Leonardus Vries
PFD Report
All Responded
Ref: 2015-0088
All 1 response received
· Deadline: 4 May 2015
Coroner's Concerns (AI summary)
Significant documentary failings and lack of audit for non-controlled medication created opportunities for abuse or theft, highlighting a need for improved internal control measures.
View full coroner's concerns
(1) It appeared in the evidence given by_ (that there were significant documentary failings in the control of medication at the Royal Orthopeadic Hospital. Specifically he said that there was no audit or any paper trail of the use of non-controlled medication. With regard to controlled medication it was accepted that there were documentary deficiencies which meant it could not be precisely ascertained what controlled medication had been taken or used or administered to patients Whilst the control of controlled medicalions appears tohave heen addressed by way of training and increased scrutiny and audit procedures] confirms that there is still no audit of non-controlled medication_ Specifically he sald (hat when stocks of non-controlled medication are delivered to wards and departments there is no check as to who uses the medication or for what purpose aged The being
It appears to me therefore that there is a significant opportunity for the abuse Or (heft of non-controlled medication. Itold me that the hospital were acting in accordance with the Department of Health guidelines in the matter and that unless the Department of Health issued further guidelines there would be no change in this process_ suggest that the Trust needs to consider putting in place its own audit guidelines to ensure lhat what] described as a "hole" in control measures is addressed,
2)
It appears to me therefore that there is a significant opportunity for the abuse Or (heft of non-controlled medication. Itold me that the hospital were acting in accordance with the Department of Health guidelines in the matter and that unless the Department of Health issued further guidelines there would be no change in this process_ suggest that the Trust needs to consider putting in place its own audit guidelines to ensure lhat what] described as a "hole" in control measures is addressed,
2)
Responses
Action Taken
The Royal Orthopaedic Hospital reviewed controls around controlled and non-controlled drugs, updated Standard Operating Procedures for Controlled Drugs, conducted audits and found compliance with required standards. (AI summary)
The Royal Orthopaedic Hospital reviewed controls around controlled and non-controlled drugs, updated Standard Operating Procedures for Controlled Drugs, conducted audits and found compliance with required standards. (AI summary)
View full response
Dear Mr Williams The late Leonardus Adrianus Gerardus VRIES Regulation 28 Response In response to your Regulation 28 Report To Prevent Future Deaths wish to clarify the existing controls on drugs used within theatres and document the changes in the last six months. With regard to non controlled" drugs, the existing controls in place are: All medicines are prescribed by an authorised registered prescriber and an audit trail exists on the patient record. All administrations of medicines are documented on the patient chart or the anaesthetic record both of which are stored in the patient's notes; Throughout the UK, this is the standard method of control and monitoring of medicines use. Pharmacy staff manage all drug issues to theatres and all clinical areas by regularly assessing stock levels in the area and supplying stock to a minimum stock level previously agreed by the department manager and the pharmacy team: This minimum stock level is determined by the historical use of the and the time between stock replenishment (normally weekly in ward areas and daily in theatres). Pharmacy staff report any concerns regarding increased drug use picked up at this point to the Chief Pharmacist who will investigate in conjunction with the Trust's Local Security Management Specialist and the police if required. In theatres, all deliveries are placed into an Omnicell secure electronic storage system by pharmacy staff after running a report on what has been issued through the machine since the last assessment: Theatres staff can then access these medicines using an individual username password or fingerprint recognition. Stock is then transferred from this central storage point into secure lockable cupboards in each anaesthetic room. registered staff may hold the keys to these cupboards_ Individual staff have a professional responsibility for the safe_ secure and legal storage of medicines under their control and only approved, registered staff may hold the keys. Registration is under the General Medical Council for doctors, Nursing and" Midwifery Council for nurses and the Health and Care Professions Council for The Royal Orthopaedic Hospital NHS Foundation Trust; Bristol Road South, Northfield, Birmingham; B31 2AP Telephone: 0121 685 4000 Fascimile: 0121 685 4100 HOSPiTA May RECEIVED '17 CORONER HM: drug drug drug drug Only
The Royal Orthopaedic Hospital NHS NHS Foundation Trust Operating Department Practitioners. Pharmacy staff are regulated by the General Pharmaceutical Council: A monthly issue report is generated the Pharmacy electronic stock control system. This is monitored by pharmacy; theatres management and finance looking for any unexplained changes in drug use. It is however unlikely that diversion by a single individual could be identified in this way because of the volume of legitimate use Medicines incidents ("non controlled" drugs and Controlled Drugs) are reported electronically and the management resolution of these incidents is monitored by the Chief Pharmacist and the Trust Medicines Safety Committee, which is a sub group of the Trust Drugs and Therapeutics Committee: Action and learning is shared across the organisation by involving all relevant staff groups including matrons and clinical directors, coordinated by the Trust Chief Pharmacist; the Lead Nurse for Medicines and the Trust Medication Safety Officer who is a senior doctor and also chairs the Drugs and Therapeutics Committee. A letter was issued to all staff in February 2015 clarifying individual staff responsibilities regarding the safe and secure handling of medicines and Standard Operating Procedures (SOPs) were issued to each anaesthetic room: Staff have signed to confirm that they have received, read and understand the SOPs Since February 2015 a weekly audit of Controlled Drug documentation is carried out by theatres management: Since March 2015 the Chief Pharmacist has carried out unannounced snapshot audits (normally two per week) on storage (all drugs) and documentation in theatres_ No concerns regarding diversion or theft of medicines have been identified through this audit cycle and all documentation is correctly completed. Additional requirements for the safe and secure storage and use of Controlled Drugs are detailed in The_Controlled Drugs Supervision and Management of Use) Regulations 2013. The Trust is compliant with these regulations and has an Accountable Officer for Controlled Drugs (the Director of Nursing and Governance) who delegates operational responsibility for this to the Chief Pharmacist: The trust is compliant with the legislation and best practice and contributes to the NHS England Birmingham Solihull and Sandwell Controlled Drugs Local Information Network. The Chief Pharmacist audited the organisational governance structures for the safe and secure use of Controlled Drugs the Care Quality Commission's audit tool in March 2015 and has reported these audit findings, action plans and progress on action plans to the Accountable Officer for Controlled Drugs, the Trust Drugs and Therapeutics Committee and the Trust Clinical Governance Committee_ In summary, the controls around both Controlled Drugs and "non-controlled" drugs have been reviewed. Standard Operating Procedures for Controlled Drugs have been updated and audits conducted by the Chief Pharmacist have shown compliance with the standards required. Controls around non-controlled" medicines have been reviewed and found to be compliant with or indeed exceed all national guidance. There remains a small risk that these medicines could be diverted as is the case in all hospitals. This is mitigated by the professional responsibilities of all staff regarding the use of medicines_ To further mitigate The Royal Orthopaedic Hospital NHS Foundation Trust; Bristol Road South, Northfield, Birmingham, B31 2AP Telephone: 0121 685 4000 Fascimile: 0121 685 4100 Mospita using drug drug using
"o The Royal Orthopaedic Hospital NHS NHS Foundation Trust this risk the Chief Pharmacist will continue to monitor trends in usage of drugs in all areas of the Trust Yours sincerelv JO lnlalbers Chief Executive Officer The Royal Orthopaedic Hospital NHS Foundation Trust; Bristol Road South, Northfield, Birmingham, B31 2AP Telephone: 0121 685 4000 Fascimile: 0121 685 4100
The Royal Orthopaedic Hospital NHS NHS Foundation Trust Operating Department Practitioners. Pharmacy staff are regulated by the General Pharmaceutical Council: A monthly issue report is generated the Pharmacy electronic stock control system. This is monitored by pharmacy; theatres management and finance looking for any unexplained changes in drug use. It is however unlikely that diversion by a single individual could be identified in this way because of the volume of legitimate use Medicines incidents ("non controlled" drugs and Controlled Drugs) are reported electronically and the management resolution of these incidents is monitored by the Chief Pharmacist and the Trust Medicines Safety Committee, which is a sub group of the Trust Drugs and Therapeutics Committee: Action and learning is shared across the organisation by involving all relevant staff groups including matrons and clinical directors, coordinated by the Trust Chief Pharmacist; the Lead Nurse for Medicines and the Trust Medication Safety Officer who is a senior doctor and also chairs the Drugs and Therapeutics Committee. A letter was issued to all staff in February 2015 clarifying individual staff responsibilities regarding the safe and secure handling of medicines and Standard Operating Procedures (SOPs) were issued to each anaesthetic room: Staff have signed to confirm that they have received, read and understand the SOPs Since February 2015 a weekly audit of Controlled Drug documentation is carried out by theatres management: Since March 2015 the Chief Pharmacist has carried out unannounced snapshot audits (normally two per week) on storage (all drugs) and documentation in theatres_ No concerns regarding diversion or theft of medicines have been identified through this audit cycle and all documentation is correctly completed. Additional requirements for the safe and secure storage and use of Controlled Drugs are detailed in The_Controlled Drugs Supervision and Management of Use) Regulations 2013. The Trust is compliant with these regulations and has an Accountable Officer for Controlled Drugs (the Director of Nursing and Governance) who delegates operational responsibility for this to the Chief Pharmacist: The trust is compliant with the legislation and best practice and contributes to the NHS England Birmingham Solihull and Sandwell Controlled Drugs Local Information Network. The Chief Pharmacist audited the organisational governance structures for the safe and secure use of Controlled Drugs the Care Quality Commission's audit tool in March 2015 and has reported these audit findings, action plans and progress on action plans to the Accountable Officer for Controlled Drugs, the Trust Drugs and Therapeutics Committee and the Trust Clinical Governance Committee_ In summary, the controls around both Controlled Drugs and "non-controlled" drugs have been reviewed. Standard Operating Procedures for Controlled Drugs have been updated and audits conducted by the Chief Pharmacist have shown compliance with the standards required. Controls around non-controlled" medicines have been reviewed and found to be compliant with or indeed exceed all national guidance. There remains a small risk that these medicines could be diverted as is the case in all hospitals. This is mitigated by the professional responsibilities of all staff regarding the use of medicines_ To further mitigate The Royal Orthopaedic Hospital NHS Foundation Trust; Bristol Road South, Northfield, Birmingham, B31 2AP Telephone: 0121 685 4000 Fascimile: 0121 685 4100 Mospita using drug drug using
"o The Royal Orthopaedic Hospital NHS NHS Foundation Trust this risk the Chief Pharmacist will continue to monitor trends in usage of drugs in all areas of the Trust Yours sincerelv JO lnlalbers Chief Executive Officer The Royal Orthopaedic Hospital NHS Foundation Trust; Bristol Road South, Northfield, Birmingham, B31 2AP Telephone: 0121 685 4000 Fascimile: 0121 685 4100
Sent To
- Royal Orthopaedic Hospital NHS Foundation Trust ›Royal Orthopaedic Hospital
Response Status
Linked responses
1 of 1
56-Day Deadline
4 May 2015
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 10"h October 2014 commenced an investigation into the death of Leonardus Adrianus Gerardus VRIES then 48 years The investigation concluded at the end of the inquest on 4"h March 2015_ conclusion of the inquest was accidental death the medical cause of death 1(a) respiratory depression, 1(b) combined toxicity of bupivacaine and morphine and diamorphine
Circumstances of the Death
Mr Vries apparently acquired medical grade drugs from his place of work and used them to inject himself at his family home where died.
Action Should Be Taken
In my opinion action should be taken to prevent future deaths and believe you have the power to take such action,
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.