Adverse Drug Reactions In Hospital Research Articles

Time series analysis of using the PDCA method combined with the Teach-back method to improve spontaneous reports of adverse drug reactions in a grade IIIA hospital in China.

Spontaneous reporting of adverse drug reactions (ADRs) is essential for the post-marketing safety evaluation of drugs. Therefore, good monitoring of ADRs is vital for strengthening drug supervision, management, and guiding rational drug use. Chinese medical institutions are the primary source of ADR case reports, but the proportion of the reports in grade IIIA hospitals is still low due to serious under-reporting. The 3rd Affiliated Hospital of Chengdu Medical College, Chengdu Pidu District People's Hospital, also has such a problem. To improve the quantity and quality of ADR reports and enhance the level of pharmacovigilance in hospitals, the Third Affiliated Hospital of Chengdu Medical College, People's Hospital of Chengdu Pidu District experienced 10years to gradually establish a management model to improve the medical staff's reporting rate of spontaneous reporting of ADRs. The management model is led by clinical pharmacists and combines the PDCA with Teach-back methods. The purpose of this paper is to introduce the management model and discuss its advantages and shortcomings of this model. This study was conducted at the Third Affiliated Hospital of Chengdu Medical College-Chengdu Pidu District People's Hospital. From 2016, the daily management of reporting, auditing, and data improvement of adverse drug reactions in the hospital was carried out by clinical pharmacists, who used the PDCA method combined with the Teach-back method to continuously improve the reporting program of ADRs in the hospital during 2016-2021. Then, the proportion of spontaneous reports of total, new, and serious ADRs was compared before and after the intervention. Also, we performed a time series analysis using an autoregressive moving average model to assess changes in the total number of spontaneous ADR reports before the intervention (2013-2015), the first intervention (2016-2018), and the second intervention (2019-2021). After the combined PDCA and Teach-back method intervention, the median number of reported ADRs per year increased from 50 (range 37-55) in the pre-intervention period to 88 (range 83-162) in the first intervention period and to 374 in the second (range 312-566). Breakpoint regression analysis of the spontaneous reporting rate of ADRs showed that the instantaneous increase after the first intervention was not statistically significant (P = 0.526). However, the reporting rate of ADRs increased at a month-by-month growth rate during the second intervention compared to the first intervention. Its spontaneous reporting rate improved 1.034 times (P = 0.002). After the second intervention, the spontaneous reporting rate of ADRs transiently increased 6.111-fold (P < 0.001), and the month-to-month growth rate increased 1.024-fold (P < 0.001) again. The management model that combines the PDCA and the Teach-back method significantly improves the reporting rate of adverse drug reactions.

Adverse drug reactions in hospitals: population estimates for Portugal and the ICD-9-CM to ICD-10-CM crosswalk

BackgroundAdverse drug reactions (ADR), both preventable and non-preventable, are frequent and pose a significant burden. This study aimed to produce up-to-date estimates for ADR rates in hospitals, in Portugal, from 2010 to 2018. In addition, it explores possible pitfalls when crosswalking between ICD-9-CM and ICD-10-CM code sets for ADR identification.MethodsThe Portuguese Hospital Morbidity Database was used to identify hospital episodes (outpatient or inpatient) with at least one ICD code of ADR. Since the study period spanned from 2010 to 2018, both ICD-9-CM and ICD-10-CM codes based on previously published studies were used to define episodes. This was an exploratory study, and descriptive statistics were used to provide ADR rates and summarise episode features for the full period (2010–2018) as well as for the ICD-9-CM (2010–2016) and ICD -10-CM (2017–2018) eras.ResultsBetween 2010 and 2018, ADR occurred in 162,985 hospital episodes, corresponding to 1.00% of the total number of episodes during the same period. Higher rates were seen in the oldest age groups. In the same period, the mean annual rate of episodes related to ADR was 174.2/100,000 population. The episode rate (per 100,000 population) was generally higher in males, except in young adults (aged '15–20', '25–30' and '30–35' years), although the overall frequency of ADR in hospital episodes was higher in females.ConclusionsDespite the ICD-10-CM transition, administrative health data in Portugal remain a feasible source for producing up-to-date estimates on ADR in hospitals. There is a need for future research to identify target recipients for preventive interventions and improve medication safety practices in Portugal.

A retrospective study of adverse drug reactions reported in a tertiary care hospital

Background: Adverse drug reactions (ADRs) are defined as noxious changes due to a drug, which can occur at doses normally used in humans that require treatment or dose reduction, and also indicate that caution should be exercised with future use of the same drug. Periodic monitoring of ADRs in hospitals can motivate health-care professionals to realize their role and responsibility in the detection, management, and reporting of suspected ADRs and also make them learn how to make sure patients stay safe and healthy. The current study is expected to raise awareness among health-care professionals on the importance of ADR reporting. Aims and Objectives: The objective of the study was to analyze the incidence and pattern of ADRs with assessing the severity and causality of ADRs reported in the hospital. Materials and Methods: All ADR cases which were reported to the pharmacovigilance unit between January 2022 and December 2022 have been evaluated. A total of 220 ADR cases were reported during the study. The demography of patients, causative drugs, reactions, causality assessment, and severity have been analyzed. Causality assessment using the WHO-Uppsala Monitoring Center Scale and severity analysis using the modified Hartwig and Siegel Scale have been done. Results: A total of 220 ADR cases have been evaluated. The main age group affected in our study was 31–45 years with male preponderance. Maximum cases were reported from the dermatology department. The most commonly affected organ was the skin. Antibiotics like cephalosporins caused most of the ADRs. After causality assessment, the maximum cases were probable type (60%), and severity assessment revealed that most of the cases were moderate in severity (64%). Conclusion: ADRs are one of the growing causes of morbidity and mortality worldwide. Underreporting of ADRs may result in a loss of clinical information that could prevent significant harm to patients. The need of the hour is to encourage health-care professionals to report any suspected ADR and also keep accurate records to analyze, process, and draw conclusions from data to ensure patient safety.

How to Use Quality Tools to Prevent Adverse Drug Reactions in Hospitals?

Adverse drug reactions (ADRs) and Drug-Drug interactions (DDIs) remain an important clinical problem in modern healthcare systems, particularly, with the rising complexity of therapeutics, ageing population and multi-morbidity. There is no doubt that the unpleasant impacts resulting from inaccurate or wrong dose which used in prophylaxis or treatment, will cause significant harm to the patient. Therefore, it is important to shed the light on these such cases in order to avoid further harm consequences. ADRs can be happened due to involvement of T-lymphocyte or IgE-mediated allergy. Hypersensitivity reactions have been highlighted in recent years, so, allergy test is a necessary step before taking medications that may cause hypersensitivity react ion. This article summarizes some of the key facts about ADRs and explores aspects related to their prevention, diagnosis, reporting and management in current clinical practice using strategies, procedures and tools for quality improvement to avoid any probable mistakes. The article will also illustrate the key role of healthcare practitioners in documenting and reporting the ADRs correctly.

Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital.

Drug safety in paediatric patients is a serious public health concern around the world. The paediatric patients are more prone to adverse drug reactions (ADRs) than adults. Moreover, there is a scarcity of information about ADRs in paediatric patients. This study was conducted to determine the frequency, causality, severity, preventability of paediatric patients’ ADRs reported in a tertiary care hospital in Adana, Turkey. A retrospective study was conducted on all spontaneously reported ADRs between January 01, 2020, to July 30, 2021, in paediatric patients. The ADRs reports were evaluated in terms of gender, age, ADR characteristics, suspected drugs and reporting source. All included ADRs reports were characterized according to the Naranjo Algorithm/World Health Organization (WHO) causality scales, Hartwig/Siegel and Common Terminology Criteria for Adverse Events (CTCAE) severity scales, the modified Schoumock and Thornton preventability scale and hospital pharmacovigilance center criteria for seriousness. Therapeutic groups were also coded using the WHO-Anatomical Therapeutic and Chemical (ATC) classification. During the study period, 8,912 paediatric patients who were admitted had 16 ADRs with 1.7 ADRs/1,000 admissions. The majority of ADRs were found in infants (31.2%) and children (56.2%) as compared to adolescents (12.5%). ADRs were observed more in females (81.2%) than males. Skin (62.5%) was the most affected organ due to the ADRs, and maculopapular rash and erythema multiforme were the most commonly reported symptoms. Most ADRs were probable/likely (93.7%), severe (50%), preventable or probably preventable (43.7%) and serious (37.5%). Antibiotics (93.7%) were found to be the most common cause of ADRs in paediatric patients. The majority of ADRs were associated with vancomycin (68.7%). Most of the ADRs were reported by a medical doctor in this study. This small sample size study highlights significant problems of ADRs in paediatric patients, mainly caused by antibiotics and with a majority of ADRs manifest as skin reactions. Furthermore, a high proportion of the identified ADRs were found to be preventable. More focused efforts are needed at the national level to avoid preventable ADRs in hospitals. Monitoring and management of ADRs and future studies would be beneficial for better patient care and safety.

An investigation of pharmacovigilance and reporting of adverse drug reactions in hospitals: a cross-sectional study in China

Background Pharmacovigilance is a science that plays a significant role in reducing ADRs and helps predict adverse reactions to drugs in community. To safely use drugs in treatment and prevention of disease, adverse drug reaction has been paid more attention. Objectives To evaluate the future needs of existing systems, the paper investigated the current state of pharmacovigilance and the reporting of ADR in Chinese hospitals. Methods This cross-sectional, questionnaire-based study involved 10,063 pharmacists, doctors, and nurses from primary, secondary, and tertiary hospitals in all 31 provinces of China. It was commissioned by the National Centre for ADR Monitoring of China and conducted in March 2020. Three areas were assessed: sociodemographic characteristics of participants, awareness of the pharmacovigilance system, and the current state of hospitals’ reporting of ADRs. Chi-square tests were used to calculate P values. Results Health care professionals had heard the term “pharmacovigilance” previously (89.40%) and knew the reporting object (68.47%), content (65.94%), and range (64.83%) of pharmacovigilance. Most hospitals dispatched responsible professionals (87.64%) and departments (86.25%) to monitor ADR reporting. A total of 58.66% of tertiary medical, 45.25% of secondary, and 38.90% of primary hospitals extracted ADRs from a hospital information system. Moreover, 53.09% of tertiary medical, 38.93% of secondary, and 23.89% of primary hospitals had established a prescription automatic screening system to warn about risks for ADRs. Health care professionals’ reports (99.92%) and patient feedback (77.99%) were included in most hospitals’ ADR reporting. Conclusions Chinese health care professionals generally have good awareness of pharmacovigilance, and pharmacovigilance is relatively more advanced in China compared to other developing countries.

Medical students as adverse drug event managers, learning about side effects while improving their reporting in clinical practice

Managing adverse drug reactions (ADRs) is a challenge, especially because most healthcare professionals are insufficiently trained for this task. Since context-based clinical pharmacovigilance training has proven effective, we assessed the feasibility and effect of a creating a team of Junior-Adverse Drug Event Managers (J-ADEMs). The J-ADEM team consisted of medical students (1st–6th year) tasked with managing and reporting ADRs in hospitalized patients. Feasibility was evaluated using questionnaires. Student competence in reporting ADRs was evaluated using a case-control design and questionnaires before and after J-ADEM program participation. From Augustus 2018 to Augustus 2019, 41 students participated in a J-ADEM team and screened 136 patients and submitted 65 ADRs reports to the Netherlands Pharmacovigilance Center Lareb. Almost all patients (n = 61) found it important that “their” ADR was reported, and all (n = 62) patients felt they were taken seriously by the J-ADEM team. Although attending physicians agreed that the ADRs should have been reported, they did not do so themselves mainly because of a “lack of knowledge and attitudes” (50%) and “excuses made by healthcare professionals” (49%). J-ADEM team students were significantly more competent than control students in managing ADRs and correctly applying all steps for diagnosing ADRs (control group 38.5% vs. intervention group 83.3%, p < 0.001). The J-ADEM team is a feasible approach for detecting and managing ADRs in hospital. Patients were satisfied with the care provided, physicians were supported in their ADR reporting obligations, and students acquired relevant basic and clinical pharmacovigilance skills and knowledge, making it a win-win-win intervention.

Adverse drug reactions to off label use of drugs in spontaneously reported cases at a tertiary care hospital

Background: Off-label prescribing is the prescription of medication in a manner different from that approved by the Food and drug administration (FDA). This term implies that the drug is given either for different indication, different dose, different dosage form, different route, or different age group as compared to the approval criteria. The safety data of drugs used for labeled use cannot be applied to safety of drugs during off-label use. Aim and Objective: The aim of the study was to analyze the pattern of adverse drug reactions (ADR) occurring during off label use from the spontaneously reported ADR cases at the pharmacovigilance unit of a tertiary care hospital. Materials and Methods: The spontaneously reported ADR cases at a tertiary care hospital ADR monitoring center were analyzed for off label use using the NFI-2016 and updates on www.cdsco.nic.in website. Results: 82 ADRs occurred due to off-label use of drugs in 77 patients, these patients had received 433 medicines of which 231 were off label drugs. Off label drug use was maximum for systemically used anti-infective (152 drugs, 65.80%) and was associated with 75 ADRs (59.52%). Non-recommended co-administration of drugs was associated with maximum number of ADRs (23.01%). Most commonly affected organ system was skin and subcutaneous tissue (38.8%) and rash was the commonly occurring ADR. Conclusion: Safety is always the main concern while prescribing drugs. Off-label use of drugs is associated with ADR and caution should be administered while prescribing. ADR monitoring is needed to reduce ADRs associated with off label use.

Assessing Drug-Drug Interaction Potential among Patients Admitted to Surgery Departments in Three Palestinian Hospitals.

Background Drug-drug interactions (DDIs) are a common issue that leads to adverse drug reactions in hospitals. Patients in the surgical department are expected to have potential DDIs that may lead to morbidity and mortality. Objectives To study potential DDI prevalence in the surgery departments in 3 hospitals in Palestine. Moreover, to identify pertinent factors that are associated with drug-drug interactions. Method A cross-sectional study in 3 governmental Palestinian hospitals: Palestine Medical Complex, Rafidia Hospital, and Beit Jala Hospital. Patients who are 20 years old or above and admitted to the surgical wards between September 2017 and February 2018 were included in the study. Patient demographics, all medications given in the hospital, and hospitalization period were obtained from medical files. The digital clinical decision support system Micromedex® was used for analysis and classification of possible drug interactions. Bivariate analysis and logistic regression were used to study the risk factors for developing DDIs. Results 502 patients were included in this report. The prevalence of potential DDIs among patients admitted to surgery wards in three Palestinian hospitals was 56%. The number of detected potential DDIs per patient was 2.22 ± 3.76. The number of prescribed medications (P < 0.001) was found to increase the possibility of having drug interactions. Conclusions DDIs in Palestinian hospitals are a prevalent problem, and caution should be taken when ordering medications to hospitalized patients in surgery departments.

Safety of Nebulized Colistin Solution as Adjunctive Treatment of Lower Respiratory Tract Infections

Background Systemic colistin is often utilized for management of drug resistant lower respiratory tract infections (LRTI). Nebulized administration of colistin allows direct instillation of active agent to maximize concentrations and limit systemic toxicities. Current literature supports efficacy of nebulized colistin as adjunctive treatment for LRTI. However, there is a paucity of data surrounding safety of this administration technique. Methods The electronic medical record (EMR) was queried to identify patients treated with nebulized colistin between January 1, 2016 and December 31, 2018. The data collected from the EMR and hospital adverse drug reaction (ADR) reporting systems included: demographics, dose, serum creatinine (SCr), concomitant nephrotoxins, infecting pathogen, treatment-emergent ADRs, and drug toxicities. The primary outcome was prevalence of renal, neurologic, or respiratory ADRs secondary to nebulized colistin. Results Thirty-two patients were administered nebulized colistin during the study period. Approximately 19% of patients had baseline chronic kidney disease. Cultures were positive in 29 patients of which 11 organisms were resistant to all tested antimicrobials. Three patients experienced acute kidney injury (AKI), 1 patient experienced a neurologic reaction, and 1 patient experienced a respiratory reaction, though none were considered treatment-related. Conclusion The results of our study signify localized administration of colistin results in a low incidence of systemic adverse events. Nebulized colistin is a safe adjunct for managing LRTI.

Detection of serious adverse drug reactions using diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems.

Canadian hospitals are legally required to report serious adverse drug reactions (ADRs). This study aimed to assess the ability to detect serious ADRs from diagnostic codes and the potential benefit of adding stand-alone diagnostic codes to the regular process for detecting serious ADRs. In this descriptive study, clinical pharmacists and a reference work on drug-induced diseases allowed to identify diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada (ICD-10-CA), reflecting clinical manifestations related to an ADR. Records for admissions to a large urban mother-child hospital in the fiscal year 2018-2019, as coded by medical archivists, were analysed. Of 69 ICD-10-CA diagnostic codes reflecting an ADR identified, 38 were included in the detailed analysis of patient records and 18 (which appeared in 130 admissions) deemed to indicate a serious ADR. Among the 130 admissions analysed, 70 serious ADRs were identified, of which 52 were previously detected by the regular process and 18 were not, increasing the detection of serious ADRs by 34.6% (18/52). These 18 serious ADRs were newly identified from 11 of the 18 codes reflecting clinical manifestation of a serious ADR. Adding ICD-10-CA diagnostic codes not associated with external cause codes can increase the capacity to detect serious ADRs in hospitals. Over a 12-month period, the use of 11 such diagnostic codes increased the detection capacity for serious ADRs by 34.6%.

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review.

This systematic review aimed to quantify the prevalence of adverse drug events (ADEs) and adverse drug reactions (ADRs) in older inpatients with dementia. A systematic search of observational studies was performed in Embase, Medline, PsycINFO, International Pharmaceutical Abstracts, Scopus and Informit. Articles published in English that reported the prevalence of ADEs or ADRs in hospital patients aged 65 years or older with dementia were included. Two authors reviewed titles and abstracts and all eligible full-text articles. Relevant information relating to ADEs, ADRs and dementia was obtained from each article. In total, 5 articles were included. One study reported the prevalence of ADEs to be 81.5%, defined using the Naranjo algorithm. Four studies assessed the prevalence of ADRs, ranging from 12.7 to 24.0%, assessed using various methods. One study defined ADRs according to the World Health Organization-Uppsala Monitoring Centre criteria, 2 studies employed the World Health Organization definition and 1 study did not explicitly define ADRs. The most frequently reported drug classes implicated in ADEs and ADRs were psychotropic, antihypertensive and analgesic drugs. Our findings suggest a high prevalence of ADEs and ADRs in older inpatients with dementia. However, only 1 study documented ADEs and there was variability in approaches to ADR assessment. A greater understanding of ADEs and ADRs, as well as tailored assessment tools, will promote prevention of ADEs and ADRs in people with dementia.

Patient satisfaction with a hospital adverse drug reaction reporting system

AbstractAimTo evaluate patients' satisfaction with the adverse drug reactions (ADR) warning card model used within a metropolitan hospital network in Melbourne, Australia.Methods and ResultsA cross‐sectional survey, with interviewer‐administered questionnaire, of patients who experienced an ADR was conducted. Of the 241 eligible cases reviewed by the adverse drug reaction committee between January 2013 and April 2016, 45% (108) consented to a phone interview with 82% (89) recalling the ADR event. Of these, 55% (49) recalled receiving a temporary ADR warning card and 73% (65) remembered receiving a permanent ADR warning card post‐discharge. The ADR warning card was carried by 75% (67) of participants. It was found that 85% (76) had informed their doctor of the ADR while 40% (36) had informed their regular community pharmacist. Overall satisfaction was high with 89% (79) agreeing that this ADR service was valuable to them.ConclusionOverall, there was a high level of satisfaction, which supports the ADR warning card model as a model of care for patients who experience ADRs. In addition to informing the patient and their general practitioner about ADRs, consideration should be given to routinely informing their community pharmacists.

Medication with caution: Analysis of adverse reactions caused by a combination of Chinese medicine and warfarin sodium tablets

Ethnopharmacological relevanceWith the extensive recent use of warfarin and traditional Chinese medicine (TCM) in combination, TCM has been found to affect warfarin's pharmacokinetic and pharmacodynamic parameters. Warfarin is a widely used oral anticoagulant, which has a narrow therapeutic window and a high likelihood of interacting with other drugs and resulting in serious adverse reactions. Contrary to widespread public expectations, TCM, despite being natural, is not always safe. Aim of the studyTo report the adverse drug reactions (ADR) resulting from the use of Chinese medicine and warfarin sodium tablets in combination. MethodsAccording to a hospital ADR monitoring report, we collected data on four clinical cases involving warfarin and single Chinese herbal medicine, warfarin and proprietary traditional Chinese medicine product, warfarin and Chinese medicinal injection, and warfarin and compound decoction. The Naranjo ADR score evaluation scale was used to analyze the relationships between warfarin and Chinese medicines. ResultsFluctuations in the international normalized ratio (INR) were accompanied by bleeding in some patients who regularly and simultaneously utilized warfarin and Chinese medicine. The potential risk of bleeding due to the interaction between TCM and warfarin is easily and often overlooked by both Western and TCM doctors. ConclusionsWarfarin in combination with different traditional Chinese herbal medicines poses risks of INR fluctuations and adverse reactions such as bleeding. In the future, the safety awareness regarding reasonable administration of warfarin and herbal medicine should be emphasized.

Preventability analysis of adverse drug reactions in a Jordanian hospital: a prospective observational study.

Background Adverse drug reactions remain to be an issue that compromisepatient's safety in Jordan and worldwide. In Jordan, an assessment of factors involved in preventability of adverse drug reactionshas not been conducted previously. Objectives To describe the proportion of preventable adverse drug reactions, and the causes of hospital-related preventableadverse reactions in one Jordanian hospital. Methods A prospective observational study of 4months duration conducted by clinical pharmacists in the hospital. Setting Surgical and medical wards in one Jordanian private hospital. Main outcome measure Proportions of admissions related to adverse drug reactions, proportions of preventablereactions and analysis of the factors involved in the preventableadverse drug reactions. Results Out of 350 admissions recorded during the study period, a total of 38 (10.8%) adverse reactionswere detected. Among those, 29 (8.3%) were detected in the hospital and 9 (2.6%) were the cause of the hospital admission. Many (44.7%) of the adverse drug reactions were preventable (31.6% were probably preventable and 13.1% were definitely preventable). About half (55.3%) were unpreventable. Insufficient monitoring was involved in 29.4% of the preventable adverse reactions and inappropriate dosing and drug-drug interactions were independently responsible for 17.6% of the preventableadverse reactions. Conclusion A high proportion of the identifiedadverse drug reactions were found to be preventable. Insufficient monitoring and inappropriate dosing were the most importantfactors associated with preventableadverse drug reactions. Nationally, more focused efforts need to be stimulated to prevent preventable adverse drug reactions in hospitals.

2231. Safety of Nebulized Colistin as Adjunctive Treatment of Lower Respiratory Tract Infections

BackgroundSystemic antibiotics used in treatment of drug-resistant lower-respiratory tract infections (LRTI) may have poor lung penetration or narrow therapeutic indices. Nebulized administration of colistin allows direct instillation of active agent to maximize concentrations at the site of infection. Theoretically, local administration also avoids treatment-limiting toxicities and adverse drug reactions (ADR). Current literature supports efficacy of nebulized colistin as adjunctive treatment for LRTI. However, there is a paucity of data surrounding safety and tolerability of this administration technique.MethodsThe electronic medical record (EMR) was queried to identify patients treated with nebulized colistin between January 1, 2016 and December 31, 2018. The following data were collected from the EMR and hospital ADR reporting systems: demographics, treatment regimen, serum creatinine (SCr), concomitant nephrotoxins, infecting pathogen, treatment-emergent ADRs, and drug toxicities. The primary outcome was prevalence of renal (acute kidney injury [AKI]), neurologic (seizure, visual disturbance), or respiratory (bronchospasm) ADRs secondary to colistin nebulization therapy. AKI was defined according to the RIFLE criteria.ResultsThirty-two patients were administered nebulized colistin during the study period. Approximately 19% of patients had a baseline renal impairment. Cultures were positive in 29 patients of which 11 organisms were resistant to all tested antimicrobials. The most common infecting pathogen was A. baumanii (n = 15) followed by K. pneumoniae (n = 9). The median duration of therapy was 4.6 days. Seventeen patients (53.1%) were exposed to concomitant nephrotoxins. Three patients experienced AKI of which two received simultaneous furosemide and one had underlying renal dysfunction and received concomitant vancomycin. The one observed neurologic reaction, seizure, occurred in a patient with underlying epilepsy. No patients had documented visual disturbances or bronchospasm.ConclusionThe results of our study are consistent with the principle that localized administration of colistin results in a lower incidence of systemic adverse events. Nebulized colistin is a safe adjunct for managing LRTI. Renal, pulmonary, and neurologic reactions in this study were likely not treatment-related. Disclosures All authors: No reported disclosures.

Drug-drug interaction study in an intensive care unit: An assessment of prevalence, nature, and severity of the medications involved

Background: Intensive care unit (ICU) patients are at an increased risk of drug-drug interactions (DDIs) due to polypharmacy and pharmacokinetic changes in critically ill patients. Adverse drug reactions in hospitals caused by DDIs pose a significant risk to the patient’s health outcome with an additional economic burden on the health -care system. Aims and Objectives: This study was conducted to measure the prevalence and nature of potential DDIs (pDDIs) as primary objective and to know the severity of pDDIs and association of pDDIs with the length of stay in ICU (if any) as a secondary objective. Materials and Methods: This was a 2-month, prospective, observational study that was conducted in an ICU of ESIC Medical College and Hospital, Gulbarga. Drugs.com interaction database was utilized to screen patient’s medication profiles for DDIs and for severity assessment. Results: Of 112 study population, 755 pDDIs were identified, averaging 6.74 interactions per patient. About 6.9% (52/755) were major, 75.9% (573/755) were moderate, and 19.9% (150/755) were minor DDIs. The most frequent drug pairs involved in pDDIs in major, moderate, and minor were rifampin and isoniazid (15.4%), furosemide and pantoprazole (4.01%), and digoxin and spironolactone (8%), respectively. Conclusions: DDIs occur frequently in the ICU. Nature and Severity of medications related to DDIs in an ICU differ from other hospital ICU settings. Based on the prescribing pattern in an ICU, a database at an institutional level can be developed so as to decrease the burden of interactions and overall result in improved patient safety.

Characterization of Serious Adverse Drug Reactions in Hospital to Determine Potential Implications of Mandatory Reporting

The Protecting Canadians from Unsafe Drugs Act will eventually require institutions to report all serious adverse drug reactions (ADRs), although the proposed regulations do not yet define what will need to be reported and by whom. Knowledge about the occurrence of serious ADRs in the hospital setting is needed to optimize the effectiveness of reporting and to determine the potential implications of mandatory reporting. To quantify and characterize suspected serious ADRs in patients admitted to a general medicine service, to assess the likelihood of causality, and to determine inter-rater agreement for identification of ADRs and assessment of their likelihood. This prospective observational study involved 60 consecutive patients admitted to a general medicine service at a tertiary care teaching centre starting on March 28, 2016. The primary outcome was the number of serious ADRs, defined by Health Canada as ADRs that result in hospital admission, congenital malformation, persistent or significant disability or incapacity, or death; that are life-threatening; or that require significant intervention to prevent one of these outcomes. Medical records were reviewed independently by pairs of pharmacists for serious ADRs, and the likelihood of causality was assessed using the World Health Organization-Uppsala Monitoring Centre system. Inter-rater agreement was calculated using the kappa score, and disagreements were resolved by discussion and consensus. Twenty-three serious ADRs occurred in the sample of 60 patients. The proportion of patients experiencing a serious ADR that contributed to the original hospital admission was 19/60 (32%, 95% confidence interval [CI] 20%-43%), and 4 patients (7%, 95% CI 0%-13%) experienced a serious ADR during their hospital stay. Inter-rater agreement for occurrence of serious ADRs was moderate (kappa 0.58, 95% CI 0.35-0.76). Reportable serious ADRs were common among patients admitted to a general medicine service. Canadian hospitals would face difficulties reporting all serious ADRs because of the frequency of their occurrence and the subjectivity of their identification.

Assessment of Adverse Drug Reactions Associated with Cardiovascular Agents and Antibiotics at a Tertiary Care Hospital

The assessment of Adverse Drug Reactions (ADRs) has become increasingly significant because of the introduction of a large number of potent toxic chemicals as drugs in the last two or three decades. Therefore, it is important that continuous monitoring of adverse drug reactions in hospitals could prevent serious consequences and unexpected effects of the drugs and improve the quality of treatment in patients. Antibiotics and cardiovascular agents are the most commonly prescribed drugs which are also involved with the highest number of adverse drug reactions in the hospitals. The objective of this study was to monitor and evaluate the adverse drug reactions caused by cardiovascular agents and antibiotics at a tertiary care hospital in Bangalore, for a period of 12 months between March “2017 to March 2018”. All in-patients of both genders who experienced an ADR during their hospital stay were enrolled for the study and exclusion criteria were patients admitted to hospital and did not experience an ADR. Out of 110 Adverse drug reactions, 57 (51.81%) were caused by cardiovascular agents and 53 (48.18%) were caused by antibiotics. Among the cardiovascular agents ADRs the most frequently reported ADRs were caused by furosemide 19 (33.33%) followed by telmisartan 5 (8.77%). Out of 53 (48.18%) ADRs caused by antibiotics, 8 (15.09%) were induced by ceftriaxone, followed by 7 (13.20%) piperacillin/tazobactam, 6 (11.32%) cefoperazone, 5 (9.43%) levofloxacin. The most common organ system affected was the gastrointestinal system with 31 (28.18%) followed by fluid and electrolytes 28 (25.45%), dermatological 21 (19.09%) and cardiovascular 7 (6.36%). The causality assessment of the ADRs was carried out using the Naranjo’s Scale algorithm and the majority of the ADRs were found to be possible 44 (40%). Antibiotics and cardiovascular agents are the most commonly prescribed medicines in hospitals, so it is important to notice the physicians with latest adverse drug reactions of these medications. This approach consequently reduces the chances of patient harm and also improves the patient's quality of treatment, reduces the cost burden and hospital stay and minimizes the antibiotics resistance due to unresponsiveness of medications in patients.

Medication-related anaphylaxis treated in hospital: Agents implicated, patient outcomes, and management lessons.

On background of increasing medication-related anaphylaxis rates in Australia, our aim was to determine epidemiology, outcomes, adverse drug reaction (ADR) reporting rates, and accuracy of coding in patients treated for nonantimicrobial medication-related anaphylaxis in our hospital network. From January 2010 to December 2015 patients treated in our hospital network for medication-related anaphylaxis were identified using International Classification of Diseases, 10th Edition diagnosis code T88.6. Cases were also extracted from the hospital ADR database. Medical records were reviewed to ensure consistent diagnosis and to extract clinical, documentation, and outcome data. Of 1110 patients coded as T88.6, 177 (15.9%) met the medication-related anaphylaxis definition. Eighty (40.8%) had anaphylaxis due to nonantimicrobial agents. Thirteen of these (16.3%) had a previous reaction to the same medication/group. In 51 (63.8%) patients, anaphylaxis occurred during inpatient stay, with 31 reactions occurring during surgery. Eighty-five medications were implicated, most commonly neuromuscular blocking agents (31, 36.5%) and nonsteroidal anti-inflammatory drugs. No trends were noted over the 6-year period, and there was no anaphylaxis-related mortality. Fifty-three (66.3%) patients were assessed in allergy clinics. One in 10 cases did not have the reaction documented in the discharge summary. Adverse drug reaction reports were received for 38 patients (47.5%). Although acute patient outcomes were excellent, gaps in practice were noted regarding ADR coding accuracy and reporting rates. One in 6 patients had a prior hypersensitivity reaction to a similar medication, so we recommend accurate documentation, ADR review with allergy follow-up, and patient held information to decrease re-exposure risk.