By: Xóchilt Girón
Functions of the Responsible Professional, according to the Technical Regulation on Pharmacovigilance.
In El Salvador since October 2016, there is the Salvadoran Technical Regulation 11.02.02:16. Pharmaceutical Products. Medicines for human use. Pharmacovigilance, of which it is known by all, was the instrument that gave rise to an organized system to develop pharmaceutical surveillance of any product that is available for the consumption of the Salvadoran in order to achieve health and its welfare.
It is known by those involved that a technical regulation is of mandatory compliance and responsibility of the public sector; however, it is necessary to develop technical standards, which although voluntary, have the purpose of organizing in a better way the development of a specific topic and to be applied by organizations not only from the public sector, but also from the private sector.
Last July 21, 2022, the Technical Norm of Pharmacovigilance was published in the official journal N° 138, volume 436, in which both sectors participated jointly, to establish a better clarity on the subject of how all those involved can be organized looking for the same purpose, which is to safeguard the health of the population that has within reach pharmaceutical products, natural, supplements, vaccines, homeopathic, whose origin is national or international.
In this standard, we find several very important points to know, in order to be active and efficient actors in the field of pharmacovigilance, developed in different chapters such as:
- The organization of the pharmacovigilance system.
- Pharmacovigilance activities
- Obligations and responsibilities in pharmacovigilance actions.
- Spontaneous notification procedures and instruments
- Supervision, auditing and monitoring of pharmacovigilance activities.
Having stated the above, in this brief article, we will focus on what is reflected in article 20, which is found within the chapter that talks about the obligations and responsibilities in pharmacovigilance actions, specifically the functions to be fulfilled by the Professional Responsible for the sanitary registration of the product in our territory.
Before pointing out the functions, it is necessary to remember that, according to the Law of Medicines in its article 37, it indicates that all registrars must be professionals in chemistry and pharmacy and must be registered and authorized by the National Directorate of Medicines; we can also find the definition of the Responsible Pharmaceutical Chemist Professional in article 3 of the General Regulation of the Law of Medicines, indicating that he is the one who responds for the quality and veracity of the product before the Directorate, authorized by the holder of the medicine.
Having said the above, the following are the functions that a Responsible Professional must perform, as indicated in the Technical Standard on Pharmacovigilance:
a) Establish an effective communication with the pharmacovigilance referent or responsible for the pharmacovigilance of the medicines and vaccines for which he/she is responsible.
b) Notify in due time and form to the CNFV, the suspicions of AMR, HAART and DRP of which he/she is aware of.
c) Deliver to the CNFV and the DNM information related to the safety of pharmaceutical products, natural products, vitamin supplements, vaccines and homeopathic products on a voluntary basis or when requested.
d) Follow up upon request of the CNFV on events related to recently marketed pharmaceutical products, natural products, vitamin supplements, vaccines and homeopathics.
e) Communicate to the CNFV any identified risk information or possible unknown adverse reactions of pharmaceutical products, natural products, vitamin supplements, vaccines and homeopathics or safety information or risk situation associated to the products they are responsible for.
f) Comply with the times established for the submission of all documents and safety information provided in this standard, guidelines, guides, procedures and tools issued by the CNFV or the DNM in pharmacovigilance matters.
g) Comply with all the instruments, guides, tools and electronic platforms issued by the CNFV or the DNM in terms of safety of pharmaceutical products, natural products, vitamin supplements, vaccines and homeopathic products.
It is important to clarify that the Responsible Professional must have a clear and effective communication with the holder of the products he/she represents, thus being a communication channel between the institutions involved in terms of pharmacovigilance, as well as in what is his/her direct responsibility in the regulatory field before the National Directorate of Medicines.
The terms Responsible Professional should not be confused with Pharmacovigilance Referent, responsible for Pharmacovigilance or Pharmacovigilance Substitute, whose responsibilities are clearly reflected in article 21 of the regulation, since they are figures with complex commitments inherent to the Pharmacovigilance practice.
To conclude this article, it is important that we participate in the implementation of pharmacovigilance, especially being direct actors in the effects that a pharmaceutical product may cause, whatever its origin, in a patient who needs such products to cure a disease, since we must tirelessly seek the benefit and welfare of the general population and there is no better job than the one that is done in an organized and joint manner, with the aim of the common good.
As a reminder, we can make effective notifications through the tools available on the web page cnfv.salud.gob.sv, its e-mail farmacovigilancia@salud.gob.sv or its telephone number (503) 2591 – 7354; or if you prefer, you can go to the nearest health center or to your trusted health professional to report any adverse effect caused by medicines.