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150129 APEC Clark SPOCs

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150129 APEC Clark SPOCs

  1. 1. APEC LSIF training program on Medical Products Integrity and Supply Chain Security: Establishment of global SPOC Systems 29 January 2015 François-Xavier Lery, EDQM/Council of Europe Practical tools and approaches for SPOCs François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  2. 2. Content 1. Practicalities: appointment, nomination 2. Information sharing between SPOCs 3. Risk communication François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  3. 3. Practicalities of establishment of SPOC network • Competent authorities (1 State): identification & nomination of SPOCs; 1 National SPOC • Network (directory of contact details SPOCs): administration & maintenance, confidentiality, updates • Support tools (SPOC): • Form/data base information exchange among SPOCs/ periodical reports • health risk evaluation procedure (suspect product) • risk communication procedure – awareness campaigns or about a concrete case François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  4. 4. Context for SPOC appointment François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved. …Combatting organised crimes requires: • appropriate powers • responsibility (data confidentiality) • security of SPOCs (national /regional network) • availability: 24/7/365 • access to information/ data (analyses, data bases systematic collection, exchange, sharing of information) Major role in reduction of health risks; involvement in investigation & judicial procedures
  5. 5. SPOC Nomination • By Ministries or Heads of Directorates or Agencies: • Fields: • Regulation for Pharmaceuticals • Official Medicines Control Laboratories • Police/ Gendarmerie • Customs (officials only) Note: Industry = reference /contact for support upon request from authorities (case by case) • Nomination Letter: to be issued by senior official • SPOC & deputy SPOC (1 per competent authority) • 1 National SPOC (international cooperation; link with national network of SPOC authorities) François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  6. 6. Profile of Nominees • Depends on job duties/functions of post held (officials involved in investigations; operational management of cases of crimes affecting medical products) • Professional experience • Contact details of deputy needed • Agreement to share SPOCs contact details with other SPOC nominees • Nomination letter duly signed (original) by Director / Head of Agency • Validity period (unlimited or limited or linked to post) of nomination François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  7. 7. Nomination • Should authorise to make information available within national network of SPOCs (administrative procedure) • SPOCs should be warned about risks and consequences of non-authorised use of information that should stay within the SPOCs network, or negligent handling of information shared through the network François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  8. 8. Content 1. Practicalities: appointment, nomination 2. Information sharing between SPOCs 3. Risk communication François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  9. 9. Receiving & signal handling/collecting information through SPOCs network 1. Signals: handling – see SPOCs toolkit 2. Rapid Alert : suspect medical product Form PIC/S (Pharmaceutical Inspection Convention Pharmaceutical Inspection Cooperation Scheme) Health risk evaluation Communication (professionals / public) 3. Closed cases: Periodic trend analyses (data/signals, reports, results of preventive /coercive measures) - databases e.g. EDQM’s KnowX or other international organisations 4. Feed-back François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  10. 10. Receiving & signal handling/collecting information through SPOCs (network) Rapid Alert : suspect medical product Example: form PIC/S (Pharmaceutical Inspection Convention Pharmaceutical Inspection Cooperation Scheme) François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  11. 11. François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  12. 12. François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  13. 13. Receiving & signal handling/collecting information through SPOC network Closed case (no Rapid Alert): Periodic trend analyses (data/signals, reports, results of preventive /coercive measures) - databases e.g. EDQM’s KnowX or other international organisations • Medical product description (genuine) – suspect or confirmed falsified (counterfeit) • Licence holder/Producer/Importer • Modus operandi (criminal activity/alteration) • Distribution path (country of origin-transit-destination) • Conditions of seizure • Signal of harm (suspected/confirmed) • Laboratory results (EDQM/OMCL Network: > 1600 test reports) François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  14. 14. SPOC to liaise with Official Medicines Control or Reference Laboratories for analytical testing In Europe, coordinated by EDQM/Council of Europe SPOC health authorities: evaluation and risk communication SPOC customs authorities: circumstances of seizure, distribution path… SPOC police/gendarmerie authorities: modus operandi, criminal organisation, investigation (Industry contact: support for risk management) Analyse of closed case by SPOCs: François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  15. 15. Content 1. Practicalities: appointment, nomination 2. Information sharing between SPOCs 3. Risk communication François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  16. 16. Risk communication should be based on risk evaluation • On-going work of Committee of Experts on Minimising public health risks posed by counterfeit medical products & similar crimes (expert & policy- making levels): CD-P-PH/CMED (EDQM secretariat) • Procedure for health risk evaluation (suspect product ) • Procedure for risk communication (courtesy of Ruth Mosimann / Sabine Thomas – Swissmedic) François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  17. 17. Approach to evaluation of suspect products • If possible comparison with reference packaging materials • In any case look up at : • Dosage form • Primary and secondary packaging (appearance, print quality, colour, typographical errors…) • logo (falsified logos with graphical differences) • Product leaflet insert (eg paper sheet frequently too thick); • Safety features (eg seal) • expiry date • lot number (primary and secondary packaging) François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  18. 18. Approach to evaluation of suspect products Example of factors to be taken into account • Population of patients • children, elderly patients, large population (antibiotics, painkillers, creams...) • Indications • chronic diseases (hypertension, diabetes...) • Route of administration • subcutaneous, oral, injectable… François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  19. 19. Approach to evaluation of suspect products Example of factors to be taken into account Side effects • Severity: death or terminal illness, disease duration> 2 weeks, mild and reversible adverse reactions Category of medical product eg therapeutic index Origin of the medical product known? François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  20. 20. Approach to evaluation of suspect products Goal = rating the health risk e.g. risk mild / moderate / severe Guidance for SPOCs for how to handle similar cases reoccuring François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  21. 21. Risk evaluation should allow sound risk communication Reactive communication ( upon concrete case) and proactive communication (awareness of risk/ risk reducing behaviours): fundamentally different approaches & target audience What is needed for both types of communication: • establish procedures • have a strategy based on hard facts • define what to communicate and to whom François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.
  22. 22. Thank you for your attention European Directorate for the Quality of Medicines & HealthCare (EDQM) François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.

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