An analysis of the pattern and profile of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective record based observational study

Background: Adverse drug reactions (ADRs) are an important concern in modern therapeutics. Due to limitations in identifying ADRs during research phase, organized post marketing studies are essential. However, there are only few recent studies on this subject available in India. Hence this study was done in a tertiary care hospital in South Kerala to evaluate the profile and causality of ADRs.Methods: The details of patients who developed ADRs during the period from October 2016 to November 2017 were collected. Data collection was done using the suspected drug reactions monitoring form by CDSCO used under PvPI and a retrospective observational cross-sectional analysis was done. The profile and causality of ADRs were evaluated.Results: The total number of ADR events reported was 300. 179 ADRs were hypersensitivity reactions (Aronson Type B) and the remaining 121 reactions were Type A reactions. The individual drug class causing majority of the ADRs was antibiotics (36%). Commonest significant dose related ADR was bleeding (7%) caused by combined use of antiplatelets and anticoagulants. The organ system most affected as per SOC classification was skin and appendages (56%). Causality assessment revealed that majority (76%) belonged to “probable” category, whereas 23.6% were of “possible” type.Conclusions: The development of ADRs can significantly affect treatment course – interruption of drug therapy, use of additional drugs and prolonged hospital stay. Employing monitors dedicated to ADR detection and education of prescribers to closely monitor patients can help manage ADRs effectively

An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study

Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course

Awareness of pharmacovigilance and adverse drug reactions among second professional MBBS students of a medical college in Kerala, India

Background: Pharmacovigilance is the science and activities related to detection, assessment, understanding and prevention of adverse drug reactions (ADR). The major challenge faced by the pharmacovigilance programme of India is underreporting. It is mainly due to lack of awareness, knowledge, attitude and practice among health care professionals. The main objective of this study was to assess the knowledge, attitude and practices of second professional MBBS students towards ADR reporting and to provide a session on pharmacovigilance as an intervention to increase their awareness since they are the future budding doctors.Methods: This questionnaire based study was conducted among 158 second professional MBBS students of Travancore Medical College, Kollam, Kerala. A pretest was conducted using the questionnaire followed by which a two-hours session on ADR reporting and Pharmacovigilance was given. A posttest was done with the same questionnaire. The response of the KAP questionnaire were analysed separately for pretest and posttest in percentages and based on scores and was compared.Results: Out of the158 students participated all the students successfully completed the questions of both pretest and posttest within stipulated time frame. In pretest 3 (1.9%), 101 (64%), 43 (27.1%) candidates were categorized to excellent, good and poor respectively. In posttest 155 (98.1%), 3 (1.9%) were in excellent and good category respectively. There was not even a single candidate in poor category. There was a marked increase in the knowledge and awareness of the students after the two hours intervention session on ADR reporting and pharmacovigilance which was statistically significant (p= 0.001).Conclusions: This study revealed the awareness of second professional MBBS students towards ADR reporting and Pharmacovigilance in our institution and also clearly showed the importance of early sensitization through educational interventions, which improved the KAP in pharmacovigilance in them. Educating medical students will improve the challenge of underreporting of ADRs and will increase the numbers of ADRs reported in our country

AN ANALYSIS OF THE PREVALENCE OF POLYPHARMACY AMONG INPATIENTS OF A TERTIARY CARE HOSPITAL IN KERALA

Objectives: The aim of the study was to estimate the prevalence of polypharmacy, identify the age groups commonly associated with polypharmacy, study the correlation between duration of hospital stay and polypharmacy, and identify the diseases commonly associated with polypharmacy Methods: Record-based, prospective, and cross-sectional study among 370 inpatients of a tertiary care hospital in Kerala. Prescriptions containing ≥3 drugs were collected from inpatient medical records of patients with at least 3 days hospital stay. The number of drugs ≥5 was considered as polypharmacy in the present study. Results: The prevalence of polypharmacy was 93% and average the number of drugs per prescription was 8.81±3.097. Average number of drugs per prescription was significantly high among patients >60 years. Percentage of prescriptions with polypharmacy among patients with duration of stay 3–5 days, 6–8 days, and ≥ 9 days was found to be 89.4, 98.6, and 100, respectively. There was a significant positive association between duration of hospital stay and percentage of prescriptions with polypharmacy as well as average number of drugs per prescription. Diseases or comorbidities most commonly associated with polypharmacy were hypertension, diabetes mellitus, cerebrovascular accidents, coronary artery disease, and dyslipidemia. Conclusion: The prevalence of polypharmacy was high in the present study (93%) when compared to similar studies. Age >60 years was strongly associated with the prevalence of polypharmacy, but gender was not found to be factor. Duration of hospital stay was an important factor positively associated with percentage of prescriptions with polypharmacy as well as number of drugs per prescription

AN ANALYSIS OF THE PATTERN AND THE RISK FACTORS OF ADVERSE DRUG REACTIONS AT A TERTIARY CARE HOSPITAL

Objective: The objective of the study was to analyze the pattern and risk factors of adverse drug reactions (ADR) in a tertiary care hospital. Methods: In this retrospective study, all the suspected ADRs reported to ADR monitoring center were analyzed for the demographic details, its temporal association, status of recovery, seriousness and outcome of reaction, details of the suspected and concomitant medications. Data on various predisposing factors responsible for an ADR, such as presence of co-morbidities, use of Fixed Dose Combinations (FDC), improper monitoring, presence of drug interactions, and presence of polypharmacy were also collected. Descriptive statistics and Chi-square were used for data analysis. A p value of <0.05 was taken as level of significance. Results: Out of the total 233ADRs, 48.9% were reported among geriatric patients. The study showed a female preponderance with 51.9%. The highest number of ADRs was reported from the therapeutic class of antimicrobials 18.9%. The skin and appendages constituted the most common organ system affected with 33.5%. Out of 106 serious ADRs, majority required prolonged hospitalization 62.3%. About 78.1 % of reactions were found to be predictable and 72.5% preventable. A positive association was found between ADR and co-exiting co-morbidity (60%), polypharmacy (66.5%), and use of FDC (18.45%). ADRs secondary to inadequate monitoring was 7.7% and those due to drug-drug interaction was 6.5%. Conclusion: Female population, age >60 years, and presence of concomitant co-morbidities were the patient related risk factors and polypharmacy, drug-drug interactions, and inadequate monitoring were the drug related risk factors for development of ADRs