Action Planned
BNF Publications will use communications, including a newsletter and social media, to remind users how to find drug class information within content, including monographs and treatment summaries. (AI summary)
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Dear Mr Spencer, We write in response to your Regulation 28 report dated 5th May 2023 which was sent to us as the Publisher of the British National Formulary. We are sorry to hear the sad circumstances surrounding this case. In the BNF and BNF for Children, where substantial amounts of information are common to all drugs within a particular drug class, a drug class monograph is used to contain this shared information. Any additional information that is not common to the drug class is included in the individual drug monographs. In such cases, information from both the class monograph and the individual drug monograph need to be considered together in order to understand the full information about the drug. Sertraline is a selective serotonin reuptake inhibitor (SSRI) and many of the side-effects of sertraline are common to this drug class. In the case of sertraline, ‘suicidal behaviour’ and ‘suicidal ideation’ are listed in the Lustral (sertraline) Summary of Product Characteristics (date of revision 12/2022). Side-effects within BNF Publications are standardised using a defined vocabulary and may not use the same wording as manufacturers' literature. In addition, individual side-effects are grouped together where there are two or more similar side-effects. As such, within BNF Publications the side-effects of ‘suicidal behaviour’ and ‘suicidal ideation’ are covered by the broader term of ‘suicidal behaviours’. As ‘suicidal behaviours’ is common to SSRIs, this side-effect appears in BNF Publications within the side- effects of the SSRI class monograph. The way that this drug class information is presented within BNF Publications depends on the product that is being used. In electronic formats, such as online or the BNF app where space constraints are not an issue, information from the class monograph is presented within the individual drug monographs, with a heading to highlight that it is drug class information (for sertraline, the heading For all SELECTIVE SEROTONIN RE-UPTAKE INHIBITORS is used). In print editions, the presence of a drug class monograph is highlighted with a flag beside the drug title. Alongside this flag, the page number of the drug class monograph is provided to help the user find this information quickly (for sertraline, the flag directs to the class monograph for SSRIs on p. 401 of BNF 85). An explanation of the standard monograph structure, including how to find class monograph information, can be found in the How to use BNF Publications in print and online. Royal Pharmaceutical Society 66-68 East Smithfield, London E1W 1AW
________________________________________________________________________________ In addition to the information within the monographs for sertraline and SSRIs, the risk of suicidal behaviour is also highlighted in the Depression treatment summary (p. 395) and the Antidepressant drugs treatment summary (p. 397), because this side-effect is associated with antidepressant therapy in general and not limited to SSRIs. In response to your report, BNF Publications will use a range of communications to remind BNF users how to find drug class information within content, including within drug class monographs and treatment summaries. This will include a news piece in the BNF newsletter, which is emailed to more than 125,000 subscribers, and communications via social media channels (e.g. Twitter). We trust that this addresses this important issue.