MS Pharm
Driving Drug Outcomes through Smart and Efficient Pharmacovigilance

The pharma industry is an immensely complex domain in that it not only has to ensure complete drug safety but also meet stringent regulatory guidelines. To that end, the pharmacovigilance (PV) department of a pharma company must keep track of the databases to categorize and extract relevant content from their records. Even the slightest omission of contextual data (drug safety-related information) can lead to ill-prepared submission to the regulatory authorities. This, in turn, can lead to untoward consequences in the drug lifecycle. While the pharma companies strive to follow the guidelines to highlight the side effects of a medical product, there are challenges. The global English-only approach to handling drug data often prevents firms from considering the medical and pharma journals that are presented in native languages.

MS Pharm, a PV service provider specialized in medical and pharmaceutical literature monitoring, helps pharma companies gain complete value from their data. “We focus on the pharma and medical journal spectrum to solely deliver quality PV-relevant content,” says Marek Bielski, Business Development Manager at MS Pharm. The company empowers PV stakeholders to view relevant material from journals not only indexed in the global databases but first and foremost from local journals. “We work with raw data, including the articles from local journals (mostly non-indexed, some of them in print), which often remains invisible to the PV professionals unless it is verified via access to the full-text,” says Bielski.

MS Pharm verifies dozens, and in some European countries up to a hundred medical journals, as well as the widely used global databases to deliver a complete view of every topic. The assessment of every record that contains information pertaining to an active substance within a product helps PV professionals with precise reports. The reports provide a complete view of information relevant to the risk-benefit considerations of a medicinal product. For a more refined structure of the report, clients can define specific risk areas of a product, and MS Pharm will tailor the review to cover information related to those key issues. As a result, pharma companies can save resources which they can reinvest in processing PV-relevant data pertaining to products in their portfolios and improve drug performance.

To highlight the advantages of a full-text review of local medical literature, MS Pharm ran structured comparisons for five popular active pharmaceutical ingredients in eight European countries by verifying the outcomes of the full-text reviews against the ones of medical database monitoring. From the study, MS Pharm discovered that over 70 percent of PV-relevant data available in local literature was not accurately indexed in the widely used global literature databases.

In a case study, MS Pharm helped a pharma company streamline and refine their ineffective process of database records and local literature reviews. Employing lots of manual steps, it created a bottleneck in the safety analysis given the rapidly growing company portfolio – the resources available in place were not able to process the accrued body of data. MS Pharm designed and introduced a new tool for the analysis and archiving of the literature safety data. MS Pharm has been monitoring, reviewing, and categorizing every article of the medical literature concerning particular products providing the output to the client in the new tool. This helps the client set the focus on the internal case processing and collating the aggregate reports based on the structured safety data provided by MS Pharm and meet the regulatory requirements.

We work with raw data, including the articles from local journals (mostly in print), which often remains invisible to the PV professionals unless it is verified via access to the full-text

In a different instance, MS Pharm managed 5,000 records every month and enhanced their overall global medical literature monitoring process workflow. As a result, the client was able to derive accurate PV-relevant content and permit their PV department to work with complete adherence to all safety compliance laws related to specific countries or regions. “We verified the articles and enabled the client to present a complete review with compliance to all safety regulations,” comments Bielski.

As a value add to its clients, MS Pharm identifies and reports any potential Individual Case Study Report (ICSR) from a specific patient reported in the literature to deliver data on any possible side-effects caused by a client’s drug product. “Our style of reporting is of utmost importance especially in countries where there is significant underreporting of spontaneous ICSRs created by local healthcare professionals that may be critical to PV stakeholders,” comments Bielski.

Working in a highly competitive environment, MS Pharm’s success emanates from its transparent relations with clients. In covering all non- English speaking countries in Europe, the PV literature review specialist has established its presence in the Nordic countries as well. MS Pharm is also venturing into the Middle East, North Africa, and South-East Asia. From a technical perspective, a prerequisite for literature monitoring is the ability to understand medical data presented in articles and MS Pharm is conducting extensive research to further enhance the utilization of machine learning in its PV data management solutions.