Local literature monitoring

Medistyl offers continuous medical literature monitoring (MLM) based on applicable European legislation, with a focus on pharmacovigilance and adverse effect reporting. We also monitor similarly oriented veterinary literature.

Every marketing authorisation holder (MAH) is obliged to perform a literature search, both in local sources (local literature monitoring) and international sources (global literature monitoring).

Our team of specialists with adequate language knowledge and professional expertise searches and monitors information concerning human medicinal substances and preparations, medical devices, vaccines, veterinary medicinal products, food supplements and cosmetic products by scanning nearly 1,000 local, mostly non-indexed journals and publications in nearly all European countries. In contrast to the conventional approach, our literature monitoring is not solely based on the abstracts: in fact, our professionals read the full texts, whereby the completeness of the information and outstanding results are achieved.

Local literature monitoring services

• Medical literature monitoring (MLM), local literature (journal) monitoring for AE reporting
• result delivery within 24 hours (Safety Mail)
• weekly/monthly result (report) delivery frequency
• reconciliation
• comments (in the local language, in English)
• Supporting services pharmacovigilance – filling out CIOMS, follow-up, medical assessment, case narrative, case management, article translation
• literature retromonitoring (retrospective search, e.g., over a specific period of time)
• data and information for periodic safety update reports (PSUR)
• monitoring of competitors and obtaining information for marketing purposes
• consulting, seminars, training courses

Local monitoring – territories where Medistyl is currently active:

• Czech Republic, Slovakia, Poland, Hungary, Austria, Romania, Bulgaria, Ukraine, Slovenia, Russia (middle and eastern Europe & CIS countries)
• Serbia, Croatia, Bosnia and Herzegovina, Macedonia, Albania (Balkans)
• Estonia, Lithuania, Latvia (Baltic countries)
• Finland, Sweden, Norway, Denmark, Iceland (Nordic countries)
• Germany, the Netherlands, France, Spain, Italy (western Europe)
• All other European countries – the services are ready for launch

One of the welcomed services is the delivery of potential Individual Case Safety Reports (ICSR) as captured in the literature. The reports are delivered within 24 from identification (Safety Mail service introduced by Medistyl). Typically, this service is combined with the delivery of weekly or monthly reports, which can then serve as the required reconciliation.

As a standard, the provided results contain complete bibliographic description including Vancouver style citation in accordance with GVP Module VI, information on an adverse event, effect or specific situation, on a specific patient (age, gender), author’s country and event location, all so as to eliminate any potential double-reporting.

Literature is scanned with a focus on pharmacovigilance aspects such as: adverse events (AE), severe adverse events (SAE), adverse effects, adverse drug reactions (ADR), inadequate efficacy, case reports, off-label medication, pregnancy, contraindications, product complaints, misuse, abuse, occupational exposure, counterfeit, medication error, etc.

We combine human effort and validated database applications when reviewing medical and scientific journals: the results are superior to those obtained by  a mechanical search.

Our specialists read the full texts, not only the abstracts, and index them for the internally developed MedisVigi database. On the one hand, the human factor eliminates the adverse effects of machine scanning while, on the other, the application facilitates work, ensures data integrity and provides a comprehensive audit trail.

The quality management system assures quality of all processes from the formal aspect, as demonstrated by the outstanding results of periodic internal and peer audits, of which 15 to 20 are organised every year.

Applicable legislation requires every MAH to make literature searches both in local and global literature.

The Medical Literature Monitoring (MLM) system, provided by EMA, is insufficient in this respect because of the range of substances to be monitored and the overly-global perspective. This is also true of the Medline and Embase international databases, which may not always capture all cases from local literature.

This means that the MLM services should optimally be completed with the monitoring of journals actually at the local level because these are frequently non-indexed and thereby no other way of obtaining the information contained in the sources exists.

We can help you attain as complete coverage of medical literature as reasonably possible, in line with the requirements of the Czech, Slovak and other national drug control authorities, as well as with Good Pharmacovigilance Practice (GVP) so that any PV audit at your site can run completely smoothly. You can always rely on Medistyl.