Yesterday you took a new medicine and you suddenly had a stomach ache.
After complaining of such trouble to the doctor, what should he do next?
Side effect – an undesirable and dangerous effect of the medicines on the body, which occurs when using the medicines during treatment, diagnosis or prevention in the recommended doses.
The task of pharmacovigilance is to account for, structure, inform and prevent the occurrence of adverse reactions.
This raises the question: how does a pharmaceutical company build a structure of interaction between data?
All data must be:
- Valid, but not duplicated, because it affects the overall picture;
- Integral – cannot be arbitrarily changed or destroyed without permission for access;
- Personalized – data entry should be accompanied by an audit trail and personal responsibility for the information entered;
- Structured – united on common grounds into certain groups and categories;
- Understandable – filled in according to the criteria. XML files in E2B (R2), E2B (R3) format, filled in according to the MedDra;
- Dynamic – ready for transportation and exchange with the authority;
- Protected – the system uses personal data of patients, so protection against leakage – one of the key criteria;
- Available for use – data organization should not take longer than their use.
As you can see, the requirements for data management are more than enough.
In addition, there are requirements for process support:
- It is necessary to organize a system for collecting information about medicines adverse reactions from doctors and patients.
- Conduct annual trainings, where employees will be trained to work with information about side effects that may come to them.
- Monitor the medical literature on a weekly basis for new information on adverse reactions.
- Regularly prepare and submit “periodically updated reports on the safety of the medicinal product”.
- Follow the timely introduction of new information in the instructions to the medicines.
- Follow the update of the requirements of the authority and the legal framework.
How can a pharmaceutical company be sure that their work fully meets these criteria?
How should an expert work with information on medicines side effects?
Let’s take a closer look.
– Make sure it is not a duplicate;
– Determine to which category to assign (classify);
– Report it to the authority;
– Monitor for a period of time whether such information has not appeared in other cases;
– Enter this information in the “periodically updated report on the safety of the medicinal product”;
– If necessary, follow the entry of this information in the instructions.
And this is just one of the options.
And when there are dozens and even hundreds of medicines?
How many qualified experts need to be involved in the department to perform this work well and monitor our safety with you?
Every pharmaceutical company and every applicant is looking for answers to these questions.
At OtiPharm Data Pro, we have brought together software developers and pharmacovigilance experts to create a digital pharmacovigilance data assistant, with the timest and most energy-intensive features.
The data entered through the OtiPharm Data Pro digital system filter is now (ALCOA+) : valid, complete, personalized, structured, protected and formatted, as well as ready for easy electronic exchange with the controller.
✓ Literary search functions are performed in semi-automatic mode and report templates are prepared.
✓ Changes in the instructions and authority status of the medicines are easily monitored using a filter system
✓ Online you can see how the pharmacovigilance function is organized for each medicines, as well as the contribution of each employee.
✓ It is possible to organize remote operation of the pharmacovigilance system during the transition to remote mode. After all, the platform can be used 24/7 from various gadgets (computer, tablet, phone).
✓ The information is comprehensively protected on servers with the international quality certificate ISO / IEC 27001: 2013.
At OtiPharm Data Pro, we aim to make it easier for every industry worker to have pharmacovigilance so you can focus on the really important things.