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Patient Comprehension of  FDA-Approved Medication Guides Allison Russell, BA  Division of General Internal Medicine Northwestern University October 19, 2011
Acknowledgements  ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Background – Medication Guides
[object Object],[object Object],[object Object],Two Complementary Studies
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Study 1 - Methods
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Results – Study 1
Results – Study 1
[object Object],[object Object],Study 2 – Methods  Oral tablet Oral liquid solution Injection Ritalin  Morphine Sulfate Aranesp
[object Object],[object Object],Study 2 – Methods
[object Object],[object Object],[object Object],[object Object],Study 2 – Interview
[object Object],[object Object],Results – Study 2 – Sample Characteristics (N=449)  Age, %     18-30 years 20.3   31-45 years 30.5   46-60 years 31.2   61-85 years 18.0 Female, % 64.4 Race, %     NH-White 35.2   NH-Black 53.5   Other 11.4 Education, %     ≤  High School 34.1   Some College 24.5   ≥  College Grad 41.4 Income, %     <$20,000 34.8   $20,000-$50,000 22.5   >$50,000 42.7
Results – Study 2 – Overall  Mean Knowledge Scores for Each Guide (N=449) Medication Points Possible Mean Points Received  % correct Oral Solution 32 19.4 60.6 Pill Form 33 16.9 51.2 Injectable 34 16.3 47.9 All Guides Combined 99 52.7 53.2
Results – Study 2 – Literacy Level    Score   Overall Score  Mean (SD) Mean (SD) Scores by Literacy Level   P value Low  (n=63) Marginal  (n=103) Adequate  (n=283) Total  (out of 99 pts) 52.7 (22.6) 24.9 (13.8) 37.8 (15.7) 64.3 (17.1) <0.0001 Percentage  Correct 53.2 % 25.2 % 38.2 % 64.9 %
Results – Study 2  Multivariate Model  of Predictors of Understanding  Medication Guides  (out of 99 points; N=449) Table  4. Multivariate Model of Predictors of `12AQUnderstanding Medication Guides.  Variables β (95% CI) p-value Literacy   Inadequate -23.7 (-28.3 - -19.0) <0.001   Marginal -14.3 (-18.0 - -10.6) <0.001   Adequate --- -- Age   18-30 years --- --   31-45 years -2.4 (-6.3 - 1.6) 0.24   46-60 years -5.9 (-10.4 - -1.4) 0.01   61-85 years -12.2 (-17.0 - -7.4) <0.001 Race   White --- --   Black -9.5 (-13.3 - -5.8) <0.001   Other -7.3 (-11.8 - -2.7) 0.002 Gender   Male --- --   Female 2.1 (-0.83 - 5.0) 0.16 Education   ≤  High School -14.6 (-19.1 - -10.1) <0.001   Some College -4.1 (-8.1 - -0.1) 0.05   ≥  College Grad --- -- Income   <$20,000 -3.1 (-7.5 - 1.4) 0.18   $20,000-50,000 -1.7 (-5.5 - 2.0) 0.37   >$50,000 --- -- Prior Experience  a   Experience -1.6 (-4.3 - 1.2) 0.28   No Experience --- --
[object Object],[object Object],[object Object],[object Object],[object Object],Discussion
[object Object],[object Object],[object Object],Limitations
[object Object],[object Object],[object Object],[object Object],Next Steps
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Questions?  Contact Information

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Patient Comprehension of FDA-Approved Medication Guides

  • 1. Patient Comprehension of FDA-Approved Medication Guides Allison Russell, BA Division of General Internal Medicine Northwestern University October 19, 2011
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  • 12. Results – Study 2 – Overall Mean Knowledge Scores for Each Guide (N=449) Medication Points Possible Mean Points Received % correct Oral Solution 32 19.4 60.6 Pill Form 33 16.9 51.2 Injectable 34 16.3 47.9 All Guides Combined 99 52.7 53.2
  • 13. Results – Study 2 – Literacy Level   Score   Overall Score Mean (SD) Mean (SD) Scores by Literacy Level   P value Low (n=63) Marginal (n=103) Adequate (n=283) Total (out of 99 pts) 52.7 (22.6) 24.9 (13.8) 37.8 (15.7) 64.3 (17.1) <0.0001 Percentage Correct 53.2 % 25.2 % 38.2 % 64.9 %
  • 14. Results – Study 2 Multivariate Model of Predictors of Understanding Medication Guides (out of 99 points; N=449) Table 4. Multivariate Model of Predictors of `12AQUnderstanding Medication Guides. Variables β (95% CI) p-value Literacy   Inadequate -23.7 (-28.3 - -19.0) <0.001   Marginal -14.3 (-18.0 - -10.6) <0.001   Adequate --- -- Age   18-30 years --- --   31-45 years -2.4 (-6.3 - 1.6) 0.24   46-60 years -5.9 (-10.4 - -1.4) 0.01   61-85 years -12.2 (-17.0 - -7.4) <0.001 Race   White --- --   Black -9.5 (-13.3 - -5.8) <0.001   Other -7.3 (-11.8 - -2.7) 0.002 Gender   Male --- --   Female 2.1 (-0.83 - 5.0) 0.16 Education   ≤ High School -14.6 (-19.1 - -10.1) <0.001   Some College -4.1 (-8.1 - -0.1) 0.05   ≥ College Grad --- -- Income   <$20,000 -3.1 (-7.5 - 1.4) 0.18   $20,000-50,000 -1.7 (-5.5 - 2.0) 0.37   >$50,000 --- -- Prior Experience a   Experience -1.6 (-4.3 - 1.2) 0.28   No Experience --- --
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Editor's Notes

  1. Purpose of Med Guides: Provide specific dosing administration instructions Warn individuals about significant health risks Underscore the importance of taking the prescribed medication to the patient’s health, and the need for proper adherence.
  2. Only one Med Guide was deemed suitable overall by having 70% or more of variables scored as adequate. The proportion of Med Guides that received suitable scores in each document category is shown in the accompanying Figure.
  3. To examine patients’ comprehension of current, FDA-approved Med Guides as well as their ability to navigate and problem-solve this information, we selected three existing Med Guides to present to participants. Since the purpose of the current study was to attempt to estimate patients’ comprehension of the information contained in Med Guides generally, it was important to choose Med Guides that could be viewed as representative material, by content and format, and likely exposure. We calculated the word count, readability as assessed via Lexile score, and frequency of annual prescriptions of the relevant drugs described in all 227 Med Guides currently in use as of May 2010. The versions of each document used in these calculations were those found on the FDA’s website at this time. Of all existing Med Guides, 26 were within the general range of the mean criteria (word count, readability, number of prescriptions). From these 26 Med Guides, we randomly chose one guide for each of the three most common routes of administration for inclusion in the current study; oral tablet, oral liquid solution, and injectable. Specifically, these Med Guides were for the medicines Ritalin (oral tablet), Morphine Sulfate (oral solution), and Aranesp (injectable) respectively. Of all 227 Med Guides examined, 26 were within the general range of the mean criteria (word count, readability, number of prescriptions)
  4. In-person interviews at two academically-affiliated, general internal medicine clinics, UIC and Northwestern, serving diverse patient populations
  5. Demographic and socioeconomic information was collected, and literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM). Ritalin Med Guide - 12 questions with 33 possible correct points Morphine Sulfate - 15 questions with 32 possible correct points Aranesp – 12 questions with 34 possible correct points
  6. Prior experience defined as current use, past use, use by a family member and/or helping a family member use one or more of the medicines featured in the Medication Guides tested.
  7. Next Steps. The FDA and Brookings Institution are already working on a potential single-document solution – that means patients will only get 1 document with a medicine, not a Med Guide plus the standard patient leaflet. Our team is helping to move this forward by developing an evidence-based and patient-centered prototype. We are starting a clinical trial shortly to study this. Other projects our team has already done is moving upstream to provide this information in the doctor’s office rather than a pharmacy.