ABSTRACT
Gestational diabetes mellitus (GDM) is a primary concern in India affecting approximately five million women each year. Existing literature indicate that prediabetes and diabetes affect approximately six million births in India alone, of which 90% are due to GDM. Studies reveal that there is no consensus among physicians and health-care providers in India regarding management of GDM prepartum and postpartum despite available guidelines. Also, there is no consensus among physicians as to when a woman should undergo oral glucose tolerance test after delivery. This clearly shows that management of GDM is challenging and controversial in India due to conflicting guidelines and treatment protocols, despite availability of straightforward protocols for screening and management. Also, a collaborative approach remains a key for GDM management, as patient compliance and proper educational interventions promote better pregnancy outcomes. Management of GDM plays a pivotal role, as women with GDM have an increased chance of developing diabetes mellitus 5-10 years after pregnancy. Also, children born in GDM pregnancies face an increased risk for obesity and type 2 diabetes. The cornerstone for the management of GDM is glycemic control and quality nutritional intake. GDM management is complex in India, and existing challenges are multifactorial. However, there are little published data outlining these challenges. This review gives an account of some of the key challenges from self-management and health-care provider perspective. The recommendations in this review provide insights for building a more structured model for GDM care in India. This research has several practical applications. First, it points out to reaching a consensus on approaches for screening, diagnosis, and treatment of care across clinical practices in the nation that can aid in overcoming certain challenges observed. Second, it highlights the importance to build capacities and capabilities, especially in resource-limited settings. Health education among pregnant women remains a priority to resolve issues related to self-management. More broadly, further research, specifically qualitative is vital to determine forthcoming challenges with respect to patients, caregivers, providers, and policy makers and to provide solutions fitted to practice setting and demographic background.
ABSTRACT
The past decade witnessed rapid development of novel drugs and therapeutic biological agents. The marketing authorization for novel therapies is often time consuming and distressing for patients. Earlier clinical trials were the only way to access new drugs under development. However, not every patient meets the enrolment criteria, and participation is difficult for patients with life-threatening, long-lasting or seriously debilitating diseases like rare diseases. Early access programs like "Compassionate Use Program (CUP)" have generated alternative channels for such patients. The European Medical Agency provides regulations and recommendations for compassionate use, upon which every European Union (EU) member state has developed its own rules and regulations. Despite previous reviews and studies, the available information is limited and gaps exist. This literature review explores CUP in 28 EU member states. Data was collected through literature review and use of country-specific search terms from the healthcare domain. Data sources were not limited to databases and articles published in journals, but also included grey literature. The results implied that CUP was present in 20 EU member states (71%). Of 28 EU states, 18 (â¼64%) had nationalized regulations and processes were well-defined. Overall, this review identified CUP and its current status and legislation in 28 EU member states. The established legislation for CUP in the EU member states suggest their willingness to adopt processes that facilitate earlier and better access to new medicines. Further research and periodic reviews are warranted to understand the contemporary and future regulatory trends in early access programs.
