Impact of economic sanctions on access to noncommunicable diseases medicines in the Islamic Republic of Iran.

BACKGROUND: It has been argued that economic sanctions and the economic crisis have adversely affected access to drugs. AIM: To assess the impact of economic sanctions on the Iranian banking system in 2011 and Central Bank in 2012 on access to and use of drugs for noncommunicable diseases (NCDs). METHODS: An interrupted time series study assessed the effects of sanctions on drugs for diabetes (5 drug groups), asthma (5 drug groups), cancer (14 drugs) and multiple sclerosis (2 drugs). We extracted data from national reference databases on the list of drugs on the Iranian pharmaceutical market before 2011 for each selected NCD and their monthly sales. For cancer drugs, we used stratified random sampling by volume and value of sales, and source of supply (domestic or imported). Data were analysed monthly from 2008 to 2013. RESULTS: Market availability of 13 of 26 drugs was significantly reduced. Ten other drugs showed nonsignificant reductions in their market availability. Interferon α2b usage reduced from 0.014 defined daily doses per 1000 inhabitants per day (DID) in 2010 to 0.008 in 2013; and cytarabine from 1.40 mg per 1000 population per day in 2010 to 0.96 in 2013. Selective ß2-adrenoreceptor agonists usage reduced from 8.4 to 6.8 DID in the same time period. CONCLUSION: There is strong evidence that sanctions have had a negative effect on access to drugs, particularly those that depended on the import of their raw material or finished products.

Capacity-building for conducting COVID-19 vaccine effectiveness studies to enhance evidence-informed vaccination policymaking in the Eastern Mediterranean Region.

Background: Vaccine effectiveness studies provide evidence on the effects of vaccines for preventing disease and the adverse outcomes following a vaccination rollout programme in a country or a specific population. Aims: To document the technical and capacity-building support provided by WHO to countries in the Eastern Mediterranean Region to conduct COVID-19 vaccine effectiveness studies. Methods: WHO implemented interventions to enhance the capacity of EMR countries to conduct COVID-19 vaccine effectiveness and similar epidemiological studies. The intervention consisted of several components, including methodological and technical support as well as data and project management at national and regional levels. Two WHO generic protocols were adopted: cohort study among healthcare workers and test-negative design in severe acute respiratory infections surveillance sites. Results: Egypt, Islamic Republic of Iran, Jordan, and Pakistan participated in the programme. The research protocols were adjusted to country context and settings. WHO provided technical, financial and infrastructure support, including the establishment of quality assessment approaches, study conduct, data management, report development, statistical data analysis, and experience-sharing between the countries. Technical capacity-building was also offered to other countries not involved in the vaccine effectiveness studies. Conclusion: COVID-19 pandemic provided an opportunity to enhance the research capacities of EMR countries for the conduct of vaccine effectiveness studies. The WHO consolidated efforts and its collaboration with countries resulted in enhancement of capacity and research infrastructure, especially in the 4 countries that were supported by this programme. The capacities acquired through the programme would be very useful for other vaccine-preventable communicable diseases, thus better informing national immunization programmes and policies in EMR countries.

Next generation support and stronger institutions for evidence-informed policy-making.

Evidence-informed policy-making benefitted from much-needed attention and resources during the COVID-19 pandemic (1). As a result, 3 key movements and innovations are now making it possible to provide better evidence support (higher quality and more aligned to the speed of advisory and decision-making) for policy-making than ever.

Affordability of Medication Therapy in Diabetic Patients: A Scenario-Based Assessment in Iran's Health System Context.

BACKGROUND: Diabetes imposes an enormous burden on patients, families, societies, and healthcare systems. Determining the affordability of medications is an important complicated and vague task, especially in low- and middle-income countries (LMICs). This study aimed to assess the affordability of diabetes medication therapy in Iran's health system. METHODS: This paper presents a scenario-based assessment of the affordability of all registered anti-diabetes medications in Iran in 2017. To this end, 4 medication therapy scenarios were defined as mono, dual, triple, and insulin therapy in accordance with the existing guidelines and clinicians' opinions. Then the affordability ratio of each treatment scenario was determined for type 1 and type 2 diabetes drawing on the World Health Organization (WHO)/Health Action International (HAI) Methodology. If the affordability ratio for treatment schedules was more than 1, the patients' out-of-pocket (OOP) expenses exceeded the lowest-paid unskilled government worker (LPGW)' wage per day, and the treatment was labelled as non-affordable. RESULTS: The results revealed that the mono, dual, and triple (non-insulin) medication therapies in type 2 diabetes were affordable, despite an increase in the dosage or a switch from the monotherapy to the combination therapy of oral medications. However, some treatment scenarios in the triple therapy, including oral plus insulin and some insulin only therapies, were proved to be non-affordable. In type 1 diabetes, only insulin glulisine, detemir, and lispro were non-affordable in monotherapy. Regarding the combination therapy, only isophane insulin with aspart or regular insulin were affordable treatments. CONCLUSION: Although oral medication therapies were documented to be affordable, insulin therapy, with current coverage conditions, for patients with lowest paid wages and those receiving even less is unaffordable and a major barrier to treatment; hence, policy-maker should consider targeting and more financial protection policies to improve the affordability of insulin therapies among this group of patients.

Evaluation of Pharmacovigilance System in Iran.

BACKGROUND: Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement. METHODS: This study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran. RESULTS: Iran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed. CONCLUSION: A robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators' status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.

WHO's support for COVID-19 research and knowledge management in the Eastern Mediterranean Region.

Health research, innovation and knowledge management remain major priorities of the WHO's response to the COVID-19 pandemic. WHO's Eastern Mediterranean Regional Office (EMRO) supports priority research initiatives that address gaps in current knowledge regarding the COVID-19 pandemic. Through a specific call for proposals, 122 research proposals were received and reviewed in 2020, of which 17 were recommended for funding from eight countries. Ten countries in the region participated in the global solidarity trial to assess potential therapies for COVID-19. In addition, WHO advocated for early serological and epidemiological investigations ('COVID-19 Unity Studies') on the general population, healthcare workers, pregnant women and neonates, and extending technical, financial and material support for them.Starting in early 2020, scholarly articles on COVID-19 have been published in every issue of the Eastern Mediterranean Health Journal More than 6300 publications on COVID-19 were made available on the WHO knowledge management portal in the last year alone. WHO is also supporting countries in conducting studies to assess the field effectiveness of vaccines deployed nationally. To build and strengthen country capacities, regional webinars and intercountry meetings were conducted on research ethics, national health information systems and evidence-based health policy making. With support from WHO EMRO's new research and knowledge management pillar, countries in the region were well equipped to contribute to a global understanding of the novel virus's characteristics, as well as employ a national response based on informed evidence.

National food policies in the Islamic Republic of Iran aimed at control and prevention of noncommunicable diseases.

BACKGROUND: Diet plays an important role in the risk of noncommunicable diseases. In the Islamic Republic of Iran, national activities were started after release of the World Health Organization's (WHO) action plan on prevention and control of noncommunicable diseases. AIMS: This study describes national food policies implemented by the government in order to reduce noncommunicable diseases in the country in line with WHO action plan. METHODS: Newly adopted food standards and regulations linked to noncommunicable diseases from 2013 to 2018 were reviewed and the maximum permitted levels of salt and trans and saturated fats were compared in the old and new standards. Nutritional traffic light labelling to raise public awareness of healthy diets was evaluated. RESULTS: Fifteen food standards associated with eight food items that make up a large share of the daily Iranian food basket and three that make up a small share were evaluated. Policies on salt included reduction in maximum permitted percentage in bread, cheese and doogh (a fermented drink) to 1%, 3% and 0.8%, respectively. For trans and saturated fats, maximum permitted percentages were set as 2-5% and 30-65% of edible oils and fats, respectively. Nutritional traffic light labelling, which indicates the content of salt, sugar, fat and trans fat in foods, has been mandatory for all foods since 2016. CONCLUSIONS: In view of the polices implemented to reduce the salt and fat/oil content of foods, significant decreases in noncommunicable diseases are expected in coming years in the country. However, further studies are needed to show the effectiveness of the interventions.

Does rural health system reform aimed at improving access to primary health care affect hospitalization rates? An interrupted time series analysis of national policy reforms in Iran.

OBJECTIVES: To evaluate the effects of rural health insurance and family physician reforms on hospitalization rates in Iran. METHODS: An interrupted time series analysis of national monthly hospitalization rates in Iran (2003-2014), starting from two years before the intervention. Segmented regression analysis was used to assess the effects of the reforms on hospitalization rates. RESULTS: The analyses showed that hospitalization rates increased one year after the initiation of the reforms: 1.55 (95% CI: 1.24-1.86) additional hospitalizations per 1000 rural inhabitants per month ('immediate effect'). This increase was followed by a further gradual increase of 0.034 per 1000 inhabitants per month (95% CI: 0.02-0.04). The gradual monthly increase continued for two years after the reforms. The higher hospitalization rates were maintained in the following years. We observed a significant increase in hospitalization rates at a national level in rural areas that continued for over 10 years after the policy implementation. CONCLUSION: Primary health care reforms are often proposed for their efficiency outcomes (i.e. reduction in costs and use of hospitals) as well as their impact on improving health outcomes. We demonstrated that in populations with unmet needs, such reforms are likely to substantially increase hospitalization rates. This is an important consideration for successful design and implementation of interventions aimed at achieving universal health coverage in low- and middle-income countries.

Medication Errors Associated With Adverse Drug Reactions in Iran (2015-2017): A P-Method Approach.

Medication errors are the second most common cause of adverse patient safety incidents and the single most common preventable cause of adverse events in medical practice. Given the high human fatalities and financial burden of medication errors for healthcare systems worldwide, reducing their occurrence is a global priority. Therefore, appropriate policies to reduce medication errors, using national data and valid statistics are required. The primary objective of this study was to provide a national 'characteristic profile' of medication error-associated adverse drug reactions (ADRs), which are also known as preventable ADRs (pADRs). A retrospective study of pADR reports submitted to the national pharmacovigilance center (PCV) within Iran's Food and Drug Administration was conducted over a 2-year period (2015-2017). Preventability Method (P-Method), which is a standardized tool developed and recommended by the World Health Organization (WHO), was used for preventability assessment. The results of the analyses revealed that while the number of pADRs increased from year one to two (601 to 630), their proportion out of all ADRs per year decreased (7.32% to 6.44%). The percentage of pADRs was higher in females (61.01%) and adults (83.27%), and the highest number of reports were received by nurses (71.57%). Having 'a documented hypersensitivity to an administered drug or drug class' was the most common preventable factor in both years (61.23% and 54.29% respectively), and 'anti-infectives used systemically' were the medication class which primarily contributed to both serious (53.29%) and non-serious pADRs (39.19%). The specific characteristics of medication errors associated with ADRs from this study, especially the preventable criteria which led to their occurrence, can help devise more specific preventative policies.

A news media analysis of economic sanction effects on access to medicine in Iran.

OBJECTIVE: In the past decades economic sanctions have been used by different countries or international organizations in order to deprive target countries of some transactions. While the sanctions do not target health care systems or public health structures, they may, in fact, affect the availability of health care in target countries. In this study, we used media analysis to assess the impacts of recent sanctions imposed by the Central Bank of Iran in 2012 on access to medicines in Iran. METHODS: We searched different sources of written news media including a database of nonspecialized weeklies and magazines, online news sources, web pages of daily newspapers and healthcare oriented weeklies from 2011 to 2013. We searched the sources using the general term "medicine" to reduce the chances of missing relevant items. The identified news media were read, and categorized under three groups of items announcing "shortage of medicines," "medicines related issues" and "no shortage." We conducted trend analyzes to see whether the news media related to access to medicines were affected by the economic sanctions. FINDINGS: A total number of 371 relevant news media were collected. The number of news media related to medicines substantially increased in the study period: 30 (8%), 161 (43%) and 180 (49%) were published in 2011, 2012 and 2013, respectively. While 145 (39%) of media items referred to the shortage of medicines, 97 (26%) reported no shortage or alleviating of concerns. CONCLUSION: Media analysis suggests a clear increase in the number of news media reporting a shortage in Iran after the sanctions. In 2013, there were accompanying increases in the number of news media reporting alleviation of the shortages of medicines. Our analysis provides evidence of negative effects of the sanctions on access to medicines in Iran.

A review of pharmaceutical policies in response to economic crises and sanctions.

An economic crisis has been defined as a situation in which the scale of a country's economy becomes smaller in a period of time. Economic crises happen for various reasons, including economic sanctions. Economic crises in a country may affect national priorities for investment and expenditure and reduce available resources, and hence may affect the health care sector including access to medicines. We reviewed the pharmaceutical policies that the countries adopted in order to mitigate the potential negative effects on access to medicines. We reviewed published reports and articles after conducting a comprehensive search of the PubMed and the Google Scholar. After extracting relevant data from the identified articles, we used the World Health Organization (WHO) access to medicines framework as a guide for the categorization of the policies. We identified a total of 40 studies, of which 10 reported the national pharmaceutical policies adopted to reduce the negative impacts of economic crises on access to medicines in high-income and middle-income countries. We identified 89 policies adopted in the 11 countries and categorized them into 12 distinct policy directions. Most of the policies focused on financial aspects of the pharmaceutical sector. In some cases, countries adopted policies that potentially had negative effects on access to medicines. Only Italy had adopted policies encompassing all four accesses to medicine factors recommended by the WHO. While the countries have adopted many seemingly effective policies, little evidence exists on the effectiveness of these policies to improve access to medicines at a time of an economic crisis.

Cost-effectiveness analysis review of exemestane in the treatment of primary and advanced breast cancer.

INTRODUCTION: 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. RESULTS: 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). CONCLUSIONS: 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.