Usability of FDA-Approved Medication Guides

Wolf, Michael S.; King, Jennifer; Wilson, Elizabeth A.; Curtis, Laura M.; Bailey, Stacy Cooper; Duhig, James; Russell, Allison L.; Bergeron, Ashley R.; Daly, Amanda; Parker, Ruth M.; Davis, Terry C.; Shrank, William H.; Lambert, Bruce L.

doi:10.1007/s11606-012-2068-7

Cited by 75 publications

(76 citation statements)

References 21 publications

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“…Current medication guides are of little value to patients due to their high complexity and poor comprehensibility [13,14], and those patients who read them had an overall lack of understanding of risks associated with the medications. In one study, the average length of the guide was over 1,900 words, which is four single-spaced typed pages, and the mean reading level was grades 10 to 11 (which is far above the recommended range for such material).…”

Section: Medication Guidesmentioning

confidence: 99%

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

2014

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The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website (www.fda.gov) were searched using the search terms "risk evaluation and mitigation strategy" (REMS). Articles for review were selected by relevance to topic, and their references were searched as well for additional relevant resources. Since the search results were not expected to contain research studies, formal quality assessment and inclusion and exclusion criteria were not utilized resulting in a narrative review. Few directly relevant research studies exist, although supporting documents such as government reports were available. For effective drugs with unclear or concerning safety records, the FDA has the option of requiring a risk evaluation and mitigation strategy, which allows a systematic approach to track and assure safe medication use. Over 100 different medications are currently covered by REMS, and each REMS is developed individually based on the needs of the specific drug or class. Although likely associated with improvements in medication safety, the potential benefit, limitations, and consequences of REMS are not yet fully understood.

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Section: Medication Guidesmentioning

confidence: 99%

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

2014

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“…To help achieve this goal, many countries require that patients be given written medication information (WMI), usually in leaflet form, when they obtain a licensed medication [6][7][8]. However, patients often have difficulty understanding and using this information [9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Communicating information concerning potential medication harms and benefits: What gist do numbers convey?

Blalock

Sage

Bitonti

et al. 2016

Patient Education and Counseling

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Objectives: Fuzzy trace theory was used to examine the effect of information concerning medication benefits and side-effects on willingness to use a hypothetical medication.Methods: Participants (N=999) were recruited via Amazon Mechanical Turk. Using 3 x 5 experimental research design, each participant viewed information about medication side effects in 1 of 3 formats and information about medication benefits in 1 of 5 formats. For both sideeffects and benefits, one format presented only non-numeric information and the remaining formats presented numeric information. Results: Individuals in the non-numeric side-effect condition were less likely to take the medication than those in the numeric conditions (p < 0.0001). In contrast, individuals in the non-numeric benefit condition were more likely to take the medication than those in the numeric conditions (p < 0.0001). Conclusions: Our findings suggest that non-numeric side-effect information conveys the gist that the medication can cause harm, decreasing willingness to use the medication; whereas non-numeric benefit information has the opposite effect. Practice Implications: Presenting side-effect and benefit information in non-numeric format appears to bias decision-making in opposite directions. Providing numeric information for both benefits and side-effects may enhance decision-making. However, providing numeric benefit information may decrease adherence, creating ethical dilemmas for providers.3

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“…Adding to the problem is that patients self-report that they seldom read the medication guides provided by pharmacies, and there is a growing body of literature suggesting that pharmacy-based medication guides are insufficient. [22][23][24] In other clinical areas where patient education has been systematically optimized, benefit has been seen with one-on-one counseling to improve patient adherence to physician recommendations about medications. 25 Additional benefit has been seen when multimodal intervention channels (written and spoken) are used, compared to a single modality intervention.…”

mentioning

confidence: 99%

Improving Patient Knowledge and Safe Use of Opioids: A Randomized Controlled Trial

McCarthy

Wolf

McConnell

et al. 2015

Academic Emergency Medicine

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Objectives: The use of opioid analgesics in the United States has significantly increased in recent years. However, there is minimal consensus on what discharge counseling should accompany these high-risk prescriptions and large variations in what is done in practice. The objective of this study was to evaluate the effect of a dual-modality (written and spoken) literacy-appropriate educational strategy on patients' knowledge of and safe use of opioid analgesics.Methods: This was a prospective, randomized controlled trial. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new prescriptions for hydrocodone-acetaminophen were enrolled. Patients were randomized to receive either usual care or the educational intervention. The educational intervention was a one-page information sheet about hydrocodone-acetaminophen, which was both given to the patients and read aloud by the research assistant (nonblinded). Follow-up phone calls were conducted 4 to 7 days after the visit to assess patient knowledge about the medication and self-report of activities associated with safety of use (e.g., double-dipping with acetaminophen, storage, use with alcohol or while driving).Results: A total of 274 patients were enrolled; 210 completed follow-up (110 usual care and 100 intervention). No significant differences in baseline characteristics emerged between the study arms; 42% were male, and 51% were white, with a median age of 43 years. Half of patients had non-back pain orthopedic injuries (49.5%). On follow-up, overall knowledge was poor, with only 28% able to name both active ingredients in the medication. The intervention group had better knowledge of precautions related to taking additional acetaminophen (usual care 18.2%, 95% confidence interval [CI] = 10.9% to 25.5% vs. intervention 38%, 95% CI = 28.3% to 47.7%; difference = 27.6, 95% CI of difference = 21.5 to 33.7) and knowledge of side effects (usual care median = 1, interquartile range [IQR] 0 to 2 vs. intervention median = 2, IQR = 1 to 2; p < 0.0001). Additionally, those who received the intervention were less likely to have reported driving within 6 hours after taking hydrocodone (usual care 13.6%, 95% CI = 7.2% to 20% vs. intervention 3%, 95% CI = -0.3% to 6.3%; difference = 10.6, 95% CI of difference = 3.4 to 17.9). There was no difference between groups related to knowledge about drinking alcohol while taking hydrocodone (overall 18.1%) or knowledge that the opioid could be addictive (overall 72.4%).Conclusions: This simple strategy improved several, but not all, aspects of patient knowledge and resulted in fewer patients in the intervention arm driving while taking hydrocodone. Integration of a patient education document into conversations about opioids holds promise for improving patient knowledge about these high-risk medications.ACADEMIC EMERGENCY MEDICINE 2015;22:331-339

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Usability of FDA-Approved Medication Guides

Abstract: Current medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.

Cited by 75 publications

References 21 publications

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

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

Communicating information concerning potential medication harms and benefits: What gist do numbers convey?

Improving Patient Knowledge and Safe Use of Opioids: A Randomized Controlled Trial

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