Report a side-Effect

• All Medicine Authorities around the world are constantly monitoring to ensure the safety of medicines. Early detection of adverse events related to the drug even after marketing is necessary to determine risks related to the pharmaceutical products. Information collected during the pre-marketing phase (clinical phase) are not sufficient be discover some of rare adverse effects. Where the drug is taken at the stage of clinical phase under limited and selective conditions such as the limited number of patients and not enough to definitively discover rare adverse effects, clinical trials do not include all different age groups who may be more vulnerable to some adverse effects such as the elderly, children and pregnant women, as clinical trials usually Do not last long enough to detect all the adverse effects that may take a long time to detect (Lag Time).

• Spontaneous reporting such as “Adverse Drug Reaction Reporting Form” received during the drug safety monitoring after marketing the product which is known as “pharmacovigilance”, have shown many rare adverse effects, and the withdrawal of many medicines from the market as a result of these adverse effects has focused attention on the importance of Pharmacovigilance and the need to ensure coordination between the different parties that drive the reporting of adverse effects.
• According to the World Health Organization (WHO), pharmacovigilance is defined as science and activities related to the detection, evaluation and prevention of adverse effects or any drug-related problems and prevention. The WHO established its Global Drug Follow-up Program in response to the “Thalidomide disaster”, which was discovered in 1961 and in collaboration with the WHO Collaborating Center for International Drug Monitoring “Uppsala Monitoring Centre” (UMC), which works to support the pharmacovigilance at the international level. By the end of 2010, around 134 countries had become part of the (WHO) pharmacovigilance program.
• Patient safety is the fundamental principle of Utopia and is a prelude to the commercial interests, Utopia is committed to implement the system of pharmacovigilance through continuous monitoring of these adverse effects and aspects related to the safety of pharmaceutical products on the market as well as the adoption of extreme caution in the control phase before marketing.
• Utopia believes that proactive risk monitoring helps to develop risk management plans throughout the life cycle of the pharmaceutical product.
• The pharmacovigilance department in Utopia is responsible for reporting suspected adverse drug reactions from healthcare professionals (including but not limited to physicians, pharmacists, nurses, dentists, caregivers, and others) with respect to pharmaceutical products promptly by notifying the Egyptian Pharmacovigilance Center “EPVC”.
• All reports of individual case safety requiring immediate notification within a period not exceeding 15 days from the date of receipt, this applies to initial and follow-up information by any Utopia employee including the company's sales representatives, for the minimum information required to send adverse effects reports such as the following (a known patient - the reporter reporting the identity - a suspected interaction and a suspected pharmaceutical product).
• Reporting adverse effects is vital to the safe use of the drug. Adequate information provided by patients enables the company to assess the safety of the pharmaceuticals in circulation.
• The pharmacovigilance department in Utopia receives information about the spontaneous adverse effects of marketed pharmaceutical products via e-mail, website, telephone or fax.

Email: utopiapharma.pv@gmail.comWebsite: www.utopiapharma.comPhone: 0223498142 - 023498143 - 023498144Fax: 0223498065Head Office: 4 Hassan El Maamoun St., Nasr, Cairo, Egypt.