INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

Background: Pharmacovigilance is a global effort to protect patients and public health by detecting and responding to adverse drug reactions (ADRs). However, underreporting is a major obstacle in reporting ADRs. An effective reporting culture is one way to overcome the challenges in ADR reporting.

Objectives: This study aimed to determine the factors affecting the patient safety culture related to adverse drug reaction reporting among healthcare professionals in a public hospital in Indonesia.

Methods: This observational cross-sectional study was conducted by Dr. R. Soedjono Selong Hospital, East Lombok, Indonesia. Data were collected using the Hospital Survey on Patient Safety Culture 2.0, conducted by the Agency for Healthcare Research and Quality, and a researcher-developed questionnaire.

Results: Among the 238 healthcare professionals who responded, 60.9% had previously reported ADRs. Age, education, working period, knowledge, perception, facilities, policies, and environment were significantly associated with patient safety culture and ADR reporting. The working period and age emerged as the most influential factors in patient safety culture and ADR reporting, respectively.

Conclusion: Age, education, working period, knowledge, perception, facilities, policy, and environment significantly affected the patient safety culture and ADR reporting.

Background: Patients with atrial fibrillation often require anticoagulation therapy to prevent stroke and thromboembolism. However, anticoagulants can have serious side effects, such as bleeding, particularly when combined with antiplatelet therapy.

Objective: The aim of this study is to estimate the prevalence of major bleeding in patients receiving either dual or triple antithrombotic therapy.

Method: This study is a single-center retrospective chart review utilizing the hospital electronic health record. The prevalence and percentage of bleeding events were reported for each antithrombotic regimen.

Results: Of the 539 patients receiving oral anticoagulants, 202 were using oral anticoagulants in combination with either single or dual antiplatelet therapy. Out of 35 patients using triple antithrombotic therapy, four (11.4%) experienced major bleeding. Based on the analysis of 73 patients using anticoagulants in combined with clopidogrel, the results showed that one patient (1.3%) suffered bleeding. Among the 94 patients treated with anticoagulants plus aspirin, seven (7.4%) experienced major bleeding events.

Conclusion: The combination of anticoagulants and antiplatelet agents is associated with an elevated bleeding risk. Patients receiving triple antithrombotic therapy experience high prevalence of bleeding. Nonetheless, the group receiving anticoagulant and clopidogrel alone exhibited low prevalence of bleeding risk.

Background: Anagen effluvium is described as abrupt hair loss during the anagen phase due to reduced follicular mitotic activity. Chemotherapeutic medicines, toxic metals, and sporadically bismuth, levodopa, colchicine, and cyclosporine are often implicated in etiology. Plica polonica is a rare disorder that develops when the scalp hair mats completely and abruptly, resulting in an extended stiff mass of hair that resembles dreadlocks.

Objective: We are describing this case because it is unusual to see plica polonica linked with azathioprine-induced pancytopenia in the literature and since the source of the condition was cuticular damage to the hair shaft as a result of the medication rather than carelessness or excessive bathing of the patient's hair.

Case description: A 32-year-old lady presented to dermatology OPD, with vitiligo over bilateral forearm and lips for 6 months. She was started on azathioprine 50 mg daily for the past 1 month, and then she complained of sudden onset of extensive hair loss on attempting to comb her hair associated with matting of rest of uncombable hairs, multiple oral ulcers, and mild grade fever for 15 days. The possibility of systemic lupus erythematosus and azathioprine-induced anagen effluvium and neutropenic ulcers was thought.

Results: We started on injectable granulocyte colony-stimulating factor for 3 days, and antibiotics and antifungals for 1 week. Improvement in clinical (oral ulcers, fever) and hematological profiles were noted.

Conclusion: Although azathioprine is not often associated with the development of anagen effluvium, it is probable that the patient's abrupt pancytopenia caused damage to the hair shaft, which resulted in hair loss, and cuticular damage to the hair shaft, which led to the formation of Plica.

Background: Over the years, it has been observed that adverse drug reaction (ADR) is a major cause of mortality and morbidity and a major cause of concern for all healthcare professionals. ADR is a leading cause for hospitalisation and increases the financial burden of the patient. Thus, it is imperative that we need steps and strategies to decrease the burden of ADRs and effectively reduce the cost of therapy to treat ADR.

Objective: This study evaluated the pattern, severity, and preventability of ADRs in a tertiary care hospital.

Methods: A retrospective observational study of all the ADR reports due to medications submitted to the ADR monitoring centre in a Northern Indian tertiary care hospital from October 2017 to December 2019. Causality assessment of the ADRs was done using the WHO-UMC causality assessment scale, and the severity was assessed using the modified Hartwig scale. Furthermore, the preventability of the ADR was assessed using the Schumock and Thornton scale.

Results: A total of 252 ADRs were reported. A maximum number of the ADRs (33%) were due to antimicrobials followed by analgesics (16%) and antihypertensives (10%). Amongst the analgesics, a majority of ADRs were associated with Diclofenac (16 ADRs). Amlodipine was associated with maximum ADRs (10) amongst the antihypertensives. The ADRs of gastrointestinal systems (34.5%) were most common among all system organ class (SOCs) followed by skin and subcutaneous tissue disorders (32%). Majority of ADRs were probable and mild in severity. According to the Schumock and Thornton preventability scale 69% were not preventable while 12% were definitely preventable.

Conclusions: Antimicrobials were associated with majority of ADRs with gastrointestinal system being the most commonest organ involved. It was also observed that most of the ADRs were not preventable but some were definitely preventable. The awareness regarding preventability of ADRs needs to be emphasised and further studies to elaborate on the preventability of ADRs needs to be carried out.

Background: Ensuring the quality of pharmaceutical products is essential for effective healthcare delivery. Good storage practices (GSPs) play a crucial role in maintaining drug integrity and safety.

Objectives: This study aimed to evaluate the adherence of Syrian drug import warehouses to GSP and identify key factors influencing compliance.

Methods: A mixed-methods research design was employed, involving questionnaires and observations of drug import warehouses in Syria. Data were collected from June to August 2022. The first questionnaire assessed the reality of applying GSP, while the second explored perceived benefits and obstacles. The majority of respondents (>80%) had at least 6 years of working experience in the drug warehouse field.

Results: Twenty-three public and private warehouses participated out of the 26 warehouses that were the subject of our study (88%). The study found that in Syria, a significant difference has been detected between existing requirements in drug import warehouses and the needed requirements for the successful implementation of GSP (p = 0.000). Key constraints to GSP implementation included a lack of a quality-oriented culture among warehouse owners (100%) and inadequate equipment (87%). Regarding the benefits of GSP application, respondents identified ensuring the quality of sensitive products (100%) and reducing waste and damage (96%) as the most important.

Conclusions: To enhance GSP adherence, warehouses should prioritize staff training, adopt electronic data loggers, secure fuel for generators, obtain GSP certificates, and raise public awareness. Government agencies and international organizations should support these efforts and provide financial incentives.

Background: Medical errors are one of the most important factors affecting patient safety and the quality of health care services, and are affected by many factors.

Objective: We aimed to investigate the relationship between hospital and medical error types, seasonality, and work shifts with the severity of medical errors (no harm, near miss, and harmful incident) in Iran's hospitals.

Methods: We conducted a cross-sectional study in 39 hospitals in a province of Iran. Data were collected using voluntary reporting forms and analyzed using multiple logistic regressions.

Results: Of 10,384 medical errors, 68.4% were no harm. Medical error type and hospital type had a significant relationship with the severity of medical errors. In terms of seasonality, all types of medical errors were more frequently reported during fall and winter as follows: no harm medical errors (28.4% and 28.3%), near miss (28.9% and 28.2%), and harmful incidents (31.0% and 26.5%). The incidence of errors in public non-educational (OR = 0.22, 95% CI: 0.17-0.30, p<0.001) and public educational hospitals (OR = 0.27, 95% CI: 0.21-0.36, p<0.001) has been significantly less as compared to other types of hospitals.

Conclusion: Policymakers should pay attention to hospital types and common medical error types when developing evidence-based interventions and policies to decrease the medical error severity in Iranian and similar countries' context hospitals.

Background: Cardiac damage is a significant risk of chemotherapy. Elevated circulating cardiac troponin I was suggested as a marker for early detection of cardiac damage.

Objective: We aim to assess the predictive value of cardiac troponin I for chemotherapy-induced cardiotoxicity in cancer patients.

Methods: We searched PubMed, Web of Science, Embase, and CNKI. Nine prospective studies involving 2033 cancer patients (pts) were included in the meta-analysis. Troponin I (TnI) levels in patients who underwent chemotherapy were categorized into cardiac troponin I (cTnI) positive and negative groups based on the cutoff concentrations described in the included studies. The cumulative effects of chemotherapy-induced cardiotoxicity between the cTnI-positive and cTnI-negative patients were represented as a summarized risk difference (RD) value with a 95% confidence interval. Subgroup analysis and sensitivity analysis were employed to address heterogeneities. Stata software (version 12.0) was utilized for the analysis.

Results: cTnI-positive pts represented significant cardiotoxicity compared to cTnI-negative pts, as a decline in left ventricular ejection fraction (LVEF): RD = 0.279 [95% CI (0.248-0.311), p = 0.000, I² = 81.3%, 8 trials], heart failure (HF): RD = 0.117, [95% CI (0.090-0.144), p = 0.000, I² = 77.8%, 6 trials], arrhythmias: RD = 0.057 [95% CI (0.028-0.086), p = 0.000, I² = 0.0%, 3 trials], and cumulative events: RD = 0.318 [95% CI (0.272-0.364), p = 0.000, I² = 73.5%, 3 trials]. No statistically significant difference in cardiac death, acute pulmonary edema, and acute coronary syndromes between cTnI-positive pts and cTnI-negative pts was identified.

Conclusions: An increase in circulating troponin I serve as a potential biomarker that reflecting the high risk of early cardiotoxicity in cancer patients who have undergone chemotherapy. The presence of intrinsic unadjusted confounding factors in the reports suggests the need for further study to address this question.

Background: Burnout and medical errors are the most prevalent issues affecting health and life outcomes among healthcare professionals.

Objective: This study aimed to investigate the longitudinal association between burnout and medical errors in healthcare workers in Japan.

Methods: We conducted a prospective cohort study involving 539 healthcare workers from January 2017 to January 2018. Burnout was evaluated using the Maslach Burnout Inventory-General Survey (MBI-GS), which included exhaustion, cynicism, and professional efficacy dimensions. Medical errors during the previous year were measured by self-assessment at follow-up. Multivariate modified Poisson regressions estimated the association between baseline burnout and follow-up medical errors.

Results: In the age and sex-adjusted model, overall burnout was significantly associated with medical errors (p = 0.008). Participants with high burnout levels exhibited a greater risk of medical errors than those with low or moderate levels (RR = 1.19, 95% CI: 1.05-1.35). Exhaustion and cynicism correlated significantly with medical errors (p < 0.05). High or moderate levels of exhaustion and cynicism were associated with elevated risks of medical errors (RR = 1.31 [95% CI: 1.10-1.55]; 1.25 [1.02-1.53]), (RR = 1.31 [95% CI: 1.13-1.53]; 1.20 [1.03-1.41]), compared to low-level counterparts, respectively.

Conclusion: Healthcare workers who experience burnout may be at an increased risk for medical errors.

Background: The safety of medicines is a critical public health concern that requires continuous monitoring and evaluation throughout a drug's lifecycle, including post-authorization. Over the past decade, Portugal has undergone significant changes in its pharmaceutical sector, driven by regulatory actions from the National Authority of Medicines and Health Products (INFARMED, I.P.), which ensures the safety, effectiveness, and quality of medicines.

Objective: This study aimed to analyze the regulatory actions taken due to safety concerns in Portugal from 2013 to 2023.

Methods: A retrospective analysis was conducted using safety alerts published by INFARMED, I.P. between January 2013 and December 2023. The analysis focused on changes in marketing status, drugs involved, causes of regulatory actions, and yearly patterns.

Results: During the study period, 602 safety and quality alerts were issued, being 41 from safety and 561 from quality. The highest number of regulatory actions occurred in 2018, with 172 cases (28.57%). Generic drugs accounted for the majority, with 432 cases (72.19%). Batch recalls (76.65%) corresponded to the main regulatory action related to quality. Quality alerts were often related to impurities or stability (65.42%), non-conformity with GMP standards (11.76%), and labeling or packaging problems (10.70%). Unfavorable risk-benefit ratios were the cause of 100% of safety-related alerts.

Conclusions: The findings highlight the importance of robust surveillance systems and continuous evaluation of manufacturing and regulatory processes to enhance drug safety. Collaboration between regulators, the pharmaceutical industry, and healthcare professionals is essential to ensure that the benefits of medicines consistently outweigh the risks associated with their use.

Background: National guidance attempts to prevent tubes remaining undetected and being used when misplaced in the respiratory tract. The 'elephant in the room' is that this guidance detects misplacement too late to prevent most pneumothoraces and pneumonias.

Objective: Review risks of undetected and detected respiratory or oesophageal tube misplacements and how 'in-procedure' methods of determining tube position might reduce them.

Methods: Tube misplacement risk was compared for different methods of checking tube position. Data were obtained from UK NHS England (NHSE), a literature search between 1986 and 12/07/2024 using CINAHL, Embase, Medline and Emcare and from a local database.

Results: Post-procedure pH or X-ray checks on tube position have failed to prevent a rising incidence of undetected respiratory misplacements (NEVER events) (0.013%). Worse, current checks cannot prevent the 0.52% of placements that lead to in-procedure pneumothorax, constituting 97% of lung complications. In addition, pH may fail to prevent aspiration risk from oesophageal misplacement. Conversely, pneumothorax-risk would be reduced to 0.021% by using a supplementary mid-procedure CO₂ check or to 0.005% with expert guided tube placement (both p < 0.0001). Guided tube placement can additionally pre-empt oesophageal-related complications, but its safety is expert-dependent, with higher rates of undetected misplacement and pneumothorax in low-use Cortrak centres (0.10%) than expert centres (0%, p < 0.009).

Conclusion: The high health burden from feeding tube-related complications could be almost eliminated if regulatory authorities recommended a mid-procedure CO₂ check for respiratory placement or expert guided tube placement, alongside mandates for the necessary training.