TP8.2.18 Every little helps. A trainee led cost saving initiative

Aim The NHS is under pressure to deliver the best quality care within a confined budget. The cost of spending on medications is growing by 12% per annum. The five year forward plan for the NHS called for £22 Billion in efficiency savings. All NHS staff are being asked to help deliver better outcomes at lower costs. We aimed to review costs in the surgical department, identify savings, implement changes and evaluate the outcome. Method Pharmacy orders from 2016-17 were reviewed. Prices of branded and generic medications were compared. Levobupivicaine was identified as a product with cost savings between branded and generic forms. Procurement officers were advised to switch to generic alternatives and the pharmacy system was adjusted to highlight that generic forms should be ordered. Orders for 2018-19 were reviewed and savings calculated. Results 29,280 units of levobupivicaine were ordered in 2016-17. 100% of these orders were of the branded product. Projected savings of switching to a generic product was £12,846 per annum. 31,355 units of levobupivicaine were purchased during the 2018-19 period. 83% of orders were for the generic product. £11,805 was saved over this period. £1,703 of further savings have been highlighted. Conclusion We have shown that simple changes can result in modest savings. All NHS staff, including trainees, can lead cost reducing initiatives. Multiple small savings will summate to larger savings, resulting in resources being better utilised to improve patient outcomes.

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices that have been implemented by SAHPRA to support the assessment of new chemical entities and generic product applications for market authorization in the business-as-usual and backlog process streams.Methods: A questionnaire was completed and verified by SAHPRA to describe the structure of the organization, the resources available, the process for regulatory review of new chemical entities and generic products and the level of implementation of good review practices and regulatory decision-making practices for market authorization. Data were collected and analyzed on the overall approval timelines for new chemical entities and generic products registered by SAHPRA in 2020 in the business-as-usual and backlog process streams.Results: A full, independent scientific review was conducted for all new chemical entities and generic product applications in the business-as-usual stream. Facilitated regulatory pathways were introduced for the review of new chemical entities and generic products in the backlog stream. As a result, the timelines for approval of applications in the backlog stream were 68% quicker for both new chemical entities and generics, using facilitated regulatory pathways, such as abridged and verification review models.Conclusion: The comparisons made through this study provided insight into the improvements that have been made through the establishment of SAHPRA and the transition in 2018 from the MCC. The re-engineered processes that have been developed and implemented by SAHPRA to address the backlog in the review of the applications for market authorization have demonstrated a decrease in the overall median approval times. The expansion of these processes into the routine review of medical products will contribute to the enhanced regulatory performance of SAHPRA and patients’ access to new medicines.

Generic Product Lifecycle Model: A Holistic and Adaptable Approach for Multi-Disciplinary Product–Service Systems

The linear economic model behind contemporary product lifecycle representations contradicts planetary boundaries and the idea of sustainability. At the same time, Circular Economy (CE) driven models lack consideration of profound technological insights. Based on observations in research and the application of projects of different industries, a quantitative and qualitative literature analysis is applied to identify both strengths and shortcomings of current lifecycle models. These findings are used to create lifecycle model portfolios and to derive a generic Product Lifecycle model (gPLC). The gPLC is validated by three industrial cases based on collaborative research projects. In practice, resource and energy consumption as well as waste production and emissions can be minimized with the help of established methods not only by economists, but also by engineers. Transparency of material and information circularity practically implies the opportunity to implement, for instance, Minimum Viable Products and DevOps approaches. The originality of the gPLC is characterized by three main aspects: first, material and information flows of multi-disciplinary product–service systems are recognized as the foundation for a modern CE; second, a differentiation between product classes and instances is elaborated to stimulate sustainable design of material core products and digital CE business models; and third, the stakeholder perspective is expanded from manufacturer and consumer/user to further perspectives, such as recycler and society.

Co-crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations.

Co-crystal is an attractive alternative new class of solid forms because that can be engineered to have desired physicochemical properties. Co-crystals have gained considerable attention from the generic pharmaceutical industry after the USFDA released its finalized guidance in the year 2018 on the regulatory classification of co-crystals. In this review, we discussed how co-crystals can be explored as a potential alternative solid form for the development of a generic product that meets the legal, regulatory, and bioequivalence requirements. In the contents, we discussed in detail concepts such as the selection of coformers, various ways of making co-crystals, the strategy of characterization to discriminate between co-crystal and salt, polymorphism in co-crystals, the aspects of intellectual property and, finally, the regulatory aspects of co-crystals.

Bioplastics for packaging in cosmetic sector towards a circular bioeconomy model

What do you want to do ? New mailCopy The Italian cosmetic industry is experiencing a period of constant growth. The materials used for industrial packaging are often produced in compliance with the hygiene standards imposed by the rules of the sector but without looking at the environmental aspect, how they are produced and how these packaging will be disposed of. In recent years, consumers' environmental awareness has increased thanks to fast and accessible media, like the internet, and to a greater consciousness of the institutions. The average consumer is no longer satisfied with the generic product found at the point of sale, but he informs himself, evaluates, and relies on companies that embrace the culture of sustainability. The aim of this paper is the analysis of the technological and environmental advantages coming from the benefit of Bio-based polymers applied to the sector of cosmetic packaging, through a project of a new start up based on production of bioplastics for that sector.