Joshua Asprey
PFD Report
All Responded
Ref: 2023-0147
All 2 responses received
· Deadline: 30 Jun 2023
Coroner's Concerns (AI summary)
Inconsistency between Sertraline's patient leaflet and the British National Formulary regarding suicidal behaviour side effects risks medical practitioners being unaware of, or not discussing, this potential risk with patients.
View full coroner's concerns
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.
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.
Responses
Noted
NICE acknowledges the report but states that responsibility for the BNF content lies with BMJ Group and the Royal Pharmaceutical Society, so they cannot comment on the concerns raised. (AI summary)
NICE acknowledges the report but states that responsibility for the BNF content lies with BMJ Group and the Royal Pharmaceutical Society, so they cannot comment on the concerns raised. (AI summary)
View full response
Dear Mr Spencer,
I write in response to your regulation 28 report, sent to NICE on 9 May 2023, regarding the very sad death of Joshua Asprey. I would like to offer my sincere condolences to Joshua’s family. We have reflected on the circumstances surrounding Mr Asprey’s death, and the concerns raised in your report regarding the British National Formulary (BNF) entry for sertraline.
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. 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.
I write in response to your regulation 28 report, sent to NICE on 9 May 2023, regarding the very sad death of Joshua Asprey. I would like to offer my sincere condolences to Joshua’s family. We have reflected on the circumstances surrounding Mr Asprey’s death, and the concerns raised in your report regarding the British National Formulary (BNF) entry for sertraline.
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. 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.
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)
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)
View full response
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.
________________________________________________________________________________ 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.
Sent To
- National Institute for Health and Care and Excellence
- Royal Pharmaceutical Society
Response Status
Linked responses
2 of 2
56-Day Deadline
30 Jun 2023
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 18 June 2021 I commenced an investigation into the death of Joshua Fynn ASPREY aged
19. The investigation concluded at the end of the inquest on 15 March 2023. I determined that the medical cause of Joshua’s death was: 1a Multiple injuries. In box 3 of the record of inquest I recorded as follows: Joshua Asprey died on 14th June 2021 from multiple injuries after deliberately jumping from a cliff
In box 4 of the Record of Inquest, I recorded a conclusion of: SUICIDE
19. The investigation concluded at the end of the inquest on 15 March 2023. I determined that the medical cause of Joshua’s death was: 1a Multiple injuries. In box 3 of the record of inquest I recorded as follows: Joshua Asprey died on 14th June 2021 from multiple injuries after deliberately jumping from a cliff
In box 4 of the Record of Inquest, I recorded a conclusion of: SUICIDE
Circumstances of the Death
1. Joshua Asprey was 19 years old at the time of his death. He had a history of anxiety.
2. On 27 May 2021, Joshua attended a telephone consultation with his GP reporting that he was feeling depressed. He was commenced on sertraline,
3. On 11 June 2021, Joshua attended a further telephone consultation with his GP and his dose of Sertraline was raised to
4. The GP did not discuss with Joshua in either consultation any risk of suicidal ideation associated with commencing or increasing the dose of Sertraline. The GP relied on the British National Formulary (‘BNF’) which does not identify suicidal ideation as a risk of prescribing Sertraline.
5. Following the increase of his dose of Sertraline, Joshua began to have thoughts contemplating suicide.
6. On 14 June 2021, Joshua took his own life by deliberately jumping from a cliff
7. Joshua left a suicide note on his computer in which he wrote: “The reason for my current state of thoughts and plans is probably due to suicidal thoughts caused by a side effect of changing from dosage of sertraline. However, while this is the trigger in the short term, these thoughts have existed and persisted within me for many years now and to blame solely the medication would be unjust.”
8. There was insufficient evidence on which to conclude that there was a causative link between the increased prescription of sertraline and Joshua’s death. CORONER’S CONCERNS During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: (brief summary of matters of concern)
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.
2. On 27 May 2021, Joshua attended a telephone consultation with his GP reporting that he was feeling depressed. He was commenced on sertraline,
3. On 11 June 2021, Joshua attended a further telephone consultation with his GP and his dose of Sertraline was raised to
4. The GP did not discuss with Joshua in either consultation any risk of suicidal ideation associated with commencing or increasing the dose of Sertraline. The GP relied on the British National Formulary (‘BNF’) which does not identify suicidal ideation as a risk of prescribing Sertraline.
5. Following the increase of his dose of Sertraline, Joshua began to have thoughts contemplating suicide.
6. On 14 June 2021, Joshua took his own life by deliberately jumping from a cliff
7. Joshua left a suicide note on his computer in which he wrote: “The reason for my current state of thoughts and plans is probably due to suicidal thoughts caused by a side effect of changing from dosage of sertraline. However, while this is the trigger in the short term, these thoughts have existed and persisted within me for many years now and to blame solely the medication would be unjust.”
8. There was insufficient evidence on which to conclude that there was a causative link between the increased prescription of sertraline and Joshua’s death. CORONER’S CONCERNS During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: (brief summary of matters of concern)
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.
Copies Sent To
2. The GP
3. Sussex Police
Inquest Conclusion
Joshua Asprey died on 14th June 2021 from multiple injuries after deliberately jumping from a cliff
In box 4 of the Record of Inquest, I recorded a conclusion of: SUICIDE
In box 4 of the Record of Inquest, I recorded a conclusion of: SUICIDE
Similar PFD Reports
Reports sharing organisations, categories, or themes
Related Inquiry Recommendations
Public inquiry recommendations addressing similar themes
Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.