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The benefits of medicines outweigh the risks of treatment — says who?

Theo Raynor writes that pharmacists need to find ways of expressing risk-benefit ratios to patients in a way that they can understand so that they can make informed decisions

By Theo Raynor

Theo Raynor: people struggle to understand the numerical information associated with treatment effectivenessTheo Raynor writes that pharmacists need to find ways of expressing risk-benefit ratios to patients in a way that they can understand so that they can make informed decisions

I am going to start somewhere unexpected — in a high street pharmacy in Middlesbrough town centre on Boxing Day 2006. I was collecting an emergency prescription for my father-in-law and, since it was bank holiday, I had time to have a look at the leaflets in the waiting area.

One leaflet was titled “High blood pressure — why you should take your tablets”, and overleaf it stated: “The benefits of these drugs in terms of saving heart attacks and strokes have been shown to outweigh any side effects.” This seemed an interesting assertion at a time when patient involvement in decision-making was gaining ground.

A year later I noticed this statement in a Times newspaper report of a study of statins, and whether they should be given to everybody: “Although statins have been associated with liver problems, muscle wasting and slightly elevated risk of cancer, the British Heart Foundation and the Department of Health say that the benefits outweigh any side effects.” Again, this was a bold statement.

Moving to 2010, the BBC News website quoted an author of a BMJ paper on statin side effects saying: “Whatever your level of risk, the benefits greatly exceed any of those hazards.”

So, we have statements telling patients why you should take your tablets, and that the benefits outweigh the side effects. It is clear that these are statements made by professionals and policy makers but should patients not have the opportunity to decide for themselves if the benefits outweigh the risks?

This is not yet generally possible, as we are a long way from effectively describing those benefits — but when we can get that benefit information across we will have truly informed patients who understand the likelihood of harm and the likelihood of benefit for them.

Health literacy

“The power of information” was the first government document that, as far as I am aware, used the term “health literacy” and it acknowledges that people should be able to consider the importance of the possible benefits and harms of treatments.

“Health literacy” is a much used term, and last year the BMJ published research confirming that low health literacy leads to worse mortality in the UK, and that a third of older people find health information difficult to understand.

In an accompanying editorial I discussed what we should do to address health literacy. Should we target those who have problems, and try and do something specifically for them? Or should we develop easy-to-read and easy-to-access information that everybody will benefit from — an approach I favour, and that is gaining ground in the US, where they call it “universal precautions”.

I favour it because even the most educated people if they are ill, do not want complicated health information; they want it simple, like everybody else. That must be the way forward, rather than trying to identify those people who have got low literacy and doing special things for them. We need to do the same thing for everybody.

Balancing benefit and harm

Terminology is important here; we talk about risk but we should be talking about harm. The words “risk” and “benefit” slip off our tongues easily, but they are not comparable words.

We should be talking about the “chance of benefit” and the “risk of harm”. This is also more respectful to the people who take medicines. I wonder if we hide behind the word “risk” when we should be honest and use the word “harm”, because that is what we are talking about.

“Always read the leaflet”, a document produced by the Medicines and Healthcare products Regulatory Agency and Committee on Safety of Medicines Working Group on Patient Information, noted that leaflets are too negative, with insufficient information on benefits.

Now, in terms of expressing harm information effectively, we have come quite a long way in describing how likely a side effect is to occur, with the current EU guideline combining a word and a frequency, eg, “rare, may affect up to one in 1,000 people”. This works quite well, and we are moving towards being able to express the likelihood of a side effect in a way that people can understand.

However, “benefit” information has only recently moved closer to centre stage, notably the most recent EU leaflet template, which explicitly encourages such benefit information.

The focus in the template, however, is more on how the medicine works — this tells people how they might benefit, not how likely they are to benefit. I believe if we are giving people numerical harm information, then I think we need to consider giving numerical benefit information, otherwise it’s not a valid or usable comparison.

Our work on the wording of benefit information began in collaboration with colleagues at the University of Sydney. We showed people information about a fictitious medicine, “Clotmed” (based on clopidogrel), which included numerical information: “If a 100 people took this medicine for two years, three would be saved from having a heart attack, one would be saved from having a stroke.”

I spent a long time trying to word that in a way that I thought would be understandable to the public — and how wrong I was. Participants in both countries were very keen on textual benefit information, but the numerical information almost caused a riot in some of the focus groups.

People did not believe it — they could not believe so few people would benefit. Some struggled to understand it, thinking that “the other 97 would have a heart attack”.

One person did not really want this information but followed this by noting that without it, how could people make a decision about whether they wanted to take it.

Some started off being against the numbers, then partly came round as they realised what the information was telling them. But the negatives predominated, with one person noting that if it was 50 or 55 per cent of people it would be more encouraging.

Another noted that “it’s different if there were a positive message saying look we’ve saved thousands of lives in the use of this medicine” — an insightful comment.

Our next steps were through a co-funded PhD studentship (jointly by the MHRA and the University of Leeds), with Rebecca Dickinson being appointed to the studentship, and including supervision by Jan McDonald from the MHRA. Ms Dickinson has run focus groups again, but with revised numerical benefit wording, to see if we can get that message across better.

We had three numerical descriptions: a percentage, one based on natural frequency and one on numbers needed to treat: “If 20 people like you take Rebastatin over the next five years, one of them will be stopped from having a heart attack or stroke.”

So, armed with these phrases, Ms Dickinson went back into the lion’s den of the focus groups. There were again negative comments, such as “What’s the point in taking if I’ve only got this chance?”.

There were some positives: “I want to know my chance and if the information was there … I would feel like the information leaflet was treating me with respect.” “Respect” used here is an interesting word — do we need to give numerical benefit information to treat people with respect? I think we do.

The format above is a type of “number needed to treat” or NNT expression. This was previously championed by the publication Bandolier, and one of the lists of NNTs it published included drugs with an NNT from 1.1, all the way up to 16, 18, 40 and 100 or more. It is clear that a lot of health professionals do not realise how many people need to be treated to have an effect, even with curative medicines. Currently the website gives an interesting angle, where it has developed a traffic light system for patients to use.

Patients’ wants or the general good?

In the Shirley Norton lecture for 2012, Nick Barber, of UCL School of Pharmacy, covered a framework for good prescribing with three intersecting circles: technical measures (is it the right drug for that particular indication?), patients’ wants and then the general good.

An informed patient is not necessarily an obedient patient. He or she might make decisions that are right for them (patient wants) but not considered correct by professionals and policy makers (for the general good).

This comes down to this fact that many people just do not understand the concept of reducing population risk, with the likelihood of little personal benefit. Clearly if a hundred people take a medicine and three are saved from having a heart attack, for the public health that is great, particularly if it is a cheap medicine, as statins are for example. But do people see it that way? I do not think they do.

The consequence is that we have got an issue, particularly with preventive medicines, if people come to realise how high the numbers needed to treat are. Will fewer people take medicines if they understand the real chance of them benefiting?

There are differences between preventive medicines, such as statins, and other public health measures, for example seat belts, the smoking ban and healthy eating. Public health interventions must have no significant “side effects”, as is the case with these behavioural examples; but medicines, like statins, do have significant side effects.

The genie is out of the bottle

People should have access to useable and accessible information about medicines, to allow them to make decisions about whether a medicine is right for them. If people are going to make such decisions, they need to know the chance of benefit and the risk of harm — and I believe we will only be treating them with respect if we provide them with such information.

Of course, how to express benefit is difficult, and the work discussed
here is the start of a journey towards being able to do this in a way that mirrors the way that we describe side effects — so we may be able to work towards something that is comparative.

Diagrams or pictorial representations might work, but we need to test them with real people, to make sure that they do work.

That leads us back to the reality — that the actual benefit might be lower than most people expect and that they do not have this concept of the general good. But that is not a reason for not giving this information.

The genie is out of the bottle and we are committed to a truly informed and engaged patient and so we have just got to get over it and decide how we take it forward. And so if we are looking at preventive medicines as a public health measure, should we try to persuade people that the benefits outweigh the risks? And, if so, how?

About the author

Theo Raynor is professor of pharmacy practice at the University of Leeds, and co-founder and academic advisor to Luto Research, which develops, refines and tests health information (

This article is based on the presentation given by Professor Raynor at the Medicines and Healthcare products Regulatory Agency in February 2013 as the Annual Shirley Norton Lecture. 

Shirley Norton was a pharmacist who died two years ago after many years of distinguished service at the MHRA. One of her passions was the need for medicines information for patients to be at the forefront of the thinking of all stakeholders.



•    Cribb A, Barber N. Prescribers, patients and policy: The limits of technique. Health Care Analysis 1997;5:292–8.
•    Department of Health. The power of information . London: DoH, 2012.
•    Hamrosi K, Dickinson R, Knapp P et al. It’s for your benefit: exploring patients’ opinions about the inclusion of textual and numerical benefit information in medicine leaflets. International Journal of Pharmacy Practice 2012. DOI: 10.1111/j.2042-7174.2012.00253.x
•    Knapp P, Gardner P, McMillan B. Evaluating a combined (frequency and percentage) risk expression to communicate information on medicine side effects to patients International Journal of Pharmacy Practice DOI: 10.1111/j.2042-7174.2012.00254.x
•    Medicines and Healthcare products Regulatory Agency. Always read the leaflet: getting the best information with every medicine. Report of the Committee on Safety of Medicines Working Group on Patient Information. London: The Stationery Office, 2005.
•    Raynor DK. Health literacy — is it time to turn the focus from patient to provider? BMJ 2012;344:e2188.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11121573

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