Pharmacovigilance is an integral part of international cooperation In today’s world. Continuous pharmacovigilance activities must be carried out in all countries where a pharmaceutical company’s products are manufactured. However, this company faces many challenges: starting with the language barrier and ending with the peculiarities of local legislation. In this article, we will try to understand one of the mandatory aspects of pharmacovigilance of a company in the international pharmaceutical market, which helps to alleviate these barriers.
To begin with, our legislation requires that all pharmaceutical companies that put drugs on the market must appoint and have a Qualified Person Responsible For Pharmacovigilance (QPPV) at all times. This is the person who interacts with regulators and is responsible for ensuring that the company’s pharmacovigilance system is up and running.
A QPPV must meet the following criteria: First, there can only be one QPPV in each pharmacovigilance system. The services of a QPPV may be used by more than one registrant in general or individual pharmacovigilance systems, or a person may serve as an QPPV for more than one pharmacovigilance system of one registrant, provided of course the QPPV can perform all its duties. Also, the QPPV must be appropriately qualified. More precisely, the holder of the registration certificate must ensure that his QPPV has acquired adequate theoretical knowledge to carry out pharmacovigilance activities. QPPV must have skills in pharmacovigilance system management, experience in medicine, pharmaceutical sciences, epidemiology, biostatistics. That is, at a minimum, the QPPV must have documented experience in all aspects of pharmacovigilance to perform the duties and tasks of the position. The holder of the registration certificate is expected to independently assess the qualifications of the candidate for the position of QPPV by verification of educational documents, knowledge of the pharmacovigilance requirements in the respective country, and his/her experience. In addition, the holder of the registration certificate must provide the necessary training before the candidate takes up the position. The QPPV, of course, must be familiar with the package of drugs whose pharmacovigilance will be performed.
Once a pharmaceutical company decides to enter the pharmaceutical market in other countries, the question of “who will provide pharmacovigilance in the new countries? This is where the need arises to appoint a Contact Person (CP), who will be responsible for the safety of the drug in that country and who will report directly to the QPPV. That is, it is important to understand that the QPPV is one person responsible for the pharmacovigilance of the entire company in all countries of production and sales, while there may be several CPs, all of whom report to the QPPV.
Now let’s understand the activities of CPs. The legislation does not regulate specific requirements for CPs and most tasks are defined individually in each company. Nevertheless, below is one example of the interaction between QPPV and CP. Most often CPs need to report reports on developed adverse reactions to the local regulatory authorities, monitor the legislation in the relevant EAEU country, and immediately report all changes to the QPPV. The CP also needs to receive/collect claims, complaints, and other communications regarding medicines from health care professionals, consumers (patients), public authorities, or other sources (e.g., national medical journals). All information collected by CP sends to QPPV within 24 hours, and QPPV confirms receipt of this information within 24 hours. That is, the CP does not send anything to the regulatory authorities until the QPPV has assessed the information received by the criteria: seriousness/non-seriousness, foreseeability/non-predictability, and has forwarded the data to the CP for reporting in the prescribed form. Also, if specified in the applicable Contract, CP shall retain all information received electronically and/or in writing. In addition, the CP will report spontaneous reports to local regulatory agencies by local requirements (in consultation with QPPV). In general, by this algorithm, it is effectively possible to maintain continuous pharmacovigilance.
Another important point is the organization of technical capability of 24/7 communication of QPPV, local regulatory authorities with CP (on weekdays, weekends, and holidays). CP must have a switched on and operable phone with a positive balance on the account, on which the Contact person makes reception 24/7 (on weekdays, weekends, and holidays) during the whole term of the Contract.
If we talk about monitoring the literature, it is obvious that this is a necessary and important source of obtaining information for pharmacovigilance. According to the GVP, information on the safety of registered drugs must be searched at least once a week. Accordingly, CP searches for such information from local sources (medical and scientific journals, databases) in the national language. All important information obtained by the CP again transmits to the QPPV in the prescribed form according to the Treaty. CP also regularly checks for updates of local legislation relating to pharmacovigilance functions.
Every month there is a “reconciliation” of the reports received with the QPPV. A report, drawn up in the form agreed upon by the Parties to the Agreement and submitted to the QPPV within the deadline also established by the Agreement, containing information about all communications received by the CP on the territory of his country in the reporting month. For this purpose, the Contact person performs a monthly query at the beginning of the month about the cases of adverse reactions to the Regulatory Authorities’ drugs of the holder of the registration certificate.
From all of the above, it is clear that the Contact person is a key link between the pharmaceutical company and the regulatory authorities of the state where the drugs are sold. The introduction of the mandatory requirement to designate a Contact person allowed for continuous pharmacovigilance activities in the context of international pharmaceutical cooperation.