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

Intervention to improve the level of documentation of antipsychotic related adverse drug reactions

Antipsychotic drugs are the mainstay of treatment for psychotic disorders according to the Standard Treatment Guidelines (2012). However, these drugs are associated with multiple severe adverse drug reactions. In order to limit the effect of adverse drug reactions on patient care, documentation is necessary. Documentation of adverse drug reactions entails recording the reaction experienced, as well as supplementary information. Proper documentation can prevent future occurrences of the same or similar adverse drug reactions. The aim of this study was to determine the effects of an educational intervention targeting increasing documentation of the adverse effects of antipsychotic drugs. The objectives of the study were: to determine the pre-intervention extent and frequency of documentation of antipsychotic-related adverse drug reactions in the patient medical record; to implement an intervention aimed at educating the relevant healthcare professionals, focusing on the adverse drug reactions of antipsychotic drugs and how to record or document these reactions; to assess the post-intervention extent and frequency of documentation of antipsychotic-related adverse drug reactions in the patient medical record; and to assess the attitude of healthcare providers towards the documentation of antipsychotic related adverse drug reactions before and after the intervention

Editorial: Adverse drug reactions

No Abstrac

Evaluating adverse drug reactions associated with antibiotic use in a public sector hospital.

Masters Degree. University of KwaZulu-Natal, Durban.Background and Aim Antibiotics are one of the most troublesome classes of drugs contributing to adverse drug reactions. These adverse drug reactions are generally under reported. This study aimed to evaluate the adverse drug reactions associated with antibiotic use in a public sector hospital. Methods A prospective, quantitative study was carried out using adverse drug reaction reports collected from a public sector hospital in South Africa, for the period 01 July 2016 – 30 September 2016. All the adverse drug reaction reports attributed to use of antibiotics were included in the study. The patient’s age, gender, weight, antibiotic prescribed, dose of antibiotic, route of administration of the antibiotic, adverse drug reaction experienced and action taken regarding the adverse drug reaction was extracted from the adverse drug reaction report. A descriptive and inferential analysis was carried out using SPSS (version 24) to determine the strength of the relationships (Pearson Chi Square test) between different variables. Results A total of 10 adverse drug reaction reports were collected during the 3 month period from which 8 were related to antibiotic use (80%). Adverse drug reactions associated with antibiotic use were experienced mostly by female patients (n=6, 75%). Adverse drug reactions were reported for Amphoteracin B (n=3), Amoxicillin (n=1), Cefazolin (n=1), Lopinavir/Ritonavir combination (n=1), Metronidazole (n=1) and Tenofoir/Emtricitrabine/Efavirenz combination (n=1). Of the 8 adverse drug reactions, 7 required intervention to prevent permanent damage/disability. There were 2 serious adverse drug reactions; 1 required hospitalization and the other prolonged hospital stay; the remaining adverse drug reactions were classified as non-serious. Discussion and Conclusion Antibiotic related adverse drug reactions constituted 80% of all adverse drug reactions reported in a single hospital. The impact of adverse drug reactions associated with antibiotic use in the public hospital ranged from treatment to manage the adverse drug reaction to hospitalization and the prolongation of hospital stay. This study provides useful information on the current status of adverse drug reactions related to antibiotic use in the public sector in South Africa, and indicates the need for adverse drug reaction reporting in hospitals to ensure safety of medicines and better treatment outcomes

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