EMA’s Medical Literature Monitoring:
Shakedown or Shakeup
Julio Dos Anjos
Professional Services Consultant, Elsevier R&D Solutions for Pharma & Life Sciences
In order to better overcome variability of reporting of adverse events from medical literature by Market Authorization Holders (MAH), the European Medicines Agency (EMA) has launched, by contract, their own service of literature screening, named Medical Literature Monitoring (MLM), covering 300 generic medicinal products and 100 herbals.
On June 11, EMA released the operational rules that will govern the
relations of the MAHs with the MLM service. Some of these had been anticipated from the requirements put forth in the RFP calling for a vendor to supply the service to EMA, but it is noticeable that a lot of thought has been put into making the service as useful as possible to the industry although still at a cost in learning new rules and tools. Implementation of new processes and extensive adaptation of existing systems is, without a doubt, necessary.
A bibliographic revolution?
EMA may have started, surely by accident, a small revolution, in the medical bibliographic information ecosystem, a subject close to the heart of Medical Information professionals.
User Manual: EV ICHISCR Export Manager, MLM EVWEB & tracking spreadsheets1 describes a daily listing of bibliographic references for each substance group, still in process. Following that, there is a daily listing of ICSRs identified by the EMA contractor. In normal circumstances, the time between a reference entering the system (first listing) and the ICSRs being confirmed should be a period of no more than 7 days.
The first listing will identify:
- Source Database
- Time stamp of search
- Literature Reference (Vancouver Style): there is a great deal of overlap between the databases being used, and we can only hope the Vancouver format can serve as robust uniform representation format
- Primary Source Country (Country of correspondence author; will act as country code for World Wide ID of ICSR)
- Lead Author (Will act as ICSR Reporter)
- MLM Document Object Identifier
Although the document, in a subdued way, identifies the field as
Document Object Identifier, the description is clear:
This is a unique identifier created by the MLM service for the article and will appear in all spreadsheets to allow easy traceability. If there are multiple cases from an article, all will have the same Document Object Identifier.
Let’s be perfectly clear: it has no relation with the DOI we all love (although some hate) created and managed by the CrossRef collaboration. It’s a new literature identifier, with a 1-1 relationship with scientific papers, scientific articles, conference presentations, conference abstracts, and many other publications types covered in the different databases screened by EMA, that happen to emerge in the search results of put in place, on behalf of EMA, for whatever a specific set of substances being monitored. Its format is very simple: YYYY-WW-NNN.
In the very short term, most automated literature screening systems, as well as safety management databases, will be implementing fields in order to register the EMA MLM DOI.
I would not be surprised to see one or more services offering lists of correspondence between EMA MLM DOIs and Embase ANs, PubMed PMIDs, CrossRef DOIs, etc, before the end of the Summer.