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1.  A Comprehensive Review of Clinical Trials on EGFR Inhibitors Such as Cetuximab and Panitumumab as Monotherapy and in Combination for Treatment of Metastatic Colorectal Cancer 
Metastatic colorectal cancer is the fourth most common cause of death due to cancer after those of lung, stomach, and liver. Anti epidermal growth factor receptor drugs as a targeting therapy seem to be good candidates for curing metastatic colorectal cancer. Two available anti epidermal growth factor receptor monoclonal antibodies are cetuximab and panitumumab which have been approved for metastatic colorectal cancer treatment. Through the available literature on NCBI and clinical trials, 31 clinical trials in which cetuximab or panitumumab as monotherapy or in combination with chemotherapy were used for the treatment of metastatic colorectal cancer patients in different line settings and 12 clinical trials in which bevacizumab was used for being compared with anti epidermal growth factor receptor monoclonal antibodies or chemotherapy were chosen for reviewing and comparing the results of overall survival, progression free survival and adverse effects. Cetuximab and panitumumab are well accepted for the treatment of mCRC patients at all stages in different line settings. Although cetuximab administration in metastatic colorectal cancer patients is mostly associated with better overall survival and panitumumab results in better progression free survival, to confirm the superiority of each of them in the treatment protocol of epidermal growth factor receptor monoclonal antibodies, more clinical trials with larger sample size are needed. Through current available data from clinical studies, it can be concluded that the best treatment outcome is achieved by a combination of anti epidermal growth factor receptor monoclonal antibodies with conventional chemotherapy.
PMCID: PMC4629455  PMID: 26605007
Anti-EGFR drugs; Cetuximab; Metastatic colorectal cancer; Panitumumab
2.  Antioxidant therapy in acute, chronic and post-endoscopic retrograde cholangiopancreatography pancreatitis: An updated systematic review and meta-analysis 
AIM: To investigate the efficacy and adverse effects of antioxidant therapy in acute pancreatitis (AP), chronic pancreatitis (CP) and post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP).
METHODS: PubMed, Scopus, Google Scholar, Cochrane library database, and Evidence-based medicine/clinical trials published before August 2014 were searched. Clinical and laboratory outcomes of randomized trials of antioxidant therapy in patients with AP, CP and PEP were included. The methodological quality of the trials was assessed by the Jadad score based on the description of randomization, blinding, and dropouts (withdrawals). The results of the studies were pooled and meta-analyzed to provide estimates of the efficacy of antioxidant therapy.
RESULTS: Thirty four trials out of 1069 potentially relevant studies with data for 4898 patients were eligible for inclusion. Antioxidant therapy significantly reduced the length of hospital stay in AP patients {mean difference -2.59 d (95%CI: -4.25-(-0.93)], P = 0.002}. Although, antioxidant therapy had no significant effect on serum C reactive protein (CRP) after 5-7 d in AP patients [mean difference -9.57 (95%CI: -40.61-21.48, P = 0.55], it significantly reduced serum CRP after 10 d {mean difference -45.16 [95%CI: -89.99-(-0.33)], P = 0.048}. In addition, antioxidant therapy had no significant effect on CP-induced pain [mean difference -2.13 (95%CI: -5.87-1.6), P = 0.26]. Antioxidant therapy had no significant effects on the incidence of all types of PEP [mean difference 1.05 (95%CI: 0.74-1.5), P = 0.78], severe PEP [mean difference 0.92 (95%CI: 0.43-1.97), P = 0.83], moderate PEP [mean difference 0.82 (95%CI: 0.54-1.23), P = 0.33], and mild PEP [mean difference 1.33 (95%CI: 0.99-1.78), P = 0.06]. Furthermore, while antioxidant therapy had no significant effect on serum amylase after less than 8 h sampling [mean difference -20.61 (95%CI: -143.61-102.39), P = 0.74], it significantly reduced serum amylase close to 24-h sampling {mean difference -16.13 [95%CI: -22.98-(-9.28)], P < 0.0001}.
CONCLUSION: While there is some evidence to support antioxidant therapy in AP, its effect on CP and PEP is still controversial.
PMCID: PMC4533052  PMID: 26290647
Acute pancreatitis; Chronic pancreatitis; Post-endoscopic retrograde cholangiopancreatography pancreatitis; Antioxidants; Meta-analysis
3.  Economic Burden of Hepatitis B Virus-Related Diseases: Evidence From Iran 
Hepatitis Monthly  2015;15(4):e25854.
Hepatitis B infection is still the main cause of chronic liver disease in Iran, which is associated with significant economic and social costs.
This study aimed to estimate the financial burden caused by CHB infection and its complications in Iran.
Patients and Methods:
Prevalence-based and bottom-up approaches were used to collect the data. Data on direct medical costs were extracted from outpatient medical records in a referral gastroenterology and hepatology research center, inpatient medical records in several major hospitals in Tehran and Shiraz in 2013, and the self-reports of specialists. Data on direct non-medical and indirect costs were collected based on the patients’ self-reports through face-to-face interviews performed in the mentioned centers. To calculate the indirect costs, friction cost approach was used. To calculate the total cost-of-illness in Iran, the total cost per patient at each stage of the disease was estimated and multiplied by the total number of patients.
The total annual cost for the activate population of CHB patients and for those receiving treatment at various disease stages were respectively 450 million and 226 million dollars, with 64% and 70% of which allocated to direct costs respectively, and 36% and 30% to indirect costs respectively. The total direct costs alone for each group were respectively 1.17% and 0.6% of the total health expenditure. Furthermore, the cost spent on drugs encompasses the largest proportion of the direct medical cost for all stages of the disease.
According to the perspectives of payers, patients, and community, CHB infection can be considered as one of the diseases with a substantial economic burden; the disease, specifically in extreme cases, can be too expensive and costly for patients. Therefore, patients should be protected against more severe stages of the disease through proper treatment and early diagnosis.
PMCID: PMC4427913  PMID: 25977694
CHB; Cost of Illness; Diseases
4.  Effectiveness of probiotics in irritable bowel syndrome: Updated systematic review with meta-analysis 
AIM: To investigate the efficacy of probiotics in irritable bowel syndrome (IBS) patients.
METHODS: PubMed, Cochrane library, Scopus, Google Scholar, and databases were searched for literature published between September 2007 and December 2013. The applied Mesh terms were “probiotics,” “irritable bowel syndrome,” and “irritable bowel syndrome treatment.” The collected data contained24 clinical trials, of which 15 were eligible for meta-analysis and nine were reviewed systematically. All studies were randomized placebo-controlled trials in patients with IBS that investigated the efficacy of probiotics in IBS improvement. The Jadad score was used to assess the methodological quality of trials. The quality scale ranges from 0 to 5 points, with a score ≤ 2 indicating a low quality report, and a score of ≥ 3 indicating a high quality report. Relative risk (RR), standardized effect size, and 95%CI were calculated using the DerSimonian-Laird method. The Cochran Q test was used to test heterogeneity with P < 0.05. Funnel plots were constructed and Egger’s and Begg-Mazumdar tests were performed to assess publication bias.
RESULTS: A total of 1793 patients were included in the meta-analysis. The RR of responders to therapies based on abdominal pain score in IBS patients for two included trials comparing probiotics to placebo was 1.96 (95%CI: 1.14-3.36; P = 0.01). RR of responders to therapies based on a global symptom score in IBS patients for two included trials comparing probiotics with placebo was 2.43 (95%CI: 1.13-5.21; P = 0.02). For adequate improvement of general symptoms in IBS patients, the RR of seven included trials (six studies) comparing probiotics with placebo was 2.14 (95%CI: 1.08-4.26; P = 0.03). Distension, bloating, and flatulence were evaluated using an IBS severity scoring system in three trials (two studies) to compare the effect of probiotic therapy in IBS patients with placebo, the standardized effect size of mean differences for probiotics therapy was -2.57 (95%CI: -13.05--7.92).
CONCLUSION: Probiotics reduce pain and symptom severity scores. The results demonstrate the beneficial effects of probiotics in IBS patients in comparison with placebo.
PMCID: PMC4356930  PMID: 25780308
Evidence-based medicine; Irritable bowel syndrome; Meta-analysis; Probiotics; Systematic review; Clinical trial
5.  Acknowledgement of manuscript reviewers 2014 
Contributing reviewers
The editors of DARU Journal of Pharmaceutical Sciences would like to thank all our reviewers who have contributed to the journal in Volume 22 (2014).
PMCID: PMC4323264
7.  From generic scheme to brand-generic scheme: Have new policy influenced the efficiency of Iranian pharmaceutical companies? 
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.
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.
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).
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.
PMCID: PMC4199197  PMID: 25328898
Data envelopment analysis; efficiency; Iran; pharmaceutical
8.  A system dynamics model for national drug policy 
Data modeling techniques can create a virtual world to analyze decision systems. National drug authorities can use such techniques to take care of their deficiencies in decision making processes. This study was designed to build a system dynamics model to simulate the effects of market mix variables (5 P’s) on the national drug policy (NDP) indicators including availability, affordability, quality, and rationality. This was aimed to investigate how to increase the rationality of decision making, evaluate different alternatives, reduce the costs and identify the system obstacles.
System dynamics is a computer-based approach for analyzing and designing complex systems over time. In this study the cognitive casualty map was developed to make a concept about the system then the stock-flow model was set up based on the market demand and supply concept.
The model demonstrates the interdependencies between the NDP variables through four cognitive maps. Some issues in availability, willingness to pay, rational use and quality of medicines are pointed in the model. The stock-flow diagram shows how the demand for a medicine is formed and how it is responded through NDP objectives. The effects of changing variables on the other NDP variables can be studied after running the stock-flow model.
The model can initiate a fundamental structure for analyzing NDP. The conceptual model made a cognitive map to show many causes’ and effects’ trees and reveals some relations between NDP variables that are usually forgotten in the medicines affairs. The model also provides an opportunity to be expanded with more details on a specific disease for better policy making about medication.
PMCID: PMC4229987  PMID: 24690531
National drug policy; System dynamics; Modeling
9.  Efficacy and tolerability of renzapride in irritable bowel syndrome: a meta-analysis of randomized, controlled clinical trials including 2528 patients 
By targeting different subtypes of 5-hydroxytryptamine (5HT) receptors in the gastrointestinal (GI) tract, several drugs have been introduced for the management of irritable bowel syndrome (IBS). Renzapride is a full agonist for 5HT4 receptor and an antagonist to 5HT2b and 5HT3 receptors which is thought a promising therapeutic agent for constipation predominant IBS (C-IBS) patients due to its accelerating effect on the GI tract. In this meta-analysis, our aim was to evaluate the efficacy and tolerability of renzapride in the management of IBS.
Material and methods
A search was done from 1992 to February 2013 for placebo-controlled trials that investigated the efficacy of renzapride in IBS.
Relative risk (RR) for clinical efficacy in IBS patients treated for 5 weeks or less comparing renzapride to placebo was 1.07 (95% CI = 0.89–1.29, p = 0.38). This value for IBS patients treated for more than 5 weeks was 1.04 (95% CI = 0.78–1.239, p = 0.77). The RR for clinical efficacy in IBS patients treated with renzapride (4 mg) for 5 weeks or less and more than 5 weeks in comparison to placebo was 1.2 (95% CI = 0.97–1.48, p = 0.1) and 1.16 (95% CI = 0.98–1.37, p = 0.08), respectively, which were statistically non-significant but clinically important. The analysis of tolerability demonstrated that amongst different reported adverse effects, renzapride caused diarrhea more than placebo (RR = 1.61 with a 95% CI = 1.16–2.24, p = 0.004). The RR for withdrawals from renzapride compared to placebo was 1.58 (95% CI = 1.26–2.07, p = 0.0007).
Renzapride is not superior to placebo in relieving IBS symptoms and causes significant incidences of diarrhea and drop-outs due to adverse effects in treated patients vs. placebo. Thus, this medicine might be a cost burden to patients without providing good effectiveness.
PMCID: PMC3953973  PMID: 24701208
renzapride; 5-hydroxytryptamine; irritable bowel syndrome; clinical trial; meta-analysis; systematic review
10.  Commercialization of biopharmaceutical knowledge in Iran; challenges and solutions 
The objective of this study was to investigate the application of the university research findings or commercialization of the biopharmaceutical knowledge in Iran and determine the challenges and propose some solutions.
A qualitative study including 19 in-depth interviews with experts was performed in 2011 and early 2012. National Innovation System (NIS) model was employed as the study design. Thematic method was applied for the analysis. The results demonstrate that policy making, regulations and management development are considered as fundamental reasons for current commercialization practice pattern. It is suggested to establish foundation for higher level documents that would involve relating bodies and provide them operational guidelines for the implementation of commercialization incentives.
Policy, regulations and management as the most influential issue should be considered for successful commercialization. The present study, for the first time, attempts to disclose the importance of evidence input for measures in order to facilitate the commercialization process by the authorities in Iran. Overall, the NIS model should be considered and utilized as one of the effective solutions for commercialization.
PMCID: PMC3974067  PMID: 24568555
Knowledge translation; Biopharmaceutical research; Facilitators and barriers
11.  A systematic cost-effectiveness analysis of pregabalin in the management of fibromyalgia: an Iranian experience 
Fibromyalgia is a neuropathic syndrome which is more common in adult females. Pregabalin is the first medicine which was approved by the United States Food and Drug Administration for treatment of fibromyalgia. In this study we aimed to evaluate the cost-efficacy of pregabalin in the treatment of fibromyalgia in Iran.
Material and methods
To evaluate the efficacy of pregabalin, a systematic review was carried out by conducting a wide literature search for the main outcomes of interest that were pain score reduction from the baseline and the percentage of patients with more than 50% pain reduction. To evaluate costs of treatment, only the direct medical costs were considered. The calculated incremental cost-effectiveness ratio (ICER) were compared with one and three times the gross domestic product (GDP) per capita as the threshold to evaluate the economic condition of treatment to be “highly cost-effective”, “cost-effective” or “not cost-effective”.
Out of 4012 searched reports, only four reports were included in the study, all of which were randomized controlled trials with placebo controls. The calculated ICERs for pregabalin 450 mg/day and 600 mg/day with both available forms of brand and generic medicines in the country were in the range of 44–1170 US dollars (USD) and 48–814 USD, which in all cases could be considered as highly cost-effective. Pregabalin 150 mg/day based on available evidence does not have significant efficacy in comparison to placebo. But for pregabalin 300 mg/day, no decision can be made based on current data.
Our analysis indicated that generic pregabalin in the treatment doses of 450 mg/day and 600 mg/day is highly cost-effective.
PMCID: PMC3902716  PMID: 24482637
pregabalin; fibromyalgia; Lyrica; cost-effectiveness; systematic review; economic model; economic evaluation
12.  Pharmaceutical supply chain risks: a systematic review 
Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended.
In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies.
Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method.
Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance.
It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.
PMCID: PMC3913399  PMID: 24355166
Supply chain risks; Pharmaceutical risks; Pharmaceutical supply risks; Medicines supply risks; Risks management
13.  Cost analysis of childhood asthma in Iran: A cost evaluation based on referral center data for asthma and allergies 
Asthma as the most common chronic disease in childhood reduces the quality of life of children and their families. We aimed to estimate the cost of managing childhood asthma in Iran and to examine its variability depending on asthma severity.
The cost of asthma was estimated by building a cost assessment model regarding the factors that influence the cost of asthma in children including age and sex distribution, prevalence of disease severity, level of resource utilization depending on disease severity (3 groups of controlled, partly controlled and uncontrolled were defined). The model was comprised of both medical (cost of medication, physician visit and respiratory tests) and non-medical (transportation and hoteling) costs. Furthermore, the average family income in each category was figured and the share of asthma managing costs from the average income was calculated in different groups.
According to model, the total cost of childhood asthma in Iran was around 516.5 million dollars. Moreover, direct medical cost represented 49% of the total costs, among which 66% accounting for medication cost. Direct non-medical costs were estimated 51% with the majority (93%) expended on transportation. In addition, the mean annual cost per child was approximately 466 dollars. In addition, the results indicate the vast majority of patients (46%) are categorized in the uncontrolled group.
The cost of childhood asthma in Iran is extremely high comparing to the average income of Iranian families in all categories of asthma severity. Considering the high amount of transportation cost, the accessibility of asthma treatment does not appear to be acceptable. The major source of costs is found to be related to medicine expenditure. Since it has been proven that using medicine does not necessarily result in a well-controlled disease status, alternative approaches should be considered in asthma management.
PMCID: PMC4076924  PMID: 24991626
Childhood asthma; cost analysis; pharmacoeconomics; Iran
14.  Induction of clinical response and remission of inflammatory bowel disease by use of herbal medicines: A meta-analysis 
AIM: To evaluate the efficacy and tolerability of herbal medicines in inflammatory bowel disease (IBD) by conducting a meta-analysis.
METHODS: Electronic databases were searched for studies investigating efficacy and/or tolerability of herbal medicines in the management of different types of IBD. The search terms were: “herb” or “plant” or “herbal” and “inflammatory bowel disease”. Data were collected from 1966 to 2013 (up to Feb). The “clinical response”, “clinical remission”, “endoscopic response”, “endoscopic remission”, “histological response”, “histological remission”, “relapse”, “any adverse events”, and “serious adverse events” were the key outcomes of interest. We used the Mantel-Haenszel, Rothman-Boice method for fixed effects and DerSimonian-Laird method for random-effects. For subgroup analyses, we separated the studies by type of IBD and type of herbal medicine to determine confounding factors and reliability.
RESULTS: Seven placebo controlled clinical trials met our criteria and were included (474 patients). Comparison of herbal medicine with placebo yielded a significant RR of 2.07 (95%CI: 1.41-3.03, P = 0.0002) for clinical remission; a significant RR of 2.59 (95%CI: 1.24-5.42, P = 0.01) for clinical response; a non-significant RR of 1.33 (95%CI: 0.93-1.9, P = 0.12) for endoscopic remission; a non-significant RR of 1.69 (95%CI: 0.69-5.04) for endoscopic response; a non-significant RR of 0.64 (95%CI: 0.25-1.81) for histological remission; a non-significant RR of 0.86 (95%CI: 0.55-1.55) for histological response; a non-significant RR of 0.95 (95%CI: 0.52-1.73) for relapse; a non-significant RR of 0.89 (95%CI: 0.75-1.06, P = 0.2) for any adverse events; and a non-significant RR of 0.97 (95%CI: 0.37-2.56, P = 0.96) for serious adverse events.
CONCLUSION: The results showed that herbal medicines may safely induce clinical response and remission in patients with IBD without significant effects on endoscopic and histological outcomes, but the number of studies is limited to make a strong conclusion.
PMCID: PMC3769914  PMID: 24039370
Herbal medicine; Inflammatory bowel disease; Efficacy; Relapse; Adverse events; Meta-analysis
15.  Pharmacists Remuneration Models in Iran and Selected Countries: a Comparative Study  
Pharmacists are members of the healthcare teams that provide valuable services to society. Their incentive to deliver such services is influenced by remuneration methods. In this study, we aimed to review the remuneration models for pharmacists’ services and the factors affecting the profitability of pharmacies in some selected countries, including France, Ireland, Canada and Turkey, and compared them to Iran. International data were collected by literature review on Google, Google scholar, PubMed and Scopus. In addition, domestic data were collected by contacting relevant organizations. There is no payment for pharmacists’ cognitive services in Iran and in the countries investigated, except for some Canadian provinces. The dispensing fee system in Iran does not seem to be adequate, especially considering that most of the insurers do not cover these fees. The pricing method in Iran has resulted in a low price level, in comparison to the other countries, and this issue has dramatically affected the profitability of pharmacies in standard practice. It could be concluded that changing the current formulation for the dispensing fee to a more appropriate one, defining a remuneration system for non-owner pharmacists other than salary and implementing the new pricing method are necessary in order to improve the services provided by pharmacies.
PMCID: PMC3920713  PMID: 24523777
Pharmacist; Remuneration; Profit; Pricing; Iran
16.  Is Certolizumab Pegol Safe and Effective in the Treatment of Patients with Moderate to Severe Crohn’s Disease? A Meta-analysis of Controlled Clinical Trials 
Tumor necrosis factor-α (TNF-α) antibodies are currently used in patients with moderate to severe Crohn’s disease (CD) who are unresponsive to conventional therapies. Certolizumab pegol (Cp) is one of the anti-TNF-α agents introduced for the management of CD and rheumatoid arthritis.
The aim of this meta-analysis is to assess the efficacy of Cp in inducing clinical response and remission in CD and the associated adverse events. The effect of Cp in terms of CD patients’ C-reactive protein (CRP) level was also studied.
Patients and Methods
Literature was searched for studies investigated the efficacy of Cp on inducing clinical response and maintaining remission in the patients with CD between 1966 and July 2012.
Among 165 potentially relevant studies, six with a total of 1695 patients met the inclusion criteria and were meta-analyzed. In comparison to control groups, patients who received Cp had a relative risk (RR) of 1.38 with absolute risk reduction (ARR) = 0.12; 95% CI = 0.03 to 0.21), number needed for treatment (NNT) = 9; P < 0.0001 ) for clinical response and RR of 1.54 (ARR = 0.09; 95% CI = -0.0198 to 0.2), (NNT = 12; P < 0.0001) for maintenance of clinical remission and non-significant RR of 1.24 (P = 0.052) for induction of clinical remission. Baseline CRP did not significantly alter the magnitude or response. Adverse events were not significantly different among patients receiving Cp comparing to placebo.
Cp is effective for inducing clinical response and maintenance of clinical remission in patients with moderate to severe CD with similar side-effect profile as the control arms.
PMCID: PMC3918190  PMID: 24578833
Meta-analysis; Certolizumab Pegol; Crohn’s Disease
17.  Trend analysis of the pharmaceutical market in Iran; 1997–2010; policy implications for developing countries 
So far, no detailed study of the Iranian pharmaceutical market has been conducted, and only a few studies have analyzed medicine consumption and expenditure in Iran. Pharmaceutical market trend analysis remains one of the most useful instruments to evaluate the pharmaceutical systems efficiency. An increase in imports of medicines, and a simultaneous decrease in domestic production prompted us to investigate the pharmaceutical expenditure structure. On the other hand, analyzing statistics provides a suitable method to assess the outcomes of national pharmaceutical policies and regulations.
This is a descriptive and cross-sectional study which investigates the Iranian pharmaceutical market over a 13-year period (1997–2010). This study used the Iranian pharmaceutical statistical datasheet published by the Iranian Ministry of Health. Systematic searches of the relevant Persian and English research literature were made. In addition, official government documents were analyzed as sources of both data and detailed statements of policy.
Analysis of the Iranian pharmaceutical market in the 13-year period shows that medicine consumption sales value growth has been 28.38% annually. Determination of domestic production and import reveals that 9.3% and 42.3% annual growth, respectively, have been experienced.
The Iranian pharmaceutical market has undergone great growth in comparison with developing countries and the pharmerging group, and the market is expanding quickly while a major share goes to biotechnology drugs, which implies the need to commercialization activities in novel fields like pharmaceutical biotechnology. This market expansion has been in favor of imported medicine in sales terms, caused by the reinforcement of suspicious policies of policy makers that necessitates fundamental rearrangements.
PMCID: PMC3718624  PMID: 23805853
Pharmaceutical market trends; Therapeutic categories; Pharmaceutical biotechnology; Commercialization
18.  Cost-effectiveness of different interferon beta products for relapsing-remitting and secondary progressive multiple sclerosis: Decision analysis based on long-term clinical data and switchable treatments 
Multiple sclerosis (MS) is a highly debilitating immune mediated disorder and the second most common cause of neurological disability in young and middle-aged adults. Iran is amongst high MS prevalence countries (50/100,000). Economic burden of MS is a topic of important deliberation in economic evaluations study. Therefore determining of cost-effectiveness interferon beta (INF β) and their copied biopharmaceuticals (CBPs) and biosimilars products is significant issue for assessment of affordability in Lower-middle-income countries (LMICs).
A literature-based Markov model was developed to assess the cost-effectiveness of three INF βs products compared with placebo for managing a hypothetical cohort of patients diagnosed with relapsing remitting MS (RRMS) in Iran from a societal perspective. Health states were based on the Kurtzke Expanded Disability Status Scale (EDSS). Disease progression transition probabilities for symptom management and INF β therapies were obtained from natural history studies and multicenter randomized controlled trials and their long term follow up for RRMS and secondary progressive MS (SPMS). A cross sectional study has been developed to evaluate cost and utility. Transitions among health states occurred in 2-years cycles for fifteen cycles and switching to other therapies was allowed. Calculations of costs and utilities were established by attachment of decision trees to the overall model. The incremental cost effectiveness ratio (ICER) of cost/quality adjusted life year (QALY) for all available INF β products (brands, biosimilars and CBPs) were considered. Both costs and utilities were discounted. Sensitivity analyses were done to assess robustness of model.
ICER for Avonex, Rebif and Betaferon was 18712, 11832, 15768 US Dollars ($) respectively when utility attained from literature review has been considered. ICER for available CBPs and biosimilars in Iran was $847, $6964 and $11913.
The Markov pharmacoeconomics model determined that according to suggested threshold for developing countries by world health organization, all brand INF β products are cost effective in Iran except Avonex. The best strategy among INF β therapies is CBP intramuscular INF β-1a (Cinnovex). Results showed that a policy of encouraging accessibility to CBPs and biosimilars could make even high technology products cost-effective in LMICs.
PMCID: PMC3698128  PMID: 23800250
Cost-Effectiveness; Decision analysis; Economic evaluation; Interferon beta; Markov model; Modeling; Switching
19.  Cost-effectiveness analysis review of exemestane in the treatment of primary and advanced breast cancer 
Exemestane was approved in 2005 for adjuvant treatment of breast cancer. In this study, we aimed to assess whether it is cost-effective in comparison to available alternatives.
Material and methods
To evaluate the efficacy of exemestane, a systematic review was conducted by searching electronic databases. The outcomes of interest were “clinical benefit”, “overall response” and “disease-free survival rate”. To evaluate the cost of treatments, costs of both domestic generic and imported brand medicines were taken into account, and the incremental cost-effectiveness ratio (ICER) was calculated for each comparison.
Regarding primary breast cancer, based upon available evidence, exemestane could not be considered as a cost-effective medicine either in generic or brand form compared with placebo (ICER: 119,100 and 215,525), with tamoxifen after 2-3 years of therapy (ICER: 35,150 and 82,400) and with sequential treatment by tamoxifen and exemestane (dominated because of lower effectiveness and higher cost). In metastatic breast cancer, exemestane was not considered a cost-effective treatment compared with both anastrozole and megestrol acetate (dominated) and was highly cost-effective compared with tamoxifen (ICERs: 2,208 and 4,326 dollars per one more patient with an overall response for generic and brand medicines) although even in this case it was not cost-effective in terms of the 1-year survival rates (dominated).
Regarding current evidence and related costs in terms of Iranian pharmaceutical market prices, exemestane could not be considered a cost-effective treatment in primary and advanced breast cancer compared with available alternatives. However, more evidence is still needed for more certain decisions.
PMCID: PMC3701982  PMID: 23847669
systematic review; cost-effectiveness; anastrozole; letrozole; megestrol acetate; exemestane; evidence based medicine
20.  Code of ethics for the national pharmaceutical system: Codifying and compilation 
Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended.
PMCID: PMC3810583  PMID: 24174954
Pharmaceuticals; pharmacy ethics; pharmacy professionalism
22.  Increasing the risk of spontaneous abortion and major malformations in newborns following use of serotonin reuptake inhibitors during pregnancy: A systematic review and updated meta-analysis 
Selective serotonin reuptake inhibitors (SSRIs) are the most frequently used antidepressants during pregnancy. There are conflicting results about their influence on pregnancy outcomes. The goal of this study was to update our previous meta-analysis about pregnancy outcomes following exposure to SSRIs. For this purpose, all relevant databases were searched from 1990 to March 2012 for studies investigating the pregnancy outcomes following exposure to any therapeutic dosage of any SSRI (fluoxetine, paroxetine, citalopram, escitalopram, sertraline, fluvoxamine) during pregnancy. Types of outcome investigated were spontaneous abortion, major malformations, cardiovascular malformations, and minor malformations. A total of 25 studies met our criteria and were included in the meta-analysis. The odds ratio (OD) values are 1.87 (95% CI: 1.5 to 2.33, P< 0.0001) for spontaneous abortion, 1.272 (95% CI: 1.098 to 1.474, P = 0.0014) for major malformations, 1.192 (95% CI: 0.39 to 3.644, P= 0.7578) for cardiovascular malformations, and 1.36 (95% CI: 0.61 to 3.04, P= 0.4498) for minor malformations. The results demonstrated that SSRIs increase the risk of spontaneous abortion and major malformations during pregnancy while they don’t increase the risk of cardiovascular malformations and minor malformations. Our previous meta-analysis only showed an increase in the risk of spontaneous abortion following the use of SSRIs during pregnancy. This might be due to increase in the number of studies included or addition of two new SSRIs (citalopram and escitalopram). The message to researchers is to try considering SSRIs individually during pregnancy to reduce heterogeneity, although all are aware of inevitable limitations to study on pregnant mothers.
PMCID: PMC3556001  PMID: 23351929
Selective serotonin reuptake inhibitors (SSRIs); Pregnancy outcome; Meta-analysis; Evidence-based medicine; Malformation; Systematic review
23.  Financial perspective of private pharmacies in Tehran (Iran); is it a lucrative business? 
Background and purpose of the study
Pharmacies as direct providers of medicine and pharmaceutical services to patients have an important role in the health status of a society. The assessment of their financial situations by healthcare policy makers is necessary to prevent any negative effects on population's health. In this study we aim to analyze the financial status of pharmacies in Tehran, Iran.
This study is a cross-sectional study based on a survey. Two-hundred and eighty-eight private community daytime pharmacies in Tehran were selected by random sampling. We used two questionnaires to collect data regarding cost, expense and income factors of private pharmacies and the significance of each of them from these selected pharmacies. The data was collected in 2011 from Tehran pharmacies. Profitability of pharmacies in Tehran, Iran was calculated in its current situation and then estimated for three defined scenarios: 1. The dispensing fee is omitted (ceteris paribus), 2. Pharmacies are prohibited from selling hygienic & cosmetic products (ceteris paribus), 3. Scenarios 1 and 2 together (ceteris paribus). These data were analyzed by using SPSS and descriptive-analytic statistics.
About 68% of interviewees responded to our questionnaires. Our analysis indicated that the average annual costs (and expenses), income and profits of pharmacies are 73,181; 106,301; and 33,120 United States Dollar (USD), respectively. The analysis indicated that omission of dispensing fee (scenario 1) and prohibition of pharmacies from selling hygienic & cosmetic products (scenario 2) would decrease income of pharmacies to 18438 and 14034 USD/year, respectively. According to respondents, the cost (or expense) of properties and buildings, energy, taxes, delays in reimbursement by insurance companies, and renting the place of pharmacy could be considered as cost factors and prescription medicines, OTC medicines, dispensing fees, hygienic & cosmetic products, and long-term payment to pharmaceutical distribution companies as income factors, which have significant effects on a pharmacy's economy.
Major conclusions
According to the results of this study, regarding the pharmacies' cost (and expenses) and incomes, the omission of dispensing fees for prescriptions has considerable negative effects on the profitability of pharmacies and likely on society's health.
PMCID: PMC3556009  PMID: 23351226
Pharmacy; Income; Cost and expense; Profitability; Dispensing fee; Iran
24.  Prevention of bone resorption by intake of phytoestrogens in postmenopausal women: a meta-analysis 
Age  2010;33(3):421-431.
Phytoestrogens as selective estrogen receptor modulators like compounds may consider as a therapeutic option in osteoporosis. In this regard, the effect of phytoestrogens on bone biomarkers was examined in several trials which their results are controversial. We aimed this meta-analysis to evaluate the net effect of phytoestrogens on bone markers. A thorough search was conducted from 2000 to 2010 in English articles. All randomized clinical trials were reviewed, and finally, 11 eligible randomized clinical trials were selected for meta-analysis. Totally 1,252 postmenopausal women were enrolled in the study by considering the changes of pyridinoline (Pyd), desoxypyridinoline (Dpyd), bone alkaline phosphatase, and osteocalcin concentrations in urine and serum after phytoestrogens consumption. The urine Pyd and Dpyd levels decreased significantly in phytoestrogens consumers. Effect size and effect size for weighted mean difference of urine Pyd levels showed −1.229171 (95% confidence interval (CI) = −1.927639 to −0.530703) and −9.780623 (95% CI = −14.240401 to −5.320845), respectively, a significant results in comparison to control group and significant results for Dpyd −0.520132 (95% CI = −0.871988 to −0.168275) and −0.818582 (95% CI = −1.247758 to −0.389407), respectively. Meta-analysis indicates that phytoestrogens intake can prevent bone resorption, but its benefits on bone formation are not significant. This favorable effect was observed in low doses and in at least 3 weeks of phytoestrogens intake.
PMCID: PMC3168592  PMID: 20827510
Phytoestrogens; Soy isoflavone; Meta-analysis; Pyridinoline; Desoxypyridinoline; Bone-specific alkaline posphatase; Osteoporosis; Oxidative stress
25.  Assessment of the vaccine industry in Iran in context of accession to WTO: a survey study 
The vaccine industry is one of the most important health-related industries. It can be affected by accession to the World Trade Organization (WTO) because of probable dramatic changes in the business environment. Iran has already initiated accession negotiations.
Purpose of the study
In this paper, we investigate the position of, challenges to, and opportunities for vaccine manufacturing in Iran with regard to accession to the WTO.
This is a qualitative and cross sectional study. To collect information, we designed a questionnaire and interviewed some of the vaccine industry’s key opinion leaders in Iran. Before the interviews were conducted, the questionnaires were sent to these individuals by email.
According to the interviewees, the country’s main challenges with regard to accession to the WTO are the lack of firm internal intellectual property (IP) rules, not being recognized as pre-qualified by the World Health Organization (WHO), the use of old equipment, and a lack of cooperation with global vaccine companies.
Major conclusions
Iran’s local vaccine industry, with a long history and international reputation that could be used as an advantage, is faced with several challenges, such as problems with keeping up with Current Good Manufacturing Practice (cGMP), a lack of adequate and meaningful investment in research and development (R&D), and limitations on private sector participation in the production of vaccines.
Gradual privatization of the industry, improved international relations, utilization of the R&D power of small hi-tech companies, consistent education of human resources, and modernization of infrastructures and equipment are among the suggested solutions.
PMCID: PMC3555710  PMID: 23351841
Vaccine; WTO; Iran; WHO

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