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Introduction: Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, including those related to research and development (R&D) and manufacturing. Such considerations could enter the decision process in collectively financed health care systems. This paper investigates whether manufacturers' costs in relation to drug prices, or profit margins, are explicitly mentioned and considered by health technology assessment (HTA) organisations. Method: An analysis of reimbursement reports for cancer drugs was performed. All relevant Dutch HTA-reports, published between 2017 and 2019, were selected and matched with HTA-reports from three other jurisdictions (England, Canada, Australia). Information was extracted. Additionally, reimbursement reports for three cases of expensive non-oncolytic orphan drugs prominent in pricing debates in the Netherlands were investigated in depth to examine consideration of profit margins. Results: A total of 66 HTA-reports concerning 15 cancer drugs were included. None of these reports contained information on manufacturer's costs or profit margins. Some reports contained general considerations of the HTA organisation which related prices to manufacturers' costs: six contained a statement on the lack of price setting transparency, one mentioned recouping R&D costs as a potential argument to justify a high price. For the case studies, 21 HTA-reports were selected. One contained a cost-based price justification provided by the manufacturer. None of the other reports contained information on manufacturer's costs or profit margins. Six reports contained a discussion about lack of transparency. Reports from two jurisdictions contained invitations to justify high prices by demonstrating high costs. Conclusion: Despite the attention given to manufacturers' costs in relation to price in public debates and in the literature, this issue does not seem to get explicit systematic consideration in the reimbursement reports of expensive drugs. [ABSTRACT FROM AUTHOR]

Background: Patient safety in primary care is an emerging field of research with a growing evidence base in western countries but little has been explored in the Gulf Cooperation Council Countries (GCC) including the Sultanate of Oman. This study aimed to review the literature on the safety culture and patient safety measures used globally to inform the development of safety culture among health care workers in primary care with a particular focus on the Middle East. Methods: A systematic review of the literature. Searches were undertaken using Medline, EMBASE, CINAHL and Scopus from the year 2000 to 2014. Terms defining safety culture were combined with terms identifying patient safety and primary care. Results: The database searches identified 3072 papers that were screened for inclusion in the review. After the screening and verification, data were extracted from 28 papers that described safety culture in primary care. The global distribution of the articles is as follows: the Netherlands (7), the United States (5), Germany (4), the United Kingdom (1), Australia, Canada and Brazil (two for each country), and with one each from Turkey, Iran, Saudi Arabia and Kuwait. The characteristics of the included studies were grouped under the following themes: safety culture in primary care, incident reporting, safety climate and adverse events. The most common theme from 2011 onwards was the assessment of safety culture in primary care (13 studies, 46%). The most commonly used safety culture assessment tool is the Hospital survey on patient safety culture (HSOPSC) which has been used in developing countries in the Middle East. Conclusions: This systematic review reveals that the most important first step is the assessment of safety culture in primary care which will provide a basic understanding to safety-related perceptions of health care providers. The HSOPSC has been commonly used in Kuwait, Turkey, and Iran. [ABSTRACT FROM AUTHOR]