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      Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries

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          vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues

          Background Individual case safety reports of suspected harm from medicines are fundamental to post-marketing surveillance. Their value is directly proportional to the amount of clinically relevant information they include. To improve the quality of the data, communication between stakeholders is essential and can be facilitated by a simple score and visualisation of the results. Objective The objective of this study was to propose a measure of completeness and identify predictors of well-documented reports, globally. Methods The Uppsala Monitoring Centre has developed the vigiGrade completeness score to measure the amount of clinically relevant information in structured format, without reflecting whether the information establishes causality between the drug and adverse event. The vigiGrade completeness score (C) starts at 1 for reports with information on time-to-onset, age, sex, indication, outcome, report type, dose, country, primary reporter and comments. For each missing dimension, a penalty is detracted which varies with clinical relevance. We classified reports with C > 0.8 as well-documented and identified all such reports in the WHO global individual case safety report database, VigiBase, from 2007 to January 2012. We utilised odds ratios with statistical shrinkage to identify subgroups with unexpectedly high proportions of well-documented reports. Results Altogether, 430,000 (13 %) of the studied reports achieved C > 0.8 in VigiBase. For VigiBase as a whole, the median completeness was 0.41 with an interquartile range of 0.26–0.63. Two out of three well-documented reports come from Europe, and two out of three from physicians. Among the countries with more than 1,000 reports in total, the highest rate of well-documented reports is 65 % in Italy. Tunisia, Spain, Portugal, Croatia and Denmark each have rates above 50 %, and another 20 countries have rates above 30 %. On the whole, 24 % of the reports from physicians are well-documented compared with only 4 % for consumers/non-health professionals. Notably, Denmark and Norway have more than 50 % well-documented reports from consumers/non-health professionals and higher rates than for physicians. The rate of well-documented reports for the E2B format is 11 % compared with 22 % for the older INTDIS (International Drug Information System) format. However, for E2B reports entered via the WHO programme’s e-reporting system VigiFlow, the rate is 29 %. Conclusion Overall, only one report in eight provides the desired level of information, but much higher proportions are observed for individual countries. Physicians and e-reporting tools also generate greater proportions of well-documented reports overall. Reports from consumers/non-health professionals in specific regions have excellent quality, which illustrates their potential for the future. vigiGrade has already provided valuable information by highlighting data quality issues both in Italy and the USA. Electronic supplementary material The online version of this article (doi:10.1007/s40264-013-0131-x) contains supplementary material, which is available to authorized users.
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            Health care in Syria before and during the crisis

            The Syrian International Coalition for Health (SICH) is a consortium of organizations and health professionals who are committed to improving health care and healthcare delivery in Syria. SICH was formed in 2012 in response to increasingly urgent calls for comprehensive reform. The coalition adopted five principles: Quality, equity, sustainability, broad participation and shared responsibility. Global Health Equity Foundation (GHEF), as a major contributor to human and community development worldwide, combines its core strategies of research, advocacy and capacity building to host this coalition. From administrative headquarters in Geneva, GHEF supports the SICH agenda in an equitable and neutral fashion. The coalition with its affiliates (Syrian American Medical Society, Syrian British Medical Society, Middle East Critical Care Assembly and others) along with its experts and specialists will play a major role in the Post-Conflict Needs Assessment in Syria and will evaluate the capacity and functionality of the health system to develop and implement the needed strategies and projects. Before the crisis: Baseline health status Health indicators improved considerably in the Syrian Arab Republic over the past three decades according to data from the Syrian Ministry of Health with life expectancy at birth increasing from 56 years in 1970 to 73.1 years in 2009; infant mortality dropped from 132 per 1000 live births in 1970 to 17.9 per 1000 in 2009; under-five mortality dropped significantly from 164 to 21.4 per 1000 live births; and maternal mortality fell from 482 per 100 000 live births in 1970 to 52 in 2009.[1] The Syrian Arab Republic was in epidemiological transition from communicable to non- communicable diseases with the latest data showing that 77% of mortalities were caused by non-communicable diseases.[2] Total government expenditure on health as a percentage of Gross Domestic Product was 2.9 in 2009.[3] Despite such low public investment access to health services increased dramatically since the 1980s, with rural populations achieving better equity than before.[1] Despite the apparent improved capacity of the health system, a number of challenges prevail which need to be addressed to reduce inequities in access to health care and to improve the quality of care; these include, addressing validity of the data, overall inequity, lack of transparency, inadequate utilization of capacity, inadequate coordination between providers of health services, uneven distribution of human resources, high turnover of skilled staff and leadership, inadequate number of qualified nurses and allied health professionals. More recently there has been an uncontrolled and largely unregulated expansion of private providers, resulting in uneven distribution of health and medical services among geographical regions. Standardized care and quality assurance and accreditation are major issues that need to be addressed; a recent study revealed that mortality rates among critically ill patients admitted to the intensive care units with severe 2009 H1N1 influenza A was 51% in Damascus compared to an APACHE II predicted mortality rate of 21% with a standardized mortality ratio of 2.4 (95% confidence interval: 1.7–3.2, P-value < 0.001).[4] During the crisis: Health care provision Syria is experiencing a protracted political and socioeconomic crisis that resulted in a severe deterioration of living conditions which has also significantly eroded the health system. At least 25,000 Syrians have been killed with many more were injured, among them women and children among the casualties; health staff were killed and injured while on-duty. Injuries include multiple traumas with head injuries, thorax and abdominal wounds. A Total of 192,825 refugees were registered by UNHCR as of September 7, 2012and residing in refugee camps in Turkey, Jordan, Lebanon and Iraq in addition to 53,442 refugees who are awaiting registration together with an undetermined number of displaced people who are being sheltered with host families outside Syria[5] . It is estimated that more than 2.3 million have been internally displaced; these numbers are rising by the day as the crisis is escalating very rapidly. Vital infrastructure has been compromised or destroyed, resulting in a lack of shelter and energy sources, deterioration of water and sanitation services, food insecurity and serious overcrowding in some areas. Access to health care is severely restricted, hampered by security factors. Maternal and child health services at the primary health care (PHC) level are disrupted. The consequences for maternal and child morbidity and mortality, among deliveries that took place during the conflict period remains unclear. Specific concerns remain for the chronically sick. It is estimated that more than half of those chronically ill have been forced to interrupt their treatment. These concerns are exacerbated by the virtual halt of referrals of ordinary patients outside the conflict areas as life-threatening injuries receive higher priority in an overwhelmed health care system. Elective surgery and nonurgent routine medical interventions are delayed or interrupted indicating that a growing number of patients, mainly with chronic conditions are facing a dire situation, while awaiting treatment. The quality of health care has been further affected by the deterioration in the functionality of medical equipment due to the lack of spare parts and maintenance shortages of drugs and medical supplies due to sanctions.[6] Routine operations are affected and many elective interventions suspended. Very few assessments were taken place to assess the status of health care services at the conflict areas; the World Health Organization (WHO) completed a rapid assessment in late June to assess the availability and functionality of health services and resources in affected areas. The survey included 342 primary health care centers (PHC) and 38 hospitals in several affected provinces: Rural Damascus, Homs, Hama, Idleb, Der El Zor, Dara’a, and Tartous. The first six provinces were selected to assess the effect of the current unrest on health services, while Tartous was selected to assess the degree of overburdened health facilities, due to high numbers of internal refugees from other affected provinces. It was found that about 43% of PHCs are partially functioning, and 2% of PHCs are nonfunctioning, 13% PHCs are inaccessible due distance of PHC from patients (50%, mostly in Idleb); lack of safety (34%, mostly in Homs and Hama); difficulties in public transportation (8%, mostly in Tartous) or temporary relocation of patients (2%) while only 50% of hospitals are fully functioning due to lack of staff, equipment and medicine. The report showed an urgent need for infant incubators in some hospitals, CT scans, Doppler, echography, anesthesia equipment, and ambulances. Antibiotics, anti-ulcer medication, sterilizers and antidotes are also urgently needed. The major obstacles are a lack of safety related to the current situation, long distances to hospitals, and difficulties in available public transportations (12.5%). These issues exist mainly in Rural Damascus, Daraa, Homs and Der El Zor provinces. The majority of PHCs and hospitals also count on the national water supply system as a main source of water (88%, 87%, respectively). A large proportion of PHCs have no available sanitation system (mostly in Hama, Der El Zor and Dara′a). Only one-tenth of PHCs have usable generators; the majority has usable blood pressure apparatuses (94%); Availability of nebulizers, fetoscopes and suction machines are 44%, 30% and 18%, respectively. This assessment is limited due security issues, the dynamic situation and the rapid escalation of the crisis, it is expected the needs are at larger scale after the recent escalation in the last 2 months.[7] There is a need for a larger assessment and evaluation of health services in the affected areas. Prompt coordinated efforts and proactive solutions of health care services for displaced people are necessary in order to mitigate the serious and negative outcomes. Multiple interventions have been attempted by the WHO in response to the crisis including the distribution of surgical kits and equipment of mobile health units in Homs and rural Damascus.[7] After the crisis: Post-conflict needs assessment In the postcrisis phase, there will be an urgent need for a development process designed to examine and assess the health situation in the country using a holistic approach; one that encompasses the health sector, socioeconomic status, the determinants of health, and upstream national policies and strategies that have a major bearing on health. Post-conflict needs assessments (PCNAs) are multilateral exercises that should be undertaken by the international organizations in collaboration with the national government of Syria. The Syrian International Coalition for Health with its affiliates (Syrian American Medical Society, Syrian British Medical Society, Middle East Critical Care Assembly and others) along with its experts and specialists will play a major role in the PCNAs and in the development and implementation of strategies and needed projects. PCNAs are increasingly used by national and international actors as an entry point for conceptualizing, negotiating and financing a common shared strategy for recovery and development in fragile, post-conflict settings. The PCNA includes both the assessment of needs and the national prioritization and costing of needs in an accompanying transitional results matrix. The assessment will evaluate the capacity and functionality of the health system in addition to the following points: Complications and permanent disabilities for people with traumatic injuries and hearing impairment caused by explosions due to inappropriate follow-up and treatment. Potential risks for women who went into labor as well as infants born during the crisis period associated with the lack of appropriate care during labor, delivery and postpartum. Complications and excess mortality in patients with chronic diseases due to suspension of treatment and delayed access to health care. Epidemic outbreaks of water and food-borne diseases due to limited access to clean water and sanitation and a weak public health surveillance system. Outbreaks of vaccine-preventable diseases due to interrupted vaccination programs. Psychological trauma and mental health problems particularly upon children due to the effects of the conflict, ongoing insecurity and lack of protective factors. Deterioration of health and nutritional status leading to increasing morbidity and mortality due to a further decline in socioeconomic and security conditions and in the quality of health care. The extent of vulnerable groups (elderly, pregnant women, and children) or individuals who are severely affected by the emergency, having reduced coping mechanisms and limited access to appropriate services or support networks. The magnitude of restricted access to specialized tertiary care. The Syrian International Coalition for health is determined within its scope and limitation to do all what it is possible not to allow a repeat of what has happened in other countries of the region, namely a total collapse of existing health infrastructure and systems.
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              Health services in Iraq.

              After decades of war, sanctions, and occupation, Iraq's health services are struggling to regain lost momentum. Many skilled health workers have moved to other countries, and young graduates continue to leave. In spite of much rebuilding, health infrastructure is not fully restored. National development plans call for a realignment of the health system with primary health care as the basis. Yet the health-care system continues to be centralised and focused on hospitals. These development plans also call for the introduction of private health care as a major force in the health sector, but much needs to be done before policies to support this change are in place. New initiatives include an active programme to match access to health services with the location and needs of the population. Copyright © 2013 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                Drug Safety
                Drug Saf
                Springer Science and Business Media LLC
                0114-5916
                1179-1942
                July 2019
                April 20 2019
                July 2019
                : 42
                : 7
                : 849-868
                Article
                10.1007/s40264-019-00807-4
                31006085
                ed46efa8-c58b-4288-b06e-36f54ea4acb4
                © 2019

                http://www.springer.com/tdm

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