Post approval Safety Information Reporting in 2012

‘From’ July 2012, new European wide legislation comes into effect whereby PharmaBio organizations that hold marketing authorizations for products in Europe will need to electronically report both serious and non-serious adverse reactions to one central point—EudraVigilance, the safety database of the European Medicines Agency (EMA), based in London.

This is a major change, and requires organizations that carry out Pharmacovigilance to be in a ready state to make these electronic E2B submissions from July 2012.

However, although the original plan was to start the process from July 2012…  due to economic pressures, the switch has now been phased across 3 years from July 2012. That said, 3 years is not a long time in Pharma Drug Development and Pharmacovigilance…

How to capture post-approval Safety information?
There has been a lot of talk about the potential of Social Media on post approval safety monitoring. A number of organizations have pro-actively begun the unofficial process of monitoring social media sites to discover and react to these unsolicited reports.

One US based organization that has made significant inroads in the social aspect to safety reporting is PatientsLikeMe.  They have built up a self reported database of over 145,000 (as of April 2012) patients. Besides self help, one of the major bi-products of the information capture and sharing process is the availability of safety monitoring information in a relatively mature and assert-able form.

Take the following example;

PatientsLikeMe – Lithium Carbonate SUSAR Information

The above information is provided online to all from PatientsLikeMe for the Side effects of Lithium Carbonate.  This is a compound often now taken for Bipolar disorder.  We can see that of a total reported population of 741,  72 (9.7%) reported severe side effect symptoms. The most common being 79 (10.7%) – tremor in hands.  In addition, not only do we see the self reported side effects, we also see the dose, and the number of patients that stopped taking Lithium Carbonate due to side effects (205).

Now for those non Safety readers, what I have described above may be classified as SUSAR’s – Suspected Unexpected Serious Adverse Reaction.  They are self reported, and are therefore not necessarily evidence based, or asserted by a health professional.   However, due to the volume, they do have statistical clout.

Statistical Assessment

The challenge presented by Social Media based SUSAR’s is the potential non measurable cleanliness of the data.  Lets imagine that the social media platform that captured this information had limited proof that the reporter of the reaction did indeed a) suffer the reported condition and b). take the actually reported medication.

Imagine if you were an unscrupulous company with a competitive product… would it (hypothetically) be possibly for you to create ‘dummy patients’ and report dummy adverse reactions to a competitors drug?  Possibly… but then… this is where the word ‘Suspected’ is important.  We have an increased % of ‘Suspected Unexpected Serious Adverse Reactions’. If these are proven later to be substantiated… then they would become actual Serious Adverse Reactions.


I believe platforms such as PatientsLikeMe already have a significant role to play in post approval safety monitoring.  Datasets remain small – 140,000 patients is only 0.00002% of world population (or 0.0004% of US population). However, compared with other Adverse reaction monitoring methods, and with the added advantage of the centralized pooling of information patients safety can be improved AND importantly, this safety knowledge can be shared directly with patients.

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