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FDA: Medication Guides…Watching out for Consumers
Outline What is a Medication Guide? What is the role of the nurse and the Medication Guide?
Medication Guide Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particulardrugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.  FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that: certain information is necessary to prevent serious adverse effects patient decision-making should be informed by information about a known serious side effect with a product, or patient adherence to directions for the use of a product are essential to its effectiveness.
Example: Avandia (Rosilitazone) http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085922.pdf
Role of the Nurse Give info to patient Inform patient that this information is different than the “usual patient education” This information requires the patient to: Make decisions – especially if adverse side effects appear Adhere to prescribed drug regimen
Example: Avandia Patient Decision Making: Inform prescriber of certain conditions… Hx of heart failure, myocardial infarction, macular degeneration, liver failure Watch for adverse effects: Chest pain (s/s of heart attack) Swelling, shortness of breath (s/s of heart failure) S/s of liver failure Vision problems (s/s of macular degeneration) Ovulation – for premenopausal women – who do not get regular periods, this increases their chance to get pregnant Brittle bones
Remember….

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Fda medication guidev2

  • 2. Outline What is a Medication Guide? What is the role of the nurse and the Medication Guide?
  • 3. Medication Guide Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particulardrugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.  FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that: certain information is necessary to prevent serious adverse effects patient decision-making should be informed by information about a known serious side effect with a product, or patient adherence to directions for the use of a product are essential to its effectiveness.
  • 4. Example: Avandia (Rosilitazone) http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085922.pdf
  • 5. Role of the Nurse Give info to patient Inform patient that this information is different than the “usual patient education” This information requires the patient to: Make decisions – especially if adverse side effects appear Adhere to prescribed drug regimen
  • 6. Example: Avandia Patient Decision Making: Inform prescriber of certain conditions… Hx of heart failure, myocardial infarction, macular degeneration, liver failure Watch for adverse effects: Chest pain (s/s of heart attack) Swelling, shortness of breath (s/s of heart failure) S/s of liver failure Vision problems (s/s of macular degeneration) Ovulation – for premenopausal women – who do not get regular periods, this increases their chance to get pregnant Brittle bones