PHARMACOVIGILANCE

According to the World Health Organization (WHO), Pharmacovigilance is defined as the science and activities related to the detection, evaluation, understanding and prevention of adverse events or any other safety related situations with the products. Responsibility for ensuring safety in the use of medicines belongs to everyone: industries, regulatory agencies, health professionals and patients. Therefore, when you become aware of an adverse event by a patient under treatment with a Cellera Farma drug, we advise you to contact us using the form below, or contact our team of pharmacists by phone:

0800 17 7003, Monday through Friday, from 8:30 a.m. to 4:00 p.m. (except on holidays).

According to ANVISA (RDC 04/09), an adverse event is any medical occurrence, which may occur during treatment with a medicine, but that doesn’t necessarily have a causal relationship to that treatment.

Therefore, an adverse event is considered:

Suspected adverse drug reactions;

Reaction to a drug that is harmful and unintentional and that occurs at doses normally used in humans for prophylaxis, diagnosis, therapy of the disease or for the modification of physiological functions.

Adverse events due to deviations from the quality of medications;

Any unfavorable medical occurrence that may occur during treatment with a drug associated with a technical claim involving such drug (e.g. changes in color, odor, taste).

Adverse events resulting from the unapproved use of medicines;

Use not described in the lable (“off label”): It encompasses the use in situations other than the recommended in the package insert of a drug registered with Anvisa. It may include differences in indication, age range / weight, dose, frenquency, presentation or route of administration.

Drug interactions;

Pharmacological, toxicological, clinical or laboratory response caused by combining the drug with other drugs.

Therapeutic ineffectiveness, total or partial;

It is the exposure to a product that does not result in the desired therapeutic effect as the indication approved in the package insert.

Drug-related intoxication;

Harmful response resulting from the intentional or unintentional use of a drug in doses higher than those usually used for prophylaxis, diagnosis, treatment or for the medication of physiological functions.

Overuse of drugs;

Intentional overuse of one or more drugs that may be persistent or sporadic, accompanied by harmful physical or psychological effects.

Drug errors, potential and real;

Any preventable event that may cause or lead to inappropriate use of medicines or harm to a patient while the medication is under the control of healthcare professionals, patients or consumers. This event may be related to professional practice, health products, procedures and systems, including prescription, verbal guidance, labeling, packaging and nomenclature of processed and handled products, dispensing, distribution, administration, education, monitoring and use.

Exposure via parent;

It is the exposure of a fetus / baby / child to a medication via the parent (during conception) or the mother (during conception, pregnancy, delivery or breastfeeding).The cases of exposure by parent should be reported with or without reaction.