Judith Marshall

ae

| Department
| of Health

POC1_ 838751

From the Rt Hon Jeremy Hunt MP
Secretary of State for Health

Richmond House
79 Whitehall
London

SIVIA 2NS

Tel: 020 7210 3000

Mr W Coverdale Mb-sofs@dh.gsi.gov.uk

Senior Coroner

Sentinel House

Peasholme Green

York

YOI 7PP 31 MAR 2014

De be . Comte

Thank you for your letter following the inquest into the death of Mrs Judith
Marshall. You conclude that Mrs Marshall died from bronchopneumonia and the
effects of morphine. I was very sorry to read about the circumstances that led to the
death of Mrs Marshall and wish to extend my sincere sympathies to her family.

I understand that on 28 September 2009 Mrs Marshall was correctly prescribed
sixty 10mg of morphine sulphate capsules by her GP. Unfortunately when the
prescription was dispensed by a pharmacist at a local pharmacy, she was given sixty
capsules at 60mg strength rather than the 10mg strength prescribed. Although the
box of capsules carried numerous clear references to its containing 60mg capsules, a
trainee dispensing technician checked the medication dispensed by the pharmacist
and confirmed it.

Mrs Marshall took the capsules twice a day as prescribed which meant she took
120mg of morphine per day rather than 20mg. She was found dead in her bed by her
husband on the morning of 30 September 2009.

You ask me to consider the following concerns:

e The Pharmacy’s Errors Book shows a number of drug errors (including
higher or lower dose tablets and the wrong drugs) over a number of years. It
is not clear whether and to what extent such internal records are policed.

e Despite a system of checking by a colleague it is apparent that there can be a
mistake in dispensing medication which in this case was a controlled opiate
drug. The consequences were fatal.

e It is not clear whether there is any software, obtainable from the Department
of Health or else-where, that could read prescriptions and raise an alert if the

label sought to be created or if the drug sought to be dispensed is wrong in
identity or amount. This would be of particular significance when a high risk
drug is dispensed or when a drug is dispensed in an unusual quantity, dosage
or form.

e Mandatory procedures requiring a ‘read-back’ of the drug, its dosage, its
frequency of administration and its total quantity may prevent such
dispensing errors. In so far as the error in this case can be attributable to
‘Human Error’ it is concluded that the dispensing pharmacist focused on the
figure of 60 and incorrectly attributed that to the dosage as well as to the
number of capsules.

e A mandatory check, by a suitably qualified pharmacist or by a third party, at
the end of the day after cashing up on the till, of records of each (prescription
only) drug dispensed against the prescription would be a further precaution
against a repetition of these circumstances.

e There is evidently no central database of all prescription errors so there can
be no central monitoring of such errors and no means of determining trends
or particular repeat errors.

It may help if I briefly explain my Department’s role as steward of the health
system in England and the part played by other relevant organisations.

As Secretary of State for Health, I am responsible for setting national priorities,
monitoring the whole system’s performance and supporting the integrity of the
system to protect the best interests of patients, the public and the taxpayer. Since 1
April 2013, most day to day decisions are taken by NHS England. NHS England is
responsible for commissioning primary care services, including pharmaceutical
services.

The Medicines, Healthcare and Regulatory Agency (MHRA) is responsible for
regulating all medicines and medical devices in the UK by ensuring they work and
are acceptably safe, The General Pharmaceutical Council is the regulator for
pharmacists, pharmacy technicians and pharmacy premises, while the Royal
Pharmaceutical Society (RPS) is the professional body for pharmacists and
pharmacy in Great Britain, representing all sectors of pharmacy.

I note that you sent your report to NHS England and nat Director
of Patient Safety at NHS England has already replied with a detailed response

which addresses each of your concerns. He has included an explanation of the
current system of reporting of, and issuing alerts resulting from, pharmacy errors,
He has also outlined NHS England’s plans to increase reporting and learning from
community pharmacy.

Department
of Health

My officials have consulted the General Pharmaceutical Council about this case.
The Council has a key role in setting standards for, and the regulation of,
pharmacies and pharmacists. It also sets standards for the education and training of
pharmacists and ensures, through inspections, that educational standards are being
maintained at pharmacy schools. The Council is aware of the need for regulators
and professional bodies to find ways to maximise learning from events such as this
one and I understand there are plans to ensure that the lessons learned from this
specific case are passed on to all registered pharmacy staff.

I understand that the Royal Pharmaceutical Society has also written to you with its
observations on the concerns you have raised.

I can also advise that the MHRA has contacted the marketing authorisation holder
for morphine sulphate MR capsules who has agreed to make improvements to the
packaging for all capsule strengths. This new packaging will be phased into use
shortly and should reduce the likelihood of similar medication errors occurring in
the future.

The MHRA will also send a reminder to pharmacists about the risks of confusing
quantity with strength when dispensing morphine sulphate MR capsules. This alert
will appear in the April edition of MHRA’s monthly publication, Drug Safety
Update. Information on the updated packaging will also be included.

As part of new European pharmacovigilance legislation that came into effect in July
2012, the definition of an ‘adverse drug reaction’ was expanded to include noxious
and unintended effects resulting not only from the authorised use of a medicine but
also from use outside the terms of authorised use. This encompasses suspected
adverse drug reactions from overdose, medication errors, off-label use, misuse and
abuse of a medicinal product. Further details can be found in the “Guideline on
good pharmacovigilance practices (GVP) Annex I — Definitions” which is available
at:

http://www.ema.europa.eu/docs/en_GB/document _library/Scientific_guideline/201
2/06/WC500129131.pdf

The MHRA continues to operate the UK’s Yellow Card Scheme for reporting
suspected adverse drug reactions. This scheme collects reports for all types of
medicines across the UK and includes adverse reactions occurring as a result of a
medication error.

The MHRA is now working with NHS England to simplify and increase reporting
of medication errors and maximise learning from these reports to minimise harm in
clinical practice arising from medication errors.

An integrated reporting route has been introduced so that reports submitted to the
National Reporting and Learning System will be shared between NHS England and
the MHRA. A National Medication Safety Network is being established which will
act as a forum to discuss safety issues, identify trends and actions to improve the
safe use of medicines. This network will also work with NHS England’s new
Patient Safety Improvement Collaboratives that will be set up during 2014. Within
hospital trusts and primary care ‘Medication Safety Officers’ (MSOs) will be
appointed to be part of the National Medication Safety Network. MSOs will act as
points of contact for NHS England and the MHRA for reporting incidents and to
allow better communication and improved learning at a local and national level.

I hope that this response is helpful and I am grateful to you for bringing the
circumstances of Mrs Marshall’s death to my attention.

Yor inv)
Jy vw

JEREMY HUNT

general (RECEIVED
Pharmaceutica
Council 21 MAR 2014

Donald Coverdale

HM Senior Coroner, York
Sentinel House
Peasholme Green

York

YO1 7PP

19 March, 2013

Dear Mr Coverdale
Re: Judith Marshall deceased

It is with deep regret that | read about the circumstances surrounding Ms Marshall’s death in your letter dated 26
January 2014. This is clearly a very sad case and our sympathy goes out to Ms Marshall’s family and friends.

We have considered the issues arising from the inquest into Ms Marshall’s death and the role of the pharmacist in
this situation. We are already aware of the circumstances surrounding this case, as the pharmacist was referred
to the previous regulator, the Royal Pharmaceutical Society of Great Britain in October 2009. When the regulation
of pharmacy was transferred the GPhC in September 2010, this case was transferred also. The GPhC has waited
for the outcome of the inquest before considering the case further.

Our regulation of registered pharmacies (through the standards and inspection process outlined below) is
complemented by our work to regulate individual members of the pharmacy profession. Under this heading we
set the mandatory regulatory standards which professionals are accountable for upholding. These include an
overarching professional obligation to make the care, well-being and safety of patients their first concern, and a
specific requirement that pharmacists ‘make sure the services [they] provide are safe and of acceptable quality’.

In order to qualify as a pharmacist in Great Britain in the first place it is necessary to succeed in a four year Master
of Pharmacy degree programme, followed by satisfactory completion of a pre-registration placement, at the end
of which a GPhC registration examination must be passed. We set the standards which university pharmacy
schools must meet and we carry out inspections of courses to check that these standards are being maintained.
These include a requirement that students successfully completing the course have the knowledge and skill to
supply medicines safely and efficiently, consistently within legal requirements and best professional practice.

In your report to prevent future deaths you set out a number of matters of concern, and it is important that
wherever possible, we ensure that learning takes place to prevent any future similar deaths. | have sought to
address the areas of concern below:

129 Lambeth Road, London, SE1 7BT. T 0203 365 3400 F 0203 365 3401
Duncan Rudkin, Chief Executive and Registrar
www.pharmacyregulation.org

1, We set standards for registered pharmacies which focus on the outcomes we expect to see in registered
pharmacies. We inspect registered pharmacies against the standards and produce reports of our findings.

As part of the inspection, our inspectors look at records maintained in the pharmacy, including error
records. Our inspection outcomes reflect on the recording, learning and risk management in place instead
of the numbers of errors. However as part of our work we will review whether our approach to inspection
on this matter should include further interrogation of errors recorded.

2. The GPhC has published guidance which contains information about minimising the risk of dispensing
errors
(http://www.pharmacyregulation.org/sites/default/files/Responding%20to%20complaints%20and%20conc
erns%20g.pdf }

The guidance explains that two people should be involved in the dispensing process where this is possible.
Whilst | understand that in this case, two people were involved in the dispensing process, we can highlight
our guidance in the next edition of our newsletter through Regulate.

3, There is research that shows the use of automation within a dispensing process can reduce the rate of
errors. Whilst we cannot require registered pharmacies to use automation, we do ensure that the way in
which we regulate does not stifle the introduction of new technology.

4, We are considering publishing a high level summary of the case you have described to us (fully anonymised
of course) in one of the next editions of our newsletter ‘Regulate’, which goes to all registered pharmacists
and pharmacy technicians 6 times per year. Regulate contains a section entitled ‘learning points’ where we
use case studies to highlight important safety and standards points.

5. There are a number of organisations that provide guidance and advice to pharmacy professionals, and the
professional body for pharmacists, the Royal Pharmaceutical Society (RPS) are well placed to provide
guidance to pharmacists on this area.

6, The medicines regulator, the MHRA, has been working with NHS England to develop draft Patient Safety
Alerts and guidance to increase adverse incident reporting via the National Reporting and Learning System
(NRLS), which is a central database of patient safety incident reports. We continue to work with the MHRA
and NHS England to ensuring that pharmacists and pharmacy technicians use the NRLS.

Let me conclude by thanking you for raising your concerns with us. It is in all our and, most importantly, the
public’s interest that regulators and professional bodies try to find ways to maximise the learning that needs to be
facilitated on the back of distressing events such as these.

Yours sincerely

Duncan Rudkin
Chief Executive & Registrar

4- 8 Maple Street 
London 
W1T 5HD 

HM SENIOR CORONER 
COUNTY OF YORK 

Dear Mr Coverdale, 

Thank you for your letter of 27th January 2014, concerning the death of Judith Lesley 
Marshall. 

In your letter you helpfully set out the events surrounding the incident.  Mrs Marshall, 
was a 72 year old lady, correctly prescribed “Morphine Sulphate M/R Capsules 10mg 
BD SIXTY CAPSULES Quant: sixty (60) capsule”. 

Unfortunately a community pharmacy dispensed 60 capsules of Morphine Sulphate 
at 60mg strength and not 10mg as prescribed. You shared that the box of capsules 
carried numerous clear references to 60mg capsules. A trainee dispensing 
technician checked the medication dispensed by the community pharmacist. 

Mrs Marshall took the capsules as dispensed to her, twice a day as prescribed 
(taking 120mg of Morphine per day rather than 20mg). She was found by her 
husband dead in her bed in the morning.  

You asked the following questions: 

1)  The Pharmacy’s Errors Book shows a number of drug errors (including 

higher or lower dose tablets and the wrong drugs) over a number of years. 
It is not clear whether and to what extent such internal records are policed. 

Community pharmacies are required to record patient safety incidents that caused 
harm or have the potential to cause harm in a pharmacy errors log. They should also 
report these incidents to the National Reporting and Learning System (NRLS). The 
aim of recording and reporting incidents is to identify risks to patient safety and 
ensure that they are addressed both locally and nationally. Community pharmacists 
and their staff have responsibility to reflect on patient safety incidents that occur and 
identify safer practice to address these risks. Health care teams and governance 
systems should be in place to ensure this occurs. In a community pharmacy the 
responsible pharmacist and superintendent pharmacist have a particular 
responsibilities in this regard. 

Pharmaceutical inspectors from the General Pharmaceutical Council also have a 
responsibility to review the error log when they inspect a community pharmacy to 
promote a patient safety culture and ensure that identified risks have been 
addressed. 

High quality care for all, now and for future generations 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 I wasn’t able to determine, from the information available to me, which of the above 
safeguards did not operating effectively in the community pharmacy involved in this 
case. I hope that in sharing your concerns you also contacted the General 
Pharmaceutical Council, as they will have an invaluable perspective on these issues.  

2)   Despite a system of checking by a colleague it is apparent that there can 

be a mistake in dispensing medication which in this case was a controlled 
opiate drug. The consequences were fatal. 

Yes that is true and why we always must review checks in place to determine if they 
can be improved.  Human factors science indicates that a double checking system is 
never infallible and where the risks resulting from a checking error are high, 
additional systems are required to further minimise the risks of serious harm.  

In a review of medication incidents reported to the NRLS from 2005 to 2010, the 
largest numbers of incidents resulting in death or severe harm involved errors of 
prescribing, dispensing and administering opioid medicine, including morphine. 

3) It is not clear whether there is any software, obtainable from the Department 
of Health or elsewhere, that could read prescriptions and raise an alert if the 
label sought to be created or if the drug sought to be dispensed is wrong in 
identity or amount. This would be of particular significance when a high risk 
drug is dispensed or when a drug is dispensed in an unusual quantity, dosage 
or form. 

We are not aware of any such software to check doses of opioids when dispensing. 
The safe opioid dose is dependent on the patients height, weight, age, clinical 
condition and other medicines they are taking at the time  and very dependent on the 
dose of opiate that they have previously taken. 

The former National Patient Safety Agency issued a Rapid Response Report on 
Reducing opioid Dosing Errors to the NHS in 2008 recommending the following safer 
practice: 

When prescribing, dispensing or administering opioid medicines the healthcare 
practitioner or their clinical supervisor should: 

  Confirm any recent opioid dose, formulation, frequency of administration and 

any other analgesic medicines prescribed for the patient.  

  Ensure where a dose increase is intended, that the calculated dose is safe for 

the patient.  

  Check the usual starting dose, frequency of administration, standard dosing 

increments, symptoms of overdose, and common side effects of that medicine 
and formulation.  

Healthcare organisations should review local medicines and prescribing policies, 
including Standard Operating Procedures, to reflect this guidance: 

http://www.nrls.npsa.nhs.uk/resources/?entryid45=59888 

High quality care for all, now and for future generations 

 
 
 
 
 
 
 
 
 
 
 In the case of Mrs Marshall, it appears that this was not a dose error in labelling the 
medicine but a medicine pack mis-selection.  However, we wouldn’t recommend the 
practice followed in this case.  The NPSA issued a Design for Patient Safety report 
on the dispensing environment in 2007. In this report it was recommended that 
selecting medicine packs from labels was unsafe practice and medicines should 
always be dispensed from the prescription: 
.http://www.nrls.npsa.nhs.uk/resources/collections/design-for-patient-
safety/?entryid45=59830 

4) Mandatory procedures requiring a ‘read-back’ of the drug, its dosage, its 
frequency of administration and its total quantity may prevent such dispensing 
errors. In so far as the error in this case can be attributable to ‘Human Error’ it 
is concluded that the dispensing pharmacist focused on the figure of 60 and 
incorrectly attributed that to the dosage as well as to the number of capsules.  

Although a ‘read-back’ procedures may be helpful. There are no such mandatory 
procedures in place.  I understand that there is no definitive research evidence that 
this would further reduce dispensing errors. 

5) A mandatory check, by a suitably qualified pharmacist or by a third party, at 
the end of the day after cashing up on the till, of records of each (prescription 
only) drug dispensed against the prescription would be a further precaution 
against a repetition of these circumstances. 

Although some form of reconciliation of prescriptions and medicines dispensed 
particularly for Controlled Drugs may be helpful, there are no such mandatory 
procedures in place.  I would welcome a system check such as this but it would 
require an evidence-base that this would further reduce dispensing errors. 

6) There is evidently no central database of all prescription errors so there can 
be no central monitoring of such errors and no means of determining trends or 
particular repeat errors.  

The National Reporting and Learning System is such a database and in 2012 
received 155,000 medication incident reports. Unfortunately only 7,500 of these 
reports were from community pharmacy, which suggests they are underreporting 
incidents. Analysis of NRLS medication incident data has identified that dosing errors 
arising from the prescribing, dispensing and administering of opioid medicines were 
the largest cause of harm. Patient Safety Alerts have been developed since 2005 
based on analysis of incident data in the NRLS.  

Other information pertinent to this case. 

Increasing reporting and learning from community pharmacy 

a)  NHS England is in the final stages of negotiating the community pharmacy 
Contract for 2014/15 and are planning to emphasise the requirement on 
community pharmacy to report patient safety incidents to the NRLS.  We will 
look to achieve this by stipulating the minimum expected reporting rate and 
highlighting the requirement for prescribing error. 

High quality care for all, now and for future generations 

 
 
 
 
 
 
 
 
 
 
 
 b)  NHS England is preparing to publish a Patient Safety Alert on March 2014 to 
improve reporting and learning of medication errors from all sectors including 
community pharmacy. This will include the establishment of a National 
Medication Safety Network, the identification of medication safety officers in 
large healthcare provider organisations including community pharmacy 
companies and other measures into to increase the number, quality, 
timeliness and learning of medication error incident reports. 

c)  There have been bar codes on medicine packs for many years. There is 
research evidence that the use of bar code technology, linked to patient 
medicine records and electronic transfer of prescriptions in addition to all the 
existing safeguards could reduce moderately severe dispensing errors by 
60%. (see Dean Franklin B, O’Grady K. Dispensing errors in community 
pharmacy: frequency, clinical significance and potential impact of 
authentication at the point of dispensing. IJPP 2007, 15: 273–281) 

Unfortunately, there is little use of bar codes in the dispensing process in 
community pharmacy at present. Greater use of this technology in 
dispensaries could improve patient safety. The Safe Medication Practice 
Team in NHS England, plan to undertake a review of community pharmacy 
incident data, together with relevant research and engage with stakeholders 
to prepare a Patient Safety Alert for possible publication in 2014. The 
proposed Alert would better describe the risks arising from dispensing 
medicines and safer practices to further minimise these risks, including better 
use of technology and checking systems. This guidance will help inform 
health care commissioners, providers and regulators of actions that they can 
take to further minimise risks arising from dispensing medicines. 

I hope you find this letter helpful and if you require any further technical 
Information on this I would be very happy to help. 

Please accept my best wishes 

Director of Patient Safety 
NHS England 

High quality care for all, now and for future generations

Pe Aw)

Yi

ROYAL

7” PHARMACEUTICAL LondonSEl INF 02077357629 werarpharmscom
a CIETY

England Team

18th March 2014-03-18

Dear Mr Coverdale,

Response of the Royal Pharmaceutical Society to the Regulation 28 report of senior coroner William
Donald Forbes Coverdale regarding the conclusion of the inquest into the death of Judith Lesley Marshall.

Thank you for contacting the Royal Pharmaceutical Society (RPS) and other pharmacy bodies regarding
the conclusion of the inquest into the sad death of Judith Lesley Marshall.

As you will know the Royal Pharmaceutical Society is the professional body for pharmacists and pharmacy
in Great Britain, representing all sectors of pharmacy. Our role is to lead and support the development of
the pharmacy profession including the advancement of science, practice, education and knowledge in

pharmacy.

We are aware that your report has simultaneously been sent to the General Pharmaceutical Council who
are the regulator of pharmacists and pharmacies, NHS England and the Secretary of State for Health.

We understand the matters of concern which you have raised, and whilst we do not have regulatory
powers, we are keen to assist through observation where this is helpful. Our observations on the concerns
you have raised are as follows.

It is positive that an error log has been maintained and we would expect that this is used by the
pharmacy as a prompt for local reflection and improvement within the pharmacy or pharmacy
chain. We believe the use of the error log other than as part of an improvement system could
inadvertently discourage pharmacy teams from recording errors.

It is terribly sad when human error contributes to a mistake in dispensing where the consequences
are a fatality. The adoption of a ‘Human Factors’ approach in healthcare is important and there is
much work in this area through the Patient Safety First campaign which was setup by the
Department of Health. RPS supports this work and other initiatives to improve safety and learning
culture within pharmacy. Further details are available on their website.
http://www.patientsafetyfirst.nhs.uk/Content.aspx?path=/interventions/humanfactors/.

The software you have described to reduce error sounds interesting and welcome. We believe
hat software with similar function is already being developed as part of the pharmacy IT strategies
England, Scotland and Wales. Further details on the developing system in England are available
n the website of the Pharmacy Services Negotiations Committee (PSNC)
ttp://psnc.org.uk/dispensing-supply/eps/

Read-back” sounds like useful method in a range of methods to reduce the occurrence of
dispensing errors and we could raise awareness and encourage use of “‘read-back” as one
technique amongst others to reduce errors in the guidance that we produce.

The option of an additional check also sounds interesting and we understand that there are some
pharmacies who do indeed use an additional check prior to supplying to the patient. We can raise
awareness of this method within future guidance that we produce.

Sree

ane)

Patron: Her Majesty The Queen Chief Executive: Helen Gordon

e Regarding a central database of prescription errors, we are pleased to report that this does exist.
The national learning and reporting system sits with NHS England and we expect they will be
providing details of this within their response to you.
http://www.nrls.npsa.nhs.uk/

Hopefully this is useful to you.

Yours sincerely,

Chairman
English Pharmacy Board, Royal Pharmaceutical Soceity
Mobile 07946547793