Jacob Wooderson

Parliamentary Under-Secretary of State for 
Health Innovation and Safety 

39 Victoria Street 
London 
SW1H 0EU 

    19th December 2025 

HM Coroner Sarah Bourke 
Inner North London  
St Pancras Coroner’s Court,  
Camley Street,  
London,  
N1C 4PP 

Dear Ms Bourke,  

Thank you for the Regulation 28 report of 6 August 2025 sent to the Secretary of State 
about the death of Jacob Matthew Wooderson. I am replying as the Minister with 
responsibility for prescribing.     

Firstly, I would like to say how saddened I was to read of the circumstances of Mr 
Wooderson’s death and I offer my sincere condolences to their family and loved ones. The 
circumstances your report describes are concerning and I am grateful to you for bringing 
these matters to my attention.  

The report raises concerns over the need for regular monitoring of heart rate and blood 
pressure of patients taking Elvanse and the risk of unreliable heart rate and blood pressure 
readings taken by patients outside of consultations being used by clinicians, which may be 
higher for remote consultations. It also raises concerns about methods used in giving 
advice to patients who have ADHD, symptoms of which can include forgetfulness and 
problems with inattention. 

In preparing this response, my officials have made enquiries with NHS England (NHSE), 
the National Institute for Health and Care Excellence (NICE) and the Medicines and 
Healthcare products Regulatory Agency (MHRA) to ensure we adequately address your 
concerns. 

When MHRA authorises a medicine for use in the UK, it publishes a summary of product 
characteristics (SPC). This sets out a medicine’s properties and conditions for safe and 
effective use by healthcare professionals. It is based on clinical trials and product research 
and is regularly updated as new data emerges. The SPC forms the basis for other guidance 
for prescribers such as the British National Formulary (BNF). The BNF is an evidence-
based independent drug formulary used by health professionals as a source of key 
information on the selection, prescribing, dispensing and administration of medicines. NICE 

 
 
 
 
 
 
 
  
   
     
 
 
  
  
  
  
  
  
 develop clinical guidelines for selected topics which set out evidence-based 
recommendations for best practice in health and care. 
First, regarding monitoring of heart rate and blood pressure (BP) of Elvanse patients, 
Guidance in the BNF and the SPC for Elvanse, available at Search Results - (emc), states 
that there is a need for baseline BP and heart rate monitoring, as well as before every 
change of dose and every 6 months.  The recommendations in the NICE guideline - 
attention deficit hyperactivity disorder: diagnosis and management [NG87] - are consistent 
with the requirements for monitoring in the SPC and the BNF.  

NICE also say the following in its Making decisions using NICE guidelines page: 
‘Healthcare professionals should take note of the contraindications, warnings, safety 
recommendations and any monitoring requirements for the medicine. These are explained 
in the SPC for the medicine, the British National Formulary (BNF) or British National 
Formulary for Children (BNFC).’ 

Recommendation 1.7.4 of guideline NG87, above, states ‘an ECG is not needed before 
starting stimulants…..unless the person has any of the features in recommendation 1.7.5, 
or a co-existing condition that is being treated with a medicine that may pose an increased 
cardiac risk.’ Recommendation 1.7.5 lists factors, symptoms and signs which may imply a 
cardiac history.  

Regarding the monitoring of heart rate, the rationale for this is given in Evidence review D, 
section 1.9.1.3, Pages 87 to 89. Although the evidence of cardiac side effects is not strong, 
this may be because of a paucity of specific large studies. In the discussion (p89) the 
committee “agreed that it was important to monitor heart rate and blood pressure every 6 
months and if there were important clinical changes the dose should be reduced and 
referral to a cardiologist may be necessary”.  

Further to this, recommendation 1.7.26, states that “During the titration phase, ADHD 
symptoms, impairment and adverse effects should be recorded at baseline and at each 
dose change on standard scales by parents and teachers, and progress reviewed regularly 
(for example, by weekly telephone contact) with a specialist”. From a regulatory 
perspective, the MHRA may request the marketing authorisation holder to produce 
additional risk minimisation measures (aRMM) in addition to the product information.  This 
is to ensure the safe and effective use of the medicine, to reduce or prevent the risk of an 
adverse event, or to reduce the severity or impact on the patient should an adverse event 
occur. The MHRA is responsible for reviewing and approving the aRMM.  

Elvanse has aRMM as conditions to their licences to address safety concerns, identified in 
their risk management plan. This includes the risk of serious cardiovascular events 
(including arrhythmias, ischaemic cardiac events, cardiomyopathy, and sudden death). The 
aRMM of Elvanse for this risk includes the following educational materials for health care 
professionals:  

•  Checklist 1: lisdexamfetamine checklist before prescribing that supports health care 

professionals in the appropriate initiation of lisdexamfetamine. This includes a 
checklist of contraindications where symptomatic cardiovascular disease is 
evaluated together with family history of sudden cardiac/unexplained death, family 
history of ventricular arrhythmia, and patient’s history and physical cardiovascular 
exam.  

 
 
 
 
 
 
 
 
 •  Checklist 2: checklist for ongoing monitoring of lisdexamfetamine therapy that 

supports health care professionals in the monitoring of patients. This includes a 
checklist to monitor new cardiovascular findings or worsening thereof exertional 
chest pain, unexplained syncope, other symptoms suggestive of cardiac disease, 
and monitoring of changes in blood pressure and heart rate. It includes a reminder to 
document blood pressure and heart rate.  

•  Chart for ongoing monitoring of lisdexamfetamine therapy that supports the health 

care professional on keeping a record and monitoring different measurements of the 
patient including blood pressure and heart rate. In line with the summary of product 
characteristics (SmPC), the chart also reminds the health care professional that 
blood pressure and heart rate should be recorded at each adjustment of dose and 
then at least every six months.  

In addressing the second concern, about ensuring advice given to patients with ADHD is 
understood and remembered, the national shared care protocol states that a shared 
decision making approach should be used, including discussing the benefits and risks of 
the treatment with the patient and/or their carer and obtaining and documenting their 
consent.  This should include a patient information leaflet (PIL), which are required by law to 
be provided with each supply of the medication. 

The PIL is not intended to replace the discussion with prescribers about the benefits and 
risks of treatments, but it aims to provide patients with information on using the medicine 
safely. The PIL information is in line with the SPC text and specifically warns patients about 
the monitoring required prior to taking Elvanse and during the therapy (including measuring 
blood pressure and heart rate), it informs patients of the possible side effects including the 
cardiovascular ones, and urges them to see a doctor straight away if they have an uneven 
heartbeat, chest pain or abnormal heart rhythm, life threatening irregular heart rhythm. 

The problems of forgetfulness and problems with inattention in people with ADHD are well 
understood; and clinicians would be expected to take this into account in communicating 
with and providing information to their patients.  Additionally, there are examples of easy 
read leaflets produced by 3rd parties to overcome this issue.(For example, 
https://youthmed.info/wp-content/uploads/2024/10/Lisdexamfetamine-Junior-Parent.pdf). 

NICE has emphasised section 1.9 in NG87 is relevant here – 1.9.2 “Be aware that the 
symptoms of ADHD may lead to people having difficulty adhering to treatment plans”. There 
are also some relevant recommendations in the NICE guideline on medicines adherence: 
involving patients in decisions about prescribed medicines and supporting adherence 
[CG76]. In particular, recommendations 1.1.24 “Offer patients information about medicines 
before the medicines are prescribed” and 1.1.28 “Do not assume that the patient 
information leaflets (PILs) that patients receive with their medicines will meet each patient's 
needs. Address concerns that patients may have after reading the standard PILs. PILs 
contain information for patients on how medicines should be used. It is a legal requirement 
that this information is included on the label or within the packaging of a medicine.” 

Regarding the third concern, about the reliability of readings taken by patients, supported 
self-monitoring is the direction of travel supported by NHSE and follows the principle set out 
in the government’s Ten-Year Health Plan (10YHP). Heart rate and BP are two of the most 
commonly self-monitored biometrics thanks to the accessibility and affordability of digital 

 
 
 
 
 
 
 
 home monitoring devices. These form an important part of routine care for millions of 
people, bringing care into their home. 

NHSE note that data can be unreliable when collected by a health care professional. An 
example is the phenomenon of ‘white coat hypertension’ where some patients have high 
blood pressure when they see a doctor, but home measurements are normal. In 
hypertension NHSE have moved towards using home measurements in preference to clinic 
measurements for most patients. 

Although NICE guideline 1.8.9 does not explicitly mention home monitoring of heart rate 
and blood pressure, it is the opinion of NICE consultant clinical advisors that good practice 
would be to arrange for these measurements to be made, either remotely or in person. This 
is supported by a recent review (Comparative cardiovascular safety of medications for 
attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic 
review and network meta-analysis - PubMed).    

Regarding online consultations more generally, we are aware that when used appropriately, 
online prescribing provides a valuable route for patient access, but additional safeguards 
are necessary when prescribing certain items online. In February 2025, the General 
Pharmaceutical Council (GPhC) published updated guidance for online pharmacies and 
prescribers which can be accessed here: Guidance for registered pharmacies providing 
pharmacy services at a distance, including on the internet.   

I do want to assure you that the Department is committed to ensuring that improving 
convenience and choice via private and online prescribing does not inadvertently reduce 
safety or quality of care. We are currently seeking views on how we can continue to ensure 
that the medicines people need are available conveniently and promptly, whilst maintaining 
the UK's high standards of medicine regulation, prescribing and use via a public call for 
evidence, which can be accessed here: Private (non-NHS) prescribing: call for evidence 
document - GOV.UK  

Ultimately, decisions about what medicines to prescribe are made by the doctor or 
healthcare professional responsible for that part of the patient’s care, and prescribers are 
accountable for their prescribing decisions. Prescribers must always satisfy themselves that 
the medicines they consider appropriate for their patients can be safely prescribed and that 
they take account of appropriate national guidance on clinical effectiveness – as detailed for 
ADHD management and Elvanse specifically in the above paragraphs. Prescribers are 
supported by specialist professional bodies (e.g. Royal Colleges) and held to account 
professionally by professional regulators, such as the General Medical Council (GMC).  

The General Medical Council (GMC) is the regulator of all medical doctors, physician 
assistants (PAs), and physician assistants in anaesthesia (PAAs) (still legally known as 
anaesthesia associates and physician associates) practising in the UK. It sets and enforces 
the standards all doctors, PAs, and PAAs must adhere to. The GMC is independent of 
Government, directly accountable to Parliament and is responsible for operational matters 
concerning the discharge of its statutory duties The GMC is responsible for ensuring that 
doctors, PAs, and PAAs have the necessary skills and knowledge to join its UK registers. 
All doctors, PAs and PAAs must register with the GMC, and meet the expected standards 
set out in the GMC’s Good medical practice to work in the UK: https://www.gmc-
uk.org/professional-standards/professional-standards-for-doctors/good-medical-practice. 

 
 
 
 
 
 
  
 
 Doctors must also hold a licence to practice. Good medical practice states that doctors 
must propose, provide or prescribe drugs or treatment based on the best available 
evidence, and only when they have adequate knowledge of the patient’s health and are 
satisfied that the drugs or treatment will meet their needs. Failure to uphold and adhere to 
the principles within Good medical practice and related guidance will put a professionals’ 
registration with the GMC at risk.  

If a concern is raised about a professional’s fitness to practise, the GMC has a statutory 
duty to investigate and take action to safeguard the health and well-being of the public 
where necessary. 

I hope this response is helpful. Thank you for bringing these concerns to my attention.                                                                                                                               

Yours sincerely, 

Parliamentary Under-Secretary of State  
for Health Innovation and Safety

Date: 16 October 2025  

Dear Ms Bourke  

Re: Jacob Wooderson (Regulation 28: Report to Prevent Future Deaths). 

Thank you for sending this Regulation 28 Report to the Royal College of 
Psychiatrists regarding the death of Jacob Wooderson. 

We are grateful for the opportunity to comment upon this report but before 
doing that, we would like to extend our deepest sympathies to the family and 
loved ones of Jacob.  

The Royal College of Psychiatrists (RCPsych) is the professional medical body 
responsible for supporting psychiatrists. The College sets standards and 
promotes excellence in psychiatry; leads, represents and supports psychiatrists; 
improves the scientific understanding of mental illness; works with and 
advocates for patients, carers and their organisations.  The College does not work 
on the care of individuals and are therefore not able to comment on the specific 
circumstances surrounding the case of the death of Jacob Wooderson. 

However, we have considered your findings and have the following comments to 
make in relation to the issues that you raise.  

In addition, we wanted to highlight actions the College has already undertaken in 
this area and what further activity we plan to take to improve practice in the 
treatment and care of people with ADHD, including issues that are directly 
relevant in this case. 

Overarching comments on issues raised in PFD 

In terms of a few overarching comments on the issues raised: 

• 

In acknowledging the importance of safe and effective prescribing, with 
benefits and risks appropriately understood and balanced in the decision 
making of the clinician, we think it is important in the context of this case to 

 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 recognise that, while we cannot comment specifically on this particular death, 
several large case series published over the last decade did not find an 
increase of cardiovascular complications in adults treated with ADHD 
medication (Habel et al., JAMA 2011). Stimulants like lisdexamfetamine have 
relative small effects on BP/pulse (Farhat et al., Lancet Psychiatry 2025).  

•  You identified within your Report issues around the recording, storage and 
sharing of information, sadly we recognise this as something as a feature in 
many Serious incidents that occur within healthcare. This is an area with 
existing guidance, but more should be done to promote awareness and 
consistent implementation of best practice, the College is committed to 
playing its part in that regard. 

•  You also highlighted the issue of remote consultations and how they 

potentially, when used for engaging with a patient runs a risk of the clinician 
not getting a full picture of the patient because of the limitations of observing 
the person compared to a face-to-face interaction. As with the point on 
information recording, storage and sharing, there is already guidance to 
clinicians on how to use this mechanism most effectively and safely so again is 
an area where further awareness raising to ensure best and consistent 
practice is needed. 

Actions already taken by the College on ADHD 

The College recognises the increasing priority needed to address the significant 
increase in neurodivergence in the population. In the case of ADHD, this 
specifically includes: 

•  The appointment of an ADHD Champion with responsibility for influencing 
and promoting increased priority to this condition both in the College and 
beyond, in particular Government and policy makers. 

•  Participation in the NHSE established ADHD Taskforce, which recently 

reported on a range of actions that need to be undertaken to improve the 
diagnosis and treatment of people with ADHD. 

•  Good practice guidance published by the College in 2023 on ADHD in 
adults based on work undertaken in relation to the health system in 
Scotland. The issues are largely generic so this has been promoted across 
the whole of the UK including advice on prescribing. ADHD in adults - 
Good practice guidance CR235 

•  Because of its higher prevalence of co-existence, we also produced 

guidelines to support the management of people with ADHD who also had 
an Intellectual Disability, this also included advice on medication related 

 
 
 
 
 
 
 
 
 issues Attention deficit hyperactivity disorder (ADHD) in adults with 
intellectual disability (CR230) 

Further actions that the College has planned in relation to relevant matters 

•  We will use suitable opportunities to remind members of the importance of 

adhering to NICE 2018/2019 (and other UK ADHD guidelines) when prescribing 
ADHD medication. 

•  We will discuss the aspects raised in this case at a RCPsych webinar on 

“Common prescribing errors and complex prescribing” planned for 12.11.2025. 
The last edition of this event was attended by more that 1500 psychiatrists in 
2024. 

•  The TIMESPAN consortium (https://timespan.eu) is currently developing 

consensus recommendations for the treatment of ADHD patients with 
increased cardio-metabolic risks that go beyond recommendations for 
BP/pulse/weigh monitoring at baseline, after dose increase of ADHD 
medication and 6 monthly reviews for patients stabilised on medication. 

•  The GMC have guidance on remote consultations (Remote consultations - 
ethical topic - GMC), mentioning that prescribers should ensure they have 
means to give all the information required about treatment options (detailed 
here: Remote prescribing high level principles - summary - GMC. We will be 
highlighting the GMC guidance in a forthcoming College newsletter. We will 
also be looking at what more the College might do to provide specific advice 
in relation to the use of remote consultations for those with ADHD.  

I do hope that this response is helpful, please come back to us if you would like to 
discuss any aspects of it.  

Yours sincerely, 

Registrar  
Royal College of Psychiatrists