Percentage of Patients with Preventable Adverse Drug Reactions and Preventability of Adverse Drug Reactions – A Meta-Analysis

BACKGROUND: Numerous observational studies suggest that preventable adverse drug reactions are a significant burden in healthcare, but no meta-analysis using a standardised definition for adverse drug reactions exists. The aim of the study was to estimate the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions in adult outpatients and inpatients. METHODS: Studies were identified through searching Cochrane, CINAHL, EMBASE, IPA, Medline, PsycINFO and Web of Science in September 2010, and by hand searching the reference lists of identified papers. Original peer-reviewed research articles in English that defined adverse drug reactions according to WHO's or similar definition and assessed preventability were included. Disease or treatment specific studies were excluded. Meta-analysis on the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions was conducted. RESULTS: Data were analysed from 16 original studies on outpatients with 48797 emergency visits or hospital admissions and from 8 studies involving 24128 inpatients. No studies in primary care were identified. Among adult outpatients, 2.0% (95% confidence interval (CI): 1.2-3.2%) had preventable adverse drug reactions and 52% (95% CI: 42-62%) of adverse drug reactions were preventable. Among inpatients, 1.6% (95% CI: 0.1-51%) had preventable adverse drug reactions and 45% (95% CI: 33-58%) of adverse drug reactions were preventable. CONCLUSIONS: This meta-analysis corroborates that preventable adverse drug reactions are a significant burden to healthcare among adult outpatients. Among both outpatients and inpatients, approximately half of adverse drug reactions are preventable, demonstrating that further evidence on prevention strategies is required. The percentage of patients with preventable adverse drug reactions among inpatients and in primary care is largely unknown and should be investigated in future research

Pharmacovigilance study in psychiatry out-patient department of a tertiary care teaching hospital

Background: Adverse drug reactions are important in psychiatry practice like any other branch of medicine. Adverse drug reactions associated with psychotropic drugs causes either noncompliance or at times discontinuation of therapy. The objective of the study was to evaluate the incidence and nature of adverse drug reactions in psychiatry outpatient department and to assess the causality and severity of the documented adverse drug reactions.Methods: Prospective observational study was done in the psychiatry outpatient department. All the patients were interviewed for basic details, history of medications and relevant history for adverse drug reactions. The causality, severity and modes of management assessment of the documented adverse drug reactions were done.Results: 2,727 patients attended psychiatry outpatient department, of which 582 patients developed at least one adverse drug reaction. The incidence of adverse drug reaction observed to psychotropic drugs was 21.34%. Majority of adverse drug reactions were seen with antidepressants 298 (10.93%) followed by antipsychotics 187 (6.86%), sedative hypnotics, anticonvulsants and antimanics. The most common adverse drug reactions were sedation 3.44%, weight gain 3.04%, and extrapyramidal symptoms 2.79%. Reported adverse drug reactions were assessed for causality and maximum belonged to probable (15.6 9%). The severity assessment of the reported adverse drug reactions revealed that most of the adverse drug reactions were mild (16.83%) in nature and majority of patients were made to continue the same treatment.Conclusions: Active monitoring of adverse drug reactions in psychiatry outpatient department can help in early detection and management of adverse drug reactions

Quality of life in children with adverse drug reactions: A narrative and systematic review

Aims Adverse drug reactions are a common problem affecting adults and children. The economic impact of the adverse drug reactions has been widely evaluated; however, studies of the impact on the quality of life of children with adverse drug reactions are scarce. The aim was to evaluate studies assessing the health-related quality of life of children with adverse drug reactions. Methods We conducted a systematic review that included the following electronic databases: MEDLINE, EMBASE and the Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Cochrane Controlled Trials Register and the Health Technology Assessment Databases). Results Nine studies were included. Four of the studies were conducted in children with epilepsy; the rest of them involved children with chronic viral hepatitis, Crohn\u27s disease, paediatric cancer and multiple adverse drug reactions compared with healthy children. Based on their findings, authors of all studies concluded that adverse drug reactions had a negative impact on the quality of life of children. No meta-analysis was conducted given the heterogeneous nature of the studies. Conclusions To date, there is no specific instrument that measures quality of life of children with adverse drug reactions, and the information available is poor and variable. In general, adverse drug reactions have a negative impact on the quality of life of affected children. For those interested in this area, more work needs to be done to improve tools that help to evaluate efficiently the health-related quality of life of children with adverse drug reactions and chronic diseases

STUDY TO EVALUATE USE OF IRRATIONAL FIXED DRUG COMBINATIONS

Objective: To identify fixed drug combinations causing the adverse drug reactions both rational and irrational.Methods: A prospective observational study was carried out over a period of 6 mo (between June 2016 to December 2016) to evaluate adverse drug reactions related to fixed drug combinations in a tertiary care teaching hospital using suspected adverse drug reaction reporting form.Results: A total number of 64 adverse drug reactions were reported during this period. Of the total adverse drug reactions reported, 27 (42%) were due to fixed drug combinations. 6 (28.5%) were serious and 21(71.5%) were non-serious. Causality was certain in 4 (14.8%) cases and probably in remaining 23 (85.2%) cases. 19(70%) irrational fixed drug combinations were reported.Conclusion: The above results show that irrational fixed drug combinations contribute major extent to adverse drug reactions. Hence, awareness programs should be conducted for all the health care workers to improve the rationality of prescription and to decrease adverse drug reactions

Adverse Drug Reactions among Critically Ill Patients at Cairo University Hospital: Frequency and Outcomes

Background: Adverse drug reactions (ADRs) are common problem in intensive care units where the poly pharmacy is involved in treating patients. Control of such events is possible if it is identified and reported. However, reporting of adverse drug reactions still in its infancy. Aim: the aim is to assess the frequency and outcomes of adverse drug reactions among critically ill patients at Cairo university hospital. Research questions: 1- What is the frequency of adverse drug reactions among a selected sample of critically ill patients at Cairo university hospital? 2- What is the outcome of adverse drug reactions among a selected sample of critically ill patients at Cairo university hospital? 3- What is the degree of severity of adverse drug reactions among a selected sample of critically ill patients at Cairo university hospital? Design: Descriptive exploratory design was utilized.  Setting: The study was carried out at the Critical Care Department affiliated to Cairo University Hospitals. Subjects: A convenience sample of 150 male & female critically ill adult patients receiving different types of medications constituted the study sample. Tools: Two tools were utilized in the study, 1.Sociodemographic and medical data sheet and, 2.Adverse drug reactions assessment sheet. Results: The study results revealed that one of fifth (21%) of study sample were suffered from adverse drug reactions. ADRs were represented on the patients in the form of dry mouth, abdominal distension, headache, insomnia, constipation, tachycardia, peripheral edema, hypertension, hypotension, cough, drowsiness. Severity of adverse drug reactions was ranged from mild severity (41.9%) to moderate and severe reaction (9.7%). Conclusion: The prevalence of adverse drug reactions among critically ill patients is prevalent in a ratio of nearly (21%); and, more than half of these reactions were life-threatening. Recommendation: A written hospital policy describing basic standards in management of ADRs is recommended to be established and before initiation of new medication, assess for potential drug–disease and drug–drug interactions, check dosages, and check the most common causes of ADRs, then starting new drugs. Key wards: Adverse drug reactions, poly pharmacy, critically ill patients, Frequency, Outcomes

A study on adverse drug reactions in a tertiary care hospital of Northeast India

Objective: Purpose of this study was to monitor adverse drug reactions reported from various departments of a tertiary care hospital in Northeast India. Reported adverse drug reactions were analysed for causality and severity assessment.Methods: This cross sectional study was conducted in a tertiary care hospital at Guwahati, Northeast India, for 7 months. Patients of all age and either sex were included. Adverse drug reactions were reported by the physicians of this hospital and their causality and severity assessments were performed as per Naranjo’s and Hartwig’s assessment criteria respectively. Descriptive statistics were used for data analysis.Results: Total 255 adverse drug reactions were reported from various departments of this tertiary care hospital. Most of the adverse drug reactions were observed in the age group of 21–30 year. Acne (46) was commonly reported reaction. Topical steroids, betamethasone sodium phosphate and clobetasol were reported to induce maximum number of reactions (59). Skin (227, 66.9%) was commonly affected organ system. Most of the adverse drug reactions were possible (240, 94.1%) and mild (222, 87%) in nature.Conclusions: The topical steroid (betamethasone sodium phosphate) was reported to induce adverse drug reactions in majority of the patients. The commonly reported reaction was acne.Keywords: ADRs; Northeast; Naranjo; Hartwig; Pharmacovigilanc

Systematic review of adverse drug reactions of ofloxacin

Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in countries having limited healthcare resources. Of all the Adverse Drug Reactions, antimicrobials contribute 28% which is highest compared to the other drugs. Ofloxacin is an antimicrobial used for treating several bacterial infections. Incidence rate of adverse drug reactions (ADRs) to ofloxacin is 4.27%. Although these figures appear to be small, it is consumed for gastrointestinal infections along with ornidazole in India contributing significant burden of ADRs. However, there is no research done in past many years focusing on the adverse drug reactions of ofloxacin. This article bridges the gap of such a need. The objective of the present study was to review the adverse drug reactions related to ofloxacin in human and animal studies. Authors conducted Pubmed and Cochrane library search to review all the articles related to the adverse drug reaction of ofloxacin from 1980 to 2016. Authors got 84 articles pertaining to the adverse drug reactions of ofloxacin. Authors conclude that ofloxacin should be judiciously used as the side effect profile is increasing.

Epidemiology of Adverse Drug Reactions

I would like to conclude by citing two rather interesting observations we have made. Three-quarters of all the patients in all our surveillance who have allergic reactions to drugs have had peptic ulcer, ulcerative colitis, or neoplastic disease of the gastrointestinal tract. Of these patients, three-quarters of the drugs producing allergic reactions are administered orally. The rates of allergic reactions to individual drugs in patients with gastrointestinal disease as opposed to those without gastrointestinal disease receiving the same medication, are significantly increased. What the impact is of inflammatory gastrointestinal disease 1) upon the absorption of the drug, 2) upon its metabolism, and 3) upon its antigenicity has not been investigated before. But from these studies it is suggested that inflammatory disease of the gastrointestinal tract may be an important factor predisposing patients receiving oral drugs to occurrence of allergic reactions. It has commonly been supposed that patients with autoimmunological disorders, e.g., system lupus erythematous, may have a predisposition to multiple allergic reactions to drugs. In our evaluation of this problem, there is no significant increase in the occurrence of allergic reactions to drugs in these patients