سومین دوره آموزشی "طراحی و توسعه سیستم فارماکوویژیلانس در شرکت های دارویی"
اهداف دوره: این دوره 7 فاز مختلف سیستم فارماکوویژیلانس را (مطابق با شکل) هدف قرار داده، اهداف آموزشی زیر را دنبال می نماید: - یادگیری اصول پایه فارماکوویژیلانس - آگاهی از قوانین کشوری و بین المللی فارماکوویژیلانس - یادگیری تعاریف مورد استفاده در فارماکوویژیلانس - یادگیری طراحی و برنامه ریزی فارماکوویژیلانس در شرکت های دارویی - یادگیری روشهای شناسایی و ارزیابی گزارشهای عوارض و اشتباهات دارویی توسط شرکت های دارویی - یادگیری روش تهیه پرونده های PSUR و PBRER توسط شرکت های دارویی - یادگیری روشهای اطلاع رسانی و برقراری ارتباط در فارماکوویژیلانس توسط شرکت های دارویی
عنوان : مبانی داروسازی بالینی و بیمارستانی
شماره :    1
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عنوان : مبانی فارماکونوتریشن
شماره :    1
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عنوان : اطلاع رسانی دارویی (اصول و روشهای کاربردی)
شماره :    1
ماه :  
هشدار جدید سازمان غذا و داروی آمریکا در مورد داروی آلیسکایرن
FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment.
اخطار سازمان غذا و داروی امریکا در مورد عوارض قلبی داروی سیتالوپرام
The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, FDA issued a Drug Safety Communication (DSC) stating that citalopram should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart.
تغییرات اعمال شده از طرف سازمان دارو و غذای امریکا بر برچسب دارویی استاتین ها
FDA Drug Safety Podcast for Healthcare Professionals: Important safety label changes to cholesterol-lowering statin drugs The FDA has approved important safety label changes for cholesterol-lowering statin drugs. The changes include the following: Monitoring Liver Enzymes Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury. Adverse Event Information Information about the potential for generally non-serious and reversible cognitive side effects (such as memory loss and confusion) and reports of increased blood sugar and glycosylated hemoglobin levels has been added to the statin labels. FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks. Drug Interactions The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury. At this time FDA recommends Healthcare Professionals be aware that: · Liver enzyme tests should be performed before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted. · There have been rare post-marketing reports of cognitive impairment (such as memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with statin use. These reporte
هشدار سازمان غذاو داروی امریکا در مورد مصرف همزمان داروهای مهارکننده پمپ پروتون و متوتروکسات
Methotrexate Safety information Addition of new safety information to methotrexate package inserts This is to inform you of changes that have been made to the package inserts for methotrexate products for intravenous administration. The following has been added to the WARNINGS section of the label
تأیید اسپری تنفسی کامبیونت رسپیمانت (ایپراپیوم بروماید و البوترول) توسط سازمان غذا و داروی آمریکا
FDA is announcing the approval of Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray for “patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.” Combivent Respimat contains two different types of medicines that open airways in the lungs to help patients with COPD breathe better. Combivent Respimat is a suitable alternative for patients who are currently using Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol. Combivent Inhalation Aerosol is being phased out because it contains chlorofluorocarbons (CFCs). CFCs are chemical compounds that decrease the ozone layer. As a result, Combivent Inhalation Aerosol will not be available after December 31, 2013. Combivent Respimat does not contain CFCs. Inhalers that contain CFCs are being phased out due to an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer. By signing this agreement, the United States promised to make it illegal to make or sell substances that decrease the ozone layer. Most inhalers that contain CFCs have already been phased out as part of this agreement. Patients who use Combivent Inhalation Aerosol will have another treatment option and a suitable alternative when Combivent Inhalation Aerosol is no longer available.