Objective: 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.
Design: A face-to-face questionnaire investigation.
Methods: 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.
Results: 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, p=0.001; group B, p<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%.
Conclusion: 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.

Background
  The Millennium Development Goals were put forth to strengthen maternal and child health, and because infectious disease has become a trend in the world, ensuring the quality and quantity of nursing is important. We report on a survey detailing the current status of legal frameworks and qualification systems in nursing in four countries: Cambodia, Lao People’s Democratic Republic (PDR), Myanmar, and Vietnam.
Method
  We conducted a semi-structured interview with nursing administrative officers, and then we confirmed those information in their countries in 2012 and 2013. We categorized the existing nursing legal framework, nursing qualification systems, professional association and council.
Results
  The King of Cambodia stipulated to a royal decree, which was established by the nursing council. In Lao PDR, following the Law on Health Care, two nursing and midwifery related regulations were developed. The Union of Myanmar enacted the Nurse and Midwife Law. In Vietnam following the Law on Medical Examination and Treatment, two Circulars were issued by the Ministry of Health to regulate the scope of practices and norms. We report on the current situation of the qualification and registration systems for nursing of each country. In addition, the development of qualifications and regulations should be reported based on the ASEAN Mutual Recognition Agreement (MRA).
Conclusion
  We conducted a comparison of four countries to ensure the quality of nursing. A challenge for the future is compliance and dissemination of the laws and regulations that have been developed. ASEAN MRA has become a driving force for improvement of these legal systems.