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Order with data in pharmacovigilance. Is it possible?

26.02.2021
Порядок з даними в фармаконагляді

Pharmacovigilance as a working monitoring system has recently appeared in Ukraine, and immediately felt a crazy information load:

  • Saving information about each medicines of the pharmaceutical company or the applicant, prompt changes;
  • Obtaining and structuring data on adverse reactions and / or lack of efficacy from physicians, health care providers and patients;
  • Systematic search and storage of valid information about adverse reactions in the literature;
  • Receipt and exchange of adverse reactions with the regulator;
  • Timely submission of drug reports;
  • Follow the instructions.

 

And this is not all the information that need to be tracked and structured.

Trends in the development of society in the information sphere are rapidly spreading around the world. In 2002, humanity received information 18… 108 bytes (18 Exabytes). Over the past five years, humanity has created more information than in all previous history.

As a result, a pharmacovigilance manager who lives and works in the vastness of information is inevitably affected by the information explosion.

 

 

The information explosion is a rapid increase in the number of publications and the amount of data, which leads to information overload, slowing down and complicating the information management process.

We are not able to predict how much information and what medicines will come to us tomorrow. The epidemic has confirmed that anything can be expected, anytime. And we must be ready for this now.

Also, don’t forget that pharmacovigilance is expert work that is regularly subject to inspections and audits, which are not ready to wait until you deal with the information. Adding fuel to the fire is the fact that in 2021 the first official inspections of the regulator will start.

 

 

The expert should check how correctly the work on systematization and organization of pharmacovigilance data is organized.

That is why attempts to stay in the house with electronic folders and Excel spreadsheets are doomed. Sooner or later there will be a moment of information explosion in every system.

Now you will not find an accountant who would not use systems like 1C accounting in their professional activities. And 15 years ago it was perceived as a fad for a specialist.

 

The market is developing and we are with it.

 

Now it offers digital solutions for pharmacovigilance.

What is the situation with professional digital platforms in the pharmacovigilance market?

Let’s take a closer look at the main ones.

Let’s start with the divisions of the world’s digital giants, such as Oracle and SAP.

For example, “Oracle health sciences”

 

 

The platform enters the orbit of Oracle products, which is a guarantee of data protection and security when using them. The information is stored in the company’s secure cloud storage.

 

Of the minuses: the company declares the same interface and functionality, each additional module with options is purchased separately. A technician is usually required to service the system. The cost of such a platform is hundreds of thousands of euros.

The next category of European developers “Extedo SafetyEasy”

 

 

The platform was created by a German developer of digital products for the pharmacovigilance system. It systematizes information about side effects by storing data in its cloud storage. Additionally, the service of informing about reporting and creating document templates in a separate system configuration can be provided. The cost of installing a basic kit with annual support will cost about hundreds of thousands of euros per user. And how many accounts do you need to provide for your pharmacovigilance department?)

Progress does not stand still. Ukrainian developers, who have repeatedly proved that they are ready to join the successful competition in digital products, have also launched their pharmacovigilance platforms. Some of them are professionals in the technical field, who decided to create a product for the pharmacological market, gaining experience from colleagues. Others seek to improve their work process by purchasing a foreign base and adapting it to “their” needs. The most promising companies have a team of pharmacological industry experts, technical specialists and internal clients who develop the most technological, intuitive “friendly” platform.

There are currently 3 groups of Ukrainian developers of such systems.

 

«DS Data Base»

Developed more than 3 years ago.

Offer their customers a drug card, the ability to exchange side effects with the SEC regulator. As with European developers, their main function is to enter and store data in the system. Despite the fact that the platform is 3 years old, it has relatively recently switched to cloud technology.

Position themselves as partners of the SEC. But is this a plus for the user? And can the system associated with government agencies change for the needs of the user, responding quickly to his needs?

At the same time, the pricing policy of the product, which is a hundred times cheaper than the described foreign counterparts, can pleasantly surprise the consumer.

 

“Drug card”

 

 

They offer a user-friendly interface and a drug card. The system has a new and important for pharmacovigilance function “automated literature search”, which aims to turn the routine work of finding new information about the drug in the literature, into an easy automated process.

 

The developer, which specializes exclusively in information technology, entered the pharmaceutical market with its offer only in December 2020, and currently there are no real reviews from pharmacovigilance experts on the safety and ease of use of the platform.

The pricing policy of the platform is quite close to the previous Ukrainian developer.

To provide you with complete information for selection, we have included our database for comparison.

The digital pharmacovigilance platform was created by our company as an integral tool in the work of our experts.

Thanks to our internal customers, the development team was able to combine a high level of data security with an intuitive interface and clear user functions for the expert.

 

The information of applicants who use the platform is stored on servers located in the TAER III Data Centers in Ukraine, installed in the failure of stable cloud solutions and received the international certificate ISO 27001: 2013.

 

Full backup to the Amazon server in Amsterdam is performed daily using the data encryption protocol.

 

What sets OtiPharm Data Pro apart from the competition?

 

 

Ability to work from a computer or smartphone or tablet. Your information with you 24/7;

The information attached to the medicines card includes not only side effects, but also instructions, accompanying documents, literature searches and all available information about the drug that you need to add;

The function of the automated literary search, gives the chance to establish regular search according to the parameters set by you;

The function of exchanging xml files with the SEC regulator and creating document templates for a pharmacovigilance expert will be an additional bonus.

 

And this is only part of the functionality that is included in the basic version of the product.

 

For two years, our team has processed a large number of requests and data received by us. Thanks to our customers, their edits and wishes, the platform system has constantly expanded its functionality, going from a raw and ambitious product to the most functional working tool, which has become a “reliable assistant PV manager”.

 

But we do not stop there. The plans for 2021 are to further improve the regular literary search and many new useful options that will not leave you indifferent.

Although the platform has been on the market for a little over two years, our clients have already become such respected domestic manufacturers as Pharmaceutical Company Darnitsa, Biopharma, STADA Group, IterChem, BCPP and others.

 

Of course, we do not set the cost of the platform at hundreds of thousands of euros, and we are confident that we can be partners not only with manufacturers of medicines, but also with manufacturers of dietary supplements and cosmetics that share our values and desire for development.

 

 

 

More details about the full functionality and exact cost of the product can be found here otipharmdatapro.com.ua