Haemovigilance

1
Haemovigilance The Role of the Irish Medicines
Board (IMB)

HV Handbook Workshop 06/06/07
Niamh Arthur, Pharmacovigilance Manager Paddy
Costello, Blood Tissues Manager
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Presentation Topics

• IMB background
• Overall IMB role/responsibilities
• Legislative background
• The IMBs haemovigilance obligations
• - SAEs/SARs
• - Blood-derived medicinal products
• - Inspection activities
• The inspection process

3
IMB - Background

• IMB established 1995 IMB Act (no.29 of 1995)
• (formerly the National Drugs Advisory Board
  1966)
• Independent agency
• Mainly self-financing
• IMB Mission
• To protect and enhance public and animal
  health through the regulation of medicines,
  medical devices and healthcare products

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IMB Role/Responsibilities

• Competent Authority for human/veterinary
  medicines, including
• - Assessment licensing of applications
• - Licensing inspection of manufacturers of
  human/veterinary medicines
• - Licensing inspection of wholesalers of
  human medicines
• - Export certification
• - Pharmacovigilance
• Competent Authority for Traditional Herbal
  Medicines
• Competent Authority for Medical Devices
• Competent Authority for Tissues and Cells
• Competent Authority for Blood Blood Components

5
Legislative Background

• EU
• Directives 2001/83, as amended by
  2004/27(Pharmaceuticals)
• 2001/20 (Clinical Trials)
• 2002/98 2004/33/EC (Blood Blood
  Components)
• 2004/23 (Tissues Cells)
• 2004/27 (Traditional Herbal Medicines)
• Regulations 2309/93
• 540/95 541/95
• 726/2004
• National IMB ACTs
• S.I. 190 of 2004
• S.I. 360 of 2005, S.I. 547 of 2006 S.I. 562
  of 2006
• S.I 158 of 2006

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Legal Framework Blood/Blood Components

• Directive 2002/98/EC
• (transposed into national law by SI 360 of 2005)
• Technical Directives
• Directive 2004/33/EC
• Directive 2005/61/EC
• (transposed into national law by SI 547 of 2006)
  
• Directive 2005/62/EC
• (transposed into national law by SI 562 of 2006)

• Setting standards of quality and safety for the
  collection testing, processing, storage and
  distribution of human blood and blood components,
  amending Directive 2001/83/EC
• Implementing Directive 2002/98/EC as regards
  certain technical requirements for blood and
  blood components
• Implementing Directive 2002/98/EC as regards
  traceability requirements and notification of
  serious adverse reactions and events
• Implementing Directive 2002/98/EC as regards
  community standards and specifications relating
  to a quality system for blood establishments

7
Legal Framework Blood/Blood Components

• S.I. 360 of 2005
• - Designates IMB as the competent authority (CA)
  in the State, for the purposes of the Directive
• - Provides for IBTS/NHO to each render to the
  IMB such assistance as the IMB may reasonably
  require, for the purposes of assisting the IMB to
  perform its functions under these Regulations
• - Allows for the IMB to enter into contractual
  arrangements for the purposes of provision of
  assistance in relation to its functions

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IMB Obligations

• Blood Establishments
• - Inspect and authorise Blood Establishments
• - Ensure availability of quality systems
• Blood Banks
• - Ensure that Blood Banks implement a quality
  system ISO 15189 by 8th Nov 2008 (SI 360 of
  2005)
• - Conduct inspections of Blood Banks, as
  appropriate
• Haemovigilance
• - Interact with NHO on SAR/SAE reporting
• - Ensure compliance with reporting requirements
• - Maintain records of information as specified
  in S.I. 360 of 2005
• - Submit relevant reports to the EU Commission
• - Notify EU Commission wrt specific
  epidemiological situations
• - Interact with other competent authorities

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Haemovigilance RequirementsBlood Establishments

• Requirements
• (with regard to collecting, testing, processing,
  storage, and distribution)
• Maintain a quality system based on the
  requirements of Directive 2002/98/EC and best
  international guidance
• Notify the CA of any Serious Adverse Reactions
  (SARs) and Serious Adverse Events (SAEs)
• Maintain records to ensure full traceability from
  donation to recipient for not less than 30 years
  (this includes imports from third countries)
• Ensure that donors of blood and blood components
  comply with the regulatory requirements

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Haemovigilance RequirementsBlood Banks

• Requirements
• (with regard to storage, distribution and
  compatibility testing)
• Maintain a quality system based on the
  requirements of Directive 2002/98/EC and operate
  to ISO 15189 standard by 08/11/08
• Notify the CA of any Serious Adverse Reactions
  (SARs) and Serious Adverse Events (SAEs)
• Maintain records to ensure full traceability from
  donation to the point of delivery for not less
  than 30 years
• (this includes imports from third countries)

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IMB/NHO Interaction

• In accordance with S.I. 547 of 2006, a reporting
  establishment shall be deemed to have complied
  with its legal requirements if all relevant
  information relating to SARs and SAEs is reported
  to the NHO
• Procedures and formats for the onward reporting
  of this information to the IMB are in place and
  will be further formalised with the NHO and IBTS
• The IMB and NHO will continue to meet regularly
  to discuss cumulative data and reporting trends
• Annual Report notification
• Guideline development, i.e. the Haemovigilance
  Handbook

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The Role of the IMB in relation to Medicines

• Competent Authority for Medicinal Products
• - Includes blood-derived medicinal products,
  e.g. Anti-D, factor concentrates Octaplas
• - Fall within pharmaceuticals legislation and
  reporting requirements for medicines apply in
  respect of suspected adverse reactions, in
  addition to NHO requirements

13
IMB Interaction with Stakeholders

• Via the Steering Committee established by DoHC to
  assist with implementation of the legislation
• - Interaction on draft legislation
• - Contribution to workshops/training
• - Identification of requirements to facilitate
  inspection of Blood Banks
• - Contribution to INAB expert group, as the
  accrediting body for ISO 15189, agreed as the
  appropriate quality system for Blood Banks

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The IMB and the Irish National Accreditation
Board (INAB)

• Expert Group on Blood and Blood Components
  Established
• - based on Steering Committee recommendation
  
• - included relevant experts, associations,
  IMB and INAB
• INAB is the accrediting body for ISO 15189 in
  Ireland
• Guidance document compiled by Expert Group
• Minimum requirements for Blood Bank
  Compliance with Article 14 (Traceability) and
  Article 15 (Notification of Serious Adverse
  Reactions and Events) of EU Directive 2002/98/EC
• Hospital Blood Banks are required to apply to
  INAB for accreditation and to undergo an
  assessment process

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Summary

• The IMBs role as Competent Authority is clearly
  designated in national law
• Reporting requirements for haemovigilance staff,
  as specified in the handbook apply, with NHO
  continuing in its primary role of collection,
  collation and evaluation of haemovigilance
  reports
• Development of further procedures to facilitate
  reporting between NHO/IBTS and IMB underway

16

• Process for Inspections
• Dr. Paddy Costello,
• Blood Tissues Manager.

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Regulations for Hospital Blood Banks

• 2002/98/EC
• Articles 7, 10, 11(1), 12(1), 14, 15, 22, 24
• Article 7 Provisions for existing
  establishments
• Article 10 Personnel
• Article 11(1) Quality System
• Article 12(1) Documentation
• Article 14 Traceability
• Article 15 Notification of Serious Adverse
  Events and Reactions
• Article 22 Storage, transport and distribution
  conditions
• Article 24 Data protection and confidentiality

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National Regulations for Hospital Blood Banks

• S.I. 360 of 2005
• Regulations 11, 12 13
• Regulation 11
• Hospital Blood Bank Requirements
• Specifies person responsible for management of a
  hospital blood bank
• Covers the requirements of the Articles
  applicable to Hospital Blood Banks in 2002/98/EC

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National Requirements for Inspection

• S.I. 360 of 2005
• 16(5) The IMB may inspect hospital blood banks
  with a view to ensuring that
• a) hospital blood banks and persons responsible
  for the management of hospital blood banks comply
  with the requirements of these Regulations
• b) problems relating to compliance with those
  requirements are identified and
• c) not later than 8 November 2008, the hospital
  blood banks operate to International Standard ISO
  15189 of the International Organisation for
  Standardisation

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National Requirements for Inspection

• S.I. 360 of 2005
• 16. (6) The IMB may also serve a notice on the
  person responsible for managing a hospital blood
  bank requiring that the person furnish the IMB
  with such information concerning the compliance
  of the blood bank with these Regulations as shall
  be specified in the notice within such period as
  shall be specified in the notice.
• (7) Any person responsible for management of a
  hospital blood bank who receives a request for
  information in accordance with paragraph (6)
  shall provide the information requested within
  the period specified in the notice.
• (8) In the event of any serious adverse event or
  any serious adverse reaction or suspicion
  thereof, the IMB shall request such information
  or conduct such inspections in accordance with
  this Regulation as it shall consider appropriate.

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Inspection

• On foot of information received
• Lack of reporting

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Inspection Process

• Overview
• Inspection Organised
• Inspection Carried Out
• Deficiencies Identified, if any
• Report written and sent
• Responses Submitted to IMB and Reviewed
• Corrective Actions Put in Place
• Further Inspections and Responses Required
• Close out of Inspection Process

23
Inspection Process

• Notification sent to Contact Person 3-4 weeks
  prior to Inspection
• Inspection may have to be conducted more quickly
  on foot of information provided.
• Unannounced inspections if needed

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Inspection Process

• Notification of what is required
• Includes
• - Organisation Chart
• - List of all personnel employed in
• blood establishment/blood bank
• - Job Descriptions of Key Personnel
• - List of SOPs
• - List of Deviations/Non-Conformances
• - List of Complaints
• - List of SAE / SAR

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Inspection Process

• Preparation
• Opening Meeting
• Departmental visit, staff interviews, document
  review
• Closing Meeting
• Issue of post inspection report, containing list
  of deficiencies, if any
• Review of responses and time frames
• Next step in process

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Inspection Process

• Opening Meeting
• Opening meeting by inspector
• Introduce inspection team
• Information gathering
• Plan for inspection
• BE/BB can present overview of activities
• Opportunities to ask questions

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Inspection Process

• Actual Inspection
• Obtaining information
• Witness tasks being performed
• Review documented procedures/charts
• AML-BB document
• Asking questions Who? What? When? Where?
• Investigating issues Why?
• Open exchange

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Inspection Process

• Closing Meeting
• Closing meeting by inspector
• Presentation of findings
• Opportunity for BE/BB to provide further
  information
• Acceptance of findings
• Notification of next steps

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Questions