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 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 being

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 a5 part of our work we will review whether our approach to inspection on this matter should include further interrogation of errors recorded: The GPhC has published guidance which contains information about minimising the risk of dispensing errors (http:/ /www:pharmacyregulation org/sites/default/files/Responding%2Oto%2Ocomplaints%2Oand%2Oconc erns%2Og_ 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_ 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_ 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. 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. 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 Vou for raising your concerns with us. It is in all our and, most importantly, the public'$ 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.

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.

HM SENIOR CORONER COUNTY OF YORK

4- 8 Maple Street London W1T 5HD

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:

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

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 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 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 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 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 ukContentaspxlpath-linterventionslhumanfactorsl. The software you have described to reduce error sounds interesting and welcome: We believe that software with similar function is already being developed as part of the pharmacy IT strategies in land; Scotland and Wales: Further details on the developing system in England are available on the website of the Pharmacy Services Negotiations Committee (PSNC) httpILpsnc org ukldispensing-supplylepsl "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 guidance that we produce: Patron: Her Majesty The Queen Chief Executive; Helen Gordon Lesley Lesley log setup Engl future

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 /Lwwwnrlsnpsa nhsukl Hopefully this is useful to you:

From the Rt Hon Jeremy Hunt MP Secretary of State for Health Department of Health Richmond House 79 Whitehall London SWLA 2NS POCI 838751 Tel: 020 7210 3000 Mr W Coverdale Mb-sofs@dh-gsi gov.uk Senior Coroner Sentinel House Peasholme Green York YOI 7PP 3 MAR ?014 Je L Wssle" 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. Iwas 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. Tunderstand that on 28 September 2009 Mrs Marshall was correctly prescribed sixty IOmg 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 strength rather than the strength prescribed. Although the box of capsules carried numerous clear references to its containing capsules; a trainee dispensing technician checked the medication dispensed by the pharmacist and confirmed it; Mrs Marshall took the capsules twice a as prescribed which meant she took 120mg of morphine per rather than 20mg. She was found dead in her bed by her husband on thc morning of 30 September 2009. You ask me to consider the following concerns: The Pharmacy' $ Errors Book shows a number of crrors (including higher or 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. 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 The consequences were fatal. It is not clear whether there is any software, obtainable from the Department of Health o1" else-where, that could read prescriptions and raise an alert if the 1Omg 60mg 60mg day day _ drug lower drug:

label sought to be created or if the sought to be dispensed is wrong in identity or amount; This would be of particular significance when a high risk is dispensed or when a is dispensed in an unusual quantity, dosage or form_ Mandatory procedures requiring a read-back' of the 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. 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) dispensed against the prescription would be a further precaution against repetition of these circumstances There is evidently no central database of all prescription errors %0 there can be no central monitoring of such errors and no means of _ 'determining trends or particular repeat errors_ It may help ifI 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'$ performance and supporting the integrity of the to protect the best interests of patients, the public and the taxpayer. Since 1 April 2013, most 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 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. Inote that you sent your report to NHS England and that_ 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 0f,and issuing alerts resulting pharmacy errors; He has also outlined NHS England 's plans to increase reporting and learning from community pharmacy: drug drug drug ` drug; drug system day - they - from;

Department of Health My officials have consulted the General Pharmaceutical Council about this case. The Council has a role in setting standards and the regulation 0f, pharmacies and pharmacists. It also sets standards for the education and training of pharmacists and ensures, through inspections; that educational standards are 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: Iunderstand 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 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 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; 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 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 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:Ilwwwema europa eu/docslen_GBldocument_library/Scientific_guideline/201 2/06[WC500129131 The MHRA continues to operate the UK's Yellow Card Scheme for reporting suspected adverse 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; key- for; being for Drug drug drug ~pdf drug

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 nctwork 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 a8 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 1 am grateful to you for bringing the circumstances of Mrs Marshall's death to my attention_ Ya- ji-uc) JEREMY HUNT