ABSTRACT
Objective: Risk Management Plan (RMP) is created and submitted by a pharmaceutical company while applying for new drug approval; it is published to be used by healthcare professionals. For example, healthcare professionals utilize RMP when considering whether to adopt a drug. However, there is no stipulation for the release date of RMPs; moreover, surveys regarding this are limited. We conducted a cross-sectional survey on the relationship between RMP-related timing and regulatory affairs-related timing.Methods: The surveyed drugs were those for which the first version of RMP was notified by PMDA Medinavi (mail delivery service) in FY2014 and FY2018. We examined regulatory affairs-related timing (i.e., “manufacturing and marketing approval date,” “drugprice standards listing date,” and “release date”) and RMP-related timing (i.e., “RMP creation date” and “Medinavi delivery date”).Results: For 7 of 43 items in FY2014 and 5 of 41 items in FY2018, the “RMP creation date” occurred later than the “drug-price standards listing date.” For one item in FY2014, the “RMP creation date” occurred later than the “release date.” For 12 items in FY2014 and 13 items in FY2018, the “Medinavi delivery date” occurred later than the “release date.”Conclusion: No considerable difference was confirmed between FY2014 and FY2018 regarding RMP-related timing and regulatory affairs timing. It was confirmed that there were several items for which the RMP creation occurred later than drug-price standard listing and items for which the publishing notice by Medinavi was delayed for drug marketing release. To promote the utilization of RMPs by healthcare professionals, RMPs must be created and published without delay.
ABSTRACT
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.
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<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>
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<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.
ABSTRACT
<b>Objective: </b>Taking the wrong medicine or medication error is a serious concern to patient safety. The aim of this study was to statistically survey the relation between the placement of drugs on medicine shelf and the occurrence of error in taking a medicine.<br><b>Methods: </b>The study comprised 2 groups. The incident group contained 43 cases that were erroneously taken in the Obihiro Kosei General Hospital. The control group contained 43 drug pairs matched by the similarity index of the drug names from among the drugs used in the hospital at random. The similarity index of drug names was based on 10 quantitative indicators. The distance of medicine shelf arrangement was represented by three variables: the horizontal distance, the vertical distance and the distance of shelf block. Conditional logistic regression analyses of the occurrence of medication errors were performed by evaluating the three variables of the distance factor and their interaction for error in taking a similar-sounding named drugs.<br><b>Results: </b>Conditional logistic regression analysis revealed that the vertical distance (OR: 0.64, 95%CI: 0.42-0.99) and the distance of the shelf block (OR: 0.74, 95%CI: 0.57-0.97) were significant risk-reduction factors of medication errors. Four variables were extracted as the most suitable logistic regression model in terms of the interaction between them. As the interaction between 3 variables (the horizontal distance, the vertical distance and the distance of shelf block) was significant (OR: 0.93, 95%CI: 0.86-0.99), they may be considered as synergistic risk-reduction factors. Moreover, the horizontal distance was found to be a risk-enhancement factor (OR: 1.52, 95%CI: 0.93-2.48).<br><b>Discussion: </b>In order to reduce the risk of medication errors due to similar-sounding drug names, placement of drug on the medicine shelf should take into consideration the three coordinates of the distance factor.