Thomas Pearson

Doncaster and Bassetlaw Hospitals /4'/s/

NHS Foundation Trust

Medical Director’s Office

Medical Director (644156)
Deputy Medical Director — Clinical Standards (642150)
7 Deputy Medical Director — Professional Standards (642124 or 75 2275)

HE Clinical & Professional Standards Co-ordinator (642149)
HE Executive PA to Medical Director (644148)

Our Ref ||

16 August 2016

Mr M A Beresford

Assistant Coroner

South Yorkshire (East District)
Crown Court

College Road

Doncaster

DN1 3HS

Dear Mr Beresford

Re: Thomas William Pearson (Deceased)

Thank you for your letter to ae .::.: 12 July 2016 and which has been

forwarded to me for action.

| write in response to the Regulation 28 Report received following the inquest held on 24"
June 2016.

| note the matters of concern identified in section 5 of the said report and particularly item
4 of that section namely hi (Consultant Respiratory Physician) gave evidence at
the inquest confirmed that fluticasone causes a reduction in the body’s defence mechanisms
and as a result carries with it an increased risk (estimated at 1.7 fold) increasing the risk of
the patient developing pneumonia”.

The report also in section 5 states “for a proportion of patients, the increased risk of
developing pneumonia may be justified by the benefits that the use of fluticasone brings.
However HS stcted that for the majority of patients, namely those without a raised
eosinophil count (a group which included — fluticasone, whilst still carrying an
increased risk of the development of pneumonia, would bring no benefits”.

HE went on to agree that is would be helpful for the use of inhaled steroids (in
particular fluticasone) to be reviewed (paragraph 6, section 5).

| now have had the opportunity of receiving a response from the respiratory team led by

a: Group Director.

BB confirmed there has been a debate within the respiratory team at Doncaster and
Bassetlaw NHS Trust regarding the matter. He advises that the wider respiratory
community is aware of the ongoing international debate over the role of inhaled
corticosteroids (ICS) in chronic obstructive pulmonary disease. The discussions took place
between the respiratory physicians within the Trust since the inquest. Management of
chronic obstructive pulmonary disease was the subject of a presentation in June 2015 prior
to the conclusion of the inquest.

This issue of inhaled corticosteroid is a matter of international scientific debate at the
moment. | understand that the consultant giving evidence pointed out that the respiratory
community is on the verge of a reappraisal of the use of inhaled corticosteroid in chronic
obstructive pulmonary disease as there remain many unanswered questions. | also
understand that the consultant giving evidence did not suggest that the recurrent
pneumonia suffered by the deceased led directly to the death.

It is important to stress that the international respiratory clinical and academic body still do
not have a unified view on the matter. The national and international guidelines still
recommend the use of inhaled corticosteroids in patients with chronic obstructive
pulmonary disease (NICE 2010 (CG101), NICE Quality Standard (QS10) updated February
2016 and international guidelines - GOLD — Global Strategy for Diagnosis Management and
Prevention of chronic obstructive pulmonary disease 2016. These acknowledge increased
risk of pneumonia and the respiratory community within Doncaster is well aware of this.
However it has been pointed out that whilst there is an increase in the incidence of
pneumonia in patients using inhaled corticosteroids this is likely to be non-severe and non-
fatal. Inhaled corticosteroids remain recommended as there is a reduction in the frequency
of exacerbations of chronic obstructive pulmonary disease through their use. There is also
evidence of improved lung function and quality of life with the use of such inhalers. Analysis
through the Cochrane review concludes (March 2014) as follows;

“Budesonide and fluticasone, delivered alone or in combination with LABA, can increase
serious pneumonias that result in hospitalisation of people. Neither has been shown to affect
the chance of dying compared with not taking ICS. Comparison of the two drugs revealed no
difference in serious pneumonias or risk of death. Fluticasone was associated with a higher
risk of any pneumonia (i.e. cases that could be treated in the community) than budesonide,
but potential differences in the definition used by the respective drug manufacturers reduced

our confidence in this finding. These concerns need to be balanced with the known benefits
of ICS (e.g. fewer exacerbations, improved lung function and quality of life)”.

It is accepted that there is a risk of patients having exacerbations of chronic obstructive
pulmonary disease should inhaled corticosteroids be withdrawn and some of these
exacerbations can be very significant. | understand that it has been suggested that a normal
eosinophil count may identify a subset of patients who will not deteriorate on withdrawal.
However | am advised by the respiratory team that there is no agreed consensus or
international agreement on the validity of this assessment. On that basis therefore the
eosinophil count cannot currently be recommended as a clinical tool to use in order to
identify patients whose inhaled corticosteroids can be withdrawn. As there is no other
reliable means of separating out those patients with an asthmatic component to their
condition there is a significant worry that there is a sub set of patients with asthma/chronic
obstructive pulmonary disease overlap syndrome (ACOS) who may be significantly
compromised by withdrawal of inhaled corticosteroids.

To summarise the position therefore | am advised that the respiratory team is well versed
with the current state of the evidence and are following appropriate current guidelines from
learned societies. | have been reassured that the respiratory team work collaboratively in
cohesive generic teams and a variety of topics are regularly discussed. At this point the
team are unable to produce a useable local guideline given the current state of knowledge
other than to be aware that possible options must be discussed with the patient while
acknowledging that the evidence for withdrawal of inhaled corticosteroid currently remains
unclear.

| trust this addresses the concerns that you have raised and provides reassurance that the
respiratory unit at the Doncaster and Bassetlaw Hospitals Trust works within currently
accepted guidance and are cognisant of the various debates that sometimes do arise in the
management or patients occasioned by the various stages of knowledge before practice
becomes generally accepted.

Please do not hesitate to refer back to me should there still be any outstanding concerns.

Yours sincerely

4
lf Loss

Deputy Medical Director - Clinical Standards

Po Chief Executive

GE Medical Director

HEE Deputy Director of Quality & Governance

fF Consultant Physician/Care Group Director
Acting Head Risk & Legal