FUTURE PERSPECTIVES OF PHARMACOVIGILANCE IN ACCORDANCE WITH CURRENT

2018 ◽  
Vol 5 (01) ◽  
Author(s):  
Rajeshwar Verma ◽  
Shubham Bhardwaj ◽  
Romil Sharma ◽  
Vimal Arora
Keyword(s):  
Spontaneous Reporting ◽  
Adverse Drug Events ◽  
Pv System ◽  
Post Marketing ◽  
Current Scenario ◽  
Regulatory Bodies ◽  
Marketing Data ◽  
Pharmaceutical Industries ◽  
Drug Adverse Effect ◽  
Regular Training

India’s participation in multinational trials has increased in past few years. This review article provides information regarding overview of the Pharmacovigilance (PV) system in India, focusing on the current scenario, its development and the challenges faced shows PV will lead robust of its tremendous effect in upcoming future. PV in India relies mainly upon the spontaneous reporting of adverse drug events and there is an improvement in the number of given reports after regular training and awareness programmes. To increase the post marketing data collection of drug adverse effect pharnacovigilance programme of India has taken an initiative by launching a toll free number for consumers to report. Actually a change in way of thinking is necessary for doctor-Pharmacist, patients, regulatory bodies and pharmaceutical industries. Pharmacovigilance will provide a better and improved future of pharmaceutical industry alongwith carrier opportunities.

scholarly journals PHARMACOVIGILANCE: DYNAMICS IN INDIAN PHARMA INDUSTRY

2018 ◽  
Vol 6 (01) ◽  
pp. 30-33
Author(s):  
Shubham Bhardwaj ◽  
Rajeshwar Verma ◽  
Romil Sharma ◽  
Rahul Solakhia
Keyword(s):  
Early Stage ◽  
Safety Issue ◽  
Safety Information ◽  
Safety Monitoring ◽  
Reporting Rate ◽  
Drug Safety Issue ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Marketing Data ◽  
Pharmaceutical Industries

Pharmacovigilance refers to the process of identifying, detecting, and responding to drug safety issue and has witnessed dynamic advancements in pharmaceutical industries throughout the world. The main objective of pharmacovigilance is to extend the safety monitoring and to detect any ADRs that previously got unrecognized in evolution during clinical trial. ADRs monitoring is required for each medicine throughout its lifecycle which includes early stage of drug design, clinical trials, and post marketing surveillance. The emerging trend in pharmacovigilance is to link the pre marketing data with the data collected during post marketing phase that include safety information. India is a vast country with population of over 1.32 Billion with different social economics status, different patterns of disease prevalence it becomes more important to have a standardized and robust pharmacovigilance. Pharmacists, as doctor remark that their involvement may increase the reporting rate and have a greater role to play in the area of pharmacovigilance

scholarly journals Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan

Breast Cancer ◽  
2021 ◽  
Author(s):  
Yucherng Chen ◽  
Satoshi Noma ◽  
Yoshio Taguchi ◽  
Masashi Takahashi ◽  
Junji Tsurutani ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Age Distribution ◽  
Metastatic Breast ◽  
Advanced Age ◽  
Spontaneous Reports ◽  
Post Marketing ◽  
Marketing Data

Abstract Background This study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan. Methods Spontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data. Results Of 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had ≥ 1 symptom at diagnosis, commonly dyspnea/shortness of breath (59%), cough (44%), and/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status. Conclusion Advanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit–risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.

Drug-induced neuropsychiatric adverse events using post-marketing surveillance

2021 ◽  
Vol 16 ◽  
Author(s):  
Tomohito Wakabayashi ◽  
Takahiro Nakatsuji ◽  
Hiroko Kambara ◽  
Iku Niinomi ◽  
Saki Oyama ◽  
...  
Keyword(s):  
Spontaneous Reporting ◽  
Abnormal Behavior ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Neuraminidase Inhibitors ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Real World Setting ◽  
Post Marketing Surveillance ◽  
Post Marketing

Background: Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs including neuraminidase inhibitors (NIs). However, information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify drugs associated with abnormal behavior using a spontaneous reporting system database. Methods: We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed. Drug associated with abnormal behavior were estimated using disproportionality analysis with calculation of the reporting odds ratio and 95% confidence interval. Results: A total of 1,144 reports of abnormal behavior were identified. Signals were detected showing the association of 4 including neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with abnormal behavior, and these signals were stronger for oseltamivir than other neuraminidase inhibitors. Signals were also detected for acetaminophen and montelukast. Conclusion: Our results should raise physicians’ awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.

scholarly journals An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

2021 ◽  
pp. 01-06
Author(s):  
Unnati Saxena ◽  
Debdipta Bose ◽  
Shruti Saha ◽  
Nithya J Gogtay ◽  
Urmila M Thatte
Keyword(s):  
Adverse Drug Events ◽  
The United States ◽  
Institutional Review Boards ◽  
Chi Square ◽  
Institutional Review ◽  
United States Food ◽  
Post Marketing ◽  
Chi Square Test ◽  
Us Fda ◽  
Review Boards

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

scholarly journals Ethical Relation between Physicians and Pharmaceutical Industries in the Perspectives of Bangladesh

2015 ◽  
Vol 6 (1) ◽  
pp. 1-5
Author(s):  
Shahinul Alam ◽  
Nahiduz Saman ◽  
Monsur Hallaj Hallaj ◽  
Jahangir Ul Alam ◽  
Shoaib Momen Majumder
Keyword(s):  
Developing Countries ◽  
Pharmaceutical Industry ◽  
Ethical Guidelines ◽  
Ethical Relation ◽  
Guide Line ◽  
Current Scenario ◽  
Pharmaceutical Industries ◽  
Scientific Meetings ◽  
The Right

Relation between physicians and pharmaceutical industry is required for the benefit of the patient. But it may turn into business and overthrow the patients’ benefit. The relation might be in question at present and in future. Several questions are flowing in Bangladesh. To solve these queries we have explored the situation in developed and developing countries. The physicians and associations of pharmaceutical industries developed several ethical guidelines in those countries. They have addressed the long lasting issues on gift provided to physician, cash back, sample, industry sponsored scientific meetings, research and hospitality. There are huge restrictions to ensure the right of the patient’s e.g. limitation of inexpensive gift by the pharmaceuticals, avoiding expensive medicine instead of equally effective low priced medicine. We are lacking behind to protect the patient right properly: regulation, adherence to existing guide line, lack of guidance from statutory bodies. The current scenario is far behind the right of patient. In Bangladesh it is not yet addressed either by professionals or by pharmaceutical associations. It is the immediate need to construct a guide line for physicians and pharmaceutical industry of Bangladesh.Bangladesh Journal of Bioethics 2015 Vol.6 (1):1-5

scholarly journals Pharmacovigilance Assessment of Drug-Induced Acute Pancreatitis Using a Spontaneous Reporting Database

2019 ◽  
Vol 38 (6) ◽  
pp. 487-492 ◽  
Author(s):  
Iku Niinomi ◽  
Keiko Hosohata ◽  
Saki Oyama ◽  
Ayaka Inada ◽  
Tomohito Wakabayashi ◽  
...  
Keyword(s):  
Acute Pancreatitis ◽  
Odds Ratio ◽  
Spontaneous Reporting ◽  
Adverse Drug Events ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Event Report ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Spontaneous Reporting Database

Background: Acute pancreatitis (AP) is associated with risks of morbidity and mortality. The incidence of AP recently increased compared to that traditionally reported in the literature. Objective: The purpose of this study was to evaluate the possible association between AP and drugs using the Japanese Adverse Drug Event Report (JADER) database, which is a spontaneous reporting database of adverse drug events. Methods: Adverse event reports submitted to the JADER database between 2004 and 2017 were analyzed. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR) with 95% confidence intervals for signal detection. Results: A total of 3,443 reports (0.17% of all adverse events) were identified as drug-induced AP, in which 431 different drugs were involved. Acute pancreatitis was frequently reported in men (58.5%) in their 60s (19.1%); 40.6% developed AP within 4 weeks after the treatment. Among the most frequently reported drugs, signals were detected for prednisolone, ribavirin, sitagliptin, mesalazine, tacrolimus, and l-asparaginase, which are well-known causes of AP. Telaprevir, donepezil, and ustekinumab also generated signals. As for drugs with high RORs, l-asparaginase and alogliptin were noteworthy. Conclusion: Most of the identified drugs were already known to induce AP, but the likelihood of the reporting of AP varied among the drugs. Our results should raise physicians’ awareness of drugs associated with AP, but further investigation of these medications is warranted.

scholarly journals Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data

2019 ◽  
Vol 51 (1) ◽  
pp. 149-157 ◽  
Author(s):  
Timothy Card ◽  
Ryan Ungaro ◽  
Fatima Bhayat ◽  
Aimee Blake ◽  
Gary Hantsbarger ◽  
...  
Keyword(s):  
Study Results ◽  
Post Marketing ◽  
Marketing Data

scholarly journals P724 Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data

2019 ◽  
Vol 13 (Supplement_1) ◽  
pp. S483-S484
Author(s):  
T Card ◽  
R Ungaro ◽  
F Bhayat ◽  
A Blake ◽  
G Hantsbarger ◽  
...  
Keyword(s):  
Study Results ◽  
Post Marketing ◽  
Marketing Data
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