Red CapsulesAt the recent DIA European Medical Information & Communications conference, Dr Juan García-Burgos, Head of Medical & Health Information Communication at the European Medicines Agency (EMA) shared the experience of providing medicines information from a regulator.  It’s the 20th birthday of the EMA and the range of sources available to many patients has never been greater.  Over those two decades we’ve witnessed the massive impact of the evolution of the internet so now patients can easily find and share information online. For example they can:

  • Readily find information on their diseases, tailored to their level of understanding
  • Access detailed information on their medicines on trusted websites like the Electronic Medicines Compendium in the UK, FASS in Sweden and of course the EMA’s own website
  • Share experiences with other patients through patient associations or forums on Facebook, Twitter or other social media

We will always have the issue of how patients will know that the information they find can be trusted.  Thus, the EMA plans to have a Medicines Portal for lay people to access information including clinical trials.

Dr García-Burgos, when asked about the limitations of giving information to patients from pharmaceutical companies, encouraged sharing of full information, as long as it’s not promotional.

 

So just what medicines information is available for patients?

According to their need and level of understanding, we have a wide range of information available from the regulatory agencies who can be considered to be unbiased, impartial expert sources of information.

  • For most patients, the Patient Information Leaflet can work.  It’s not ideal but covers many questions commonly asked
  • For the patient who wants to know more, they can probably cope with the Summary of Product Characteristics (SmPC), with some explanation that it is really a medico-legal document. and that it is certainly not a stand alone document!  Most patients would probably want more disease treatment-focused information.
  • Last, but not least, there is the European Public Assessment Report (EPAR) – but who would best appreciate the EPAR?

The European Public Assessment Report

It’s been a while since I took a look at an EPAR and was pleasantly surprised!

 

I have a personal interest as I have a chronic health condition which necessitates using a biosimilar.  It’s been a while since I’ve done any research myself on my condition as I’ve been well for a long time.  So this was a great opportunity to revisit the EPAR.  I checked out a biosimilar for infliximab.  I was surprised how detailed it was – it was 105 pages long.  For the expert patient, it is ideal: it includes all the detailed clinical and scientific data and decision making.

 

Combined with the Disease Treatment leaflet I got from my consultant, I found it very helpful at satisfying my scientific curiosity….

 

But it didn’t really help me anticipate the emotional and physical journey I am about to undertake…

Facebook Group

As a Facebook user, I was curious to revisit a patient group, as a patient myself.

I have looked at various groups from a professional viewpoint a number of years ago, when groups like these were in their infancy.

 

Wow – how things have moved on!  Critical mass is the main factor shifting them from small self-help groups – like a Phase III trial – to a more useful discussion and sharing forum – like Post Marketing Experience programs.  The group I joined has over 15,000 members, mainly UK based.   There are no holds barred!  Off-label uses, how to use medication in ways I’m sure the medical information personnel don’t know about, shared personal experiences and a lot of general venting of how tough they find coping with a potentially debilitating disease.

 

I feel conflicted when using it. I love hearing other stories and ideas about taking very unpalatable medicines so I can use the tips myself.  I definitely feel like I am not alone and there are many more people who are worse off than me.

 

But part of me is alarmed that shared experience/advice from other patients can seem to carry so much weight in decision making.  However I don’t think a HCP moderating the content would help!  Ultimately patients living with their diseases mostly want to be treated with respect and in an adult manner.  Patients have to learn to deal with their illnesses, negotiate the healthcare systems and staff and learn how to find a new normal in their life.

EPAR + Wikipedia + Facebook = Great mix!

So for me, the EPAR and Wikipedia are an ideal mix to intellectually inform me about my disease and the specific medication I’m going to take (not all medicines have EPARs).  The PIL is not enough for someone like me and neither is the SPC either!  The EPAR helped me be more reassured about clinical equivalence and safety profile.

But the Facebook group helps me to connect emotionally with my condition and the impact it has on my life.

 

Have I changed my mind about information for patients?

 

No – I still believe that we should explain that more detailed information is available beyond the PIL.

 

I also fully endorse that we should always encourage patients to discuss their treatment with a HCP.

 

But I even more strongly believe that we should not sell patients short.  We need to tell them that there is more detailed information available from the government agency that approves medicines, if they would find it useful.  Add the qualifiers and disclaimers by all means but don’t patronise patients by withholding information that our regulators tell us that they have a right to know.