By: Karla Salmerón
The present Norm establishes the dispositions for the organization and operation of the technical and administrative processes related to the pharmacovigilance of pharmaceutical products, natural products, vitamin supplements, vaccines, homeopathic and donations of the above mentioned manufactured, imported, exported, commercialized, distributed and dispensed in the national territory. This Technical Standard for Pharmacovigilance in El Salvador was published in the Official Gazette No. 138, volume 436 on July 21, 2022.
This Technical Standard is applicable to all natural or legal persons providing health services, as well as those who develop processes related to the manufacture, import, export, commercialization, distribution, prescription, dispensation and administration in the national territory of pharmaceutical products, natural products, vitamin supplements, vaccines, homeopathic products and donations of the aforementioned.
Chapter V of the Technical Standard on Pharmacovigilance details the procedures and instruments for spontaneous notification. Spontaneous notification (passive pharmacovigilance) corresponds to information on adverse reactions to a drug/vaccine, therapeutic failure, medication error, programmatic error or any other drug-related problem, obtained through a voluntary report from a health professional, patient/citizen.
Notifications will be made by the effector units responsible for pharmacovigilance which correspond to:
a) Institutions that make up the integrated national health system.
b) Natural or legal persons engaged in the provision of health services and which include the occasional or permanent prescription or dispensing of medicines.
c) Municipalities that provide health services
d) Sanitary registration holders, manufacturers, importers, conditioners, exporters, distributors, pharmacies, drugstores, including any other kind of establishments authorized by the DNM for the commercialization, distribution, dispensation and administration of pharmaceutical products, natural products, vitamin supplements, vaccines, homeopathics and donations of the aforementioned.
Likewise, the notifications of all the effector units must be made in compliance with the following:
1-The notification must be in Spanish language.
2- It must have the following 4 minimum fields to be valid before the CNFV:
- Name or initials of the patient
- Name of the pharmaceutical product, natural product, vitamin supplement, vaccine and suspected homeopathic product.
- Reaction or adverse event presented
- Notifier’s contact information
3- Must be in accordance with the provisions of this standard, guidelines, procedures, guides, tools and forms established by the CNFV.
4- Must be reported: - Individual cases, series of suspected cases of known or unexpected adverse reactions, adverse reactions, ESAVI, programmatic errors and any other problem related to pharmaceutical products, natural products, vitamin supplements, vaccines and homeopathics occurred in El Salvador.
- Rumors of adverse reactions, therapeutic failure and medication errors related to the use of pharmaceutical products, natural products, vitamin supplements, vaccines and homeopathic products occurred in El Salvador.
5- All reported cases should be submitted through the NFP’s official spontaneous reporting system and along with it, the paper form or information received from the initial source that the institution, facility or company captures should be attached.
In addition, suspicions of adverse reactions, therapeutic failures, medication errors or any other problem related to pharmaceutical products, natural products, vitamin supplements, vaccines and homeopathic products including ESAVIS must be submitted through the official forms in digital format mainly in accordance with the times established for notification by the CNFV; it may be sent to the CNFV in paper form, when for proven special situations it is not possible to make the notification in digital format always in accordance with the times established for notification.
The initial spontaneous notification time is established as follows:
1- For the case of health professionals and institutions providing public and private health services:
a) For “non-serious” adverse reactions should be reported within a maximum of 10 working days from the date on which the adverse event was identified.
b) For “serious” (severe) adverse reactions or life threatening, unexpected, recently marketed drugs should be reported within a maximum of 72 hours from the date the adverse event was identified.
c) For cases of death (including those due to unspecified causes) should be reported within 24 hours from the date the adverse event was identified.
2- In the case of holders of sanitary registration, importers, exporters, drugstores, distributors, professionals responsible for sanitary registration, pharmacies, medicine cabinets and dispensers in supermarkets, markets and others authorized by the DNM:
a) For “non-serious” adverse reactions must be reported within a maximum of 30 calendar days counted from the date on which the adverse event was identified.
b) For “serious” adverse reactions it will be a maximum of 15 calendar days from the date on which the adverse event was identified.
c) For “death” cases (including those due to unspecified causes), it should be reported within 72 hours from the date on which the adverse event was identified.
Time of delivery of spontaneous notification follow-ups:
For adverse event notifications, should be sent no later than 25 calendar days from the date the initial notification was sent and for non-serious adverse event notifications should be sent no later than 30 calendar days from the date the initial notification was sent.
In conclusion, it is important that all the parties involved carry out the activities that correspond to them, as this will help to meet the objectives of the current standard and will help to improve patient care and safety.