Causality Assessment Of Adverse Drug Reactions Research Articles

Inter-rater agreement between WHO- Uppsala Monitoring Centre system and Naranjo algorithm for causality assessment of adverse drug reactions

Determining the causality of Adverse Drug Reactions (ADRs) is essential for management and prevention of future occurrences. The WHO-Uppsala Monitoring Centre (UMC) system is recommended under the Pharmacovigilance Program of India whereas Naranjo's algorithm is commonly utilized by clinicians, but their agreement remains a subject of investigation. This study aims to compare the inter-rater agreement between these two scales for causality assessment of ADRs. In this cross-sectional study, two groups of pharmacovigilance experts were given a set of total 399 anonymized individual case safety reports, collected over six months. The raters were blinded to each other's assessments and applied the WHO-UMC system and Naranjo algorithm to each case independently. Inter-rater agreement was then evaluated utilizing Cohen's kappa. The suspected ADRs were also comprehensively analysed on parameters like age, sex, route of administration, speciality, organ system affected, most common drug categories and individual drugs, outcome of ADRs. Analysis of 399 suspected ADRs revealed that mean age of patients was 36.8 ± 18.0 years, females were more frequently affected, highest proportion of reports were from psychiatry inpatients, seen with antipsychotic drugs, involved the central nervous system, with oral administration, and 91% resolved. On causality assessment by the WHO-UMC system, 53.3% were “Certain” whereas Naranjo's algorithm categorized 96.74% of ADRs as “Probable”. Cohen's kappa showed a “Minimal” agreement (0.22) between WHO-UMC and Naranjo system of causality assessment. The considerable lack of agreement between the two commonly employed systems of causality assessment of ADRs warrants further investigation into specific factors influencing the disagreement to improve the accuracy of causality assessments.

Ptosis Following the use of Dexamethasone-Based Eye Drops

Ptosis is a known adverse reaction of local ocular corticosteroids, mainly due to those administered by local injections. Topical corticosteroid eye drop-induced ptosis is becoming increasingly observed in ophthalmology practice. We report the case of a 6-year-old child hospitalized in the Hematology Department for first consolidation chemotherapy for acute myeloblastic leukemia, who received local corticosteroids via dexamethasone eye drops for ocular prevention and who presented five days later with bilateral ptosis of abrupt onset. Given the normality of ophthalmological examination and cerebral CT scan, and following an adverse drug reaction causality assessment, incrimination of Dexamethasone was suspected and thus it was stopped. The ptosis improved rapidly and disappeared after one week. Ptosis is a little-known adverse effect of corticosteroid eye drops in our context; therefore, more vigilance is required to better understand and manage it.

Evaluating the performance of ChatGPT in clinical pharmacy: A comparative study of ChatGPT and clinical pharmacists.

To evaluate the performance of chat generative pretrained transformer (ChatGPT) in key domains of clinical pharmacy practice, including prescription review, patient medication education, adverse drug reaction (ADR) recognition, ADR causality assessment and drug counselling. Questions and clinical pharmacist's answers were collected from real clinical cases and clinical pharmacist competency assessment. ChatGPT's responses were generated by inputting the same question into the 'New Chat' box of ChatGPT Mar 23 Version. Five licensed clinical pharmacists independently rated these answers on a scale of 0 (Completely incorrect) to 10 (Completely correct). The mean scores of ChatGPT and clinical pharmacists were compared using a paired 2-tailed Student's t-test. The text content of the answers was also descriptively summarized together. The quantitative results indicated that ChatGPT was excellent in drug counselling (ChatGPT: 8.77 vs. clinical pharmacist: 9.50, P = .0791) and weak in prescription review (5.23 vs. 9.90, P = .0089), patient medication education (6.20 vs. 9.07, P = .0032), ADR recognition (5.07 vs. 9.70, P = .0483) and ADR causality assessment (4.03 vs. 9.73, P = .023). The capabilities and limitations of ChatGPT in clinical pharmacy practice were summarized based on the completeness and accuracy of the answers. ChatGPT revealed robust retrieval, information integration and dialogue capabilities. It lacked medicine-specific datasets as well as the ability for handling advanced reasoning and complex instructions. While ChatGPT holds promise in clinical pharmacy practice as a supplementary tool, the ability of ChatGPT to handle complex problems needs further improvement and refinement.

Adverse drug reactions in the ambulatory internal patients at the emergency department: Focus on causality assessment and drug-drug interactions.

A non-interventional retrospective study in ambulatory patients was conducted at the emergency department of the Division of internal medicine. In 2 months, 266 suspected adverse drug reactions (ADRs) were identified in 224/3453 patients (6.5 %). In 158/3453 patients (4.6 %), an ADR was the reason for emergency department visit and in 49 patients (1.4 %), ADRs led to hospitalisation. A causality assessment algorithm was developed, which included Naranjo algorithm and levels of ADR recognition by the treating physician and the investigators. Using this algorithm, 63/266 ADRs (23.7 %) were classified as "certain", whereas using solely the Naranjo score calculation, only 19/266 ADRs (7.1 %) were assessed as "probable" or "certain", and the rest of ADRs (namely, 247/266 = 92.9 %) were assessed as "possible". There were 116/266 (43.6 %) ADRs related to potential drug-drug interactions (DDIs), stated in at least one of the literature sources used. Based on the causality relationship, the rate of the clinically expressed DDIs was 19.0 %, or 12/63 "certain" ADR cases. Of these, 10 cases presented serious DDI-related ADRs. In summary, ADR causality assessment based exclusively on Naranjo algorithm demonstrated low sensitivity at an ambulatory emergency setting. Additional clinical judgment, including the opinion of the treating physician, proved necessary to avoid under-rating of the causality relationship, and enabled the determination of clinically expressed DDIs.

Study of pattern and time-reaction sequence for adverse drug reactions reported to antiretroviral drugs

Background: Adverse drug reactions (ADRs) to antiretroviral drugs have a varied pattern and wide spectrum of severity from mild to very serious. The lack of a pre-established time-reaction sequence hampers the causality assessment of ADRs. Recognition of pattern of ADRs to antiretroviral drugs in a particular setup might sensitize the reporters to report ADRs, especially in setups dependent on spontaneous reporting. Aim and Objectives: The study of pattern and time-reaction sequence for ADRs reported to antiretroviral drugs. Materials and Methods: Retrospective study was conducted at a first-line antiretroviral therapy (ART) center after obtaining approval from the Institutional Ethics Committee. Pattern of ADRs associated with ART was done by analyzing the type of ADRs, severity, and outcome of ADRs reported to antiretroviral drugs. Mean duration of time lapse between administration of drug to onset of adverse drug reaction was calculated. Descriptive statistics was used for data analysis. Results: There were 73 adverse reactions reported. Most common type of adverse reaction was cutaneous (53.42%) followed by anemia (31%). Causality assessment of most ADRs was concluded as possible (60.27%). Most ADRs were of moderate severity and 12% were severe reactions. Reactions such as anemia and neuropsychiatric ADRs often occurred late, while maculopapular rash usually occurred within 30 days of drug administration. Conclusions: ADRs to ART include an array of reactions ranging from mild rash to psychosis or severe anemia. Most of these reactions are of moderate severity and have a favorable outcome. Many of these reactions actually occur almost a month after initiating a drug regime suggesting the need for intensive monitoring around this time.

Assessment of Causality in Hospitalized Children With Aminoglycoside-Related Nephrotoxicity

To evaluate the incidence of aminoglycoside-related nephrotoxicity and ascertain drug causality and its risk factors. This prospective study was conducted from January, 2019 to January, 2021, and recruited 110 consecutively admitted children aged 1 month to 12 years, receiving aminoglycosides for ≥4 days. Drug causality was assessed using Liverpool adverse drug reaction causality assessment tool. 42 (38.2%) children developed acute kidney injury (AKI), with 71 (64.5%) having composite nephrotoxicity (AKI and/or tubular-dysfunction). Only 17 (15.5%) had AKI definitively attributable to aminoglycosides. Hypotension [OR 0.016 (95% CI 0.01-0.71), P=0.03], PRISM-III score 20-29% [OR 55.48 (95% CI 3.66-840.53), P=0.004] and post-surgery patients [OR 3.2 (95% CI 1.01-10.1), P=0.047] were independent predictors of AKI. Only a small proportion of children receiving aminoglycosides had AKI definitively attributable to the drug.

A STUDY ON ADVERSE DRUG REACTION PATTERNS OF INJECTABLE ANTIBIOTICS REPORTED IN THE PHARMACOVIGILANCE CENTRE OF A TERTIARY CARE TEACHING INSTITUTE, MANIPUR

Background:Antibioticsare one of the most commonly used drugs in hospitalised patients and are sometimes associated with significant safety concerns. However, there is still insufficient data about the incidence of adverse drug reactions(ADR) especially in case of injectable antibiotics. This study was done to assess the severity and pattern of different types of adverse drug reaction that occurs with commonly used injectable antibiotics. Method: A retrospective cross-sectional study was done at Pharmacovigilance centre RIMS utilizing data from January 2018 till December 2019. Result: A total of 146patients who presented with antibiotic associated ADR reported during the study period were included in this study. Incidence was higher in males (90) as compared to females (56). The most common injectableantibiotic responsible for ADR was found to be the cephalosporin group (42.6%). A total of 178 different ADRs were observed among 146 patients, out of which the dermatological system (27.4%) was the most commonly affected system. On evaluation of WHO-UMC causality assessment of ADRs, majority were found to be possible (64.4%). Conclusion:Injectable antibioticsare one of the most importantdrugs used for treatment of various clinical conditions and the sheer magnitude of their usage among hospitalised patientsrequires special monitoring especially with respect to the adverse reactions they can cause.A more active pharmacovigilance is needed for better understanding of the types of injectable antibiotics associated ADRs. Active monitoring can also help promoterational use of these important life saving drugs.

Knowledge and Perception of Pharmacy Practice Students on Causality Assessment of Adverse Drug Reactions

Pharmacy Practice students play an important role in identifying and reporting Adverse Drug Reactions (ADRs). Prior studies focused on knowledge of pharmacy students on reporting ADRs. There are no studies conducted to assess the knowledge and understand the perception of students on causality assessment of ADRs. A web-based cross-sectional study was conducted from October 2019 to April 2020 among the Pharmacy Practice students in various pharmacy colleges across India. Consent form was obtained before filling the questionnaire. The questionnaire was distributed through social media applications and staff of respective colleges. Descriptive analysis was performed to calculate frequencies and percentages of categorical variables. A total of 723 students, 608 responses were received from 30 pharmacy colleges across India. The mean age (SD) of participants was 22.95 (1.61) years. The majority of responses were received from females (70.39). The majority of participants (90.78%) were aware of various causality assessment scales. More than half (58.55%) strongly agreed that there is a need for hands on training on causality assessment of ADRs at college level. Around 80% of the participants strongly agreed that clinical pharmacist is necessary in the healthcare team for causality assessment of ADRs. The knowledge of students on causality assessment of ADRs was found satisfactory. Students believed that having regular workshop on causality assessment of ADRs may help improve their skills in identifying the suspected medications that caused ADRs and helps in better patient care.

Causality assessment of adverse drug reactions by applying a global introspection method in a high complexity hospital

BackgroundCausality assessment of adverse drug reactions (ADRs) is an essential approach in pharmacovigilance. The World Health Organization-Uppsala Monitoring Center (WHO-UMC) system has been considered one of the most adequate method for establishing causal relationship in hospitalized patients. ObjectiveTo describe the causality of potential ADRs in hospitalized patients assessed by the WHO-UMC system and by different healthcare professionals. MethodsThree healthcare professionals, with different backgrounds, acted as judges to adjudicate the causality categories for potential ADRs according to WHO-UMC system, in a Brazilian high complexity hospital. Judges' agreement was evaluated by using Fleiss' and Cohen's kappa coefficients. ResultsNinety potential ADRs identified in 300 participants were adjudicated by each judge, comprising a total of 270 assessments. Most potential ADRs were classified as probable or possible (77.8%). Fleiss´ kappa revealed slight concordance among judges (k = 0.096;CI:95%;0.01–0.18). ConclusionsDiverse backgrounds may have influenced the results for causality assessment of ADRs by employing the WHO-UMC system. Despite the slight concordance found for the method, this result suggests potential opportunity to enrich the ADRs management by engaging multiprofessional teams in the process. Further studies should be considered to investigate the performance of methods for ADRs assessment in hospitalized patients in low- and middle-income countries.

Causality assessment between reported fatal cerebral haemorrhage and suspected drugs: developing a new algorithm based on the analysis of the Japanese Adverse Event Report (JADER) database and literature review.

Cerebral haemorrhage is a life-threatening event with various causes including adverse drug reactions (ADRs). Several methods have been proposed for the causality assessment of ADRs, but none specific for cerebral haemorrhage. The purpose of this study was to develop an algorithm for causality assessment between drugs and fatal cerebral haemorrhage, based on the analysis of data from the Japanese Adverse Drug Event Report (JADER) database and literature review. All fatal ADRs reported in the JADER database between April 2004 and March 2020 were searched, and literature on drug-related cerebral haemorrhage or general causality assessment was reviewed to summarise the information on causality between cerebral haemorrhage and ADRs. Of the 50,095 cases identified in the JADER database, cerebral haemorrhage was the fifth most reported cause of fatal ADRs, but the causality of >80% of the events was published as 'Unassessable'. The literature review identified articles on drug-related cerebral haemorrhage and causality assessment methods in general. Based on these articles, information on five categories (temporal relationship, previous knowledge about the relationship between drug action and ADRs, alternative aetiological candidate, appropriateness of drug use, and the relationship between death and ADRs) was determined for causality assessment between a suspected drug and fatal cerebral haemorrhage; a new algorithm was created using this information. In this study, the information considered necessary for causality assessment between drugs and fatal cerebral haemorrhage was reviewed and an assessment algorithm was developed. Future studies are needed to validate the usefulness of this method.

A STUDY OF AGREEMENT BETWEEN WHO-UPPSALA MONITORING CENTRE CRITERIA, NARANJO ALGORITHM, AND LIVERPOOL ALGORITHM FOR CAUSALITY ASSESSMENT OF ADVERSE DRUG REACTIONS

Objective: A standard causality assessment tool of an adverse drug reaction (ADR) is essential to compute the risk-benefit assessment of the medication taken by the patient and categorize its relationship likelihood. It should be reproducible and should not differ with the background and experience of the evaluator. Though there are a large number of causality assessment tools, none is unanimously accepted worldwide. So, this study was done to assess the agreement between three frequently used methods of causality assessment, the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) system, the Naranjo’s algorithm, and the Liverpool algorithm.
 Methods: 172 ADR forms from the pharmacovigilance unit were randomly selected for the study. Causality assessment was done using three different methods, the WHO-UMC system, Naranjo’s algorithm, and the Liver pool algorithm. Cohen’s Kappa statistics was applied to look for agreement between the causality assessment methods.
 Results: The agreement between the WHO-UMC criteria and Naranjo’s algorithm was the highest (136), with a Kappa value of 0.511, suggesting a moderate level of agreement. A maximum number of disagreements were noted between the WHO-UMC system and the Liverpool algorithm method (110).
 Conclusion: A moderate agreement exists between the WHO-UMC system and the Naranjo algorithm. There is poor agreement between the Liverpool algorithm and the other two scales. Therefore, it is recommended that both the WHO-UMC system and the Naranjo algorithm be used for causality assessment of ADRs.

Safety of Pyrazinamide for the Treatment of Tuberculosis in Older Patients Over 75 Years of Age: A Retrospective Monocentric Cohort Study.

Pyrazinamide (PZA) has a controversial safety profile in older patients. We aimed to assess the frequency and risk factors for adverse drug reactions (ADRs) in patients over 75 years of age treated for tuberculosis with or without PZA. We conducted a retrospective monocentric study including patients aged over 75years treated for active tuberculosis between 2008 and 2018. The frequency, type, seriousness, and causality assessment of ADRs to anti-tuberculosis treatment were compared between patients receiving PZA or not. Risk factors for ADRs were investigated using univariable and multivariable analyses by logistic regression. Among the 110 patients included, 54 (49.1%) received PZA (group 1) and 56 (50.9%) did not (group 2). ADRs to anti-tuberculosis drugs occurred in 31 patients (57.4%) in groups 1 and 15 (26.8%) in group 2 (p=0.003). PZA-related ADRs occurred in 40.7% of exposed patients. Frequency of renal ADRs was higher in group 1 (9.3% vs 0%; p=0.026). Rates of hepatic (18.5% vs 12.5%; p=0.38), digestive (22.2% vs 8.9%; p=0.054), and allergic (14.8% vs 5.4%; p=0.12) ADRs were numerically higher in group 1 although the differences were not statistically significant. Serious ADRs occurred more frequently in group 1 (24.1% vs 8.9%; p=0.03). The use of PZA was the only independent risk factor for ADRs to anti-tuberculosis drugs (odds ratio 3.75, 95% CI 1.5-9.6; p=0.0056). No risk factors for PZA-related ADRs were identified. In older French patients, the use of PZA was associated with more frequent ADRs to anti-tuberculosis drugs.

Causality Assessment of Adverse Drug Reaction Using Naranjo Probability Scale: A Retrospective Study


 
 
 
 Introduction: Globally, Adverse Drug Reaction (ADR) has been listed as the sixth leading causes of death. Recognition of ADR and establishment of relationship of drug with the symptom is the first step to the management of the problem. In this study, Naranjo algorithm has been used which is one of the most accepted tools for the assessment of causality of ADR with the suspected drug.
 Methods: A retrospective descriptive study was done which included 35 reported cases of ADRs in Drug Information Unit (DIU) in tertiary care teaching institute of Nepal from Dec 2015 to Oct 2016. Based on the information in the reported ADRs forms, categorisation was done using Naranjo’s ADR Probability scale. The data was analysed using SPSS version 16.0 and descriptive statistics was used.
 Results: It was seen that ADRs were more common in male (n=20) as compared to female (n=15). Amongst male, ADRs were more common in age group 50-75 years (n=8). ADRs were most commonly seen with antimicrobial agents (40%) followed by Non-Steroidal Anti-inflammatory Drugs (NSAIDs) (20%) and immunosuppressants (20%). Within the antimicrobial agents, anti-tubercular drugs (20%) contributed the most in ADRs and hepatotoxicity was the most common ADR seen. Majority of ADRs were categorised under possible (n=29) followed by probable (n=6).
 Conclusions: Naranjo algorithm could be a useful tool for causality assessment of ADR which can help physicians to guide the therapy.
 
 
 

A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL IN SOUTH INDIA

Objective: The objective of this study was to determine the prevalence of adverse drug reactions (ADRs) in a tertiary care teaching hospital in South India and to analyze the causality according to the Naranjo scale.
 Methods: This study was carried out at the SRM Medical College, Chennai, a tertiary care hospital, which is an ADR monitoring center under Pharmacovigilance Programme of India, over a period of 1 year, from September 2017 to August 2018, after approval by the Institutional Ethics Committee. These ADRs were reported by the clinical pharmacy team of our hospital to the department of pharmacology. The relevant data were collected from the patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview, and reporter interviews after written informed consent was obtained from each patient. Patients of either sex of all ages who developed ADR within the hospital were included in the study. Patients who developed ADR outside the hospital were excluded from the study. The collected ADRs were subjected to the Naranjo causality assessment scale. Hartwig’s scale was used to assess the severity of the reaction. The causalities and other aspects of the ADRs were analyzed in detail.
 Results: A total of 80 ADRs were reported during this study period. The ADRs were most frequently reported in the adult age group (75%) with slight female preponderance (60%). Antibiotics contributed to the maximum number of ADRs which accounted for 52.5% of the total, of which beta-lactams were the highest (37.5%) followed by analgesics. Causality assessment of ADRs by the Naranjo scale showed that the maximum reactions could be categorized as probable (85%) followed by the possible category (15%). The most common presentation of ADR was itching (45%) followed by rashes (30%). Three cases of severe adverse reactions were reported, one case each of anaphylaxis to pantoprazole and diclofenac and one case of Steven–Johnson syndrome to cotrimoxazole.
 Conclusion: ADRs are a common occurrence but are often not recognized. Even if recognized, they are underreported as many physicians are unaware that all ADRs should be reported to ADR monitoring centers. ADRs are an important cause of morbidity and mortality all over the world and are an important public health concern. It inflicts a negative impact on the treatment and exerts a greater economic burden on the patient if it results in prolongation of the duration of hospitalization or other comorbidities. Therefore, the practicing physicians, as well as the nursing staff, should be sensitized of the importance of ADR reporting to their respective pharmacovigilance centers.

Adverse drug reactions monitoring of anticoagulant drugs used in cardiac coronary care unit of a tertiary care hospital

Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probability. The severity was assessed by modified Hartwig and Siegel scale, and preventability of ADRs was assessed by Schumock and Thornton scale.Results: Out of the total forty-one ADRs recorded, 40 (97.56%) were mild and 1 (2.44%) was reported as severe on the Hartwig and Siegel severity scale. Hematuria (68.29%) was the most common ADR followed by hemoptysis (14.63%). Among all anticoagulants, low molecular weight heparin was associated with the majority of ADRs (85.37%). The WHO causality and Naranjo Scale revealed that maximum of the ADRs (~80%) were possible. All ADRs reported was Type “A” reactions according to Wills and Brown classification of ADRs. Majority of ADRs (97.56%) were probably preventable.Conclusions: In the present study, hematuria was the most common ADR reported. Among all anticoagulants, Low molecular weight heparin accounted for the majority of ADRs followed by acenocoumarol and heparin. Intensive monitoring and frequent reporting need to be done in cardiac units to improve patient safety.

Prevalence of hospitalisation caused by adverse drug reactions at an internal medicine ward of a single centre in Japan: a cross-sectional study

ObjectivesFew studies have investigated the prevalence of adverse drug reactions (ADRs) leading to hospitalisation in Japan. The aim of this study was to determine the prevalence of ADRs leading to...

Naranjo Question Answering using End-to-End Multi-task Learning Model.

In the clinical domain, it is important to understand whether an adverse drug reaction (ADR) is caused by a particular medication. Clinical judgement studies help judge the causal relation between a medication and its ADRs. In this study, we present the first attempt to automatically infer the causality between a drug and an ADR from electronic health records (EHRs) by answering the Naranjo questionnaire, the validated clinical question answering set used by domain experts for ADR causality assessment. Using physicians' annotation as the gold standard, our proposed joint model, which uses multi-task learning to predict the answers of a subset of the Naranjo questionnaire, significantly outperforms the baseline pipeline model with a good margin, achieving a macro-weighted f-score between 0.3652 - 0.5271 and micro-weighted f-score between 0.9523 - 0.9918.

Correction to: Adverse drug reaction causality assessment tools for drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: room for improvement.

The correct name of the 9th Author is David J. Margolis. The original article was corrected.

A prospective study on causality assessment rating, mortality rate, and case fatality rate for adverse drug reactions among medical inpatients at the University of Benin Teaching Hospital, Nigeria

Background: An adverse drug reaction (ADR) is a special form of adverse drug event (ADE) in which a causative relationship can be shown or established and is attributable to the offending/precipitating medication. ADR causality assessment is used to determine the likelihood that a particular drug caused a suspected ADR. Causality assessment rating evaluates the relationship between drug treatment and the occurrence of an ADE. It is also used to evaluate, check, confirm, and ascertain that the particular treatment is the cause of an observed adverse event or not. Aim: This study was designed to evaluate the causality assessment rating, mortality rate, and case fatality rate for ADRs among adult medical inpatients in clinical practice setting with the goal of preventing them and improving their treatment outcome. Methods: The patients admitted to the adult medical wards of a Nigerian University Teaching Hospital over 9 months from December 2013 to August 2014 were prospectively recruited for the study and followed up till discharge. Results: Five hundred and seven patients were evaluated during the study, of which 269 (53.1%) of them were male and 238 (46.9%) were female. The mean age of the study population was 48.9 ± 17.8 years (median of 46 years). In this study, the causality assessment rating for the observed ADRs was evaluated using both the World Health Organization (WHO) causality rating criteria and the Naranjo algorithm. Using the WHO causality rating criteria, certain cases were 10 (19.6%), probable cases were 17 (33.3%), and possible cases were 24 (47.1%). Using the Naranjo algorithm, definite cases were 9 (17.6%), probable cases were 19 (37.3%), and possible cases were 23 (45.1%). The number of patients admitted solely because of ADRs (ADR-out) was 18 (3.6%) patients, whereas those that experienced ADRs during admission (ADR-in) stood at 33 (6.5%) patients. Furthermore, the case fatality rate for ADRs was 7.8% (4/51), while the ADR-associated overall mortality rate was 0.8% (4/507). Conclusion: In this study, the two methods used to ascertain causality rate for ADRs caused by a suspected drug; both the WHO causality rating criteria and Naranjo algorithm, showed similar causality ratings, which strengthening the ascribed ADR causality rating. In addition, the mortality rate and case fatality rate for ADRs were significantly high among these adult medical inpatients.

Prescribing pattern of antimicrobials and adverse drug reactions in children suffering from lower respiratory tract infection in tertiary care hospital

Background: Acute respiratory tract infections are leading cause of mortality in children in India. Further, indiscriminate use of antimicrobials has led to increased drug resistance and large number of adverse drug reactions (ADR). Therefore, aim of study was to study antimicrobial prescribing pattern and record incidence and causality assessment of ADRs in pediatric in-patients having lower respiratory tract infection (LRTI).Methods: In this prospective and observational study total of 300 children aged 2 months to 12 years suffering from LRTI and hospitalized for minimum 48 hrs duration were included. A descriptive analysis was carried out to determine frequency and combinations of antibiotics prescribed and causality and number of ADRs.Results: Out of 300 subjects, 70.3% of patients were males and 54.6% of cases with LRTI belonged to 2-6 months age group. The most frequently prescribed antibiotic was ceftriaxone alone in 67 (22.3%) patients while ceftriaxone and amikacin was the most common 2 drug combination in 60 (20%) patients. Ceftriaxone, ampicillin and gentamicin was most common 3 drug combination in 7 (2.3%) patients. There were 49 cases (16.3%) of ADRs and maximum were in 2-6 months age group and ceftriaxone with amikacin was associated with maximum number 10 (20.4%) of cases. Diarrhoea was most frequent adverse effect associated with antibiotics in 36 (76.6%) cases.Conclusions: The use of cephalosporins (single or combination) are most commonly used drug and associated with maximum number of ADRs in 2-6 months male children with LRTI so clinicians should use them judiciously and rationally.