Analysis

Unhelpful information about adverse drug reactions

BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g5019 (Published 12 August 2014) Cite this as: BMJ 2014;349:g5019
  1. Kirin Tan, medical student1,
  2. Keith J Petrie, professor2,
  3. Kate Faasse, postdoctoral fellow2,
  4. Mark J Bolland, associate professor1,
  5. Andrew Grey, associate professor1
  1. 1Departments of Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand
  2. 2Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand
  1. Correspondence to: A Grey a.grey{at}auckland.ac.nz
  • Accepted 1 August 2014

Kirin Tan and colleagues find that information about adverse drug reactions for commonly prescribed drugs is excessive, inconsistent, often poorly presented, and contaminated by symptoms commonly experienced in daily life. They suggest how we could do better

Drug treatment is an important part of managing chronic disease, but people often choose not to start or continue with recommended treatments.1 As the efficacy of a drug is central to the decision to start or continue treatment, accurate and succinct communication of the benefits of treatment is emphasised in clinical practice. But the disadvantages and adverse effects of drugs are also important. Concerns about adverse drug reactions—noxious and unintended effects of a drug (box 1)—can deter patients from starting treatment,2 3 and their occurrence during treatment can prompt cessation.4 5 Accurate information about adverse drug reactions, and its careful communication to patients, is likely to influence the outcomes of chronic disease management.6

Box 1: Terminology

Drug effects*

Side effect—a secondary effect of a drug that might be adverse or beneficial

Adverse effect—an untoward occurrence in response to administration of a drug, which does not necessarily have a causal relation with the treatment

Adverse drug reaction—a response to a drug that is noxious and unintended and that occurs at doses normally used for prophylaxis, diagnosis, or treatment of disease or for modification of physiological function

Seriousness—a measure of the degree of harmfulness of an adverse response to a drug

Severity—a measure of the intensity of an adverse response to a drug

Other6

Placebo—beneficial effects produced by positive expectations

Nocebo—adverse effects produced by negative expectations

  • *International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, www.ich.org/

An important concept in considering information about adverse drug reactions and its clinical impact is the nocebo effect, the …

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