Khwaja Amtul Raouf Qazi
MRM College of Pharmacy, India
Title: 3G system in pharmacy practice with vigilance
Biography
Biography: Khwaja Amtul Raouf Qazi
Abstract
India is a hub of global clinical trials and a destination for drug discovery & development. However, whether patients in India receive safe drugs or not is still very much in question. Rapid induction of high tech pharma products in the market throw up the challenges of monitoring Adverse Drug Reaction (ADRs). The complete safety data commonly is captured through Pharmacovigilance. True challenge lies in recognizing the importance & applying current 3G system in pharmacy, i.e., Good Manufacturing Practices, Good Laboratory Practices & Good Pharmacy Practices with vigilance in order to improve public health. This article mainly highlights on Medwatch program & its goal and patient safety. It mainly focuses on adverse effect reporting & producing new safety information to patients. Medwatch is the FDA reporting system for an adverse effect, aimed to detect safety hazard signals for medical products. It deals with pre-market review and approval & post-market monitoring for safety. It also determines the benefit and limitation of clinical trials. It focuses on adverse event monitoring and new drug safety problems. Approaches like–Yellow Card Scheme for ADR reporting in the UK should also are encouraged worldwide to identifying new information about hazards associated with medicines. Even, mandatory reporting is required by manufacturer to submit the reports to the healthcare provider & post-authorization safety experience should be conducted to ensure the benefits of use of drugs. Thus, it generates a great way towards a safe medical practice.