he Prescription Medicines Code of Practice Authority (PMCPA) in the UK has stated that patient case studies are likely to be viewed as promotional, and this obviously significantly limits how and when they can be employed. This article focuses on how compliance with the Association of the British Pharmaceutical Industry (ABPI) Code can still be achieved when case studies differ in their content and use. The ABPI code sets standards for pharmaceutical companies with respect to the promotion of medicines as well as the provision of information to patients.

• Patient case studies can be theoretical or actual examples of a patient’s story, or in clinical terms, a particular medical case.
• These stories can range from discussing symptoms and diagnoses as well as charting the impact of treatment(s) and eventual outcome(s).
• They are used to make the intended audience aware of and more educated about patients and/or treatments.
• They are used in a variety of different educational or supporting materials like educational tools for healthcare professionals or supporting materials for patients that are prescribed a specific medicine and by different pharma functions.

But there are also questions that cause confusion or inconsistency in how and when they can be used in an effective and compliant way. The questions below frame some of the confusion.

• Passively: Insights gathered from discussions, presentations, papers, or even advisory boards and market research can be used by pharmaceutical companies to create case studies.
• Actively: Patients or healthcare professionals (HCPs) can be engaged under an agreement and with compensation to specifically provide case studies. Patients can be approached directly, but often this is done through HCPs, patient organizations, or other third-party vendors.

When Are Theoretical Versus Actual Versus Anonymized Case Studies Best?

• Actual: To use the “testimony,” name, and photograph of a patient requires their prior explicit consent because a pharmaceutical company is storing and processing their sensitive personal data. But from an impact perspective, it can be credible for the company and valuable for the audience to hear the patient’s own words.
• Anonymized: These medical cases include minimal but relevant information (e.g., “Caucasian female, age 52 years”) that does not identify the patient. They are often used to avoid getting consent, particularly in scenarios where logistics can be problematic; e.g., an HCP engaged to speak at a meeting on behalf of a company about their experience may choose to describe several patients and convey their clinical experiences rather than relay their thoughts.
• Theoretical: Some clinical data about the use of a medicine may be best illustrated or “brought to life” in story terms. These case studies can still be based on actual stories.

Can Treatments Be Mentioned?

If a case study mentions a specific company, medicine, or the class it belongs to, then the company must consider carefully how this case study can be used.

• Acceptable: in promotional materials (campaign documentation, speaker slides, mailings) with a clear promotional intent.
• NOT acceptable: in proactive medical education.
• Might be acceptable: certain non-promotional settings, such as advisory boards or market research, but with very strict criteria in place. Furthermore, if the case study mentions the use of the medicine outside the approved label, then it has very limited uses (possibly in response to a very specific request for information).

If a case study mentions disease only (such as signs, symptoms, markers, diagnosis) and not medicine, then it could be used in a variety of promotional and non-promotional settings.

What Are Typical Versus Atypical Case Studies?

• Typical case studies reflect the summary of product characteristics (SPC) and the data that support the license approval. They should give a picture of what should generally be expected from treatment.
• Atypical case studies portray unexpected outcomes and can be associated with unlicensed uses or dosages.

While care should be taken that atypical case studies are never used in a manner similar to typical case studies, disclaimers are not enough in mitigating poor perception. For example, an HCP speaker should not present an atypical patient case study at a promotional meeting, because it is a European requirement that promotion of a medicine must not be inconsistent with its license particulars. So, a disclaimer cannot simply say “These are my views and not that of X company,” as the company is still liable under the code in ensuring that code requirements are always met.

Who can Case Studies be Used With?

• Members of the public: The case study is used as part of an effective disease awareness campaign, describing the disease but not the medicine/drug class.
• Patients on a company’s medicine: The case study describes a patient’s treatment experience as part of the medicine’s accompanying patient support material or programs.
• Journalists: To include case studies in a press release (e.g., backgrounders), it is imperative that the press release is newsworthy and relevant to a media outlet and its audience.
• Other audiences include regulators, e.g., Medicines and Healthcare Products Regulatory Agency (MHRA); national public bodies, e.g., National Institute for Health and Care Excellence (NICE); payers, parliamentarians, charities, and patient organizations.

Medical Versus Nonmedical Uses

Often, the demarcation between medical and nonmedical functions forces case studies to be used for one or the other. But if a case study mentions the respective disease only, then it can be used in both promotional and non-promotional contexts by all functions, for example:

• Promotional sales representatives can use the case study to help the HCP identify which of their patients present with the same symptoms and carry the conversation on to treatments.
• Non-promotional medical scientific liaison staff can use the case study to proactively educate HCPs on possible diagnoses.
• Head offices can use the case study in disease awareness campaigns, mailings to patient organizations, and internal education.

Given that patient case studies have the potential to convey meaningful information and compliance risks can be easily mitigated, there are actually very few boundaries to furthering their use. What’s required is greater awareness of how to capture engaging content from patients and how to best use case studies with different audiences. This should lead to more confidence within the pharmaceutical industry in reaching out and collaborating with patients meaningfully.