Background The implementation of pharmaceutical services in hospitals contributes to the appropriate use of medicines and patient safety. However, the relationship of implementation with the legal framework and organizational practice has not been studied in depth. The objective of this research is to determine the role of these two factors (the legal framework and organizational practice) in the implementation of pharmaceutical services in public hospitals of the Ministry of Health of Mexico. Methods Semi-structured interviews were conducted with four groups of actors involved. The analysis focused on the legal framework, defined as the rules, laws and regulations, and on organizational practice, defined as the implementation of the legal framework by related individuals, that is, how they put it into practice. Results The main problems identified were the lack of alignment between the rules and the incentives for compliance. Decision-makers identified the lack of managerial capacity in hospitals as the main implementation barrier, while hospital pharmacists pointed to poor regulation and the lack of clarity of the legal framework as the problems to consider. Conclusions Although the legal framework related to hospital pharmaceutical services in Mexico is inadequate, organizational factors (such as adequate skills of professional pharmacists and the support of the hospital director) have facilitated gradual implementation. To improve implementation, priority should be given to evaluation and modification of the current legislation along with the development of an official minimum standard for activities and services in hospital pharmacies.
Background: Policies for health technologies such as medical devices are essential and contribute to improved quality of healthcare. The regulation, assessment, and management represent important functions of medical devices. Insufficiently developed interactions between these functions impact the quality of delivered healthcare. To date studies lack to analyse these functions in a broad way. The aim of this study is to analyse the regulation, assessment, and management of orthopaedic medical devices in Mexico and how they shape healthcare. Methods: This qualitative study included 42 stakeholders involved directly or indirectly in the regulation, assessment, or management for orthopaedic medical devices in Mexico. Results: The fragmentation of responsibilities for medical device functions may be a central aspect of our findings concerning challenges reported by interviewees. Strengthening technovigilance based on improved reporting across health care institutions emerged as pathway to improve medical device regulation. With regard to improving the medical device assessment, a comprehensive update of the standard list represents a relevant opportunity. Integrating advanced quality attributes into procurement processes regarding decision-making, purchasing strategy, and procurement agent is needed to fostering the management. Conclusions: This study provides a broad analysis of medical device functions within a health system and highlights in this specific context how improvements might be achieved. It addresses a broad range of interest groups represented by policy makers, health service providers, managers and administrators of healthcare facilities, and doctors with an interest in health technologies. In this paper we highlight important themes that influence outputs and outcomes of the regulation, assessment, and management and discuss strategies in fostering these areas. To date, the regulation, assessment, and management of medical devices are rarely analysed in a broad way, even though these functions importantly contribute to the successful implementation of health technology policies. The quality of delivered healthcare is influenced by the performance between and within these functions. In Mexico, little discussion has been raised on challenges of the regulation, assessment, and management of medical devices. Changes to current processes and practices can improve outputs and outcomes of these functions and positively influence the quality of delivered healthcare. Stakeholder involvement and commitment is essential to this.
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