March 2022 - Spravato (esketamine) summary report
Published 13 April 2022
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March 2022 Promotion of Spravato (esketamine) by Nightingale Hospital London
The website of the Nightingale Hospital London came to the attention of the MHRA. The website homepage made reference to a prescription-only medicine (POM) called Spravato (esketamine, a treatment for some eligible patients with major depressive disorder). Further webpages that highlighted this POM showed a photograph of a named healthcare professional pictured with a box of the medicine with a caption underneath stating that the professional was “proudly pictured with Spravato”; the webpages also made references to the medicine being “safe”.
Regulation 280 of the Human Medicines Regulations 2012 outlines overall quality standards and states an advertisement must: comply with the particulars listed in the Summary of Product Characteristics (SPC); encourage rational use of the product; and not be misleading.
Regulation 284 prohibits the issue to the general public of an advertisement for a POM, which is likely to lead to its use.
Regulation 289 states a person may not publish an advertisement relating to a medicinal product that refers to a recommendation by healthcare professionals.
MHRA upheld that the material was likely in breach of the above regulations. MHRA considered that references to Spravato as “safe” were not consistent with the quality standards required because all medicines have the potential to cause side-effects and no medicine is risk-free. MHRA considered that the website likely promoted a specific POM and may lead a member of the public to request Spravato treatment. MHRA further considered that the webpages included recommendation of Spravato treatment by a healthcare professional.
The decision to prescribe a particular treatment for a condition is one that should be made by the healthcare professional in conjunction with the patient as part of the clinical consultation. Clinics can promote the service they provide (such as a treatment service for depression or mental health support) and the consultation they offer. This guidance for treatment service providers is outlined in Appendix 6 of the MHRA Blue Guide.
Nightingale Hospital London confirmed that they were amending their website and any associated material so as to comply with the Regulations and the above guidance.