DrugCard Data Dose August 2023 p.2
Identifying and assessing new drug safety signals is a standard task in pharmacovigilance. However, it's worth noting that both the EU GVP guidelines and the UA Guideline on good pharmacovigilance practices consider this process to be critically important. Consequently, understanding how to recognize and detect these signals is crucial.
The scientific and medical literature is essential for monitoring the safety profile and the drug risk/benefit ratio, especially concerning detecting new signals or other safety issues. Continuous monitoring of the safety profile and assessing the risk/benefit ratio of drugs are critical pharmacovigilance processes. The literature monitoring process is always checked during the GVP audit. Auditors determine the existence of the process, its functioning, and compliance with the requirements of the guidelines and current pharmacovigilance legislation. Inappropriate literature monitoring by MAHs may lead to drug safety inconsistencies. Pharmaceutical companies certainly need to improve this component of the pharmacovigilance system. Company management should understand the importance of the proper pharmacovigilance system functioning as part of the business process. Today, there is an urgent need for the industry to use newer, more comprehensive, practical, and economic literature screening solutions to meet regulatory, marketing, and strategic requirements.
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In recent years,?pharmacovigilance?has become a critical aspect of ensuring patient safety in healthcare. One key element of pharmacovigilance is screening medical literature to identify potential adverse drug reactions (ADRs) and other safety concerns associated with medications. With the advancement of technology, cloud-based screening has emerged as a valuable tool in enhancing pharmacovigilance efforts. This article will explore the advantages of cloud-based medical literature screening in pharmacovigilance.
Cloud-based medical literature screening uses cloud computing to analyze vast medical literature for potential ADRs and safety concerns. It involves storing and accessing data over the Internet for efficient analysis. Here are some of the key advantages of using cloud-based medical literature screening in pharmacovigilance
Medication is one of the most powerful tools available for preventing and treating disease and alleviating symptoms. However, all medicines can cause adverse drug reactions (ADRs) despite their benefits. ADRs are harmful and unintended effects of drugs that occur at doses used in humans for prevention, diagnosis, or treatment. Due to their small sample size, pre-marketing clinical trials cannot detect all ADRs. Therefore, evaluating a medicine’s safety requires using it in less selected populations and for more extended practice periods. This ongoing assessment of the safety of marketed medicines is what pharmacovigilance entails.?Pharmacovigilance?is an essential component of drug safety and regulatory compliance. Pharmacovigilance risk assessment is a systematic approach to identifying, evaluating, and managing the potential risks of using medicinal products. This article will discuss how to conduct a pharmacovigilance risk assessment.