AMS - Summary of webinars

Alert management system - news as of September 30, 2021

 

During August and September 2021, NOOL organized several webinars on the benefits of NOOL's Alert Management System (AMS) for Marketing Authorization Holders (MAHs) as well as for end-users (pharmacists and distributors) and IT companies providing software to NSOL end-users. An abbreviated summary of the news can be found in the following text. Records and presentations of all webinars * are available on request at registration@czmvo.cz.

Complete information on AMS and user manuals are published on the NOOL website: www.czmvo.cz

 * webinar for pharmacists was organized by ČLnK; record only on request there.

 

New functionalities in AMS NOOL - Release R4.0

The implementation into the Production Environment took place on September 3, 2021.

Since the end of August 2021, intensive communication has been taking place with SW providers, MAH and pharmacists.

Newly occurred:

  • reworking of the process workflow of the entire AMS NOOL,
  • addition of the “pre-analysis of the alert” phase, when individual AMS NOOL alerts are assessed and supplemented with identification of whether they are alerts created directly at the MAH/OBP or parallel distributor, or if they are so-called intermarket operations; it shall also be assessed whether an exemption has been granted for the product in accordance with Section 11r ZoL; at the same time, possible technical/process errors of the end user are assessed,
  • modifications to the system for logging changes in alerts,
  • addition of communication functionalities with NOOL via "chat" in AMS NOOL,
  • adjustments to notifications and notifications of inactivity of individual entities in dealing with alerts,
  • the possibility to reopen an already closed alert if a significant reason for reopening the alert is identified,
  • other minor adjustments.

A complete description and explanation of the operation of AMS can be found on the NOOL website in the section of alert management in individual sections according to the role of the subject in NSOL; here:

https://www.czmvo.cz/en/alert-management/

 

Trend in the number and closing of alerts

There is a constant decrease in the number of alerts. Currently, the rate of alerts (net data) is around 0.01–0.02%.

The obligation to investigate and close all alerts applies.

NOOL focuses on alerts that are not closed and contacts companies (MAH and end-users) that do not deal with alert handling. Inactivity of MAH and end-users is always reported after 30 days to SÚKL. MAHs with alerts waiting for end-user explanation will be removed.

 

Status of alerts in 2021 in 1. — 8. month: not closed 97,014 alerts (ie. 9.19%). Since May 2021, there has been a significant extension of the solution time and the closing of alerts (a total of 3.5 times).

  • 2% closed alerts are resolved within 14 days.
  • Inactive MAHs are notified after 7 days, the second warning is sent after 10 days.
  • Notifications of inactivity of end users (pharmacists, distributors) are also triggered two and five days after the request for information or photos.

 

Other functionalities in preparation - continuous implementation; R5.0 (02/2022) could include:

  • Investigation of exceptions via API communication with NSOL, downloading reports directly to AMS from NSOL (October–November 2021).
  • Records – in the registration database during verification for another entity (see agreement with SÚKL).
  • Redesign – a quick overview (dashboard) of the status of user alerts.
  • Alert A1 investigation and other possible functionalities.

 

National medicines verification system

NSOL – R9.0 version is being prepared and tested; it will be put into operation on October 24th, 2021 from 8.00 pm, ie. at the time when the modification will not interfere with the daily medicines verification. IQE is fully available from August 25th.

At the same time, API 1.5 support is being discontinued, making it impossible for end users to connect. End users (their IT providers) still using this no longer supported version were contacted and invited to upgrade the API.

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