Medicines and Healthcare products Regulatory Agency

Information regarding medicine safety should be made accessible to members of the public. 

The information should be definitive and downloadable (as a pdf file) with referenced pages so that a patient could take it to their GP or other treating clinician and know that the information was trustworthy and definitive. MHRA reporting of adverse reactions to medication is difficult, if you are not computer literate and also if you do not have reasonable writing skills. The form is both confusing and needlessly complex.

Where the patient has an online connection, the MHRA site does not appear easily navigable for the reporting of adverse reactions. The drug analysis prints are not easily discovered and a patient has no easy way of checking whether their adverse reaction(s), which they have associated with a particular medication, have ever been recorded.

Patients cannot be expected to make an informed consent when their treating clinician is using MIMS, the BNF or some commercially produced drug compendium, to discover all that is necessary to know at the time a new prescription is initiated. There appears to be a great reluctance on the part of clinicians to accept that an adverse reaction has occurred. The relationship between the patient and the medical practitioner is a power relationship. The patient asks for assistance and the clinician dispenses it. Many patients are frightened to tell their treating clinician that they suspect that the prescribed treatment may be making them unwell.

The threat of being removed from the GP’s patient list or labelled as a trouble-maker is usually all that is required to encourage patients to keep their thoughts to themselves. One of the anomalies that is apparent is that the database concerning drug safety is quite a long way behind current medical research. Patients are unlikely to have access to current medical research but the internet often permits some ideas to filter down and then inaccurate information circulates and grows legs and needless confusion is created.

The example par excellence is HMG-CoA reductase inhibitors. There is a wealth of peer-reviewed research in the medical literature that shows this class of drugs to be dangerously toxic. Their prescription is based on flawed science and there is no scientific evidence whatsoever to demonstrate that lowering cholesterol, either in total or by any particular fraction, reduces the incidence of cardiovascular events. Initially, there may be a very small anti-inflammatory action but it is of no value in females, whether for primary of secondary treatment and only of very limited value in men within a very narrow age band.

The literature has demonstrated in a reproducible manner the adverse effects of statins. For some reason, clinicians are reluctant to report events. The evidence points to much that is wrong and medical practitioners are not persuaded to complete adverse reaction reports. Rather than inviting the clinicians to report an adverse reaction or anything that may possibly be associated with a particular drug, it should be a mandatory requirement. It could be made easier by having a form available to patients, downloadable pdf for the computer literate and available at each site of clinical intervention.

The form would be simple to read and simple to complete. I suggest tick boxes for symptoms or groups of symptoms so as to avoid the patient with limited time or writing skills having to engage in a long form completion exercise that will be stressful. Perhaps a member of staff could be invited to help a patient complete the form. It needs name and date and possibly a contact telephone number for MHRA staff to pick up on the complaint. A general practice is less likely to have sufficient time to deal with such a complaint in a timely manner. 

The form needs to detail which drug is being taken, what is the dose and the treatment duration and note any concurrent administration of therapeutic substances. An open access database might well lead the way if it was simple to operate. It could be a dedicated terminal at a GP’s surgery or hospital outpatient’s department. All drugs would be known and searchable by members of the public using the trade name, the pharmaceutical name and the colloquial name. e.g. Aspirin, Salicylates, Pain-killers. For professionals, other labels could be also be used such as anti-pyretic or dispersible, for example.

In all probability database management has advanced considerable since MHRA first set up a database that dealt with drug adverse reactions. New methods can search on a particular word or phrase. It is in the interests of the patient to know much more about the drugs they are given and they will be most diligent about looking after their own health. they do not have the lives of thousands of other patients to consider and the patients are best placed to manage their own health, in partnership with their treating clinicians. 

Part of the reporting of adverse reactions depends on the perception of clinicians as to the efficacy of the treatment they have prescribed and on their personal experience. If the clinician has never heard or seen of a particular event associated with the prescribed therapy, and the information is not readily available to them, the probability is that any event that is an adverse reaction to a drug, may well be ignored. In an informal study concerning statin adverse events, a recent report has shown that 61% of patients could not continue with their treatment because of very severe adverse reactions to the therapy. The MHRA Drug Analysis Prints for this class of drugs do not support such a finding. 

The depressing conclusion is that clinicians find it difficult to support the finding because of a lack of adverse reaction reports, with the inevitable endpoint being that more people are being harmed and will continue to be harmed. This is because of the under-reporting of very severe adverse reactions that do not look plausible to the average clinician because the reports are not seen on your drug analysis prints.

For patients to use the system effectively, it has to be made user-friendly and fast and efficient so that clinicians and other healthcare professionals can avail of the service and be more likely to use it. Patients should not be discouraged from reporting their experiences and it should be made as easy as possible to do that. Information should be permitted to be fed into the MHRA service from a variety of sources. I have just had some information rejected by MHRA because it is spontaneous! While that is true, it does not negate the findings.

The disparity between the available information, the difficulty (for lay people) in finding or adding to the current information and the intentions of the MHRA, is marked. Current medical research from randomised clinical trials is not generally made available to the public. It is crucial when deciding whether a treatment is beneficial. In the end it is the patient who should decide whether they want to take the risk of significant adverse reactions and permanent harm, when compared with the purely theoretical reduction in the relative risk of developing a particular condition or syndrome.

The MHRA is well-placed to tie current medical research literature (positive and negative) to any particular group of drugs. In this way, it will support patients and assist them to make a truly informed consent. It will also gather data about any therapeutic measure if it can encourage participation (without threat of punitive measures) and make the reporting of adverse reactions to therapeutic substances and easy and commonplace matter.

Information that is essential to the MHRA adverse reaction database, was rejected as 'spontaneous' by MHRA. 

The idea is important because it puts the ability to affect the course of their treatment and their healthcare, back where it belongs... in the hands of the patient. The MHRA needs to have information from all sources if it is to be an effective body.  There is sufficient evidence to suggest that clinicians do not report all of the adverse events which they witness. Patients are effectively prevented from reporting adverse reactions because of the difficult and tortuous pathway that must be followed if they are to use the MHRA website system.

It requires four clicks to get to the MHRA adverse event reporting pages, if one does not register and the accent is on the registration buttons rather than making a report. There is far too much text on each of the patients and it is at quite small font sizes. The adverse event reporting page is tucked away (if one can find the menu item on the dropdown list) instead of being a big red box (hyperlink) on the MHRA  front page. The box would be named something like report a drug reaction and it would, ideally, occupy about 25% of the visible screen. On arrival after a single click, the visitor would complete the form on screen uncluttered by all of the verbiage that is currently placed on your pages. The form should be self-driven and there should be no need for the patients to click on links to advance the pages. HMRC are very good at this sort of thing and a visit to their own form completion pages would be instructive. 

I was never a supporter of the trend for government regulatory agencies to become known by friendly acronyms (NICE) or odd neologisms that suggested the type of subject matter with which a specific government office would deal, e.g. Ofsted. MHRA is not especially user-friendly and the full title does not trip easily off the tongue. The now unfashionable committee for the safety of medicines made far more sense and its three letter acronym (CSM) was easy to remember and to say.

it would be of great assistance if the MHRA could re-market themselves to the public they serve. Simple and memorable titles that underpin the functions of the organisation, simplified web pages that offer the visitor an opportunity to report a drug adverse event, with a single click. Receiving reports concerning adverse reactions to therapeutic substances is one of the primary functions of the MHRA. It should be afforded absolute priority on the home page, with a dedicated link box because it is the raison d'être for the existence of the MHRA.