You may remember some time ago, HealthUnlocked and the University of Manchester conducted research into medication side effects and the perceptions around reporting them. We found some very interesting insights:
- Over 95% of people surveyed took regular medication and 87% had experienced a side effect that they believed was caused by their medication. Where people had experienced side effects, people stopped taking their medication in 59% of cases. In 10% of cases, the reaction was severe enough to cause them to be admitted to hospital as a result.
- Of those people who had experienced a side effect of medication, over 90% had reported this to someone else, most commonly their GP (79%), a pharmacist (17%), or to a family member or friend. However, few (3%) had reported this to the Medicines and Healthcare products Regulatory Authority (MHRA), the regulatory agency responsible for monitoring drug safety in the UK.
- People varied in their level of understanding about the laws, regulations and systems for monitoring medication safety in the UK. Awareness of the MHRA’s ‘Yellow Card’ scheme for reporting drug side effects was low, with over 70% of people reporting little or no knowledge of the MHRA or the scheme.
- We asked survey respondents whether they would be happy if the MHRA or researchers used content posted on HealthUnlocked communities to monitor side effects - 94% of people agreed in each case.
This feedback has given us valuable insight into the reporting of medication side effects and how this could be improved in the future.
The next stage of the research is to hold a series of face-to-face focus groups with people to explore better ways of reporting medication side effects, making use of online health communities on HealthUnlocked. If you live in or around Manchester and are interested in taking part, click this link to see the details: patientsafety.manchester.ac...
If you have any questions about this research, don’t hesitate to get in touch with us at support@healthunlocked.com.
Thank you!
HealthUnlocked and The University of Manchester
Written by
MaddieHU
HealthUnlocked
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It depends if "side effects" was properly defined, and consistently used, for those findings to have value, but it surprises me that people consuming an exogenous substance designed to have a measurable effect on / make a change to, a living organism, are surprised that it has more than a single effect. Surely the issue is the nature of the secondary effect (side effect isn't really an accurate term). But for myself, I certainly don't like the idea of MHRA, researchers, or indeed anyone else with an ulterior motive, lurking here and using information so gleaned for their corporate ends.
The information about the yellow card scheme should be included in every Patient Information Leaflet with a supply of drugs. Perhaps when patients are started on new medication they should be able to log into an online portal, register the start date of a new medicine and then register symptoms, or none, then an end date if they stop taking the medicine due to side effects. This could be collated as part of the monitoring process.
I'd never noticed the MHRA reference on the PIL. I don't know if people would register online but perhaps you only get your next repeat if you bring a printout proof of registration??
There's enough obstructions to being properly medicated, without being refused one's meds simply because of not registering with something we may never need to use. I'm sure that would be readily challenged in law.
There is a big yellow MHRA poster on the wall in my pharmacy, facing anyone standing at the counter, about reporting side effects of prescribed medications. It tells people that they may report them, and how - complete the yellow card available right where they are, or do so online, together with the web address. If people want the report card they only have to ask there and then, but if not convenient to complete the form there, they they can take the card home and complete it later, or can take a photo of the poster with their camera, have the info with them at home, and go online to report the problem, where all the necessary info is available. The side effects can also be reported calling freephone 0800 731 6789 (10am to 2pm Monday-Friday), or in writing by Freepost to MHRA, 10 South Colonnade, Canary Wharf, London E14 4PU. As mentioned, it is also specified in the PIL accompanying the med. Drs surgery walls are usually awash with info for patients, and presumably some will have the same poster, but if not, it's easy to resolve. I'm not sure what else is required, either by additional information availability, or increased reporting options.
postscript I have just typed into my search bar "how can I report side effects of my meds UK" and instantly the exact advice necessary, popped up (163 million results actually).
Unfortunately it hasn't worked well in the past. So I hope a better system can be devised that doesn't rely on self reporting which is difficult with a hormone that takes 6 weeks to adjust to and longer for some.
It took over 5 years for MHRA to investigate problems with levothyroxine and patients were getting sicker and sicker. In fact more than 5 years because internationally the MHRA knew there was a problem even before the UK problems were verified. So, from 20o5 increase in reported problems to 2015 when old stock was finally cleared off the shelves patients were left to suffer. The info is on the Internet if you dig although the New Zealand investigation and reports seem to have been taken down now. It all makes very interesting reading if you're interested in how mens are regulated.
Even when a letter went out from the Commission for human medicine to recall patients in high risk categories. Hospitals, pharmacies and doctors ignored it. My pharmacy was still issuing a recalled batch and to my knowledge no patienrs were recalled by GPS. Even our (then) PCT did nothing about it although the information was in the public domain. Doctors are still unaware that levothyroxine was reviewed in 2013, and is being kept under review according to the report. However, I don't know what action they are taking to monitor it.
I'm not sure how, other than patients reporting their experience, any organisation might know there was a problem. But what you describe though, isn't a problem of reporting, which is what HU's post is about; it's a problem with appropriate and effective action being taken in response to that reporting, and that's distinct from accessing the information in the first place, especially if as you say, problems were known about long before action was taken. Regarding the problems you describe, one would need to know if it was a problem with the active 'levothyroxine' as you describe, or with the reformulation or manufacture of specific brands, or specific batches, or with excipients and not the active ingredient at all; and were all levothyroxine patients suffering or only some? Those factors are key to judging what action or safeguards might be necessary in any given set of circumstances, and therefore what criticism might be properly levied against the relevant parties in the absence of that action & those safeguards. That is especially the case where not every patient consuming even the same brand, is experiencing adverse or unexpected effects. If a pharmacy continues to dispense a recalled batch as you describe, it may be evidence of dishonesty, negligence, incompetence, or poor dissemination of information from the responsible agency etc, and what needs to be done to rectify the situation, and prevent it happening again, will differ accordingly. During the period you mention of 2005 - 2015, I was certainly taking levothyroxine and had no problem with whichever brands were variously dispensed to me, so it clearly wasn't a universal problem that might reasonably necessitate unilateral withdrawal of all stocks of generic levothyroxine. I assume though, that you are referring to Teva & Numark and the suspension of the marketing authorisation relating to the 100 mcg tablets; which came about as a result of studies carried out at the MHRA’s Medicines Testing Laboratory and the CHM examining sporadic reports of potential reduced efficacy, when switching to Teva levothyroxine from other levothyroxine products; and evidence of manufacturing difficulties. I can't speak to what warnings the CHM itself, may have issued, but the UK Govt certainly gave explicit guidance to all healthcare professionals as to what should happen, including close monitoring and testing of individual patients in certain at risk groups, who were taking Teva tablets. Additionally, the MHRA issued a press release advising of the suspended license, and a report was also distributed through the Central Alerting System. However, I have no information about the international concerns about Teva so can't comment, but as we know, the company has since met every CHM recommendation and its product has been allowed back onto the market. So perhaps HU and Manchester Uni are focusing on the wrong end of the process, and what is required more urgently is a review of what happens when a yellow card or whatever report, is received; and only when that is right, do you need to look at front end mechanisms to get to that point. I suppose we don't know what may be happening in the bigger scheme of things.
According to the MHRA 2013 report on Levothyroxine. It was wrongly classified, (that applies to all levothyroxine) the dissolution tests were unsuitable and inappropriate, the science was wrong. Also, the regulations applied to manufacture did not control quality adequately. This resulted in 50% difference from stated potency between some of the generics 100mcg and a smaller but still significant difference in other doses. The results was unexpected lack of efficacy or bioavailability and lack of bioequivalence even by the same manufacturer. However, it was also the reporting process that was inadequate since it was very difficult for patients newly taking levothyroxine to work out what was causing the problem and report it due to inexperience in symptoms. People on the higher or lower end of levo dosing or with coexisting conditions were most affected, this includes pregnant women, cancer patients and people with heart disease.
The information from the CHM and the MHRA did not get through adequately to health professionals it seems and it wasn't acted on in our local area as far as I know, meaning that doctors were not aware of potential problems with bioequivalence and were not likely to report symptoms on behalf of patients'.
It's possible, judging by comments on this forum, that doctors blamed patients for non-compliance and in other cases, were issuing SSRI's for inexplicable symptoms.
In people with Hashimotos, as symptoms and thyroid hormone test results can fluctuate, the problems may have been less apparent than for thyroid cancer patients for example. Some people are much more sensitive to thyroid hormone changes than others so it may not have affected everyone. However, it's impossible to say who it affected since it's possilbe that most cases were not reported as they might have been attributed to other reasons.
My opinion is that there is a general cavalier attitude to thyroid hormone and I've been told by health professionals that it's a very tolerant drug but this is not my experience. I would like to see tighter monitoring and control of quality and reporting of side effects has to be part of this.
I guess the research is not for me even if I wanted to get involved. To do so, you apparently need to have been diagnosed with at least 2 of 5 health conditions. In my case, my health was damaged by side effects of a prescription drug (which itself was not taken for a health condition)!. But the GP has not accepted that the drug he prescribed caused the damage - surprising that!!!!
Anyhow I completed an MHRA yellow card >2.5 years ago for what it's worth.
Since then, my father has tried to get justice via solicitors but found it to be a closed shop with GP protectionism.
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