Evaluating the affordability of asthma, chronic obstructive pulmonary disease, and cystic fibrosis medicines in a middle-income country.

BACKGROUND: A heavy financial burden is imposed on patients suffering from chronic diseases due to medicine out-of-pocket payments. OBJECTIVES: This study focuses on assessing the affordability of medications used for chronic respiratory diseases (CRDs) such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF) in Iran, specifically on the category R medicines listed in the 2017 Iran drug list (IDL) that are used for the treatment of these diseases, based on the anatomical therapeutic chemical (ATC) drug code. METHODS: The affordability of medicines in mono and combination therapy approaches was assessed in CRDs using the World Health Organization/Health Action International (WHO/HAI) methodology. Accordingly, if out-of-pocket payment for 30-days of pharmacotherapy exceeds one day for the lowest-paid unskilled government worker (LPGW), it's considered non-affordable. RESULTS: Based on the monotherapy approach, our finding demonstrates that all generic medicines of category R were affordable. However, branded drugs such as Symbicort®, Pulmicort Respules®, Flusalmex®, Seretide®, Fluticort Plus®, Seroflo®, and Salmeflo® cost between 1.2 and 2.5 days' wage of LPGW and considered unaffordable despite 70% insurance coverage. Moreover, based on the affordability ratio in the combination therapy approach, all medicines used in asthma, COPD, and CF patients with mild respiratory problems are affordable except omalizumab (inj), which is non-affordable due to its high price and no insurance coverage. CONCLUSION: Results showed that the existing insurance coverage does not protect households from hardship, so more considerations are needed such as different insurance schedules and patient support programs.

Exploring health seeking behaviors for common cold management.

Background: The prevalence of common cold can impose financial burden on the healthcare systems, despite its simple and self-limiting symptoms. Objective: This study examines the behavior of patients suffering from symptoms of the common cold and explores the factors that may influence such behaviors. Methods: A descriptive-analytic cross-sectional study was conducted in 2019, in Tehran, Iran, using cluster sampling in socioeconomically diverse areas within the city. The participants' behaviors and related factors were evaluated using a 10-item questionnaire. Data collection process involved selecting 5 shopping centers and 404 individuals participated the study. SPSS version 24 was used for analysis. Results: The results showed that 42.1% of the respondents would consult a physician immediately upon experiencing cold symptoms, while 11.4% would consult a pharmacist.In addition, 14.3% would try self-medication, 28.3% relied on traditional home remedies, and 15%indicated not to make use of any remedies or interventions. The study indicated a correlation between people's behaviors concerning the common cold and their level of health self-confidence, knowledge of the common cold, lifestyle, gender, marital status, occupational status, insurance status, and average family spending. Conclusion: The findings of this study are significant in that they shed light on the behaviors of individuals and associated factors related to seeking medical assistance for the common cold. This knowledge can assist healthcare systems in developing strategies aimed at enhancing treatment outcomes, and decreasing costs.

How does external reference pricing work in developing countries: evidence from Iran.

Introduction: Governments apply different pricing policies to ensure public accessibility, availability, and affordability of medicines. In this way, external reference pricing (ERP) because of its easy implementation is used widely across countries. However, ERP is completely path dependent, and it would both bring pros and cons, related to its implementing strategy which makes understanding of its impact in different countries challenging. In this study, we examine the performance of the ERP approach in Iran as a pricing tool. Method: We conducted a cross-sectional descriptive study. Although Iran officially uses a reference country basket for ERP, in this study, we use different reference countries based on socioeconomic comparability, access to their price data, medicine pricing approaches, and pharmaceutical expenditure to examine the effect of reference countries as well as the method performance. Then, an empirical study was applied to a list of selected samples of medicines in the Iranian market to compare their price with our new reference countries. Then, we discuss the performance of ERP process based on the real prices in the Iranian pharmaceutical market. Result: The prices of 57 medicines, which contain about 69.2% of the imported Iran pharma market in value, were compared with their prices in selected reference countries. It was found that 49.1% of prices were more expensive in at least one of the reference countries, and in 21% of products, the average price in Iran was higher than the average price in reference countries. Conclusion: Achieving efficient and fair pricing of pharmaceuticals between and within countries is still a complex conceptual and policy problem that ERP in short term can handle. ERP cannot be considered a perfect tool for pricing alone, although its effectiveness is acceptable. It is expected that using other pricing methods alongside the ERP will improve patients' access to medicines. In Iran, we use value base pricing as the main pricing method for every new molecule. Then, we use other methods such as ERP as a complementary method.

Main drivers of diabetes pharmaceuticals expenditures: evidence from OECD countries and Iran.

Purpose: This study aimed to identify the impact of prominent drivers on drug expenditure for diabetes. Method: Following the examination of previous studies, this study identified possible factors contributing to diabetes pharmaceutical expenditures. The explanatory variables for the study were the median population age, access to innovative drugs, GDP per capita, prevalence, price, and consumption of diabetes drugs. Then, to estimate the per capita expenditure among diabetic patients, this study developed the panel data model and two time-series regression models for OECD countries and Iran, respectively. Results: In the panel data regression model, R2 was 0.43. The influence of the age, prevalence, consumption volume and GDP per capita coefficients were + 1.79, + 0.704, + 3.86057, + 0.00054, respectively. Also, the probability level of all variables was less than 0.05. In Iran's comparative time-series regression model, R2 was 0.9, and the only significant influence coefficient was the age (ß=+0.91). In the another model for Iran, R2 was 0.99, the influence coefficient of age was + 0.249, the prevalence was + 0.131, innovation was + 0.029, and the price was + 0.00054; all the probability levels were less than 0.05. Conclusion: Pharmaceutical per capita expenditure is affected by several factors. These factors are not the same in various counties. Passing a judgment on drug utilization only based on pharmaceutical per capita expenditure cannot be perfect. Also, judging whether the per capita drug expenditure in one country is desirable without attention to the affecting factors and only relying on the value of utilized medicines is defective.

A Cost-effectiveness Analysis of Adding Cetuximab to the First-line Treatment of Metastatic Colorectal Carcinoma in Iran; Considering Genetic Screening for Precision Medicine.

PURPOSE: This study aimed to evaluate the cost-effectiveness of cetuximab in different genetic populations of metastatic colorectal carcinoma patients, including KRAS and RAS wild types and mutants, when added to FOLFIRI treatment regimens for evidence-based disease management in Iran. METHOD: A Markov decision model was designed in TreeAge software with the three states of stable, progress, and death. Clinical outcomes were extracted from published clinical studies, and costs were extracted from the Iranian local data. The primary outcome was an incremental cost-effectiveness ratio (ICER) in the simulated population. RESULTS: The cost-utility model from the perspective of the health system indicated that the average direct medical costs of a patient that has not been genetically screened are $56,985.27 and $20,767.74 in FOLFIRI + cetuximab and FOLFIRI regimens, respectively. However, costs per patient in the KRAS wild-type population were $21,845.52 in FOLFIRI and $78,321.22 in FOLFIRI + cetuximab. In RAS wild-type patients, FOLFIRI and FOLFIRI + cetuximab costs per patient were $23,111.62 and $84,976.39, respectively. Incremental QALYs for the above scenarios were 0.069, 0.193, and 0.285, respectively. Therefore, the ICER of add-on cetuximab in Iran compared to the treatment alternatives in the scenarios with and without KRAS screening was $520,771.55/QALY, $292,768.16/QALY, and $217,460.51/QALY. CONCLUSION: Although genetic screening in precision medicine reduces costs per outcome, according to the willingness-to-pay threshold of $4349.50 in the Iranian health system, add-on cetuximab to the FOLFIRI regimen is not a cost-effective strategy even with genetic screening and a 20% price reduction.

Cost-Effectiveness Analysis of Macitentan in Comparison With Bosentan in the Treatment of Pulmonary Arterial Hypertension in Iran.

OBJECTIVES: Pulmonary arterial hypertension (PAH) is a chronic and progressive disease that, if left untreated, shortens the life expectancy of patients. Endothelin receptor antagonists, such as macitentan and bosentan, play an essential role in improving the patient's symptoms, quality of life, and life expectancy. This study aimed to evaluate the cost-utility of macitentan compared with bosentan in treating PAH from the health system perspective in Iran. METHODS: For evaluating the cost-effectiveness of macitentan, a Markov model consisting of 5 states, functional class (FC) I, FC II, FC III, FC IV, and death, was designed using the TreeAge software. The lifetime time horizon and a 3-month cycle length were set. Patients entered the model from FC II or FC III states based on the initial probabilities. Costs were measured in US dollars (USD), and outcomes were measured in terms of quality quality-adjusted life-years (QALYs). Consequently, the incremental cost-effectiveness ratio (ICER) was calculated. In addition, sensitivity analysis was performed to determine the robustness of the model by examining the possible effects of uncertainties on the final result. RESULTS: The costs of treatment with macitentan and bosentan in PAH in Iran were calculated at 19 429 and 17 246 USD, and the outcomes were 4.02 and 3.04 QALYs, respectively. Therefore, ICER was calculated at 2233.46 USD/QALY. One-way sensitivity analysis demonstrates that the model is robust; nevertheless, it is most sensitive to the price of macitentan and bosentan. CONCLUSION: Treatment with macitentan was associated with both higher costs and QALYs than bosentan. Nevertheless, it is considered the cost-effective treatment strategy in Iran given that the calculated ICER falls below the willingness to pay threshold.

Catastrophic pharmaceutical expenditure in patients with type 2 diabetes in Iran.

OBJECTIVES: This study aimed to assess the financial burden of out-of-pocket (OOP) payments to purchase antidiabetic medicines for type 2 patients in Iran. METHOD: The "budget share" and "capacity to pay" approaches were employed to assess the catastrophic pharmaceutical expenditures of antidiabetic medication therapies. The catastrophic thresholds were adjusted for pharmaceutical sectors. The data was 2019 monthly household expenditures in rural and urban areas, insurance coverages of antidiabetic medicines and patients' out-of-pocket (OOP) payments in 30-day treatment schedules. RESULTS: The results show that expenditure on diabetes medication therapies in the form of mono-dual therapy and some cases triple oral therapies were not catastrophic even for rural households. Insulin puts patients at risk of catastrophic pharmaceutical expenditures when added to the treatment schedules, and lack of financial protection intensifies it. In general, the poorer households and those resistant to first-line treatments were at increased risk of catastrophic pharmaceutical expenditures. The number of treatments that put patients at risk of catastrophic pharmaceutical expenditure in "budget share" was higher than the "capacity to pay" approach. CONCLUSIONS: Assessing medication treatment affordability instead of a single medicine assessment is needed. Assessment could be done by utilizing a macro-level data approach and applying adjusted pharmaceutical sector threshold values. Considering the variation between treatment schedules that put patients at risk of catastrophic pharmaceutical expenditures, targeted pharmaceutical policies and reimbursement decisions are recommended to promote Universal Health Coverage (UHC) and to protect vulnerable populations from hardship.

The cost of dispensing errors in Iranian health system: a retrospective evaluation.

OBJECTIVE: The problem of medication errors (MEs) has constantly been receiving considerable attention worldwide due to their health impact and costly consequences. MEs occur in all phases of prescription, preparation, administration, distribution and delivery to the patient; however, dispensing errors are more common in this study, we have attempted to identify various MEs that occurred by pharmacists and calculate their financial and physical harm costs. DESIGN: This was a 8-year retrospective study. SETTING: This study evaluated the costs of MEs in the Iranian health system caused by dispensing mistakes from 2012 to 2019. We retrieved documents and reports from the Tehran Medical Council Archive. Then, we extracted dispensing error data from ME record forms and analyzed them using SPSS software. MAIN OUTCOME MEASURES: Cost of dispensing errors. RESULTS: Among 3000 available MEs documents, only 2.6% of cases were dispensing errors. Errors included dispensing of wrong medication (75.6%), delivering expired medicines (11.5%), wrong medication order (9%), wrong medicine compounding (2.6%) and wrong dose of medication (1.3%). The most common cause of dispensing errors was physicians' poor handwriting (23.1%). Legal reactions, due to MEs, occurred in a range of actions from written reprimand in the professional records to some months of deprivation from professional activities. CONCLUSION: The analysis of the MEs that lead to the legal prosecution in the Iranian Medical Council shows that most cases, according to the severity of harm, were dispensing wrong medicines which caused temporary patients harm.

How Do Iranian Stakeholders Think About Pharmaceutical Managed Entry Agreements?

Background: Uncertainty in real-world product profiles is the main barrier to pharmaceutical market access. Managed entry agreements (MEAs) are the formal arrangements to overcome these uncertainties. Despite the extensive experience of developed countries in implementing such agreements, the experience of developing countries is minimal. As health decision-makers in Iran have moved towards implementing MEAs since 2020, seeking stakeholders' insights is crucial for filling this experience gap and facilitating the optimal implementation of these new policies. Methods: Our research was done in three phases: (1) Focus group interviews to disclose the main objectives of implementing MEAs in Iran, (2) the AHP approach to prioritize uncertainties, and (3) individual semi-structured interviews to carry out strengths, weaknesses, opportunities, and threats (SWOT) analysis. Results: Based on our stakeholders' views, increasing flexibility in improving patients' access to innovative and expensive drugs and responding to budget impact uncertainty seems highly prioritized for conducting MEAs in Iran. The SWOT analysis showed that although MEAs have the chance for success due to their strengths and opportunities, such as providing early and assured access, allocating resources efficiently, and enhancing the efficiency of post-marketing studies, policymakers should consider the weaknesses and threats such as difficulty in defining outcomes, high transaction cost, and lack of suitable infrastructure to increase the success rate. Conclusions: Efficient implementation of MEAs depends on the weaknesses and threats and considering the views of relevant stakeholders. Constructive interaction among all stakeholders is essential for adequately executing MEAs.

An investigation into the pharmaceutical advertising in Iranian medical journals.

BACKGROUND: Pharmaceutical advertising is not only considered a key factor in the successful launch of pharmaceutical products, but is also an important source of public health information with a significant impact on consumer choice and behavior. Nowadays, advertising has become the broadest dissemination channel for various products, including medicines, which may ultimately lead to the generalization of self-treatment or mistreatment. Improper drug promotion can exacerbate unhealthy outcomes by making false or misleading claims, using inferior references, and failing to meet international standards. This study aimed to examine the requirements for pharmaceutical advertising from regulatory perspective and the compliance of Iranian pharmaceutical advertisements to related standards and guidelines. It is limited to print advertisements in Iranian national medical journals and magazines. METHOD: The present study is a descriptive-analytical study using bibliometric methods. As a first step, a comprehensive review of the national and international regulations on drug advertising was conducted and a comparison of different regulations was provided. In the second step, a checklist was created to evaluate the compliance of drug advertising with the extracted regulations. RESULT: The results of the present study show that the claims made in Iranian drug advertisements are 29.10% valid, 27.67% exaggerated, 23.10% controversial, 12.62% misleading, and 6.8% invalid. In general, we found that most medical advertisements in Iranian journals and magazines comply with national laws and regulations. However, many international requirements are not met in these advertisements. CONCLUSIONS: Although we found that printed medical advertisements in Iran are roughly compliant with national regulations, there is still a long way to achieve full compliance. Monitoring processes should be improved and clearly defined penalties should be set to avoid misleading claims and their likely health consequences. It is very important in Iran to update the existing rules and regulations for medical advertisements according to international guidelines. More careful monitoring of the content of advertising and the accuracy of claims are also needed.

Investigation the determinants of pharmaceutical expenditure share of GDP in Iran and selected OECD countries.

AIM: This study estimated the GDP share of pharmaceuticals in Iran based on the drivers of pharmaceutical expenditure and compared it with that of 31 members of the Organisation for Economic Cooperation and Development (OECD). SUBJECT AND METHODS: The factors contributing to pharmaceutical expenditure were identified through literature review and studied by 8 experts to classify the factors. Then, using the panel data method, a model was built to estimate the GDP share of pharmaceutical expenditure based on the extracted factors of the selected countries in Iran's model. To explain the observed differences, several regression analyses were performed based on cross-sectional data. The analyses were performed using EVIEWS software, version 10. RESULTS: The explanatory variables for the selected countries in the panel model (R2 = 0.98) were specified. Government health expenditure (ß = 0.1432), the share of generic drugs (ß = - 0.0143), gross domestic product (GDP) per capita (ß = - 0.0058) and the rate of disability-adjusted life-years (DALY) (ß = 0.0028) contributed most to pharmaceutical expenditure. In comparison, in the Iranian estimation model (R2 = 0.84), government health expenditure (ß = 0.0536) and the share of generic drugs (ß = 0.0369) had a significant impact on pharmaceutical expenditure. In the estimation model with more estimators for Iran (R2 = 0.99), government health expenditure (ß = 0.1694), disease prevalence (ß = 0.0537), the share of generic drugs (ß = 0.0102), the DALY rate (ß = 0.0039), GDP per capita (ß = - 0.0033), and the drug price index (ß = 0.0007) contribute most to pharmaceutical expenditure. CONCLUSION: In the models of the study, factors related to the structure of the healthcare system and the pharmaceutical system contributed most to pharmaceutical expenditure as a share of GDP. Moreover, disease profiles show its predictive role in the second model for Iran.

Simultaneous Analysis of 10 Priority PAHs in Iranian Sangak Bread Samples by Developing a GC-MS Method.

Human exposure to polycyclic aromatic hydrocarbons (PAHs) is known as a carcinogen risk factor. In this study, a gas chromatography-mass spectrometry (GC-MS) technique combined with the QuEChERS extraction method was developed for concurrent analysis of 10 polycyclic aromatic hydrocarbons (PAHs) in Iranian traditional Sangak bread samples. The method was validated by determining different parameters, including; linearity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ). Calibration curves showed a linear relationship in the concentration range of 10-500 ng/g with a coefficient of determination (R2) ranged between 0.994 and 0.999. The obtained mean recoveries were 92-106% with the relative standard deviations (RSDs) in the range of 3-7% with an acceptable precision (RSD < 20%). The Limit of detections (LODs) for different PAHs were between 0.14-0.78 ng/g, while the limit of quantitation (LOQ) was 0.46-2.60 ng/g. Matrix effect studies showed that the analytes concluded signal suppressions or enhancements. Therefore, spiked calibration curves were used for overcoming this issue. The result of Sangak bread samples analysis using the validated method showed that 9 (19.4%) out of 47 Sangak bread samples were contaminated with phenanthrene (PHE) and anthracene (ANT) at the mean level of 10.08 ± 6.38 ng/g which were higher than the permissible limit of European Commission regulatory control value for BaP (1 µg/kg of wet weight) in processed cereal-based foods and baby foods for infants and young children.

How Much Iranian Parents Know of and How Well They Practice Regarding Antibiotics?

Irrational use of antibiotics as a global health concern has led to excessive treatment costs, failure of treatments, and antimicrobial resistance. Parents' knowledge of and practice regarding antibiotics are two important factors contributing to the (ir) rational use of antibiotics. This study aimed to evaluate ill children's parents' knowledge and practice of prescribed antibiotics. Our subjects included only parents with children up to 12 (inclusive) years of age in Tehran, Iran's capital. A prospective cross-sectional survey was conducted at 203 health care centers in Tehran. Parents' knowledge was evaluated using a 37-item researcher-made questionnaire, and their practice about antibiotics was measured with a self-stated questionnaire, followed by an observational method to gain a real insight into their practice. SPSS 22 was used to analyze the data. A total of 401 randomly selected parents were enrolled in the study. The average score of parents' knowledge of antibiotics regarding administration, indications, storage, and antimicrobial resistance was found to be 9.72 out of 17.00. In the self-stated method, an appropriate practice of antibiotic use was reported in 49.4% of participants who also got an average score of 3.95 points out of a total 8. In the observational method, most parents' practice (68.4%) regarding antibiotic use was found to be acceptable; their average score was 5.93 points out of a total of 10. The findings of this study showed that half of the parents had adopted an acceptable practice regarding antibiotic use.

Public and decision-maker stated preferences for pharmaceutical subsidy decisions in Iran: an application of the discrete choice experiment.

BACKGROUND: The argument about funding criteria poses challenges for health decision-makers in all countries. This study aimed to investigate the public and decision-maker preferences for pharmaceutical subsidy decisions in Iran. METHODS: A discrete choice experiment (DCE) was used for eliciting the preferences of the public and decision-makers. Four attributes including health gain after treatment, the severity of the disease, prevalence of the disease, and monthly out of pocket and relevant levels were designed in the form of hypothetical scenarios. The analysis was done by using conditional logit analysis. RESULTS: The results show all of four attributes are important for pharmaceutical subsidy decisions. But a medicine that improves health gain after treatment is more likely to be a choice in subsidy decisions (by relative importance of 28% for public and 42% for decision-makers). Out of pocket, severity, and prevalence of disease subsequently influence the preferences of the public and decision-makers, respectively. The greatest difference is observed in changing the health gain after treatment and out of pocket levels, between public and decision-makers. CONCLUSION: This research reveals that the public is willing and able to provide preferences to inform policymakers for pharmaceutical decision-making; it also sets grounds for further studies.

Assessing the Performance of Community Pharmacies in Iran by Measuring Responsiveness to Non-Medical Needs: An Application of WHO Responsiveness Framework.

OBJECTIVE: Despite growing debates about the health systems' nonmedical performance, there has not been any empirical research on nonmedical performance and patients' rights consideration as a driver of human rights in the pharmaceutical sector. This study's main objective was to assess the nonmedical performance of community pharmacies of Shiraz, Iran. METHODS: A cross-sectional study was conducted using two self-administrated Likert-based questionnaires based on the World Health Organization (WHO) responsiveness framework and the legal charter communicated by the Ministry of Health and Medical Education of Iran. The population was patients older than 18 years who took a prescription from community pharmacies located in Shiraz and willing to answer the questions voluntarily, from 2018 to 2019. Considering the weights of subdimensions of responsiveness provided by the WHO framework, the total score of responsiveness was calculated ranging from 0 to 100. FINDINGS: The response rate was 80.5%. The mean (standard deviation) overall score of responsiveness was 57.18 (21.61), with a median of 56.71. The mean score of client orientation was lower in respondents with a high education level than those with a diploma and under diploma (P = 0.028). CONCLUSION: Nonmedical pharmacy performance was considered either medium or high in more than half of the cases based on the participants' views. Regarding client, orientation was seen less often in patients with high education level compared to those with a lower education level.

Development of A Liquid Chromatography-Mass Spectrometry Technique for Evaluation of Multi-class Pesticides in Rice Samples.

In the current study, a liquid chromatography coupled mass detector was set up to detect and quantify 108 pesticide residues in rice samples. QuEChERS method was applied for sample preparation and different validation parameters were determined to ensure the suitability of the method. The calibration curves were linear in the concentration 0.01-1.00 mg/kg with a coefficient of determination (R2) of more than 0.990 for all compounds. Based on signal to noise studies, the calculated LODs and LOQs were 0.005-0.060 mg/kg and 0.018-0.199 mg/kg, respectively; and acquired mean recoveries at three spiked levels (0.025, 0.200 and 0.800 mg/kg) were 72% - 117% with RSD < 20%. The developed method was used to investigate the occurrence of the studied pesticides in 65 internal and 65 foreign rice samples. The results showed that 14 internal and 15 imported samples were found to be contaminated 12 pesticides in the amounts between 0.027 mg/kg to 0.078 mg/kg and 0.031 mg/kg to 0.081 mg/kg, respectively. According to the Iranian regulations, with the exception of nine prohibited pesticides for rice production in Iran, bioallethrin, cypermethrin, deltamethrin, flutriafol, foramsulfuron, imazalil, phosphamidon, TCMTB, and triasulfuron, three permitted pesticides, cinosulfuron, triadimenol, and tricyclazole, found in positive rice samples were below MRLs established by Iranian National Standard Organization (INSO).

Irrational use of antibiotics in Iran from the perspective of complex adaptive systems: redefining the challenge.

BACKGROUND: Irrational use of antibiotics is proving to be a major concern to the health systems globally. This results in antibiotics resistance and increases health care costs. In Iran, despite many years of research, appreciable efforts, and policymaking to avoid irrational use of antibiotics, yet indicators show suboptimal use of antibiotics, pointing to an urgent need for adopting alternative approaches to further understand the problem and to offer new solutions. Applying the Complex Adaptive Systems (CAS) theory, to explore and research health systems and their challenges has become popular. Therefore, this study aimed to better understand the complexity of the irrational use of antibiotics in Iran and to propose potential solutions. METHOD: This research utilized a CAS observatory tool to qualitatively collect and analyse data. Twenty interviews and two Focus Group discussions were conducted. The data was enriched with policy document reviews to fully understand the system. MAXQDA software was used to organize and analyze the data. RESULT: We could identify several diverse and heterogeneous, yet highly interdependent agents operating at different levels in the antibiotics use system in Iran. The network structure and its adaptive emergent behavior, information flow, governing rules, feedback and values of the system, and the way they interact were identified. The findings described antibiotics use as emergent behavior that is formed by an interplay of many factors and agents over time. According to this study, insufficient and ineffective interaction and information flow regarding antibiotics between agents are among key causes of irrational antibiotics use in Iran. Results showed that effective rules to minimize irrational use of antibiotics are missing or can be easily disobeyed. The gaps and weaknesses of the system which need redesigning or modification were recognized as well. CONCLUSION: The study suggests re-engineering the system by implementing several system-level changes including establishing strong, timely, and effective interactions between identified stakeholders, which facilitate information flow and provision of on-time feedback, and create win-win rules in a participatory manner with stakeholders and the distributed control system.

An application of multi-criteria decision-making approach to sustainable drug shortages management: evidence from a developing country.

BACKGROUND: Drug shortage is a significant public health problem, especially for drugs related to life threatening conditions. Almost all countries affected by variety of supply problems and spent a considerable amount of time and resources responding to shortage. The aim of present study is to determine and prioritize strategies to achieve best solutions for these considerable healthcare system challenges and to evaluate this strategies base on practical criteria. METHODS: To achieve the study objectives, the research was conducted in two phases. Determining of the strategies to control drug shortage, and comprehensive assessments of priority of possible strategies. For each phase, a self-design questionnaire was developed. The five main managerial strategies dimensions including: regulatory, financial, supply chain, information system and policy-making were set out. Forty-five alternatives were elicited from literature, and were evaluated and trimmed to 37 strategies based on experts' opinion. The Multiple criteria decision-making (MCDM) methods were applied in second phase. Five important criteria including cost, time, labor, compliance with law and culture were weighed by Analytic Hierarchy Process (AHP) technique. Then, 37 alternatives have been rated base on the five criteria on the Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) technique. RESULTS: "Creating integrated Supply chain information system to manage medicines inventory in the country", "Creating and using the databases to predict the shortage of medicines", "Using track and trace system" are alternatives 20th, 24th and 25th, which related to supply chain (SC) and information system (IS) dimensions have higher priority in the experts' point of view. The results show IS dimension has 100 percentage of priority; following that policy and supply chain have higher priority, respectively. CONCLUSION: Health systems rely on consistent supplying of pharmaceuticals to support patient care. The results show that information system, policy-making and supply chain are in the top-ranking priorities. Warning system needs to be improved to the advance system via better collaboration with stakeholders, publish precise and explicit national guidelines for drug shortage management, enforce the guidelines, and improve Iran FDA's pharmaceutical market control capability.

Impact of the Trade-Related Aspect of Intellectual Property Rights Agreement on Pharmaceutical Industry in Developing Countries: A Scoping Review.

Pharmaceutical companies in developing countries are heavily influenced by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and economic liberalization rules. To adjust to the new patent regime, pharmaceutical companies had to adopt some strategies. A systematic review was conducted on the experiences of the pharmaceutical industry in developing countries and strategies adopted by local pharmaceutical companies to survive after the TRIPS agreement. Scopus, PubMed, and ProQuest databases were searched, and twenty-five papers were reviewed. The pharmaceutical industry experiences have been classified into successful and unsuccessful experiences based on criteria developed by the authors. Firm strategies were also divided into four categories based on external and internal factors: aggressive, conservative, competitive, and defensive strategies. Companies were able to survive and even grow after the TRIPS agreement by rebuilding their structures, improving their competencies, and adopting appropriate strategies in line with the new conditions.

The Effect of Organizational Resilience and Strategic Foresight on Firm Performance: Competitive Advantage as Mediating Variable.

The pharmaceutical industry's performance in the global economy has been affected by the growing competition associated with globalization, economic liberalization, and the trade-related aspect of the intellectual property rights (TRIPS) agreement. To maintain performance, organizations need to consider strategic foresight (SF) and organizational resilience (OR) to anticipate future trends and survive crises. By proposing a conceptual framework, this study examines the relationship between organizational resilience, strategic foresight, competitive advantage (CA), and firm performance (FP). A conceptual framework was developed to assess the hypotheses in the pharmaceutical industry. Then, partial least squares structural equation modeling (PLS-SEM) was applied to investigate the relationships quantitatively. The results of structural equation modeling (SEM) based on the data generated from 202 completed questionnaires by the pharmaceutical companies in Iran demonstrate that OR, SF, and CA have significant positive impacts on FP. Moreover, CA partially mediates the relationship between OR and FP and also between SF and FP. The findings of this study enrich the existing literature by demonstrating that early detection of environmental change and resilient manner assist Iranian pharmaceutical firms to survive if joining the WTO. This is the first study that examines the direct and indirect effect of OR and SF on the FP, considering the mediating impact of CA. This investigation attempts to address the mechanisms through which OR and SF affect organizational performance, especially in the pharmaceutical industry.