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Written information on medicines for patients: learning from the PIL
  1. D K Theo Raynor
  1. School of Healthcare, University of Leeds, Leeds LS2 9JT, UK
  1. Correspondence to D K Theo Raynor; d.k.raynor{at}

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Key learning points

  • Medicine information leaflets that are well written and well designed can improve peoples’ knowledge and understanding.

  • The focus of information about medicines should be on empowering decision-making and supporting safe and effective use rather than encouraging people to take a medicine.

  • People want information that is tailored to their circumstances and needs.

  • Written information should support spoken information from a health professional—not replace it.


Everyone should expect accurate, accessible and usable information about their medicines. A generation ago, the only source was the label on the bottle. Since then, there has been a gradual increase in regulated information provided to patients. Pharmacists began to include additional administration and safety information on the label, and then leaflets started to appear—notably with non-oral dose forms such as inhalers.

Work on developing more comprehensive leaflets began in the late 1980s, with research on a generic style of leaflet that outlined the effects of a group of medicines (eg, diuretics, benzodiazepines).1 This was overtaken in the mid-1990s with the European Union (EU) initiative to provide inside every pack what are generally called patient information leaflets (PILs). These comprehensive leaflets (covering indication, warnings and precautions, administration and adverse effects) became mandatory in 1999, and from 2005, they were required to be user-tested for readability with members of the public.2,3 Alongside, these developments has been an increase in the number of regulated and unregulated sources of information about medicines published online.

Over time, the emphasis has shifted from basic ‘how to use’ information, through to more detailed information on safe use. More recently, there has been a focus on providing patients with information to enable them to make an informed decision about whether a medicine is right for them. In 2005, the Committee of Safety of Medicines published guidance, which highlighted the variable quality of PILs and focused on strategies to improve the quality of information provided with medicines.4 Subsequently, despite improvements arising from user testing, reports from the European Commission (published in 2014) and the UK Academy of Medical Sciences (published in 2017) noted there was further room for improvement.5,6

UK sources of information for patients on medicines

Key sources of written information for patients in the UK include:

  • Mandatory PILs produced by market authorisation holders and authorised by UK and EU medicines regulators.

  • National Health Service (NHS)-produced content published by national organisations (eg, NHS Inform, NHS medicines A–Z).

  • NHS-produced content published by local organisations (eg, hospitals, primary care organisations).

In addition, information leaflets on medicines are widely available from professional organisations (eg, Royal Colleges), organisations representing patients (eg, health charities) and commercial sources.

Patient information leaflets

PILs that accompany every medicine are the most widely available source of printed information, as pharmaceutical companies are required to include them inside every pack. Regulated by the European Medicines Agency (EMA) and national authorities (eg, the UK Medicines and Healthcare products Regulatory Agency [MHRA]), PILs have to reflect the full technical information aimed at prescribers and other health professionals contained in the Summary of Product Characteristics (see Box 1).2,7

Box 1

Main sections of the PIL7

  • What drug X is and what is it used for.

  • What you need to know before you take/use drug X.

  • How to take/use drug X.

  • Possible adverse effects.

  • How to store drug X.

  • Contents of the pack.

As well as being included inside every pack, the leaflets are available online from the electronic Medicines Compendium (eMC), EMA and MHRA websites. Leaflets are also mandated in other countries, notably the USA and Australia, where the degree of regulation varies.8

Patient alert cards and safety information

In addition to the PIL, regulators may require other risk minimisation materials to be produced by the pharmaceutical company for a new medicine or product that has already been marketed, for which a safety issue has been identified. Such material may include educational content for patients (eg, information booklets, alert cards, consent forms) and is accessible from the eMC website (

NHS-produced content

In 2017, the NHS started publishing information on some common medicines on its website (, that was developed in collaboration with the NHS UK Medicines Information pharmacists network (see Box 2). The information is produced in line with the NHS website editorial and governance policies and is available for syndication.

Box 2

NHS website medicines information sections

  • About drug X and key facts.

  • Who can and cannot take drug X.

  • How and when to take it.

  • Adverse effects and how to cope with them.

  • Use in pregnancy and breast feeding.

  • Cautions with other medicines.

  • Common questions.

In addition, NHS organisations such as hospitals and primary care organisations may produce their own leaflets for patients.

What type of information do patients want?

An NHS-funded systematic review on the role and effectiveness of written information about medicines (published in 2007) concluded that patients need information which helps them with:9

  • Making decisions about whether the medicine is right for them.

  • On-going decisions about the use of a medicine and interpreting symptoms.

It also described the need for PILs to contain a balance of the possible negative effects with the potential benefits, so that people can make informed decisions about their medicines.10 The Academy of Medical Sciences’ report recommended that PILs be revised to present a clearer, more simplified and balanced appraisal of the benefits and potential harms of the medicine.6 Patients may, however, be surprised by the perceived lack of benefit of many medicines. In a study, people taking statins overestimated the benefits of treatment and expressed surprise when presented with numerical information on the effect of statins (‘If 17 people like you take this medicine over the next 5 years, one of them will be prevented from having a heart attack or stroke’).11

Earlier research showed that patients did not want written information to be a substitute for verbal information from healthcare professionals.9 This was supported by a key finding of a report from the European Commission that the PIL should not stand alone, but that the information should be integrated to become part of the healthcare process.5

However, patients also want information that is relevant to them—which means that standard leaflets are less able to meet their needs.5,9,12 Conversely, internet-based information (if well-structured and layered) may allow readers to focus on the information that is important to them.

What sources are currently used?

Evidence relating to the use of sources of medicines information for patients is patchy, and much is not current. A 2010 study found that 97% of patients were aware of the PIL supplied with the medicine, and 35% said they had read at least some of the leaflet. This was considerably higher for first-time users (71%).13 However, for repeat users, nearly 60% said they had never or rarely looked at the leaflet after the first supply. The adverse effects section was most commonly read and was the most common specific reason given for reading the PIL. In a survey of hospital in-patients (conducted in 2013), 74% said they read the leaflet (42% always and 32% for new medicines).14

What is the purpose of the information and does it work?

With health information, a distinction needs to be made between effect on knowledge and understanding, and impact on behaviour. The former could be said to be the primary function of patient information rather than whether it increases adherence. It could be argued that an informed decision not to take a medicine is a good outcome for the individual and hence the focus here is on the impact on knowledge and understanding—not on what action the patient subsequently takes.15 A systematic review (conducted in 2007) noted that some health professionals saw increasing adherence as the prime function—contrasting with patients who saw an informed decision not to take a medicine as an acceptable outcome.9 The review found no robust evidence that written information improved medicine adherence.

Information for patients

The leaflets inside all medicine packs contain approved information to help you learn more about your medicine. The quality of these leaflets has improved over the past decade, through their readability being tested with members of the public. There is also information on many common medicines available on the NHS website (

When reading any information on medicines, ask yourself three questions:

  • Who has produced it?

  • When was it produced?

  • Why was it produced?

If you want help with information about your medicines, ask your healthcare professional—that is what they are there for.

A Cochrane review (25 studies, 4788 participants) examined whether written information about individual medicines improved knowledge or attitudes, or changed behaviours.16 Several trials that used different types of information and different measures found that written information improved knowledge. However, the quality of the studies was generally poor. The review concluded that it is important that medicines information be well written and designed to maximise the possibility of improving knowledge.

User testing of PILs

A key change in the nature of PILs took place from 2005, when EU legislation required that they ‘reflect the results of consultations with target patient groups to ensure [they are] legible, clear and easy to use’.3 Most pharmaceutical companies fulfil this obligation by user-testing PILs with laypeople. There are two parts to the interview: the first determines whether people can find and understand key points of information; the second asks open questions about what they did and did not like about the leaflet. The testers provide feedback on what is wrong with a PIL, allowing the application of expertise in information writing and design to make improvements. The PIL is then tested again. It is important that the testing process avoids using expert patients.

User testing has resulted in improvements to PILs since 2005, but there are still issues that need to be addressed to maximise their benefits. The 2014 European Commission report called for the implementation of user testing to be a more iterative cycle of writing, designing and testing that results in PILs that enable users to act appropriately.5

How information should be presented for maximum effect

Although there is no single right way to present written information, there are general principles associated with good information writing and design that need to be applied.5,17–19 Such principles include the need to write conversationally, addressing the reader as ‘you’, which helps ensure the writer uses simple, everyday language. It also helps engage with people who do not do much reading or writing. Using the active voice is also important (‘Researchers studied the effect of X’, rather than ‘The effect of X was studied’) and a good way of determining whether the language is appropriate is to read it aloud to see whether it sounds conversational. Pictures and graphics need to be simple and shown to be understandable through testing. They are not a panacea as information in pictorial form is not necessarily easier to understand and can mean different things to different people. Layout and design can be as important as the wording and the appearance of a document and how attractive and easy to read it looks is critical to its effectiveness. Other key tools include using bullet points to organise lists, using bold lower case text for emphasis and lay-friendly headings and subheadings.

The European Commission report called for more experience and evidence on the use of a key information listing of five to nine bullet points summarising the most important points related to that medicine.5

A study suggested that a revised order of information would enable readers to locate information more effectively.20 Crucially it showed that laypeople see warnings and precautions and adverse effects as one category and would like a single section on usage problems.

Practical advice

The advice to those producing medicines information for patients is to follow good practice in information writing and design and to test information with real people from the target group. It is important to remember that design and layout are as important as the words used. Online information should not just be a static reproduction of the hard copy as patients’ value tailored information, set in context of their characteristics and particular illness.9,12 Automated computer systems could also allow for leaflet tailoring in the pharmacy or general practitioner surgery.12

All professionals should critically appraise the information they give out or recommend—does it follow good practice in information writing and design? As well as recommending sites they trust, professionals need to help patients understand the basic rules for assessing such information:21

  • Who has produced it?

  • When was it produced?

  • Why was it produced?

PILs are far from perfect, but following the introduction of user testing, they are much improved and can still make a difference if used in conjunction with input from health professionals. Notably, they provide a focus and key points for pharmacy staff to discuss with patients at the point of dispensing or during a medication use review.10

Regulators should note that the negative public and professional views may be linked to the old-style PILs of the past and that the new regulations have resulted in improvements. A public education campaign led by regulators could help to raise awareness of the information that is provided with medicines.

Advice for patients is to use their pharmacy and ask for information if it is not offered. The Care Quality Commission’s survey of adult in-patients found that 43% of patients said they were not told about which adverse effects to look out for.22 Equally, it appears that most people collecting prescriptions from pharmacies are not given any spoken information.23


Medicines information, if well written and designed, can increase people’s knowledge and understanding—enabling them to make informed decisions about their medicines and to take them safely and effectively. Such information should contribute to a shared decision-making process that considers the harms and benefits of drug treatment and be given in addition to spoken information from healthcare professionals. Steps need to be taken to integrate the provision of medicines information into the care process.

There are established principles for good information writing, design and user testing that information producers should take into account. Healthcare professionals should use these principles to assess the information they supply or resources that they recommend.

CPD activity

Choose two medicines that patients you care for commonly take—then go to and and look at the information patients can access.

  • Could you integrate these web pages into what you say to patients when prescribing, supplying or administering a medicine?

  • Does your clinical computer system provide similar information—how does it compare?

Passive provision of standardised generic leaflets is outdated and the use of technology offers greater opportunities to tailor information to meet individual needs. A key challenge is to develop new ways of providing information that are flexible and allow uptake of varying amounts and types of information, depending on an individual’s needs at different stages in the care process.



  • Competing interests Theo Raynor is emeritus professor of pharmacy practice at the University of Leeds, and co-founder and academic adviser to Luto Research, which develops, refines and tests health information materials.

  • Provenance and peer review Commissioned and peer reviewed.