Safety incident reporting and barriers (SIRaB) study: Strategies and approaches for investigating patient safety events in a hospital set-up.

BACKGROUND: Unsafe patient events not only entail a clinical impact but also lead to economic burden in terms of prolonged hospitalization or unintended harm and delay in care delivery. Monitoring and time-bound investigation of patient safety events (PSEs) is of paramount importance in a healthcare set-up. OBJECTIVES: To explore the safety incident reporting behaviour and the barriers in a hospital set-up. METHODS: The study had two sections: (a) Retrospective assessment of all safety incidents in the past 1 year, and (b) Understanding the barriers of safety reporting by interviewing the major stakeholders in patient safety reporting framework. Further root cause analysis and failure mode effect analysis were performed for the situation observed. Results were statistically analyzed. RESULTS: Of the total of 106 PSEs reported voluntarily to the system, the highest reporting functional group was that of nurses (40.57%), followed by physicians (18.87%) and pharmacists (17.92%). Among the various factors identified as barriers in safety incident reporting, fear of litigation was the most observed component. The most commonly observed event was those pertaining to medication management, followed by diagnostic delay. Glitches in healthcare delivery accounted for 8.73% of the total reported PSEs, followed by 5.72% of events occurring due to inter-stakeholder communication errors. 4.22% of the PSEs were attributed to organizational managerial dysfunctionalities. Majority of medication-related PSE has moderate risk prioritization gradation. CONCLUSION: Effective training and sensitization regarding the need to report the patient unsafe incidents or near misses to the healthcare system can help avert many untoward experiences. The notion of 'No Blame No Shame' should be well inculcated within the minds of each hospital unit such that even if an error occurs, its prompt reporting does not get harmed.

Need for implementation of safe medication practice to avoid medication errors - A journey through case series.

Patient safety is seriously threatened by medication errors. Pharmacological therapy aims to accomplish particular therapeutic objectives that improve patient quality of life while reducing patient risk. To develop a clear plan for minimizing medication errors and establishing safe and effective medication practices, the study's major goal is to identify the key locations at which medication errors usually occur. The five scenarios presented here demonstrate the frequent errors that took place, including communication problems, technical errors, rule-based errors, and knowledge-based errors. Patients' quality of life must be improved by educating both patients and healthcare workers on safe medication practices. This involves monitoring for and recognizing errors, reporting them in a blame-free environment, analyzing their root causes, changing procedures on the lessons learned, and ongoing monitoring.

Leukocytoclastic vasculitis secondary to clozapine.

Leukocytoclastic vasculitis (LCV) may be secondary to drugs, underlying infection, collagen vascular disorders, or malignancy. Drug-induced vasculitis contributes to 10% of vasculitic skin lesions cases usually developing within 7-21 days of treatment initiation. The present case highlights a report of LCV in a 59-year-old male with a history of paranoid schizophrenia on clozapine therapy. The report upsurges the need to promote awareness and expedite diagnosis and treatment of drug-induced LCVs.

Etoricoxib-induced toxic epidermal necrolysis: A fatal case report.

Cyclooxygenase inhibitors were developed in the quest of enhanced analgesic efficacy devoid of gastric side effects. High usage of etoricoxib by prescription as well as self-administered routes has led to increasing reports of side effects and adverse reactions including dermatologic reactions in 0.1%-0.3% of cases. The present report enumerates a case of toxic epidermal necrolysis induced by etoricoxib.

Assessment of Drug Usage Pattern in Patients Treated for Vernal Keratoconjunctivitis Attending a Tertiary Eye Care Centre in Eastern India: A Cross-Sectional Study.

INTRODUCTION: Vernal keratoconunctivitis is a recurrent, seasonal, allergic condition affecting children and adolescents in warmer regions worldwide. OBJECTIVE: To assess the drug usage pattern for the management of vernal keratoconjunctivitis (VKC). MATERIALS & METHODS: This was a 12 weeks long hospital based cross sectional study conducted in the outpatient unit of the department of ophthalmology of a teaching hospital. It included all consecutive patients diagnosed with VKC who satisfied the inclusion criteria. Patients underwent clinical examination and the severity of their disease was graded. Their prescriptions were scanned for duration of therapy, total number of medications, route of administration, the frequency of dosage and change in medications if any, generic names of drugs being prescribed or not and all demographic parameters were recorded in a suitable record form. A p value of <0.05 was considered to be statistically significant. RESULTS: 248 patients were enrolled in this study of whom the majority were male (172). The average age of the patients was 8.27 years (SD ± 3.02 years). The mean duration of disease was 15 months (SD ± 9.13 years). The greatest number of children belonged to severity grade 1 (27.82%). The total number of drugs prescribed in this study was 583 with an average of 2.26 drugs per encounter. The commonest prescribed drugs were topical anti-allergics (26.75%) followed closely by lubricants (25.73%) and topical steroids (21.42%). CONCLUSION: Anti allergics and lubricants are the mainstays in the management of VKC. The current study is reflective of this. Clearer guidelines need to be formulated for the better and rational management of VKC.

Adverse drug reaction monitoring in patients on antiretroviral therapy in a tertiary care hospital in Eastern India.

BACKGROUND: Besides unparalleled benefits, highly active antiretroviral therapy is also associated with wide range of potential adverse drug reactions (ADRs), which hinders treatment adherence. The present study was thus designed to monitor and explore the pattern of occurrence of ADRs to various antiretroviral therapy (ART) regimens in a tertiary care ART setup. MATERIALS AND METHODS: A prospective, observational clinical study was carried out in the outpatient setting of nodal ART center of Eastern India. A total of 610 patients on various ART regimens were studied for suspected ADRs over 12 months. Adverse event history, medication history, and other relevant details were captured. Causality and severity of each reported ADR were duly assessed. RESULTS: 32.45% patients of total study participants presented with a total of 330 ADRs. Patients from zidovudine-based regimens presented with majority of ADRs such as anemia (up to 36%), central nervous system (CNS), and gastrointestinal (GI) side effects. Tenofovir-based regimens were, however, found to be mildly safer. The combination with Efavirenz was associated with majorly CNS side effects while that of nevirapine was associated with rash and pigmentation of nails. Atazanavir boosted second-line regimens were notably associated with increased serum lipid levels followed by other GI and CNS adverse effects. Increased liver enzymes were found in atazanavir-based second-line ART. CONCLUSION: The study enables to obtain information on the incidence and pattern of ADRs associated with various antiretroviral regimens, thereby reducing its occurrence and protecting the patient population from avoidable harm. Need of intensive monitoring for ADRs in ARTs thus seems to be a mandate.

Fatal Nevirapine-Induced Toxic Epidermal Necrolysis in a HIV Infected Patient.

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are the most Severe Cutaneous Adverse Reactions (SCARs) which mainly caused by exposure to drugs and having significant morbidity and mortality. TEN represents an immunologic reaction to a foreign antigen and is most often caused by drugs. Nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is an important component of Highly Active Antiretroviral Therapy (HAART). It is sometimes associated with life-threatening adverse reactions. Here, we report the fatal case of 72-year-old male who developed TEN secondary to intake of nevirapine. This fatal case report will increase awareness among treating physicians for careful monitoring of patients on NNRTI-based antiretroviral therapy and better counseling of the patient on NVP regimen for early identification and reporting of SCARs so that fatalities due to adverse drug reactions can be prevented with timely intervention.