On his travels through Siberia, Colin Thubron recounts meeting a doctor in a remote town who was struggling to translate medical leaflets from a pharmaceutical company in Mumbai. The doctor undertook this translation to improve communication with his patients when prescribing the medicines in question. Faced with dense, jargon-heavy language, he appealed to Thubron for help in simplifying the English text into a more accessible style that he was then going to translate into Russian. However, Thubron found himself at a loss, describing the encounter as follows:

I unfolded a leaflet of smudged directions… ‘Metoclopramide has an antidopaminergic effect in the hypothalamus and thereby raises the threshold for vomiting at the chemo-receptor trigger zone. Its effects on the GI tract are thought to result from the blocking of dopaminergic receptors, potentiation of cholinergic effect.’

– I said bleakly: ‘I don’t think I can do this.’

– ‘But, Nikolai, you’re English!’

– I know, but this leaflet has a language of its own.

This exchange, which occurred in the late 1990s, captures a snapshot of the post-Soviet chaos where receiving medicines with foreign labelling was commonplace. During this period, and until the implementation of Russian labelling and packaging legislation in 2010, doctors frequently faced the challenge of deciphering complex medical information written in languages that were not easily understood by them or their patients.

“This leaflet has a language of its own”. Reflecting on this, it is striking how little progress has been made in improving the quality of written medicine information worldwide. Even in regions like the European Union, where User Testing of Package Leaflets has been mandatory for twenty years, the situation remains troublingly similar. In 2025, it is still common to encounter tested and approved leaflets that are as complex and inaccessible as the one Thubron struggled to understand.

Patient Information Leaflets (PILs) in the UK and EU and medication guides in the USA are supposed to be there to educate the consumer about the treatment in question. It is an opportunity for the pharmaceutical company to engage with their clients. Patients need to know about safety, dosage instructions, contraindications, and so on. In Europe, it is unfair to suggest there has not been some progress in the content and presentation of product information intended for patients. The QRD template (Quality Review Document template), now in Version 10.4, has shaped patient information provision in Europe for 20 years. It allows for harmonisation across languages, regulatory compliance, quality assurance, amongst many other benefits.

In addition, it has made some improvements to the overall tenor of leaflets. For example, package leaflets address the patient as ‘you’. Compare this with a leaflet I picked up recently in Central America and it looks like how leaflets were written in the past in Europe, where the target audience is not the patient, but health professional or instruction is expressed in the passive (forgive me for my own translation):

• “pacientes que experimenten síntomas (ej. angina de pecho, mareos, náusea…)”  ("Patients who experience symptoms (e.g., chest pain, dizziness, nausea...)"

  
  

• “en caso de sobredosis, se deben de adoptar las medidas de soporte requeridas.” ("In case of overdose, the necessary supportive measures should be taken.")

However, there are also weaknesses to the template:

• It imposes over 1500 additional words to the package leaflet template that increases the cognitive burden on the reader of the leaflet.

  
  

• It does not adequately balance benefit information and focuses more on the potential risk. The amount of space that the QRD wording takes up in a typical leaflet reduces potential leaflet ‘real estate’ for companies to communicate about benefit information.

Has the introduction of the QRD template and mandatory user testing of package leaflets led to clearer patient information? My hunch is that, probably, yes, when comparing to information provision in other regions. In reality, however, too much poor practice seems to be met with regulatory approval: poor leaflets are still getting through to the market. Lots and lots of them. You only need to do a brief search for Patient Information Leaflets that have been supposedly user tested and approved. The following examples are from the first pharmaceutical company I came across on Google – remaining anonymous, of course – and I took a very brief look at a sample of leaflets from their website. These are from leaflets that have been user tested and approved by the EMA:

Exhibit 1:

• Do note take [Name of Product] if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour

Exhibit 2:

• [Name of Product] is used for the long-term treatment of pulmonary arterial hypertension (PAH):

  
  

• in adults of WHO Functional Class (FC) II to III

  
  

• in children under 18 years and body weight of at least 40 kg with WHO Functional Class (FC) II to III.

• It can be used on its own or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).

Exhibit 3:

• It is used to treat adult men with prostate cancer that has metastasised to other parts of the body and still responds to medical or surgical treatments that lower testosterone (also called hormone-sensitive prostate cancer) or has not metastasised to other parts of the body and no longer responds to medical or surgical interventions.

Exhibit 4:

• [Name of Product] is an antibody, a type of protein which has been designed to recognise and attach to specific targets in your body. [Name of Product] targets B cell maturation antigen (BCMA), which is found on multiple myeloma cancer cells, and cluster of differentiation 3 (CD3), which is found on so-called T cells of your immune system.

The same applies to PILs for device-medicine combination therapies, as well as IFU for medtech products:

Exhibit 5:

• Damage to soft tissues including swelling, abnormal scar formation, functional impairment of the musculoskeletal system, Sudeck’s disease (complex regional pain syndrome CRPS), allergy/hypersensitivity reactions

Exhibit 6: (referring to possible side effects)

• Allergic response or adverse biological response

Exhibit 7:

• The implant is used for soft tissue approximation and/or ligation. Reattachment of soft tissue to bone aims to alleviate pain and improve limb function to allow you to resume many daily activities that may have been limited due to pain, weakness or restricted range of motion. It consists of a non-absorbable or partially absorbable braided suture.

Etcetera…

I have seen worse. This is just from a convenience sample for the purpose of this article. I am certain a more systematic review would reveal many more sins.

Written patient information is a key way that pharmaceutical and device companies can engage with their patients. It could be part of closing the knowledge gap between the medical profession and the patient. It could be part of enabling, empowering and encouraging patient-centricity. Yet, patients are being served up poorly written, badly designed information, as in the examples above. It makes me wonder what kind of user testing is being conducted, what kind of in-house knowledge the sponsor has about communicating with patients and what kind of person is involved on the regulatory approval side. There does not appear to be much information design expertise involved at any of these stages. Maybe, as I have suggested in other articles, the awareness of the patient’s informational needs is absent across all these stakeholders.

Have Patient Information Leaflets improved since Thubron’s observation? The needle hardly seems to have moved.

Thank you for reading.

Mark Gibson

Leeds, United Kingdom, February 2025