Friday, 31 August 2007

The MHRA - Taking patient reporting seriously - Part II

I think I may withdraw my complaint about the MHRA's failure to follow-up on my Yellow Card report. It seems that the last thing the scheme is about is providing feedback and "follow-up" really doesn't mean to me what it means to the MHRA. My most recent reply is below the MHRA's:

Mr Matthew Holford

FOI 07-246 Yellow Card Scheme

Dear Mr Holford,

Thank you for your Freedom of Information (FOI) Act request of 15 August about the Yellow Card Scheme. As this is for my division it has been passed to me for reply.

The Yellow Card Scheme is the UK system for collecting and monitoring information on suspected Adverse Drug Reactions (ADRs). The Scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the Commission on Human Medicines (CHM), and relies on the voluntary reporting of suspected ADRs by health professionals and patients. Adverse Drug Reaction reports are also received from pharmaceutical companies who have a legal obligation to send the MHRA reports of serious suspected ADRs they receive which are associated with their products. The purpose of the Scheme is to continually monitor the safety of medicines and to provide an early warning that the safety of a product may require further investigation.

Please note, the National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. It is a separate body from the MHRA and as such is not involved in the Yellow Card Scheme.

There are a number of possible actions when a new safety issue is confirmed, in order to prevent or minimise the level of risk to patients. Very rarely, if the risks of a medicine are found to outweigh the benefits, it may be necessary to remove the medicine from the market. More usually, the risk of a side effect may be avoided or reduced in the following ways: by including warnings in the product information (Summary of Product Characteristics and Patient Information Leaflet) or on the package label; and by restricting the indications for use of a medicine.

All Yellow Card reports received are entered onto our database for rapid analysis, allowing us to identify potential new safety concerns. For this reason each report we receive (whether from a healthcare professional or a patient) is valuable as it may represent a previously unrecognised side effect. All spontaneous Adverse Drug Reaction (ADR) reports that we receive at the MHRA are treated identically regardless of whether the reporter is a patient or a health professional.

When a report is entered onto our database, it is analysed by our physicians, pharmacists, and scientists who use Yellow Card reports (including both those from patients and healthcare professionals) to assess the relationship between the suspected medicine and reported side-effect. We also evaluate information on medicines safety from other data sources from the United Kingdom and from around the world including data from international medicines regulators, clinical trial data, and medical literature.

If during the assessment of the report it is felt further information is required for a full evaluation, additional information may be requested. The term ‘follow up’ refers to this communication with the reporter of the Yellow Card, to ask for further information. For example, reports with a fatal outcome are routinely followed up to request a copy of the post mortem report. Other reports that may be subjected to follow-up requests include reports that concern previously unrecognised potential side effects and new drugs that are on the intensive monitoring list (These are known as ‘Black Triangle’ products and are new drugs and vaccines which are being intensively monitored in order to confirm the risk/benefit profile of the product).

However the request for further information or ‘following up’ of a report does not necessarily signify these reports are of greater importance or interest. It may simply be due to the fact that only basic information had been provided or that the information provided was unclear and therefore unassessable at present. Furthermore all reporters are encouraged to report additional information should this become available at a later date and details of how to do so are provided in the reporter’s acknowledgement letter.

Health professionals and patients do not receive direct feedback on their particular Yellow Cards from the MHRA. A key role of the MHRA is to provide doctors with advice on the safe use of medicines, although the final responsibility for the clinical care of their patient remains with the doctor. Given their specific knowledge of the patient and clinical expertise, it is for the doctor to decide on the treatment and/or tests which the patient may receive.

As you are aware Yellow Card reporting has been extended to include patients as well as health professionals. Since the launch of the pilot scheme for patients in January 2005, the MHRA has received over 5000 Yellow Card reports from patients. Each individual report is acknowledged in order to provide a unique reference number so individual reports can easily be located on our pharmacovigilance system for any future correspondence and also to direct patients to the relevant sources if they are concerned.

Patient reporting offers a variety of advantages including greater insight into patient experience, as well as permitting patient involvement in regulation and greater availability of information to patients concerning their medication. The objectives for patient reporting are achieved through the promotion of the Yellow Card Scheme and working together with patients as much as possible. To develop the patient reporting scheme, a Working Group of the Committee on Human of Medicines was set up in 2004, which included patient and consumer groups, pharmacist and medical representatives to work alongside the MHRA to provide helpful insight into patient’s opinions and help in gauging effectiveness of systems to enable patients to send reports of the suspected ADR experiences. This patient working group was involved in the production of the patient Yellow Card in order to ensure the form is user friendly and effective. Furthermore a new patient acknowledgement letter is currently being developed with the Yellow Card Strategy Group and Patient Working Group to manage patient’s expectations from filling out a Yellow Card and to provide greater insight into the processes behind the Yellow Card Scheme.

You may also be interested to note that independent research is planned in order to formally evaluate the patient reporting component of the Yellow Card Scheme. This project is due to commence on the 1st September 2007 for a duration of 2 years.

You also asked about how your own Yellow Card report was handled. On 27 August you raised a separate, formal complaint about this you will receive a response to this in due course.

I hope this information is of use to you.

Yours sincerely


Information for Public Health Group, VRMM Division
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110 1, Nine Elms Lane, London SW8 5NQ

Dear [redacted],

Many thanks for this. I have a couple of questions/comments, below.

If I understand your words aright, then, the Yellow Card scheme is not specifically designed to provide feedback to patients on side effects? If that is correct, may I ask how Dr Wilkie imagined that the Yellow Card scheme would provide information about drugs to patients? Incidentally, (and I generalize, for my own case), if the scheme does not provide feedback to patients routinely, then I imagine that you will find that "patient involvement in regulation" (TM Kent Woods), is such a one-sided thing that patients will tend not to bother. Indeed, I understand that healthcare professionals tend only to report the most serious side effects, as it is. That is to say, at its best "involvement" is a reciprocal arrangement, I would argue.

In fact, if I understand correctly, the Yellow Card scheme currently operates for the sole purpose of providing information to the regulator - it permits greater understanding for the regulator, and others, but there is no prompt reciprocation? The regulator collects, collates and disseminates the information as it sees fit - the patient is there as a provider of information, and any "feedback" will be limited to any modifications that the regulator may choose to make to the PIL, at some disconnected point in the future, by which time the patient may have lost interest. Or, not wishing to be melodramatic, died.

The upshot is, then, that the GP is responsible for the patient, and if the GP's knowledge is deficient, or information concerning an emerging pattern of serious side effects is not available, then the GP's care may not be to the standard that it might? At what point are GPs notified of an apparent emerging risk? It seems to me that there are several large gaps, there, for patients to fall through. As I did, of course.

Best regards

Matthew Holford

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