Bibliometric analysis of drug package insert adaptation for the elderly based on Web of Science / 中国药房

OBJECTIVE To explore the hotspots of aging adaptation of drug package inserts， and to provide evidence for the development of aging adaptation of drug package inserts in China. METHODS The relevant English literature on drug package inserts for the elderly published from 2012 to 2022 was retrieved from Web of Science Core Collection； bibliometric analysis was performed by using VOSviewer and CiteSpace software， to explore research hotspots in this field， and summarize obstacles and solutions for the development of this field. RESULTS & CONCLUSIONS This study collected a total of 335 literature related to the aging adaption of drug package inserts， from 819 research institutions in 51 countries （regions）， involving 2 174 authors. The research development of drug package insert adaptation for the elderly has slowed down in the past decade， and developed countries such as the United States and Japan dominate this field. Authors such as Wolf from Northwestern University in the United States， have the largest number of publications（12 literature）. The research focuses in this field include the risk management of medication for the elderly， the updating of medication information for the elderly in drug package inserts， and the understanding and compliance of the elderly with drug package inserts and their influencing factors. The solutions to related obstacles in the development of aging adaption in drug package inserts include improving the visibility and readability of drug package inserts， filling in the information on elderly medication in drug package inserts， and so on. China can learn from the experiences and methods of other countries， conduct investigations into the influencing factors of elderly package inserts and pharmacokinetic studies based on the characteristics of the Chinese population， and improve the safety of medication for elderly patients in multiple dimensions.

A quality audit of the medicinal package insert information of drugs marketed in India

Background: A package insert (PI) accompanying medicinal products is a concise and accessible source of evidence-based information for health professionals and consumers alike. In India, the supplied information should be adequate and fulfill the statutory regulations of the Drug and Cosmetics Rules (1945) to ensure the safe and effective drug use. Aim and Objectives: The present observational study aimed to evaluate the uniformity and adequacy of information on PIs available in India. Materials and Methods: PIs of approved and marketed drugs were collected from pharmacies and analyzed with the help of a 30-item checklist comprising of components of statutory guidelines and other quality indicators. Each item was assigned a weightage of two points if the information was complete, one if inadequate, and 0 if absent. The total score was calculated for each PI. Results: The median score of the 150 analyzed PIs was 41 (Inter quartile range, 36.00–45.25) out of a maximum value of 60. The major deficiencies observed were in providing missed dose instructions (91.33%), further reading resources (84.67%), supporting references (83.33%), and drug disposal instructions (76%). Other notable missing information were laboratory parameter interference (68.67%), clinical trial data (62%), adverse drug reaction reporting contact information (56.67%), and list of excipients (49.33%). Conclusion: There are important inadequacies in the clinical information provided in Indian PIs which can affect patient health and hinder rational drug use. Thorough evaluation and revision of the PIs is warranted to make them more reliable and popular among users.

Changes in Registration Status of Identification Codes on PMDA’s Information Search Site of Pharmaceuticals for Prescription / 医薬品情報学

The identification code of a drug is defined as “a code for identifying tablets, etc.” and is described in the “Composition/Properties” section of the package insert. We investigated whether the Pharmaceuticals and Medical Devices Agency (PMDA) website, which allows users to search package insert information, can be used for drug identification using identification codes in 2019 before the new package insert guidelines were implemented, and in 2022, during the revision period. Approximately 30% of the investigated high-risk drugs were unidentifiable in both years. The most common reason was that images were used to register identification codes on the PMDA website, and character strings were not searchable. We then conducted a questionnaire survey of pharmaceutical companies, and only approximately half of the respondents opined that it would be preferable if the registration format for identification codes was established within the pharmaceutical industry. However, hospital pharmacists urged for more simplified identification of drugs on the PMDA website.

Study of Contraceptive Duration Described in the Information Materials of Prescription Drugs Requiring Contraception / 医薬品情報学

Objective: In the instructions for package inserts (PI) of prescription drugs revised in June 2017, the section “persons with reproductive potential” was established under “precautions concerning patients with specific backgrounds.” The description rules associated with contraceptive duration were modified in these. In this study, we investigated descriptions of contraceptive duration in PI that were prepared based on the revised instructions, interview forms (IF), and other proper use materials (PM).Methods: We collected PI, IF, and PM of prescription drugs containing a new active ingredient approved from April 2017 to March 2022 for which the PI were prepared based on the revised instructions and investigated descriptions of PI, contraceptive duration, and its evidence in each information material.Results: Of the 181 drugs studied, 43.1 and 12.7% required females and males to use contraception during the period of drug consumption, respectively. Among these, the ratio of drugs that had descriptions of contraceptive duration were 15.4 and 0% for females and males at PI, respectively; 51.3 and 39.1% for female sand males at IF, respectively. Anticancer drugstended to describe contraceptive duration in the PM rather than PI or IF. For some drugs, there was no description of contraceptive duration in any of the materials. Contraceptive durations ranged from the period of administration of that drug to over a year for females and approximately one week to six months for males. The reasons for these contraceptive durations were diverse.Conclusion: Contraceptive information in the PI based on revised instructions were not sufficient for use by healthcare workers, even when the IF and PM were confirmed. These results suggest that there is a need for standardizing the descriptions, types of materials to be described, and choice of evidence for contraceptive duration.

Finite element analysis of artificial ankle elastic improved inserts / 中国修复重建外科杂志

OBJECTIVE@#To discuss the influence of artificial ankle elastic improved inserts (hereinafter referred to as "improved inserts") in reducing prosthesis micromotion and improving joint surface contact mechanics by finite element analysis.@*METHODS@#Based on the original insert of INBONE Ⅱ implant system (model A), four kinds of improved inserts were constructed by adding arc or platform type flexible layer with thickness of 1.3 or 2.6 mm, respectively. They were Flying goose type_1.3 elastic improved insert (model B), Flying goose type_2.6 elastic improved insert (model C), Platform type_1.3 elastic improved insert (model D), Platform type_2.6 elastic improved insert (model E). Then, the CT data of right ankle at neutral position of a healthy adult male volunteer was collected, and finite element models of total ankle replacement (TAR) was constructed based on model A-E prostheses by software of Mimics 19.0, Geomagic wrap 2017, Creo 6.0, Hypermesh 14.0, and Abaqus 6.14. Finally, the differences of bone-metal prosthesis interface micromotion and articular surface contact behavior between different models were investigated under ISO gait load.@*RESULTS@#The tibia/talus-metal prosthesis interfaces micromotion of the five TAR models gradually increased during the support phase, then gradually fell back after entering the swing phase. The improved models (models B-E) showed lower bone-metal prosthesis interface micromotion when compared with the original model (model A), but there was no significant difference among models A-E ( P>0.05). The maximum micromotion of tibia appeared at the dome of the tibial bone groove, and the ​​micromotion area was the largest in model A and the smallest in model E. The maximum micromotion of talus appeared at the posterior surface of the central bone groove, and there was no difference in the micromotion area among models A-E. The contact area of the articular surface of the insert/talus prosthesis in each group increased in the support phase and decreased in the swing phase during the gait cycle. Compared with model A, the articular surface contact area of models B-E increased, but there was no significant difference among models A-E ( P>0.05). The change trend of the maximum stress on the articular surface of the inserts/talus prosthesis was similar to that of the contact area. Only the maximum contact stress of the insert joint surface of models D and E was lower than that of model A, while the maximum contact stress of the talar prosthesis joint surface of models B-E was lower than that of model A, but there was no significant difference among models A-E ( P>0.05). The high stress area of the lateral articular surface of the improved inserts significantly reduced, and the articular surface stress distribution of the talus prosthesis was more uniform.@*CONCLUSION@#Adding a flexible layer in the insert can improve the elasticity of the overall component, which is beneficial to absorb the impact force of the artificial ankle joint, thereby reducing interface micromotion and improving contact behavior. The mechanical properties of the inserts designed with the platform type and thicker flexible layer are better.

Serviço Social e inserção social da Pós-graduação: reflexões a partir do oeste do Paraná / Social Work and social insert of Post-graduate: reflexions from west of Paraná

Resumo: O artigo objetiva evidenciar a concepção e ações desenvolvidas no campo da inserção social a partir da realidade sócio-histórica da pós-graduação em Serviço Social na Universidade Estadual do Oeste do Paraná - Unioeste, localizada na tríplice fronteira internacional no Sul do país. Reflete sobre o sentido ético-político do Serviço Social como área de conhecimento e da inserção social incluída como quesito no modelo de avaliação da Capes.

Abstract: The goal of the paper is to highlight the conception and actions developed in social insert field having as starting point the historical and social reality of Social Work Post Graduation course at Western State University of Paraná - UNIOESTE, located in the triple internacional border in the south of the country. It reflects upon the political and ethical meaning of Social Work as a field of knowledge and the social insert included as requirement in Capes evaluation model.

Comparative evaluation of intravaginal slow release Dinoprostone insert, transcervical foley’s catheter, intracervical Dinoprostone gel for induction of labor in patients with poor Bishop’s score: a randomized control study

Background: Induction of labor is indicated when the continuation of pregnancy poses risk to the mother or fetus. A variety of mechanical and pharmacologic methods are available but the best method of labor induction still remains unknown, study aimed at comparing the efficacy and safety among the two agents: transcervical Foley’s balloon catheter (FBC) and intravaginal slow release Dinoprostone E2 insert (DVI) with dinoprostone gel as control.Methods: A total of 174 patients were randomized into three groups of 58 each (Group A: dinoprostone 10 mg slow release intravaginal insert, Group B: transcervical Foley’s 16 French catheters, and Group C as control: 0.5 mg intracervical Dinoprostone gel. The safety and efficacy was compared among the groups. A p value of < 0.05 was considered statistically significant.Results: The mean insertion to active labor time (in hours) was significantly lower in Group A as compared to Group B (5.88±3.06 versus 13.56±2.8, p < 0.0001). Meantime of insertion to delivery (in hours) was significantly lower in Group A as compared to Group B (10.91±5.24 versus 21.17±2.99, p < 0.0001). The requirement of oxytocin for induction and augmentation in Group A was significantly lower as compared to Group B. Majority of the patients had normal vaginal delivery (NVD) in all the three groups. Regarding safety profile we found that slow-release DVI had more incidence of uterine tachysystole, but none of the cases had any fetal heart rate abnormality. Maternal fever was more in the FBC group, however, neonatal outcomes were comparable in both groups.Conclusions: The study concludes that slow release DVI is better in terms of efficacy as compared to transcervical FBC for induction of labor as assessed by improvement in Bishop score, insertion to active labor time and insertion to delivery time and comparable in terms of safety profile.

Development and validation of analytical method by HPLC-DAD for determination of vasodilator active in pharmaceutical ophthalmic forms

The substance 4-Aminobenzamidine dihydrochloride (4-AD) is one of the degradation products of diminazene aceturate and has demonstrated antiglaucomatous potential. Glaucoma is the second leading cause of blindness worldwide; thus, new therapeutic alternatives must be studied, for example, the molecule 4-AD vehiculated into polymeric inserts for prolonged release. The present work aims to develop and validate an analytical method to quantify 4-AD in pharmaceutical ophthalmic forms. A HPLC was used with UV-Vis detector, at 290 ƞm and ACE® C18 column (125 × 4.6 mm, 5 µm), in which the mobile phase consists of phosphate buffer (pH 7.4) and triethylamine (30 mmol/L), under an isocratic flow of 1.0 mL/min. The retention time of 3.2 minutes was observed. The method was developed and validated in accordance with ANVISA recommendations and ICH guides. The linearity range was established between the concentrations 5 and 25 µg/mL (correlation coefficient r = 0.993). The accuracy, repeatability, and intermediate precision tests obtained a relative standard deviation less than or equal to 5%. In addition, the method was considered selective, exact. and robust, with pH being its critical factor. Therefore, the HPLC analysis method is robust and can be used to quantify 4-AD in pharmaceutical forms for ocular application.(AU)

O perfil dos egressos da residência multiprofissional de um complexo de serviços de saúde público / The profile of graduates from the multiprofessional residency of a complex of public health services

O Grupo Hospitalar Conceição é um complexo de serviços de saúde que atende de forma exclusiva pelo Sistema Único de Saúde/SUS e possui assistência em todos os níveis de atenção. Sua Residência Multiprofissional forma profissionais há 16 anos e tem sete programas. O objetivo desta pesquisa foi identificar o perfil sociodemográfico e de empregabilidade de egressos destes programas, no período 2004 até 2019, permitindo que o egresso fizesse uma avaliação da formação recebida. Método: estudo exploratório, descritivo e com abordagem quantitativa. O questionário foi encaminhado e respondido pela internet. Os dados foram processados em planilhas do Programa Excel e foram analisados no programa Statistical Package for the Social Sciences ­ SPSS, na Versão 16, por meio de medidas descritivas e teste Exato de Fisher expandido. A significância estatística adotada foi de 5% (p<0,05). A população do estudo envolveu todos que concluíram o Programa entre 2004 e 2019, totalizando 279 participantes. Resultados: em relação ao perfil, 90,3% dos egressos são mulheres, 49% são solteiros e 57% nascidos no interior. Na empregabilidade, 93% dos egressos estão trabalhando, 90% consideram que a residência contribuiu para sua inserção, 74% possuem trabalho relacionado à formação, 49% têm vínculo público e 42% tem carga horária de até 36 horas. Homens ganham 36% a mais do que as mulheres. Houve significância estatística entre vínculo anterior e ocupação atual, assim como entre satisfação profissional e inserção na área de formação e remuneração. Os princípios do SUS são bem aplicados na prática profissional dos egressos. Na avaliação do curso, a avaliação geral ficou com 84% de ótimos e bons, os itens mais bem avaliados foram Formação recebida ­ com 97% (ótimos e bons); Aprendizado e Conhecimentos práticos oportunizados ­ ambos com 94% de ótimos e bons.

The Conceição Hospital Group is a health services complex that provides services exclusively through the Unified Health System/SUS, having assistance at all levels of care. Its Multiprofessional Residency has trained professionals for 16 years and has seven programs. The goal of this research was to identify the sociodemographic and employability profiles of graduates from these programs, in the period between 2004 and 2019, allowing the graduate to assess the training received. Method: exploratory, descriptive study with a quantitative approach. The questionnaire was sent and answered over the internet. The data were processed in Excel spreadsheets and were analyzed using the Statistical Package for the Social Sciences - SPSS, Version 16, using descriptive measures and an expanded Fisher's exact test. The statistical significance adopted was of 5% (p <0.05). The population of the study involved everyone who completed the Program between 2004 and 2019, totaling 279 participants. Results: regarding the profile, 90.3% of the graduates are women, 49% are single and 57% are born in the countryside. With respect to the employability, 93% of graduates are currently working, 90% consider that the residency program contributed to their insertion in the labor market, 74% have jobs related to their training, 49% have a public job and 42% have a workload of up to 36 hours. Men earn 36% more than women. A statistical significance has been found between previous employment and current occupation, as well as between job satisfaction and insertion in the area of training and remuneration. SUS principles are well applied in the professional practice of graduates. In the evaluation of the course, the overall evaluation was 84% excellent and good; the best rated items were Training received - with 97% (excellent and good); Learning and practical knowledge provided - both with 94% of great and good.

Costo de recolocación de catéter central inserción periférica en neonatos de un hospital de tercer nivel / Relocation cost peripherally inserted central catheter in neonates of a tertiary hospital / Custo da recolação do cateter central de inserção periférica em neonatos de um hospital de terceiro nivel / Coüt du repositionnement du cathéter central á insertion périphérique chez les nouveau-nés d'un hopital tertiaire

Resumen Objetivo: Determinar los costos por recolocación de catéter central de inserción periférica (PICC) por complicaciones mecánicas en neonatos de un hospital de tercer nivel. Material y métodos: Estudio de análisis de costos de recolocación de catéter central de inserción periférica en el área de cuidados intensivos neonatales de un hospital de tercer nivel de Tabasco durante el año 2016. Para el cálculo de costos se elaboró un modelo de costeo adaptado del sistema ABC para ser aplicable en un hospital; se diseñó la fórmula: a + b + c + d + e. Para obtener el costo total de recolocación de PICC; donde a= Costo servicio personal por procedimiento para reparación del Evento Adverso X número de trabajadores participantes, b = Insumo requerido para reparar el Evento Adverso, c = Costo por auxiliar diagnóstico (USG, Tomografia, Rayos X, Labs.), d = Costo medicamento y material de curación utilizado por Evento Adverso, e = Número dia estancia en UCIN X costo D-C-O en UCIN. Resultados: Se revisaron 43 expedientes clínicos obtenidos de la base de datos del programa SICALIDAD del hospital; se identificaron 22 casos de ruptura de PICC, 20 casos por obstrucción, 1 caso por retiro accidental. Conclusiones: El costo derivado de las 22 recolocaciones fue de $1,512,248.56 afectando los recursos financieros del hospital. Se observó una cadena de procedimientos e intervenciones altamente generadores de costos.

Abstract Object: To determine the costs of repositioning peripheral central insertion catheter (PICC) due to mechanical complications in neonates of a tertiary hospital. Materials and methods: Cost analysis study of peripherally inserted central catheter in the neonatal intensive care unit of a tertiary hospital in Tabasco during 2016. To obtain the total cost of repositioning PICC; where a = Cost of personal service by procedure for repairing the Adverse Event X number of participating workers, b = Input required to repair the Adverse Event, c = Cost per diagnostic assistant (USG, Tomography, X-ray, Labs.), d = Medication cost and healing material used by Adverse Event, e = Day number stay in NICU X cost D-C-O in NICU. Results: 43 clinical files were reviewed obtained from the database of the SICALIDAD program of the hospital; we identified 22 cases of PICC rupture, 20 cases due to obstruction, 1 case due to accidental withdrawal. Conclusions: The cost derived from the 22 relocations was $ 1,512,248.56 (Mexican pesos), affecting the financial resources of the hospital. A chain of highly cost-generating procedures and interventions was observed.

Resumo Objetivo: Determinar os custos do recolocação do cateter central de inserjao periférica (PICC) devido a complicares mecânicas em neonatos de um hospital de terceiro nível. Materiais e métodos: Estudo sobre o custo do recolocação de um cateter central inserido perifericamente na área de cuidados intensivos neonatais de um hospital terciário em Tabasco durante o ano de 2016. Para o cálculo dos custos, foi desenvolvido um modelo de cálculo de custos adaptado do sistema ABC para ser aplicado num hospital; com a seguinte fórmula: a + b + c + d + e. Para obter o custo total do reposicionamento da PICC; onde a = custo com os profissionais de saúde por procedimento para reparar o evento adverso X número de trabalhadores participantes, b = entrada necessária para reparar o evento adverso, c = custo por exame auxiliar de diagnóstico (USG, tomografia, raios-X, laboratórios), d = custo do material e tratamento usado pelo Evento Adverso, e = Número de dias nas UCIN's X custam DCO em UCIN. Resultados: Revisou-se 43 registos clínicos obtidos no banco de dados do programa SICALIDAD do hospital; Identificou-se 22 casos de ruptura de PICC, 20 casos de obstrução, 1 caso de remojao acidental. Conclusões: O custo derivado das 22 recolocajoes foi de US $ 1.512.248,56, o que prejudicou os recursos financeiros do hospital. Observou-se uma série de procedimentos e de intervenções altamente geradores de custos.

Résumé Objectif: Déterminer les coüts de repositionnement du cathéter central á insertion périphérique (PICC) par des complications mécaniques chez les nouveau-nés d'un hopital tertiaire. Matériaux et méthodes: Étude de l'analyse des coüts de la relocalisation de cathéter central á insertion périphérique dans l'unité de soins intensifs néonatals dans un hopital tertiaire á Tabasco en 2016. Pour le calcul des coüts un modéle d'établissement des coüts adapté du systéme ABC a été élaboré pour étre applicable dans un hopital : la formule a été conjue: a + b + c + d + e. Pour obtenir le coüt total du repositionnement du PICC; ou a = Coüt du service personnel par procédure pour la réparation du nombre d'événements indésirables X des travailleurs participants, b = entrée nécessaire pour réparer l'événement indésirable, c = Coüt par assistant de diagnostic (USG, Tomographie, X-Ray, Labs.), d = coüt des médicaments et matériel de guérison utilisé par l'événement indésirable, e = Le nombre de jours reste dans l'USIN X coüte D-C-O dans l'USIN. Résultats: 43 dossiers cliniques ont été examinés obtenu á partir de la base de données du programme SICALIDAD de l'hopital; nous avons identifié 22 cas de rupture de PICC, 20 cas dus á une obstruction, 1 cas dü á un retrait accidentel. Conclusion: Le coüt des 22 réinstallations s'est élevé á 1 512 248,46 $, ce qui a eu une incidence sur les ressources financiéres de l'hópital. Une chame de procédures et d'interventions trés coüteuses a été observée.

A Rare Case Of Cong Corneal Dystrophy Associated With Cong Ant Stapjyloma Left Eye

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The study of pathogenic mechanism in hereditary gingival fibromatosis / 实用医学杂志

Objective To determine the role of B cell specific moloney leukemia virus insert site 1 (Bmil) in hereditary gingival fibromatosis (HGF). Methods The HE staining was used to analyze the HGF and normal groups. The protein and mRNA of the Bmil, PCNA and caspase-3 in 2 groups were detected by immunohistochemistry and PCR, respectively. Results In HGF group, the gingival epithelial was incrassation, epithelial spikes was elongation, connective tissue was rich in fibroblast and collagen fibers, aless blood vessels and mild inflammatory hyperplasia. Bmil expression was higher (P < 0.05) and caspase-3 expression was lower (P < 0.05) in HGF group than in normal group. There was no difference of PCNA expression in the 2 groups (P> 0.05).Conclusion The Bmil might have a role in the pathogenesis of HGF by decreasing caspase-3 and caspase-3 mRNA.

Association between genetic variation of kinase insert domain receptor and prognosis in colorectal cancer patients received 5-FU based adjuvant chemotherapy / 中国肿瘤生物治疗杂志

@# Objective: To investigate the association between genetic variation of kinase insert domain receptor (KDR) and the prognosis in colorectal cancer (CRC) patients received 5-FU based adjuvant chemotherapy. Methods: The clinical data of 176 CRC patients, who underwent surgical treatment at the Department of Anus and Intestine Surgery, People’s Hospital of Zhengzhou during January 2012 and December 2017, were retrospectively analyzed, and 93 cases of tumor tissues were collected for this study. The genotype of KDR polymorphism locus was detected by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). qPCR was used to detect the expression of KDR mRNAin colorectal cancer tissues. The correlation between the polymorphism genotypes and other variables was analyzed by logistic regression model. The expression of different genotypes of KDR was analyzed by nonparametric test. The relationship between KDR genotype and prognosis of patients was analyzed by Kaplan-Meier survival analysis, and the other variables were adjusted by Cox risk scale model. Results: Of the polymorphisms analyzed, only rs2071559 was of clinical significance. The distribution frequency of KDR rs2071559 in 176 CRC patients was as follows: TT genotype in 95 cases (53.98%), TC genotype in 70 cases (39.77%) and CC genotype in 11 cases (6.25%); the minor allele frequency was 0.26; and the distribution of three genotypes was in accordance with Hardy-Weinberg's Equilibrium (P=0.690). The median disease free survival (mDFS) of patients carrying C allele and wild type TT genotype was 4.4 and 3.2 years, respectively (P<0.05); The median overall survival (mOS) of patients with TC/CC genotype and TT genotype was 5.2 and 4.0 years, respectively (P<0.05). After COX model modification, the effect of TC/CC genotype on mOS was still statistically significant (OR=0.55, P<0.05). The mRNA expression of KDR in cancer tissues of the patients with TC/CC genotypes were significantly lower than those of the wild type TT genotype (P<0.01). Conclusion: The polymorphism of KDR rs2071559 is associated with clinical outcomes in patients with colorectal cancer. KDR rs2071559 may affect the prognosis of colorectal cancer patients by affecting the mRNAexpression of KDR.

A study of clinical information of various package inserts: an approach to encourage adverse drug reaction reporting and emphasis on black box warning

Background: The package insert (PI) is important for providing accurate and reliable product information which is essential for the safe and effective use of medications.Methods: A total number of 115 PIs from pharmacological drug class such as antibiotics, drugs acting on central nervous system and drugs acting on endocrine system were collected from pharmacy store. Contents and presentation of the PIs was critically evaluated by comparing the information as listed in the Drugs and Cosmetics Rules, 1945.Results: The results were expressed under headings as listed in the Drugs and Cosmetics Rules, 1945. The information in the package inserts was inadequate in many aspects; for example, adverse drug reactions were not mentioned completely, information for special population and guidelines for use of the drugs also was lacking. Moreover, black box warning was seen only in few PI. For PI of antibiotics; legibility 80%, use in special populations 76.66%, undesirable effects 46.66%. For PI of CNS of legibility 60%, use in special populations 73.33%, undesirable effects 70%. For PI of endocrine system of legibility 70%, use in special populations 70%, undesirable effects 36.66%.Conclusions: The results reveal that, information relevant to the safe and effective use of medication was not mentioned in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.

Status of package insert guidelines for drugs accessible as over the counter drugs

Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs. Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use.

Practice and Enlightenment of Patient Medication Guide in Foreign Countries such as Europe and America / 医药导报

Objective To study and analyze the current situation of patient medication guide in foreign countries, aiming to provide references for the preparation of patient medication guide in China. Methods The current situation of patient medication guide by consulting literatures was mastered. In addition,the design concept of patient medication guide in foreign countries was summarized, the existing problems were analyzed, and the need for improvement was discussed. Results America,Australia,European countries and some Asian countries have developed a mature patient medication guide system under the supervision of the government departments. Patient medication information overseas takes patients ' health literacy into consideration.It employs the concept of information design,focuses on risks and adverse reactions of drugs,and tells patients how to communicate with doctors and pharmacists.At the same time,it has some problems such as improper content and presentation, excessive emphasis on medication risk, not satisfying drug information demand of patients, as well as a lack of medication information for special groups such as the elderly. Conclusion The design,management and practice of patient medication guide in foreign countries set a good example for us.

Similar Drug Proposals Based on Package Inserts Using Latent Semantic Analysis / 医薬品情報学

Objective:The topic model is a well-known method used in the field of natural language processing (NLP)that defines adocument as constructed of topics that combine specific t erms. This method is used to model topic co-occurrencemathematically. In this study,we extracted topics from featu re vectors of explicit documents called medical package insertsby using cluster analysis. Methods:We counted the terms(nouns)recognized by the morphological analysis engine MeCab and created a documentterm matrix. A value of“tf・idf”was calculated in this matrix for term weighting to avoid the effect of term frequency. We reduced the dimensionality of the matrix using singular v alue decomposition,which removed unnecessary data,and weextracted feature vectors attributed to each medical package insert. The distance between feature vectors was calculatedusing cosine distance,and cluster analysis was performed based on the distance between the vectors.Results:Cluster analysis on our document-term matrix show ed that medical package inserts of drugs that have the sameefficacy or active ingredient were included in the same cl uster. Moreover, using term weighting and dimensionalityreduction,we could extract topics from medical package inserts.Conclusion:We obtained a foothold to apply our findings t o the recommendation of similar drugs. Cluster analysis ofmedical package inserts using NLP can contribute to the pro per application of drugs. In addition,our study revealed thesimilarities of drugs and suggested possibilities for new applications from several points of view.

Role of kinase insert domain containing receptor (KDR) positive cells in formation of cardiospheric structure, myocardium and vessels / 中国胸心血管外科临床杂志

@#Objective    To investigate the role of kinase insert domain containing receptor (KDR) positive cells in the formation of cardiospheric structure, myocardium and vessels. Methods    Twenty-four Wistar rats weighting 250 g were selected. Cardiosphere-derived cells were isolated by enzymatic digestion of rat hearts, and their immunological phenotypes were analyzed by using fluorescence-activated cell sorting (FACS). The cardiomyogenic and vasculogenic potential was diagnosed by immunohistochemistry. Results    KDR positive cells grew exponentially and formed cell clusters. It also could generate myocardial precursor cells (cardiac troponin T positive). And these cells can develop spontaneous contraction activity in vitro. Meanwhile, KDR positive cells formed many vessel-like structures through a budding process. Conclusion    KDR positive cells form cardiospheric structure in vitro culture, and exhibit differentiation potential towards the cardiac and vascular cells. Therefore, KDR positive cells may have a broad prospect of clinical application as cell donors.

Fracture and Posterior Dislocation of Meniscal Bearing Insert in Mobile Bearing Unicompartmental Knee Arthroplasty: A Case Report

@#Dislocation of meniscal bearing insert is a rare but wellrecognised complication in meniscal bearing unicompartmental knee arthroplasty (UKA). On the other hand, fracture of meniscal bearing insert of phase III Oxford UKA has only been reported once in the current literature. The authors report a case of fracture and posterior dislocation of one of the fragments of the meniscal bearing insert in a mobile bearing medial UKA. The fracture was only diagnosed during the revision surgery. The posteriorly dislodged fragment was subsequently retrieved through the same skin incision and a new polyethylene insert of the same size was implanted.

Thoughts and suggestions on the use of of chinese patent medicines in pediatrics / 中国药学杂志

OBJECTIVE: To investigate the varieties and use of oral proprietary Chinese medicines in our hospital, analyze the problems existing in their labelings, and put forward suggestions to provide reference for clinical rational drug use. METHODS: The properties of the 101 kinds of oral proprietary Chinese medicines in regard to the category, dosage form, essential drug, health care, OTC, and so on were summarized. Their labelings were collected to analyze the specification, usage and dosage, adverse reactions, contraindications and precautions, etc. RESULTS: Among the 101 traditional Chinese medicines, 44.6% were developed specially for children. When counted by categories and dosage forms, the medicines for regulating spleen and stomach and granules accounted for the majority, respectively. Essential drugs, drugs belonging to the directory of insured drugs, and OTC drugs accounted for 19.8%, 70.4%, and 26.7%, respectively. It was found that 51.5% of the labelings included dosage information for different ages in detail, 59.4% did not state adverse reactions and contraindications clearly, and the smallest dosage suggested by 14.9% of the labelings were less than the smallest packaging dose. CONCLUSION: Chinese patent medicines are widely used in pediatrics, but the information for children is still incomplete. The problems in the prescribing mainly include inappropriate selection of drugs and combination of medications. It was recommended that the relevant authorities carry out pediatric drug reevaluation and improve the labelings of pediatric drugs.