Demystifying drug safety: The significance of global and local literature in pharmacovigilance
By TOI Desk Report December 15, 2023 Update on : January 17, 2024
Gathering information about medications in clinical practice is crucial for ongoing analysis of the risks and benefits of drug use. Medical literature, in turn, is an essential source of new information on the safety of pharmaceuticals. However, in pharmacovigilance, there are many myths and biases. Literature monitoring, as one of the vital critical processes in pharmacovigilance, is certainly not immune to such misconceptions. In pharmacovigilance, there is a concept of “global” and “local” literature. Here lies one of the common myths. Some believe that only articles published in leading journals deserve scrutiny. In other words, screening of global literature should be conducted, neglecting the local. Yet, this ignores a vast amount of relevant safety information about drugs that can be found in small specialized publications. There is compelling evidence for this.
Evidence #1 – Regulatory requirements for good pharmacovigilance practice
Regulatory requirements for pharmacovigilance state that the applicant of medicinal products must ensure the process of checking the literature for information on the safety of their medicinal products at least once a week. However, if, for example, the EMA shows the screening of certain active substances on its own in the European Union, monitoring local literature remains the applicant’s responsibility. Considering that not all countries have a list of such local literature, the applicant decides and justifies the list of journals and sources for monitoring. Of course, this is challenging and cumbersome for pharmaceutical companies, but regulatory requirements must be adhered to. It is essential to remember that such requirements aim to improve safety, and there is an explanation for this. So, let’s move on to evidence number two.
Evidence #2 – Population-specific features of drug use in different countries
Well-known scientific and medical journals typically publish articles related to the safety of pharmaceuticals. However, new and vital information may be first presented at international symposiums or in local journals. Local medical literature is a treasure trove of knowledge and a valuable source of information about the peculiarities of drug effects on patients in different countries. Frequently, journals not indexed in global databases contain information about the impact of drugs on a limited cohort of patients in a specific locality. When it comes to the effects of drugs, it refers to both the safety of use, such as cases of side effects, and effectiveness. One should remember the genetic characteristics of different populations, which can also influence the use of drugs.
Evidence #3 – Delay in the publication of journals in global databases
Fully indexed publications in bibliographic databases become available later than their publication in journals. That is, the issue has already been published on the official website of the medical journal, but it will appear much later in the global database. Of course, this can cause a delay in collecting and identifying safety information. It’s important to note that such a delay can extend beyond six months. The DrugCard platform blog recently published a vivid example of such a delay. It turned out that the platform detected a case of a side reaction to a drug published in a new issue of the journal several weeks before this issue appeared in PubMed. Regarding patient safety, it is still necessary to be one step ahead, trying to reduce such temporal gaps.
Conclusion for pharmacovigilance
Medical journals publish the results of clinical studies and descriptions of clinical cases that contain valuable information about drug side effects. Therefore, regulatory authorities consider medical literature an essential source of new information about the safety of pharmaceuticals. The literature review should include using bibliographic databases and monitoring full-text articles from local medical journals. When conducting a literature review solely based on global databases, there is a risk of missing messages primarily presented in journal supplements or conference materials. Additionally, publications in bibliographic databases become available later than their publication in journals, which can cause a delay in collecting and identifying safety information. Both methods have advantages and limitations, but neither should be a standalone system. Therefore, a combination of both is necessary for an adequate drug safety assessment.Read more: Demystifying drug safety: The significance of global and local literature in pharmacovigilance