Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2022-0208, written 7 Jul 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 7 Jul 2022 |
|---|---|
| Reference | 2022-0208 |
| Deceased | Seema Haribhai |
| Coroner | Mary Hassell |
| Coroner area | Inner North London |
| Category | Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: Prevention of Future Deaths report Seema Pravin HARIBHAI (died 18.12.21) THIS REPORT IS BEING SENT TO: 1. Medicines and Healthcare Products Regulatory Agency (MHRA) 10 South Colonnade Canary Wharf London E14 4 PU 2. Ayurvedic Professionals Association c/o ZRS Accountants Building 3 North London Business Park Oakleigh Road South New Southgate London N11 1GN 3. Department of Health and Social Care 39 Victoria Street London SW1H 0EU 4. The Enterprise Practice Belmont Health Centre 516 Kenton Lane Belmont Harrow Middlesex HA3 7LT 1 CORONER I am: Coroner ME Hassell Senior Coroner Inner North London St Pancras Coroner’s Court Camley Street London N1C 4PP 2 CORONER’S LEGAL POWERS I make this report under the Coroners and Justice Act 2009, paragraph 7, Schedule 5, and The Coroners (Investigations) Regulations 2013, regulations 28 and 29. 1 3 INVESTIGATION and INQUEST On 30 December 2022, I commenced an investigation into the death of Seema Haribhai, aged 37 years. The investigation concluded at the end of the inquest earlier today. I made a determination that Seema Haribhai died as a consequence of the administration of Ayurvedic medicines intended to treat psoriatic arthritis. I recorded a medical cause of death of: 1a) sepsis 1b) recurrent intestinal ischaemia 2 idiosyncratic Ayurvedic drug induced liver injury (treated with transplant) 4 CIRCUMSTANCES OF THE DEATH Seema Haribhai suffered with psoriatic arthritis that was becoming increasingly disabling. She was concerned at the potential effects of conventional medication and so consulted an Ayurvedic practitioner, who prescribed an array of herbal based remedies. She took these, developed liver failure as a consequence, and died some weeks later. 5 CORONER’S CONCERNS During the course of the inquest, the evidence revealed matters giving rise to concern. In my opinion, there is a risk that future deaths will occur unless action is taken. In the circumstances, it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. Medicines and Healthcare Products Regulatory Agency (MHRA) I am aware that one of the treating hepatologists from the Royal Free Hospital attempted to report this matter to the MHRA under the yellow card scheme, but was in some difficulty because he could not identify which drugs or drug combinations had been prescribed and had caused the liver injury. However, I now have the statement of the treating Ayurvedic practitioner detailing the medicines prescribed, and so I attach this in the hope that it will assist you. 2 Ayurvedic Professionals Association The Ayurvedic practitioner who prescribed the medicines that killed Seema Haribhai told me that she had undertaken a five year degree and a one year post graduate training to enable her to practise Ayurvedic medicine. However, when she first discovered that her patient had developed a yellow discolouration, whilst she recognised that the liver was probably responsible, she did not recognise that the cause might be her own prescription. She did not advise the only course of action with the potential to save Seema Haribhai’s life: an immediate cessation of all the herbal remedies. Even when she gave evidence in court, the Ayurvedic practitioner did not seem to canvass the possibility that the medicines she had prescribed could have caused harm. She had at one stage advised her patient to have a routine blood test, but she had not at any stage advised immediate attendance at a hospital emergency department. It appears from the evidence I heard in court that Ayurvedic practitioners do not necessarily have the possible complications of Ayurvedic treatment as part of their routine frame of reference. All medicines can cause harm, even those that are herbal based. Department of Health I heard evidence at inquest that Ayurvedic practitioners are not in any way regulated. Even those who are members of the Ayurvedic Professionals Association receive as little as two hours of continuing professional development training per annum. The medicines prescribed by Ayurvedic practitioners are manufactured abroad. I did not hear evidence of any quality control. The Enterprise Practice Seema Haribhai made an appointment with her general practitioner, explaining that she had taken Ayurvedic medicines, and complaining of yellow skin and yellow eyes. The doctor she consulted asked to see a photo of her face and ordered a blood test. However, the GP did not record the detail of the history, he did not record exactly when the yellow discolouration first appeared, and he did not record the absence of any other signs and symptoms. He did not ask for attendance at the surgery so that he could perform a physical examination. He did not advise immediate cessation of the Ayurvedic medicines. 3 The GP consultation was on 5 November, the blood test was conducted on 9 November, the results came back to the surgery on 10 and 11 November, and an appointment was booked for 15 November. Meanwhile, same day admission to hospital was arranged on 15 November solely because a nurse had noted the blood test result at a routine rheumatology appointment. The blood test result was so abnormal that, even without examination, the consult rheumatologist saw no option but immediate admission. 6 ACTION SHOULD BE TAKEN In my opinion, action should be taken to prevent future deaths and I believe that you and your organisations have the power to take such action. 7 YOUR RESPONSE You are each under a duty to respond to this report within 56 days of the date of this report, namely by 5 September 2022. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the following. , general practitioner , husband of Seema Haribhai , Ayurvedic practitioner • • • • • • Care Quality Commission for England • NHS England & NHS Improvement • Professor Chris Whitty, Chief Medical Officer for England • HHJ Thomas Teague QC, the Chief Coroner of England & Wales , hepatologist, Royal Free Hospital , rheumatologist, Northwick Park Hospital I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any other person who I believe may find it useful or of interest. 4 The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response. 9 DATE 07.07.22 SIGNED BY SENIOR CORONER ME Hassell 5
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
c/o ZRS Accountants
Building 3
North London Business Park
Oakleigh Road South
New Southgate
London N11 1GN
26/08/2022
Coroner ME Hassell
Senior Coroner
Inner North London
St Pancras Coroner’s Court
Camley Street
London N1C 4PP
Regulation 28 Prevention of Future Deaths Report
Dear Ms ME Hassell,
Please see below, the Ayurvedic Professional Association (APA) response to
Regulation 28: Prevention of Future Deaths, following the tragic death of
Seema Haribhai. The APA and its members would firstly like to offer sincere
condolences to the family of Seema Haribhai.
Introduction
The APA is a voluntary members association with an elected committee and
as such it has no powers to regulate the Ayurvedic profession.
The APA was established as, and it remains an unincorporated association
with the sole purpose of representing Ayurveda as practiced within the UK.
The APA promotes the practice of safe and authentic Ayurveda with a view to
improving health and well-being, by and through its membership sharing
knowledge and best practice in accordance with the APA’s constitution, which
can be found at: https://apa.uk.com
Representing Ayurvedic Practitioners throughout the United Kingdom
Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com
Limited Company No. 05391909, Registered in England
1
The APA encourages professional development and it seeks to provide
support to its members, as well as using its website to offer the public a
platform from which to find trained Ayurvedic professionals in their area. It is
within this context that the APA responds to your PFD.
Ayurveda background
Ayurveda is a traditional system of medicine as practiced and taught in India.
Ayurveda is regulated in India by The Ministry of Ayush (AYUSH), which was
formed on the 9th of November 2014 with a vision of reviving the profound
knowledge of ancient systems of medicine and ensuring the optimal
development and propagation of the AYUSH systems of healthcare. Earlier,
the Department of Indian System of Medicine and Homoeopathy (ISM&H)
formed in 1995, was responsible for the development of these systems. It was
then renamed as the Department of Ayurveda, Yoga, and Naturopathy, Unani,
Siddha and Homoeopathy (AYUSH) in November 2003 with focused attention
towards education and research in Ayurveda, Yoga and Naturopathy, Unani,
Siddha, and Homoeopathy https://main.ayush.gov.in/about-the-ministry
Regarding whether the APA can identify if the Ayurvedic herbs used by the
Dr. in this instance, who holds a Bachelor of Medicine and Surgery (BAMS)
degree from India, had the potential to cause harm, AYUSH is likely to be the
only authority able to answer this question and it may be helpful if the PFD
could also be directed to AYUSH via the Indian High Commission. AYUSH
can be contacted via its website at:
https://www.ayush.gov.in
https://main.ayush.gov.in
https://www.hcilondon.gov.in
If it will assist the Coroner, the APA will be happy to make this representation
to AYUSH.
Representing Ayurvedic Practitioners throughout the United Kingdom
Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com
Limited Company No. 05391909, Registered in England
2
Regulation
Ayurveda is not currently regulated in the UK, something the APA
had campaigned for in the past. Consequently, the APA has no power to
oversee, or control how individual's practice other than through advice and
guidance. However, as an association, the APA has taken this incident very
seriously and has investigated as far as possible how this unfortunate event
occurred in order to alert its members and prevent a reoccurrence.
In addressing the specific points directed to the APA in your PFD report:
i.
Ayurvedic practitioners training
On receipt of her application for APA membership, the APA requested sight of
the Dr’s BAMS degree and internship certificates, which were received and
recorded. We have investigated more and cannot find evidence of the
postgraduate certificate even though mentioned in your report and court
document. The Dr was accepted as Category A APA member in accordance
with the APA’s category classification. As with all APA members the APA also
requested evidence of the Dr’s current insurance.
ii.
Recognising risks to patients
The APA provides its members with webinars with guest speakers on a
variety of Ayurvedic topics, as a way of keeping members abreast of
developments in Ayurvedic practice, but the APA is not a training
organisation, nor does the APA accredit any Ayurvedic curriculum.
APA members have received recognised training and qualifications from
recognised external accredited training providers and the APA satisfies itself
that the individuals applying for membership are qualified by an outside
training Institute and insured to practice at the appropriate level. UK Ayurveda
courses are accredited by organisations such as the Federation of Holistic
Therapists and The Complementary Medical Association. The BAMS degree
in India is accredited by the National Commission for Indian System of
Medicine (India Curriculum):
• https://www.fht.org.uk/welcome-to-accreditation
• https://www.the-cma.org.uk/Articles/Join-The-CMA-as-a-College-
and-get-all-these-benefits-4708/
Representing Ayurvedic Practitioners throughout the United Kingdom
Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com
Limited Company No. 05391909, Registered in England
3
Identifying potential harm from herbal remedies is part of members' training.
In terms of whether the APA can identify if the Ayurvedic herbs used by the
BAMS Dr in this case had the potential to cause harm, the APA would again
refer the Coroner to AYUSH.
The APA has a Pharmacopoeia document that is available to all APA
members as part of its information programme. All APA members are
encouraged to familiarise themselves with the content of all documentation
that the APA provides. Members are made aware of this documentation both
on joining the APA and annually thereafter.
Within the pharmacopoeia documentation there are references to possible
adverse effects from some known drug/herb interactions and some known
herb contraindications. This information is not exhaustive, however, possible
complications form part of all APA members initial training.
The APA does operate a voluntary yellow card adverse event reporting
system under which is designed to be completed by the member and emailed
to relevant authorities and the APA for escalation if needed, this did not
happen with this incident.
A report on the regulation of herbal medicines and practitioners, 26th March
2015, by; Prof.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/
attachment_data/file/417768/Report_on_Regulation_of_Herbal_Medicines_an
d_Practitioners.pdf provides that:
“Some herbal sector representative bodies have attempted to collect data on
adverse reactions to herbal medicines using the Yellow Card system used for
conventional drugs but the number of reports is relatively small and it is not
clear whether this is because there are few adverse reactions or whether the
low numbers recorded are due to under-reporting”.
Representing Ayurvedic Practitioners throughout the United Kingdom
Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com
Limited Company No. 05391909, Registered in England
4
iii. Recommending medical advice/treatment
As previously mentioned, the APA is a member’s association for pre-trained
professionals who have undergone extensive training that includes them
being able to identify situations where they (a BAMS Dr.) may need to advise
on whether their patient needs more urgent medical attention, specifically a
medical intervention. In the case of the BAMS Dr involved in this incident, this
training is set to the curriculum set by the National Commission for Indian
Systems of Medicine as she held a BAMS degree. Details of the
training provided to BAMS doctors can be found at https://ncismindia.org,
but it is not within the APA’s remit to provide individual advice on treatment
protocols.
iv. Consideration of possible complications
Although the APA conducts regular webinars with guest speakers on
Ayurvedic topics including herbs, this is simply an opportunity for these
members to undertake Continued Professional Development as the APA is
not a training organisation. As a part of their training, APA members are
taught to consider possible complications and this should therefore be within
their routine frame of reference.
In terms of identifying potential harm from herbal remedies, again this is
covered in the members training, which is beyond the APA’s remit. In this
case, the BAMS Dr was trained in India under the BAMS curriculum, as set
out by the NCISM India and approved by AYUSH. Safety and potential harm
in using herbs is covered in the Dravya Guna (Indian medicine
pharmacopoeia). Within the APA’s pharmacopoeia document, there are
references to known possible adverse effects from drug/herb interactions, as
well as to the voluntary yellow card adverse event reporting form.
The Herbs mentioned in this incident are all of Indian origin and as such they
come under the remit of the Indian High Commission and imports.
The APA has no control over herbs or treatments given by its members.
However, the APA committee has in the past considered an approved supplier
scheme of herbs for members, but as APA membership is voluntary it was
found that it would be very difficult to enforce.
Representing Ayurvedic Practitioners throughout the United Kingdom
Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com
Limited Company No. 05391909, Registered in England
5
In order to prevent future deaths, the APA will, within 90 days, write to
the Indian High Commission to suggest that Indian herbal imports could
benefit from a review and ask the Commission to consider its role in the
import of Indian herbs into the UK.
The APA believes that all herbs sold in the UK should, at the very
least, display the botanical name as well as the Ayurvedic common name, to
ensure correct identification of all herbal material and reduce the risk of
potential harm by misidentification. The APA will, within 90 days, petition the
Food Standards Agency to change UK labelling to require herb labelling to
display both the botanical and common name of herbs.
We trust that the above information adequately responds to your PFD report
in this case. However, please do not hesitate to contact the President if the
APA can be of further assistance in this case.
Yours sincerely,
APA President
On behalf of the APA Committee
Representing Ayurvedic Practitioners throughout the United Kingdom
Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com
Limited Company No. 05391909, Registered in England
6
10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra Coroner ME Hassell Senior Coroner Inner north London St Pancras Coroner’s Court Camley Street London N1C 4PP United Kingdom 17 January 2023 Dear Coroner Hassell, Regulation 28: Prevention of Future Deaths report Seema Pravin HARIBHAI Thank you for your e-mail of 11th July 2022 regarding a Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Seema Haribhai, I am sorry for the delay in responding. The report raised a matter of concern that one of the treating hepatologists from the Royal Free Hospital attempted to report this matter to the MHRA under the yellow card scheme but was not able to submit a report online, as they did not have any details for the herbal products taken by the patient. The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health and Social Care (DHSC) with responsibility for the regulation of medicinal products and traditional herbal medicinal products that hold a traditional herbal registration (THR) in the UK. In the UK, reports of adverse reactions suspected to be associated with the use of a medicine are submitted to the MHRA via the Yellow Card scheme. Reports can be submitted by healthcare professionals, patients or family or carers on behalf of patients. The Yellow Card scheme is voluntary and reports can be submitted when there is a suspicion that a medicinal product or combination of products has caused a side effect. Reports are used alongside other safety information and help the MHRA to monitor the safety of products and take action if safety issues are identified. In addition to the electronic form for completing a Yellow Card, concerns about medicinal products can be raised via our free helpline (0800 731 6789) or via customer services by email (mhracustomerservices@mhra.gov.uk) or telephone (0203 080 6000) In order to complete a Yellow Card report, details of the specific product or products suspected to have caused the adverse reaction must be provided along with an identifiable patient and reporter in order for a case report to be assessed. Using the additional information provided in the statement from Ayurvedic products provided, a yellow card report has been created with the reference number , the herbal practitioner, regarding the There is no statutory definition of ‘herbal practitioner’ in the UK. Anyone - irrespective of qualifications or experience - can practice herbal medicine in the UK and, after making a diagnosis and forming a judgment about the treatment required, can prepare and supply herbal medicine to a member of the public following a one to one consultation. There are a number of voluntary registers of herbal practitioners which require that certain standards of practice and education are met, but membership of these registers is not a legal requirement. The exemptions in the Human Medicines Regulations 2012 that apply are: • Regulation 3 (6) of the Human Medicines Regulations 2012 provides an exemption from the need for a manufacturer’s licence and a marketing authorisation for a herbal product that is made up and supplied by a herbal practitioner on the premises following a one to one consultation with a member of the public. • Regulation 3 (9) of the Human Medicines Regulation 2012 states that the herbal medicinal product is not manufactured or assembled on a large scale or by an industrial process. • Regulation 241 of the Human Medicines Regulations 2012 allows herbal practitioners to prepare certain herbal medicinal products themselves on their premises using a range of single or multiple herbal ingredients following a one to one consultation, providing certain additional requirements are met. The herbal practitioner has provided details of the ingredients she suggested and refers to these as food supplements and herbs. It is not clear from the herbal practitioner’s statement if the preparations were made up under the herbalist exemption or whether they were recommended to the patient and then purchased elsewhere or if in fact it was a combination of both i.e. recommended and the practitioner provided herbs. There are restrictions on what substances can be used by herbal practitioners to prepare unlicensed herbal medicines. Schedule 20 of the Human Medicines Regulations lists substances which are restricted or prohibited for use in unlicensed herbal products prepared by practitioners. None of the ingredients included in the herbal practitioners statement are included on the list of restricted ingredients. However, it is important to note that the products referred to in the herbal practitioners statement are not licensed by the MHRA and therefore we are not able to comment on the quality control of the products taken by Seema Haribhai or any medicinal claims that may have been made for these products. The MHRA continually monitor safety and ensure that possible side effects which have been recognised to occur with use of a medicine or tradition herbal remedy are appropriately described in the authorised product information. Unfortunately, as none of the products listed as being suggested to Seema Haribhai are authorised by the MHRA, we cannot comment on what information that may have been provided with these products regarding their safety or possible side effects. There is published literature regarding a risk of hepatotoxicity associated with traditional Ayurvedic herbs1,2 and this information would be taken into account if any of these products were submitted for authorisation by the MHRA. No changes are proposed to the Yellow Card scheme as it is essential to have information about the specific products involved in order to assess the specific safety concern. The healthcare professional involved in the patients care did not have details of the herbal products taken and therefore could not complete the online form for the Yellow Card scheme. However, their concern about the safety of the herbal products could have been raised with the MHRA through multiple other routes while further details of the products were sought from the herbal practitioner either by the original reporter or the MHRA, if the MHRA were provided with the herbal practitioner’s details. The exemptions in the Human Medicines Regulations 2012, allow herbal practitioners to produce and supply herbal medicines following a one to one consultation with the patient. The MHRA has no regulatory oversight over products provided under this exemption. I hope this information is of assistance. Yours sincerely, Head of Neuropsychiatric disorders, Cognition and Mental Health Safety and Surveillance 1 Comprehensive review of hepatotoxicity associated with traditional Indian Ayurvedic herbs - PMC (nih.gov) 2 Case series and review of Ayurvedic medication induced liver injury | BMC Complementary Medicine and Therapies | Full Text (biomedcentral.com)
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