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Are we expecting too much from the EMA’s MLM service?
Posted on December 16th, 2015 by James Dunstan in Pharmacovigilance
At the beginning of September 2015, the EMA launched the Medical Literature Monitoring (MLM) service. I recently read the EMA’s MLM launch phase closure report in addition to information from a recent EMA information day and have highlighted some key points below.
The essential premise of the MLM centres around making the literature monitoring process more efficient for Marketing Authorisation Holder (MAH) companies. In the launch phase report, the EMA cites a “significant reduction in duplicate literature reports’’ and a “streamlined pharmacovigilance function’’ as key benefits. Certainly these goals are to be applauded. The EMA also benefits by reducing duplicate reports that they receive from MAHs which significantly decreases its workload. The key question that comes to my mind though is why have MAHs been so dissastisfied with the EMA’s MLM service until recently?
I spoke at a PV conference in Vienna in September and had the opportunity to speak with PV professionals across a broad spectrum of organisations. All communicated to me their frustration with the MLM service and how it essentially meant an increased workload with few tangible benefits. Whilst I appreciate these concerns, I think a lot of the frustration stems from our expectations being too high of what the MLM can deliver.
The launch closure report provides overviews of the MLM service, KPIs, business processes, search strategy methodology, a summary of issues and resolutions and a summary of stakeholder feedback. It is a very comprehensive report and it is great to see the EMA engaging with its stakeholders.
Some key highlights from the report:
- The EMA is going to set up an expert panel to review the search strategy for the MLM on a monthly basis and create ‘’standards of excellence’’ (p. 3)
- Of the 12,000 records that were screened for 50 active substances more than 100 ICSRs were created (p 6)
- Over 73% of survey respondents considered the ICSRS received to be of ‘’good quality’’ (p 13)
- EVWeb presented many challenges with only 63% of survey respondents stating that the export manager provides easy access to ICSRs (p 14)
- The MLM’s service desk response time was approximately 20 hours (p 6) and 83% of the time the MLM service desk responded within two business days (p 7)
- 83% of the ICSRs identified during the launch phase were entered by Day 7 (p 8)
- The comment back from some respondents on MLM output was that ‘’too much data is provided on a daily basis making it difficult to track for users’’ (p 13).
Encouragingly, most of these points have improved greatly from the recent communication I saw from the EMA from their information day.
In terms of stakeholder feedback, four key points were raised in the report:
- Literature monitoring is still needed for PSURs and signal detection: A number of my team’s customers have been under the impression that they will be able to stop monitoring the scientific literature for ICSRs. This is not the case. The MLM service will most likely reduce the time needed to submit ICSRs to the EMA but MAHs will still need to search the medical literature. As the report highlights ‘’The MLM service is only focussed on detection of ICSRs, and therefore literature must still be monitored by MAHs for routine safety surveillance activities in signal detection and periodic reports” (p 14).
- The exclusion of non-serious ICSRs is a problem: a number of customers remarked that their internal processes were complicated by the need to screen for ‘’non-serious ICSRs outside the EEA to enter in their database” and that ‘’searching of local literature was still a requirement for complete coverage’’ (p 14).
- Replacing one workload for another: several survey respondents stated that the MLM did not ‘’reduce the workload’’ but replaced the submissions with ‘’reconciliation and daily checking of EV and the tracking spreadsheets’’ (p 14). When I spoke at the 2nd Annual Pharmacovigilance & Risk summit in Vienna this year, I asked for feedback on whether the MLM service meant a decrease in workload. No one put up their hand to say this was the case. Two people, both working at top 10 generic companies, made comments about the MLM adding significantly to their workload. In time the MLM will reduce the workload required but this won’t be until later this year at the latest
- The struggle with day zero – the ‘’additional layer of activity’’ (p 14) the MLM requires is adding significantly to the workload burden by the need to check whether an article has been identified previously or from another source. Using software to organise your PV workflow can help enormously with this challenge but it still means an increased workload. Unfortunately no one can expect the EMA to solve this problem.
Overall I think the EMA is improving rapidly with the MLM service. The expectations of the EMA’s MLM service have been too great – all companies will still need to monitor the literature and, whilst at the moment the MLM services means an increased workload for PV departments, in time the functioning of the MLM will become smoother and should result in greater benefits for MAHs.
Why is there is so much dissatisfaction with the MLM service? It is mainly due to excessive epectations. I’m looking forward to seeing how the EMA continues to improve the MLM service offering. In the meantime, I will continue consulting with my team’s customers about how Elsevier can best support PV departments in light of the EMA’s ongoing changes.
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