Source · Prevention of Future Deaths

Christina Fletcher

Ref: 2017-0295 Date: 13 Oct 2017 Coroner: Lisa Hashmi Area: Manchester (North) Responses identified: 0 / 1 View PDF

A lack of clear regulatory guidance on 'red flag' systems for pharmacies to identify patients with similar details and inconsistent chain of custody protocols for controlled drugs pose risks.

Date 13 Oct 2017
56-day deadline 22 Jan 2018 est.
Responses identified 0 of 1
Product related deaths

Coroner's concerns

AI summary
A lack of clear regulatory guidance on 'red flag' systems for pharmacies to identify patients with similar details and inconsistent chain of custody protocols for controlled drugs pose risks.
View full coroner's concerns
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 of future deaths in the absence of guidance and/or policy from the Regulator.

Report sections

Investigation and inquest
On the 10 th October 2017, I commenced an inquest into the death of Ms Christina Ann Fletcher. 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 medication was 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 medication was delivered alongside medication that was intended for the 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 error going 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 available to police at the time. Delays were placed on the police FWIN. An Officer attended the deceased’s home in the early hours of the 13th August. There was no response and therefore a further 5 hour delay was entered. Later the same morning an Officer was allocated and the decision made to force entry whereupon the deceased was found dead in the living room. The Zomorph was found within the property. Nine 30mg tablet were 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 cumulative effect). Despite any potential post-mortem redistribution, on the balance of probabilities it was still possible to directly attribute the level of free Morphine found to the direct cause of death.
Copies sent to
delivery driverPharmacyGreater Manchester PoliceLocum Pharmacist

Similar PFD reports

Shared signals

Related inquiry recommendations

Similar themes

Report details

Reference
2017-0295
Date of report
13 October 2017
Coroner
Lisa Hashmi
Coroner area
Manchester (North)

Responses identified

Responses identified 0 of 1
1 response not yet linked

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 22 Jan 2018 (estimated).

Sent to

General Pharmaceutical Council

Source links