Clinical view on adverse drug reactions, pharmacovigilance in India and role of clinical pharmacist

An Adverse Drug Reaction (ADRs) is still a challenge in modern healthcare, increasing complication of therapeutics, an elderly populace and increasing multimorbidity. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. This article is having objective of evaluating the pharmacist perception about Pharmacovigilance and ADRs monitoring through ample literature review. In India pharmacovigilance activity begins in 1986 with ADR monitoring system under supervision of drug controller general of India. The prescribed National Pharmacovigilance Program was commence in 2005; with unsuccessful attempt in 1998, and renamed as Pharmacovigilance Program of India (PvPI) in 2010. Adverse drug reactions monitoring has become an essential part to be executed together with other health-care services for a safe use of medicines. Pharmacist can play an important role in evaluation of ADRs. Pharmacist – drug expert- having abundant knowledge of pharmacological action, pharmaco-therapeutics, adverse reactions, and disease pathophysiology, can make the drug therapy safer.

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10–19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of “death” and “did not recover” as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10–19 years, respectively. The most frequently reported vaccine–reaction pair was Haemophilus influenzae type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10–19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.

PENGETAHUAN DAN PERSEPSI APOTEKER TERHADAP SISTEM PELAPORAN MONITORING EFEK SAMPING OBAT (MESO) DI APOTEK WILAYAH KOTA YOGYAKARTA

The importance of pharmacovigilance activity is the Adverse Drug Reaction (ADR) reporting system. Many pharmacists who do not report ADR incident and number of ADR indicated that more knowledge and good perception of ADR is needed. This study was aimed at investigating the knowledge and perception of pharmacists towards the ADR reporting system of Community Pharmacists in Yogyakarta City, Indonesia. Cross sectional study design was conducted to community pharmacists (n=275) in Yogyakarta City, Indonesia on the period of November 2016 to March 2017. All data were analysed by Statistical Package for Social Sciences (SPSS) software V.16.0. Results were reported as frequency, and we used cross tabulation. The questionnaire consisted of questions about the sociodemographic characteristics of the Pharmacists. Furthermore, questionnaire with nine and eight points for assessing knowledge and perception about ADR Reporting System in Indonesia was used. The response rate of community pharmacists reached 36% (n = 100). A majority of the respondent was female (81%) and respondents of age group 20–30 years were predominantly (55%). Most of the respondents was graduated as pharmacist (85%), in the graduation year of 2010-2016 (55%). Most of the pharmacist had 1-5 years of work experience (44%) and never get pharmacovigilance training (86%). Most of the pharmacists had fair knowledge ( 40%) and fair perception (65%) towards the ADR reporting system. Pharmacovigilance training and last education of community pharmacists could influence the pharmacists’ knowledge (p: 0.00 and 0.013, respectively). Moreover, there was no significant association between pharmacists’ knowledge and perception (p > 0.496).

AWARENESS, KNOWLEDGE AND ATTITUDE TOWARDS PHARMACOVIGILANCE AMONG MEDICAL GRADUATES IN A TERTIARY CARE TEACHING HOSPITAL IN SOUTH INDIA.

Objectives: As an ever growing scale people are using newer and more effective drugs for various medical conditions. Adverse drug reactions (ADRs) are preventable if the health-care professional pays close attention to the details of the adverse effects, following a drug administration. Awareness about ADRs can decrease the irrational use of drugs. Hence, there is an urgent need to create awareness among the prescribers about the ADR monitoring. Hence, this study is undertaken to assess the awareness, knowledge, and attitude toward Pharmacovigilance among the future health-care professionals.Methods: Questionnaire-based study was conducted in a tertiary health-care hospital after getting approval from the Institutional Ethical Committee. The questionnaire was developed to assess the knowledge, awareness, and practice of Pharmacovigilance activity. The questions were distributed to the final year students, interns, and postgraduate’s students and allowed to write down the answers independently. Each correct answer was given a score of ‘1,’ whereas the incorrect/incomplete was given a score of “0.”Results and Conclusion: The study reported that awareness (UGs - 53.3%, interns - 54.9%, PGs - 30.75) was adequate among undergraduates and interns, in the knowledge part (UGs-65.5%, interns - 35.4%, PGs - 9.2%), undergraduates excel far than the interns and PGs. However, in the application of Pharmacovigilance (UG - 22.2%, interns - 59.8%, PGs - 63.1%) postgraduates and interns fair better than the undergraduates. Hence, there is need to increase the awareness and also increase the ADR reporting practice among medical graduates.