Maciej Szewczyk, CEO
The monitoring of medical literature is becoming critical for marketing authorisation holders (MAHs) in the wake of the tightening regulations, which stress that the literature reviews for pharmacovigilance (PV) should include global databases that contain the largest reference of articles relating to the medicinal properties of products that are in the MAHs portfolio, as well as the medical publications in local journals in countries where medicinal products have a marketing authorisation. Although compliance demands that MAHs need to possess robust procedures in place to monitor local journals, no further instructions are given by the most of regulatory agencies. However, the database allows accessing the abstracts only with English as the prevalent language, without indexing articles published in the local language. This can lead to missing important data in the PV of medical products. Realising these shortcomings in the PV space, MS Pharm utilised its premium processes with automatic steps, involving validated tools, and proficient team of reviewers to offer a full range of relevant information on PV from local literature sources.
MS Pharm employs native reviewers to conduct a manual, full-text review of the local articles and identify the safety-relevant information for PV purposes. The reviewers have the medical or pharmaceutical background, and they extract relevant data from full-texts and deliver it with all possible details—products used, PV classification, patient details and more. The information captured from the local literature is indexed and coded into MS Pharm’s internal database. This data, beyond that resulting from just abstract review, brings added value to the MAHs. MS Pharm can provide PV-relevant information (i.e. potential valid ICSR), which would have been otherwise overlooked by the abstract review. Furthermore, MS Pharm reviews local literature—mostly published in local languages, in non-indexed journals—that may be completely ‘invisible’ to the big pharma world. This data source, which is not accessible in any other way than just reading it, is of great significance as spontaneous reporting in CEE and CIS countries is, in fact, lower than in the US and western Europe.Currently, the company renders its services in over 40 countries, reviewing around 1000 medical and pharmaceutical journals not indexed in any global literature database. “Our goal is really to bring deep local knowledge and insights from local experience to the MAHs so that they can benefit from them,” mentions Maciej Szewczyk, CEO at MS Pharm.
Speaking further, Szewczyk highlights that local medical literature monitoring is often burdened by discussions that eventually obscure the key relevancy of data captured in the literature.
Our goal is really to bring deep local knowledge and insights from local experience to the MAHs so that they can benefit from them
“If we take into account the publishing process, the cases reported in the literature usually occurred at least several months or years earlier,” he says. Thus, if the key importance lies in the discussion, if Day 0 should be understood as the day when the journal was accessed or 1 day later when the review was performed or, if the data maintains its value in terms of the PV-relevancy? It needs to be understood that database search does not equal full-text review in terms of when the data can be verified. How does MS Pharm steer ahead of this challenge?
To answer this, Szewczyk mentions that the company combines its deep local knowledge and presence in the countries, comprehensive review process and self-developed IT tools that allow proper indexing of Safety Relevant information along with timely reporting to its MAH clients, so that MAHs can reap the complete benefits of their literature monitoring.
Additionally, MS Pharm renders services in several regions that provide cost-effective, scalable solutions to its customers. Szewczyk adds, “Many MAHs, who started with a single affiliate in one country, are presently outsourcing their data as regional or global projects after using our services.” To assist such MAH clients, the company offers added value by providing them access to critical data beyond the information resulting from abstract reviews.
Elaborating on the significance of this functionality, Szewczyk cites an instance where a global pharma organisation in Poland had employed MS Pharm’s local monitoring services. The organisation had to cover literature reviews for over 40 countries. To help them in this task, MS Pharm expanded the client's local literature monitoring coverage across the countries of operation. The company then started to discuss the possibility of performing the analysis of the global database records for the client as the process performed in-house was time-consuming and inefficient. Based on its local monitoring software, MS Pharm developed a sister one for the analysis of global database records. Result? The client was able to achieve significant resource savings and enhanced efficiency. “We can use this software in other projects, we are also able to offer it to the MAHs to be used in-house independent from MS Pharm projects,” says Szewczyk.
To augment the operations of such pharmaceutical companies and keep pace with the evolving compliance landscape, MS Pharm is constantly upgrading its software and adding new functionalities. On this path of technological progress, MS Pharm is looking into the utilisation of AI as a tool to assist its reviewers in locating and analysing critical information. The next step for MS Pharm is to expand its services to Nordic countries. “We want to be the leader in Local Medical Literature Monitoring services in Europe and CIS countries, and be the reliable partner for all our customers,” concludes Szewczyk.