Construction of Evidence Body for Revision of Safety Information on Package Inserts of Chinese Patent Medicines in Post-marketing： Taking Xiaoke'an Capsules as an Example / 中国实验方剂学杂志

ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.

Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

Signal Detection and Safety Information Generation of Aripiprazole in Spontaneous Adverse Event Reports Database / 대한정신약물학회지

OBJECTIVE: Korea Institute of Drug Safety and Risk Management works for signal detection and safety information generation by analyzing spontaneous adverse event reports database. As the number of reports and detected signals of aripiprazole by each data mining indices were more than other drugs, aripiprazole was selected as a subject of study. METHODS: 1989-2012 spontaneous reporting database was analyzed and the model drug ingredient was aripiprazole. We estimated proportional reporting ratio, reporting odds ratio, and information component for data mining. Then we assessed the causality through review of local and foreign drug labels and literatures. RESULTS: In reconstructed 1989-2012 spontaneous reporting database, there were 2,062 reports on aripiprazole and 2,565 aripiprazole-adverse events pairs. As a result of data mining analysis and signal prioritization, 78 adverse events were detected, 20 adverse events of them were not included in drug label. After literature review, back pain, epistaxis, xerophthalmia and ejaculation disorder were generated as novel safety information on aripiprazole. CONCLUSION: Those 4 novel safety informations of Aripiprazole, back pain, epistaxis, xerophthalmia and ejaculation disorder had become listed on the local label in April 2013.

A Survey of the Collection, Provision, and Application of Drug Safety Information at Hospitals / 医薬品情報学

<b>Objective: </b>We conducted a questionnaire survey to comprehend the situation regarding the collection, provision, and utilization of drug safety information at hospitals.  In addition, we asked pharmaceutical companies how they select medical institutions to provide drug safety information.  We also investigated the current situation of information provision to Tokyo Medial Center by pharmaceutical companies.<br><b>Method: </b>A questionnaire was mailed to all hospitals in Japan.  The survey was conducted between January 13 and February 10, 2011.  Moreover, we asked thirteen pharmaceutical companies by telephone and e-mail about the implementation status of the provision of information and performed a survey at Tokyo Medical Center on the current situation of information provision by pharmaceutical companies regarding revisions to precaution sections in package inserts.<br><b>Results: </b>The results of the questionnaire survey (response rate: 41.2%) showed that the major information sources for hospitals were medical representatives (77.8%), Drug Safety Update (50.3%) and direct mails (49.3%).  Furthermore, in the case of drugs prescribed exclusively for extramural dispensing, fewer hospitals responded that medical representatives of the pharmaceutical companies provided drug safety information and more hospitals responded that they did not obtain any drug safety information at all, compared with drugs listed in the hospital formularies.<br><b>Conclusion: </b>To minimize the risks of drugs, healthcare professionals must collect a wide range of drug safety information and must utilize this information in their medical practice.  Therefore, it is important that pharmaceutical companies and regulatory authorities make an effort to provide suitable information dissemination to medical institutions.  Furthermore, medical institutions must also strengthen their systems for collecting drug safety information and providing such information to healthcare professionals.

Usefulness of Electronic Mailing as an In-Hospital Drug Information Transmittal System: Assessment of Active Transmissions for Adverse Effect Information / 医薬品情報学

<b>Objective: </b>In the management of drug information, pharmacists are required to appropriately transmit information to the corresponding medical staff.  However, it is unclear whether the transmitted information is received and utilized effectively.  In this study, we assessed the effectiveness of drug safety information transmitted to doctors by pharmacists and investigated the requirements of doctors for the transmitted drug safety information in Okayama University Hospital.<br><b>Design and Methods: </b>We performed the assessment via questionnaire from doctors who had been sent drug safety information by electronic mail (e-mail) from January to October 2010.  The return rate and responses for the questionnaire were investigated.<br><b>Results: </b>For the study time period, 15 cases of e-mail drug safety information transmissions occurred.  The questionnaire was sent to 204 doctors, and the recovery rate of the questionnaire was 46.1%.  Seventy-six percent of doctors who responded to the questionnaire answered that the e-mail information was useful for the clinical practice.  Among the comments, it was noted that an improvement in the content of e-mail information would allow doctors to access the required information more conveniently.<br><b>Conclusion: </b>In this study, it was demonstrated that the majority of doctors were satisfied with the transmission of drug safety information using e-mail, although some improvement was needed.  Furthermore, it was considered that the feedback assessment and re-construction of information transmittal system were important to improve usability and availability of the drug information service.

Risk Communication Regarding Drugs:The FDA Strategic Plan for Risk Communication / 薬剤疫学

In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.<br>FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".<br>In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.

Analysis and Evaluation of Drug Safety Information Available in a Community Pharmacy for the Event Monitoring System in Japan / 薬剤疫学

Objective : We studied the effective utilization of the community pharmacy-based prescription data for the event monitoring system in Japan, and attempted to evaluate the association between symptoms suspected of adverse drug reactions (ADRS) and the drug, inorder to improve the quality of ADR reports.<BR>Methods : 1) The community pharmacy-based prescription data obtained from 98 patients to whom medicines were dispensed in a community pharmacy, were examined to select subjects who had discontinued drug treatment and to evaluate outcome after the discontinuation.2) In the cases who discontinued treatment, risk information (for example, timing from the onset of therapyto the appearance of symptoms, outcome after discontinuation, relapses and disease states, etc....) was collected from the prescription data. The association between the specific symptoms and the suspected drug was evaluated using the algorithm of Kitaguchi et al. (IYAKUHIN KENKYU 1983; 14 : 980-992).3) Also, the 98 patients were screened for subjective symptoms by interview using an ADR check list, and the cases that complained of symptoms of suspected ADRS were selected.4) In the selected cases, risk information was collected by talking with the patients, and the association between symptoms and the suspected drug was evaluated by this algorithm.<BR>Results : 1) 16 cases with 26 symptoms had discontinued drug treatment. In these cases, the information related to the outcome after the drug discontinuation and disease states were obtained;not much information was available from the medication records. By using the algorithm, in 46% of the symptoms of these cases, the association between the symptoms and the drug was assessed as “possible”. Percentages of “definite”, “probable” and “remote” were 4%, 27% and 23%, respectively. 2) As a consequence of screening, 27 patients with 82 symptoms were suspected of ADRS. In these cases, there was little information related to timing, outcome and disease state. In fact, in half of the symptoms of these cases, the association between symptoms and the suspected drug could not be precisely determined.<BR>Conclusion : For the purpose of improvement in quality of ADR reports, community pharmacies need to develop a good relationship with health care agencies or providers to share clinical information and risk informations, as well as, to collect the time course information related to ADRS from the appearance of the symptoms to disappearance after drug discontinuation. The event monitoring system in Japan does not require causality evaluations for suspected ADRS now, however, the intention to effectively evaluate causality will improve the usefulness of ADR reports.