The industry is looking at utilising available tools and technologies to be efficient and provide more accurate and reliable data in support of the regulatory requirements, eventually working towards data-backed information for the medical fraternity and the public. Blockchain offers a decentralised, uniformly distributed node-based database that protects data security and transparency. With the help of numerous nodes, blockchain enables diverse entities to handle data. This decentralisation helps the entities to see real-time transactions/revisions without the intervention of any third party. In this article, we will demonstrate how this innovation offers a system and technique for secure data management in pharmacovigilance and present potential advantages and known disadvantages/problem areas thereof.
INTRODUCTION
There is a significant conflict between accessibility and safety in the creation of drugs. Even though pharmaceuticals can effectively treat illnesses and enhance the quality of life1 , drug research and development are costly and pharmaceutical corporations could prioritise making a profit on their investment2 . However, medications can also cause ADRs that may be fatal and the detection of such responses necessitates extensive and time-consuming testing of the drug’s safety, significantly lengthening the time it takes for new medications to reach the market3 . ADRs could have serious implications. To identify safety signals related to medications, pharmacovigilance specialists typically manually evaluate ADR reports. ADR reports now routinely overwhelm pharmacovigilance networks because of the recent expansion of reporting to patients and the growth of mass media-related sanitary emergencies. The traditional system that applies pharmacovigilance is very expensive and often fails to monitor ADRs experienced by users if these are not reported to the authorities, pharmaceutical companies, or medical professionals4,5. The reporting of these ADRs is important because it may help to protect public health1 . Overall, pharmacovigilance is the cornerstone in the regulation of drugs1 . Introducing tools and practices from blockchain in the research field of pharmacovigilance will alleviate various tensions. Blockchain can perform ongoing monitoring of ADRs of existing drugs and the tracking of large amounts of data. It will minimise the time-to-market of effective drugs and will allow their long-term safety post-market authorisation to be continuously examined.
