Cause Of Adverse Drug Reactions Research Articles

Association Between Readmission After Liver Transplant and Adverse Immunosuppressant Reactions: A Prospective Cohort With a 1-Year Follow-up

ObjectiveTo measure the association between readmission after liver transplantation and corresponding adverse drug reactions. MethodsA total of 48 patients undergoing liver transplantation were prospectively followed for 1 year. Of these, 23 were readmitted and evaluated by a pharmacist for causes of adverse drug reaction. The detection of adverse drug reactions was based on a combination of clinical interviews and physical and laboratory exams. Adverse reactions were defined in accordance with the Naranjo algorithm. ResultsA total of 67.6% of all readmissions were related to adverse drug reactions, with tacrolimus accounting for 80% of the drug reactions. The most common cause of readmission was infection (48.6%), followed by procedure-related reasons (29.7%). Of all patients requiring admission, 39.1% had Model for End-stage Liver Disease (MELD) scores below 21 at the time of transplantation, 17.4% had MELD scores between 21 and 29, and 43.5% had MELD scores above 29. Most (66.7%) of those readmitted more than twice had MELD scores above 29. ConclusionAdverse drug reactions related to immunosuppressants frequently lead to readmission among liver transplant patients, and in our series tacrolimus was the most frequently associated drug.

Imputation of adverse drug reactions: Causality assessment in hospitals.

Background & objectivesDifferent algorithms have been developed to standardize the causality assessment of adverse drug reactions (ADR). Although most share common characteristics, the results of the causality assessment are variable depending on the algorithm used. Therefore, using 10 different algorithms, the study aimed to compare inter-rater and multi-rater agreement for ADR causality assessment and identify the most consistent to hospitals.MethodsUsing ten causality algorithms, four judges independently assessed the first 44 cases of ADRs reported during the first year of implementation of a risk management service in a medium complexity hospital in the state of Sao Paulo (Brazil). Owing to variations in the terminology used for causality, the equivalent imputation terms were grouped into four categories: definite, probable, possible and unlikely. Inter-rater and multi-rater agreement analysis was performed by calculating the Cohen´s and Light´s kappa coefficients, respectively.ResultsNone of the algorithms showed 100% reproducibility in the causal imputation. Fair inter-rater and multi-rater agreement was found. Emanuele (1984) and WHO-UMC (2010) algorithms showed a fair rate of agreement between the judges (k = 0.36).Interpretation & conclusionsAlthough the ADR causality assessment algorithms were poorly reproducible, our data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report. However, to improve the ability of assessing the causality using algorithms, it is necessary to include criteria for the evaluation of drug-related problems, which may be related to confounding variables that underestimate the causal association.

Adverse drug reactions in high-risk pregnant women: A prospective study

BackgroundBecause pregnant women are often excluded from clinical trials, there is still very limited information about the risk and safety of prescription drugs during pregnancy. ObjectiveWe aimed to determine the prevalence of Adverse Drug Reactions (ADRs) in high-risk pregnant women after hospital admission. A prospective study was carried out in a teaching maternity hospital in Brazil during six months. Causality of ADRs was assessed through the Naranjo Algorithm and Korean Algorithm for ADR Causality Assessment. Severity of ADRs was assessed using Hartwig’s Severity Assessment Scale. ResultsThe prevalence of ADRs among the 294 inpatients studied was 8.8%. The mean age was 27.14 (±7.5) y.o. Patient's age was related to the presence of ADRs, while the manifestation of these events was not associated with any adverse pregnancy outcome. 75.9% of the ADRs reported in the study were of mild severity and 24.1% were of moderate severity. No ADR was caused by drug-drug interaction; however, a significant increase in blood pressure was observed in all patients using concurrent methyldopa and ferrous sulfate. ConclusionOverall, ADRs were not common events among high-risk pregnant women and no adverse pregnancy outcomes following these events were observed.

Pattern of spontaneously reported adverse drug reactions in ANIIMS Port Blair REACTIONS IN ANIIMS PORT BLAIR

Background: The data pertaining to Adverse drug reactions is very limited especially in India. Adverse drug reactions are known to cause mortality and increased morbidity and hence increase the burden of disease. Therefore this study was done over a period of 18 months to assess the causality of adverse drug reactions, nature of their seriousness and to know if they could have been prevented or not. Materials & Methods: A number of spontaneous reports of ADRs were included in the study over a period of 18 months from June 2015 to December 2016 reported from different clinical Departments of ANIIMS, Port Blair. The World Health Organization (WHO) definition of an ADR and its seriousness was adopted. The organ system involvement was labeled by WHO-ADR terminology. ADRs were analyzed for causality by Naranjos algorithm. Results: A Total of 200 reactions were reported in this time period, and out of these, most common Adverse drug reactions were Hypersensitivity reactions accounting for more than half of cases ie 54 %. A look at the causative agents revealed antimicrobials as the commonest agents causing these ADRs 48%, followed by drugs affecting GIT 20%, then autacoids 10%. Of these, about two-thirds of the reactions i.e. almost 65% were classified as probable and one-tenth were classified as preventable. Serious ADRs were 0.25 per 1000 patients. Conclusion: Most of the ADRs were caused by Antimicrobial Agents, and further large sample size studies are needed to confirm the association of particular Drugs with the ADRs.

Study of adverse drug effects of antiepileptic drugs used in pediatric patients in a tertiary care rural hospital – a Pharmacovigilance study

: Objective: To assess the prescription pattern & Adverse Drug Reaction (ADR)) profile of Antiepileptic drug (AEDs) therapy in children of rural population. Materials and Methods: This prospective open label, observational study was carried out over one and half year duration on 142 newly diagnosed epileptic children below 12 yrs age receiving AEDs in pediatric department in a tertiary care rural hospital. Follow up was done every month for 6 months duration. Prescription pattern and incidence, causality and severity of ADRs due to AEDs were assessed at each visit. Results: Out of 142 patients on AEDs, 97.2% patients were on mono-therapy and 2.8% patients were on poly-therapy. Valproic acid was the most commonly prescribed drug (58) and Lorazepam was the least prescribed drug (1). Central nervous system related ADRs (50%) were most common followed by gastrointestinal system (14.7%). Sedation and gastrointestinal distress were among the most frequently reported ADRs and29.4% of probable category while 70.5% ADR’s were possible category. 72% ADRs were mild, 22% were moderate and 5.8% of ADRs were severe. Conclusions: Children receiving AEDs should be closely monitored for the development of any ADRs, especially related to their behavior and cognition. as it can influence their learning and memory, Active surveillance can help in knowing the exact incidence of ADRs. This study emphasizes on the role of patient / parent education and importance of health care professionals in pharmacovigilance studies.Key words: Adverse Drug Reactions, Antiepileptic Drugs, Pharmacovigilance

REAÇÃO ADVERSA A MEDICAMENTOS COMO FATOR CONTRIBUINTE PARA A INTERNAÇÃO HOSPITALAR DE IDOSOS

Introduction: The increase in life expectancy and population aging are associated with a higher prevalence of chronic diseases and an increase in the number of drugs used. In this context, the occurrence of adverse drug reactions (ADR) in the elderly people is greater than the other individuals due to the vulnerability of their organism. Goals: To describe the occurrence of ADR related to home pharmacotherapy contributing to hospitalization for the elderly population. Methods: This is a Cross-sectional study involving patients older than 60 years old. The dependent variable was the occurrence of ADR related to drugs used at home. The ADRs were identified by analyzing the medical evolutions and laboratory examination results recorded in the medical record. Causality of ADR was verified employing the Naranjo algorithm. Results: The study included 183 elderly people, 22 of them (12%) had at least one ADR related to drugs used at home. There were 26 ADR identified, the most frequent were digitalis intoxication (n =4; 15.4%), raising the RNI (n = 2; 7.7%) and bradycardia (n = 2; 7.7%). The main drugs related to ADR were digoxin (n = 4), warfarin (n = 4) and amiodarone (n = 3). Regarding the causality, there were 21 (80.7%) of the ADR as probable and 5 (19.3%) as possible. Univariate analysis showed a statistically significant association with polypharmacy (OR: 3.05; IC95% 1.14-8.1; p= 0.021). Conclusions: The occurrence of ADR was positively associated with polypharmacy and it is an important issue for the health of the elderly population and should contribute to hospitalization.

A study on the effect of atorvastatin on the pharmacokinetic and antidepressant activity of fluoxetine

Background: Polypharmacy is of wide concern in drug interaction. It is the leading cause of adverse drug reaction, and consequently, increasing the possibility of hospitalization and escalating the cost of care. The incidence of coexisting depression and hyperlipidemia in patients is generally managed by providing numerous drugs for a longer period of time. Aims and Objectives: This study was conducted to observe the effect of atorvastatin on pharmacokinetic parameters of fluoxetine in healthy albino rabbits and to find possible interactions of atorvastatin on the antidepressant activity of fluoxetine using animal screening test. Materials and Methods: Two drugs: Fluoxetine and atorvastatin used concurrently were selected. Healthy male albino rabbits were used to determine the effect of atorvastatin on fluoxetine addressing its pharmacokinetic parameters, whereas rats and mice were used to assess the antidepressant activity of fluoxetine. Two animal models were used to determine its antidepressant activity. Forced swim test (FST) and tail suspension test (TST) were employed in exploring antidepressant activity. High-performance liquid chromatography was used to estimate fluoxetine concentration. Results: The concentration of serum fluoxetine showed slight increment after the atorvastatin treatment for 7 days at 2nd, 4th, 8th, 16th, and 24th h. The pharmacokinetic parameters: Area under the curve, area under first-order moment curve, t1/2, and Cmax of fluoxetine varied after atorvastatin treatment for 1 week in healthy albino rabbits. ‘’Furthermore, atorvastatin treatment for a week revealed a reduction in immobility time in rats and mice as shown by the FST and TST respectively. Conclusion: The results revealed the possibility of drug-drug interaction between fluoxetine and atorvastatin.

Adverse drug reactions: Two years' experience from a tertiary teaching hospital in Kerala

Background: Adverse drug reactions (ADRs) have become a major clinical problem causing additional burden on the total cost of a patient’s treatment. Aims and Objectives: To determine the characteristics of ADRs reported in a tertiary care center. Materials and Methods: Descriptive analysis of ADRs reported to the Department of Pharmacology over a period of 2 years from July 2012 to June 2014 was done. ADR reports were analyzed on the basis of patient characteristics, drug characteristics, predictability, preventability, severity, causality, and seriousness of the ADR. The continuous variables were expressed as mean ± standard deviation. Categorical variables were expressed as frequencies and percentages. Odds ratio (OR) was calculated to assess the risk factors for severe ADRs using SPSS 16. Results: From the 359 ADR reports, 377 ADRs were identified with mean age 43 ± 19 years. 95.3% affected single organ system, the most common being skin and appendages. The most common ADR reported was maculopapular rash. Antibiotics accounted for the maximum ADRs of which beta-lactams were the most common. 30.1% (108) ADRs occurred within 1 h of administration of the drug. In 12.73% (48) drug interactions (DIs) were cause of ADRs. Risk analysis showed that DIs (OR = 2.25, 95% confidence interval [CI] = 1.1-1.53), concomitant use of more than one drug (OR = 1.75, 95% CI = 1.97-3.18) and delayed onset ADRs (OR = 1.89, 95% CI = 1.22-3.51) were risk factors for development of severe ADRs. Conclusions: Skin and integumentary system was the most commonly affected system and beta-lactams were the most common drug class implicated to cause ADR.

Potentially inappropriate prescribing andthe risk of adverse drug reactions in critically ill older adults.

Background:Potentially inappropriate medication (PIM) use in the elderly is associated with increased risk of adverse drug reactions (ADRs), but there is limited information regarding PIM use in the intensive care unit (ICU) setting.Objective:The aim of the study is to describe the prevalence and factors associated with the use of PIM and the occurrence of PIM-related adverse reactions in the critically ill elderly.Methods:This study enrolled all critically ill older adults (60 years or more) admitted to medical or cardiovascular ICUs between January and December 2013, in a large tertiary teaching hospital. For all patients, clinical pharmacists listed the medications given during the ICU stay and data on drugs were analyzed using 2012 Beers Criteria, to identify the prevalence of PIM. For each identified PIM the medical records were analyzed to evaluate factors associated with its use. The frequency of ADRs and, the causal relationship between PIM and the ADRs identified were also evaluated through review of medical records.Results:According to 2012 Beers Criteria, 98.2% of elderly patients used at least one PIM (n=599), of which 24.8% were newly started in the ICUs. In 29.6% of PIMs, there was a clinical circumstance that justified their prescription. The number of PIMs was associated with ICU length of stay and total number of medications. There was at least one ADR identified in 17.8% of patients; more than 40% were attributed to PIM, but there was no statistical association.Conclusions:There is a high prevalence of PIM used in acutely ill older people, but they do not seem to be the major cause of adverse drug reactions in this population. Although many PIMs had a clinical circumstance that led to their prescription during the course of ICU hospitalization, many were still present upon hospital discharge. Therefore, prescription of PIMs should be minimized to improve the safety of elderly patients.

Drug Safety of Celecoxib

Introduction: Non-steroidal anti-inflammatory drugs presently are the most widely used drugs in medicine and are the most frequent cause of adverse drug reactions, affecting multiple systems, mainly gastric, renal & cardiovascular, which is a major public health concern. Previous studies report, that selective COX-2 inhibitors are safer when compared to non-selective cyclooxygenase inhibitors. But, recent studies reveal, that the safety of these selective COX-2 inhibitors is not much better than that of conventional NSAIDs. In view of the wider usage of selective COX-2 inhibitor, celecoxib in day to day practice by many clinicians, the study has been taken up to report, whether selective COX-2 inhibitor celecoxib has got any advantages over conventional NSAIDs or not. Methodology: 15 patients were taken up for the study & all the patients were given celecoxib for 15 days. Both pre and post-treatment values of Hb%, blood urea, serum creatinine, serum bilirubin, bleeding time, clotting time, heart rate & blood pressure were recorded, tabulated & subjected to statistical analysis. Results: Selective COX-2 inhibitor, celecoxib has shown significant changes in bleeding time values & also good amount of gastric toxicity when assessed clinically. Hepatic, renal & other cardiovascular parameters were absolutely normal. Conclusion: In our short-term study, selective COX-2 inhibitor, celecoxib has shown good amount of gastric toxicity, showing no advantage over non-selective drugs. But, there is no hepatic, renal & cardiovascular toxicity.

The development and piloting of “ATTEND DR,” a clinical teaching tool to identify and prioritize potential causes of adverse drug reactions

BackgroundThe identification, management, and reporting of adverse drug reactions are integral to clinical practice and education; however, undergraduate teaching related to adverse drug reactions may be inadequate for practice. Existing methods of causality assessment have a number of limitations in relation to clinical teaching, for example, they do not deal well with the concurrent use of other medications. ObjectiveTo develop and pilot a teaching tool to guide students through the process of identifying and prioritizing potential causes of an adverse drug reaction. SettingUniversity-based School of Pharmacy, Australia: an undergraduate Quality Use of Medicines course. MethodA contrived acronym (mnemonic) was developed from causality assessments and discussions with practitioners. The acronym ATTEND DR (abnormality, taken, timeline, evidence, nothing else?, dose, dechallenge, and rechallenge) was piloted in workshops that focussed on adverse drug reactions and their management. Students’ responses to “What did you find most valuable about today’s workshop?” and “How could we improve?” were analyzed. ResultsAll attendees responded (65/65). Students indicated that the ATTEND DR acronym was easy to remember, and facilitated causality assessment in a clinical context, due to an easily followed, step-by-step, comprehensive process that was easy to remember. More practice case studies were requested. ConclusionThe ATTEND DR acronym was designed to address limitations of the existing methods of causality assessment in relation to clinical teaching and preparation of students for future clinical roles. Students responded favorably to its introduction, commenting that it was easily remembered and provided a comprehensive, clinically orientated, step-by-step process.

Multidisciplinary approach to improve spontaneous ADR reporting in the pediatric outpatient setting: a single-institute experience in Korea.

In order to improve the reporting of adverse drug reactions (ADRs) as part of the routine practice at the pediatric outpatient department (OPD), we modified our ADR reporting strategy into one that facilitates the reporting process by means of a multi-disciplinary approach. In this study, we retrospectively reviewed ADR records during the period from March to September 2014 when we changed our reporting process as a part of institutional quality assurance (QA) activity. Yearly differences in the number and composition of ADRs were compared, and the descriptive analyses were done for cases reported from OPD during the QA activity in terms of the suspected drugs, type, causality, and severity of ADRs. There were 1211 pediatric ADR reports including 520 cases with underlying hemato-oncologic diseases during the period of 2014. Among the 691 non-oncologic cases, 76 were reported from the OPD, which was a significant increase (347 %) from the 17 cases reported during the previous year. Further analyses of these 76 cases revealed that the caregivers (47.4 %) initiated about half of the reports, the most frequently affected organ was the skin (32.9 %), and the most frequent suspected drugs were anticonvulsants (14.5 %). In contrast to the in-ward system, moderate cases were more frequent (51.3 %) than mild ones. In conclusion, this study provides a profile of pediatric ADRs in the OPD, which were largely under-reported during the usual clinical practice. A multi-disciplinary approach would improve spontaneous ADR reporting at the pediatric OPD.

Adverse Drug Reactions in Patients Receiving Systemic Antifungal Therapy at a High-Complexity Hospital.

The aim of the present study was to determine the frequency of adverse drug reactions (ADRs) associated with the use of systemic antifungal drugs in patients hospitalized at a high-complexity hospital. In addition, factors associated with ADRs were investigated. This cross-sectional retrospective study involved the investigation of 183 medical records of patients receiving systemic antifungal therapy. Antifungal drugs were classified using the fourth level of the Anatomical Therapeutic Chemical System. ADR causality was classified using the Naranjo algorithm. Drug interactions were assessed using DRUG-REAX software. Data were analyzed with descriptive statistics and univariate and multivariate logistic regression. A total of 53 patients (29.0%) had at least 1 ADR involving antifungals. Ninety-six ADRs were detected. The main ADRs observed were an infusion reaction in 24 patients (25.0%), hypokalemia in 22 (22.9%), nephrotoxicity in 18 (18.7%), and hepatotoxicity in 15 (15.6%). Amphotericin B and voriconazole were associated with ADRs of major clinical impact. Eleven of the ADRs (11.4%) were related to drug interactions. The following 3 factors were contributors to the multivariate model for the occurrence of ADRs caused by antifungal drug use: neoplasm diagnosis (odds ratio [OR], 3.9; 1.9-7.9), length of hospital stay (OR, 2.2; 1.1-4.5), and the use of ≥13 drugs (OR, 3.4; 1.6-7.2). Our study revealed positive associations between the occurrence of ADRs and diagnosis of a neoplasm, the length of stay, and the use of multiple drugs concomitant with antifungals. These risk factors should be considered in antifungal stewardship, among other actions, to promote the rational use of antifungal agents.

Patterns of Adverse Drug Reaction in the Medical Wards of a Teaching Hospital: A Prospective Observational Cohort Study.

According to the World Health Organization (WHO) definition, an Adverse Drug Reaction (ADR) is a response to a drug that is noxious and unintended and occurs at doses normally used in humans for the prophylaxis, diagnosis, and treatment of disease. The risk factors of ADR are multi-factorial and include poly-pharmacy, age, gender, race, genetics and inter-current disease. This was a hospital based, prospective, observational cohort study undertaken in a tertiary care hospital in south India to assess the different patterns of adverse drug reaction in medical wards over 6 months. The severity of ADR was assessed using Hartwig Siegel scale and causality by Naranjo and WHO UMC Scale. Preventability was assessed using Schumock and Thornton scale and other parameters such as incidence, onset, duration, management and outcome were also assessed. Risk factors were assessed by bi-variate logistic regression analysis and length of hospital stay by T test. The incidence of ADR was 10.42% in medicine wards. The causality of ADR done by Naranjo scale showed that most of the ADRs were probable (7.38%). Anti-tubercular agents were the leading cause of ADR. Duration of hospitalization was significantly longer (7.18 ± 2.64 vs. 5.06 ± 2.13 days) in patients with ADR (Odds ratio 1.38, 95% Confidence interval 1.26 to 1.51). 7.28% of ADRs were moderately severe. Seriousness criteria assessment showed that 0.33% were serious reactions. Most of the ADRs were definitely preventable. Most of the ADRs were managed by discontinuing the suspected drug. The present study showed female gender predominance over males for ADRs and no relationship with age. Adverse drug reactions impose significant burden on hospitals through prolonging patient stay and by increasing admission rates. The occurrence of ADR in this study was higher when compared to that reported in previous studies. This study highlights the importance of ADR reporting among ADR reporting among health care professionals in hospital.

English

Administration of drugs via oral route is the most common and convenient. Three major factors can affect drug absorption from this route: physiologic, physicochemical and formulation. Drug absorption mainly takes place in small intestine after oral administration. Within the small intestine, there are 2 major families of proteins involved in transport that have significant roles on drugs absorption: Solute-carrier and adenosine triphosphate-binding cassette (ABC) superfamilies. There are 48 ABC transporters in humans as well as seven subfamilies: ABCA to ABCG. ABCB1, ABCC1/2, and ABCG2 are widely described for their impacts in the absorption of drugs. Polymorphism on ABC transporters can significantly affect the absorption of drugs from the gastro intestinal (GI) tract. Some polymorphisms can result in over expression of the transporter in the small intestine and hence reduce absorption of drugs and some result in reduction in expression and increase in absorption. These polymorphisms are an important cause of adverse drug reactions and therapeutic failures. Key words: Polymorphism, adenosine triphosphate binding cassette, oral drug absorption, expression, ABC transporters.

Analysis and prediction of drug–drug interaction by minimum redundancy maximum relevance and incremental feature selection

Drug–drug interaction (DDI) defines a situation in which one drug affects the activity of another when both are administered together. DDI is a common cause of adverse drug reactions and sometimes also leads to improved therapeutic effects. Therefore, it is of great interest to discover novel DDIs according to their molecular properties and mechanisms in a robust and rigorous way. This paper attempts to predict effective DDIs using the following properties: (1) chemical interaction between drugs; (2) protein interactions between the targets of drugs; and (3) target enrichment of KEGG pathways. The data consisted of 7323 pairs of DDIs collected from the DrugBank and 36,615 pairs of drugs constructed by randomly combining two drugs. Each drug pair was represented by 465 features derived from the aforementioned three categories of properties. The random forest algorithm was adopted to train the prediction model. Some feature selection techniques, including minimum redundancy maximum relevance and incremental feature selection, were used to extract key features as the optimal input for the prediction model. The extracted key features may help to gain insights into the mechanisms of DDIs and provide some guidelines for the relevant clinical medication developments, and the prediction model can give new clues for identification of novel DDIs.

Measuring the preventability of adverse drug reactions in France: A 2015 overview

In recent years, the preventability of adverse drug reactions (ADRs) has gradually gained ground as an additional criterion for assessing drug-related risk, alongside seriousness, causality mechanism of action or frequency. However, the definition of preventability itself remains a concept that needs to be defined clearly so as to compare study results. After an overview of the current methods of measuring preventability, which include a French instrument, this work proposes a synthesis of the French studies assessing the preventability of ADRs over the last 30 years. Measuring preventability is important to classify ADRs as preventable/not preventable, but the ultimate aim remains to characterize these preventable ADRs, highlighting the clinical situations and drug classes related to the risk. It is then possible to provide targeted clinical actions to correct these situations and improve the clinical use of these drugs. Thus, assessing medical preventability should address the causes of ADRs and not the responsibility of healthcare professionals. Finally, certain ideas are proposed to improve the French scale and pursue its validation.

How polymorphisms of the cytochrome P450 genes affect ibuprofen and diclofenac metabolism and toxicity.

Interindividual variability in drug metabolism is an important cause of adverse drug reactions and variability in drug efficiency. Polymorphisms of cytochrome P450 (CYPs) genes have a significant effect on drug metabolism and toxicity. This review brings an update about how genetic polymorphisms of CYP2C8 and CYP2C9 enzymes affect the disposition and clinical outcomes of ibuprofen and diclofenac, two of the most common pain relievers. The most common side effects associated with the influence of CYP2C8*3 and CYP2C9*2*3 variants on ibuprofen and diclofenac pharmacokinetics are hepatotoxicity and gastrointestinal bleeding. CYP genotyping may therefore identify patients at increased risk of these adverse reactions, and these patients could have their doses adjusted or start receiving another NSAID that does not share the same metabolic pathways with ibuprofen or diclofenac. However, before genotyping is introduced into regular clinical practice, more research is needed to evaluate the effectiveness of this strategy in improving treatment with ibuprofen and diclofenac.

Adverse Drug Reactions in Hospitalized Pediatric Patients: A Prospective Observational Study.

To determine the incidence, pattern, causality, preventability, severity and predictors of adverse drug reactions (ADRs) in pediatric population. It was a prospective, observational study that included patients of either sex, of any age treated in the pediatric wards of a tertiary care hospital. Study patients were followed throughout their hospital stay. Whenever an ADR was detected, all the required data was collected and analyzed. Data was analyzed for incidence, causality (by using WHO Probability scale and Naranjo's algorithm), preventability (by using Modified Shumock and Thornton scale), severity (by using Modified Hartwig and Siegel scale) and predictors of ADRs. Of the 1775 children admitted in the pediatrics ward, 1082 patients met study criteria and were enrolled into the study. A total of 64 ADRs were identified from 54 patients. The incidence of ADRs was 4.99%. Male patients experienced majority (68.52%) of ADRs. Drugs most commonly implicated in ADRs were amoxicillin + clavulanate (21.87%) followed by ceftriaxone (20.31%). Most (51.56%) of the ADRs reported belonged to the system organ class, gastrointestinal system disorders. Among the ADRs reported, 82.85% of ADRs were mild. Majority (87.5%) of the ADRs were of 'probable' causality category and 96.9% were not preventable. There was a significant association between occurrence of ADRs and the use of ≥4 number of medications, age (infants) and gender (male). Among the pediatric population, infants, male gender and those receiving ≥4 number of medications are at risk of developing ADRs. Constant monitoring is required to address the safety issue in pediatric population especially in infants and patients receiving ≥4 drugs.

Computerized techniques pave the way for drug-drug interaction prediction and interpretation.

Introduction: Health care industry also patients penalized by medical errors that are inevitable but highly preventable. Vast majority of medical errors are related to adverse drug reactions, while drug-drug interactions (DDIs) are the main cause of adverse drug reactions (ADRs). DDIs and ADRs have mainly been reported by haphazard case studies. Experimental in vivo and in vitro researches also reveals DDI pairs. Laboratory and experimental researches are valuable but also expensive and in some cases researchers may suffer from limitations. Methods: In the current investigation, the latest published works were studied to analyze the trend and pattern of the DDI modelling and the impacts of machine learning methods. Applications of computerized techniques were also investigated for the prediction and interpretation of DDIs. Results: Computerized data-mining in pharmaceutical sciences and related databases provide new key transformative paradigms that can revolutionize the treatment of diseases and hence medical care. Given that various aspects of drug discovery and pharmacotherapy are closely related to the clinical and molecular/biological information, the scientifically sound databases (e.g., DDIs, ADRs) can be of importance for the success of pharmacotherapy modalities. Conclusion: A better understanding of DDIs not only provides a robust means for designing more effective medicines but also grantees patient safety.