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Non-compliance: a side effect of drug information leaflets
  1. F Verdú,
  2. A Castelló
  1. Department of Legal Medicine, College of Medicine and Odontology, University of Valencia, Valencia, Spain
  1. Correspondence to:
 Dr F Verdú
 Department of Legal Medicine, College of Medicine and Odontology, University of Valencia E G, Av/ Blasco Ibañez, n°15, 46010-Valencia (Spain);

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The problem of non-compliance with treatment and its repercussions on the clinical evolution of different conditions has been widely investigated.1–4 Non-compliance has also been shown to have significant economic implications, not only as a result of product loss but also indirectly through the complication of disease management and its subsequent healthcare and social costs.5–7

Non-compliance as a health problem

The term “non-compliance” might be taken to refer both to the failure to follow a drug regimen and to the failure to adopt other measures that contribute to improvement in health—for example, changes in lifestyle or diet. This letter focuses on the former.

Non-compliance with a drug regimen can be the result of a number of different factors9–11 and a variety of techniques have been developed in an attempt to control it.12,13 Of these, the few techniques that have been shown to be effective have only managed to solve the problem in specific situations over short periods of time. The use of such techniques to control non-compliance, particularly where these are effective, raises interesting ethical questions about the extent to which their application constitutes an infringement of the patient’s right to decide on how to manage their own health.8 Here we suggest that in some cases one factor that leads to non-compliance is the tendency to provide extensive and exhaustive information on side effects in patient information leaflets. Consider the following case.

A true story

One morning Dr Smith woke up with a slight cold—muscular aches, headache, chills, and nasal congestion. He decided to take some medicine to counteract its effects. His initial thought was to find something to combat his runny nose, so he chose a product specially indicated for nasal congestion: “StopSnot”. After reading the product information leaflet, however, Dr Smith felt another kind of chill run down his spine. He was struck cold by the contraindications, warnings, interactions, precautions, and adverse reactions listed in the leaflet. If he used this drug, it said, he would run the risk of suffering nausea, anxiety, agitation, insomnia, hallucinations, convulsions, amazement, weariness, arrhythmia, dizziness …. Rather than risk all of this, he thought, why not suffer a few bothersome snuffles? For his muscular aches, Dr Smith chose another drug, “Abatache”, but the risks described in the accompanying information leaflet seemed even worse. These included baldness, skin blistering, aseptic meningitis, pneumonitis, fatal hepatitis, gastrointestinal perforation, blood in the urine, jaundice, kidney disease, peptic ulceration, mouth ulceration, visual abnormality …. So in the end, armed with his clinical and pharmacological knowledge, Dr Smith simply opted to continue blowing his nose and suffer a few muscular aches. He had no desire to play Russian roulette with his health.

The principle of autonomy and the right to information

The principle of autonomy in medical ethics places the patient at the centre of medical decision making about his or her care. It places particular emphasis on the importance of informed consent, and suggests that, except in rare situations,14 no patient should undergo medical treatment or surgical intervention without his or her fully informed authorisation. This is the basis of patient-centred medicine.

To obtain valid informed consent, it is argued that the patient must receive sufficient understandable information to make a fully informed choice. In practice this means that someone undergoing a specific treatment receives information from at least two sources. First they will be given direct information from their doctor or another health professional about the drug to be taken, recommended lifestyle changes, and perhaps a warning of the hazards related to non-compliance. At this time, they will also be provided with information on some of the side effects attributed to the drug being prescribed. Individual patients will tend to understand this information in a range of different ways, and it is well recognised that they will respond with a variety of known behaviour patterns.8

Secondly, the patient will also receive additional information on side effects from the information leaflet provided with the drug itself. These leaflets tend to cite each and every one of the undesirable effects related—note “related”—to the principle active ingredient used in the drug. The information can in some cases be so complete or detailed that even any extremely unusual syndrome described in relation to the use of the drug will inevitably be listed in the leaflet as a possible “side effect”.

This information can sometimes have a significant effect on the likelihood that a patient will take the drug in question and may lead to significant “non-compliance”. When patients with minor ailments read about all the problems that may occur from using the prescribed medication, they may start worrying, to say the least. Some people read the leaflet again and again. They may then consult another source of medical information such as a website and perhaps decide to take only half the dose for half the amount of time prescribed, or simply decide not to take the medicine at all.

In addition to the problem of non-compliance, the so called nocebo effect15 needs to be considered, whereby the patient’s mindset is often a key element in the appearance of either physical or imaginary side effects, as has been shown in various studies.16,17 Such an effect may be caused by information leaflets.

Complete information versus sufficient information

Practically any city dweller would refuse to use transport services, work tools, or recreational facilities if they were supplied with complete, absolute, and extensive information on the hazards using these might entail. Precautions and warnings are usually good things, but they should be kept within reasonable limits to avoid creating outright alarm. Too much information can sometimes undermine autonomy and also lead to significant harms through non-compliance.

It was shown some years ago18 that information supplied by doctors can generate side effects that cannot subsequently be corroborated by physical examination. As it happens all too often, the information was not as exhaustive or complete as it might be.

In view of this, we believe that the kind of information given in drug descriptions should be reassessed. The information should be true, accurate, and easy to understand in as complete a way as possible, but it should not generate alarm that can lead to deleterious consequences in the healthcare sector or in the economic sphere.

So what did the patient decide?

The patient, shocked and dismayed at the drug’s side effects, finally decides not to follow the doctor’s recommendation. He (or she) will try to relax, perhaps by smoking a cigarette laced with nicotine, tar, and a number of other substances. True enough, doctors recommend giving up smoking. But who will listen to what a doctor says about smoking when they appear to be prescribing drugs truly hazardous to health? After all, a pack of cigarettes only says that cigarette smoking seriously damages your health. There is certainly no leaflet listing each and every one of its possible side effects. Tobacco kills, but it sometimes looks as if medication is worse.