drug safety – ComFit Europe Ltd.

AUDIT LEARNINGS – Training of personnel involved in the literature reviewing process

ComFit Europe — Tue, 27 Nov 2018 16:32:19 +0000

At ComFit, we have been collecting the questions of audits and quality checks for years and turn them into sources of further developments as well as to make them a part of a check-list for the next milestone. We have decided to write a summary (travel book) on our experiences. We have started to line our audit questions with the applicable chapter of GVP (tour guide) and to think about the potential challenges in the answers.

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AUDIT LEARNINGS – Keeping track of the monitored journal list

Comfit Europe — Tue, 13 Nov 2018 16:30:14 +0000

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7 Questions + 7 Answers = A Brief Guide to an Effective Literature Monitoring System

Comfit Europe — Tue, 06 Nov 2018 17:24:54 +0000

As we reached the end of our series on questions and GVP references to build and effective literature system, we would like to provide an overview of the topics we touched upon in the last few weeks as a guide to the 7 steps to be successful in literature monitoring:

Firstly, we posted about WHERE to search for PV data. The common audit question we discussed in relation to that was: What’s your process for duplicate search? Follow the link for more details: https://comfiteurope.eu/literature-search-pv-data/

Second came WHAT to search FOR in literature. The related audit questions discussed were: What safety data are you searching for in literature? and What’s your indexing method? Or search terms? Find out details here: https://comfiteurope.eu/search-literature-terms-pharmacovigilance/

The third step would be to find out WHICH journals are RELEVANT to monitor. Here we answered to What is a “relevant” source? and Why is a journal out or in the monitored list?: https://comfiteurope.eu/journals-relevant-monitor-pharmacovigilance/

Next we looked at HOW to prove WHICH drugs have been monitored in a given period of time, providing strategies how to answer to challenges such as When and how did you communicate it to the service provider? and How can you prove that the service provider started monitoring?: https://comfiteurope.eu/prove-drugs-monitored-given-period-time/

Then we touched upon HOW to DOCUMENT successfully the literature monitoring activities. Here the most important audit questions to answer are What data are backed up? How often is back-up of critical data done?, Are records probably discarded according to retention rules when no longer needed for business, regulatory or other legal purposes?, How do you control access to archives? How is access authorised?, Are back-up servers located at a different location than the working servers? The details here: https://comfiteurope.eu/document-successfully-literature-monitoring-activities/

Strict timing is crucial in pharmacovigilance. Thus, the sixth step is to find out WHEN to carry out literature monitoring. In relation to that at audits one can be usually asked How can you check whether reviewing meets the timelines as outlined in the agreement? Find out our experience here: https://comfiteurope.eu/carry-literature-monitoring/

The last step we discussed was HOW to successfully SEARCH for PV data without missing anything. The challenges you would often face are: How do you make sure that indexes of the database match the Clients’ search terms, so there will be no loss? and How can you make sure that the medicinal products are indeed the ones specified in the agreement? For details go to: https://comfiteurope.eu/successfully-search-pv-data-without-missing-anything/

We believe that being able to answer to these 7 steps and challenges can form the basis of an effective, audit-proof literature monitoring system. Keep following our feed, as we will continue sharing with you our audit learnings and how we have answered well to common audit questions through our practice!

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HOW do you successfully SEARCH for PV data without missing anything?

Comfit Europe — Tue, 30 Oct 2018 16:30:02 +0000

As GVP is clear that there is “no acceptable loss” (VI.App.2.3.4.) regarding the collection of PV data, ensuring the most reliable search strategy to cover ALL possible challenges and being able to justify its methods is crucial for the functioning of a literature monitoring system. Monitoring professionals face numerous difficulties while looking for important information – from spelling variations of drugs through language differences in indexing to the “hidden” case information in pictures and diagrams. Thus, can you rely only on search engines to find all relevant terms without a potential loss? If you want to learn ComFit’s answer to these challenges and more, please refer to our answer below.

This post is the seventh and last in a series. We believe that answering basic questions on search in literature such as which drugs, when etc., can guide us in building an effective literature monitoring system in compliance with GVP. We zoomed into seven questions and shared our experience how we have successfully answered them at ComFit. Stay tuned for more interesting literature monitoring information coming soon!

ComFit’s answer to “How to search” challenges

In order to detect all PV relevant information and to manage different variants of terms in articles, our method of literature monitoring combines the knowledge of trained, medical professionals and a validated software with our clients’ requirements.

With our method, there is no need to specify different variants of search terms.

At ComFit, local medical professionals and pharmacists review the articles, because they are outstanding at understanding texts, and they never miss to index e.g. paclitaxel and lack of efficacy, no matter which spelling or terms are used. Their job is to build our literature database according to our standardised method of indexing and they record all substances and drug names from the articles, independently of who are ComFit’s clients. Our reviewers are not involved in searching and reporting to our clients as multiple variations of data are over the capacity of the human brain. It is a software that searches and reports in the indexed content by matching hundreds of search terms of clients with our database.

Our software is taught on our clients’ product portfolio and search terms such as special situations. We integrate their drugs into our product database. This product database is the basis of our reviewers’ indexing. The field of active substances and products are not open fields for reviewers, but they have to select among the terms in the database while indexing articles. The same is true for special situations, we have our database that backs up indexing and in this database we integrate our clients’ search terms.

Our standardisation method ensures you do not need to bother with different variants of your search terms.

To minimise the risk of any mistakes, there are cross checks built in our revieweing process. All articles are processed by three persons concomitantly and a software algorithm compares their decisions. Accordances, discrepancies and the solution to discrepancies are documented by our software.

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WHEN to carry out literature monitoring

Comfit Europe — Thu, 25 Oct 2018 15:57:31 +0000

One of the most challenging parts of reviewing is proving that the frequency and method of checking whether the literature monitoring activities are meeting the GVP timelines is efficient enough. Not only should you prove that you have covered ALL publications within a certain period of time without a miss, no matter if they have been published or delivered with delay, earlier or several simultaneously, but be able to provide proper explanation for any inconsistencies in publishing and when and how you have tracked them. If you want to find out more details on those challenges and how we answer to them in our ComFit software, please refer to the schemes we have prepared below:

This post is the sixth in a series. We believe that answering basic questions on search in literature such as which drugs, when etc., can guide us in building an effective literature monitoring system in compliance with GVP. We are going to zoom into seven questions and share our experience how we have successfully answered them at ComFit. Stay tuned!

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HOW do you DOCUMENT successfully the literature monitoring activities?

Comfit Europe — Wed, 24 Oct 2018 15:30:05 +0000

The GVP dictates that detailed documentation and record keeping for extended period of time is crucial for proving that the literature monitoring process for collecting adverse drug events and special situations is being carried out in a systematic, well structured and reliable manner. A successful documentation system can easily and clearly answer who, what, when, where and how in regards to the personnel involved and the way of conduct of literature search, as well as to data collection, storing and back-up. If you want to find out how we have effectively covered these points through our ComFit database management system, please refer to the schemes we have prepared below.

This post is the fifth in a series. We believe that answering basic questions on search in literature such as which drugs, when etc., can guide us in building an effective literature monitoring system in compliance with GVP. We are going to zoom into seven questions and share our experience how we have successfully answered them at ComFit. Stay tuned!

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Consultation about the recommended Hungarian local medical literature list (PV Conference by HURAS – 17th Oct 2018)

Comfit Europe — Thu, 18 Oct 2018 14:55:18 +0000

At the conference on 17th October 2018, organized by the Hungarian Regulatory Affairs Society (HURAS), the CEO of ComFit Europe Ltd., Katalin Timár-Horváth gave a presentation on the recommended list of local medical and scientific literature in Hungary. The recommendation list is under updating on the request of HURAS, by a working group of 6 literature monitoring experts in Hungary, led by Katalin Timár-Horváth.
The aim of the presentation was to reveal to the members of HURAS that forming the list of local medical journals relevant from pharmacovigilance point of view is challenging because there are journals on the threshold of being relevant or not. The literature list revision working group raised several aspects to consider and asked the opinion of PV professionals attending the yearly PV conference of HURAS. A lively dialogue was set off between around 100 pharmacovigilance professionals. The following aspects were raised: Can serious difficulties of certain journal’s procurement be an exclusion aspect? Does unpredictable periodicity matter in the decision to monitor a medical journal or not? Can we exclude journals targeted at doctors which do not have in focus to publish cases, but they publish some from time to time?

After a spirited discussion, a majority, though slight, of the attendees of the pharmacovigilance conference decided not to consider any of these aspects at forming the list of recommended journals except for being targeted at medical professionals. At the end there are 69+38 journals on the list with the purpose of pharmacovigilance.

The recommended list of local medical and scientific literature was born under the guidance of HURAS in 2012 and updated ever since with the participation of the same experts. Uniquely in the region, this recommended list is approved by the Hungarian Medicines Agency.

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HOW do you prove WHICH drugs have been monitored in a given period of time?

Comfit Europe — Tue, 16 Oct 2018 15:30:23 +0000

According to GVP “The marketing authorisation holder has an obligation to review… in the period between the submission of the marketing authorisation application and the granting of the marketing authorisation.” (VI.App.2.1.)

While the starting date of monitoring of drugs is something pharma companies agree on, most of them have different interpretation and practices regarding the end date. At audits they must be able to answer how they communicate changes in monitoring periods of drugs to their literature monitoring service provider and prove that the service provider has been following the respective drug in the necessary period of time. If you want to find out how at ComFit we meet all of our clients’ expectations in documenting the monitoring period of each drug in our system with an audit trail, please refer to the schemes we have prepared below.

This post is the fourth in a series. We believe that answering basic questions on search in literature such as which drugs, when etc., can guide us in building an effective literature monitoring system in compliance with GVP. We are going to zoom into seven questions and share our experience how we have successfully answered them at ComFit. Stay tuned!

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WHICH journals are RELEVANT to monitor for pharmacovigilance?

Comfit Europe — Thu, 11 Oct 2018 16:26:56 +0000

GVP says “The marketing authorisation holder should establish the most relevant source of published literature for each product.” (VI. App 2.2. Where to look).

How do we define what a ‘relevant source’ is? It is an open question because authorities do not specify the sources to be monitored and they do not give the definition of relevance either. It is left for MAHs to decide what ‘relevant’ means and which journals stand for it. But be careful how you answer the question! The most frequently applied principles are not in compliance with GVP. If you would like to read more on selection principle for journals, please refer to the schemes we have prepared below.

This post is the third in a series. We believe that answering basic questions on search in literature such as which drugs, when etc., can guide us in building an effective literature monitoring system in compliance with GVP. We are going to zoom into seven questions and share our experience how we have successfully answered them at ComFit. Stay tuned!

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If literature, WHERE to search PV data?

Comfit Europe — Tue, 09 Oct 2018 14:51:36 +0000

As for literature, GVP says “It is best practice to have selected one or more databases.” (VI. App 2.2. Where to look) It mentions the need to monitor reference databases, local journals and to be attentive to find PV related data in lay and digital media. The challenge in answering the question where to search is how to eliminate duplicates. The same cases coming from different literature sources have to be screened in order to prevent duplicate submissions and double work.

This post is the second in a series. We believe that answering basic questions on search in literature such as what for, which drugs, when etc., can guide us in building an effective literature monitoring system in compliance with GVP. We are going to zoom into seven questions and share our experience how we have successfully answered them at ComFit. Stay tuned!

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