OBJECTIVE: To evaluate the quality of patient information leaflets provided with dispensed medications in the United States, United Kingdom, and Australia. DESIGN: Quantitative survey by an expert panel. SETTING: United States, United Kingdom, and Australia. PARTICIPANTS: Not applicable. INTERVENTION: Patient information leaflets for atenolol, glyburide (glibenclamide), atorvastatin, and nitroglycerin (glyceryl trinitrate) from the United States, United Kingdom, and Australia. MAIN OUTCOME MEASURES: Leaflets were evaluated against U.S. consensus criteria for both clinical information and general criteria, including the design of the leaflets. RESULTS: Leaflets from Australia received a mean overall score of 90% (range 83%-94%) adherence with criteria, those from the United Kingdom a score of 81% (range 73%-84%), and those from the United States a score of 68% (range 65%-77%). The U.S. leaflets achieved 50% or less adherence for contraindication and precaution information. Omissions included warnings about preexisting allergy and illness and information about drug interactions. The U.S. leaflets also scored poorly (60%) for legibility and comprehensibility. The lower U.K. score reflected shortcomings in information about how to use and monitor the medications (46% adherence) and on adverse drug reactions (64%), largely due to the lack of clear advice about urgency of action in relation to adverse drug reactions. CONCLUSION: Leaflet quality varied more among the three countries than within each country, reflecting the regulatory context. The Australian leaflets performed well across all criteria, whereas the U.S. leaflets had significant shortcomings with the omission of vital information for the safe and effective use of the medications. A repeat survey is needed to assess whether new legislation and guidance in all three countries successfully addresses the shortcomings identified.
OBJECTIVE: To evaluate the quality of patient information leaflets provided with dispensed medications in the United States, United Kingdom, and Australia. DESIGN: Quantitative survey by an expert panel. SETTING: United States, United Kingdom, and Australia. PARTICIPANTS: Not applicable. INTERVENTION: Patient information leaflets for atenolol, glyburide (glibenclamide), atorvastatin, and nitroglycerin (glyceryl trinitrate) from the United States, United Kingdom, and Australia. MAIN OUTCOME MEASURES: Leaflets were evaluated against U.S. consensus criteria for both clinical information and general criteria, including the design of the leaflets. RESULTS: Leaflets from Australia received a mean overall score of 90% (range 83%-94%) adherence with criteria, those from the United Kingdom a score of 81% (range 73%-84%), and those from the United States a score of 68% (range 65%-77%). The U.S. leaflets achieved 50% or less adherence for contraindication and precaution information. Omissions included warnings about preexisting allergy and illness and information about drug interactions. The U.S. leaflets also scored poorly (60%) for legibility and comprehensibility. The lower U.K. score reflected shortcomings in information about how to use and monitor the medications (46% adherence) and on adverse drug reactions (64%), largely due to the lack of clear advice about urgency of action in relation to adverse drug reactions. CONCLUSION: Leaflet quality varied more among the three countries than within each country, reflecting the regulatory context. The Australian leaflets performed well across all criteria, whereas the U.S. leaflets had significant shortcomings with the omission of vital information for the safe and effective use of the medications. A repeat survey is needed to assess whether new legislation and guidance in all three countries successfully addresses the shortcomings identified.