How the new network of NHS Medication Safety Officers and Medical Device Safety Officers are affecting patient safety 9 th December 2015 April 2015 Dr David Gerrett Senior Pharmacist Patient Safety NHS E
Agenda 1. Scene setting 2. MSO and MDSO responsibilities 3. Making it safer in the NHS 4. How are MSO and MDSO affecting patient safety? Slide 2 NHS E | Presentation for NHSLA 9 th December 2015
Agenda 1. Scene setting Slide 3 NHS E | Presentation for NHSLA 9 th December 2015
Slide 4 NHS E | Presentation for NHSLA 9 th December 2015
Directive 2001 - 2010/84/EU Pharmacovigilance Under paragraph 5 For the sake of clarity, the definition of the term ‘adverse reaction’ should be amended to ensure that it covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product . Slide 5 NHS E | Presentation for NHSLA 9 th December 2015
ADE’s ADR’s and Medication Errors THE FOCUS No harm Preventable (ADEs, ADRs and AEs) Low harm NHS E Medication errors Things we don’t know ADE’s NHS E Non preventable (ADR, MHRA) Potential ADE’s Intercepted NHS E Bates DW, Boyle DL, Vander Vliet MB, Schneida J, leape L. Relationship between medication errors and adverse drug events. J. Gen. Intern. Med, 1995;10:199-205. Slide 6 NHS E | Presentation for NHSLA 9 th December 2015
ADE’s ADR’s and Medication Errors THE FOCUS No harm Preventable (ADEs, ADRs and AEs) Low harm NHS E add MHRA Medication errors Things we don’t know ADE’s NHS E Non preventable (ADR, MHRA) Potential ADE’s Intercepted NHS E Bates DW, Boyle DL, Vander Vliet MB, Schneida J, leape L. Relationship between medication errors and adverse drug events. J. Gen. Intern. Med, 1995;10:199-205. Slide 7 NHS E | Presentation for NHSLA 9 th December 2015
PSIs Routine Basic error types Reasoned Reckless & Malicious Violations Rule & Knowledge Based errors Intended actions Skill based errors Mistakes Memory failures Unsafe acts Lapses Unintended Skill based errors Attentional failures actions Slips Slide 8 NHS E | Presentation for NHSLA 9 th December 2015
Competence Consciously incompetent Assess and learn Learn PSDA Consciously competent Unconsciously incompetent Practice Lapse Unconsciously competent The implications: we are all capable of error and things change NPC. MeReC bulletin.2011;22(no1) http://www.npc.nhs.uk/merec/mastery/mast3/resources/merec_bulletin_vol22_no1.pdf Slide 9 NHS E | Presentation for NHSLA 9 th December 2015
Patient safety Incidents reported from Oct 2003 - Dec 2014 500000 450000 400000 350000 300000 Incidents Submitted 250000 200000 150000 100000 50000 0 Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Apr - Oct - Dec Jun Dec Jun Dec Jun Dec Jun Dec Jun Dec Jun Dec Jun Dec Jun Dec Jun Dec Jun Dec Jun Dec 2003 2004 2004 2005 2005 2006 2006 2007 2007 2008 2008 2009 2009 2010 2010 2011 2011 2012 2012 2013 2013 2014 2014 Slide 10 NHS E | Presentation for NHSLA 9 th December 2015
The National Reporting and Learning System Slide 11 NHS E | Presentation for NHSLA 9 th December 2015
Reported to NRLS 2005-2014 250000 200000 190619 164907 152460 150000 144609 132069 reported 113837 100000 94280 79280 MSO/MDSO 64484 50000 42398 0 2004 2006 2008 2010 2012 2014 2016 In 2014 the absolute number of medication reports to the NRLS increased more than in any previous year, representing a 15.6% increase on the year before. Slide 12 NHS E | Presentation for NHSLA 9 th December 2015 12
New style Patient Safety Alerts (PSAs) • Stage One Alert: Warning • Warns organisations of emerging risk. It can be issued very quickly once a new risk has been identified to allow rapid dissemination of information • Stage Two Alert: Resource • Provision of resources, tools and learning materials to help mitigate risk identified in stage one • Stage Three Alert: Directive • Organisations are required to confirm they have implemented specific actions or solutions to mitigate the risk Slide 13 NHS E | Presentation for NHSLA 9 th December 2015
Medication Safety Officer Slide 14 NHS E | Presentation for NHSLA 9 th December 2015
Medical Device Safety Officer Slide 15 NHS E | Presentation for NHSLA 9 th December 2015
Supporting documents Slide 16 NHS E | Presentation for NHSLA 9 th December 2015
Which organisations? Count of Name Row Labels As of 2 nd November 2015 CCG 75 Community Interest Company 8 Community pharmacy sector 21 Guests: + 60 Cosmetic Surgery 1 Independent 1 Mental Health 1 NHS Acute Large 41 NHS Acute Medium 46 NHS Acute Small 25 NHS Acute Specialist 18 NHS Acute Teaching 30 NHS Ambulance Trust 9 NHS Community Trusts 16 NHS England Area Team 14 NHS Mental Health Trust 51 Other Independent Sector 20 Social Care Enterprise 1 Grand Total 378 Slide 17 MSO 5 th November 2015
Medication Incident Adverse drug reactions Report to MHRA via (ADRs) but not Medication Yellow Card Scheme errors Healthcare Professionals and www.mhra.gov.uk/yellowcar Patients d Identify and REPORT Analysis & regulatory action Medication errors Risk /Complaint Managers Oversight & Quality Assurance Medicines Safety Officer (MSO) Local Medication Safety Committee Quality Assurance Oversight and Support Request Submit reports to NRLS through additional organisation's system or online e-form information MHRA & NHS England Analysis Slide 18 NHS E | Presentation for NHSLA 9 th December 2015 18
MHRA NHS England Analysis Analysis MHRA’s National Medication Safety Network Yellow Card Scheme National learning & safety communications www.mhra.gov.uk/yellow card Analysis & regulatory action feedback and interaction loop Feedback and NHS England safety action to minimise communications: risk Formally by three stage Alerts, Organisational Patient MHRA safety Safety Incident to NHS communications: organisations by NRLS Drug Safety Update reports (6 monthly) (monthly) Publication in Safety Warnings (as professional journals required) Alerts (as required) Recalls (as required) Healthcare Professionals Medicines Safety Officer two way interaction Implementation Ensures implementation and dissemination of safety communications education, training and support support Local Medication Safety Committee Oversight and support Slide 19 NHS E | Presentation for NHSLA 9 th December 2015 19
Agenda 2. MSO and MDSO responsibilities Slide 20 NHS E | Presentation for NHSLA 9 th December 2015
Beware the detail Slide 21 NHS E | Presentation for NHSLA 9 th December 2015
MSO responsibilities Agenda Slide 22 NHS E | Presentation for NHSLA 9 th December 2015
MSO responsibilities Slide 23 NHS E | Presentation for NHSLA 9 th December 2015
MDSO responsibilities Slide 24 NHS E | Presentation for NHSLA 9 th December 2015
MDSO responsibilities What is in store for the MSO MDSO? Slide 25 NHS E | Presentation for NHSLA 9 th December 2015
Agenda 3. Making it safer in the NHS Slide 26 NHS E | Presentation for NHSLA 9 th December 2015
National Patient Safety Agency 10 years of Medication 2002-2012 Devices 2010-2012 Medication • 45 Alerts, Rapid Response Reports • Signals • 6 design guides • Medication Safety updates Slide 27 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 28 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 29 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 30 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 31 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 32 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 33 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 34 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 35 NHS E | Presentation for NHSLA 9 th December 2015
New style Patient Safety Alerts (PSAs) Slide 36 NHS E | Presentation for NHSLA 9 th December 2015
Agenda 4. How are MSO and MDSO affecting patient safety? Slide 37 NHS E | Presentation for NHSLA 9 th December 2015
MSOs/MDSOs local and national focus Essential focus 1. Local learning from PSIs 2. Taking National messages and implementing [Alerts] locally 3. Frequency and quality of reporting 4. Identifying and disseminating best practice 5. Conduit between NHS England/MHRA and practice Slide 38 NHS E | Presentation for NHSLA 9 th December 2015
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