Author: Xótchil Girón
Pharmaceutical Chemistry – LatinAlliance El Salvador
In our territory, Pharmacovigilance (FV) is a responsibility of the Ministry of Health through the National Pharmacovigilance Center (CNFV), who together with the National Directorate of Medicines develop it in the country.
On October 17, 2016, the Salvadoran Technical Regulation 11.02.02.16 Pharmaceutical Products was published in the Official Gazette. Medications for Human Use. Pharmacovigilance, which became the instrument that gave rise to an entire organized system to develop pharmaceutical surveillance.
All of us who are involved must participate in VF, from the researchers and developers of the molecules that are later passed on to laboratories that manufacture pharmaceutical specialties, Health Professionals that are involved in their registration process, Regulatory Authorities that grant authorizations and give them follow-up to its post registration and commercialization, and the general population.
In the registration process of a pharmaceutical specialty, among the requirements requested by the DNM we find the FV sub-file, in which the Risk Management Plan (PGR) is presented, which is mandatory for products with innovative molecules, biological, biotechnological and vaccines.
The PGR must also be submitted for products that have new dosages, routes of administration, new manufacturing procedures (biotechnological), new populations and indications, if the reference drug is subject to risk minimization activities (vaccines) or if the CNFV so requires. considers convenient.
What should a PGR contain:
Yo. Data and information from the Sanitary Registry
ii. Data from the Pharmacovigilance Reference
iii. General drug information
iv. Pharmacovigilance Plan
v. Risk minimization plan
There is the figure of the Pharmacovigilance Referent, who is a professional who knows the VF process that is followed when encountering a health alert and who has knowledge of the products it represents, as well as the management that must be carried out.
With this we can ask ourselves the question: what is the main objective of Pharmacovigilance? Its objective is to verify, report, evaluate the benefits and risks that a medication causes to the population that is exposed to them, many with the desire to cure a condition, whether chronic or palliative, since it is known by all those involved that for medicines there is no zero risk; Furthermore, when they are released by the pharmaceutical industry to undergo a registration process before a health authority, they must have at least phase III clinical studies, since in this phase the drugs demonstrate whether they are safe or not, taking Keep in mind that the safest phase is IV; however, it affirms the benefit-risk of a medicine over time, during its commercialization.
Therefore, it is important to comply with the requirements requested by the authorities involved, to give FV the importance it deserves, and thereby minimize the safety risk that a medication can cause; In addition, it is our duty to participate actively, notifying by the means provided by the CNFV: Effective Notifications, which are available on the website cnfv.salud.sv, e-mail: cnfv.elsalvador@gmail.com, pharmacovigilancia.elsalvador@medicamentos.gob.sv , by physical means RAM-ESAVI Sheets that are reported through your trusted health professional about adverse effects that are not evidenced in the product information, or by phone call to your call center 2522-5056.
To know the information in detail, you can contact our team of Life Sciences – Regulatory Affairs:
elsalvador@latinalliance.co
or contact the author of this article, our pharmaceutical chemist, Xotchil Giron xgiron@latinalliance.co