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Pages 3-18

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From page 3...
... In the hospital environment, health professionals prescribe and monitor the use of medications and have extensive support systems. In the ambulatory setting, however, patients play a key role in drug safety since medications may be prescribed by a health professional or may be self-prescribed by the patient, and patients or other laypersons   Medication error is defined as any preventable event that may lead to inappropriate medication use or patient harm.
From page 4...
... Across the top of the matrix are the three entities among which the interactions traditionally occur to cause an injury or disease: the host or patient, the agent or drug, and the environment. When the phase–factor matrix was used to identify interventions for ADEs from Warfarin, the first two environmental changes identified were standardized naming and dosing conventions and improved medication label readability for patients (Budnitz and Layde, 2007)
From page 5...
... Louisiana State University Health Sciences Center Ninety million Americans have trouble understanding and acting on health information, reported Terry Davis of the Louisiana State University Health Sciences Center. How well people understand medication container labels is a function of both the clarity of the labels and the degree of people's health literacy.
From page 6...
... Of the 114 auxiliary labels, few have been translated into Spanish and none into other languages. The Walgreen Company is implementing a program that provides translations of medication information in several languages, but the effectiveness of the program has not yet been evaluated.
From page 7...
... were "take two tablets by mouth twice daily," 71 percent said they would take two pills two times a day but only about a third could demonstrate what that meant -- that is, actually count out four pills. The study authors then measured comprehension of the instructions "take two pills in the morning and two pills in the evening" (seventhgrade level writing)
From page 8...
... While medication container labels appear simple, they are not necessarily clear and mistakes are common. There is a tremendous amount of variability in the wording of the instructions, in the icons used, and in the colors of auxiliary medication labels.
From page 9...
... Studies dating back to the late 1980s have found high rates of patient misunderstanding of both dose instructions and auxiliary warnings on medication labels. For example, a recent study examined patients' understanding of label instructions and found that 46 percent of all patients misunderstood one or more dosage instructions.
From page 10...
... These studies point to the need for standards that address what content should be on the drug label, the formatting and font size to use, the best types of icons to support auxiliary instructions, how better to present dosage instructions on the label, and how to be more explicit and concise when telling people how to take their medicine. Finding number three of the ACP Foundation white paper states that "An evidence-based set of practices should guide all label content and
From page 11...
... Language should be standardized to improve patient understanding for safe and effective use." While the drug label is of primary importance, it is only one part of a larger system of written material on medication use that includes such things as patient information leaflets, package inserts, and CMI sheets. These materials do not meet acceptable standards for the design of health information, Wolf observed.
From page 12...
... Finally, it is crucial that systems of prescribing and dispensing be integrated to provide the best information. The final finding of the ACP Foundation white paper states that "Research support is necessary to advance the science of drug labeling and identify best practices for patient medication information." Wolf concluded that variability is most likely a major cause of medication error and that there is evidence to support the conclusion that the way we currently communicate information on prescription medications leads to a variety of problems.
From page 13...
... While there are a number of steps in the process at which interventions to reduce medication errors could be made, the focus of this workshop was on improving medication container labels. To take medicines properly, one needs to know what to take, how many pills to take, and when to take them.
From page 14...
... Do not lie down." 30 minutes - "Take one tablet every day." Bactrim DS tabs - "Take one tablet by mouth twice daily for UTI" Take one tab BID - "Take one tablet by mouth twice daily for urinary tract infection." Dispense #6 Indication: UTI - "Take 1 tablet by mouth 2 times a day." No refills - "Take 1 tablet twice daily for 3 days." Ibuprofen 200 mg tabs - "Take 1 to 2 tablets by mouth as needed for pain." Take 1-2 tabs TID PRN pain - "Take 1 to 2 tablets by mouth three times daily as needed for pain." Dispense #30 No refills - "Take 1 to 2 tablets by mouth as needed for pain.
From page 15...
... TABLE 2-1  Patient Misunderstanding of Medication Instructions Dosage Instruction Patient Interpretation Take one teaspoonful by mouth three Take three teaspoons daily times daily Take three tablespoons every day Drink it three times a day Take one tablet by mouth twice daily for Take two pills a day 7 days Take it for 7 days Take one every day for a week I'd take a pill every day for a week Take two tablets by mouth twice daily Take it every 8 hours Take it every day Take one every 12 hours SOURCE: Wolf et al.
From page 16...
... . TABLE 2-3  Simplified Medication Schedule for TID, QID, and BID Time of Day TID QID BID Breakfast X X X Lunch X X Dinner X X Bedtime X X SOURCE: Wood (2007)
From page 17...
... One question is whether a UMS would improve understanding. In a study of 500 patients in two sites in Chicago and Shreveport, Louisiana, Wolf and colleagues compared patients' understanding of instructions for the standard labels for BID, TID, and QID with the UMS (personal communication, Michael Wolf, Northwestern University Feinberg School of Medicine, October 2007)
From page 18...
... Finally, variability and complexity of labels are excessive. The potential advantages of the UMS include a simplified dosing schedule with no loss of efficiency, improved patient understanding and patient adherence, reduced errors, reduced variability, and improved therapeutic outcomes.


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