Prevention of Future Deaths reports · 2017
Regulation 28 report to prevent future deaths, reference 2017-0295, written 13 Oct 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 13 Oct 2017 |
|---|---|
| Reference | 2017-0295 |
| Deceased | Christina Fletcher |
| Coroner | Lisa Hashmi |
| Coroner area | Manchester North |
| Category | Product related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | none published |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
General. Pharmaceutical. Council. Private & Confidential Coroner’s Officer H M Coroner’s Court via email only Margaret.Turner@Rochdale.gov.uk — 7 December 2017 Please quote: G-CM1705-051 Dear Margaret, Re: Concern regarding delivery of incorrect medication by Hopwood Pharmacy, 50 Manchester Road, HEYWOOD 0110 2AH The General Pharmaceutical Council (“GPhC”) has now completed its inquiries into information you provided concerning an Inquest into the death of a Christina Ann Fletcher. Investigation into the concern As part of the GPhC’s investigation, we contacted the local GPhC Inspector at the time of the incident and the CDLO at Greater Manchester Police to obtain information about their visit to the pharmacy shortly after the incident in August 2016. Neither had concerns about the pharmacy and were satisfied that the error was human error and noted that the Superintendent (“SI”) had taken action, such as amending the SOP relating to the Delivery of Controlled Drugs (“CD”). We also obtained information from the SI in relation to the investigation he had undertaken into the error and the changes he had made within the pharmacy to prevent a delivery error like this occurring again in the future. We have reviewed all of the available evidence and information and have concluded that the concern should not progress to the Investigating Committee. There was not enough evidence to prove that either the SI or the Responsible Pharmacist (“RP”) could be held accountable for the delivery error made by the driver who failed to follow the Standard Operating Procedure (“SOP”) in place at the time. On that basis, there was not enough evidence to establish that any specific pharmacy professional’s fitness to practise was impaired. We were satisfied that the changes that the SI had made, such as updating the SOP and enrolling their drivers on the Buttercup training course would assist in the prevention of a similar error occurring in the future. To reach this decision, we have also considered the GPhC’s Threshold Criteria. The GPhC uses its 25 Canada Square. London E145LQ T020 3713 8000 F02037138145 www.pharmacyregulation.org Threshold Criteria to decide whether the case should be closed or referred to the Investigating Committee. The Threshold Criteria have been developed against the principles in the Standards for conduct, ethics and performance which all pharmacy professionals must comply with. The Threshold Criteria are published on our website at: http://www.pharmacyregulation.org/raising concerns/registrants/what-happens-if-complaint-made-against-me/jnvestjgatjon-procedure. The GPhC is committed to upholding professional standards and. although this matter will not progress to a hearing, we have written to the SI to provide them with advice to remind him to ensure that all staff, including delivery drivers, are regularly reviewing and refreshing their knowledge of the SOPs, and that locum staff are aware of the pharmacy’s SOPs. The GPhC takes all concerns against pharmacy professionals very seriously and I would like to assure you that all reasonable lines of enquiry were pursued prior to our decision to close our investigation. We should be grateful if you would share your experience of the Fitness to Practise process by completing the feedback survey at the following link: http://surveys.pharmacyregulation.org/s/review Thank you for your cooperation with my inquiries into this matter. My colleagues in the Standards and Policy team will be responding the Regulation 28 notice in due course. Yours sincerely - -——::-—- Case Officer Professionals Regulation Team GPhC General Pharmaceutical Council Ms Li Hashmi HM Area Coronerforthe Coroner area of Manchester North H M Coroners Court Phoenix Centre L/Cpl Stephen Shaw MC Way Heywood OL1O 1LR By email: coroners.office@rochdale.gov.uk 11 December 2017 Dear Ms Hashmi Re: Regulation 28 Notice response Christina Ann Fletcher, deceased. - Thankyou foryour letter regarding the tragiccircumstances surroundingthe death of Ms Christina Ann Fletcher. As you are aware, we carried out an investigation and wrote to you with the outcome on 7 December 2017. This letter deals specificallywith the Regulation 28 Notice. We have a statutory purpose to protect patients by setting and upholding standards for individual pharmacists and pharmacytechnicians and for registered pharmacies, and also maintaining a registerof pharmacists, pharmacy technicians and pharmacies. The purpose ofour standards for registered pharmacies is to create and maintain the right environment, both organisational and physical, forthe safe and effective practice of pharmacy. The standards can be found at https://www.pharmacyregulation.org/standards/standards-registered pharmacies. The responsibility for meetingthe standards for registered pharmacies lies with the pharmacy owner and superintendent pharmacist. The pharmacy owner and superintendent pharmacist must decide how to meet these standards, taking into consideration the services they will be providing, the associated risks and the needs ofthe patient. As well as meeting ourstandards the pharmacy owner must make sure they comply with all legal requirements. Our standards require the pharmacy owner/superintendent pharmacist to considertheir governance arrangements including assessing and managing any risks involved with the way they have chosen to set up the services they offer and to provide services that are managed and delivered safely and effectively. When a GPhC inspectorvisits the pharmacytheywill expect to see evidence to help them decide whether a pharmacy is meeting these standards. We publish a range ofguidance, which is focussed on helping pharmacy professionals, pharmacy owners and superintendent pharmacists meet our regulatory standards. We have produced guidance for pharmacyowners and superintendent pharmacists who provide services at a distance: Pagelof2 20171211 ChristinaAnn Fletcher https://www.pharmacyregulation.org/sites/default/files/guidance for registered pharmacies providing pha rmacy services at a distance including on the internet april 2015.pdf This guidance applies to the delivery of medicines. Whether a pharmacyservice is provided face to face in the pharmacy or delivered to a patient’s home, it is importantthat the pharmacist is satisfied the medicine is delivered safely. The guidance sets out some ofthe areas thatshould be considered before setting up this type of service and specifically highlights the risk around medicines being lost or delivered to the wrong person and the importance of stafftraining. Whilst we produce guidance and advice of ourstandards, we do not produce detailed advice on the law. However, the Royal Pharmaceutical Society (RPS) (www.rpharms.com) is the professional bodyfor pharmacists in Great Britain and has produced guidance on the delivery and posting (including abroad) of medicines to patients and maintains practice guidance on the management of controlled drugs. Forfurther information about the chain of custodyfor Controlled Drugs the Home Office, as the body responsible for controlled drug legislation, is best placed to provide you with this information. It is important that pharmacy learns from the tragic circumstances ofthe death of Ms Fletcher, and whilst we will ofcourse not make reference to the specific circumstances of her death, we will raise awareness ofthis issue through an article our online registrant bulletin, Regulate. We produce the bulletin every two months and notify all our registrants and pre-registration pharmacytrainees (around 75,000 recipients in total) of a new edition via email. Thankyou again forwritingto me and raising this important matter. Yours sincerely, L zJ Duncan Rudkin Chief Executive and Registrar Email:
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORTTO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Chair of the General Pharmaceutical Council, 25 Canada Square, London E14 5LQ I CORONER I am Ms L J Hashmi, HM Area Coroner for the Coroner area of Manchester North. 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroner’s and Justice Act 2009 and Regulations 28 and 29 ofthe Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On the 1th0 October 2017, I commenced an inquest into the death of Ms Christina Ann Fletcher. 4 CIRCUMSTANCES OF DEATH: At the time of her death, the deceased was under treatment for a number of complex health issues. Her diagnoses included Macular Dystrophy resulting in marked visual impairment and Somatisation Disorder. Prescribed medicationwas delivered to her home address in Dosette boxes on a weekly basis by the community pharmacist. On the 4th August 2016 medication (Zomorph an opiate and controlled drug) was delivered to the deceased as - a result of human error. The intended recipient lived in close proximity to the deceased’s home address (within doors, on the same side of the street) and had a very similar name to that of the deceased. The erroneous medicationwas delivered alongside medication thatwas intended forthe deceased. The Standard Operating Procedure (‘SOP’) in force at the material time relating to the delivery of controlled drugs (‘CDs’) was not followed. A signature was not obtained at the point of delivery, the name and address of the intended recipient was not verified and the duplicating delivery book was not checked for a delivery signature upon its return to the pharmacy (rather, verbal confirmation of delivery was accepted). This resulted in the drug errorgoing undetected until the 12th August. Adequate training of the delivery driver was not evidenced however, more likely than not, he had seen something akin to an SOP. Steps were subsequently taken by the Pharmacy to try and trace the deceased (and retrieve the Zomorph). On the thrust of the evidence, the deceased had last been seenlspoken to on the 10th August. On the afternoon of the 12th August the Pharmacist contacted the deceased’s father who reassured him regarding the deceased’s apparent lack of response. However there was sufficient ongoing cause for concern, given the nature of the erroneous medication delivered 8 days earlier. Initial enquiries proved fruitless and there was no response at the deceased’s home address. Police were contacted at 19:53 on the 12th August regarding concern for the deceased’s welfare. In reliance upon the information provided by the Pharmacist, the deceased’s family and prevailing circumstances, a decision was taken not to force entry to the deceased’s house. That was a reasonable decision based on the information availableto police atthe time. Delays were placed on the police FWIN. An Officer attended the deceased’s home in the early hours ofthe 13th August. There was no response and therefore a further 5 hour delay was entered. Later the same morning an Officerwas allocated and the decision made to force entry whereupon the deceased was found dead in the living room. The Zomorphwas found within the property. Nine 30mg tabletwere missing. Forensic post mortem examination and toxicological analysis revealed the presence of pneumonia and a markedly elevated level of free morphine, alongside a slightly elevated level of Pregabalin (relevant as to cumulativeeffect). Despite any potential post-mortem redistribution, on the balance of probabilities it was still possible to directly attribute the level offree Morphine found to the directcause of death. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: 1. There is no specific guidance, policy or protocol from the GPhC on the requirement for a ‘red flag’ system within pharmacies in relation to patients with identical names, similar addresses, living in close proximity etc. as demonstrated by the very tragic circumstances of this case. Whilst the Pharmacy in question did have internal processes in place at the time, concern remains that other Pharmacies throughout England and Wales might not, in the absence of specific guidance from their Regulator. 2. Again, there is no specific guidance, policy or protocol from the Regulator (or indeed legal definition) as to when, where and how the chain of custody (for Controlled Drugs) is completed. It currently appears to be a matter of local practice with some Pharmacies make an entry into the CD Register at the point the CD is handed to the delivery driver, with others making an entry once delivery has been confirmed. Both matters potentially give rise to a risk offuture deaths in the absence of guidance and/or policy from the Regulator. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe each of you respectively have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 16:30 on the 1th1 December 2016. I, the Coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely: The deceased’s son - The deceased’s sister - The delivery driver - The Pharmacy - Greater Manchester Police - The Locum Pharmacist - I am also under a duty to send the Chief Coroner a copy ofyour response. The Chief Coroner may publish either or both in a complete or redacted or summary from. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me the coroner at the time of your response, about the release or the publication of your response by the Chief Coroner. \ Date: ()
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