January, 2017 - SUPPORT Summary of a systematic review | print this article |

What are the effects of written information about medicines for consumers?

Medicines are the most common intervention used in most health systems. As with any treatment, patients need sufficient information to make informed decisions about their use. Written information, such as leaflets or online information, is the most common way of providing this information.

 Key messages

 

  • Written medicine information may slightly improve knowledge and attitudes about medicines compared with no written information.

  • Written medicine information may lead to little or no difference in adherence to instructions compared with no written information.

  • The effect of written medicine information on health outcomes is uncertain. The review did not find studies that evaluated this.

  • Written medicine information delivered in an ‘easy to read’ format compared with a standard manufacturer’s format may lead to little or no difference in knowledge about and behaviours related to medicines, but it may slightly improve attitudes towards the information presented.

  • Written numerical information about the risks of medicines may slightly improve knowledge and attitudes about medicines compared with the same information as text.

  • The effects of written medicine information are mediated by the ability to read the information presented. Low literacy levels in low income countries could make these findings less applicable.
 
 

Background

In order to make informed decisions about the use of medicines, people taking them need good quality information. This information could be provided through written leaflets accompanying prescribed and over the counter medicines or written information available on the internet.


About the systematic review underlying this summary

Review objectives: To assess the effects of providing written information about prescribed and over-the-counter medicines on patient outcomes.
Type of What the review authors searched for What the review authors found
Study designs & interventions Randomised trials, nonnrandomised trials, controlled before after and interrupted time series studies in which the effects of written information were compared with a control group or alternative intervention. 25 randomised trials were included.
Participants Patients of any age receiving written information about a prescribed or over-the-counter medicine in any setting (hospital in- and out-patients and primary care) 4788 participants were enrolled in the included trials. 19 studies involved patients with chronic conditions (using NSAIDs or cardiovascular medicines), 5 trials were focused on patients with acute conditions, and 1 on both.
Settings Any setting The trials were conducted in 9 countries: USA (8 trials), UK (8), Belgium (2), Canada (2), Finland (1), France (1), Hong Kong (1), Switzerland (1) and Turkey (1).
Outcomes Patient knowledge about the medicine, patients’ attitudes towards taking the medicine, patients’ medicine-taking behaviour, and patients’ health outcomes Patients’ knowledge: recall of information about the medicine, recall of side effects; patients’ attitudes towards taking medicines; and patients’ medicine-taking behaviour
Date of most recent search: March 2007
Limitations: This review had important limitations related to the assessment of the risk of bias for included studies and the analysis of heterogeneity. Additionally, it has not been updated since 2007.
Nicolson DJ, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev 2009; 2: CD002104.

Nicolson DJ, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev 2009; 2: CD002104.

Summary of findings

The review included 25 trials. All of them were conducted in high income countries except for one carried out in Turkey. The two comparisons assessed by the review are detailed below.

 There was an important variation in the content of the interventions used in the included trials, but most of the interventions (19 trials) included information about ‘What this medicine is and what it is used for’ and ‘Possible side effects’.

 The outcomes assessed were measured with many different methods. For instance, measures of knowledge and satisfaction were often developed for individual trials and appeared to be measuring different components of those outcomes.

 1) Written medicine information versus no written information

 

Twenty trials assessed this comparison: 12 of them compared written medicine information to no information and in the other 8 trials both groups were given additional verbal information. Seventeen of the 20 trials measured a change in knowledge, 3 a change in attitudes, and 8 assessed a behavioural outcome.

 

 

  • Written medicine information may slightly improve knowledge and attitudes about medicines compared with no written information. The certainty of this evidence is low.
 
  • Written medicine information may lead to little or no difference in the adherence to instructions compared with no written information. The certainty of this evidence is low.
 
  • The effect of written medicine information on health outcomes is uncertain. There were no studies that evaluated the impact of written medicine information on health outcomes.
 

Written medicine information compared to no written information

People:  patients in treatment for suspected late onset neonatal sepsis
Settings
:  Hospital and primary care in middle- and high-income countries
Intervention
: Written medicine information
Comparison
: No written medicine information
Outcomes Impact Certainty of the evidence
(GRADE)
Knowledge about the medicine and its side effects (measured with different instruments)
Findings were mixed, although  most studies measuring knowledge found that either the written medicine information increased knowledge (recall of information or recall of side effects) or made little or no difference Low
Attitudes towards the information provided (scales of satisfaction with the information provided) In 1 trial assessing attitudes regarding the usefulness and ease of comprehension of the written medicine information, there were differences favouring the intervention group. In the other 2 trials participants given written medicine information expressed greater satisfaction with the information provided. Low
Behaviour (self-reported adherence scales and biological markers of adherence) In the trials examining adherence to instructions, adherence was higher among people given written medicine information. However, little or no difference was found when biological markers were used to assess adherence. Low
Health outcomes No studies assessed this outcome -
GRADE: GRADE Working Group grades of evidence (see above and last page)

2) Different presentations of written medicine information

Eight trials compared the effect of presenting written medicine information in different ways. The comparisons assessed included ‘easy to read’ leaflets versus standard manufacturer’s leaflets, numerical versus text descriptions of risks, and the order of presentation of the information (benefits and risks). Five of the studies measured a knowledge outcome, 4 an attitudinal outcome, and 2 assessed behaviour change. Because of the diversity of comparisons it was not possible to prepare a single Summary of Findings table for this group of comparisons.

 

  • Written medicine information delivered in an ‘easy to read’ format compared with a standard manufacturer’s format may lead to little or no difference in knowledge or behaviours related to medicines, but it may slightly improve attitudes towards the information presented. The certainty of this evidence is low.

 

  • Written numerical information about risks may slightly improve knowledge and attitudes about medicines compared with the same information as text. The certainty of this evidence is low.

 

 

Relevance of the review for low-income countries

Findings Interpretation*
APPLICABILITY
All the trials – except one conducted in Turkey -  were carried out in high-income countries. 

Implementation of written medicine information depends on the health systems’ regulatory context. For instance in high-income countries there are specific laws that already govern the use of written medicine information. The implementation and impact in low-income countries without similar laws could be different from the findings from this review.

 

 

  • The effects of written medicine information are mediated by the ability to read the information presented. Low literacy levels in a country could make these findings less applicable.

 


EQUITY
Overall, the review provides little data regarding differential effects of the interventions for disadvantaged populations.

Interventions requiring skills unequally distributed in the population (such as reading) could increase inequalities regarding information about medicines and other health issues.

 

 

  • In order to avoid an increase in inequalities, the design of the intervention should consider the level of literacy in the countries where the intervention is planned to be implemented.

 


ECONOMIC CONSIDERATIONS
There was no information about the cost or cost effectiveness of the interventions
Although the cost of scaling up the intervention could be affordable (written materials are relatively inexpensive), costs will depend on the regulatory context of the specific health system in which the intervention is implemented.
MONITORING & EVALUATION
The certainty of the available evidence is low and no evidence was found for some comparisons and outcomes.

Consideration should be given to monitoring and evaluating the effects of changes in policies regarding the provision of information about medicines to patients on knowledge and behaviours. Randomised trials or interrupted time series studies should be used to evaluate the effects of changes in these policies when there is important uncertainty about the effects.


*Judgements made by the authors of this summary, not necessarily those of the review authors, based on the findings of the review and consultation with researchers and policymakers in low-income countries. For additional details about how these judgements were made see: http://www.support-collaboration.org/summaries/methods.htm

 

Additional information

Related literature

Ciciriello S, Johnston RV, Osborne RH, et al. Multimedia educational interventions for consumers about prescribed and over the counter medications. Cochrane Database Syst Rev 2013; 4: CD008416.

 

Ryan R, Santesso N, Lowe D, et al. Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews. Cochrane Database Syst Rev 2014; 4: CD007768.

 

This summary was prepared by

Tomás Pantoja, Unit of Health Policy & Systems Research, School of Medicine, Pontificia Universidad Católica de Chile, Chile.

 

Conflict of interest

None declared. For details, see: www.supportsummaries.org/coi

 

Acknowledgements

This summary has been peer reviewed by: Peter Knapp and Fatima Suleman.

 

This review should be cited as

Nicolson DJ, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev 2009; 2: CD002104.

 

The summary should be cited as

Pantoja T. What are the effects of written information about medicines for consumers? A SUPPORT Summary of a systematic review. January 2017. www.supportsummaries.org

 

Keywords

evidence informed health policy, evidence based, systematic review, health systems research, health care, low and middle income countries, developing countries, primary health care, medicines, consumers, access, information, pharmaceuticals

 



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