Exception Events Overview

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Gwendolyn Lynch
5 years ago
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1 Alerts 17 Jan 2019

2 Objectives What is SecurMed UK? We are the UK Medicines Verification Organisation (UK MVO). We are a non-profit set up by industry stakeholders to deliver the UK Medicines Verification System (UK MVS). The objective of this presentation is to provide summary level information to enable decisions to be taken around changes to business processes. Disclaimer: The picture regarding Alerts is developing and SecurMed does not warrant that this information is or will remain accurate in all details.

Exception Events Overview NMVS Success Green Proceed Derived Status Pack Dataset Product Code (GTIN) Lot (Batch) Number Product Status Batch Status Exception Message (L1-4

3 Exception Events Overview NMVS Success Green Proceed Derived Status Pack Dataset Product Code (GTIN) Lot (Batch) Number Product Status Batch Status Exception Message (L1-4 Process Exceptions) Grey Message For Information, operator action Expiry Date Serialisation Number Pack Status Process Factors Alerts (L5 Process Exception) Red Intervention Required

4 How it works - Status Model The system performs the checks in order

5 Alert Handling and Escalations Overview Pharmacy Reporting Alert Message NCAs Confirmed Falsification End user NMVO EMVO OBP MAH Exception Handling Screening out technical Issues with: a) Repositories System, b) Data, c) End-user/Software Issues Investigation & Confirmation Process Start: L5 Process Exception in NMVS Alert Message End-user System Alert Message NMVS Alert Message EMVS Alert Message OBP System Quarantine Pack

6 How it works Simple Cases PC LOT EXP SN Case Active Active Correct Active Success Active Active Expired N/A Batch expired, follow current procedure Active Recalled N/A N/A Batch recalled, follow current procedure Withdrawn N/A N/A N/A Product withdrawn, follow current procedure All four data-points okay GREEN Batch Recalled or Batch Expired - RED Product Withdrawn - RED

7 How it works Data & Process Exceptions PC LOT EXP SN Case Unknown N/A N/A N/A PC is not found in the entire EMVS Active Not Found N/A N/A LOT is not found Active Active Different N/A EXP in query differs from NMVS data Active Different Correct Active LOT does not match SN Active Active Correct Inactive SN is inactive Active Active Correct Unknown SN is unknown Product Not Found RED (See later) Batch Number not found, mismatch or Batch Expiry mismatch - RED Serial number Not Found, Inactive RED

8 How it works Alert Return Codes Code Description Transaction type NMVS_NC_PC_01 Unknown product code V, D, U NMVS_FE_LOT_03 Failed to find a batch for the given data V, D, U NMVS_FE_LOT_12 Expiry date does not match the date held in the NMVS V, D, U NMVS-FE_LOT_13 The batch ID does not match the serial number in the NMVS V, D, U NMVS_NC_PCK_22 Pack is already inactive D NMVS_NC_PCK_19 Property is already set on pack 1 D NMVS_NC_PC_02 Unknown serial number V, D, U NMVS_NC_PCK_06 Actual pack status doesn't match the undo transaction (set U and undo status must be equivalent) NMVS_NC_PCK_20 Defined timeframe between setting this property and the U undo was exceeded 1 NMVS_NC_PCK_21 Undo can only be executed by the same user who previously set the attribute 1 U 1 Alert generated only as a result of an inter-market transaction. If the pack data is available in the respective NMVS, an alert will not be generated. Process Issues: Double Dispense (>5), Using the wrong Undo transaction, etc., New code added to list: NMVS_NC_PCK_27 1 Also IMT related (and analogous to NMVS_NC_PC_06) Key: V = Verify D = Do (Dispense etc) U = Undo (Dispense etc)

9 UK Government Consultation FMD Consultation Outcome: there will likely be a large proportion of medicines that will pass through the system in the initial period following implementation which may be in scope of the new requirements but may not yet exhibit the new packaging, and it will not be immediately obvious to those asked to scan these products whether they should be scanned or not; i.e. were they placed on the market before or after 9 February In such circumstances it is crucial to prevent unnecessary disruption to the supply of medicines, and we would expect organisations to have clear operating procedures in place, and to empower individuals to make judgment calls that they would feel able to justify. The Government is aware that various stakeholders are producing sector-specific guidance on this important issue for a variety of audiences. See next page There are likely to be many Alerts of the types Unknown Product Code and Batch Not Found initially due to ongoing use of non-fmd packs and delays in loading of data Note: In some EU countries the NMVOs have agreed with the NCA to have a soft launch of the system meaning that Product code unknown alerts will not be considered potential falsifications. During this soft launch the system will be monitored and corrective actions, if required, will be performed.

10 What to do in case of receiving an Alert Community Pharmacy Draft Guidance

National Medicine Verification System SecurMed UK Technical Workshop Meeting

ARVATO SYSTEMS National Medicine Verification System SecurMed UK Technical Workshop Meeting Darius Kubarth NMVS UK Project Manager London, 28th September 2017 Schedule Time Planning, High Level Perspective