Background The objectives of this study were to determine if clinical trials in breast cancer, with an investigational drug, created direct drug cost savings for the healthcare system related to cost avoidance of the best standard of care treatments used in these studies. The aim was to quantify this potential drug cost avoidance. Methods We conducted a retrospective observational study of the drug cost avoidance during the study period (2014-2016). We included clinical trials with investigational drug, managed by pharmacy department and provided by the sponsor. The patients included had a therapeutic alternative defined as standard treatment that should have been received in case of not participating in the clinical trial. Direct cost savings, to national healthcare system, associated to clinical trials were calculated. Results Thirty-seven clinical trials with a total of 89 breast cancer patients were included in the study. A total of 62.2% were phase III and 75.7% belonged to the pharmaceutical industry. They provided a total cost avoidance of 957,246€ (1,130,028$), an average cost avoidance per patient of 10,756€ (12,697$). Conclusions Our study suggests that those clinical trials in which investigational drug are provided or refunded by the sponsor provide substantial cost savings. Due to the shortage of published articles that calculate the cost avoided in medication, we cannot compare directly the results obtained in the different institutions.

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year early-listing model was estimated at 0.68% of the total anticancer drug sales in 2017. Conclusions: Prices of anticancer drugs in Korea were similar to those among A7 countries based on the lowest price of anticancer drugs. It is recommended that a new 'pre-listing and post-evaluation' model, which references prices from A7 countries, be implemented to improve patient access to novel anticancer drugs.

BackgroundDrug shortages are caused by many factors, therefore medicines errors are reported. It is necessary to know how much health quality is a concern of clinical practice and how patient safety is involved.PurposeTo check out the drug supply problems; analyse the characteristics of drug shortages and assess their impact on a medium-sized hospital.Material and methodsA retrospective study of drug supply issues was conducted from September 2012 to September 2014. Variables analysed: type of drug, expected duration of the shortage and strategies. All data were exported from the National Drug Agency website. Drug purchases were gathered from a drug management application.Results172 drugs were affected by shortages. 19.77% of the drugs belonged to the digestive and metabolic group (mainly mineral supplements); 18.02% to the nervous system (mostly psycholeptics); 16.86% to the anti-infective group (primarily antibacterials); 11.05% to the cardiovascular system (predominantly beta blockers); 11.05% to the hormones group (mostly systemic corticosteroids). The expected length of the shortage was 235 days, although in 29% of cases, planned end date was not prompted. In 63.37% of the cases, the same drug was marketed by another firm so it could be obtained. 21.51% could be requested through other brands under special conditions, and in 15.12% the option was to look for a therapeutic alternative.ConclusionThe increasing frequency of drug shortages raises many difficulties and has a profound impact on patient safety and clinicians. Although it is impossible to predict for every drug shortage, establishing clear procedures and guidelines for managing drug shortages can improve patient safety, help prevent medicines errors and improve quality of care.ReferenceLee Ventola C. The drug shortage crisis in the United States. PT 2011;36(11):740–2,749–57No conflict of interest.

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