Practical Considerations for the Implementation and Monitoring of Risk Minimisation Measures for High-Risk Teratogenic Medicines.

There is considerable societal interest in making medicines more affordable. A critical factor often inadequately considered early in the process of adding drugs to a company's product portfolio is that some products may require additional monitoring and complex, demanding and expensive additional risk minimisation measures (aRMMs). These aRMMs may have a sizeable impact on a company's commitment to that medicinal product throughout the product's entire life cycle. The teratogenic phthalimides were selected as an example of medicines that are recently being genericised and require a substantial commitment in terms of additional monitoring and aRMMs, most notably in the form of pregnancy prevention programmes (PPPs) with controlled distribution systems (CDSs). Implementing PPPs with CDSs is complex and demanding and encompasses all routine activities, aRMMs, local/regional Health Authority (HA) requirements, and commercialisation strategies. Considerations have been summarised that can support decision-making during due diligence processes, implementation and monitoring. Proactive, effective pharmacovigilance requires innovative, sustainable and flexible solutions to maintain high standards across the board. In particular, generic marketing authorisation holders operate with limited resources and may benefit appreciably from the following proposed suggestions and solutions such as early planning and preparation, knowledge-sharing, utilisation of new technologies and implementation of measures beyond HA-mandated requirements.

Measurement of Body Composition in Pancreatic Cancer: A Systematic Review, Meta-Analysis, and Recommendations for Future Study Design.

BACKGROUND/OBJECTIVES: Sarcopenia in pancreatic cancer may increase the risk of chemotherapy-related toxicity and post-operative morbidity. This systematic review and meta-analysis aimed to quantify the prevalence of sarcopenia in early stage pancreatic cancer. METHODS: Relevant studies were identified using Ovid Medline and Elsevier Embase. Pooled estimates of prevalence rates (percentages) and corresponding 95% confidence interval (CI) were computed using a random-effects model to allow for heterogeneity between studies. RESULTS: The majority of the 33 studies (n = 5,593 patients) included in this meta-analysis utilized computed tomography (CT)-derived measures for body composition assessment in patients undergoing pancreatic resection. Reported prevalence of sarcopenia varied between 14 and 74%, and the pooled prevalence was 39% (95% CI: 38-40%) Heterogeneity was considerable, however, (I2 = 93%) and did not improve significantly when controlling for assessment method, and use of pre-defined cut-offs for sarcopenia, limiting potential to evaluate the true impact of sarcopenia. CONCLUSION: The ready availability of sequential CT offers a valuable opportunity for body composition assessment, but the quality of assessment and interpretation must improve before the impact of body composition on treatment-related outcomes and survival can be assessed. We suggest recommendations for the assessment of body composition for the design of future studies.