From time to time the regulatory authorities report on their websites that an instruction for use of a drug must be amended. But how do we know that the instructions must be updated? Who is responsible for these activities within pharmaceutical companies and at the state level? These and other questions to be answered in a new article by PSK Pharma.
Should Russian companies monitor the use of drugs?
The obligations of pharmaceutical companies to ensure the quality and safety of the use of drug products do not end once the development, clinical trials and production have been completed.
Any responsible Russian manufacturer, including PSK Pharma, closely monitors the safety of drugs used by patients. This activity is handled by pharmacovigilance departments, whose tasks include monitoring of adverse reactions to manufactured drugs, implementation of risk minimization measures to prevent the development of adverse reactions, informing regulatory authorities, healthcare professionals and patients about all issues related to the safety of drug use, ensuring that information about the drug complies with the current level of scientific medical knowledge, including evaluation reports and recommendations of regulatory authorities.
Anyone can report an adverse reaction to pharmacovigilance specialists using the contact details, which should always be placed in the public domain on the website of the manufacturing companies and in the instructions for medical use of the drug.
If pharmacovigilance department is staffed by company employees, how can they be objective?
Pharmaceutical companies operating in Russia are required to have Qualified Person Responsible for Pharmacovigilance to monitor compliance with the strict requirements of the EAEU legislation. To perform pharmacovigilance tasks, companies usually create a pharmacovigilance department or service.
The pharmacovigilance department does not just monitor adverse reactions and use this information at its discretion, but regularly passes on information about them to the Federal Service for Health Surveillance. It is this Service that controls the proper performance of pharmacovigilance duties by pharmaceutical companies, records all the information received from them, accumulates and systematizes it. The data obtained is analyzed on a regular basis, on the basis of which recommendations can be made to amend the instructions for medical use, conduct additional studies, and transfer medicines from over-the-counter to prescription to reduce the risk to patients. The information is transferred to the database of the World Health Organization, thus it is possible to combine information on a certain international nonproprietary name (INN) from all over the world and take them into account.
The Federal Service for Health Surveillance is authorized to externally control the activities of pharmacovigilance departments, in particular, to conduct inspections. This is a way not only to check the level of work quality, but also to support specialists in processes improvment.
In addition, the Ministry of Health monitors the pharmacovigilance departments by assessing the pharmacovigilance system Master File (a document describing the entire pharmacovigilance system). If there are problems with processes and resources, this authority can report this.
How is the pharmacovigilance department structured?
The key figure in the pharmacovigilance system is the qualified person for pharmacovigilance, who ensures that the pharmacovigilance system and the supporting quality system of the pharmacovigilance system are built to guarantee an adequate level of monitoring of drug safety and to satisfy regulatory authorities, the owner, managers at all levels of the company, and implementors. Under the supervision of qualified person for pharmacovigilance, a whole team of pharmacovigilance staff works, the number of which depends on the quantity of drugs in the company's portfolio.
However, all employees of the pharmaceutical company are responsible for reporting adverse drug reactions. Each specialist must be aware of the procedure for handling information received from a doctor or patient. In case of non-compliance, the company is subject to administrative and even criminal liability. Therefore, all employees of PSK Pharma undergo regular training on pharmacovigilance.
That is why everyone who uses our company's medicines can be sure that their quality and safety are continuously monitored. In the event of an adverse reaction, be sure to report it.
PSK Pharma - caring for your health!