Claire Copeland

a Since 1049

03 May 2022 Boots Support Office
Superintendent Pharmacist’s

Office

D90 EF08&

Thane Road

Nottingham

NG90 1BS

suptpharmoffice@boots.co.uk

Mr Jeremy Chipperfield

Senior Coroner for County Durham and Darlington
HM Coroner’s Office

PO Box 282

Bishop Auckland

County Durham

DL14 4FY

Dear Mr Chipperfield

Re: Ms Claire COPELAND, deceased (around 17 June 2021)
Boots Pharmacy, Station Yard, Consett, County Durham, DH8 5YB
Inquest date: Friday 04 March 2022
Regulation 26 Report to Prevent Future Deaths (dated 08 March 2022)

Further to the inquest into the death of Claire Copeland that concluded on 04 March 2022,
lam writing on behalf of Boots UK Limited (‘Boots’) in reply to the Regulation 28 Report to
Prevent Future Deaths (‘the Report’) dated 08 March 2022.

This response addresses (in turn) the four matters of concern highlighted within Section 5 of the
Report which, taken together, were held to constitute ‘arrangements’ with no fail-safe provisions
ensuring continuity of care in the event of a failed prescription delivery, namely:

1. Arrangements ... rely upon delivery of a physical prescription document

The prescription in question for Ms Copeland was for methadone oral solution, a Schedule 2
Controlled Drug, the supply of which from a community pharmacy is governed by the Human
Medicines Regulations 2012 and the Misuse of Drugs Regulations 2001 (as amended).

Schedule 2 Controlled Drugs can be prescribed via the NHS Electronic Prescription Service;
however, methadone and other treatments for managing substance dependency are
prescribed in instalments. The prescribing of such medication in instalments must be effected
using a designated prescription form (FPIOMDA). There is currently no electronic equivalent
for this form, so the paper prescription remains the only legal mechanism for instalment
prescribing for the treatment of addiction in England.

To comply with the regulations, a community pharmacist must receive an appropriate
FPIOMDA form before making a supply of methadone for the treatment of addiction. The
Human Medicines Regulations 2012 do not permit the making of an emergency supply of a
Schedule 2 Controlled Drug under Sections 224 or 225 (those governing emergency supply).

Boots UK Limited. Registered office: Nottingham, NG2 3AA - Registered in England & Wales: Number 928555

Since 1849
2. Arrangements ... allow that delivery be neither witnessed nor confirmed

This would be within the power of individual treatment clinics or the service commissioners,
who could require all clinics posting FPIOMDA forms to use recorded in-person delivery and
also put in place an administrative system to monitor for failed deliveries of prescription forms.

There are no steps that Boots can take independently to address this concern, but Boots will
support individual treatment clinics that seek confirmation of receipt.

3. Arrangements ... lack effective mechanism immediately to detect failed delivery

Patients have a free choice regarding the community pharmacy that they attend for the
dispensing of their prescriptions. It is therefore not possible for pharmacies to detect any
failed deliveries.

However, Boots will encourage clinics to contact the pharmacies to confirm receipt where
FPIOMDA forms are posted to try and avoid the risk of future failed deliveries.

4. Arrangements ... lack mechanism to remedy failed delivery

As noted under (1) above, the supply of a Schedule 2 Controlled Drug from community
pharmacies is governed by the Human Medicines Regulations 2012 and the Misuse of Drugs
Regulations 2001 (as amended). A pharmacy is not permitted in law to provide medication
(including an emergency supply), where there is a failed delivery of an FPIOMDA form, unless a
replacement paper FPIOMDA form is provided.

Community pharmacies typically provide dispensing services, including the dispensing of
methadone for the treatment of addiction, for more hours each week than clinics are
available. When a problem with an FPIOMDA form (including a missing prescription) is
detected outside of clinic hours, there is no route for a pharmacist to contact one of its
prescribers (who will be familiar with the patient’s medical history) and request an urgent
replacement prescription.

Boots will remind its pharmacists that, where any problems regarding FPIOMDA forms are
reported outside of clinic hours, patients must be directed to the Accident & Emergency team
at a local hospital, so that an appropriate prescriber can review the patient’s circumstances
and consider providing an interim prescription, pending the clinic reopening.

Reflection on the death of Ms Copeland

Given the seriousness of the incident involving Ms Copeland and the tragic circumstances
which prevailed in this case, Boots has taken the opportunity to reflect carefully on any
different actions that could be taken at individual pharmacy level and from a Company-wide
perspective to help prevent recurrence.

Ms Copeland’s clinic (Human Kind) was closed on Saturday 12 June 2021 when she arrived at
the Boots pharmacy in Consett, expecting to collect her medication. On reflection, the
pharmacist has considered whether direct contact with the Accident & Emergency team at the
local hospital (to explain the unique circumstances and ascertain whether they would review
the patient’s prescription needs) could have addressed the lack of other ‘out-of-hours’ support
for Ms Copeland. As a Company, we have taken the opportunity to renew our focus on
Controlled Drug Stewardship, with the development of a dedicated resource to support all our
pharmacy teams’ understanding of the need for compassionate, person-centred care when
managing supplies of Controlled Drug medication.

Boots UK Limited. Registered office: Nottingham, NG2 3AA - Registered in England & Wales: Number 928555

Since 1849

| hope this letter provides the necessary assurance that Boots has duly noted the gravitas of
the concerns raised during the course of the inquest into Ms Copeland’s death, reflected on the
circumstances of this sad case and shared its insights appropriately. As a founder member of
the (external) Community Pharmacy Patient Safety Group, Boots has liaised with its Chair so
that further dissemination of our insights from this case can be effected, using an anonymised
case study format, at its next meeting.

Yours sincerely

Deputy a —— - —_ . a

Boots UK Limited

Boots UK Limited. Registered office: Nottingham, NG2 3AA - Registered in England & Wales: Number 928555

Jeremy Chipperfield 

Senior Coroner 

County Durham and Darlington 

Via E-mail 

29/04/2022 

Regulation 28 Report to Prevent Future Deaths, Claire Copeland 

Dear Mr. Chipperfield, 

On behalf of Humankind, please find below our response to the matters of concern to which Humankind 
were deemed as being party following the inquest into the death of Claire Copeland. 

Rely upon delivery of a physical prescription document 

Unfortunately, the County Durham Drug and Alcohol Recovery Service, along with all other community 
drug  and  alcohol  services,  must  rely  on  paper  prescriptions  as  pharmacies  cannot  legally  use  faxed 
copies of prescriptions to dispense from for controlled drugs, including buprenorphine.  

Further to this, at this time there is no functionality for the electronic transfer of FP10 MDA blue instalment 
prescriptions. This is a national issue and not specific to Humankind/Spectrum/County Durham Drug and 
Alcohol Recovery Service. Humankind have continued to escalate this issue, for example with Controlled 
Drugs Local Intelligence Networks and the Office of Health Inequalities and Disparities, especially during 
the COVID-19 pandemic where the ongoing need for this to be resolved became especially pertinent.  

When  the  functionality  for  electronic  FP10  MDA  blue  instalment  prescriptions  becomes  available, 
Humankind plan to implement this across our services at the earliest opportunity, removing the current 
unavoidable  need  to  rely  upon  delivery  of  a  physical  prescription.  The  timescale  for  this  change 
unfortunately sits outside of our control. 

Allow that delivery be neither witnessed nor confirmed 

A  comprehensive  standard  operating  procedure  for  all  team  members  delivering  prescriptions  to 
pharmacies  has  been  implemented.    This  includes  the  mandatory  requirement for  prescriptions to be 
handed directly to a member of the pharmacy staff team, obtaining details of the person taking receipt 
and a signature from that person  to confirm delivery. Completed paperwork is returned to the service 
base and stored for reference and also included within the service’s management information system. 

Service  managers  ensure  that  only  team  members  authorised  to  do  so  deliver  prescriptions.  The 
authorisation process includes written confirmation that the team member is aware of, and understands, 
the instructions for prescription delivery.  

Lack effective mechanism immediately to detect failed delivery 

Humankind Charity (Humankind) is a company registered in England, Registered 
Charity No. 515755, Registered Company No 182 0492 

VAT 3346763 43, Registered Provider ) 4713                  

 
 
                                                               
                                
 
              
 
 
 
 
 
 The service’s prescription delivery standard operating procedure states that should it not be possible to 
directly deliver and confirm delivery of a prescription, the team member should return to their vehicle and 
make telephone contact with a nominated manager who is on-site within the service base.  

The nominated manager will be identified before the team member leaves the service base to deliver the 
prescription and they will be fully aware that they are the nominated contact in case of a failed delivery. 
The team member making the delivery will ensure they have their work mobile phone and the number of 
the nominated contact to enable the call to be made immediately upon failed delivery. 

Lack mechanism to remedy failed delivery 

During  the  telephone  contact  between  the  team  member  attempting  to  deliver  the  prescription  and 
nominated  manager a contingency plan will be agreed. This plan will take into account the individual 
circumstances of the delivery including known pharmacy availability  and the timescale requirement of 
dispensing  from  the  prescription.  Continuity  of  care  for  the  service  user  and  safe  prescription 
management will be equally paramount in agreeing a course of action. If an effective contingency plan 
cannot be immediately agreed, the issue will be escalated to the service Area Manager and Clinical Lead 
for further guidance and resolution. 

For any failed deliveries on a Friday that cannot be resolved on that day, the service is available on a 
Saturday morning, enabling an opportunity to remedy delivery and ensure provision for the weekend.  

Any  failed  delivery  attempt  of  a  prescription  is  recorded  as  an  incident  within  Humankind’s  incident 
management  system.  This  system  notifies  all  relevant  managers  and  team  members  of  the  incident, 
creates a review process and supports identification of learning to prevent further occurrences.    

Humankind recognises the importance of learning from Miss Copeland’s tragic death and are committed 
to working together with our workforce and other organisations to prevent this from occurring again. We 
extend our sincere sympathies to Miss Copeland’s friends and family. 

Yours Sincerely, 

Director of Community Substance Misuse Services 

On behalf of Humankind Charity