Transcript Medication Errors – The Regulatory Role Speaker: Ms

Medication Errors – The
Regulatory Role
24th November 2016, CMG Events - ME Conference
Niamh Arthur,
Pharmacovigilance Manager
HPRA
Presentation Overview
•
Areas of HPRA responsibility and legal provisions related to reporting
of medication errors
•
HPRA communications highlighting legislative requirements
•
Practical reporting aspects
•
The regulatory role in the area of medication error, national/EU
•
Some examples of regulatory interaction on medication error issues
Organisational Name & Roles
• 1966 – The National Drugs Advisory Board
(NDAB)
• 1996 – The Irish Medicines Board (IMB)
• 2014 – The Health Products Regulatory Authority
(HPRA)*
* July 1st 2014
Areas covered by the HPRA Regulatory Role
Legal frameworks have evolved and expanded the regulatory
role across a range of areas over the past 20 years
Adverse (Drug) Reaction - Definition
• ‘A response to a medicinal product which is noxious and unintended’
• Provides for reporting and taking regulatory action outside the
'normal conditions of use’ (part of the previous legal definition)
• This expanded definition provides for reporting of:
- Medication errors, associated with harm
- Occupational exposure
- Other uses outside the terms of the marketing authorisation, i.e.
misuse
EU – Legislative Text
• Directive 2010/84/EU - Article 107a (5):
‘ Member States shall ensure that reports of suspected adverse
reactions arising from an error associated with the use of a
medicinal product that are brought to their attention are made
available to the Eudravigilance database and to any authorities,
bodies, organisations and/or institutions, responsible for patient
safety within that Member State. They shall also ensure that the
authorities responsible for medicinal products within that Member
State are informed of any suspected adverse reactions brought to
the attention of any other authority within that Member State.
These reports shall be appropriately identified in the forms referred
to in Article 25 of Regulation (EC) No 726/2004’
National Legislative Requirements
•
S.I. 272 of 2012 (Regulation 11)
‘Suspected adverse reactions – obligations of the Board
and other authorities…
• (5) The Board shall ensure that reports of suspected
adverse reactions arising from an error associated with
the use of a medicinal product that are brought to its
attention are made available to the Eudravigilance
database and to any State authorities responsible for
patient safety.
• (6) Where any State authority receives a report of a
suspected adverse reaction, it shall promptly inform the
Board of same’.
HPRA Communications on
Requirements - HCPs
HPRA Communications on Requirements
for Patients and Consumers
Reporting Medication Errors to
the HPRA
• Adverse reactions resulting from medication errors
(those associated with harm, i.e. where a patient has
experienced an adverse reaction) should be
reported to the HPRA
Reporting Medication Errors
• Medication errors not resulting in harm, should continue to be
reported internally and nationally, as appropriate, in
accordance with local procedures
• HPRA working with NAEMS to support exchange of relevant,
anonymised information to reduce duplicate reporting
requirements
• Medication errors not resulting in harm should additionally be
notified to the relevant Marketing Authorisation Holders
(MAH), for consideration in their cumulative overviews of
safety information for review by competent authorities
What is the role of the Regulator?
•
Availability of medicines, particularly innovative
treatments and technologies, without unnecessary delay
Proactive vigilance based on best evidence and prompt
risk management
•
Information to patients and healthcare professionals on
benefits and risks
•
Monitor experience and demonstrate that risk has been
effectively managed
Benefit - Risk Management
Goal - Promote and protect public
health by reducing the burden of adverse
drug reactions through effective
risk minimisation and optimising use
of medicines – maximise the benefit-risk
profile of medicines used in everyday
healthcare practice
Partners
• Patients and carers
• Healthcare
professionals
• Patient safety
organisations
• Pharmaceutical industry
• Medicines regulators
• Academics, scientific
community
• Payers
Pharmacovigilance and Risk
Management
• Collect and analyse data
• Detect and manage signals
• Evaluate safety issues
• Benefit risk assessment
• Regulatory action / risk minimisation
• Communication
• Audit – check that the measures are effective
Spectrum of Evidence Considered
• Meta-analysis
• Clinical trial
Variable degree of
certainty
(e.g. causality,
incidence)
• Prospective cohort (with
controls)
• Case control study
• Observational cohort (no
controls)
• Individual case report /
case series
Objectives of the Pharmacovigilance
Legislation
– Clear roles and responsibilities
– Better evidence, more science based
– Better link between assessments and regulatory
action
– Risk based/proportionate
– Increased proactivity/planning
– Reduced duplication/redundancy
– Integrate benefit and risk where appropriate
– Ensure robust and rapid EU decision-making
– Engage patients and healthcare professionals
– Increase transparency and accountability
– Provide better information on medicines
Pharmacovigilance – The EU Network
Lancet Publication – Dec 1961
Impact of Adverse Reactions
• 5% of hospital admissions are due to adverse
reactions
• 5% of hospital patients experience an adverse
reaction
• Adverse reactions are the 5th most common
cause of hospital death
• Estimated 197,000 deaths per year in EU from
adverse reactions
• EU Societal cost of ADRs Euro 79 Billion / year
Irish Experience
Irish Experience
• National Poisons Information Centre (NPIC) Beaumont Hospital
3 year prospective study - epidemiology/type of medication errors
• Results: 9.56% (2,348) - medication error
Children: non prescription meds i.e. anti-pyretics/ non-opioid analgesics/cough &
cold remedies
Adults: prescription medication, including antipyretics/neuroleptics/psychotropic
agents
97% = drug admin errors, 0.68% = prescribing errors, 2.26% = dispensing
errors
• Highlights the need for close collaboration between stakeholders to support
patient safety and reduce the occurrence of medication errors
Ref; Cassidy N et al; Clin Toxicol 2011 July;49(6):485-91
Preventable Adverse Drug Reactions
Literature suggests no common understanding of
the concept of preventability.
Harms from
• Medication errors?
• Intentional abuse or misuse?
• Intentional overdose?
• Unintended/occupational exposure?
• Drug quality problems?
Inconsistent use of terminology and different
perspectives .....unified by a common
risk management goal?
Guidance on Managing Risk of Medication Errors
National Medication Safety Forum
•
Commission on Patient Safety
and Quality Assurance (CPSQA)
established in January 2007, by
the Health Ministry.
•
CPSQA report ‘Building a Culture
of Patient Safety’ published in
July 2008.
•
Medication Safety Forum
established by Department of
Health and Health Information
Quality Authority as multiagency/stakeholder group to
explore medication safety issues
and report recommendations.
Methotrexate and Cases of Unintentional Overdose
due to Medication Error
Risk of Unintentional Overdose - methotrexate
Risk of unintentional Overdose - Methotrexate
Risk of unintentional overdose methotrexate
EU Perspective
Intravenous Paracetamol - Additional Risk
Minimisation Activities
National Dissemination of
Recommendations
Medication Errors due to Incorrect
Dosing
Advagraf/Prograf Medication Errors – Risk
Management
Errors occurred at various stages of the medication use process prescribing, dispensing and administration
Risk Minimisation Activities:
• DHPC to specialists, general practitioners and pharmacists
• Patient organisations
• Modified product information – Summary of Product Characteristics
(SmPC) and Package Leaflet (PL)
• Revision of labelling of the Advagraf outer-packaging – clearly states
‘Once Daily’
Pharmacovigilance Activities:
• specific targeted questionnaire to collect case information, continued
review in cumulative reviews and addressed in the RMP
High Strength Insulin Preparations
EMA Guidance
Regulatory Review
Effectiveness of Risk Minimisation
Measures
• What action needs to be taken?
• Clarity of the messages in the product information
• Is this sufficient to influence clinical actions?
• Limiting factor – message clarity or tools for delivery?
• How to improve accessibility of information?
• Is the risk sufficiently characterised to consider process
indicators as a reasonable proxy for outcome indicators?
• Fit for purpose PV plan to inform risk minimisation and to
avoid preventable harms
• What does success look like?
Conclusions
• Effective risk minimisation is a shared goal.
• Supporting the provision of the right drug, at the right dose, at the
right time, to the right patient, and with the right information and
monitoring
• Analysis and understanding of data collected is critical in defining
risk management strategies
• New legislation increases focus on real world use of the medicine
and preventing harms from medication errors, unintentional
overdose, misuse and abuse
• Challenges and opportunities for collaborations and synergies
• Continuous Pharmacovigilance required to ensure risk minimisation
relevant, effective and sustainable
‘Avoiding risk is impossible, but managing it is
critical to sustained success’
Thank You
Questions/Comments?
Further Information
•
EU Legislation:
-
Directive 2010/84/EU
-
Regulation (EU) No1235/2010
•
The legislation is accompanied by an implementing regulation:
•
Regulation (EU) No 520/2012
•
National legislation transposing the EU legislation published in the Irish Statute
Book:
•
SI 272 of 2012 (Medicinal Products (Control of Placing on the
Market)(Amendment) Regulations2012)
•
SI 273 of 2012 (Medicinal Products (Control of Manufacture)
(Amendment)Regulations 2012)
•
SI 274 of 2012 (Medicinal Products (Control of Wholesale
Distribution)(Amendment) Regulations 2012)