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Background: Pegylated (PEG) interferon beta 1a has been approved by the United States Food and Drug Administration (USFDA) as an alternative to interferon beta 1a for multiple sclerosis (MS). Due to its higher price, this study aimed to evaluate the cost-effectiveness of PEG-interferon beta 1-a compared with interferon beta 1a from an Iranian payer perspective. Methods: A Markov model was designed according to health states based on Expanded Disability Status Scale (EDSS) and one-month cycles over a 10-year time horizon. Direct medical and non-medical costs were included from a payer perspective. Results: The incremental cost-effectiveness ratio (ICER) was estimated around 11111 US dollars (USD) per quality-adjusted life-year (QALY) gained for the PEG-interferon versus interferon regimen [with currency rate of 29,000 Iranian Rial (IRR) to 1 USD in 2016]. Conclusion: Considering the cost-effectiveness threshold in Iran [three times of gross domestic product (GDP) per capita or 15,945 USD], PEG-interferon beta 1-a could be considered as a cost effective treatment for Iranian patients with MS.
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OBJECTIVE: To develop a valid and reliable instrument in the Persian language for evaluating patient satisfaction with services provided in community pharmacies. METHODS: We selected a valid and reliable instrument from the literature and translated it to the Persian language. Some new items were added to the first draft based on the special characteristics of the Iranian health system. Then, the feasibility of utilizing the new instrument was assessed. In the third step, we conducted a formal content validity study to calculate content validity indices. Having completed the content validity study, the factorial structure of new instruments was determined by implementing a factorial analysis. Finally, the reliability of the instrument was assessed by assessment of Cronbach's alpha coefficient and test-retest reliability. FINDINGS: The developed instrument demonstrated suitable validity and reliability. The final instrument showed desirable content validity, with inter-rater agreement of 94% and 97% for relevance and clarity, respectively. Scale content validity indices for relevance and clarity were calculated as 96% and 92%, respectively, and comprehensiveness was calculated as 100%. Factor analysis resulted in seven factors with a cumulative variance of 62.14%. In internal consistency reliability, Cronbach's alpha for the whole instrument was 0.912. About test-retest reliability, six items showed almost perfect agreement, 18 items showed substantial agreement, and three items showed moderate agreement. Therefore, test-retest reliability assessment too demonstrated appropriate results. CONCLUSION: The instrument demonstrated excellent validity and reliability for application in Iran. This instrument is useful for evaluating patient satisfaction with services provided in community pharmacies in the Persian-speaking communities.
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The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy.
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OBJECTIVE: In this study, we aimed to assess comparative productivity of 21 pharmaceutical companies in Iran during 2000-2013. METHODS: To evaluate the productivity trend of pharmaceutical companies in Iran, we used data envelopment analysis-based Malmquist index. "Total assets" and "capital stock" as inputs and "net sales" and "net profit" as outputs extracted from Tehran stock exchange, were selected to be included in the analysis. This method provides the possibility for analyzing the performance of each company in term of productivity changes over time. We also used an estimation generalized least square panel data model to identify the factors that might affect productivity of pharmaceutical companies in Iran using EViews 7 and Deep 2.1 software. FINDINGS: The mean total productivity during all years of the study was 0.9829, which indicates the improvement in their overall productivity. The results, over the 13-year period, indicated that the range of productivity changes in pharmaceutical companies, that were included in this study, was between 0.884 and 1.098. Panel data model indicated that age of company could positively (t = 4.765978, P < 0.001) and being located in cities other than Tehran (the capital) could negatively (t = -5.369549, P < 0.001) affect the productivity of pharmaceutical companies. The analysis showed the new policy (brand-generic scheme) and also the type of ownership did not have a significant effect on the productivity of pharmaceutical companies. CONCLUSION: In this study, pharmaceutical productivity trends were fluctuated that could be due to the sub-optimal attention of policy makers and managers of pharmaceutical companies toward long-term strategic planning, focusing on productivity improvement.
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OBJECTIVE: Brand-generic scheme was implemented in Iran to improve the competition in the pharmaceutical market. In this study, we aim to assess if this policy had any positive effect on efficiency of Iranian pharmaceutical companies. METHODS: We used data envelopment analysis to evaluate the relative efficiency of pharmaceutical companies during 1999-2008. The Wilcoxon matched-pairs signed-rank and sign tests were used to assess the difference between mean technical efficiency of companies before and after implementation of the new policy. FINDINGS: Although the Wilcoxon matched-pairs signed-rank tests did not show any significant differences in favor of the new policy in terms of both relative and pure (managerial) technical efficiency for included companies (P = 0.079 and 0.07, respectively), but the one-sided sign test indicated that only relative pure (managerial) efficiency has been improved after this policy (P = 0.031). CONCLUSION: The "brand-generic scheme" does not seem to be a successful policy to improve efficiency level and prompt competition in pharmaceutical companies in Iran. To achieve this aim, consideration of infrastructural requirements including transparent and non-discriminating laws and regulations to support competition, the competitive pricing policies, the presence of international companies in the market, and full privatization of companies had to be also deeming by policy makers.