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Working with information in pharmacovigilance?

10.03.2021

Pharmacovigilance is the activity of identifying, storing, evaluating, understanding, and preventing side effects or other potentially drug-related problems.

During its operation, a large amount of paper and digital documentation are produced, which the pharmacovigilance manager (QPPV) needs to structure.

 

 

Let’s look at a few of them.

The first type:

The simplest – storage in the form of paper forms or documents in word format, which are then sorted into folders and stored in the archive.

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Advantages:

⁃ Cheap

⁃ Does not require special skills in using a PC

Disadvantages:

⁃ Dependence on the person who owns the information where files and folders are stored.

⁃ Only possible with a small amount of the applicant’s drugs.

⁃ High risk of loss or distortion of information.

⁃ Large time and human costs to find the necessary information.

⁃ Submitting reports to the controller only in manual mode.

 

Second type:

Storage of information using excel tables.

 

 

Advantages:

⁃ Ability to organize one type of data for several dozen drugs in one place.

⁃ Ability to sort data by one or more criteria.

⁃ Ability to select, indicate in the table the type and status of the procedure manually.

⁃ Simultaneous viewing and modification by multiple users when using google spreadsheets online.

⁃ Information is stored on servers and in the company’s archives.

Disadvantages:

⁃ With a large number of medicines there is a dependence on the person who organizes the storage of information.

⁃ There is a risk of losing or distorting information.

⁃ It is not recorded who makes changes and when.

⁃ Time costs for introducing a new employee.

⁃ Information is stored on servers and in the archives of the enterprise only when controlling the entry of this data by the head

⁃ Submitting reports to the controller only in manual mode.

The third type:

Using Google Workspace software

 

 

Advantages:

⁃ All the advantages of excel tables and documents in word format.

⁃ Digital track for each user of information.

⁃ Possibility of limited access or granting only viewing rights.

⁃ The information is stored on a google drive.

Disadvantages:

⁃ Software is paid

⁃ Information of the medicines is stored simultaneously in several places

⁃ Long time to train a new employee

⁃ All the information has a good protected?

⁃ All changes are made manually

⁃ Submitting reports to the controller only in manual mode

 

The fourth type:

Specialized automatic databases, which for convenience can be divided into foreign and domestic platforms.

  1. A) Foreign developments

 

 

Advantages:

– Companies are world-renowned developers.

– High level of data security.

– Modular functionality (you can buy additional functions to the basic set)

Disadvantages:

– High cost of the platform

– Complex process of purchase, installation.

– Maintenance requires a special staff member.

– Conservative heavy interface (requires special training to master user skills) is not always convenient for our users.

– Not everyone has the opportunity to choose the language of the database.

– Non-compliance of some blocks and templates of documents with Ukrainian legislation

– Customer support is not always convenient and usually takes a long time to resolve issues.

 

B) Domestic platforms

 

 

Advantages:

– Developer companies are available to communicate with customer support 24/7

– Some companies, as well as foreign ones, have a high level of data security.

– Training and integration of the base into the company usually does not take much time.

– Legally easy approval of the agreement and execution of payments.

– Created for the Ukrainian market (for our “realities”).

– Ability to select the language for the database.

– Ability to create documents from templates according to Ukrainian law

Disadvantages:

– Not all platforms are intuitive and user-friendly, you need to spend time choosing

– Cheap suppliers are not always ready to adapt to user needs

– The market is new and not fully formed, a small choice of supplier-partner

– Developers in the field of IT (the risk of constant system bugs and improvements)

Finally, given all the advantages and disadvantages of different accounting systems, we can unequivocally recommend that you start pharmacovigilance in a digital environment (if you have not already done so), and “keep up with the times” now.

Among the Ukrainian software solutions in terms of security / convenience, we offer to consider the digital platform OtiPharm Data Pro.

 

 

Its functionality includes:

  • Ability to access data from any device (computer, tablet, phone) 24/7
  • Easy and fast data transfer even for large corporations
  • Convenient intuitive interface, easy to use
  • All data of the medicines are tied in one place (dossier, instructions, reports, literature)
  • Automated regular literary search by valid sources
  • Creating report templates and the ability to share them with the regulator
  • Ability to search and sort medicines and side effects by various filters
  • Ability to record all requests for pharmacovigilance for further information processing
  • The newest version of the MedDra dictionary
  • Tracking of duplicate adverse reactions

 

 

An added benefit of the database is complete privacy and security of your data storage. The annual validation of the system is performed by an independent validator in accordance with the requirements of GxP, GAMP 5, GMP EU and 21CFR Part 11 FDA USA. Information is stored on servers with ISO 27001: 2013 security certificate. Only you manage your information. And OtiPharm Data Pro at the same time can become the Reliable assistant of your pharmacist.

!!! The platform will be useful for both Ukrainian pharmaceutical companies and applicants, as well as manufacturers of dietary supplements and cosmetics.