As you know, before a medication may be prescribed by a physician for his/her patients, there are many years of drug studies during which enough data is collected reporting its therapeutic efficacy and lack of significant adverse effects that might made drug use not so safe for humans..
However, let’s have in mind there is no way of research capable to disclose any and all pharmacologic activities, including possible adverse effects, that a drug might affect the body before the agent is used on a long-term basis and on regular conditions by people.
Proving safety, giving constructive information about unexpected effects, and identifying such effects as soon as possible in order to establish frequency and incidence are necessary data for life and growth of our product within the market.
Out of the different test systems created to assess drug clinical safety during their market life, the spontaneous notification a physician carries out about an eventually adverse effect he has observed in his patients is the fastest way to warn about an adverse event related to medications.
The clinical event reported is assessed in order to validate or not its possible association with treatment. For that reason, a methodology to follow-up has been set: Pharmacovigilance. Pharmacovigilance enables us to clarify the cause of the events mentioned above.
PHARMANOVE, in allegiance to the highest ethical and methodological standards, is interested in knowing any and all aspects related to their product behavior when administered to patients. Pharmacovigilance provides us scientific contributions regarding the best application for drugs. This is possible by means of identification and notification of such events.
By definition, pharmacovigilance is the procedure that identifies, records, and VERIFIES adverse events related to medication during the period of use by the population in order to identify special risk or benefits and then be able to apply a more rational, beneficial and safer therapy.
-Fostering identification and notification by healthcare professional related to adverse events and eventual efficacy failure observed in the medication.
-Collecting inherent case data.
-Incluiding such information to company database which will enable to assess nature, incidence, new drug interactions, new contribution factors, etc.
-Confidentiality shall be kept in all cases. Information will only be available for technical-scientific use exclusively.
Since the National Food, Drug and Medical Technology Administration (ANMAT) was created by mid 1993, implementing a National Pharmacovigilance System was something authorities cared about.
PHARMANOVE notifies adverse effect reported by healthcare professionals to the mentioned agency, thus fostering technical-scientific information sharing towards the best safeguarding of our products and the people as a whole.
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Our Medical Department, by means of its Pharmacovigilance Service, will get in touch with you in order to advise you and share information complementing the case. They will then review data collected and physician will get an answer that may help to complete his/her information. A case search will be performed throughout all scientific literature available. This information is included in lab database where pharmacologic safety experts will assess incidence, interactions, new contributing factors, etc. This will obviously helps to provide safety when prescribing by means of rational use of product. At the same time, this allows PHARMANOVE to comply with their ethical and regulatory responsibilities regarding products company trades.
