150129 APEC Clark SPOCs

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.

Content
1. Practicalities: appointment, nomination
2. Information sharing between SPOCs
3. Risk communication

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

Context for SPOC appointment
…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

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)

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

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

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

information through SPOCs (network)
Rapid Alert : suspect medical product
Example: form PIC/S (Pharmaceutical Inspection
Convention Pharmaceutical Inspection Cooperation
Scheme)

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)

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:

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)

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)

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…

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?

Goal = rating the health risk
e.g. risk mild / moderate / severe
Guidance for SPOCs for how to handle similar
cases reoccuring

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

Thank you
for your attention
European Directorate
for the Quality of Medicines
& HealthCare (EDQM)

150129 APEC Clark SPOCs

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