British Journal of Healthcare and Medical Research

Global Medicines Regulation in Pregnancy and Lactation: Addressing Emerging Therapies, Safety, and Access Inequalities

Tue, 02 Dec 2025 00:00:00 +0000

Safe medication use during pregnancy and lactation is fundamental to protecting maternal and neonatal health. However, global variability in regulatory frameworks, pharmacovigilance systems, and access to therapies presents major challenges-particularly for emerging treatments such as biologics, GLP-1 receptor agonists, and novel small molecules. This review aimed to synthesize international regulatory frameworks, evaluate safety monitoring practices, and explore disparities in access to medicines for pregnant and lactating populations. A narrative review was conducted using PubMed, Embase, Scopus, Web of Science, and regulatory agency websites (FDA, EMA, Health Canada, MHLW Japan, WHO), supplemented by pharmacovigilance databases (FAERS, VigiBase, EudraVigilance). Publications in English from 2000-2025 addressing regulatory policies, safety monitoring, or access inequalities were included. Extracted data were analyzed to identify global trends, gaps, and best practices in maternal-fetal pharmacotherapy. High-income countries demonstrate mature systems, including the FDA Pregnancy and Lactation Labeling Rule, EMA risk management plans, and comprehensive pharmacovigilance infrastructures. In contrast, low- and middle-income countries (LMICs) often face fragmented regulations, limited monitoring capacity, and restricted access to innovative therapies. Global initiatives such as the World Health Organization (WHO) guidelines, the International Council for Harmonization (ICH) E11(R1) guideline, and TransCelerate programs promote harmonization, yet substantial gaps remain. Active and passive surveillance mechanisms, pregnancy registries, and real-world data enhance safety assessment for emerging therapies, while access inequalities persist due to regulatory delays, cost, and sociocultural barriers. Despite meaningful advances in high-resource settings, LMICs continue to experience major challenges in ensuring safe and equitable access to medicines. Strengthening evidence-based, harmonized regulatory frameworks, expanding pharmacovigilance coverage, and integrating real-world evidence are essential to safeguarding maternal and neonatal health. Coordinated global collaboration is imperative to achieve equitable access to innovative therapies worldwide.

Exploring the Challenges of Senior Midwives in Providing Mentorship to Pre-service Student Midwives at Women and Newborn Hospital, University Teaching Hospital, Lusaka, Zambia

Miyanda-Mwiinga Betty, Ngoma-Mubita Catherine, Kabinga-Makukula Marjorie — Sun, 09 Nov 2025 00:00:00 +0000

The aim of this study was to explore the barriers and strategies experienced by senior midwives in mentoring pre-service student midwives during clinical placements at the Women and Newborn Hospital within the University Teaching Hospital in Zambia. An existential phenomenological design was used. Data were collectively engaged in employment when analyzing the qualitative data obtained from the interviews and focus group discussions. Senior midwives reported multiple barriers to mentorship, including overwhelming student numbers, short clinical rotations, staff and resource attitudes, inconsistent use of supervision manuals, limited time for feedback, and overcrowded clinical spaces. Patient care responsibilities were frequently prioritized over mentorship, limiting opportunities for guided learning. Despite these challenges, midwives employed adaptive strategies such as improvising with limited resources, encouraging students to bring their own equipment, and mentoring during less busy shifts. This study underscores the importance of addressing barriers and innovating current strategies in daily nursing midwives' routines. The key results highlight the need to create a sustainable, continuous mentoring process. Further research should focus on developing frameworks to improve mentoring for senior midwives.

Colon Fistula: A Conditioning Treatment

Sun, 09 Nov 2025 00:00:00 +0000

Introduction: colon or rectal fistula is a medical/surgical challenge that, with precedents and resilience, is presented as a complication of another real cause and fistula is defined as the path in abnormal communication between one epithelium and another. Objective: to present the experience of seven years in diagnosis and treatment in four hospitals in Mexico City. Method: this is a study with a multicenter, retrospective, longitudinal, observational and descriptive design. In the Colon and Rectal Surgery services, as well as General Surgery of the second and third level of health care. Results: from 118 records, a total of 46 patients with colon fistula were chosen, of which 17 were male (36.95 %) and 29 were female (63.04 %). With an age range of 21 to 82 years, with an average of 61 years and a bimodal value of 33 and 64 years. Its etiology was diverse, but its presentation was documented as entero-cutaneous, entero-bladder, entero-vaginal, entero-uterine, entero-enteric fistulas. Discussion: the diagnosis of colon fistula is made with a complete medical history, which is mostly clinically evident with the classic triad. The gold standard for confirming a diagnosis of acute diverticulitis and evaluating complications is CT scan with contrast of the abdomen; the treatment alternatives for colon fistulas to another organ varies according to the case, the clinical conditions and/or their prognosis of cure according to the Chapman and Sheldon stages; successful conservative management or treatment in hemodynamically stable patients, offering less invasive alternatives in selected clinical scenarios, or even fecal transplants in patients with complicated diverticulitis; however, surgical intervention remains the definitive treatment for symptomatic or complicated fistulas. Conclusions: regarding the treatment of colon fistulas, this will be conditioned according to each patient, by the hemodynamic conditions, the etiology, the characteristics of nutrition/infection and of course the surgeon's expertise, as well as the infrastructure of the installed capacity that is available.

Is it a Wasp or is it a Wasp? The Human Cost of Algorithmic Decision-Making: Why Connection and Judgement Matter

Wendy Thomson — Tue, 11 Nov 2025 00:00:00 +0000

Traumatic Birth and Chronology of Losses

Faida Barazi, Izhar Ben Shlomo — Wed, 12 Nov 2025 00:00:00 +0000

This study examines the impact of traumatic birth experiences on parents of children with cerebral palsy. Background: Traumatic births affect 9-45% of women, potentially causing significant psychological consequences. Objectives: To investigate the losses experienced by parents following traumatic deliveries and their impact on family dynamics and identity. Methods: Twenty-four parents (21 mothers, 3 fathers) from diverse backgrounds in northern Israel participated in qualitative interviews analyzed through thematic and narrative approaches. Results: Six domains of loss emerged: idealized birth experience, autonomy during labor, initial bonding, normative family structure, financial stability, and health security. Parents experienced profound identity disruption while navigating between idealized expectations and the reality of raising a child with special needs. Conclusions: Traumatic births create a domino effect that necessitates reconstruction of family life and self-perception. These findings highlight the need for comprehensive support systems for affected families, addressing both immediate and long-term consequences of traumatic birth experiences.

Endoscopy is a Resource With Diagnostic/Therapeutic Power

Wed, 12 Nov 2025 00:00:00 +0000

Introduction: endoscopy is in a unique position at the interface between various medical and surgical disciplines. Endoscopy is a medical procedure that allows the interior of the entire gastrointestinal tract to be visualized by means of an instrument, among other organs and/or systems of the human body. Objective: To carry out art history based on an exhaustive search of the national and international medical literature on endoscopy in the medical field. Discussion: endoscopic studies have evolved the form of better diagnosis, in prevention, or as a screening, for an early cure, for a timely treatment or, failing that, in a palliation in the prognosis of patients in symptomatologic scenarios, to a degree as specific or even surprising. From procedures where only observation is performed to specialized surgical treatments with effective, decisive techniques and in a multi-application environment. Conclusions: endoscopy is currently a resource that has evolved by leaps and bounds due to abrupt and constant technological progress, allowing its application in such a varied way in the medical and/or surgical field, with the aim of a diagnostic/therapeutic approach, which benefits patients in their health exponentially, facilitates medical work and reduces costs exorbitantly.

What’s is the Current Situation about Health Care in the Maternity Facilities of Defense Forces in Benin?

Sat, 22 Nov 2025 00:00:00 +0000

Introduction: Still with this aim of extending this approach to other health centers, UNICEF supported "optimized care" on the maternity wards of the health centers of the Defense and Security Forces (FDS). As part of the implementation of optimized care in the mother-child services of the FDS, it was necessary to carry out an initial assessment in order to train staff on good practices. The main objective of this study was to assess the quality of maternal -child health care in the health centers of the FDS. Materials and Methods: It was devoted to training investigators on data collection techniques and tools. The training was led by a team of trainers from the Beninese Armed Forces (gynecologist, pediatrician) supported by UNICEF resource persons and national facilitators. Data collection was carried out by investigators in the four (04) health centers in the northern zone and three (03) in the southern zone with the supervision of the FABs supported by UNICEF resource persons and national facilitators. The data collection tools were made available by UNICEF BENIN and included interview questionnaires, observation sheets, and counting sheets. Data analysis was done in an EXCEL data mask designed and made available by UNICEF BENIN. Results : These indicators are identified: Proportion of newborns who benefited from early breastfeeding within the first hour of birth: 89% ; Proportion of newborns receiving cord care during the first 48 hours with chlorhexidine gel: 33% ; Availability of resuscitation equipment and standard newborn care supplies : 62% ; Rate of use of CPN 4 by qualified personnel : 75% ; Percentage of SONUB functions offered by the center: 86% ; Percentage of SONUB functions correctly implemented by the center: 60%. Conclusion: At the end of this preliminary study, it is important to set up an improvement plan based on the identified defects. This will contribute to improving the quality of care provided there.

Steady Progress and Significant Challenges in the Field of Tumor and Cancer Research in Bangladesh: An Overview

Tue, 25 Nov 2025 00:00:00 +0000

Tumor and cancer research in Bangladesh is an evolving field with both steady progresses recently and significant challenges. The 2013 Series Bangladesh: Innovation for Universal Health Coverage, published in The Lancet, reported on Bangladesh’s health achievements and challenges particularly on exceptional health advances at low cost than other countries in Asia. Additionally, several national and subnational studies have reported the burden of different diseases and risk factors in Bangladesh at different points during the past three decades i.e. from 1990 to 2019 in Bangladesh. Cancer is a leading cause of death of children and adolescent worldwide and it represents one of the most significant public health problem and challenges of the century with a particularly devastating impact on developing nations. Several studies have been reported evaluating qualitatively and quantitively documenting research progress on tumors and cancers situation from Bangladesh. In the present article, we have made an overview of this field with background to burden of diseases and risk factors, some reported studies from Bangladesh on tumors and cancers and steady research progress on tumors and cancers and significant challenges to it in Bangladesh. Further continued research affords along these fronts are therefore warranted and vitally important.

The Delusional Addiction & Ignorance Associated with Fitness Regimes

Wendy Thomson — Tue, 25 Nov 2025 00:00:00 +0000

This article explores the risks of exercise regimes that, while intended to promote health, may instead cause physical and psychological harm. Both the public and professional athletes are vulnerable—athletes face intense pressure to adhere to extremely demanding training programs, often under the influence of under-qualified trainers, resulting in excessive injury, career-ending conditions, or even suicide.