Pharmacovigilance
Protecting your health
We are committed to maintaining the safety and efficacy of our medicines.
What is it?
Pharmacovigilance "is the science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other problem related to medicines" (World Health Organization-2002). It arises from the need to evaluate the safety and effectiveness of drugs available in the market in order to avoid unnecessary harm to patients. Pharmacovigilance is a shared responsibility, in which different actors participate: the health authority (COFEPRIS), the pharmaceutical industry, distributors, pharmacies and, as a fundamental part, health professionals and patients.
Sanfer Commitment
Sanfer is committed to the well-being of patients, for this reason it has a Corporate Pharmacovigilance Unit which has the philosophy of "Ensuring the health of patients and consumers by offering safe and effective medicines through a solid and effective Pharmacovigilance system, that guarantees a benefit through absolute adherence to national and international standards and guidelines, always making decisions based on knowledge, analysis and risk management, but above all with professional ethics and commitment to the population”.
What to report?
All unwanted events that occur after the administration of a drug, also known as Suspected Adverse Drug Reactions (SRAM), whether expected or unexpected, must be reported. These reports allow us to estimate frequencies or find out about new adverse reactions. for the product.
According to NOM-220-SSA1-2016 for the Installation and Operation of Pharmacovigilance, a Suspected Adverse Drug Reaction (SRAM) is "any unwanted clinical or laboratory manifestation that occurs after the administration of one or more drugs ”, that is, there is no certainty that the signs and/or symptoms are related to the use of the medication, however, there is a possibility that it may have contributed, for this reason it is important to report it so that it can be evaluated.
In addition, other situations can be reported that have not been evaluated during the development of the product and in which a SRAM is not necessarily present, such as:
- Exposure during pregnancy (maternal or paternal)
- Exposure during lactation
- Misuse, use other than that indicated in the prescribing or instructive information and medication error:
- product confusion
- Unauthorized use in pediatric patients
- handling of medications
- medication diversion
- Therapeutic ineffectiveness or ineffectiveness
- Abuse
- Overdose
- underdose
- Interactions with other medications and/or foods
- Transmission of an infectious agent
- Beneficial unexpected effect
- Suspected Counterfeiting
- Events related to quality (Quality Complaints)
- Occupational exposure or acci