The MHRA - taking patient reporting seriously - Part IV

Well, I feel properly satisfied with the outcome of this. Thank goodness my experience isn't a trivial matter for those who have an interest in the drugs I take:


Dear (redacted),

Many thanks for this. I believe it answers my questions satisfactorily, and I consider the complaint dealt with.

The issue, then, lies elsewhere: the manufacturers are not responsible, because the risk of suicidal ideation was noted on the PIL; my GP was not responsible, even though he was responsible for my care, because he brought the side effect to my attention, when he prescribed the drug (and then, when I experienced the side effect, told me that it wasn't the drug); the MHRA is not responsible, because it is not required to be responsible.

May I ask who is responsible - and this is not a rhetorical question, I would like an answer? Could you seek guidance from the Secretary of State on this one, please, because I am keen to understand whether it is believed that I should be responsible for my reaction to chemicals that, with the greatest of respect to the MHRA, are not controlled particularly effectively, judging by the less than scientific approach that is taken to licensing (both by manufacturers and regulators)?

I have to be honest, rarely have I experienced such a sorry catalogue of failure and incompetence as this. There are so many gaps in this system that it is a wonder to me that anybody survives it. More to the point, when a flaw is identified, the MHRA (and others) appear determined to argue that everything is just hunky dory, and that a complainant is somehow deranged to even suggest that anything is wrong. In short, full defensive mode is initiated. And yet, the MHRA is characterized as a world leader?

Best regards

(redacted)




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From: "Pharmacovigilance,"
To: (redacted)
Subject: Yellow Card Complaint
Date: Mon, 10 Sep 2007 10:36:39 +0100


Dear (redacted)

You raised a formal complaint that your Yellow Card report was not subject to follow-up. This complaint has been investigated by the Signal Management Group and I will address your concerns below.

Further to your Freedom of Information (FOI) request FOI 07-246 on the 15th August 2007 concerning the Yellow Card Scheme, a response was sent to you on 30 August 2007 explaining what a ‘follow-up’ is and detailing the process by which it is determined whether it is necessary for a Yellow Card report to be followed-up. Please refer to this communication for further explanations of the process of ‘follow-up’. In summary I will reiterate that the term follow-up refers to the communication with the reporter to request further information regarding their Yellow Card report.

The following up of a report is at the discretion of our pharmacovigilance scientists and assessors at the MHRA and is in no way a compulsory part of the Yellow Card Scheme. As stated in the FOI 07-246 response the request for further information or ‘following up’ of a report does not necessarily signify these reports are of greater importance or interest.

With regards to your Yellow Card report, I can confirm it was determined a request for further information from yourself was not necessary at that time for two main reasons:

Firstly the report you completed was adequately filled in to provide enough information to be entered onto our database for rapid analysis and assessment by our physicians, pharmacists and scientists.

Secondly the suspected adverse reaction reported by yourself was suicidal ideation. As you are well aware, Suicidal ideation is listed as a potential side effect in the Patient Information Leaflet (PIL) for fluoxetine. Whilst we are not in any way dismissing the seriousness of this reaction, this in itself does not necessarily warrant a Yellow Card report being followed up.

The risk of suicidal ideation and suicide with SSRIs are continually monitored by the MHRA. In May 2003, in response to continuing public concerns about the safety of SSRIs, an Expert Working Group of the Committee on Safety of Medicines (CSM) was convened to investigate ongoing safety concerns with these medicines, in particular around suicidal behaviour and withdrawal reactions/dependence. I believe you are already aware of this ‘Report of the CSM Expert Working Group on the Safety of SSRI’s’ and your questions regarding its contents and conclusions have already been satisfactorily addressed.

With regards to provision of the manufacturer’s details of the generic fluoxetine you were prescribed, I am unable to provide you with this information. Currently there are approximately 32 marketing authorisation holders for generic brands of fluoxetine in the UK and therefore I am not able to inform you which of these MAHs provided the fluoxetine you were prescribed by your practitioner. However the MAHs name would clearly have been stated on the packaging and also on the Patient Information Leaflet provided with the pack as a legal requirement.

I hope you feel this letter addresses your complaint in all respects. If you remain dissatisfied, you can make representations to the Central Complaints Officer:

(redacted)
MHRA
16-107 Market Towers
1 Nine Elms Lane
Vauxhall
SW8 5NQ