Roszdravnadzor passed to the updated base of pharmacovigilance. What waits for pharmaceutical company – opinion of the expert

2019

Transition to work in the updated Pharmacovigilance/monitoring of KI LS base

In the last week of summer Roszdravnadzor was sent to users of databases by Pharmacovigilance and Monitoring of KI LS of the letter on transition to work in the updated Pharmacovigilance/monitoring of KI LS base.

Since September 1, 2019 the possibility of introduction of new information to old databases was closed. The chief executive of Flex Databases and one of leaders in the country of specialists in pharmacovigilance Olga Loginovskaya told on September 3, 2019, than the updated base differs from old and what to do to those who did not manage to be prepared for transition to the updated format.

Work on updating of base took about a year and demanded a large number of resources — from creation of technical specifications which specialists of Roszdravnadzor carefully thought over and transferred to developers, before multistage final testing in which not only developers and the staff of Roszdravnadzor, but also representatives of the industry took part.

According to Olga Loginovskaya, the updated base represents cardinally a different approach to data collection, it is a professional system which can accept XML files in E2B R3 format. With transition to this Russia format becomes in one row and even advances in something the advanced countries of Europe, Australia, the USA, etc. Now collecting of messages about undesirable reactions will become more modern: electronic and fast.

At the same time, together with electronic submission of information also manual entry for the companies which cannot support the high level of work with the electronic systems remains. But the leading players of pharmaceutical industry making precise strategic plans for the future taking into account need for a didzhitalization and process automation, as a rule, passed to electronic giving, the expert noted.

After the regulator took serious steps for automation of pharmacovigilance, in the market offers of the electronic systems which look attractively, especially that seem simple in use began to appear. Actually, at the enterprises it is often heavy to users of a system to estimate their technical characteristics and to notice that they do not correspond to regulyation, to be exact, are created not according to the E2B format. Creation of a system on regulyation, with unloading and other necessary minimum implemented by the browser MedDRA, XML is the large-scale development requiring professional examination in IT and work experience in the international pharmacovigilance. Beginners cannot consider all nuances of such difficult process as pharmacovigilance, and the holder of the registration certificate who decided to begin work with such system will inevitably face problems which can be avoided, selecting the provider of an electronic system having considerable experience in the market — Olga Loginovskaya noted.

According to her, validation of the computerized systems in the pharmaceutical industry — a subject which is owned by not all providers of electronic products at the same time they are often let out by those who never faced before and did not work in the pharmaceutical industry. Many new providers advertize interesting price offers, but the total price of a product is many times higher initially stated as acquires additional "options" in the course of work.

Such large-scale and difficult project as mass transfer of the industry to the updated base cannot pass without roughnesses, and in certain cases, serious problems. The most serious problems which can wait for holders of registration certificates is problems with the statement of cases on pharmacovigilance, terms, quality and null information that, finally, will result in unsatisfactory results of inspection of Roszdravnadzor, first of which are expected within the next one and a half years — Olga Loginovskaya added.

Implementation of AI a system on pharmacovigilance

On April 16, 2019 the St. Petersburg IT company Flex Databases announced use of artificial intelligence in a system on pharmacovigilance. The self-training neuronet which developers named Ania looks for signals on security of medicines on the basis of an array of messages about undesirable reactions, is engaged in automatic coding of medical terms according to the MedDRA dictionary and detection of duplicates of messages about undesirable reactions. Ania is capable to process artificial intelligence in 30 seconds prior to hundred thousand messages about undesirable reactions. Read more here.