Safe Use Of Medicines Research Articles

Effectiveness of Patient Medication Counseling in a Tertiary Care Hospital: A Cross-Sectional Study

Background: Medicine is prescribed to help the patient. But it can cause unwanted effects in the patient if one take too much or multiple medicines that don’t go together. Many patients have problems each year, some serious, because of taking the wrong medicine or not taking the right medicines correctly. This cross-sectional study was done to assess the effectiveness of patient medication counseling in a tertiary care hospital. Methods: This cross-sectional questionnaire-guided study was carried out in the dispensary of a tertiary care hospital, from January to April 2024. convenient sampling technique was employed to select study participants. Results: A total of 540 respondents were included in this study. Only 50.3% of the participants knew the correct frequency and dose of the prescribed medications. Majority of the patients did not knew the indications of the medication they were taking. Conclusion: There is a need to strengthen the patient medication counselling process so that patients understand & remember what have been advised during counselling. As a healthcare provider, it is our responsibility to educate the patient about the prescribed medicines to obtain the positive healthcare and ensure safe use of medicines.

Tackling Inequalities in Access to Medicines for People Experiencing Homelessness: A Meta-Ethnography and Qualitative Systematic Review.

Despite increased awareness of the detrimental relationship between homelessness and health, people experiencing homelessness remain an underserved population in health and social care research. Due to barriers affecting the accessibility of medicine and healthcare services, as well as reported competing priorities such as food and shelter, evidence has demonstrated that people experiencing homelessness are less likely to undergo routine examinations, receive diagnoses and adhere to prescribed medical treatments. To enhance service design and access for those experiencing homelessness, it is critical to better recognise, understand and address the barriers these individuals face. This meta-ethnography aims to identify barriers, enablers and interventions to begin addressing this inequality gap. A systematic literature search was undertaken in October and re-ran in December 2023 across four databases: MEDLINE, Embase, CINAHL and Scopus. Qualitative studies were included if they addressed barriers, enablers and interventions aimed at tackling medicines and health service inequalities among populations experiencing homelessness. Study quality was assessed using the Joanna Briggs Institute critical appraisal checklist. Data were synthesised using a meta-ethnographic approach, as outlined by Noblit and Hare. The review was registered on PROSPERO (CRD42024511502) and performed according to PRISMA guidelines. This meta-ethnographic systematic review synthesised data from eight studies across multiple countries. Three overarching third-order constructs (termed 'themes') were developed through reciprocal translation and centred around: recognising and acknowledging the discrimination, stigma and barriers experienced when using current services; exploring safe and practical use of medicines and the promotion of general health education and appreciating strategies to tackle inequalities, namely community outreach programmes designed for homeless communities. This work highlighted the barriers, enablers and interventions that sought to address the inequalities affecting people experiencing homelessness in accessing medication and healthcare services. Future research should utilise lived-experience narratives and co-design to further explore ways to tackle wider healthcare accessibility inequalities for this minoritised population. Not applicable, as this is a systematic review. Public contributors (minority research champions and one public health research champion, H.K.G. and T.G.) informed and shaped this project during study design and conceptualisation. They helped to ensure that the study was conducted, and the findings were reported with sensitivity.

A Study on Internet News for Patient Safety Campaigns: Focusing on Text Network Analysis and Topic Modeling.

Background/Objectives: This study aimed to identify the main issues related to public patient safety campaigns reflected in Korean online news. This study utilized a text-mining method to identify keywords and topics related to patient safety campaigns. Methods: The data collection period was from 1 January 2022 to 31 December 2023, and 4110 news articles were extracted. Through data preprocessing, 2661 duplicated news and 1213 unrelated news were removed, and 236 news were selected. Using the NetMiner program, keyword co-occurrence frequency calculation, keyword centrality analysis, and topic modeling analysis were performed. Results: The results showed that the most frequently mentioned keywords with high degree centrality, betweenness centrality, and closeness centrality in online news were "hospital", "medical", "medicine", "project", and "treatment". The topics of online news related to the patient safety campaign were "patient-centered care for medical safety", "health promotion projects at a regional institution", "hand hygiene education to prevent infection", "healthcare quality improvement through the Mint Festival", and "safe use of medicines". Conclusions: This study analyzed patient safety campaign news topics using text network analysis and topic modeling. It was confirmed that patient safety campaigns are essential for fostering a patient safety culture, improving medical quality, and encouraging patient participation in hospitals. Therefore, to build a safe medical environment, it is necessary to establish an effective patient safety campaign for not only medical staff providing medical care, but also patients and their caregivers, and for this, cooperation and participation from various professional occupations are necessary.

Identifying interventions that improve medication safety & rational use of medicines in India.

Background & objectives Medication-related harm is known to be the cause for about 1/10th of hospitalizations. Some estimates from India show that about 90 per cent of medicines consumed are inessential or irrational and contribute towards high out-of-pocket expenditure on health. In this context, the Indian Council of Medical Research in 2022 constituted a National Task Force (NTF) to explore possible solutions that could improve safe and rational use of medicines (SRUMs). The objective of this study was to identify research ideas in the field of SRUM through a survey of relevant stakeholders, and further to prioritize the research ideas using a pre-identified set of criteria. Methods The responses from the identified stakeholders were assessed using the Child Health and Nutrition Research Initiative method, which is an established research priority-setting methodology. First, the NTF asked for two to six research ideas from relevant Indian and global stakeholders on solutions to improve SRUM. The ideas were checked for duplicates, re-phrased where necessary and classified into various sub-themes. Subsequently, the research ideas were scored by Indian experts with relevant technical expertise using a pre-defined set of five criteria: innovativeness, effectiveness, translational value, answerability and applicability. Each research idea received from a stakeholder was assigned a score under each of the five criteria. The overall research priority score was calculated as a mean of all five criteria-specific scores and converted into a percentage. Results The final output of the prioritization process was a list of research ideas or questions, ranked by their scores. Total 209 unique ideas were received from 190 respondents, which were scored by 27 experts. The top three research topics on medication safety focused on cost-effective strategies for improving antimicrobial stewardship, safe use of poly-pharmacy in geriatric patients and drug take-back policy interventions. Regarding the rational use of medicine, the top three topics included testing mobile application-based antimicrobial stewardship interventions, development of diagnostics for antimicrobial resistance, and behavioural interventions. Interpretation & conclusions Several priority ideas found in this study also align with those of global priority, e.g., safe disposal practices and enhanced pharmacovigilance, rational use of medicines. Patient engagement, which underlines many of the top scoring ideas found in this study, is also inclined with the top research priorities reported by the WHO priority exercise on research into the safe use of medicines. However, to the best of our knowledge, this is the first such work from a low- and middle- income country on medication safety and rational use of medicines. The findings of this research priority-setting exercise can help to guide research for the development of policy-relevant and novel interventions to improve SRUM in India.

Collaborative discussions between GPs and pharmacists to optimise patient medication: a qualitative study within a UK primary care clinical trial.

There has been significant investment in pharmacists working in UK general practice to improve the effective and safe use of medicines. However, evidence of how to optimise collaboration between GPs and pharmacists in the context of polypharmacy (multiple medication) is lacking. To explore GP and pharmacist views and experiences of in-person, interprofessional collaborative discussions (IPCDs) as part of a complex intervention to optimise medication use for patients with polypharmacy in general practice. A mixed-method process evaluation embedded within the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial conducted in Bristol and the West Midlands, between February 2021 and September 2023. Audio-recordings of IPCDs between GPs and pharmacists, along with individual semi-structured interviews to explore their reflections on these discussions, were used. All recordings were transcribed verbatim and analysed thematically. A total of 14 practices took part in the process evaluation from February 2022 to September 2023; 17 IPCD meetings were audio-recorded, discussing 30 patients (range 1-6 patients per meeting). In all, six GPs and 13 pharmacists were interviewed. The IPCD was highly valued by GPs and pharmacists who described benefits, including: strengthening their working relationship; gaining in confidence to manage more complex patients; and learning from each other. It was often challenging, however, to find time for the IPCDs. The model of IPCD used in this study provided protected time for GPs and pharmacists to work together to deliver whole-patient care, with both professions finding this beneficial. Protected time for interprofessional liaison and collaboration, and structured interventions may facilitate improved patient care.

Resident pharmacist participation in shared medical appointments in palliative care in São Paulo, Brazil: experience and contributions.

To describe the resident pharmacist's participation in Shared Medical Appointments (SMA) in palliative care. The resident pharmacist participated in face-to-face SMA with the attending physician, medical and gerontology students, and a nurse. The resident pharmacist supported interdisciplinary discussions and performed pharmaceutical interventions. He helped raise awareness about the effective, safe, and convenient use of medicines, helping improve the quality of life of patients and caregivers. Providing pharmaceutical care to patients in palliative care helped to improve the quality of clinical services offered to these patients, as well as adding value to resident pharmacists' interprofessional practice.

Community pharmacy discharge medicines service activity as recorded in PharmOutcomes: a retrospective exploration and analysis.

Transition of care when a patient moves between healthcare locations is a risk factor for medication errors and medicines-related preventable harm. The aims of this retrospective service evaluation were to understand, by classifying and quantifying, the nature of interventions made by community pharmacy when receiving a discharge medicines service referral from a secondary care hospital, with a focus on two groups of high-risk medicines supplied at discharge-oral anticoagulants and weak opioids following hip or knee surgery. Records made on the PharmOutcomes™ platform by community pharmacists in response to referral for the NHS England discharge medicines service were analysed and summarized. This analysis was exploratory and interpretative in nature and used a convenience sample of patients who had consented for the service over 12 months from May 2022 to April 2023. During 12 months, 6811 referrals occurred, of which 71% were recorded as having different stages of the service completed on PharmOutcomes™. Medicines reconciliation, first-prescription review, and consultation stages decreased as patients progressed through the service. Slightly greater rates of completion were observed for patients receiving oral anticoagulants and for codeine or dihydrocodeine following hip and knee surgery, although overall referrals were low for this latter cohort. Through this service, community pharmacists are well placed to support the safe and effective use of medicines including oral anticoagulants and weak opioids posthospital discharge and potentially reduce incidents of avoidable harm. The variations in recorded completion rates across the three stages of the service and the apparent greater finalization rates for the high-risk medicines studied require further investigation.

Established and emerging theatre pharmacy services: a scoping review

Abstract Introduction Guidelines recommend that pharmacists contribute to perioperative patient care.[1,2] Expansion of perioperative pharmacy services was considered in Tallaght University Hospital following the appointment of a Critical Care & Anaesthesia Chief II Pharmacist. Preliminary research indicated that activities at surgical pre-assessment clinics, in critical care and on inpatient wards are well-documented, while theatre pharmacy services appear comparatively under-developed. Pharmacists are well-placed to promote the safe and cost-effective use of medicines in this high-risk environment. An understanding of the evidence base could provide a foundation on which pharmacy departments seeking to expand their clinical services can build. Aim To determine the range, extent and nature of theatre pharmacy services internationally, and to describe any reported outcomes of these services. Methods This scoping review was conducted and reported as per the Joanna Briggs Institute methodology for scoping reviews and the PRISMA-ScR checklist. The review protocol was registered on Open Science Framework. A search was conducted across electronic (Ovid® MEDLINE, Embase, CINAHL and PsycInfo) and grey literature databases (Google Scholar, BASE, CADTH, and Google) without limitations on date of publication, study type or language (where English translation available). A manual search of the citation lists of all included publications supplemented the electronic search. One reviewer screened titles and abstracts and carried out data extraction, with a 10% sample screened by a second reviewer. Two reviewers evaluated full texts. Critical appraisal was performed using the Mixed Methods Appraisal Tool where appropriate. A narrative approach to evidence synthesis was employed. Extracted data about the type of pharmacy service(s) and associated outcomes were studied to inform development of key concepts through which results were presented. Results Ninety-two publications were included from 3924 results. Fifty-seven were primary research articles. Most publications were descriptive in nature. Over half of the included publications described services in the United States; the remainder were from Australia, several European countries, Egypt, Morocco, Japan, China and Taiwan. The majority of theatre pharmacy services involved medication management, i.e. procurement, spending, storage, formulary development and distribution of medicines. Clinical services incorporated provision of medicines information, protocol and guideline development, antimicrobial stewardship, education and training of healthcare professionals, engagement with health informatics and medication safety projects, practice-based research and intraoperative emergency support. Reported outcomes included financial savings, improved accountability of controlled substances, improved patient safety and staff satisfaction with the service. Many publications highlighted improved inter-departmental relationships between pharmacy and anaesthesiology. Of the 57 primary research articles, 48 lacked a clear research question and so did not satisfy the MMAT screening criteria. Of the nine assessed, adherence to quality criteria ranged from 40-100%. Conclusion Evidence for theatre pharmacy services is extensive and varied. Empirical research of high methodological quality is required to assess the outcomes of these services. Strengths of this review include the use of reporting guidelines and quality appraisal of the evidence. This review may have been limited by the exclusion of non-English language publications. This review collates practical guidance on the development of theatre pharmacy services and highlights facilitators of successful service establishment.

Quantitative analysis of the illegal addition of Atenolol in Panax notoginseng based on NIR-MIR spectral data fusion and calibration transfer.

To address the issue of the common illegal addition of Atenolol in Panax notoginseng, we propose an approach that realizes multivariate calibration transfer between different particle sizes based on near-infrared (NIR) and mid-infrared (MIR) spectral data fusion. To achieve high prediction accuracy, we construct three data fusion schemes (full-spectrum fusion, feature-level fusion, and decision-level fusion) that combine NIR and MIR spectral data. Among three data fusion schemes, the feature-level fusion based on the UVE-SPA-PLS model for 120-mesh spectral data achieves optimal prediction accuracy. Here, a Piecewise Direct Standardization (PDS) algorithm has been applied to calibration transfer from 100-mesh and 80-mesh to 120-mesh to reduce the influence of particle size and improve the robustness of the model. The correlation coefficient (R2) of 100-mesh, and 80-mesh prediction sets can reach 0.9861 and 0.9823, respectively. The corresponding root mean square error (RMSE) are 0.1545 and 0.2045, respectively. This research provides a method for illegal additions in precious herbs and reduces the effect of particle size on spectral modeling, enabling high-precision quantitative detection. In addition, it has important application prospects in reducing experimental losses of precious medicinal materials and ensuring the safe use of Chinese and Western medicines, which provides an alternative method for non-destructive testing.

Impaired kidney function: supporting the safe use of medicines for patients.

Due to the increasing incidence of acute kidney injury (AKI) and chronic kidney disease (CKD), nurses in most healthcare settings are likely to care for patients with some degree of impaired kidney function. Impaired kidney function can adversely affect the way the body excretes, absorbs, distributes and metabolises medicines (pharmacokinetics), potentially resulting in a wide range of drug-related complications. This article provides an overview of the effects of impaired kidney function on pharmacokinetics and the importance of accurate drug dose adjustments for patients with related conditions. It also discusses various aspects of medicines use in patients with AKI, the pharmacological management of patients with CKD and the use of immunosuppressive therapy in patients who have had a kidney transplant. The authors consider the role of the nurse in ensuring safe medicines use for patients with impaired kidney function throughout the article.

Conformity of Package Inserts Information to Regulatory Requirements

ABSTRACT Background: Accurate and reliable information regarding drugs is essential for safe and effective use of drugs. It is not possible for the clinician to refer research articles every time for complete updates. In such situations, package inserts (PIs) form an authentic information for the doctor and patient. The study was intended to assess the information completeness and precision of PIs using the criteria laid down by, sections 6.2 and 6.3 of Schedule D (II), Schedule Y of Drugs and Cosmetic Act (1940) and Rules (1945). Materials and Methods: PIs of different formulations were collected from various departments, and also local and regional chemists. The information adequacy was done by 25 checklist proposed by the Indian Drug and Cosmetic Act (1940) and Rules, 1945 under sections 6.2 and 6.3 of Schedule D and Schedule Y. A score of “1” was given, if information was present, and “0” if there was no information. Information adequacy scores also calculated. Results: A total of 207 PIs were analyzed. Majority of PIs belong Grade B category of drug information (174). Generic name, composition, posology and method of administration, undesirable effects, contraindications, drug interactions, special precautions, legibility, storage and contraindications during pregnancy and breast feeding were mentioned by nearly all. Gaps were observed in handling instructions, influence on person’s self-driving and machinery operation capabilities, pharmaceutical incompatibilities, shelf life, excipients and Pharmacokinetic and dynamic information not updated regularly. Conclusion: The current study shows that there is still inadequacy of particulars regarding drug information. Hence, it is essential to establish proper uniform standards for the currently available PIs. An absolute and flawless PI should provide complete information. This requires continuous and constant effort from manufacturer and regulatory authorities to promote safe and rational use of medicines.

Organization of pharmaceutical education of the adult population: from theory to practice

Introduction. Health literacy is defined by WHO as one of the reliable parameters that allow predicting the state of public health in the future. The level of health literacy is integral to the pharmaceutical literacy of the individual, since a significant part of the issues of health care is related to the use of medicines (LP). Pharmaceutical literacy can be considered as one of the most important components of health literacy in general. At the moment, there is no unified methodology for improving pharmaceutical literacy of individuals and society as a whole. The purpose of the study. Development of a scientific and practical approach to the organization of pharmaceutical education of the adult population with the participation of pharmaceutical specialists. Material and methods. Content analysis, logical analysis, systematization method, modeling method. Results. The components of the theoretical basis for the formation of pharmaceutical competence of the adult population are determined. The differentiation of information about drugs has been carried out, the types of pharmaceutical information have been identified and their subject content has been formed for the purposes of pharmaceutical education of the population. Socio-demographic groups and factors correlating with a higher level of pharmaceutical literacy have been identified. Additional conditions are formulated that should be taken into account in the development of pharmaceutical literacy and the formation of pharmaceutical competence of the adult population. Organizational technologies relevant to the goals of pharmaceutical education have been identified and systematized. The key positions of effective pharmaceutical education practice have been identified. Potential mechanisms for the organization of pharmaceutical education are presented, taking into account the realization of the professional potential of pharmaceutical workers. A multilevel model for the formation of pharmaceutical competence of the adult population has been developed. Conclusion. The proposed methodology for the gradual formation of pharmaceutical competence of the adult population based on the relevant choice of organizational technologies and rules of andragogy, based on the international concept of health education and existing levels of public health, acts as a scientific and practical approach to the formation of an adequate level of pharmaceutical knowledge for the effective and safe use of medicines and the formation of a culture of responsible attitude of citizens to their own health.

Focusing on what matters to the patient when prescribing

As Head of Effective Prescribing and Therapeutics for the Scottish Government, Dr Alpana Mair is responsible for advising ministers on the safe, sustainable and effective use of medicines. Here, she talks to Joy Ogden about her work tackling polypharmacy and ensuring the focus is on what matters to the patient when prescribing.

Could pharmacy technicians play a role in supporting the appropriate and safe use of traditional and complementary medicines?

Across the world traditional and complementary medicine (T&CM) product use is prevalent with some countries reporting greater than 50% of the population using these products. T&CM products are primarily self-selected through retail outlets including pharmacies. Pharmacists across the world generally agree they should play a role in ensuring the appropriate and safe use of T&CM products but report being time and resource poor to do so. In this commentary, it is proposed that pharmacy technicians as members of the pharmacy workforce, who with adequate education, and supportive technologies could support pharmacists in providing guidance to consumers and patients about the appropriate and safe use of T&CM products. Pharmacy technicians play a crucial role in the pharmacy workforce, serving as integral members of healthcare teams fulfilling a wide array of tasks essential for the efficient functioning of pharmacies and ensuring the safe dispensation of medications. They have been described by pharmacists as the “the face of the pharmacy” in the community setting and relied on not only for mitigating and triaging problems, but also be primarily responsible for developing rapport, eliciting trust and even loyalty from pharmacy patrons. As such, there is a momentous opportunity for pharmacy technicians to play a role in providing T&CM advice and triaging the need for pharmacists’ intervention where harm, or risk of is identified.

Beyond pillbox: a national cross-sectional study on the attitudes, practices, and knowledge of community pharmacists regarding complementary and alternative medicine

BackgroundWhile community pharmacists are uniquely positioned to promote the safe and effective use of complementary and alternative medicine, their potential role remains largely untapped. The objective of this study was to assess the knowledge, attitudes, and practices related to complementary and alternative medicine products among community pharmacists in the United Arab Emirates and explore the correlates of knowledge in the study sample.MethodsUsing a stratified random sampling frame, a national survey of community pharmacists was conducted in the United Arab Emirates. In a face-to-face interaction, participants completed a multi-component questionnaire consisting of four sections: sociodemographic and general characteristics; knowledge of complementary and alternative medicine products and usage; attitudes towards complementary and alternative medicine and practices related to complementary and alternative medicine. Based on participants’ answers, scores were calculated with higher scores indicating more positive knowledge, attitudes, and practices.Results373 community pharmacists participated in the study (response rate: 83%). For the knowledge questions, more than 50% of community pharmacists correctly answered the functions of complementary and alternative medicine, however lower percentages were noted for the side effects and drug interactions questions. Most community pharmacists had positive attitudes towards complementary and alternative medicine, except for particular aspects such as efficacy, where 40% agreed that complementary and alternative medicine is only effective in treating minor complaints. As for practices, while more than 70% of participants counseled patients on complementary and alternative medicine use, only 47% reported the toxic effects when encountered. Multiple linear regressions showed that community pharmacists working in independent pharmacies, those with fewer years of experience, and those who did not receive complementary and alternative medicine education during their academic degree had lower knowledge scores (p < 0.05).ConclusionsThe findings of this study showed that community pharmacists in the United Arab Emirates have good knowledge of complementary and alternative medicine functions and generally positive attitudes and practices, with few gaps identified in each. Together, these findings provide critical evidence for the development of targeted interventions to promote the role of community pharmacists towards safe and effective complementary and alternative medicine use in the country.

Knowledge, attitude and practice of pharmacovigilance among medical students

Background: Spontaneous voluntary adverse drug reaction (ADR) reporting is the backbone for the successful functioning of the Pharmacovigilance Programme of India. The aim of pharmacovigilance is to ensure safe and rational use of medicines, once they are released for general use in the society. Targeting the younger doctor for sensitization toward pharmacovigilance is the key to ensure practice of adverse drug reactions (ADR) reporting in clinical practice. The objectives of this study are to evaluate the knowledge, attitude, and practice (KAP) of pharmacovigilance among medical students at LLRM Medical College, Meerut, a tertiary care teaching hospital. Methods: A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The medical students (2nd year, final year, and interns) were included in the study. Only the participants who gave their consent were included in the study. Results were calculated by proper statistical analysis. Results: The current study was conducted in a LLRM Medical College, Meerut, which included a total of 250 medical students of which 40% 2nd year, 40% final year students, and 20% interns. Most of them (83%) accepted that reporting ADR is necessary, and pharmacovigilance should be taught in detail to health-care professionals. Conclusions: This study demonstrated that knowledge of pharmacovigilance among medical students is improving gradually and pharmacovigilance and ADR reporting needs to be made compulsory, have better, interesting ways to learn and understand it, so that the students can practice it with confidence in their clinical practice.

Medicine formulary writing for hospitals: A systematic review on development, approval, dissemination, and review

Background: A hospital formulary is a guiding manual developed to enhance the rational prescribing of medicines based on the local prevalence of diseases and hospital settings. This systematic review aimed to identify and evaluate the existing literature on hospital formulary development and management to ensure the availability of safe, cost-effective, quality, and efficacious medicines that all practitioners must use. Methods: A qualitative evidence and experience synthesis approach was chosen to create evidence on the development and use of hospital formulary. PubMed was the database used to search for similar reviews using Boolean operators. Results: Out of 1,347 potentially relevant literature and abstracts identified and screened, 25 publications were used in developing the hospital formulary. The hospital formulary should be developed and reviewed after using the current STG/NEMLIT to use updated medicine lists and indications. Medicines selected for the model are “medicines of choice.” The development of hospital formularies should be based on a comprehensive and transparent process that involves a multidisciplinary team of experts, a clear selection criterion, a reliable and updated source of information, and a regular evaluation of the clinical and economic outcomes. Conclusion: Hospital formularies promote the rational, safe use of medicines to improve the quality and efficiency of healthcare.

Unveiling the Chemical Composition of Sulfur-Fumigated Herbs: A Triple Synthesis Approach Using UHPLC-LTQ-Orbitrap MS-A Case Study on Steroidal Saponins in Ophiopogonis Radix.

Ophiopogonis Radix (OR) is a traditional Chinese medicine. In recent years, in order to achieve the purpose of drying, bleaching, sterilizing and being antiseptic, improving appearance, and easy storage, people often use sulfur fumigation for its processing. However, changes in the chemical composition of medicinal herbs caused by sulfur fumigation can lead to the transformation and loss of potent substances. Therefore, the development of methods to rapidly reveal the chemical transformation of medicinal herbs induced by sulfur fumigation can guarantee the safe clinical use of medicines. In this study, a combined full scan-parent ions list-dynamic exclusion acquisition-diagnostic product ions analysis strategy based on UHPLC-LTQ-Orbitrap MS was proposed for the analysis of steroidal saponins and their transformed components in sulfur-fumigated Ophiopogonis Radix (SF-OR). Based on precise mass measurements, chromatographic behavior, neutral loss ions, and diagnostic product ions, 286 constituents were screened and identified from SF-OR, including 191 steroidal saponins and 95 sulfur-containing derivatives (sulfates or sulfites). The results indicated that the established strategy was a valuable and effective analytical tool for comprehensively characterizing the material basis of SF-OR, and also provided a basis for potential chemical changes in other sulfur-fumigated herbs.

Assessment of Pharmacokinetic Effects of Herbal Medicines on Escitalopram.

Herbal medicines are occasionally used in combination with conventional antidepressants to mitigate various depression-associated symptoms. However, there is limited information on herb-antidepressant interactions. In this study, we investigated the pharmacokinetic (PK) effects of four herbal medicines (Gami-soyosan, Banhasasim-tang, Ojeok-san, and Bojungikgi-tang) on escitalopram, a commonly used antidepressant. In this open-label, fixed-sequence, three-period, crossover study, 18 participants were enrolled and divided into two groups. Each group received a 10 mg oral dose of escitalopram in period 1. Participants took escitalopram once daily and their assigned herbal medicines thrice a day for 7 d in periods 2 (group 1: Gami-soyosan, group 2: Ojeok-san) and 3 (group 1: Banhasasim-tang; group 2: Bojungikgi-tang). The primary endpoints were Cmax,ss and AUCtau,ss of escitalopram. Cmax,ss and AUCtau,ss in period 1 were obtained using nonparametric superposition from single-dose data. The PK endpoints were classified according to the CYP2C19 phenotype. Of 18 participants, 16 completed the study. Systemic exposure to escitalopram resulted in a minor increase in the presence of each herbal medicine. The geometric mean ratios (GMRs, combination with herbal medicines/escitalopram monotherapy) and their 90% confidence intervals (CIs) for Cmax,ss and AUCtau,ss were as follows: Gamisoyosan- 1.1454 (0.9201, 1.4258) and 1.0749 (0.8084, 1.4291), Banhasasim-tang-1.0470 (0.7779, 1.4092) and 1.0465 (0.7035, 1.5568), Ojeok-san-1.1204 (0.8744, 1.4357) and 1.1267 (0.8466, 1.4996), and Bojungikgi-tang-1.1264 (0.8594, 1.4762) and 1.1400 (0.8515, 1.5261), respectively. Furthermore, no significant differences in the GMRs of Cmax,ss and AUCtau,ss were observed across different CYP2C19 phenotypes in any of the groups. The co-administration of escitalopram with Gami-soyosan, Banhasasim-tang, Ojeok-san, or Bojungikgi-tang did not exert significant PK effects on escitalopram. These findings provide valuable insights into the safe use of herbal medicines along with escitalopram.

The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance

In 2019, the International Working Group (IWG), focusing on New Developments in Pharmacovigilance, was established. This group is coordinated by the Drug Safety Research Unit in the United Kingdom, and the mission of the IWG is to progress pharmacovigilance methodologies and promote the safe and effective use of medicines and vaccines, thereby further protecting patients. Novel therapeutics are continuously being developed to alleviate medical conditions, but with advancing technologies, innovative pharmacovigilance methodologies need to be developed to effectively monitor the use and safety of these products. With reduced timelines proposed for premarketing clinical trials and increased application of real-world evidence supporting regulatory approvals, products may be used in real-world clinical practice in shorter timeframes than before. Therefore, the need for effective methods of monitoring medicines and collecting safety data in real-time is of paramount importance to public health. The IWG aims to advance existing methodologies used in the detection, monitoring, and analysis of safety data in pharmacovigilance and to communicate best practice proposals to support decision making in health care. The IWG will identify areas requiring review of current processes or methodologic research and will communicate the output of the IWG through peer-reviewed publications, reports, and presentation of findings at relevant conferences and scientific meetings. The IWG is currently reviewing two areas in pharmacovigilance; case-level causality assessment and the strengths and limitations of data sources. The IWG is advancing these areas by producing two scoping reviews which will be easily accessible to regulatory agencies, industry, academia, and interested persons or organizations. The scoping reviews comply with the IWGs mission to progress pharmacovigilance methodologies and promote the safe and effective use of medicines and vaccines. The present article shares details of the objectives of the IWG and provides an overview on the status of IWG activities.