The GVP rules set stringent regulations for what pharmaceutical companies must do to manage safety data. Given these requirements, it is important for companies to establish a proper pharmacovigilance system, which can cause a number of difficulties. One such problem is the proper process of medical literature monitoring. Scientific and medical literature is an important source of information on suspected adverse reaction case reports. For the European Medicines Agency, the scientific literature is even the second-largest source of reports. There are two options for conducting medical literature monitoring: in-house or outsourcing this part of pharmacovigilance activities. Therefore, the company faces the question of what to choose: in-house vs outsourcing literature monitoring? And is it possible to find an intermediate solution? In this post, we will look at the advantages and disadvantages of outsourcing. In addition, we will consider the advantages of performing in-house literature monitoring with automating techniques.
Challenges in medical literature monitoring
GVP requires that literature searches be conducted not only to identify adverse drug reactions but also to detect other information that may impact the risk-benefit ratio of drugs. For example, PSURs must now include a summary of new and significant safety literature findings from a given reporting period. A large amount of scientific medical literature for screening is one of the major challenges. The huge number of journals and published articles make it difficult even to maintain a complete list of relevant journals. Therefore, companies conduct regular checks of its completeness. The company must demonstrate that its list of journals is adequate and relevant during audits. Inspections and audits are other challenges for pharmaceutical companies. Recently, regulators have begun to pay increased attention to the verification of the medical literature screening. Therefore, the proportion of major and minor audit and inspection findings related to literature monitoring has also increased.
Advantages and disadvantages of outsourcing medical literature monitoring
The main advantage of outsourcing is the absence of the need for new full-time staff. With outsourcing, there is no need to find and train in-house staff. However, outsourcing is not without its risks. It is important for companies to ensure that the vendor is fully qualified to perform the agreed-upon tasks. The contractual agreement includes and clearly defines all responsibilities for literature monitoring. In-house specialists, depending on the conditions of the SDEA, process and analyze all the data received from the vendor. It is necessary to remember the responsibility not to miss any adverse events or other important safety information. Whether the work is done in-house or by a vendor, the responsibility is on the marketing authorization holder. There is a number of conditions to keep in mind when deciding on the services to outsource, and some of them are the company size and type of drugs.
Advantages and disadvantages of in-house literature monitoring
Internal pharmacovigilance units in pharmaceutical companies in many instances have much greater ‘in-house’ expertise on the safety of their products. Safety teams collect pharmacovigilance data from all sources of information around the world. Thanks to this data collection, the teams monitor safety and are able to adjust the benefit-risk profile of products. A high level of knowledge about the company’s products is the main advantage of in-house specialists. Due to the increased awareness of specialists about the safety of drugs, the company can always be confident in its products. But, some companies still monitor the literature manually and fill in excel tables. Manual literature monitoring takes too much time and effort. This outdated approach leads to findings from regulators during audits and inspections.
Solution model for conducting literature monitoring
To manage some of the challenges associated with outsourcing and in-house system functions, companies can automate their literature monitoring process. This will increase its efficiency and improve the quality of the continuous literature review. Using automated literature monitoring software may be the right solution for most companies. The software solution can help companies manage their literature monitoring workflows. In-house software solutions provide oversight of users. Thus combining in-house resources with an automated literature monitoring tool can help companies solve literature search problems. This will greatly improve efficiency and provide extended flexibility in workload management. The automated platform DrugCard is such a solution. The workflow on the platform is separated into user roles for full compliance with GVP regulatory requirements. The audit trail helps keep track of all processing and editing of each entry. This allows you to control the entire process of medical literary monitoring for the pharmacovigilance department.
Advantages of in-house literature monitoring when automating this process with the DrugCard platform
The DrugCard platform does all the routine work of the medical literature screening among web pages, any PDF files (even scanned ones), DOC\DOCX files and images. Thus, the “manual” search for articles on a variety of resources and hourly reading of full-text medical journals is completely excluded for in-house specialists. Sources for literature search in the DrugCard platform are constantly updated, and new journals are added from different countries. Platform specialists independently maintain the list of sources up to date. Therefore, the list of sources is available at any time and can be easily customized to the company’s needs. The platform contains a built-in reporting system for monitoring the medical and scientific literature. Thus, all solutions implemented in the DragCard platform fully meet the requirements of the GVP.
Summary for pharmaceutical companies
Pharmacovigilance will continue to grow and develop as a discipline. Strict regulation of pharmacovigilance activities remains important. But in the future, pharmacovigilance work will be more focused on the science and not just on the aspects of regulation. The key tasks will be to identify rare but serious adverse reactions and actions to prevent them or minimize their negative impact. The proper functioning of the PV system depends on the company having effective solutions for its work. Pharmaceutical companies often have an internal drug safety team. Also, companies work with vendors to scale and reduce pharmacovigilance costs. But companies can make the work of their pharmacovigilance in-house specialists easier. Automation of pharmacovigilance processes helps specialists to pay more attention to clinical and scientific issues. Therefore it is time to automate the process of medical literature monitoring for in-house pharmacovigilance departments, taking into account future challenges.