MedGuide

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Introduction

Required to be given by pharmacists for certain drugs, especially those with black box warning.

The Medication Guide presents specific, comprehensive, accurate information based on the professional prescribing information. It is written in non-technical English & contains the following headings with explanations:

  • What is the most important information I should know about (name of drug)?
  • What is/are the indication(s) for use?
  • Who should not take (name of drug)?
  • How should I take (name of drug)? Including: importance of adherence to dose instructions, special instructions about administration what to do in case of overdose what to do if a dose is missed
  • What should I avoid while taking (name of drug)?
  • What are possible or reasonably likely side effects?
  • General information about the safe and effective use of prescription drug products
  • Additional information as appropriate

The manufacturer of a drug product submits the Medication Guide to the FDA for approval prior to issuance.

Physician may ask pharmacist not to dispense guide, but if patient asks for one, pharmacist must comply with patient's request.

Medication Guides exist for:

More general terms

References

  1. Prescriber's Letter 13(3): 2006 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220331&pb=PRL (subscription needed) http://www.prescribersletter.com
  2. U.S. Food and Drug Administration, Center for Devices and Radiological Health, Code of Federal Regulations 21CFR 208.2. http://www.gpoaccess.gov/fr/index.html
  3. Prescriber's Letter 16(12): 2009 COMMENTARY: Frequently Asked Questions About MedGuides CHART: Drugs with Required Medication Guides Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=251209&pb=PRL (subscription needed) http://www.prescribersletter.com