] at 95%CI, p = 0.048), poly-pharmacy (AOR 8.7[2.4-15.77] at 95%CI, p < 0.001) and drug-drug interaction (AOR 6.06[2.79-12.5] at 95%CI, p = 0.004) were significantly associated with ADRs among HF patients. CONCLUSION: More than half of the hospitalized HF patients experienced at least one ADR during their hospital stay. The use of herbal medicines, poly-pharmacy, and drug-drug interaction were associated with a high risk of ARDs whereas the age group 19-59 years was less likely to experience ADRs.

Why mothers die at a busy tertiary urban hospital in Kampala, Uganda: a comprehensive review of maternal deaths 2016-2018 and implications for quality improvement to reduce deaths.

Background: Reviewing maternal deaths and drawing out lessons for clinical practice is part of an effective cohesive intervention strategy to reduce future deaths. Objective: To review maternal deaths at the National Referral hospital in Kampala over a 3-year period (2016-2018) to determine causes of death, extent of preventability, proportion of deaths notified and audited as per national guidelines. Methods: Trained-multidisciplinary panels (obstetricians and senior midwives) conducted retrospective reviews of maternal deaths that occurred. Results: Major causes of deaths: obstetric haemorrhage (158/350; 45%), hypertensive disorders of pregnancy (87/350; 25%) and infection (95/350; 27%). Overall, 294/350 (84%) of maternal deaths were considered preventable. In 95% (332/350) of cases, delays within healthcare facilities were identified (64%; 226/350). We note that only 115/350 (33%) cases had been audited. This proportion did not change during the studied period. In 48% (167/350) of cases, notification to the Ministry of Health occurred, but only 11% of deaths (39/350) were notified within the recommended 24-hours. Conclusions: A high proportion (84%) of deaths were preventable. Significant delays to care occurred within health-care facilities. Results suggest that a well-supported, and timely maternal death review process with targeted and pragmatic interventions might be effective in reducing maternal deaths in this setting.

Maternal mortality in women with pre-viable premature rupture of membranes: An analysis from the French confidential enquiry into maternal deaths.

INTRODUCTION: Pre-viable premature rupture of membranes (pre-viable PROM) is a rare event occurring in less than 1% of pregnancies. Nevertheless, it can be responsible for severe maternal complications, the risk of which needs to be balanced with the possibility to prolong the pregnancy up to viable gestational age. Maternal sepsis was reported in 1%-5% of women who received conservative management and prophylactic antibiotics, but information on maternal mortality is lacking. Our objective was to identify maternal deaths in women who had pre-viable PROM, describe the characteristics of the women, explore preventability factors within the care they received, and estimate the lethality of pre-viable PROM. MATERIAL AND METHODS: We identified all maternal deaths associated with pre-viable PROM from the 2001-2015 French National Confidential Enquiry into Maternal Deaths (NCMM). Data on women's characteristics and the care they received were extracted from the ENCMM database. The lethality was determined after estimating the total number of pregnant women with pre-viable PROM from the national hospital discharge database. RESULTS: Between 2001 and 2015, we identified seven maternal deaths associated with pre-viable PROM, representing 0.6% of all maternal deaths over this period (ie, maternal mortality ratio 0.06/100 000 live births). Six maternal deaths were attributed to sepsis after genital infection by Gram-negative bacilli and one to postpartum hemorrhage due to placenta accreta. Four of these seven cases were considered preventable. The main preventability factors were delayed diagnosis, delayed fetal extraction, and inappropriate antibiotic treatment. The estimated lethality was 4.5/10 000 women with pre-viable PROM. CONCLUSIONS: Maternal death associated with pre-viable PROM is rare but possible. Most of these deaths seem preventable, with areas for improvement related to earlier diagnosis and better treatment of uterine infections, which can evolve rapidly.

Adverse drug reactions and correlations with drug-drug interactions: A retrospective study of reports from 2011 to 2020.

Introduction: Adverse drug reactions (ADRs) represent a public health problem worldwide that deserves attention due to the impact on mortality, morbidity, and healthcare costs. Drug-drug interactions (DDIs) are an important contributor to ADRs. Most of the studies focused only on potential DDIs (pDDIs), while the detailed data are limited regarding the ADRs associated with actual DDIs. Methods: This retrospective study evaluated ADRs reported between 2011 and 2020 in a tertiary hospital. The causality and severity of ADRs were evaluated through the Naranjo Algorithm and Hartwig's scale, respectively. Preventability classification was based on the modified Schoumock and Thornton scale. For ADRs with at least two suspected drugs, pDDIs were identified according to the Lexi-Interact. We further checked whether the ADR description in the reports corresponded to the clinical consequences of the pDDIs. Results: A total of 1,803 ADRs were reported, of which 36.77% ADRs were classified as mild, 43.26% as moderate, and 19.97% as severe. The assessment of causality showed that the distributions of definite, probable, and possible categories were 0.33%, 58.68%, and 40.99%, respectively. A total of 53.97% of ADRs were identified as preventable ADRs, while 46.03% were recognized as unpreventable. The severity of ADRs was significantly correlated with age, the number of suspected drugs and preventability. Antimicrobial agents were the most common implicated pharmacological group, and the most frequently affected system was the gastrointestinal system. Considering individual drugs, aspirin was the most frequently reported drug. Among 573 ADRs with at least two suspected drugs, 105 ADRs were caused by actual DDIs, of which only 59 and 6 ADRs were caused by actual DDIs in category D and X, respectively. The most frequent drugs involved in actual DDIs of category D were aspirin and heparin, with the majority of ADRs being gastrointestinal bleeding. Conclusion: This study analyzed the pattern of ADRs in detail and obtained clinical evidence about ADRs associated with actual DDIs. These findings may be useful to compare patterns between different centers and to design preventive strategies for ADRs. Continuous education and training should be provided for physicians regarding the knowledge and recognition of ADRs associated with DDIs.

Shortcomings of Administrative Data to Derive Preventive Strategies for Inhospital Drug-Induced Acute Kidney Failure-Insights from Patient Record Analysis.

Structured analyses of hospital administrative data may detect potentially preventable adverse drug events (ADE) and therefore are considered promising sources to prevent future harm and estimate cost savings. Whether results of these analyses indeed correspond to ADE that may be preventable in clinical routines needs to be verified. We exemplarily screened all adult inpatients admitted to a German University Hospital (n = 54,032) for International Classification of Diseases-10th revision (ICD-10) diagnoses coding for drug-induced kidney injury (AKI). In a retrospective chart review, we checked the coded adverse events (AE) for inhospital occurrence, causality to drug exposure, and preventability in all identified cases and calculated positive predictive values (ppv). We identified 69 inpatient cases of whom 41 cases (59.4%) experienced the AE in the hospital (ppv-range 0.43-0.80). Causality assessment revealed a rather likely causal relationship between AE and drug exposure in 11 cases (15.9, 11/69, ppv-range 0.17-0.22) whereby preventability measures could be postulated for seven cases (10.1%, 7/69). Focusing on drug-induced AKI, this study exemplarily underlines that ICD-10-code-based ADE prevention efforts are quite limited due to the small identification rate and its high proportion of primarily outpatient events. Furthermore, causality assessment revealed that cases are often too complex to benefit from generic prevention strategies. Thus, ICD-10-code-based calculations might overestimate patient harm and economic losses.

Allopurinol-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: Signal detection and preventability from Vietnam National pharmacovigilance database.

WHAT IS KNOWN AND OBJECTIVE: Allopurinol, the first-line medication for hyperuricemia is well-known for its association with severe cutaneous adverse reactions, especially Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In the current study, we analysed the Vietnamese spontaneous reporting database to identify signals and preventability of allopurinol-induced SJS/TEN in Vietnam from 2010 to 2019. METHODS: Signal generation was assessed using the case/non-case method. Reporting odds ratios (RORs) and 95% confidence intervals (95% CI) were calculated. RESULTS: Among 72,822 spontaneous ADR reports submitted to the Vietnam National Drug Information and Adverse Drug Reaction Monitoring Centre, 392 reports were on SJS/TEN, of which, 65 cases (16.6%) were related to allopurinol. The signals of allopurinol-induced SJS/TEN in Vietnam started in 2014 (ROR of 3.531, 95% CI: 1.830-6.810) and annually increased until 2019 (ROR of 11.923, 95% CI: 8.508-16.710). The preventability assessment showed that no allopurinol-induced SJS/TEN case was definitely unpreventable. 61.6% of the SJS/TEN cases were avoidable because they were associated with inappropriate prescribing such as unapproved indications, too high initial dose and even rechallenging in patients with a history of allopurinol allergy. WHAT IS NEW AND CONCLUSION: The signals of allopurinol-induced SJS/TEN in Vietnam started in 2014 and annually increased until 2019. Our first report specifically focusing on the ADR preventability of allopurinol showed that correction of medical errors relating to prescription could prevent more than 60% of SJS/TEN cases in Vietnamese allopurinol users. This is a feasible and practical solution, provided that there would be a systematic change in both healthcare systems and public awareness.

Drug-Related Hospital Admissions via the Department of Emergency Medicine: A Cross-Sectional Study From the Czech Republic.

Background: Drug-related hospital admissions (DRAs) represent a significant problem affecting all countries worldwide. This study aimed to determine the prevalence and preventability of DRAs, identify the most common medications involved in DRAs, the most common clinical manifestations of DRAs and describe the preventability aspects of DRAs. Methods: This cross-sectional study examined unplanned hospital admissions to the University Hospital Hradec Králové via the department of emergency medicine in August-November 2018. Data were obtained from electronic medical records. The methodology of DRA identification was adapted from the OPERAM DRA adjudication guide. Results: Out of 1252 hospital admissions, 195 DRAs have been identified (145 related to treatment safety, 50 related to treatment effectiveness). The prevalence of DRAs was 15.6% (95% CI 13.6-17.6). The most common medication classes involved in DRAs related to treatment safety were Antithrombotic agents, Antineoplastic agents, Diuretics, Corticosteroids for systemic use, and Beta blocking agents. The most common medication classes involved in DRAs related to treatment effectiveness included Diuretics, Antithrombotic agents, Drugs used in diabetes, Agents acting on the renin-angiotensin system, and Lipid modifying agents. Gastrointestinal disorders were the leading causes of DRAs related to treatment safety, while Cardiac disorders were the leading causes of DRAs related to treatment effectiveness. The potential preventability of DRAs was 51%. The highest share of potential preventability in medication classes repeatedly involved in DRAs related to treatment safety was observed for Anti-inflammatory and antirheumatic products, Psycholeptics, and Drugs used in diabetes. Potentially preventable DRAs related to treatment safety were most commonly associated with inappropriate drug selection, inappropriate monitoring, inappropriate dose selection, and inappropriate lifestyle measures. On the contrary, DRAs related to treatment effectiveness were more commonly associated with medication nonadherence. Conclusion: It should be emphasized that in most DRAs, medications were only a contributory reason of hospital admissions and that benefits and risks have to be carefully balanced. It is highlighted by the finding that the same medication classes (Antithrombotic agents and Diuretics) were among the most common medication classes involved in DRAs related to treatment safety and simultaneously in DRAs related to treatment effectiveness. The study highlighted that apart from problems related to prescribing, problems related to monitoring and patient-related problems represent significant preventability aspects.

Medication-Related Readmissions: Documentation of the Medication Involved and Communication in the Care Continuum.

Background: Of all readmissions, 21% are medication-related readmissions (MRRs). However, it is unknown whether MRRs are recognized at the time of readmission and are communicated in the care continuum. Objectives: To identify the prevalence of MRRs that contain a documentation on the medication involved (and therefore are regarded as recognized), and the proportion of communicated MRRs. Setting: The study was performed in a teaching hospital. Methods: In a previous study, a multidisciplinary team of physicians and pharmacists assessed the medication-relatedness, the medication involved and preventability of unplanned readmissions from seven departments. In the current cross-sectional study, two pharmacy team members evaluated the patient records independently. An MRR was regarded as recognized when the medication involved was documented in patient records. An MRR was regarded as communicated to the patient and/or the next healthcare provider when the medication involved or a description was mentioned in discharge letters or discharge prescriptions. The relationship between documented MRRs and whether the MRR was preventable as well as the relationship between (un)documented MRRs and the length of stay (LOS) were assessed. Descriptive data analysis was used. Results: Of 181 included MRRs, 72 (40%) were deemed preventable by the multidisciplinary team. For 159 of 181 MRRs (88%), a documentation on the medication involved was present. Of 159 documented MRRs, 93 (58%) were communicated to patients and/or caregivers, 137 (86%) to the general practitioner, and 4 (3%) to the community pharmacy. The medication involved was documented less often for potentially preventable MRRs than for non-preventable MRRs (78 vs. 95%; p = 0.002). The LOS was longer for MRRs where the medication involved was undocumented (median 8 vs. 5 days; p = 0.062). Conclusion: The results of this study imply that MRRs are not always recognized, which could impact patients' well-being. In this study an increased LOS was observed with unrecognized MRRs. Communication of MRRs to the patients and/or the next healthcare providers should be improved.

A rose by any other name would smell as sweet: defining patient safety-related terminology.

The definitions of terms related to iatrogenic harm and the potential for iatrogenic harm (e.g. error, medication error, near miss) in the anaesthesia literature are imprecise and variable, resulting in wide discrepancy in conclusions about their rates and potential solutions. Clarification of these terms is both critical and difficult: a concerted effort to achieve expert consensus is warranted.