Comparison of the Effects of a Brand-name Drug and Its Generic Drug on the Quality of Life of Alzheimer's Disease Patients

OBJECTIVE: The pharmacological effects of generic (GE) donepezil are the same as Aricept, its brand-name counterpart. However, little is known as to whether these two drugs provide the same quality of life (QOL). The study subjects were patients with Alzheimer's disease who were taking donepezil hydrochloride tablets, and were selected by visiting either the local pharmacies or the patients' homes. We chose the brand-name drug Aricept and its GE form donepezil to investigate, from a long-term caregiver's perspective, the influence of both drugs on the patients' QOL. METHODS: An EuroQol-5 Dimension (EQ-5D) was used to assess the QOL of patients with Alzheimer's disease, before and after various Aricept and/or donepezil regimens. Patients were divided into four groups: first time users of Aricept (n=43), first time users of GE donepezil (n=45), users refilling previous prescriptions of Aricept (n=51), and users switching from Aricept to GE donepezil (n=51). RESULTS: The average change in the EQ-5D utility indices rose significantly in the patients starting a new regimen of Aricept and its GE drug. The patients continuing an existing regimen of Aricept showed no significant differences, even after Aricept was switched to a GE drug. CONCLUSION: The QOL of patients starting a new regimen of Aricept and its GE drug improved. The QOL was maintained upon switching to the GE drug form.

Development of a Method to Determine the Level of Understanding of Package Inserts for Over-the-Counter Medication / 医薬品情報学

<b>Objective: </b>To develop a label comprehension study (LCS) of package inserts for over-the-counter medications in Japan, we evaluated whether it would be possible to detect differences in the level of understanding due to layout, and font size of different types of package insert using the interview method for LCS we developed previously.<br><b>Design: </b>A face-to-face questionnaire investigation.<br><b>Methods: </b>Two different types of package insert (including layout, and font size) for H₂-antagonists (package insert groups A and B) were used.  Study participants (≥18 years old) comprised consumers who visited a drugstore with a dispensing service in Saitama Prefecture.  They were randomly assigned to group A or B and divided by age range (young, 18-39 years; middle-aged, 40-59 years; eldely, ≥60 years).  First, the volunteers read the package insert with no time limitation and then answered 14 scenario-type questions during an interview to determine the level of understanding of the insert.  When both the correct answer and correct reason were given, the response was judged as correct.  The level of understanding of the package insert was calculated as the number of persons giving correct responses divided by all respondents.<br><b>Results: </b>Questionnaire responses from 86 consumers (43 in each group) were obtained.  The mean age in groups A and B was 46.5 years and 47.0 years, respectively.  The mean level of understanding of the package insert (14 questions) in groups A and B was 50.2 and 38.1%, respectively.  By age range, the mean level of understanding of the package insert in groups A and B in the young group was 60.6 and 56.9%, respectively, and there was no statistically significant difference between the two groups.  However, the mean level of understanding in groups A and B was 56.9 and 35.0% in the middle-aged group and 26.3 and 14.5% in the elderly group, respectively.  The mean understanding in group A was therefore higher than that in group B in both age ranges.  The association between understanding and age within groups indicated that with increasing age, understanding was lower in both groups (group A, <i>p</i>=0.001; group B, <i>p</i><0.001).  There was no difference in the level of understanding between the young and middle-aged in group A, but the difference in group B was greater than 20%.<br><b>Conclusion: </b>By comparing two package inserts of products in a similar pharmacological category using our LCS method, it suggested that font size and layout influenced consumers’ understanding of package inserts.  It might be able to evaluate the difference in the understanding of the package insert by using our LCS method.