PFD report

Joshua Asprey · Prevention of Future Deaths report

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Issued 5 May 2023•East Sussex

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
1

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
1

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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Report evidence summary

Concerns raised1

  1. Failure of sertraline BNF information to identify the risk of suicidal behaviour
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    The Royal Pharmaceutical Society is better placed to respond to concerns about the BNF entry for sertraline.

    Stated by National Institute for Health and Care ExcellenceRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure of sertraline BNF information to identify the risk of suicidal behaviour

Wider context from the report

“1. The evidence heard during the course of the inquest highlighted an inconsistency between the literature provided by the manufacturer of sertraline (the patient information leaflet (‘PIL’)) and the British National Formulary (‘BNF’) produced by the Royal Pharmaceutical Society (latest version: BNF 85, March 2023). 2. The PIL contains a list of “uncommon” side effect of suicidal behaviour, which includes the following in bold: “Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 2).” 3. The BNF relating to Depression (3.4, p395) and the use of Antidepressant Drugs states under the heading “Suicidal depression and antidepressant therapy” (p397): “The use of antidepressants has been linked with suicidal thoughts and behaviour; children young adults and patients with a history of suicidal behaviour and particularly suicidal behaviour are particularly at risk. Where necessary patients should be monitored for suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment or if the dose is changed.” 4. The section of the BNF relating to SSRIs (p401) also identifies “suicidal behaviours” as a potential uncommon side-effect. 5. However, the section with respect to sertraline does not specifically identify suicidal tendencies at all, although it does identify “thinking abnormal” as an uncommon side effect (p.405). 6. I am concerned that there is a risk that a medical practitioner consulting the BNF with a view to determining dosage and treatment with Sertraline will be unaware of the potential risk of the onset of suicidal behaviour and/or would not consider it necessary to discuss that risk with the patient. The evidence heard at the inquest suggested that it would not be appropriate or practical for GPs to consider PILs before prescribing. 7. On the other hand, the PIL and BNF are intended for different purposes. It may be that the evidence of risk of suicidal ideation associated with Sertraline specifically (as opposed to SSRIs) is so low that it need not be referred to in the BNF, notwithstanding its inclusion in the PIL. Nevertheless, this is a matter of concern that would in my view benefit from further consideration. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The Royal Pharmaceutical Society is better placed to respond to concerns about the BNF entry for sertraline.

Verbatim wording from the response

“I am aware that your report has also been sent to the Royal Pharmaceutical Society who will be better placed to respond to your concerns.”

Source location

Response from NICE
Page 1 · response
Published 9 May 2023

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Responsibility for BNF content rests with its publishers, so commenting on the concerns falls outside NICE’s authority.

Verbatim wording from the response

“The BNF is a joint publication of BMJ Group and Pharmaceutical Press, the publishing division of the Royal Pharmaceutical Society. While we make the BNF available on the NICE website, responsibility for the content remains with the publishers and therefore NICE cannot comment on the concerns you have raised.”

Source location

Response from NICE
Page 1 · response
Published 9 May 2023

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. 1

    Use newsletter and social media communications to remind BNF users how to find drug class information.

    Stated by Royal Pharmaceutical SocietyStated plannedThe respondent said that this action was planned when they made their response on 9 May 2023.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Use newsletter and social media communications to remind BNF users how to find drug class information.

Verbatim wording from the response

“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).”

Source location

Response from British National Formulary Publications
Page 2 · response
Published 9 May 2023

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
2/2

Data last updated 7 September 2026