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WHO guideline Repor&ng and learning systems for Medica&on Errors: The role of Pharmacovigilance Centres
G. Benabdallah, R. Soulaymani, L. Alj, R. Benkirane, D. Cousins, S. Olson, S. Pal
1 Prague 2015, 27-‐30 Oct 28/10/2015
Burden of ME on public health § Since 1984: first studies on Adverse Drug Events(ADEs): § Harvard Medical Prac3ce Study:
19.4% ADEs , 17.7% are preventable ADEs (30195 pa&ents) § 1999: Ins3tute of Medicine -‐ USA:
1st Report on Pa&ent Safety 44000 – 98000 deaths/year due to Medical Errors 7000 DUE TO MEDICATION ERRORS
Prague 2015, 27-‐30 Oct 2 28/10/2015
Burden of ME on public health § Developed countries: 1/10 paGents is harmed while receiving hospital care (Bates 2010)
§ Developing countries: probability of pa&ents being harmed in hospitals is higher than in industrialized na&ons (World Alliance for Pa3ent Safety 2010)
§ Cost is between US$ 6 billion and US$ 29 billion per year (World Alliance for Pa3ent Safety 2010)
3 Prague 2015, 27-‐30 Oct 28/10/2015
World Health Organiza&on (WHO)
Prague 2015, 27-‐30 Oct 4
§ The direc&ng and coordina&ng authority on interna&onal health within the United Na&ons’ system
§ The leading interna&onal organiza&on in health
§ 194 Member States § WHO experts produce health guidelines
and standards, and help countries to address public health issues
28/10/2015
WHO programme for Interna&onal Drug Monitoring
WHO HQ + Regional and country offices
WHO Collabora&ng Centres: Sweden Norway-‐ Ghana Morocco The Netherlands
150 Na3onal Centres
Advisory CommiMee on Safety of Medicinal Products
(ACSoMP)
Exchange of informa&on Guidelines and Standards Support, Fundraising
Management of the internaGonal database
Signal generaGon Tools development
Prague 2015, 27-‐30 Oct 5 28/10/2015
Problema&c § Since ever, Pharmacovigilance Centres (PVCs) collect Medica&on Errors (MEs)
BUT
§ PVCs are not aware of that because MEs are part of Adverse Drug Reac&ons (ADRs)
Prague 2015, 27-‐30 Oct 6 28/10/2015
WHO/UMC/CAPM 2006-‐2007 Pilot project
§ Moroccan Pharmacovigilance database contain preventable ADRs:
§ Prev ADRs= 14.6% of ADRs
§ In Moroccan ICU: Prev ADRs = 7.5% of ADRs
Aim of project: Extend the role of PVCs to detect MEs
7
Available models Percentage of respondents n = 21
Countries with PVC, but no PSO 28.5
Countries with PVC and PSO 71.4
Collabora&on between PVC and PSO 28.5
No collabora&on between PVC and PSO
23.8
PVC plays the role of PSO 19
Results: § Ability of PVCs to manage ME
§ Need to develop and strenghten competencies
Prague 2015, 27-‐30 Oct 8
§ Coordina3on objec3ve 1: support and strengthen consumer reporGng of ADRs and adverse events
§ Coordina3on objec3ve 2: expand the role and scope of naGonal pharmacovigilance centres to prevent medicine-‐related adverse events: WP5 and WP6 leaded by Morocco (CAPM)
§ Coordina3on objec3ve 3: promote beMer and broader use of exisGng pharmacovigilance data for paGent safety
§ Coordina3on objec3ve 4: develop addiGonal methods of pharmacovigilance to complement data from spontaneous reporGng systems
Prague 2015, 27-‐30 Oct 9 28/10/2015
Repor&ng and learning systems for medica&on errors: The role of pharmacovigilance centres
Prague 2015, 27-‐30 Oct 10 28/10/2015
Available at: hep://apps.who.int/medicinedocs/documents/s21625en/s21625en.pdf
WHO Guideline § Objec&ves
§ Increase the capacity of na&onal pharmacovigilance centres to idenGfy and analyse preventable ME
§ SGmulate cooperaGon between na&onal pharmacovigilance centres and the World Alliance for Pa&ent Safety
§ Guideline intended for § Pharmacovigilances Centres § Medica&on Safety Organiza&ons § Pa&ent Safety Organiza&ons
Prague 2015, 27-‐30 Oct 11 28/10/2015
Contents 1. Objec&ves 2. Burden of medica&on errors on public health 3. Organiza&ons involved in medica&on error preven&on 4. Terminology and defini&ons 5. Classifica&on 6. Iden&fying and repor&ng medica&on errors 7. Analysing medica&on error incident reports 8. Medica&on error preven&on strategies 9. Collabora&ons
Prague 2015, 27-‐30 Oct 12 28/10/2015
Role of PVCs § Raising awareness § Improving exis&ng ICSR § Using specific tools to iden&fy preventable ADRs § Using specific tools to iden&fy risk contribu&ng factors
§ Pu&ng in place Risk Minimisa&on ac&ons § Outlining importance of collabora&ons
Prague 2015, 27-‐30 Oct 13 28/10/2015
Raise Awareness on the ability to detect ME
Raise Awareness on the importance to manage ME
PV centres
Health care professionals
Raise Awareness on the ability to manage ME through reported adverse event
Raise Awareness on the importance of reporGng ADRs and ME
14 Prague 2015, 27-‐30 Oct 28/10/2015
Role of PVCs § Raising awareness § Improving exisGng ICSR § Using specific tools to iden&fy preventable ADRs § Using specific tools to iden&fy risk contribu&ng factors
§ Pufng in place Risk Minimisa&on ac&ons § Outlining importance of collabora&ons
Prague 2015, 27-‐30 Oct 15 28/10/2015
Improving exis&ng ICSR IdenGfying ME through ICSR § Basis for PVC to establish causality assessment § To op&mize detec&on of ME, the ICSR should be improved § Proposed Items to be added in ICSR form:
§ Pa&ent weight, § Relevant medical history, § Suspected and concomitant drug, § Narra&ve case, § Relevant laboratory test, § Informa&on about the process of prescrip&on and dispensa&on
Prague 2015, 27-‐30 Oct 16 28/10/2015
Role of PVCs § Raising awareness § Improving exis&ng ICSR § Using specific tools to idenGfy preventable ADRs § Using specific tools to iden&fy risk contribu&ng factors
§ Pu&ng in place Risk Minimisa&on ac&ons § Outlining importance of collabora&ons
Prague 2015, 27-‐30 Oct 17 28/10/2015
Using specific tools to iden&fy preventable ADRs
Iden&fying ME through ICSR: The P Method § Systema&c way used to detect ME among ADRs reported to PVCs § Not intended to classify ME nor to perform RCA § Based on iden&fica&on of 20 defined preventability criteria § Issue of the method assessment:
§ Preventable: at least one preventability criteria is iden&fied § Non preventable: none of the preventability criteria is iden&fied § Not assessable: there is insufficient data for preventability assessment Prague 2015, 27-‐30 Oct 18 28/10/2015
Preventable and Non Preventable ADR
NOT FROZEN Statement § Closely linked to how drug is used and monitored
§ Depends on: § Time, space § Current state of knowledge on mechanism of ADR occurrence § Capacity of health services in developing therapeu&c protocols and making tools and analysis for reducing the occurrence of ADR
Then a Non preventable ADR may, in future, become a preventable ADR
Non preventable ADR in a country may be stated as a preventable ADR in another one
Prague 2015, 27-‐30 Oct 20 28/10/2015
Role of PVCs § Raising awareness § Improving exis&ng ICSR § Using specific tools to iden&fy preventable ADRs § Using specific tools to idenGfy risk contribuGng factors
§ Pu&ng in place Risk Minimisa&on ac&ons § Outling importance of collabora&ons
Prague 2015, 27-‐30 Oct 21 28/10/2015
Preventability Assessment Adverse Drug ReacGon
Adverse Event
Causality Assessment
Preventable ADR =
MedicaGon Error
Non Preventable ADR
Root Cause Analysis
Classic PV
Competencies to develop
22
Using specific tools Root Cause Analysis
§ Systema&c inves&ga&on technique to iden&fy underlying causes and contribu&ng factors that lead to ME occurrence
§ Goals § What happened ? § Why did it happen? § What can be done to reduce the likelihood of a recurrence?
§ Ishikawa diagram: § A fish diagram used as a tool to help classify all the possible
contributory factors to ME occurence § Allow us to establish risk minimisa&on ac&ons
Prague 2015, 27-‐30 Oct 23 28/10/2015
Ishikawa Diagram The fish diagram of contributory factors to a pa&ent safety risk
Healthcare Professionals Medicine
PaGent and RelaGves
Method (RegulaGon procedures, Protocols)
Resources Equipments
Interprofessional management
Workplace
Error Medicine
Prague 2015, 27-‐30 Oct 24 28/10/2015
Role of PVCs § Raising awareness § Improving exis&ng ICSR § Using specific tools to iden&fy preventable ADRs § Using specific tools to iden&fy risk contribu&ng factors
§ Pueng in place Risk MinimisaGon acGons § Outlining importance of collabora&ons
Prague 2015, 27-‐30 Oct 25 28/10/2015
Public Health Risk Minimisa&on Ac&ons
Tools used to put in place risk minimisaGon acGons:
§ Educa&onal tools for sensi&za&on, educa&on, trainings
§ Involvement of the Medicine’MAH , DRA (helping to disseminate the Dear HCP leeers…)
Prague 2015, 27-‐30 Oct 26 28/10/2015
Role of PVCs § Raising awareness § Improving exis&ng ICSR § Using specific tools to iden&fy preventable ADRs § Using specific tools to iden&fy risk contribu&ng factors
§ Pufng in place Risk Minimisa&on ac&ons § Outlining importance of collaboraGons
Prague 2015, 27-‐30 Oct 27 28/10/2015
1st, 2nd, 3rd and 4th level of Partnerships
Prague 2015, 27-‐30 Oct 28 28/10/2015
Thank you for your aMenGon
Prague 2015, 27-‐30 Oct 29 28/10/2015