scholarly journals Healthcare professionals’ perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Helen Byomire Ndagije ◽  
Ronald Kiguba ◽  
Leonard Manirakiza ◽  
Elijah Kirabira ◽  
Allan Sserwanga ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Healthcare Professionals ◽  
Post Marketing Surveillance ◽  
Post Marketing

scholarly journals Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future

2020 ◽  
Vol 11 ◽  
pp. 204209862093859 ◽  
Author(s):  
Muaed Alomar ◽  
Ali M Tawfiq ◽  
Nageeb Hassan ◽  
Subish Palaian
Keyword(s):  
Adverse Effects ◽  
Health Professionals ◽  
Healthcare Professionals ◽  
Spontaneous Reporting ◽  
Future Prospects ◽  
Innovative Strategies ◽  
Post Marketing Surveillance ◽  
The Future ◽  
Post Marketing ◽  
Reporting Programs

Background: To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to post marketing surveillance and spontaneous reporting programs were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. The health professionals’ awareness regarding existing spontaneous reporting programs is highlighted. Future prospects of pharmacovigilance are discussed. Results: Though beneficial, spontaneous reporting programs encounter several limitations and difficulties in diagnosing adverse drug reaction. Under-reporting and bias are major challenges. Online signal detection tools and innovative methods are needed to strengthen the spontaneous reporting programs. We provide the various issues to be considered while depending on spontaneous reporting programs as a method of post marketing surveillance. Conclusion: To strengthen the spontaneous reporting programs as an effective post marketing surveillance method, more awareness among health professionals and innovative strategies is needed. Integrating pharmacogenetic data can be a potential aspect of future pharmacovigilance. Plain language summary Monitoring adverse effects of marketed medicines through reporting by healthcare professionals and its challenges and way forward Introduction: This article highlights the importance of safety monitoring of medicines after they are launched in the market, mainly through reporting by healthcare professionals. We also highlight the strengths and weaknesses, and provide an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to the topic were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. Health professionals’ awareness regarding existing programs on reporting safety of medicines is highlighted. Results: Though beneficial, reporting of adverse effects by healthcare professionals who deal with patient lacks clarity in diagnosing the adverse effects. Under-reporting and bias are the major challenges. Online software is needed to strengthen reporting by healthcare professionals. We list the various issues to be considered while depending on healthcare professionals’ reporting of adverse effects as a method of post marketing surveillance. Conclusion: To strengthen medicine safety monitoring and reporting by healthcare professionals, more awareness among health professionals and innovative strategies are needed. Integrating the genetic data of patients can be beneficial in predicting adverse effects, therefore avoiding them and enhancing safe prescribing and dispensing by healthcare professionals.

scholarly journals Research Clinical Trial- A Review

2021 ◽  
Vol 01 (09) ◽  
Author(s):  
Dr. Ishita Attri ◽  
Keyword(s):  
Clinical Trial ◽  
Healthcare Professionals ◽  
Research Study ◽  
Research Protocol ◽  
Team Members ◽  
Roles And Responsibilities ◽  
Post Marketing Surveillance ◽  
Post Marketing

Majority of healthcare professionals are struggling with conducting and writing a protocol for a research study. Thus, the purpose of this article is to summarize significant steps and necessary guidelines for producing a standard research protocol, roles and responsibilities of various team members involved in the study, and conduction of actual clinical trial including its initiation, phases (I-III), termination or post-marketing surveillance phase. It is important to note that the quality of a clinical trial largely depends on the protocol to achieve success in the research study.

scholarly journals Interim analysis for post-marketing surveillance of dabrafenib and trametinib combination therapy in Japanese patients with unresectable and metastatic melanoma with BRAF V600 mutation

2020 ◽  
Vol 25 (10) ◽  
pp. 1870-1878
Author(s):  
Yasutomo Teshima ◽  
Minako Kizaki ◽  
Ryohei Kurihara ◽  
Ryosuke Kano ◽  
Miki Harumiya
Keyword(s):  
Combination Therapy ◽  
Metastatic Melanoma ◽  
Group Performance ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Japanese Patients ◽  
Post Marketing Surveillance ◽  
Daily Dose ◽  
Median Daily Dose ◽  
Post Marketing

Abstract Purpose To investigate the safety and efficacy of dabrafenib and trametinib combination therapy for BRAF V600 mutation-positive unresectable and metastatic melanoma in over 100 Japanese patients of a real-world clinical setting. Patients The surveillance period of interim post-marketing surveillance (PMS) analysis was from June 2016 to November 2018, and 112 patients with unresectable and metastatic BRAF V600 melanoma who received dabrafenib and trametinib were enrolled. Results The safety analysis set included 112 patients whom almost all patients had stage IV disease (n = 97, 86.61%) with an Eastern Cooperative Oncology Group performance status 0 or 1 (n = 102, 91.07%), and mean (standard deviation) lactate dehydrogenase level was 354.3 (456.4) U/L (n = 105) at baseline. Median daily dose of dabrafenib was 300.0 mg/day (118–300), and median daily dose of trametinib was 2.00 mg/day (1.0–4.0). Adverse drug reactions (ADRs) were reported in 84 patients (75%), and common ADRs (incidence ≥ 5%) were pyrexia (n = 49, 43.75%), hepatic function abnormal (n = 11, 9.82%), rash and blood creatine phosphokinase increased (n = 9 each, 8.04%), and erythema nodosum (n = 6, 5.36%). Majority of ADRs reported in this study were consistent with that reported in previous trials. In the efficacy analysis set of 110 patients, the objective response rate was 55.45% (95% confidence interval 45.67–64.93%), and median progression-free survival was 384.0 days (251.0 days-not reached). Conclusions No new safety or efficacy concerns were observed in this interim PMS analysis in Japanese patients with unresectable and metastatic melanoma with BRAF gene mutation who received dabrafenib and trametinib combination therapy.

EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

1983 ◽  
Vol 22 (03) ◽  
pp. 135-148 ◽  
Author(s):  
T. Kitaguchi ◽  
T. Nojiri ◽  
S. Suzuki ◽  
T. Fukita ◽  
T. Kawana
Keyword(s):  
Data Base ◽  
Clinical Case ◽  
Drug Information ◽  
Case Record ◽  
Post Marketing Surveillance ◽  
Japanese Character ◽  
Record Data ◽  
Post Marketing ◽  
On Line ◽  
Line Drug

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Term Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Long Term Therapy
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