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Description of Important Potential Risks of Japanese Risk Management Plan on Each Package Insert

Takashi Tomita ; Yuki Ono ; Kumi Nejihashi ; Takanori Taogoshi ; Hiroaki Matsuo

Japanese Journal of Drug Informatics.2016;18(3):214-217. doi:10.11256/jjdi.18.214

Objective: The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs.  One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts.  In this study, we investigated the description of potential risks on package inserts.
Design: Document analysis.
Methods: We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.
Results: Of 268 important potential risk items in 81 products, 56 items were not described on package insert.  The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.
Conclusion: About 20% of important potential risks are not described in package inserts.  Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.

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Fluoropyrimidines S-1 and Capecitabine may Prolong International Normalized Ratios of Prothrombin Time by 3-Fold in Cancer Patients Receiving Warfarin

Masayuki Ikenishi ; Akiko Kuroda ; Haruhiko Tsukazaki ; Masahiko Nakao ; Masashi Takeuchi ; Yuji Konishi ; Toshiyuki Matsuda ; Tohru Ohtori ; Kenji Matsuyama ; Mitsutaka Takada ; Hiroki Satoh ; Yasufumi Sawada ; Mutsuaki Ueda

Japanese Journal of Drug Informatics.2016;18(3):172-178. doi:10.11256/jjdi.18.172

Objective: To compare effects of the fluoropyrimidines S-1 and capecitabine on prothrombin time international normalized ratios (PT-INR) of warfarin following coadministration and after discontinuation of each fluoropyrimidine treatment.
Methods: Medical records of patients receiving warfarin with either S-1 (6 patients) or capecitabine (7 patients) were obtained from four hospitals.
Results: Increased PT-INR was observed until peak levels of warfarin were achieved in all patients in S-1 and capecitabine treatment groups.　Moreover, PT-INR significantly changed after coadministration within each group (p＜0.05).　Specifically, ratios of peak PT-INR after coadministration of each fluoropyrimidine and those following administration of warfarin alone (PT-INR elevation ratio) were 3.31 and 3.29 in S-1 and capecitabine coadministration groups, respectively.　Moreover, numbers of days to peak PT-INR were 38.3 and 31.3 days, respectively, and did not significantly differ between the treatment groups.　Furthermore, PT-INR returned to pretreatment levels by 17.5 and 15.1 days after discontinuation of S-1 and capecitabine, respectively, and did not significantly differ between the treatment groups.
Conclusion: Coadministration of S-1 and capecitabine similarly prolongs PT-INR by approximately 3-fold compared with administration of warfarin alone; therefore, these drug-drug interactions were clinically suggested to be of high risk for episodes of bleeding and remarkable alterations in coagulation parameters.　Therefore, blood coagulation ability should be more carefully monitored with regard to PT-INRs in patients receiving warfarin with S-1 or capecitabine not only during coadministration but also after discontinuation of fluoropyrimidine treatments.

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Questionnaire on Reciprocal Patient-Pharmacist Relationships for Good Self-Medication Practices

Yuka Takahashi ; Itsuko Ishii ; Mayumi Mochizuki ; Jun Yamashita

Japanese Journal of Drug Informatics.2016;18(3):160-171. doi:10.11256/jjdi.18.160

Objective: It is unclear whether the importance of the healthcare professional’s role and the relationship between healthcare users and providers are well understood in self-medication (SM) practices.  We conducted a self-report survey to examine how the role of healthcare professionals in SM is interpreted and how the reciprocal relationship between consumers and pharmacists in SM is recognized.
Design: Questionnaire survey.
Methods: The sample comprised 493 medical professionals (283 pharmacists at hospitals, community pharmacies, and drug stores; 74 instructors at colleges of pharmacy; and 136 personnel of SM-related academic societies).  We mailed questionnaires with informed consent forms from September to November, 2014; those who agreed to participate mailed completed questionnaires back.  We examined how individuals define and interpret SM, clarified each role of pharmacists and consumers regarding several aspects of SM, and collected respondents’ demographic information.
Results: Of the 493 questionnaires mailed, 125 (25%) were returned.  Over 65% of respondents reported familiarity with the preexisting definitions of SM that include the healthcare professional’s role.  However, when asked to define SM in their own words, only 30% included the role of healthcare professionals.  Among respondents who were not engaged in SM-related research, education or promotion, only 24% included the healthcare professionals’ role.  Also, when asked to describe the concrete roles of both pharmacists and consumers, respondents wrote fewer comments on improving living habits, consulting about health concerns, and implementing self-checks than on serving consumers with over-the-counter drugs and health foods.
Conclusion: The importance of reciprocal relationships in SM was not well recognized in our sample.  Our results suggest that it is imperative to disseminate information to raise healthcare professional’s recognition on the importance and clarification of some or all roles of theirs in SM.

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The Surveillance for Contents of Pharmacogenomics Information in Package Inserts and Interview Forms

Fusao Komada ; Hiroshi Nakai

Japanese Journal of Drug Informatics.2016;18(3):149-159. doi:10.11256/jjdi.18.149

Objective: Pharmacogenomics (PGx) is the study of the relationship between the efficacy and/or safety of drugs and the genetic polymorphism.  Since PGx information can be used to personalize medical treatments, there has been a recent increase in the development of drug and companion diagnostic devices based on genome-wide analyses.  Therefore, we surveyed the contents of PGx information in package inserts and interview forms (IF) of Japanese pharmaceuticals, and investigated potential problems with the PGx information supplied by Japanese pharmaceuticals.
Methods: PGx information content in package inserts and the IF used by Japanese pharmaceuticals was compared with that listed in the U.S. pharmaceuticals “Table of Pharmacogenomic Biomarkers in Drug Labeling.”
Results: There were 166 PGx information content listings for 137 drugs described in the “Table of Pharmacogenomic Biomarkers in Drug Labeling.”  However, there were 31 PGx information content listings for 20 biomarkers of 24 drugs that were described in the U.S. but not the Japanese package inserts.  In addition, there was no PGx information for 17 biomarkers of 20 drugs in both the Japanese package inserts and the IF.  We additionally found that 57.7% of the biomarkers with PGx information listed in the package inserts were for drugs that are normally covered by in vitro diagnostic medical insurance.  These biomarkers were mainly the gene mutations and expression of the target molecules.
Conclusions: The Japanese PGx information associated with gene mutations and expression of the target molecules was similar to the U.S. PGx information.  However, the contents of the PGx information for drug-metabolizing enzymes differed widely among each of the drugs.  In order to more effectively use PGx information, a more careful inspection of the information regarding efficacies and side effects will need to be undertaken to ensure better evaluations of patient therapies.

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Hiroyasu Sato ; Yusuke Kanetaka ; Kohei Fujita ; Yuto Taniguchi ; Kiyomi Ishida ; Marino Ishio ; Hitoshi Komori

Japanese Journal of Drug Informatics.2016;18(3):186-191. doi:10.11256/jjdi.18.186

Objective: Similarity in drug appearance is one of the major environmental factors influencing dispensing errors, such as picking the wrong medication (picking error).  The purpose of this study is to verify if the index values of appearance similarity calculated objectively for multiple-specification drugs are the factors of picking error.
Methods: Four variables (number of total prescription, deviation of prescriptions between the specifications, sheet size, and color similarity of the sheet surface) were calculated.  The number of total prescription and deviation of prescriptions were extracted from the dispensing system.  Sheet size and color similarity were calculated, respectively, from the area ratio and by the Histogram Intersection method using the press through package (PTP) sheet image.  To evaluate the relationship between the picking error rate and these four variables, univariate and multivariate analyses were performed.
Results: The number of total prescription and the deviation of prescriptions were not significant factors.  In contrast, sheet size and color similarity significantly influenced the picking error rates.
Conclusion: Similarity in appearance between multiple-specification drugs is a risk factor of picking error.  When the multiple-specification pair has the same sheet size or high color similarity, one needs to be caution of picking error.  Further, in the pharmaceutical industry, to reduce the risk of dispensing errors, it is desirable to carry out the devise to enhance the identity of each specification.

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Problems Regarding Prescription Confirmation and Solutions in Community Pharmacies

Masaki Fujieda ; Takuya Nonaka ; Aiko Hayashi ; Yoshitaka Hasegawa ; Ryota Tsukioka ; Azusa Morisawa ; Miya Ohishi ; Hiroki Satoh ; Yasufumi Sawada

Japanese Journal of Drug Informatics.2016;18(3):192-200. doi:10.11256/jjdi.18.192

Objective: Prescription check and inquiry is one of the most important operations of pharmacists to provide optimal drug therapy to the patient.  Although a number of studies related to inquiries of prescriptions have already been reported, there is little report about requests for doctor and hospital based on the examples.  Therefore, this study aimed to clarify the current problems revealed by inquiries about prescriptions by not only analyzing these inquiries but also investigating requests for doctors and hospitals.
Methods: We investigated 6,255 inquiries about prescriptions and requests for doctors and hospitals at 584 insurance pharmacies from August 4 to 10, 2014.  Then, the inquiries about prescriptions and requests for doctors and hospitals were categorized.
Results: The most frequent category of inquiries about prescriptions was “Questions about administration and dosage” (21.5%).  On the contrary, the most frequent request for doctors was “Efficiency in gathering information from and providing information to a patient” (2,067 cases).
Conclusions: The present study clarified current problems revealed by inquiries about prescriptions by investigating requests for doctors and hospitals that were based on examples.  Furthermore, the problems were classified into ten categories, and these should be noted by doctors and hospitals at the time the prescription was issued.

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Evaluation of Dermatological Disorders Caused by Anti-neoplastic Agents with an Adverse Event Spontaneous Reporting Database

Yuuki Hane ; Ryogo Umetsu ; Junko Abe ; Natsumi Ueda ; Yamato Kato ; Toshinobu Matsui ; Yumi Motooka ; Sayaka Sasaoka ; Haruna Hatahira ; Akiho Fukuda ; Misa Naganuma ; Siori Hasegawa ; Yasutomi Kinosada ; Mitsuhiro Nakamura

Japanese Journal of Drug Informatics.2016;18(3):201-208. doi:10.11256/jjdi.18.201

Introduction: Dermatological disorders are one of the adverse events caused by cancer chemotherapy and are a dose-limiting factor for some anti-neoplastic agents.  The severe symptoms associated with these disorders affect the patients’ quality of life (QOL).  Early countermeasures for the onset of dermatological disorders associated with anti-neoplastic agent administration might be important.
Materials and Methods: We analyzed the occurrences of dermatological disorders after administration of an anti-neoplastic agent in the Food and Drug Administration Adverse Event Reporting System (FAERS), and compared the adverse event (AE) reporting ratio of the total reports.  In addition, we studied the association between anti-neoplastic agents and dermatological disorders using cluster analysis.  Reports for 15 anti-neoplastic agents (4 anti-neoplastic agents and 11 molecular target drugs) were analyzed.
Results: After excluding duplicate data in FAERS, 6,157,897 reports were analyzed.  The number of reports that showed a dermatological disorder was 534,934.  The reporting ratio of hand-foot syndrome with sorafenib and capecitabine was 11.20% and 7.05%, respectively.
Conclusions: We set the cluster number at six; cluster features obtained were as follows: (1) the reporting ratio of hand-foot syndrome was especially high, followed by the reporting ratio of rash, (2) the reporting ratio of rash and erythema was high.  Similar anti-neoplastic agents may demonstrate similar occurrence tendencies of AEs and cluster features.  Further studies are required to draw conclusions over these findings.  Information services based on the feature of each cluster might be useful to improve patient QOL at the clinical site.

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Comparison of Usefulness of Switch OTC Eye Drops among Products

Masahiro Murakami ; Mayumi Nakatani ; Megumi Yasuda ; Manabu Amano

Japanese Journal of Drug Informatics.2016;18(3):209-213. doi:10.11256/jjdi.18.209

Objective: The squeezing force and one-drop weight, suggested to directly influence adherence, were measured in 6 eye drop products containing a switch OTC drug, ketotifen fumarate, to investigate useful information for product selection.
Methods: The squeeze force, one drop weight, and pH were measured using a digital force gauge, analytical balance, and pH meter, respectively.  Information on additives contained in each product was collected from package inserts.  For the total number of drops, the number per 10 mL was calculated from the obtained value.
Results: The maximum squeeze force was 14.8 N of Irice AG Guard, and the one drop weight (33.2 mg) of Raferusa®AL was the minimum.  The total number of drops per 10 mL was 215 in Sutto eyes Z, being the minimum.  The pH was in the range of 5.2-5.7.  On comparison of additives among the products, a cooling agent was contained in only 2 products.
Discussion: Since the squeeze force was in the range of 5.3-14.8 N, it was less likely that the squeeze force reduces usability.  Since the one-drop weights of 2 products were more than 10 mg lower than the weights of the other products, the dose may be insufficient and the effect may not be attained.  The pH was within the acceptable range in all products.  Two products contain a cooling agent as an additive, and this has to be explained beforehand.  Information related to usability, actual feeling of the effect, and sense of the use of the products containing ketotifen fumarate was collected.

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Pharmacoepidemiological Examination for the Safety of the Oral laxatives in the Elderly Patients

Yoshihiro Noguchi ; Yuta Hayashi ; Aki Yoshida ; Ikuto Sugita ; Hiroki Esaki ; Kousuke Saito ; Kazumasa Usui ; Misa Kato ; Tomoya Tachi ; Hitomi Teramachi

Japanese Journal of Drug Informatics.2016;18(3):179-185. doi:10.11256/jjdi.18.179

Objective: Many of the elderly patients are suffering from constipation, are using the oral laxative.  However the risk assessment of the oral laxative is not performed.  Therefore, we used Japanese Adverse Drug Event Report database (JADER) and examined for the safety of the oral laxative in the elderly patients.
Methods: Since the analysis target medicines; 12 oral laxatives and target ADEs; “digestive disorders” and “electrolyte abnormality,” the JADER database for April 2004 to January 2015 were analyzed in adults of age exceeds 60.  We used the reporting odds ratio for a safety index of drugs, using reporting odds ratio, when the Lower bound of the 95% two-sided confidence interval exceeds 1, it is the signal detection of ADE.
Results: The oral laxatives detected the signal of “digestive disorders” were three medicines, and “electrolyte abnormality” were five medicines.  Especially, for electrolyte abnormalities not only increases the blood magnesium values as magnesium oxide, that there is also affect other electrolyte revealed.
Conclusion: Some oral laxatives were also intended to signal detections of the adverse events that are not listed in the attached document, it is necessary to pay attention to the use of them for the elderly patients.

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Factual Survey of Patient Compliance Instructions by Finger-Tip Units for the Purpose of Proper Usage of Adrenocorticosteroid Ointments and Use-Related Evaluation of Such Pharmaceutics

Harunori Takeshita ; Tomomi Inoue ; Naotake Takase ; Takashi Hatae ; Nobuyuki Muroi ; Tsuneo Hamaguchi

Japanese Journal of Drug Informatics.2017;18(4):270-276. doi:10.11256/jjdi.18.270

Objective: Finger-tip unit (FTU) has been used in Western countries to apply a specific amount of steroid ointment available in tube form.  Although prescription ointments for treating skin disorders are available in Japan, there are no indications for patients regarding the amount to be used.  Therefore, we investigated the factual assessment of patient compliance instructions on using the ointments given by pharmacists and conducted a comparative test on the amount of ointment in 1 FTU using commercially available ointment tube products.
Methods: We conducted a questionnaire survey for 21 hospital pharmacists on patient compliance instructions for ointments.  Using six types of ointments, we measured the aperture area of ointment tube, weight of 1 FTU and squeezing number of tube.
Results: Fewer than 50% of pharmacists explained the application methods and amounts for one-time use when they provided patient compliance instructions.  There were many patients who used an ointment inadequately.  The most were problems about the quantity of application.  Wide variations were found among the amount of ointment in 1 FTU weight and number of available uses.
Conclusion: The survey results demonstrated that the methods used to apply the ointments are items that must also be emphasized by pharmacists when providing patients compliance instructions.  Furthermore, the patient compliance instructions should include the amount of ointment in 1 FTU and number of available uses within pharmaceutical products.

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