What patient material may say
What material for patients may say is governed by laws, industry codes and guidelines that differ with the stage of a medicine's life, from clinical trials through public disclosure of results to marketed and over-the-counter products, and each stage has its own do's and don'ts. How far material that educates patients may persuade rather than explain is contested, and coercing a patient to join a clinical study or to take a medication is forbidden.
The laws, codes and guidelines that apply
The many ethics guidelines, industry codes of practice and regulations that govern content for patients differ by country and region and are periodically updated, and they can be challenging for a writer to navigate.
The regulations, guidelines and codes of practice most pertinent to patient communications are, by stage:
- Clinical trials: the ICH good clinical practice (GCP) guidelines; the EU clinical trial legislation, Directive 2001/20/EC; the FDA Code of Federal Regulations Title 21, part 50, on the protection of human subjects in clinical trials (US); the CIOMS ethical guidelines; and the guidelines of institutional review boards and independent ethics committees.
- Public disclosure of results: the EU Clinical Trials Regulation 536/2014; the EMA transparency policies on access to documents (Policy 0043) and on publication of and access to clinical trial data (Policy 0070); the EFPIA Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases; the PhRMA Principles on Conduct of Clinical Trials (US); and section 801 of the Food and Drug Administration Amendments Act (US).
- General patient communications involving pharmaceutical products: as legislation, the Human Medicines Regulations, Directive 2001/83/EC on the Community code relating to medicinal products for human use as amended by Directive 2004/27/EC, and the FDA Code of Federal Regulations Title 21, part 202, on drug advertising (US); as industry codes of practice, those of IFPMA and EFPIA, and each country's own; and as guidelines, the PhRMA Principles on Interactions with Patient Organizations (US) and the MHRA's Advertising and Promotion of Medicines in the UK: The Blue Guide (UK).
- Over-the-counter products: as ethical criteria, the WHO Regulatory Assessment of Medicinal Products for use in Self-Medication; as a code, the PAGB consumer code (UK).
- Patient communications not involving specific pharmaceutical products: the MHRA Disease Awareness Campaign Guidelines (UK).
The list is not exhaustive, and national-level guidelines may exist beyond it. The GCP guidelines are grounded in the ethical principles of the Declaration of Helsinki. Each review board or ethics committee has its own set of guidelines, all in the spirit of the regulatory guidance, so where the board of record is known it is worth checking its guidance documents before developing materials. The FDA has also published guidance for institutional review boards. Most European country-specific codes of practice reflect the requirements of European and national law, and in many cases go beyond them. In Great Britain the PAGB pre-approves advertisements and other information for the public to ensure they adhere to the regulations, whereas some other countries, including Germany, Croatia, Mexico, Argentina and the US, are governed by a post-publication control system.
Do's and don'ts at each stage
General do's and don'ts for patient content follow from ICH GCP, FDA and review-board guidance for clinical trials and from the ABPI and EFPIA codes for marketed products. They are not exhaustive, and the relevant national and international guidelines should always be adhered to.
In a phase I–IV clinical trial, before a participant is enrolled:
- Do not use coercive language.
- Avoid the name of the drug or device, generic or trade, because it can be viewed as promotional, unless prior use of the product is part of a key eligibility criterion. This does not apply to the informed consent process, which requires full transparency and an explanation of the investigational product.
At all stages of a trial, before and after enrolment and in informed consent:
- Do not talk about "free medical care" or emphasise "free". Mentioning payment for participation, in countries where payment is permissible, and free study-related medical care is acceptable.
- Do not state that the drug is "new" without also explaining that it is investigational.
- Avoid implying therapeutic benefit, for example by saying "medicine" without "investigational".
- Avoid explicit claims of safety or efficacy for the investigational product.
- Use language as non-technical as is practical, so that the participant or their legally acceptable representative can understand it.
For a marketed product:
- Avoid "safe", which should not be used without proper qualification.
- Avoid claiming that a product has no side effects.
- Include a statement about reporting side effects.
- Avoid "new" for a product marketed for more than one year. "New" is acceptable within the first year, but it limits the shelf life of the materials.
- Ensure that the artwork does not mislead, for example by implying use in a different patient population.
- Product comparisons must be fair and balanced and not misleading.
- Health education materials that refer to specific medicinal products must contain balanced, non-promotional information about the alternative treatments.
- Websites containing health education information must always advise the reader to consult a healthcare professional for further information.
In Europe, patient communications relating to pharmaceutical products must be completely non-promotional, balanced and factual. Content needs vary, but patients frequently rate information about the side effects of the products they take as highly important.
Explaining and persuading
Written communications that aim to educate patients require a descriptive style that is factual and balanced and that explains rather than persuades. Even in that style, carefully chosen language can be extremely powerful in connecting with the reader. For example, avoiding language that defines people by their condition, such as "people with diabetes" rather than "diabetes patients", can be more effective for engagement, and tailoring material to the reader's health literacy level and preferred learning style improves understanding and therefore engagement.
More persuasive writing is appropriate on some occasions in patient education, where there is a clear call to action, such as finding out more about a clinical trial or signing up to a patient support programme. Effective persuasive writing typically uses the three main techniques of Aristotle's rhetoric: ethos, the ethical appeal through credibility, appropriate language and fair, unbiased content; pathos, the emotional appeal; and logos, the logical appeal and the use of reason. Not all of them need to be carried by words alone, and graphics can be made to work with the content towards the same ends. Persuasive writing in this sense differs from coercion to participate in a clinical study or to take a particular medication, both of which are forbidden.
Other sources give engaging and persuasive writing a wider place in patient education. On one account, writing for patients does not preclude engaging writing, leads that create interest, or empathy and acknowledgment of the patient's condition to enhance patient engagement and activation. Writing a lead that gets readers to start and finish reading what they need to know to understand and act on information, ensuring a patient's belief in their clinician's concern about a devastating diagnosis and not just the treatment options, and crafting a respectful letter about repeated missed appointments that expresses concern for the patient's health and meets the clinician's schedule needs and economic realities all require engaging, "real-voice" writing, in a different realm from other engaging or literary writing and from conventional instructional design writing. Writers need to do more than give readers the information they want: they often need to convince patients to read the information, and to present it in the way patients can best understand and act on it. Patient education sometimes has several audiences with potentially conflicting needs, and effective, high-quality medical writing can often best be advanced by using journalistic and literary techniques as well as technical writing based on formal analysis, development, design, implementation and evaluation, with all audiences considered.
On another account, writing for patients should, beyond medical information, validate readers' experience, support them emotionally and promote healthy behaviours, and medical information by itself will not keep readers engaged. Patient education is medical-technical writing insofar as it communicates the information needed to use health care technologies and helps a specific audience achieve a specific purpose, but much of it is, appropriately, promotional, with elements of selling and advertising. Writing that addresses readers' emotional and psychosocial needs crosses into literary or journalistic writing, which justifies literary devices. Technical writing also persuades, but with fact and logic; it need not be stilted, but what keeps its reader engaged is the intrinsic value of the information rather than emotional support. Effective patient education writing must cross that line, and medical writers would do well to study the principles of marketing, behaviour change and persuasion that would make it even more effective. On this account, the challenge of several audiences with conflicting needs applies to all forms of writing, and only technical writing has dealt with it systematically and comprehensively from an author's perspective.