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.

A Pharmacologic Study on Risk Factors of Hyperkalaemia or Increased Blood Potassium Associated with ACE-Inhibitor Therapy / 薬剤疫学

<b>Objective:</b> To investigate quantitatively the risk factors of hyperkalaemia or increased blood potassium associated with ACE-inhibitor therapy<br><b>Design:</b> Nested case-control study<br><b>Methods:</b> We used the antihypertensive drug database(72,379 subjects)developed by the RAD-AR Council, Japan and the Institute of Statistical Mathematics based on the post-marketing surveillance(PMS) data of pharmaceutical companies. Of 37,372 subjects taking ACE-inhibitors, the case group was composed of 64 patients who experienced hyperkalaemia or blood potassium increase while taking ACE-inhibitors, and the control group was composed of 1,280 patients(20 patients per case)randomly selected from patients who did not experience hyperkalaemia or blood potassium increase while taking ACE-inhibitors. The relevant factors that can be extracted from the database were the followings: age, WHO classification of hypertension, complications, antihypertensive drugs used before the PMS survey, and concomitant drugs.<br><b>Results:</b> Among the subjects taking antihypertensive agents, 65 patients experienced hyperkalaemia orincreased blood potassium, 64(98.5%)of whom were taking ACE-inhibitors. The factors that were significantly different between two groups(p<0.05)by univariate analysis were WHO classification of hypertension(p=0.005), complications of nephritis/nephrosis(p<0.001), other disorder of urinary system(p<0.001), unclear symptom or diagnosis(p=0.005), taking diuretics as antihypertensive drugs before study(p=0.032), and concomitant treatment with diuretics(p=0.004), vasodilators(p<0.001), and antigout agents(p=0.001). Conditional multivariate logistic analysis of these factors yielded adjusted odds ratio of 21.31 for complications of nephritis/nephrosis(p<0.001), 6.83 for other disorder of urinary system(p<0.001), and 2.30 for concomitant therapy with diuretics(p=0.049).<br><b>Conclusion:</b> The risk factors of hyperkalaemia or blood potassium increase associated with taking ACE-inhibitors were nephritis/nephrosis, other disorder of urinary system and concomitant therapy with diuretics.

Willingness to Pay for Over-the-counter Pravastatin in Self-medication for the Primary Prevention of Myocardial Infarction / 薬剤疫学

Objective:The aim of this study was to measure the value of over-the-counter (OTC) pravastatin as a healthcare-related item by investigating the public's willingness to pay(WTP)in self-medication for the primary prevention of myocardial infarction (MI)if pravastatin were switched to OTC status.<br>Methods:A questionnaire survey was distributed among those receiving health checkups at Kitasato Institute Hospital. For the WTP question format, the double-bound dichotomous choice approach was employed. Participants were randomly assigned to three groups. Group A was provided with a starting price per month of \5,000, group B with \8,000, and group C with \12,000. To investigate factors affecting WTP, Weibull regression analysis was used.<br>Results:The questionnaire survey was completed by 242 individuals(150 men, age range 30-82 years), and the mean WTP was \9,583 per month. Weibull regression analysis showed that age significantly affected WTP. The monthly cost for a physician consultation to receive prescribed pravastatin is \3,540 to \6,590 in the Japanese health insurance system.<br>Conclusion:The WTP was about \10,000 per month, and the WTP based on the questionnaire responses was more than two-fold higher than the present cost for a physician visit. This study clarified the WTP if pravastatin for the primary prevention of MI were switched to OTC status. Further studies are necessary to elucidate whether this would contribute to the promotion of self-medication among Japanese.

A Report from Task Force on Pharmacoepidemiology and Pharmaceutical Education / 薬剤疫学

For the purpose of pharmacists to be able to be more involved clinically, the pharmacy education system in Japan was revised in April 2006 and the term length of pharmacy education was extended from 4 years to 6 years.<Br> The Japanese Society for Pharmacoepidemiology is deeply concerned about the new curriculum which will be adopted for the 6-year course, especially the handling of pharmacoepidemiology education. Two questionnaire surveys were sent to the dean of all schools of pharmacy to inquire whether they lecture pharmacoepidemiology and, if not, what study in pharmaceutical sciences would be most closely related to pharmacoepidemiology. The surveys were conducted just before and just after the introduction of the new system, in October 2005 and July 2007. The recovery of the first and second survey were 90% and 76%, respectively.<Br> In the first survey only 17 universities (31%) had lectures on pharmacoepidemiology but in the second survey 31 universities (57%) did, and in 55% of these 31 universities the lecture was required. The result indicates that the understanding of professors of pharmacy school regarding the lecture have been gradually promoted and they feel that pharmacoepidemiology is going to be considered to be one of the essential lectures in pharmacy education in Japan. However, many responders indicated that pharmacoepidemiology was still an immature field of study and there are few appropriate textbooks and no teaching experts, and therefore, the society should take these matters into reconsideration.

The ideal focus of the study in the drug information sciences / 医薬品情報学

  In 2008, Japanese Society of Drug Informatics (JASDI) organized the Future Vision Committee (the Committee) to propose the essential focus of drug informatics.  To explore a future vision about the drug information sciences, it was necessary to collect a variety of opinions widely from researchers.  Therefore, at the 11^th annual meeting of JASDI in July 5-6, 2008, the Committee convened a workshop to extract problems in the researches of drug informatics by using KJ method and evaluated the contents.  The major problems raised were “the field of drug informatics is too broad” and “there is no definition and/or no system of the drug informatics”.  Related problems raised are the shortness of the history and lack of originality in the study.  From different viewpoints, it was also pointed out that the methodology of the research is not well established and no systematic education is provided.  Taken together, major problems in drug informatics are concluded to be the lack of definition and the lack of systematizations, and will be solved to a certain extent by defining the outcome of the researches in drug informatics.

Investigation of Label Information on Over-the-Counter Medicines / 医薬品情報学

<b>Objective </b>: To determine how much label information on over-the-counter (OTC) medicines is contained on packaging, we investigated the items, description methods, and area of label information on packages.<br><b>Methods </b>: We selected 75 common cold remedy products for investigation and classified the items into 3 categories (“items for use”, “items with a regulation requirement”, “items related to product image”) and measured the space given to each item in the total package area.<br><b>Results </b>: All 75 products had “items with a regulation requirement (total 13 items),” but 8 products (only 2 manufacturers) had “consult a physician or pharmacist before use,” which was not a regulation requirement.  There were differences in description methods, especially in “caution” and “product name.”  Sixty percent of the OTC products used non-red characters with no box-frame, and 11% used red characters and box-frames.  The description order was not standardized, but “caution” was located in the lowest space on 80% of products.  Many item descriptions appeared in one place, but “product name” generally appeared in more than 4 places. While 4.5 to 8.0 points were commonly given for “items for use,” 16 to 100 points were given for “product name,” and the difference in number of points was greater than 6-fold among products.  The percentage of average area for “items related to product image” (6.1%) was 2-fold greater than for “items for use” (3.1%) and “items with a regulation requirement” (2.9%).  Almost half of the total package area was blank space.<br><b>Conclusion </b>: Current descriptions in label information vary among items, products, and pharmaceutical companies.  Rules on describing information on OTC medicine packaging are thus necessary.