Survey of the Description of “Medication Guides for Patients” and “Early Post-Marketing Phase Vigilance” on Additional Risk Minimization Activities of Risk Management Plans / 医薬品情報学

Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.

Survey of the Description of the Risk Minimization Activities in Pharmaceutical Risk Management Plans / 医薬品情報学

<b>Objective: </b>Currently, the creation of a pharmaceutical risk management plan (RMP) for new drug information is obliged to pharmaceutical companies.  The created RMP is published on the Pharmaceuticals and Medical Devices Agency (PMDA) website.  RMP is a useful information source to ensure drug safety by healthcare professionals, including pharmacists.  “Risk minimization activities” of the RMP are especially important elements for healthcare professionals because they describe measures to minimize risk to patients.  We conducted a cross-sectional survey of the description of the contents of “risk minimization activities” in the RMP.<br><b>Methods: </b>The RMP of 177 drugs that had been published in February 22, 2016 were investigated.<br><b>Results: </b>Total risks enumerated for the study drugs were 1,678.  “Routine risk minimization activities” constituted 92.0% of total risks.  The most listed item on “routine risk minimization activities” was “attention on the product labeling of the drug package insert” (91.3%).  Differences in the expression level on “attention on the product labeling” were observed.  On the other hand, the most listed item of “additional risk minimization activities” was “the creation of documents for healthcare professionals” (38.3%) and “implementation of Early Post-marketing Phase Vigilance” (27.1%).<br><b>Conclusion: </b>A clear understanding of RMP by healthcare professionals is important.  In the RMP, “risk minimization activities” (especially “additional risk minimization activities”) are the most important contents for healthcare professionals, because they include information of documents created by the pharmaceutical company for patient safety.  The level of description of the contents of RMP varies between drugs.  It is essential that these descriptions be uniform the expression level to be easily and accurately utilized by healthcare professionals.

Factors Influencing the Dispensing of One-Dose Package Medications to Elderly Outpatients / 社会薬学

<p>Decreased adherence to medications among the elderly has become a problem in recent years. To overcome this problem, the dispensing of one-dose packages of medicines has been suggested. The purpose of this study was to survey elderly outpatients in a regional hospital at the Tokachi Development and Promotion Bureau and to analyze the factors that influence patients’ preference for a one-dose package medicine. The dispensation of one-dose package medication was observed in 20% of elderly outpatients. A correlation between the percentage of dispensed one-dose package medications and the number of agents was observed. Furthermore, dispensing rates of one-dose package medications increased with aging. Within the various departments analyzed, one-dose packaging rate was high in the Departments of Cardiology and Psychiatry. In this study, the correlation between residential municipalities of outpatients and one-dose package medications was examined. In the municipalities with a high rate of aged individuals and high average of household members, one-dose package medication rate was low. Multivariate logistic regression analysis confirmed these factors as significant. That one-dose packaging rates increased with the number of drugs and aging are consistent with the notion that one-dose package medications are designed to increase drug adherence among the elderly. Interestingly, one-dose package dispensing rate was low in areas with advanced aging. Because aging in Japan is expected to advance in the future, it is important to survey one-dose package dispensations.</p>

Influence of Similarity of the Sheet Appearance in Multiple-Specification Drug on Taking Error / 医薬品情報学

<b>Objective: </b>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.<br><b>Methods: </b>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.<br><b>Results: </b>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.<br><b>Conclusion: </b>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.

Comparison between Risks Listed in the Risk Management Plan and the Product Labeling of the Drug Package Insert / 医薬品情報学

<b>Objective: </b>Currently, Risk Management Plans (RMPs), plan that provide new risk information about drugs, are published on the Pharmaceutical and Medical Devices Agency (PMDA) website.  The aim of this study was to compare enumerated risks in RMPs to the product labeling (PL) of the drug package insert.<br><b>Methods: </b>The risks listed in RMPs on the PMDA website were assessed on February 10, 2014.  We investigated the documentation of these risks on the PL.<br><b>Results: </b>Seven-hundred and eighty-five risks were enumerated in the RMPs of 77 drugs.  The enumerated risks were classified as “important identified risks” (66%), “important potential risks” (22%), and “important missing information” (12%).  Ninety-four percent of risks listed in RMPs were documented on the PL.  A portion of both the “important identified risks” and “important potential risks” groups were not documented on the PL.<br><b>Conclusion: </b>This study was clearly the relation between risks listed in RMPs and documents on the PL.  Because a portion of the risks listed in RMPs was not documented on the PL, RMPs provide more safety information.  It is necessary to better understanding their characteristics, considering RMPs are a new source of drug information.