Alzheimer’s disease (AD) is a neurodegenerative disease and the most common cause of dementia affecting millions of people yearly. On June 7, 2021, the U.S FDA granted accelerated approval to highly expensive Aducanumab (Aduhelm), the first-ever disease-modifying drug for the treatment of AD based on its efficacy in reducing Amyloid-beta (Aβ) plaques in the brain. A systematic search of the clinical studies available on the newly approved disease modifying AD drug, aducanumab was done. Aducanumab was investigated in two Phase-3 placebo-controlled trials (EMERGE: 1638 and ENGAGE: 1647) for its anti-Alzheimer efficacy, in patients with mild AD or mild cognitive impairment due to AD. Findings from both studies revealed no significant changes between the two groups in both the trials, except in trial EMERGE, in which subjects who had received high-dose aducanumab demonstrated a smaller clinical decline from baseline compared to those treated with placebo i.e., 22 % relative reduction in the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) at week 78. Further, nearly 40% of participants showed Amyloid-Related Imaging Abnormalities (35%) (ARIA), including edema and microhaemorrhage (ARIA-E and ARIA-H).Those pharmaceutical agents approved based upon surrogate bio-markers fail to show any clinical efficacy against to symptoms of patients, in spite of high cost and severe adverse events. Therefore any pharmaceutical agents must be approved only based upon evidence from the confirmatory clinical trials. Clinicians also should be vigilant over any newly approved medications over their clinical evidence rather than believing their efficacy and safety based upon decision of approval bodies, especially the drug like aducanumab.

Background: The aging growth rate is more rapid in developing countries than in more developed countries. This rate is higher in Tehran metropolitan than in most of the other regions of Iran. This study aimed to indicate of disparity and inequity of levels of health related quality of life between different districts of the Tehran metropolitan. Methods: This study analyzed the data of 1890 elderly aged ≥65 years who responded to questionnaires of the Urban-HEART survey. The Persian version of Short-Form Health Survey version 2 (SF 12 v2) was used for the assessment of the health-related quality of life. This instrument has two major components, including Physical Component Summary (PCS) and Mental Component Summary (MCS), and also has eight subscales. The mean of these scores was compared between genders and age groups and districts of the Tehran metropolitan using a one-way Analysis of Variance (ANOVA). Results: Mean±SD age of participants was 73.65±5.91 years. The Mean±SD age in men was 72.97±5.76 years. The Mean±SD PCS score in the participants was 33.36±10.48 and Mean±SD MCS score was 44.26±11.22. The Mean±SD PCS and MCS scores were lower in females than males. The highest Mean±SD PCS scores were observed in district 22 (37.25±11.51) and the lowest Mean±SD PCS scores were observed in district 16 (30.17±9.27). Conclusion: The result of this study help health and urban policymakers could better diagnose and plan for decreasing these inequities in Tehran.

Background: Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, acquired disorder of hematopoietic stem cells, in which red blood cells become susceptible to complement-mediated hemolysis. PNH is associated with a wide range of medical consequences and costs. This study was done to estimate the economic burden of PNH and the secondary consequences caused by PNH in Iran.Methods: This study is a cross-sectional and non-interventional study conducted using the cost-of-illness framework. The top-down prevalence method was used to quantify the annual PNH-related costs. This study was conducted from the societal perspective, including all direct medical, non-medical, and indirect costs associated with PNH. Productivity losses were calculated using the human capital method. Costs were collected using the relative value unit of health services in Iran, related literature, and from one of the referral hospitals in Iran, as well. Results: The average annual costs of blood transfusion and anemia, thromboembolic events, and renal problems are estimated to be around $5400, $5382, and $6422, respectively. The total average costs of the three mentioned consequences caused by PNH are estimated to be $17,204 US dollars per PNH patient per year in Iran.Conclusion: This study suggests that the average cost of managing anemia, blood transfusion, thromboembolic events, and renal problems in PNH equals $17,204 annually. Dependent on the severity of the disease and other factors, this amount could increase significantly. Additional cost-effectiveness studies should be carried out to identify the most cost-efficient disease management protocol.  

Background: Empagliflozin and liraglutide are anti-hyperglycemic agents with proven cardiovascular benefits in Type 2 Diabetes Mellitus (T2DM) patients with established Cardiovascular (CV) disease. Although both drugs are available in Iran’s pharmaceutical market, no local or regional study has analyzed the cost-effectiveness of these drugs in terms of reduction in the rate of CV-related mortality in T2DM patients in this country. In the present study, a one-year Cost-Effectiveness Analysis (CEA) was conducted based on decision-analytic modeling to compare the effectiveness of empagliflozin versus liraglutide in the prevention of CV-related death in T2DM patients in Iran.Methods: A one-year CEA was performed to compare the effects of empagliflozin in contrast to liraglutide on the prevention of CV-related mortality from the Iranian T2DM payers’ perspective. Clinical data were extracted from the results of LEADER and EMPA-REG OUTCOME studies. Economical and cost data were taken from the FDA official website of Iran (http://irc.fda.gov.ir/nfi) and the national book of tariffs. The data then were converted to the 2021-USD using governmental conversion rates and presented in terms of Incremental Cost-Effectiveness Ratio (ICER). In order to assess the robustness of the results, scenario analysis and multiple Deterministic Sensitivity Analysis (DSA) were also performed.Results: Empagliflozin dominated original brand liraglutide and biosimilar liraglutide with reduced costs in preventing one extra CV-related death in T2DM patients. The annual cost was $30,585 (95%CI: $22,283- $48,745), $736,179 (95%CI: $457,206- $2,286,029), and $445,512 (95%CI: 276,686- 1,383,432) for empagliflozin, original brand liraglutide, and biosimilar liraglutide, respectively. These results were in line with the findings from scenario, base-case and deterministic sensitivity analyses.Conclusion: Empagliflozin is projected to be highly cost-effective in terms of the prevention of CV-related death compared to liraglutide in Iran.

Background: Proton pump inhibitors (PPIs) are the most effective medications in acid-related disorders. Inappropriate use of Intravenous (IV) pantoprazole can cause unwanted consequences like hypersensitivity reactions, prolonged duration of treatment, and increased treatment cost. This study aimed to evaluate the effect of the utilization of a preprinted protocol for the use of IV pantoprazole on its appropriate administration. Methode: This prospective, cross-sectional, two-phase study was conducted on the four departments of a tertiary teaching hospital. In the first phase, December 22, 2018, to March 19, 2019, all older than 18-year old patients who were admitted to internal medicine, general surgery, and neurosurgery, and received IV pantoprazole were included in the study. In the second phase of the study, April 4, 2019, to July 6, 2019, the neurology ward was added to the study according to the high consumption of IV pantoprazole. We evaluated the effect of the utilization of a preprinted protocol for the appropriate of IV pantoprazole on its consumption, and the frequency of appropriate administration based on the approved protocol, the need to change the patient's medication regimen, and the physician's feedback on the changes. The consumption of IV pantoprazole was compared with the same period times at the last year of intervention as the pre-intervention phases. Results: Four hundred forty-six prescriptions of IV pantoprazole were screened during the 2 phases of the study. The utilization of the approved protocol consequent decrease in IV pantoprazole consumption in intervention phases compared with pre-intervention phases in all departments. This difference was statistically significant in the general surgery  (p= 0.016) and neurosurgery (p= 0.012) wards in phase 2. Related data to the comparison of the IV pantoprazole consumption between two phases of the intervention also showed a significant decrease in the neurosurgery ward (p= 0.011). In the total of the two phases, the use of the protocol led to an 8.3% decrease in consumption in comparison with pre-intervention periods. During these six months, we detected that the administration of IV pantoprazole was not based on the protocol in 81.2% of patients and the use of the protocol led to correct 63.89% of physician's orders. Conclusion: This study showed that the majority of IV pantoprazole prescriptions were inappropriate. Using the preprinted forms to administer the IV pantoprazole could improve its appropriateness in terms of indication for use, dose, and duration of treatment and decrease consumption.

Background: In public health emergencies, such as the COVID-19 pandemic, the work strategies of clinical pharmacists need to be modified according to the rapid spread of the disease, where information and resources are constantly changing. The aim of this study was to describe the role of clinical pharmacists in the COVID-19 pandemic by the implementation of clinical practice guidelines.Methods: This was a prospective study from September 2020 to March 2021 in a COVID-19 center hospital. A clinical pharmacist visited patients in the ICU and internal ward three times per week and delivered Comprehensive Medication Management (CMM) on a consultation paper in patient’s files. In October 2021, a consensus regarding the improvement of the rational use of COVID-19 medications and their costs was developed. The high-cost medications were selected based on the hospital information system to evaluate direct medical costs from the provider’s perspective. Results: During six months, in addition to pharmacotherapy consultation for 193 patients, pharmacotherapy evaluation was done 903 times for COVID-19 patients and their medication was also assessed. After implementation of the updated COVID-19 protocol in the hospital, the use of main drugs reduced by 8.950.328.786 IRR equivalent to 21,317 USD based on reference currency within two months.Conclusion: The participation of a clinical pharmacist in a COVID-19 center by the implementation of pharmacotherapy guidelines and comprehensive medication management may lead to cost reduction and improved drug safety.