Maria McGauran

, 

, H.M. Coroner's Officer 

For the attention of Coroner Sabyta Kaushal – 
Dear
Ref. 28 McGauran M.S. 28112018; Alvaston Medical Centre response to 'Action should be taken' 
The Coroner, as part of the 'lessons learned' from the inquest of Mrs McGauran, has requested we 
introduce an action plan to prevent/reduce the risk of future deaths occurring under similar 
circumstances to that of Mrs McGauran. We welcome any opportunity for improvement in the 
provision of clinical care. 
The Coroner identified Mrs McGauran's 'hoarding' of Codeine as a matter of concern. As part of our 
ongoing programme of improvement: 

1. Taking advantage of the expanding of job roles within primary care, over the period January
to February 2021, Alvaston Medical Centre recruited two clinical pharmacists to undergo
patient medication reviews. The clinical pharmacist's area of professional expertise means
they are ideally suited to conducting structured medication reviews of patients – including
extensive knowledge of controlled drugs. As part of the medication review, they explore the
patient’s compliance and understanding of their medication, along with addressing other
concerns within their remit.

2. The structured medication reviews take a patient centred approach, whereby the patient is
reviewed holistically, exploring both lifestyle and medication. This includes taking a social
history alongside reviewing the compliance of their medication and outlining changes to the
medication regime. Lifestyle suggestions are advised based on individual  evidence base. The
actions and changes proposed are agreed through a shared decision process. The
effectiveness of the reviews is dependent upon patient honesty and clarity.

3. Alvaston has also made it good practice, to ensure wherever possible, any high risk

scheduled drugs do not form part of the repeat prescription. Furthermore, we have a robust
system in place to ensure the prescribing of medications is not automatically ordered too far
in advance of their due date. This reduces the risk of any patients 'stock-piling' medication.
This is an ongoing project that is constantly being reviewed and refined, and we continue to
further assess which areas or medications would benefit from additional surveillance during
the prescribing and issuing of the prescription.

None of the above actions have been taken as a response to Mrs McGauran's death (as said, these 
changes have come about as a result of our ongoing programme of improvement). Ultimately, the 
above will only reduce the risk of patients stockpiling prescription medications – there is no way to 
totally eliminate the possibility of a determined patient doing so. And we, of course, will continue to 
seek further opportunity to reduce that risk for our patients. 

Our clinical pharmacists have asked me to clarify with you the point raised in the inquest on the 
combined toxicity of the two prescribed medications, Citalopram and Codeine. To their knowledge, 
prescribing these two medications conjointly  – and taken to the recommended dosage - should not 
have led to drug toxicity. We are assuming, based on the concern you have raised, that the patient 
very significantly exceeded the recommended dosage of these 2 drugs (i.e. overdosed) and that was 
what caused the fatal level of toxicity?  

You have mentioned "alternative pain management aids…(such as Fentanyl patches…)".  

The Government's advice on Fentanyl patches Transdermal fentanyl patches for non-cancer pain: do 
not use in opioid-naive  patients - GOV.UK (www.gov.uk) is as follows:  

Advice for healthcare professionals: 

• fentanyl is a potent opioid – a 12 microgram (µg) per hour fentanyl patch equates to

daily doses of oral morphine of up to 45mg a day 

 • do not use fentanyl patches in opioid-naive patients 
• use other analgesics and other opioid medicines (opioids) for non-cancer pain 

before prescribing fentanyl patches 

• if prescribing fentanyl patches, remind patients of the importance of: 

• not exceeding the prescribed dose 

• following the correct frequency of patch application, avoiding touching the 

adhesive side of patches, and washing hands after application 
• not cutting patches and avoiding exposure of patches to heat 

including via hot water (bath, shower) 

• ensuring that old patches are removed before applying a new one 
• following instructions for safe storage and properly disposing of used 

patches or patches that are not needed (see advice issued previously); 
it is particularly important to keep patches out of sight and reach of 
children at all times 

• make patients and caregivers aware of the signs and symptoms of fentanyl 

overdose and advise them to seek medical attention immediately (by dialling 999 
and requesting an ambulance) if overdose is suspected 

• remind patients that long-term use of opioids in non-cancer pain (longer than 
3 months) carries an increased risk of dependence and addiction , even at 
therapeutic doses (see Drug Safety Update on risk of dependence and addiction 
with opioids); before starting treatment with opioids, agree with the patient a 
treatment strategy and plan for end of treatment 

• report suspected adverse drug reactions, including dependenc e, accidental 

exposure, or overdose associated with fentanyl patches, via the Yellow Card 
scheme 

Review of opioid medicines 
Considerable concern has been raised regarding the prescribing of opioids in the UK (see 
Drug Safety Update on risk of dependence and addiction with opioids). In 2019, the 
Commission on Human Medicines (CHM) convened an Expert Working Group to examine 
the benefits and risks of opioids in the relief of non-cancer pain. 

During this review it was noted that there have been reports of serious harm, 
including fatalities, associated with fentanyl patches in both opioid -naive patients and 
opioid-experienced patients. Up to May 2020, we have received 13 Yellow Card reports in 
which opioid-naive patients have experienced respiratory depression following use of 
fentanyl and additional Yellow Card reports in which respiratory depression was reported in 
patients switched from another opioid to an inappropriately high dose of fentanyl. There was 
no evidence of intentional overdose in these cases. 

There is considerable risk of respiratory depression with the use of fentanyl especially in 
opioid-naive patients. There is also significant risk with too rapid an escalation of dose, even 
in long-term opioid users. 

Fentanyl is a potent opioid analgesic – a 12 microgram (µg) per hour fentanyl patch equates 
to daily doses of oral morphine of up to 45mg a day. Because of the risk of significant 
respiratory depression, in non-cancer patients fentanyl patches should only be used in those 
who have previously tolerated opioids. CHM has recommended a strengthening of the 

 current warnings and a contraindication for use in opioid -naive patients in the UK for 
non-cancer pain. 

The above guidance is reflected in NHS Nottinghamshire County medicines information for staff 
working in a social care setting (see attached) which advises that "Fentanyl is a strong opioid which is 
often used in the management of cancer pain". Specific training is required for staff administering 
fentanyl patches. 

The Nottinghamshire guidance mentions 2 specific risks from Fentanyl patches:  

• 

"Ensure the old patch is removed before applying a new one…..a new patch MUST only be 
applied if the staff are satisfied that the resident does NOT have remaining patches on 
them" 

•  Heat (e.g. hot baths, electric blankets, hot water bottles) should NEVER be applied over the 

top of the patch as it may enhance absorption of fentanyl" 

In turn, this advice reflects the outcome of a Coroner's report in England 2011 regarding the death of 
a 67 year old lady who died after taking a hot batch while wearing 2 fentanyl patches; this led to the 
Regulation and Quality Improvement Authority reissuing warnings already presented by the 
Medicines and Healthcare products Regulatory Agency (MHRA) in response to earlier deaths related 
to the misuse of Fentanyl patches.  

In light of the suggestion that Mrs McGauran's death was due to an overdose, pain relief options 
such as Fentanyl patches would not be considered as a viable safer option. 

We hope this addresses the Coroner's concerns. If there is any additional follow up required, please 
do not hesitate to contact me. 

Regards,  

Business Manager 
Alvaston Medical Centre 
_____________________________________________________ 

A: 14 Boulton Lane, Alvaston, Derby DE24 0GE 
Practice Number C81047