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The EMA's literature screening service and pharma

Complexities and new potential in pharmacovigilance

The EMA'S

The EMA may have inadvertently started a minor revolution in the medical bibliographic information ecosystem with its new literature-screening service, Medical Literature Monitoring (MLM). Whether it will ultimately facilitate the pharmacovigilance work of market authorisation holders or considerably complicate their workflows remains to be seen, but it is certain that the service will take some getting used to.

The European regulator certainly seems to have expended considerable effort to make the MLM as useful as possible to industry stakeholders. The intention behind the project is to correct some weak spots in the EMA's ability to assess the safety of generic medications, and to establish the safety profiles of herbal substances and food products. But what does it actually mean for medical information professionals?

Complex reporting 
Concerns voiced by those in the industry focus on the potential for MLM to introduce considerable complexity into the process of reporting adverse events. The workload of people involved in pharmacovigilance will not decrease: literature monitoring to detect all mentions of their products will continue. In addition, the EMA's new daily listings of literature with one or more individual case safety reports (ISCRs) will now have to be taken into account before adverse drug reaction and adverse event reports can be filed.

 This compliance with MLM reporting takes a number of forms. At the simplest level, market authorisation holders are now expected to identify the articles being monitored by the EMA within their own literature findings. Under MLM procedures, unique document object identifiers (DOIs) are assigned to each piece of scientific literature that the EMA reviews. In some cases, these DOIs are the identifiers traditionally used in scientific literature: CrossRef DOIs, Embase ANs, PubMed PMIDs and so on. However, they can also be EMA-assigned tracking numbers or URLs for embase.com.

 More significantly, with MLM in place, market authorisation holders also have to wait for the EMA to identify ICSRs before they can make their report. Looking at this in more detail, if the market authorisation holder finds an article reporting that an adverse event is not serious and happens in an EEA country member, or if an adverse event is serious, then the market authorisation holder is expected to check whether the EMA has found the article. If that is the case, then the market authorisation holder still needs to wait for an ICSR to be created and only then can he consider his reporting obligation.

Scanning all the databases
The greatest difficulty will be dealing with the differences between the means of finding the adverse events.The EMA is scanning a particular set of databases that does not necessarily include all of the literature that market authorisation holders are expected to scan. In addition, the market authorisation holder may not be scanning all of the databases recommended for pharmacovigilance. Thus, for any given substance covered by the MLM initiative, the EMA has its set of bibliographic references to review and the market authorisation holder has his. There will be overlap, but it will never be a 100% match.

The market authorisation holder must report all ICSRs found in literature not covered by the EMA. He must not report ICSRs that the EMA has already reported but he must incorporate those cases into his safety management systems. If he finds that the EMA has not reported an ICSR that should be reported, then it must be reported as a quality control incident.

The greatest difficulty will be dealing with the differences between the means of finding the adverse events

Short-term challenges 
Cross-referencing all of the articles that entered the EMA system and harmonising that information is the most daunting task facing market authorisation holders under the new initiative. In the long term, integrating the literature references and articles found by the EMA into its literature screening systems may pay off, but, in the short term, it certainly adds to the workload of data engineers and pharmacovigilance workers.
 Ultimately, solutions can and will be found (see box).
  
Although there is currently considerable worry about the impact of MLM and some feel that a seamless workflow is not achievable, it is important to remember that these positive synergies are there to be explored. As more information experts and drug safety professionals become familiar with the ins-and-outs of the process, we may see new approaches emerge and facilitate the ever-challenging and essential task of pharmacovigilance.

Idea 1: Each company should find a way to identify the literature that it must monitor but that will not be monitored by the EMA and perform all the screens and ICSR preparation while waiting for the EMA to complete the screening of the newest literature.

Idea 2: Companies should lobby the EMA to automate the delivery of the spreadsheets with the daily listings of literature

Idea 3: Drug safety teams should invest time in studying the data the EMA turns up from sources that are not normally on their radar. If those ICSRs matter to them, their monitoring strategies may need to change. There is a possibility to leverage that information and capitalise on the EMA's time investment.

Article by
Julio Dos Anjos

is a professional services consultant, Elsevier R&D Solutions for Pharma & Life Sciences

19th February 2016

Article by
Julio Dos Anjos

is a professional services consultant, Elsevier R&D Solutions for Pharma & Life Sciences

19th February 2016

From: Regulatory

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