An annual retrospective analysis of adverse drug reactions reported at adverse drug reaction monitoring center, Nalgonda

Background: Adverse drug reaction (ADR) monitoring is important for risk benefit analysis and for patient’s safety. ADR monitoring helps in maintaining the database which is specific to Indian population. Aims and Objectives: This study aims to analyze the pattern of ADRs, drug implicated, organ system affected, severity of ADRs, and their causality assessment. Materials and Methods: It was a retrospective analysis of all the ADRs reported to ADR monitoring center, Nalgonda, from January 2019 to December 2019. Prior ethics committee approval was obtained. ADRs were collected using suspected ADR forms provided by National Coordination Center-Pharmacovigilance Programme of India (NCC PVPI). All the ADRs were reported to NCC PVPI through VigiFlow software. Results: A total of 273 ADRs were reported of which 59% were female and 41% were male. According to the age group, 30–39 years were the most common age group affected about 26%. The most common drug class implicated for ADRs was antimicrobials. Skin was the most common system affected. Most of the ADRs belonged to probable category according to the WHO causality assessment scale. Only 9 (3%) ADRs were of serious nature. Conclusion: Pharmacovigilance is important for identification of ADRs due to drugs. Still, lot of awareness about pharmacovigilance needs to be created among health-care professionals to improve the reporting of ADRs. This, in turn, will improve the drug safety among patients

Analysis Of Adverse Drug Events Reported At Peripheral Adr Monitoring Centre In Gujarat

Objective: Hospital-based ADR (Adverse drug reaction) monitoring and reporting programmes are useful for identifying and minimizing preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The objective of this study was to evaluate and analyze the spontaneously reported adverse drug events from various departments of Shree Krishna Hospital, Karamsad. Methods: This was a retrospective study and data was analyzed for adverse drug events reported during the period of April 2018 to March 2019 from various departments of Shree Krishna Hospital, Karamsad. Analysis was done on the basis of the demographic profile of patients, health care professionals who have reported and drugs causing ADRs, with their causality assessment using WHO probability scale. Results: Out of 36 patients, 20 (55.55%) were males and 16 (44.44%) were females. Antibiotics were the most common culprit group of drugs for reported ADRs in 21 patients. The number of ADRS related to the skin was 21 (58.33%) followed by GIT 11 (30.55%), cardiovascular 2(5.55%) and neuronal 2(5.55%). According to WHO causality assessment scale 01 (2.77%) of the suspected ADR was certain, 27(75%) were probable and 8 (22.22%) were possible. Conclusion: Our study concluded that the most commonly reported ADRs were dermatological reactions like itching and rashes. Antimicrobials were the most common drug group involved in causing ADRs. Even though there were continuous efforts for adverse drug event reporting awareness, still there is need to sensitize health care professionals to improve reporting.

A pharmacovigilance study of adverse drug reactions in a tertiary care hospital in Haryana

Background: Adverse drug reaction (ADR) is an inevitable risk associated with all the prescribed medicines. They vary in severity & duration in any population. Thus, ADRs are monitored and assessed on a large scale in our country by the Pharmacovigilance programme of India through adverse drug reaction monitoring centres. This study was taken to assess the pattern of ADR reported in a tertiary care hospital in Haryana.Methods: This study was conducted in the Kalpana Chawla Government Medical College, Karnal, Haryana from January 2018 to June 2019. ADRs were collected from different departments and were analysed according to gender, age, department wise distribution, drugs class involved and ADR that was reported.Results: A total of 233 ADRs were reported in the above mentioned period. Females were affected more than males, maximum number reported in the age group of 21-60 years. The maximum number of ADRs reported was from Dermatology department. Antimicrobials were the class of drugs that were responsible for the maximum number of ADRs reported. Skin manifestations of various types were the most reported ADRs.Conclusions: By keeping a careful and timely watch majority of the ADRS can be prevented by early intervention. There is also a need to ensure timely check on the drugs supplied by the various pharmaceutical companies who get the contract for government supply. This will be a step towards improving patient safety.

Analysis of adverse drug reactions in a tertiary care teaching hospital in Southern India

Background: Medication use has been there since time immemorial. Also, it was well known that all medications carry risk of adverse drug events. Hence regular and periodic monitoring of medications for adverse events has assumed importance. With this background pharmacovigilance has an important role to play in monitoring of adverse events to medications. Hence the present study was undertaken to analyze the pattern of adverse events reported to a tertiary care teaching hospital in Southern India (Shivamogga Institute of Medical Sciences (SIMS), Shimoga).Methods: This study is a retrospective observational study of 150 adverse drug events reported at McGann teaching hospital, SIMS, Shimoga. The adverse events reported were analyzed for their age and gender distribution, drugs causing ADRs, organ systems affected, causality, type, severity and preventability of ADRs.Results: Patients in age groups of 21-40 were most commonly affected by ADRs with a slight increase in male population affected. Cutaneous ADRs were most common and beta lactam antibiotics were most common drug group implicated in causing these ADRs. Probable/likely category most common WHO-UMC causality category, with type A ADRs being most common. Majority of ADRs were of moderate severity and nearly 86% of ADRs were of not preventable category.Conclusions: Antimicrobials were most commonly involved in causation of ADRs with cutaneous ADRs being most common. Most of ADR were not preventable category, majority of ADRs were of moderate severity and causality grading was probable/likely category.

Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

A Questionnaire Study on the Knowledge, Attitude, and Practice of Pharmacovigilance among the Medical Post Graduates in a Teaching Hospital in West Uttar Pradesh

Background: Pharmacovigilance aids in early detection of ADRs and as well as identification of various risk factors. Reporting of ADRs is crucial for the success of pharmacovigilance program. Aims/Objective: This questionnaire based study among medical resident’s aims at assessing knowledge, attitude & practice towards adverse drug reaction reporting in the teaching hospital attached to a private medical college and design methods to improve existing ADR reporting system in our setup. Methods: This study is a questionnaire based cross-sectional study. It was conducted at Teerthanker Mahaveer Medical College & research Centre, Moradabad, West Uttar Pradesh, among the first year and final year medical post graduates/PGs, by using a pre-validated, modified questionnaire on knowledge, attitude & practice. A total of 90 questionnaires were duly filled out by the post graduates. Data was analyzed by using SPSS V.20. The chi-square test was used to determine statistical significance. Results: Majority (89%) reported to have reasonable knowledge of adverse drug reactions, but reported an average degree of knowledge regarding various aspects of pharmacovigilance. 61% respondents were not aware of presence of an AMC affiliated to this hospital. Final year medical post graduates were found to have poor attitude towards acts of reporting of adverse drug reactions although they pose better knowledge regarding drug safety as well as importance of ADR reporting. Lack of training (90%) on ADR reporting was also recorded. Conclusions: This study recorded average knowledge, positive attitude towards necessity of reporting of ADRs of medical post graduates. Necessity of educational interventions to update knowledge and improve practice of ADR reporting were identified as important measures that need to be taken care of.

Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases.

Background: Epidemiological data are limited regarding clinical characteristic of adverse drug reactions (ADRs) in India. Aim: The aim was to assess ADRs with reference to the causative drugs, seriousness and their other clinical characteristics in Indian tertiary care teaching hospital. Methods: A spontaneous reporting based ADR monitoring study was conducted over a period of 2 years. 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 Naranjo’s algorithm, preventability by modified Schumock and Thornton’s criteria and types of reactions by Rawlins and Thompson classification. Subgroup analysis was performed between serious and non-serious reactions. Results: Of the total of 135 reactions reported 111 reactions from 97 patients were included for analysis. The incidences of overall and serious ADRs were 0.25 and 0.06 per 1000 patients, respectively. The most commonly implicated organ systems were skin and appendages (52.25%). The major causative drug classes were antimicrobials (40.28%), central nervous system (23.61%) and autacoids (15.97%). About twothirds of the reactions (65.77%) were classified as probable and one-tenth (8.10%) as preventable. The factors significantly associated with serious reactions were age group 40-60 years (odds ratio [OR]: 5.51), parenteral drugs (OR: 2.96), central and peripheral nervous system disorders (OR: 5.06), body as a whole - general disorders (OR: 9.05) and acute onset reactions (OR: 52.62). Conclusion: Antimicrobials are common causative agents. Cohort study is recommended to confirm the risk factors of serious ADRs in Indian population.

ADVERSE DRUG REACTION BRIEFING SYSTEM SOFTWARE AND ITS APPLICATION / 现代医院

Objective To use computer and network technologies for Adverse Drug Reaction(ADR) monitoring.Methods Design adverse drug reaction clinical briefing system software, use the advance of the briefing system in monitoring the adverse drug reactions with fast and convenient and high efficiency.Results The reported rate of adverse drug reactions increased significantly.Conclusion Hospitals strengthen ADR monitoring will help improve quality of medical care and safety of rational drug use.

Moral Protection for the Implementation of Medical Safety Principle / 中国医学伦理学

The function of morality in medicine lies in turning moral principles into moral practice.In the contexts that medical activities have transformed from the diagnosis and treatment of diseases to the current mode of the integration of prevention-diagnosis-treatment-rehabilitation of diseases,medical safety is drawing ever broader concern.The realization of medical safety calls for a perfect combination of qualified professional skill and professional morality.The principle of medical safety is the most basic principle for the production and clinical use of medicine.Practice of this principle in medical activities and in monitoring adverse drug reactions are the most basic requirements for every medical staff.