ICH/GCP

The manufacturing process of phenylephrine hydrochloride drug substance contains the use of different solvents in synthesis. USP monograph doesn't provide a method for the residual solvents of active pharmaceutical ingredients (API) as the usage of solvents in the manufacturing process depends on the route of synthesis. Thus, a novel method has been developed and validated as per ICH guidelines for the quantification of solvents in APIs. The method has been developed for the quantification of ethanol, methanol and isopropanol residual solvents present in phenylephrine hydrochloride USP by head-space gas chromatography (HS-GC) using Agilent GC-7890B with HS-7697A and Restek MXT-502.2 (diphenyl/ dimethyl polysiloxane) 105 m x 0.53 mm x 3.0 µm column. The method has been validated according to ICH Q2R2 guidelines with validation parameters including specificity, linearity, limit of detection (LoD), limit of quantification (LoQ), precision (System precision, method precision, LoQ precision), and accuracy. The system precision obtained the %RSD of 2.5, 2.7 and 2.7 and the LoQ was established as 23.5. 39.0 and 16.4 ppm, respectively for ethanol, methanol and isopropanol. The LoD of 7.7 ppm, 12.8 ppm and 5.4 ppm for ethanol, methanol and isopropanol indicated the sensitivity of the method for the detection of analytes. The linearity range of 1 to 100% level of specification revealed the correlation coefficient of 0.9987, 0.9978, and 0.9991, respectively for ethanol, methanol and isopropanol solvents.

In the 21 st century, medical ethics has been combined with informatics ethics to form medical informatics ethics, and medical education researchers need to be aware of medical informatics ethics principles. An important medical informatics ethics principle is guarding against excess: gathering only those data that are required, and using all the data that have been gathered. An example of excessive data gathering can be found in the gathering of demographic data: it is considered excessive when these data are gathered for no explicit reason, used minimally in the Results, and mostly ignored in the Discussion. This paper details the problem of excessive data gathering, and then outlines five steps requiring the cooperation of institutional ethics review boards, researchers, journal editors and journal reviewers that should be followed in order to guard against excess in medical education research.

BACKGROUND AND OBJECTIVE: To evaluate a pilot eLearning program (Sydney Local Health District Well Child Health program) and whether it could improve the knowledge of general practitioners and trainees in child health and developmental surveillance. METHOD: A mixed method quantitative and qualitative study was performed involving comparisons of pre and post-course test results, and analysis of feedback surveys following a face-to-face general practice training workshop along with in-depth telephone interviews. RESULTS: Comparisons of pre and post-test scores of 25 course participants demonstrated a significant mean score increase of 2.92 out of 14.00 (CI 1.56-4.28; P < 0.001). Qualitative results from 18 feedback surveys and 8 telephone interviews provided mostly positive feedback regarding the information content and usefulness in meeting educational needs. DISCUSSION: With increased uptake and completion, the Sydney Local Health District Well Child Health eLearning program has the potential to be an effective medical education tool for general practitioners and can lead to an increase in knowledge of child health and developmental surveillance.

This article was migrated. The article was marked as recommended. COVID-19 is a strong disruptive force that has not only influenced our global health and economy but also has changed the way we teach, learn and communicate with our students. It has disturbed the regular education pattern and the standard practices that we adapted over many years. The challenge is beyond changing the mode of delivering instructions from face to face to online. The real challenge is in creating a culture that supports the adoption of innovative practices, which require different skills and competences from the teacher, student, mentor and administrator, and at the same time maintaining the quality of the products. In other words, changing what was exceptional to be the norm over a short period of time. This article describes our approach &quot;Open Learning&quot; in managing such change. Our over-riding philosophy is about ensuring that students have high quality resources, and the enthusiasm and lea...

Background: Posters are an integral part of academic conferences, but have limitations. e-Posters offer a new way to overcome these limitations, but their potential is largely under-utilised because of misconceptions regarding their design, creation and use at conferences. Aim and Method: By drawing on literature and our own experience of creating and judging eposters, we aim to present some ideas for e-poster designers so that they can fully utilise the potential of this new medium. Results: We present ideas that begin with conceptual considerations and then move to practical applications (including technical suggestions) for designing, creating, and presenting effective eposters. Conclusions: In the not-too-distant future, we believe that e-posters will evolve to become the standard poster format, and these ideas will assist in the presentation of research at conferences through this format.

RESUMEN. La evaluación de la bioequivalencia es un procedimiento dentro del análisis de medicamentos que permite comparar el desempeño in vivo de distintos productos farmacéuticos. Para su realización, las autoridades sanitarias que regulan las investigaciones clínicas con medicamentos exigen la presentación del protocolo correspondiente, junto con la autorización del Comité de Docencia e Investigación del Centro donde se realizará el estudio y de un Comité de Ética independiente, entre otros documentos. En esta publicación se brinda una serie de pautas a tener en cuenta por los investigadores independientes a la hora de diseñar un protocolo de un estudio de Bioequivalencia (BE). Se resumen aquellos aspectos que se consideran más importantes, como por ejemplo la información general y clínica a incluir, así como la estructura en particular que debe tener un protocolo, resaltándose los aspectos éticos que posee este tipo de estudio donde se incluyen a voluntarios sanos. En qué consiste un consentimiento informado, cómo se determina el número de voluntarios, cuáles son los criterios de inclusión y exclusión de los mismos, cómo se debe armar un cronograma de muestreo, cómo analizar las muestras biológicas y qué criterios estadísticos se siguen para determinar BE, son algunos de los puntos desarrollados en el trabajo. SUMMARY. "Recommendations for the Elaboration of a Protocol of Bioequivalence Study in an Independent Center". Determination of bioequivalence is a procedure included into the pharmaceutical product evaluation, used for determining if two products meet the same or comparable in vivo effects. National drug regulatory authorities require that clinical trials should be carried out in accordance with a written protocol. This protocol and other relevant documentation should be reviewed from a scientific and ethical focus-point by one or more review bodies, e.g. institutional review board, peer review committee, ethics committee or drug regulatory authority, constituted appropriately for this purpose and independent of the investigators and sponsor. In this work we provided a guidelines for the design of an appropriate in vivo bioequivalence study protocol. Guideliness included general and clinical information, ethical principles, selection of subjects, clear criteria for inclusion and exclusion, general study design, validation of the bioanalytical method, statistical analysis, acceptance criteria, acceptance ranges and other important aspects.

This article was migrated. The article was marked as recommended. Learning Management Systems (LMS) are powerful tools for the organization and presentation of curricular learning materials, for monitoring of student and faculty members performance, and for overall quality control. However, there is limited evidence regarding the acceptance and performance of LMS in Africa. This manuscript describes the implementation, the outcomes, and the challenges of the first five years of a LMS at the Kilimanjaro Christian Medical University College (KCMUCo). The LMS has been fully adopted into KCMUCo curriculum and deployed to 1356 students. It has been demonstrated to enhance learning with strength of consensus measure of 84% for basic sciences and 78% for clinical classes. 80% of faculty members have been satisfied with the use of LMS. Electronic assessment has become an obligatory platform for theory examinations. LMS adoption may improve education outcomes at other medical schools in Tanzania and sub-Saharan Africa.

Background: Superficial fungal infections of the hair, skin, and nails are a major cause of morbidity in the world and their incidence continues to increase. While self-medication is also one of the major health concerns for health authorities worldwide. The aim of the study was to evaluate the effects of topical agents used by patients for selfmedication, to enlisting the topical agents used by patients for self-medication, to ensure by whose suggestion's patients engaged in self-medication. Methods: It was an observational cross-sectional study which was conducted at the outpatient department (OPD) of dermatology in tertiary care hospital. A detailed history of the participant was recorded regarding topical agents used for self-medication and their effects were documented in a predesigned case record form. Results: The population consisted of 128 males and 87 females. All these 215 participants had used 61 topical agents of different brand names and the majority of were irritant, corticosteroids and antifungal much high in use. Among 215 participants, 111 had temporary relief from the infection and reoccurred after stopping its use. 98 showed aggravation in their infection among which 90 showed effects like irritation, burning and itching at the application site, while 8 participants showed dryness or flaking of skin. Conclusions: Self-medication is widely practiced among patients with a superficial fungal skin infection in Mumbai. A pharmacist was the major source for obtaining these topical agents. We can conclude, there is a need to counsel and discourage patients from self-medication and regulations for dispensing the prescribed drugs should be made stringent.

Background: Glucocorticoids, are one of the commonly prescribed drugs in a large fraction of patients in the dermatology department. The use of corticosteroids has brought a remarkable change in the field of dermatology as these drugs afford a dramatic relief in inflammatory and pruritic skin conditions but may lead to deleterious effects if irrationally used. Moreover, the data related to drug usage pattern of corticosteroids in skin conditions is particularly lacking. Hence, it is vital to study the drug prescribing pattern of corticosteroids in skin diseases. Aims and Objective: To study the demographic details and drug prescription pattern of corticosteroids in patients with skin diseases. Materials and Methods: It was a retrospective, observational study carried out on dermatology inpatients over a period of 6 months. Case sheets of the patients were retrieved from medical record department and scrutinized systematically to know about the usage of corticosteroids in various skin conditions. Results: Out of the total 187 inpatients in whom corticosteroids were prescribed, 41.7% (n = 78) were male patients and 58.3% (n = 109) were female patients. The most common conditions for which corticosteroids prescribed were psoriasis in 30.5% patients followed by urticaria in 23.5% of patients. The topical corticosteroids were prescribed for 149 patients. Super potent topical corticosteroids were prescribed in 59.7% of patients whereas potent corticosteroids were prescribed in 26.1% of patients. None of the prescriptions used generic names. Conclusion: In this study, we observed the safe prescribing pattern for corticosteroids. However, none of the corticosteroids were prescribed by generic name. This indicates the need for continuing medical education for practicing physicians.

This article was migrated. The article was not marked as recommended. BackgroundA pilot project aimed to understand the experience and performance of medical students as peer tutors (Student In Medical Education Program, SIME) in the undergraduate ultrasound module at the University of Hong Kong.MethodsFour SIME tutors contributed to teaching of third year medical students (n=184) via a 3-hour hands-on session. Pre-module training was given to SIME tutors. Students were divided into small groups to practise abdominal ultrasound scanning on each other under the guidance of senior tutors (radiologists/sonographers) or SIME tutors. Learning outcomes were assessed through pre- and post-module quizzes. Qualitative exploration was undertaken through thematic coding of dedicated observers&#39; notes from teaching sessions and the round table discussion conducted with SIME tutors to discuss the project effectiveness.ResultsSeventy-five percent (n=138) of the medical students submitted both ...

This article was migrated. The article was marked as recommended. Faculty development (FD), or staff development, as it is often called, has become an increasingly important component of medical education. Staff development activities have been designed to improve teacher effectiveness at all levels of the educational continuum. The use of online tools offers many advantages for FD, and online learning can help overcome the numerous obstacles that challenge classic educational activities.Video-based lectures (VBLs) are one of the tools of online learning. This particular instruction format has gained popularity in recent years as a component of the &quot;flipped classroom&quot; (FC) and the much more emergent &quot;massive open online course&quot; (MOOC) styles of health profession education at both under- and post-graduate levels.The aim of this study was to describe the author&#39;s experience in developing VBLs to be used as a tool for faculty development in the field of medical ...

This article was migrated. The article was marked as recommended. Concept maps are evidence based pedagogical tools to fathom how meaningfully students have accomplished their learning objectives. They also give intuitive insights to improvise instruction to enable better and deeper understanding the foundations of learning. In this paper we provide an overview of concept maps and share our experiences of using concept maps for the 4 t&#39;s of education - teaching, training, testing and thinking.

This article was migrated. The article was marked as recommended. Responding to the COVID-19 pandemic, universities world over are aggressively moving their learning, teaching and assessment to online platforms. Educators suddenly feel unsettled, unprepared and unsupported.This inevitable segue from a traditional to online environment will need faculty to grapple quickly and efficiently with the technological imperatives. The purpose of this article is to present ten maxims to navigate the academic challenges posed by out of class learning. The article includes a user-friendly checklist to facilitate the blooming of online teachers.

This article was migrated. The article was not marked as recommended. The introduction of free, online training in Good Clinical Practice (GCP) was introduced in 2016 by the Research and Education Training Program (RETP), an enabling platform of the Western Australian Health Translation Network (WAHTN) for health and medical research professionals. The modules are accessible to all staff and students within the 21 WAHTN partner institutions (including all major hospitals and universities) in the state of Western Australia. This report evaluates perceptions of the online participants of the GCP modules. After completing the GCP course, each participant was given an evaluation asking their opinion about the modules. Underpinned by a mixed-method approach, a multi-level analysis assisted the RETP to identify aspects which called for sustainable maintenance and improvement for improved delivery. Over 90 users participated in the online training. A case example describes that both of qua...

A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the blood stream, this promotes healing to an injured area of the body. The advantage of a transdermal drug delivery route is that the patch provides a controlled release of the medication into the patient, usually through either a porous membrane covering a reservoir of medication or through body heat melting thin layers of medication embedded in the adhesive. A wide variety of pharmaceuticals are now available in transdermal patch form. The objective of the undertaken study is the preparation of transdermal patches of varying thickness using Hydroxy Propyl Methyl Cellulose (HPMC) as polymer and Carboxy Methyl Cellulose as copolymer. Our purpose of study is to ascertain the diffusion and permeation of aspirin as transdermal patch and to correlate the drug delivery through skin.

This article was migrated. The article was marked as recommended. COVID-19 is a strong disruptive force that has not only influenced our global health and economy but also has changed the way we teach, learn and communicate with our students. It has disturbed the regular education pattern and the standard practices that we adapted over many years. The challenge is beyond changing the mode of delivering instructions from face to face to online. The real challenge is in creating a culture that supports the adoption of innovative practices, which require different skills and competences from the teacher, student, mentor and administrator, and at the same time maintaining the quality of the products. In other words, changing what was exceptional to be the norm over a short period of time. This article describes our approach &quot;Open Learning&quot; in managing such change. Our over-riding philosophy is about ensuring that students have high quality resources, and the enthusiasm and lea...

Background: Good Clinical Practice (GCP) is an international quality standard for conducting trials that involve participation of human subjects. Good Clinical Practice guidelines are provide the human rights protection, assurance of the safety and well being of subject participating in clinical trials of the newly developed compound. The objective of this study was to show the effectiveness of workshop training in basic principles of Good Clinical Practice among the Medical teachers of Government Medical College, Bhavnagar and will learn the practical application of GCP regulations for critical components of the clinical research Process. Objective: The main objective of this study was to show the effectiveness of workshop training in basic principles of Good Clinical Practice among the Medical teachers Methods: A total 125 medical teachers of Government Medical College attached with Sir Takhtsinhji Hospital, a tertiary care hospital, Bhavnagar, Gujarat professionals were participated in Good Clinical Practice training workshop. The study was included total twenty questioners based on the most widely accepted international document forming the base for ICH Harmonised Tripartite Guideline for GCP (ICH-GCP E6), which defines in detail the responsibilities and obligations of parties engaged in clinical research. They were submitted given questioners with answers before and after the workshop training. The data was Mean and SD calculated using SPSS software. Results: The total twenty questions were analyzed and compare with the standard key of this. Pre training test score of Question no. 2, 5, 7, 16 was 19(15%), 35 (28%), 21 (17%), 14 (11%) and post training score was 70(88%), 95(76%), 64(51%), 75(60%) respectively. This number as well as percentage could show more improvement in knowledge regarding basic principle of Good Clinical Practice. In our study results shown that there was improve overall knowledge after the given Good Clinical practice training. Conclusion-Training workshop with interactive sessions among the participants after some lectures followed by Multiple Choice Questions test not only improved but also update the participations knowledge regarding subject.

This article was migrated. The article was marked as recommended. In the 21st century, medical ethics has been combined with informatics ethics to form medical informatics ethics, and medical education researchers need to be aware of medical informatics ethics principles. An important medical informatics ethics principle is guarding against excess: gathering only those data that are required, and using all the data that have been gathered. An example of excessive data gathering can be found in the gathering of demographic data: it is considered excessive when these data are gathered for no explicit reason, used minimally in the Results, and mostly ignored in the Discussion. This paper details the problem of excessive data gathering, and then outlines five steps requiring the cooperation of institutional ethics review boards, researchers, journal editors and journal reviewers that should be followed in order to guard against excess in medical education research.

Background: Glucocorticoids, are one of the commonly prescribed drugs in a large fraction of patients in the dermatology department. The use of corticosteroids has brought a remarkable change in the field of dermatology as these drugs afford a dramatic relief in inflammatory and pruritic skin conditions but may lead to deleterious effects if irrationally used. Moreover, the data related to drug usage pattern of corticosteroids in skin conditions is particularly lacking. Hence, it is vital to study the drug prescribing pattern of corticosteroids in skin diseases. Aims and Objective: To study the demographic details and drug prescription pattern of corticosteroids in patients with skin diseases. Materials and Methods: It was a retrospective, observational study carried out on dermatology inpatients over a period of 6 months. Case sheets of the patients were retrieved from medical record department and scrutinized systematically to know about the usage of corticosteroids in various skin conditions. Results: Out of the total 187 inpatients in whom corticosteroids were prescribed, 41.7% (n = 78) were male patients and 58.3% (n = 109) were female patients. The most common conditions for which corticosteroids prescribed were psoriasis in 30.5% patients followed by urticaria in 23.5% of patients. The topical corticosteroids were prescribed for 149 patients. Super potent topical corticosteroids were prescribed in 59.7% of patients whereas potent corticosteroids were prescribed in 26.1% of patients. None of the prescriptions used generic names. Conclusion: In this study, we observed the safe prescribing pattern for corticosteroids. However, none of the corticosteroids were prescribed by generic name. This indicates the need for continuing medical education for practicing physicians.

This article was migrated. The article was marked as recommended. COVID-19 is a strong disruptive force that has not only influenced our global health and economy but also has changed the way we teach, learn and communicate with our students. It has disturbed the regular education pattern and the standard practices that we adapted over many years. The challenge is beyond changing the mode of delivering instructions from face to face to online. The real challenge is in creating a culture that supports the adoption of innovative practices, which require different skills and competences from the teacher, student, mentor and administrator, and at the same time maintaining the quality of the products. In other words, changing what was exceptional to be the norm over a short period of time. This article describes our approach &quot;Open Learning&quot; in managing such change. Our over-riding philosophy is about ensuring that students have high quality resources, and the enthusiasm and lea...

A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the blood stream, this promotes healing to an injured area of the body. The advantage of a transdermal drug delivery route is that the patch provides a controlled release of the medication into the patient, usually through either a porous membrane covering a reservoir of medication or through body heat melting thin layers of medication embedded in the adhesive. A wide variety of pharmaceuticals are now available in transdermal patch form. The objective of the undertaken study is the preparation of transdermal patches of varying thickness using Hydroxy Propyl Methyl Cellulose (HPMC) as polymer and Carboxy Methyl Cellulose as copolymer. Our purpose of study is to ascertain the diffusion and permeation of aspirin as transdermal patch and to correlate the drug delivery through skin.

Background: Topical corticosteroids (TC) have a reputation as anti-acne, antiblemish effects and popularly used as fairness creams. In India, there has been a rise in misuse of TC in last10 years. The present study was conducted to analyse the magnitude of adverse effects of topical corticosteroids abuse in dermatology outpatient department of a tertiary care hospital. Methods: A retrospective observational study was conducted on patients after categorizing them as a TC misuser by dermatologists. The socio-demographic data, chief complaints, details of drugs misuse and adverse drug reaction outcome was collected. Results: A total of 1240 patients was screened, out of which 80 patients misused TC without dermatologist prescription for their skin disease. TC was mainly misused by teenagers (43.8%). Misuse of topical corticosteroids was more common among females (76.3%). Betamethasone valerate (72.5%) was most common TC misused. Most common source of advice of TC misuse was friends (37.5%). Most common purpose of TC misuse was acne (55%) followed by cosmetic purposes (21.3%). The most common morphological varieties of adverse drug reactions were burning and itching sensation (53%) followed by increase severity of acne (44%). Conclusions: TC misuse was more common in teenage females. Most common adverse effect reported is burning and itch sensation followed by increase severity of acne. The study data indicates a significance of problem and requirement of urgent measures to control TC misuse.

Developing online training for health and medical researchers across multiple sites and institutions requires careful consideration to meet the needs of all learners. The Research Education and Training Program (RETP) has attempted to provide a suite of learning modules which are freely accessible to the 21 partner institutions of the Western Australian Health Translation Network (WAHTN). Many lessons have been learnt along the way of this multi-stage process. This paper aims to provide 12 tips in three key areas of online development: writing, online development and maintenance of learning modules. The tips provide a brief summary of these key areas to enable others who may be considering developing and delivering a broad scope of learning modules. This paper is written in the context of modules being delivered for the purpose of continuing professional development and not for highstakes university courses or similar course requirements.

Background: Corticosteroids are a group of commonly used drugs in dermatology practice whose non judicious use frequently results in undesirable and unwanted effects. Prescribing them rationally with care allows us to derive the maximum benefit out of them with minimal side effects. Methods: Retrospective analysis of 112 case files belonging to patients admitted in the department of dermatology over a period of one year was undertaken to ascertain the usage pattern of corticosteroids in relation to their potency, strength, frequency, duration, route, quantity to be applied. The data thus collected was expressed in terms of averages, ratios and proportions. Results: The total number of formulations prescribed were 929 out of which 10.8% were corticosteroids. The average number of formulations prescribed per patient was 8.29. About 78(70%) patients admitted in dermatology received corticosteroids. Topical steroids were prescribed in 50 patients (44.7 %) out of whom 36 (72%) received only topical, the remaining 14(28%) were prescribed both systemic and topical corticosteroids. Brand names were used in all cases. Highly potent corticosteroids like clobetasol, halobetasol and mometasone were prescribed to 39(50%) of all cases who received topical corticosteroids. Conclusion: The study reveals the deficiencies which exist in the present prescribing pattern of corticosteroids. Educational interventions among the doctors as well as students should be carried out to in order to promote rational drug use.

This article was migrated. The article was not marked as recommended. Background: Medical students collaborate with one another, during problem based learning sessions and clerkships. Teamwork has three components; input, process and outcome. Team Objectively Structured Bed side Assessment (TOSBA) is a tool used in clerkships to assess the outcome of team work. Team dynamics have not been previously elaborated. In the present study team dynamics will be explored using examiner observations in TOSBA as a reference. Aim: To explore the teamwork dynamics in settings of TOSBA among final year medical students during their clerkship rotation to medical wards, taking examiner observations of TOSBA as a reference. Methods: A qualitative study using focus groups and purposive sampling. Perceived team dynamics among these students were compared to the observed dynamics by examiners in the earlier settings of TOSBA. Results: Three themes; factors positively affecting the negatively influencin...

This article was migrated. The article was not marked as recommended. The introduction of free, online training in Good Clinical Practice (GCP) was introduced in 2016 by the Research and Education Training Program (RETP), an enabling platform of the Western Australian Health Translation Network (WAHTN) for health and medical research professionals. The modules are accessible to all staff and students within the 21 WAHTN partner institutions (including all major hospitals and universities) in the state of Western Australia. This report evaluates perceptions of the online participants of the GCP modules. After completing the GCP course, each participant was given an evaluation asking their opinion about the modules. Underpinned by a mixed-method approach, a multi-level analysis assisted the RETP to identify aspects which called for sustainable maintenance and improvement for improved delivery. Over 90 users participated in the online training. A case example describes that both of qua...

This article was migrated. The article was not marked as recommended. Introduction Teaching consultation skills requires a structured description of consultations. The objective of this is to describe how consultation topics may be classified and ordered logically. Methods All our last semester medical students make video recordings of their consultations with real patients. The feedback method is systematically developed into a grading system that takes into account both structure and content.This includes the relevance of the topics handled, the extent to which they cover all aspects of the clinical problems of the patient, whether the goal of each step is reached, and the extent to which the topics are handled in the logical order. Results The consultation may be described in nine steps. The order of steps is based on the logic of clinical reasoning. Each topic can only be placed on one step. The steps and logic is shown in Table 1. Figure 1 shows the relationship between the the...

This article discusses the process of defining competencies and development of a best practices training course for investigators and clinical research coordinators who conduct social and behavioral research. The first project phase established recommendations for training in Good Clinical Practice (GCP) and was done in conjunction with representatives from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in behavioral clinical trials and differences in regulation of behavioral trials compared with clinical trials involving drugs, devices, or biologics necessitated a separate Social and Behavioral Work Group. This group worked with CTSA representatives to tailor competencies and fundamental GCP principles into best practices for social and behavioral research. Although concepts underlying GCP were deemed similar across all clinical trials, not all areas were equally applicable and the ways in which GCP would be enacted differ for behavioral trials. It was determine...

Background: Superficial fungal infections of the hair, skin, and nails are a major cause of morbidity in the world and their incidence continues to increase. While self-medication is also one of the major health concerns for health authorities worldwide. The aim of the study was to evaluate the effects of topical agents used by patients for self-medication, to enlisting the topical agents used by patients for self-medication, to ensure by whose suggestion’s patients engaged in self-medication.Methods: It was an observational cross-sectional study which was conducted at the outpatient department (OPD) of dermatology in tertiary care hospital. A detailed history of the participant was recorded regarding topical agents used for self-medication and their effects were documented in a predesigned case record form.Results: The population consisted of 128 males and 87 females. All these 215 participants had used 61 topical agents of different brand names and the majority of were irritant, c...

This article was migrated. The article was not marked as recommended. The introduction of free, online training in Good Clinical Practice (GCP) was introduced in 2016 by the Research and Education Training Program (RETP), an enabling platform of the Western Australian Health Translation Network (WAHTN) for health and medical research professionals. The modules are accessible to all staff and students within the 21 WAHTN partner institutions (including all major hospitals and universities) in the state of Western Australia. This report evaluates perceptions of the online participants of the GCP modules. After completing the GCP course, each participant was given an evaluation asking their opinion about the modules. Underpinned by a mixed-method approach, a multi-level analysis assisted the RETP to identify aspects which called for sustainable maintenance and improvement for improved delivery. Over 90 users participated in the online training. A case example describes that both of qua...

A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the blood stream, this promotes healing to an injured area of the body. The advantage of a transdermal drug delivery route is that the patch provides a controlled release of the medication into the patient, usually through either a porous membrane covering a reservoir of medication or through body heat melting thin layers of medication embedded in the adhesive. A wide variety of pharmaceuticals are now available in transdermal patch form. The objective of the undertaken study is the preparation of transdermal patches of varying thickness using Hydroxy Propyl Methyl Cellulose (HPMC) as polymer and Carboxy Methyl Cellulose as copolymer. Our purpose of study is to ascertain the diffusion and permeation of aspirin as transdermal patch and to correlate the drug delivery through skin.

How to cite this article: Abrol S, Sharma R. Knowledge, attitude, and behavior in the prescription of topical steroid for dermatological disorders among medical practitioners. Our Dermatol Online. 2020;11(4):357-359. Submission: 01.03.2020; Acceptance: 25.05.2020 DOI: 10.7241/ourd.20204.5 Knowledge, attitude, and behavior in the prescription of topical steroid for dermatological disorders among medical practitioners

Usted ha sido invitado a participar en el presente proyecto de investigación, el cual es desarrollado por el Instituto Nacional de Salud Pública en colaboración con (incluir el nombre de la institución con la que se colabora). El estudio se realizará en (describir el lugar: esta comunidad/esta clínica, en varias comunidades/clínicas). Si Usted decide participar en el estudio, es importante que considere la siguiente información. Siéntase libre de preguntar cualquier asunto que no le quede claro. El propósito del presente estudio es… (Describir de forma sencilla el objetivo principal de su estudio y la población objetivo) Le pedimos participar en este estudio porque usted forma parte de…(describir los criterios de elegibilidad) Procedimientos: (Se sugiere utilizar frases cortas y lenguaje sencillo, para facilitar la comprensión de la información, así como también, se sugiere utilizar bullets y/o diagramas).

A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the blood stream, this promotes healing to an injured area of the body. The advantage of a transdermal drug delivery route is that the patch provides a controlled release of the medication into the patient, usually through either a porous membrane covering a reservoir of medication or through body heat melting thin layers of medication embedded in the adhesive. A wide variety of pharmaceuticals are now available in transdermal patch form. The objective of the undertaken study is the preparation of transdermal patches of varying thickness using Hydroxy Propyl Methyl Cellulose (HPMC) as polymer and Carboxy Methyl Cellulose as copolymer. Our purpose of study is to ascertain the diffusion and permeation of aspirin as transdermal patch and to correlate the drug delivery through skin.

A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the blood stream, this promotes healing to an injured area of the body. The advantage of a transdermal drug delivery route is that the patch provides a controlled release of the medication into the patient, usually through either a porous membrane covering a reservoir of medication or through body heat melting thin layers of medication embedded in the adhesive. A wide variety of pharmaceuticals are now available in transdermal patch form. The objective of the undertaken study is the preparation of transdermal patches of varying thickness using Hydroxy Propyl Methyl Cellulose (HPMC) as polymer and Carboxy Methyl Cellulose as copolymer. Our purpose of study is to ascertain the diffusion and permeation of aspirin as transdermal patch and to correlate the drug delivery through skin.

Background  Steroid modified tinea has become the worst nightmare to the society which delays the access to the proper treatment and sometimes leaves  permanent mark on the user. This is because of the unawareness of the molecules in the medications used, both by the user and the prescriber. Objectivem  To elucidate the common social factors involved in the misuse of topical steroids in fungal infections. Methods  Over a period of 6 months, 187 patients were enrolled in the study with informed consent. Their demographic profile, socioeconomic status (SES), educational level, clinical picture, adverse events were noted in this study. Results  Equal sexual distribution was noted and 21-30 year age group is the commonest age in this study (37.5%). High school graders (49%) and undergraduate holders (26%) were using the irrelevant fixed dose combinations (FDCs) and also the class 3&4 (42.%&32%) of SES.  Irrelevant FDCs (86.6%) were misused more than plain steroids. Pseudo imbricata patt...

Developing online training for health and medical researchers across multiple sites and institutions requires careful consideration to meet the needs of all learners. The Research Education and Training Program (RETP) has attempted to provide a suite of learning modules which are freely accessible to the 21 partner institutions of the Western Australian Health Translation Network (WAHTN). Many lessons have been learnt along the way of this multi-stage process. This paper aims to provide 12 tips in three key areas of online development: writing, online development and maintenance of learning modules. The tips provide a brief summary of these key areas to enable others who may be considering developing and delivering a broad scope of learning modules. This paper is written in the context of modules being delivered for the purpose of continuing professional development and not for highstakes university courses or similar course requirements.

Background: FDCs are highly popular in Indian pharmaceutical market. The FDCs have both advantages as well as disadvantages. To be advantageous WHO guidelines for the manufacture and use of FDCs must be strictly followed. Irrational use of FDCs is a major public health problem and leads to increased risk of adverse drug events, higher treatment costs and antimicrobial resistance. FDCs as well as other single component drugs cannot be used rationally unless everyone involved directly or indirectly in the health care profession is involved. Pharmacist is a coordinator between different members of healthcare team and the patients. Hence, his role in safe use of medicines is important. The present study was undertaken to assess the knowledge of pharmacists about FDCs.Methods: A descriptive questionnaire survey was conducted in various government and private pharmacies of two Central Kashmir Districts, Srinagar and Budgam, aiming to assess the knowledge of pharmacists about FDCs. The que...

Background: Owing to the rampant availability in the market, corticosteroids, the mainstay in the treatment of diverse dermatological conditions, is frequently used for their palliative effect leading to its misuse in medicine practice. This study aimed to monitor the utilization pattern of corticosteroids and to analyze the rationality of drug usage in a dermatology outpatient department setup. Materials and Methods: A cross-sectional observational study was conducted in which patients attending dermatology department, receiving corticosteroids in any form were included in the study. Demographic profile, clinical presentation, and undergoing treatment plan were recorded on a prestructured, customized data collection sheet. Trends in steroidal prescribing were duly analyzed. Results: A total of 328 prescriptions were analyzed during the entire study period. A number of drugs per prescription varied from 1 to 3 with an average of 2.01. Of 328 prescriptions analyzed, the most common i...

Topical corticosteroids prescribed for various dermatological conditions, if used haphazardly have their adverse effects too, like aggravation of underlying infections - tinea, herpes etc. Tinea incognito is a fungal infection of skin masked and often exacerbated by application of topical immunosuppressive or steroid agent. Tinea incognito results because local physicians/chemists might mistake tinea with a simple rash. Availability of a topical steroid cream as an over the counter (OTC) drug is also one of the causes. Once it is diagnosed (clinically with or without KOH mount preparation), it should be thoroughly treated with oral and topical antifungal agents. Four cases presenting to Dermatology OPD VSGH with chief complaints of itching and aggravation of existing lesions due to application of potent topical corticosteroids like Clobetasol and Beclomethasone have been discussed here. They were diagnosed as cases of Topical Corticosteroids induced Tinea Incognito. The patients wer...

Topical corticosteroid’s anti-inflammatory action is the common property that induces the misuse of the topical steroids. Most of the time, even a medical graduate is misguided about the steroidal molecules in the combination formulation for the treatment of infections which gives temporary relief of symptoms such as itching and lightening effect in short term, But on long term will lead onto local adverse reactions such as dryness, burning sensation and striae etc. To analyse the knowledge of the medical students towards topical steroids and bridges the gaps in the knowledge.6 semester students who gave consent for the inclusion in the study were enrolled and a pretested validated questionaries were given to be filled. After the pretest, a video presentation of the topic was presented and the post test was given with the same format after 3 months. Results were analyzed using SPSS software.75% of the students heard about the topical steroids, out of which 57% were irrelevant steroi...

This checklist is an English translation of the Good Clinical Practice (GCP) compliance checklist prepared by the Japanese agency for on-site inspections of medical institutions. y Please note that the checklist was translated by the authors and has not received official review by any Japanese agency including the Organization for Pharmaceutical Safety and Research (OPSR). This checklist is an addendum to a previously published article on the evaluation of overseas GCP inspections by the Japanese Regulatory Agency [1].

Introduction: Rational use of corticosteroids is very important in the long term for improving patient safety. The main objective of the study was to analyze the prescribing patterns of steroids in a district general hospital, Amravati. Materials and methods: A prospective observational study was carried out over a period of six months in a district general hospital. All patients receiving any category of steroid therapy were enrolled, and the prescribing tapering patterns of steroids were reviewed. The demographic data, disease data and data on the utilization of various steroids were analyzed, and the knowledge of the patients was assessed by using a Michigan questionnaire. Results and discussion: 179 patients were recruited for the study. Steroids were prescribed for various (29.6%) respiratory conditions, (10.1%) CVS diseases, (11.7%) CNS, (1.6%) in hepatic disorders, (1.1%) musculoskeletal disorders, (3.4%) skeletal disorders, (0.6%) renal impairments, (3.9%) GI disorders, (19....

Background: Glucocorticosteroids, one of the common drugs used by the dermatologists brought a revolutionary change in their practice. Unfortunately steroids are misused in dermatological panacea due to dramatic relief in inflammatory and pruritic skin conditions but may lead to deleterious effects if irrationally used. Hence this study was planned to know the prescribing pattern of corticosteroids. Methods: It was a cross sectional observational study. The prescriptions of patient attending the dermatology OPD were screened for the usage of the corticosteroids. The demographic data, chief complaints, diagnosis and the details of the drugs was collected. Results: Out of 384 prescriptions screened, 14.06% were prescribed corticosteroids. Average number of drugs per prescription was 2.28±0.83. Polypharmacy (≥4 drugs) observed in 9.26% of prescriptions. Corticosteroids prescribed by generic name were 24.07% and brand name was 75.93%. Corticosteroids alone prescribed in 38.89% and along with antihistaminics/antibiotics/emollients in 61.11%. Topical corticosteroids prescribed in 79.6% and 20.4% by systemic route. Moderately potent steroids prescribed in 74.42% followed by potent (13.95%) and very potent steroids (11.63%). Patients on corticosteroid self-medication were 28%, among them 4 developed adverse reactions with severe acneiform eruptions over the face. No fixed dose combination drugs were prescribed. Conclusions: In this study we observed the rationale and safe prescribing pattern. However, the corticosteroids prescribed by brand names (75.93%) were more than generic names (24.07%), information about the strength of the steroid not mentioned and usage of emollients was less. This indicates the need for continuous medical education for the clinicians.

The introduction of free, online training in Good Clinical Practice (GCP) was introduced in 2016 by the Research and Education Training Program (RETP), an enabling platform of the Western Australian Health Translation Network (WAHTN) for health and medical research professionals. The modules are accessible to all staff and students within the 21 WAHTN partner institutions (including all major hospitals and universities) in the state of Western Australia. This report evaluates perceptions of the online participants of the GCP modules. After completing the GCP course, each participant was given an evaluation asking their opinion about the modules. Underpinned by a mixed-method approach, a multi-level analysis assisted the RETP to identify aspects which called for sustainable maintenance and improvement for improved delivery. Over 90 users participated in the online training. A case example describes that both of qualitative and quantitative data were useful to provide possible improve...