The effectiveness of varenicline medication guide for conveying safety information to patients: a REMS assessment survey.

Cheryl Enger, Muhammad Younus, Kenneth R. Petronis, Jingping Mo, Robert V Gately, John D. Seeger
Published 2013 in Pharmacoepidemiology and drug safety

Abstract

PURPOSE Risk Evaluation and Mitigation Strategies (REMS) include various mechanisms to enhance safe use of medications, including a patient medication guide (MG) that provides key information regarding the potential risks associated with the medication. To evaluate the effectiveness of the varenicline MG as a REMS tool for educating patients, we undertook a… (More)

DOI: 10.1002/pds.3400

Topics

7 Figures and Tables

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Of Health and Human Services 21 Cfr

Victor P Frattali
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Rothman KJ
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The effectiveness of varenicline medication guide for conveying safety information to patients: a REMS assessment survey.

Abstract

Topics

7 Figures and Tables

Cited By

Measuring the impact of medicines regulatory interventions – Systematic review and methodological considerations

Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study.

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Patient understanding of drug risks: an evaluation of medication guide assessments.

Ongoing challenges in pharmacovigilance.

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

References

Usability of FDA-Approved Medication Guides

for good pharmacoepidemiology practices (GPP)

Nicotine receptor partial agonists for smoking cessation.

Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial.

Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial.

Survey of disability, medication use, and medication satisfaction among members with rheumatoid arthritis of a large health care plan database

Of Health and Human Services 21 Cfr

Epidemiology: an introduction

Slides referencing similar topics

The effectiveness of varenicline medication guide for conveying safety information to patients: a REMS assessment survey.

Abstract

Topics

7 Figures and Tables

Cited By

Measuring the impact of medicines regulatory interventions – Systematic review and methodological considerations

Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study.

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Patient understanding of drug risks: an evaluation of medication guide assessments.

Ongoing challenges in pharmacovigilance.

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

References

Usability of FDA-Approved Medication Guides

for good pharmacoepidemiology practices (GPP)

Nicotine receptor partial agonists for smoking cessation.

Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial.

Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial.

Survey of disability, medication use, and medication satisfaction among members with rheumatoid arthritis of a large health care plan database

Of Health and Human Services 21 Cfr

Epidemiology: an introduction

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