This monograph reviews the history and development of promoting a sound policy in public health in Lebanon, with particular reference to the efforts that lead to the establishment of the Quality Assurance of Pharmaceutical Products Program at the Ministry of Public Health in Lebanon in 2012. The steady involvement in the developmental work by Dr. Rita Karam is covered, and so is her supervision of the efforts leading to it. The presented monograph is well documented and supported by a list of rich references.(Read More...)
The Statistical Bulletinof the Ministry of Public Health (MOPH) is the annual compilation of data available at the Ministry which is growing year after year due to the increase in availability of the data in statistical form. This report responds to the demand from the community which is eager to familiarize itself with the activities of the MOPH, and is the fruit of the dedication of concerned employees to keep the flow of information going. (Read More)
The Lebanon Clinical Trials Registry (LBCTR) is officially announced a primary registry where organizations and individuals can register their trials and in turn is serving as a data provider to the World Health Organization – International Clinical Trials Registry Platform (WHO ICTRP).
The LBCTR public website consists of two main areas; Public users’ area, and the Applicant users’ area. The public area is accessible for any visitor of the website, where they can review and obtain different information about the LBCTR and its contents as well as answers for the most popular questions they may have about the LBCTR; what it is, who is responsible for it, how does it work, and how to be an applicant and publish trials. All users are also able to review the publicly published trials as well as search for a specific or a group of trials using the “Simple” and/or the “Advanced” search capabilities available on the website.(Read More..)
Lebanon has an estimated total population of 6 million with an annual growth rate of 1.3% and a life expectancy at birth of 80 (total years) (World Bank, 2018). It continues to enjoy favorable population and health indicators despite the unusual circumstances in the middle East and arab region.(Read More...)
Cancer incidence continues to increase: 104.1 and 102.8 in 1966 in male and female respectively, in 2015 the incidence of cancer is estimated to 262.4 and 240.1 in male and female respectively.
Similarly the incidence of colorectal cancer (CRC) continues to increase:25.4 in male and 20.6 in female in 2015.
The mean age at diagnosis of CRC in Lebanon is 65years in female and 66 in male With a sex ratio M/F: 1.14...
The Statistical Bulletinof the Ministry of Public Health (MOPH) is the annual compilation of data available at the Ministry which is growing year after year due to the increase in availability of the data in statistical form. This report responds to the demand from the community which is eager to familiarize itself with the activities of the MOPH, and is the fruit of the dedication of concerned employees to keep the flow of information going. (Read More)
This essay on “The collaborative governance of Lebanon’s health sector” is a well-documented, easily read, review of the transformation of Lebanon’s health care system, over the past two decades. I would like to commend Dr. Wim Vanlerbergh, Dr. Abdel Hay Mechbal and Dr. Nabil Kronfol, who put this together based on evidence, published robust surveys, extensive interviews and mapping of all stakeholders’ positions...
The national School Health program was revised in 2007 with a tripartite agreement between the Ministry of Public Health, the Ministry of Education and Higher Education, and the World Health Organization, to implement activities related to three main areas: medical screening, health awareness and education, and school health environment. Initiatives and interventions are in line with the National school health strategy that was revised in 2010 and approved by the National School health committee. The committee includes the main stakeholders involved in supporting youth health interventions such as line ministries, national NGOs, academic institutions and UN agencies. While all interventions are joint and under the umbrella of the National School Health Program, the role of the MOPH was more on the normative side, whereas the role of the MEHE was more on the implementation and coordination side. Below is a summary of the main activities supported by the line ministries...
This study aims to evaluate trends in the increasing costs of oncology drugs procured by the Lebanese Ministry of Public Health (MOPH) between 2014 and 2016 and to assess the impact of the introduction in mid-2015 of new immunotherapy drugs for the treatment of lung cancer on the overall and specific costs of that treatment.
A secondary analysis of data from the MOPH Cancer Drug Scientific Committee data base was conducted using a total of 18,133 cancer files between 2014 and 2016.
Over the 3-year period, about $140 million (USD) was spent on cancer drugs by the MOPH free cancer drug dispensing program. The expenditures increased by 27% after immunotherapy was phased in. The average cost of drugs per patient per year measured across all cancer types increased from $7,000 in 2014 to $8,400 in 2016. Trastuzumab, approved for treating human epidermal growth factor receptor 2–positive breast cancer ranked first in total expenditures for 2014-2015. By 2016, two new immunotherapy drugs had topped the list: pembrolizumab ranked first and nivolumab ranked third, representing 64% of the total cost of lung cancer treatment and approximately 19% of the total yearly budget; beneficiaries represented only 3% of all patients.
This update documents the increasing financial impact of newer cancer drugs on the procurement process in the middle-income country of Lebanon. The trend is aligned with the financial burden of cancer drugs worldwide, which calls for a collaborative global response to this crisis.(Read More...)
In line with the Good Storage & Distribution Practices of Pharmaceutical Products project that has brought core improvements at the level of the Lebanese pharmaceutical warehouses, the MoPH launches today through its Quality Assurance of Pharmaceutical Products program, the Good Storage & Distribution Practices of Food Supplements guideline.
The adequate storage and distribution of Food Supplements are a crucial activities to maintain their quality and integrity, to protect consumers from potential health risks and to ensure that they are not provided with misleading information.
A National Non Communicable Disease Prevention and Control Plan (NCD-PCP) has become a necessity in Lebanon, in view of the increasingly heavy epidemiological and economic burden that these diseases are causing. NCD-centered activities are currently conducted in Lebanon by various public agencies and organizations from the civil society, with a clear predominance of curative activities over preventive ones. Recently, a first Plan aimed at coordinating activities and setting landmark indicators was proposed under the auspices of the WHO Representative Office in Lebanon, originally for the period 2008-2013. Before this Plan could be adopted, it had to be updated to remain aligned with a newer version of the WHO Global Action for NCD Prevention and Control (2016-2020). This present document proposes a set of strategic objectives specifically tailored for Lebanon, largely inspired by the Global document. The vision enshrined in this document is the importance of multi-sectoralism in addressing NCD Prevention and Control. Under this vision, non-health sectors and non-governmental stakeholders are invited to play a major role in collaboration with the Ministry of Public Health (MOPH).
This Plan is constructed on three basic concepts:
NCD Prevention and Control is a multisectoral responsibility in which the roles of non-health stakeholders have to be defined and activated.
For the health sector, NCD Prevention and Control will enhance the integration of the concept of case-management including both curative AND preventive care as a standard of practice at the PHC level, and a re-orientation of PHC practitioners to community-based primary prevention.
This plan should contribute to the overarching goal of providing adequate universal health coverage to the entire population of Lebanon...
The good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products.
These guidelines are consistent with the requirements of the WHO guidelines for good Laboratory practices and with the requirements of the International Standard ISO/IEC 17025:2005, and provide detailed guidance for laboratories performing quality control of medicines.
National pharmaceutical quality control laboratories usually encompass essentially two types of activity:
Compliance testing of APIs, pharmaceutical excipients and pharmaceutical products employing “ofﬁcial” methods including pharmacopoeial methods, validated analytical procedures provided by the manufacturer or validated analytical procedures developed by the laboratory;
Investigative testing of suspicious, illegal, counterfeit substances or products, submitted for examination by medicine inspectors, customs or police.
The Drug Technical Document covers all the Quality, Safety and Efficacy information of a drug in a common format called the Common Technical Document (CTD). It has revolutionized the regulatory review processes, led to harmonized submission enabling the implementation of good review practices. For the pharmaceutical industries, it has eliminated the need to reformat the information for submission to the different regulatory authorities.
To improve the review and evaluation of the Module 3 and Module 5 of the Drug Technical file, the MOPH drafted the following 3 Guides:
These Guides are prepared by scientific experts and are intended to provide guidance and requirements for the preparation of the technical file to be submitted to the MOPH Technical Committee of Drugs. They are based on ICH standards and are useful for the Applicants of Generic Drug Technical file.
In end of 2014 the MOPH embarked in a large exercise of developing a 2015-2020 strategic plan for the health sector. All MOPH departments, main stakeholders, the academia and renowned experts were involved in this exercise. In mid 2015 OMSAR, in the framework of an EU financed project, recruited consultants to assist 4 ministries, including the MOPH, to develop a strategic plan according to a nationally standardized model.
Based on the many documents produced by the MOPH drafting team and following thorough consultations with the MOPH departments and national experts, the consultant produced a draft strategic plan 2016-2020...
Lebanon is a low TB burden country with estimated incidence of 16/100000, prevalence of 20/100000 and TB mortality rate of 1/100000.
The National Tuberculosis Program (NTP) in Lebanon operates through the PHC network and nine TB control centers across the country and implements all WHO recommended TB strategies: DOTS, stop TB, and End TB strategy. The NTP has a high treatment success rate of 90% among Lebanese nationals. However, the treatment success rate remains below the desired among the non-Lebanese patients where almost 50% in these groups leave the country before the completion of their treatment. Noting that currently over half of the persons referred to the program for investigation and treatment are non-Lebanese among whom one third are of Syrian nationality…
These guidelines aim to help healthcare workers deal with TB patients and are part of our national prevention strategy. Adopting these guidelines and measures will certainly help in decreasing the overall incidence of the disease at the national level.
Universal Health Coverage and the Lebanese Dilemma
Achieving Universal Health Coverage (UHC) is a main goal of the National Health Strategy, and is based on the principles of justice, equity, poverty reduction and the rational use of resources. It requires financing or providing preventive and curative quality health care for all, to satisfy each one’s needs against affordable contributions. Whereas alleviating the financial burden, as much as possible, on households, especially the poor, remains a main objective of UHC.
The purpose of Universal Health coverage is to ensure universal accessibility to services that address population health needs and country health priorities with adequate quality, without incurring households financial ruin. This implies reaching a consensus over two major policy decisions: 1st defining a benefit package, and 2nd, setting an acceptable level of financial burden on households, more specifically the OOP bearable level by income category. Starting up from scratch, the benefit package would include essential health services such as PHC, and the government would cover as much health interventions as its budget allows, by beginning with the most cost effective ones such as immunization, TB treatment and prenatal care. Thus the population would expect regular upgrading of the system and would welcome incorporating progressively more advanced services such as renal dialysis, treatment for cancer, and sophisticated surgeries. The dilemma of the health system in Lebanon is the current existence of a universal coverage for tertiary care and sophisticated treatments such as open heart and joint replacement surgeries and expensive cancer patent drugs, whereas, paradoxically, prevention and PHC services are not universally covered..(Read More...)
Abstract—Since 2009, the Ministry of Public Health (MoPH) in Lebanon has been going through a major reform initiative to improve its contracting system with private and public hospitals. The private sector is the main provider of hospital care in the country and the main contractor to the MoPH for the provision of curative care. As an “insurer of last resort,” the MoPH plays an important role in providing hospital coverage to 53% of the population who lack coverage by private or public insurance schemes, through contractual arrangements with the private sector. Historically, the MoPH used hospital accreditation as the basis for contracting and for determining the reimbursement rate. However, recent studies by the MoPH showed that reimbursing hospitals solely on accreditation results was not appropriate and led to an unfair and inefficient reimbursement system. The reform program included the development of several components, in particular, an automated billing system, a utilization review function, standardized admission criteria, and a hospital case mix index that accounts for case complexity. In 2014, the MoPH started implementing a new mixed-model contracting system with private and public hospitals. Preliminary evaluation of the new model suggests that the system incentivized hospitals to admit fewer inappropriate cases and more cases that are more complex/serious. This article shares one experience of how to introduce a merit-based system to face the common practice of political clientelism and confessional/religious-based favoritism in Lebanon. It highlights the importance of stakeholder engagement in a framework of networking and participatory governance that proved to be a key element behind the resilience of a diversified health system.(Read More...)
The Ministries of Public Health, Social Affairs, Education and Higher Education, Interior and Municipalities and Justice have launched the “Inter-ministerial Substance Use Response Strategy for Lebanon 2016-2021” on December 22, 2016.
The strategy was the result of a participatory process involving all stakeholders in order to respond to the challenges posed by substance use, including alcohol, drug and tobacco use. The goals and domains of action of the Strategy constitute a framework that will guide national efforts engaged for the prevention of substance use disorders; the harm reduction, treatment, rehabilitation and re-integration into society of persons with substance use disorders, and supply reduction.
The Ministry of Public Health (MOPH) in Lebanon provides cancer drugs free of charge for uninsured patients who account for more than half the total caseload. Other categories of cancer care are subsidized under more stringent eligibility criteria. MOPH's large database offers an excellent opportunity to analyze the cost of cancer treatment in Lebanon. (Read More...)
Background Between 2011 and 2013, the Lebanese population increased by 30% due to the influx of Syrian refugees. While a sudden increase of such magnitude represents a shock to the health system,threatening the continuity of service delivery and destabilizing governance,it also offers a unique opportunity to study resilience of a health system amidst ongoing crisis...
a. Burden of maternal mortalityMaternal mortality (MM) constitutes one of the major health problems facing women worldwide with unacceptable high numbers of preventable mortality. Every day close to 830 women die from pregnancy or childbirth-related complications around the world with reported 303 000 maternal death in 2015 according to WHO. Almost all of these deaths occurred in low-income countries (LICs), and most could have been prevented . Six countries account for over half of maternal deaths around the world (India, Nigeria, Pakistan, Afghanistan, Ethiopia and the Democratic Republic of Congo). This discrepancy is manifested in the substantial variation in the maternal mortality ratio (MMR) by country, from 956.8/100 000 (685·1–1262·8) in South Sudan to 2.4/100 000 (1·6–3·6) in Iceland .According to WHO, over 20% of all healthy life years lost in women of childbearing age are due to 3 factors: maternal morbidity and mortality, sexually transmitted infections including HIV/AIDS, and gynecological cancer .It is well known that every pregnancy can embody risks for mother and baby, but these risks vary among communities, countries and regions. Unfortunately, those risks are higher in countries with poor resources and week dysfunctional health services, with the largest gap between wealthy and impoverished observed in MM levels. Out of all the global maternal deaths, 99% occur in low-resource countries (284 000 maternal death), the majority of which are in sub-Saharan Africa (162 000 maternal death) and Southern Asia (83 000 maternal death) .The MMR, being an indicator of development as well as quality of life in a population, is 15 times higher in low-resource regions than in high resource regions . Among countries classified in the “low resource regions”, sub-Saharan Africa ranks lowest with the highest MMR, at 500 maternal deaths per 100 000 live births, while Eastern Asia ranks highest with the lowest, at 37 maternal deaths per 100 000 live births. Looking at the ratings of MMR in all the “low resource regions”, Western Asia where Lebanon belongs ranks 2ndafter and Caucasus and Central Asia . The overall ranking according to MMR (shown in brackets) is as follows: Southern Asia (220), Oceania (200), South eastern Asia (150), Latin America and the Caribbean (80), Northern Africa (78), Western Asia (71), and Caucasus and Central Asia (46).The adult lifetime risk of MM in women from sub-Saharan Africa was the highest at 1:39, in contrast Maternal Mortality in LebanonA story of successEvery day close to 830 women die from pregnancy or childbirth-related complications around the world in 2015Six countries account for over half of maternal deaths around the world (India, Nigeria, Pakistan, Afghanistan, Ethiopia and the Democratic Republic of Congo)The rest of the worldThe rest of the worldOver 50%The discrepancy is manifested in the substantial variation in the MMR by country in 2013 956.8 2.4The risks are higher in countries with poor resources and week dysfunctional health servicessub-Saharan AfricaSouthern Asia57%29.3%13.7%South SudanIcelandMaternal Mortality in Lebanon A Story of Success7to 1:130 in Oceania, 1:160 in Southern Asia, 1:290 in South-eastern Asia, and 1:3800 among women in high-resource countries .MM is closely linked to several health and socioeconomic conditions such as total fertility rate, HIV, and gross domestic product. It is important to keep this in mind when looking at the variation in reported MM numbers and indicators across countries. (Read More..)
With the shift from a state of emergency into a state of protracted crisis in Syria, the humanitarian response in Lebanon ought to take a strategic turn. Funding spontaneous and sporadic humanitarian initiatives, though a necessity at the beginning of the crisis, is no longer an option in 2015.
We call upon the international community to reconsider its approach towards the relief of the impact of this crisis in the region. Resources are scarce and ought to be directed strategically, after careful deliberations with national authorities. Priorities ought to be set at the government level instead of being driven by calls for funding emanating solely from UN agencies and NGOs.
The Ministry of Public Health (MoPH) is the primary national authority in the health sector in Lebanon and will, as such, assume its leadership role in coordinating health response efforts and guiding them in the direction which best fits the national strategy.
This strategy, henceforth the Health Response Strategy (HRS), serves two interdependent strategic objectives:
To respond to the essential health needs (primary, secondary and tertiary care) of the displaced Syrians and host community; and
To strengthen national institutions and capacities to enhance the resilience of the health system.
We plead the international community to reorganize its aid and efforts to serve this strategy.
Despite the ongoing insecurity climate and socio-political instability for decades, the Lebanese healthcare system has been able to sustain achievements among which, controlling and preventing outbreaks, ensuring universal accessibility to essential quality care, decreasing out of pocket expenditures and lowering of maternal and child mortality (achievement of MDGs 4 and 5). Five years into the Syrian crisis, the Lebanese health system is still showing considerable resilience, despite the unprecedented increase of demand and strain on the healthcare system. The continuous focus on non-emergency reforms in the health sector shows that progress in achieving strategic goals has been maintained against all odds. It is, hence, noteworthy to look at the main historical stages of the health system development following the 1975-1989 civil war. (Read more...)
The impact of the Syrian crisis on Lebanon has been profound particularly in the healthcare sector. The influx of Syrian refugees has strained the public hospitals and their ability to respond to the crisis, resulting in:
An increased demand for healthcare services;
An increase in unpaid health services to refugees;
A sharp rise in communicable diseases and emergence of new diseases in Lebanon;
Increased risks of epidemics such as water-borne diseases, measles, and tuberculosis 1.
Neither United Nations High Commissioner of Refugees (UNHCR) nor other Non-Governmental Organizations (NGO) was able to meet the required level of funding to provide refugees with an acceptable level of secondary and tertiary healthcare services. They, therefore, decided to change their model of response in terms of healthcare support to Syrian refugees. As of 2014, UNHCR started covering 75% instead 85% of the hospitalization cost, leaving the patient with the remaining share of 25% to be paid out of pocket or by a third party. The healthcare referrals covered by UNHCR are limited to deliveries and life-threatening emergencies 2.
Hospitals are overburdened with Syrian patients who are unable to pay their part of the bill (increased to 25% of their total hospital fees) as well as patients whose hospitalizations are not subsidized at all. Some hospitals have put in place strategies to recover as much of the 25% as possible (deposits, retaining IDs/corpses, inflating bills). Referral of uncovered Syrian patients with complicated morbidities to public hospitals has become a common practice by private hospitals.
Overwhelmed by the high demand of healthcare by Syrian refugees, public hospitals end up treating patients without any specific reimbursement scheme thus creating a huge financial burden. This burden adds up to the existing difficult financial situation of public hospitals, putting the whole healthcare sector under stress. Public hospitals are restrained from completing their mission and incapable of providing healthcare services neither to Syrians refugees nor to Lebanese citizens...
As human beings, we have many fears that generate anxiety and panic; some of these fears fade away with time, while others control our thoughts and actions throughout a lifetime. What is fascinating is the fact that some fears are passed on from generation to generation, leaving an entire population crippled with negative perceptions. Unfortunately, for several years, one of these hereditary horrors has been dominating over the health system in Lebanon, which transformed the privilege of being part of the elderly group into a dreaded and shameful misfortune...
Dr Ammar exemplifies the role that public health professionals need to play in furthering the development of health and health care in their country and the Region. His intense endeavor for the development of health services in general, and primary health care and health policy in particular and his efforts in translating research and evidence into policy, programs and practice place him as a pioneer not only within Lebanon but also across the region and beyond...
Competition in the Pharmaceutical Industries and among drug manufacturers is inevitable; therefore, Drug Promotion is an essential activity that is adapted for marketing and advertising in the midst of all present competing factors. Yet, are all persuasive activities performed by the manufacturers and distributors of medical drugs considered ethical? To what effect can these actions significantly alter the way medicines are prescribed, dispensed, and used? Is there any kind of protection that serves as a barrier against over-prescribing or poor quality prescribing of drugs arising from a conflict of interest? Endless questions may arise from the concerned parties including patients, physicians, pharmacists, drug manufacturing industries, and syndicates, but the multiple answers remain linked to a single concept “Ethics”....
These guidelines were developed by Dr. Ghada El-Hajj Fuleihan, with members of the Lebanese National Task Force for Osteoporosis and Metabolic Bone Disorders, and expert input from Drs. John Kanis, Michael McClung, Bill Leslie and Angela Cheung.
These guidelines are endorsed by the following Lebanese Scientific Societies and Associations: Lebanese Society of Endocrinology Diabetes and Lipids, Lebanese Society of Rheumatology, Lebanese Society of Obstetrics and Gynecology, Lebanese Association of Orthopedics, Lebanese Society of Radiology, Lebanese Society of Internal Medicine, Lebanese Society of Family Medicine, Lebanese Society of General Practitioners.
Report of the mapping exercise conducted by the National Mental Health Programme for the year 2014 using the WHO “4Ws” mapping tool, which is an essential component for locating, assessing, coordinating and planning MHPSS services.
The report compares the 2014 results to those of the previous and first mapping exercise of the 4Ws in Lebanon published in the December 2013 UNHCR commissioned report, "Assessment of Mental Health and Psychosocial Support Services for Syrian Refugees in Lebanon" to display the changes in service delivery.
The report concludes with a set of recommendations in relation to five main domains: training, service provision, research, coordination and the future “4Ws” mappings.
This document lists a selection of 13 Key Achievements of the Ministry of Public Health over the last decade*.
1. The Creation of a Unified Beneficiaries Database, Its Maintenance & Updating
In 2003, a unified Beneficiaries Database was created, including beneficiaries of the Ministry of Public Health (MOPH), National Social Security Fund (NSSF), Civil Servants Cooperative (CSC), Army, Internal Security Forces (ISF), General Security Forces (GSF) and State Security Forces (SSF). The unification of beneficiaries information implied that double-coverage or double-billing from more than one fund, was no longer possible for beneficiaries, and thus considerably improved the efficiency of the system. It also aimed at simplifying administrative procedures and reducing waiting time for getting the prior authorization of the MOPH for hospital admission. (Read More...)
The Ministry of Public Health, in collaboration with the World Health Organization (WHO), UNICEF, and International Medical Corps (IMC), launched on the 14th of May 2015 the Mental Health and Substance Use Prevention, Promotion, and Treatment Strategy for Lebanon 2015-2020.
With the vision that all people living in Lebanon will have the opportunity to enjoy the best possible mental health and wellbeing, the mission driving the Strategy is:
To ensure the development of a sustainable mental health system that guarantees the provision and universal accessibility of high quality mental health curative and preventive services through a cost-effective, evidence-based and multidisciplinary approach, with an emphasis on community involvement, continuum of care, human rights, and cultural relevance.
The strategy document was the result of a participatory process involving all actors in the field of mental health and substance use in Lebanon as well as international experts. The strategy underwent many stages of consultations to ensure that it addresses all national priorities identified by the main actors in the field.
To download the strategy, please click on the link below:
The prevalence of Non-communicable diseases (NCDs) are increasing in a secular trend worldwide including in low and middle-income countries that are experiencing epidemiological transition from communicable diseases towards NCDs.
The burden is majorly attributed to cardiovascular diseases (CVD), which arel transition from communicable diseases towards NCDs.
The burden is majorly attributed to cardiovascular diseases (CVD), which are the leading cause of mortality around the globe (WHO, 2011a). In Lebanon NCDs account for 84% of all deaths, of which 22-25% is premature occurring before the age of 60. It is estimated that 63% of all deaths and 45% of NCD mortality, are ascribed to CVD (WHO, 2011b), with age standardized mortality rate from CVD and diabetes reaching 404.4 per 100,000 in men and 262.7 per 100,000 in women (WHO, 2011a).
A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. The risk of therapeutic inequivalence of two immediate release products can never be reduced to zero, even if a full clinical study is performed.
The conclusion of comparative clinical studies, in vivo bioequivalence studies, in vitro equivalence tests and biowaivers is based on statistics and scientific data that are assumed to be representative for the products at issue. The aim of biowaiver guidance is to reduce the risk of bioinequivalence to an acceptable level. Pharmaceutical development work aims at reducing the probability of manufacturing inequivalent formulations taking into account the critical aspects of the product at issue. In this context, the absorption phase is regarded as the critical process determining the equivalence of the pharmacokinetic profiles and thereby the therapeutic equivalence of the test and reference product.
In this report we will focus on BCS-based Biowaivers. However, other type of biowaivers had been discussed in regulation.
In order to maintain product quality, safety and efficacy during distribution, Good Distribution and Storage Practices specify that temperature-sensitive products are to be stored, handled and distributedcarefully throughout the distribution network.
Environmental controls play a key role in maintaining drug safety, quality and efficacy. Temperature is one ofthe most important parameters to control. Drugs must be stored, and transported according to predeterminedconditions as supported by stability data. Temperature excursions outside oftheir respective labeled storage conditions, for brief periods, may be acceptable provided stability data andscientific/technical justification exists demonstrating that product quality is not affected.
This annex is issued, to complete the Lebanese Good Storage and Distribution Practices of pharmaceutical products, by the Lebanese Ministry of Health, which stresses the importance of adhering to it by all parties involved in any aspect of the cold chain, as relevant to the particular role that they play, from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his agent.
Byblos Bank SAL Economic Research & Analysis department and based upon a study published by the Economist Intelligence Unit revealed that Lebanon had the 32nd best health care outcome globally in a study comparing health care outcomes and costs among 166 countries.
يعتبر الغذاء من أهم أسس استمرار الحياة، ولتأدية مهامه وفوائده على أكمل وجه ينبغي المحافظة على سلامته من الضرر والفساد وعدم تعريضه لمصادر التلوث انطلاقا من أماكن إنتاجه مرورا بمراحل تصنيعه وتجهيزه وصولا إلى تقديمه للمستهلك . من هنا تبرز أهمية الحفاظ على سلامة الغذاء والإلتزام بالأنظمة والتعليمات الصحية لحمايته من التلوث.
Distribution is an important activity in the integrated supply chain management of pharmaceutical products that involves various members responsible for the handling, storage and distribution of such products.
The objective of these guidelines is to ensure the quality and identity of pharmaceutical products during the whole distribution process. Furthermore, it sets out appropriate steps to assist in fulfilling the responsibilities involved in the different aspects of the distribution process within the supplychain and to avoid the introduction of counterfeits products into the marketplacevia the distribution chain.
These guidelines are issued, according to the guidelines and instructions of the World Health Warehouse, by the Lebanese Ministry of Health, which stresses the importance of adhering to itby all parties involved in any aspect of the distribution of pharmaceutical products, as relevant to the particular role that they play, from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his agent.
يهدف هذا الدليل إلى تجديد المستندات اللازمة والشروط المفروضة والمراحل التي تمر بها المعاملات الإدارية في مصلحة الصيدلة في وزارة الصحّة بغية تسهيل مهمة أصحاب العلاقة والموظفين على حدٍ سواء وهو يأتي تطبيقاً لقرار معالي وزير الصحّة رقم 1/1635 تاريخ 9 تشرين الأول 2013 والمتعلّق باعتماد دليل إجراءات المعاملات الإدارية في مصلحة الصيدلة والدوائر التابعة لها.يتضمن هذا الدليل جميع المعلومات حول الخدمات التي تقدّمها مصلحة الصيدلة بالإضافة الى نماذج الإستمارات والقوانين والأنظمة التي ترعى هذه المعاملات.
يھدف ھذا الدليل الى تحديد مھام دائرة التفتيش الصيدلي فيما يتعلّق بمراقبة الصيدليات ومستودعات الادوية ومعامل انتاج الادوية وصيدليات المستشفيات الخاصة الخ... والشروط المفروضة والمراحل والإجراءات التي تمر بھا المعاملات الادارية في دائرة التفتيش الصيدلي بغية تسھيل مھمة اصحاب العلاقة والموظفين على حد سواء وھو يأتي تطبيقا لقرار معالي وزير الصحة العامة الاستاذ علي حسن خليل رقم ١٦٣٥/1 بتاريخ ١٩ تشرين الاول ٢٠١٣ والمتعلق باعتماد دليل إجراءت المعاملات الادارية في دائرة التفتيش الصيدلي.
يهدف هذا الدليل الى تحديد المستندات اللازمة والشروط المفروضة والمراحل التي تمر بها المعاملات الادارية في دائرة المخدرات بغية تسهيل مهمة اصحاب العلاقة والموظفين على حد سواء وهو يأتي تطبيقا لقرار معالي وزير الصحة العامة الاستاذ علي حسن خليل رقم١/١٦٣٥ بتاريخ ۹تشرين الاول ٢٠١٣ والمتعلق باعتماد دليل إجراءت المعاملات الادارية في دائرة المخدرات. يتضمن هذا الدليل جميع المعلومات حول الطلبات الخاصة بالمواد الخاضعة للرقابة من قبل دائرة المخدرات والمدرجة على الجداول الملحقة بقانون المخدرات رقم ٦٧٣/۹۸ تاريخ١٦/٣/٠١۹۹۸
إن طبيعة الدواء الخاصة تفرض على الحكومات وعلى المعنيين بصناعته وتسويقه عدم التعامل معه كسائر السلع التجارية. لذلك فقد وضعت القوانين التي ترعى جميع مراحل الدواء من التصنيع الى التسويق والإستيراد والتصدير والحفظ والتوزيع والتسعير والبيع . ان هذا الدليل يأتي تنفيذاً للقرار (رقم 868/1 تاريخ 2 أيار 2014) ويهدف الى تفصيل وشرح عمليّة تحديد سعر الدواء في لبنان وذلك وفق القوانين والأنظمة والقرارات المرعيّة الإجراء .
يهدف هذا الدليل إلى تجديد المستندات اللازمة والشروط المفروضة والمراحل التي تمر بها المعاملات الإدارية في مصلحة الصيدلة في وزارة الصحّة بغية تسهيل مهمة أصحاب العلاقة والموظفين على حدٍ سواء وهو يأتي تطبيقاً لقرار معالي وزير الصحّة رقم 1/1635 تاريخ 9 تشرين الأول 2013 والمتعلّق باعتماد دليل إجراءات المعاملات الإدارية في مصلحة الصيدلة والدوائر التابعة لها. يتضمن هذا الدليل جميع المعلومات حول الخدمات التي تقدّمها مصلحة الصيدلة بالإضافة الى نماذج الإستمارات والقوانين والأنظمة التي ترعى هذه المعاملات.
Lebanon Achieves the MDG 5 Target of Reducing Maternal Mortality by Three Quarters between 1990 & 2015 in their Maternal Death Rate:
EMBARGOED FOR RELEASE UNTIL MAY 2, 4 A.M. PACIFIC/7 A.M. EASTERN (US TIME) Sharp decline in maternal and child deaths globally, new data show Child deaths cut nearly in half since 1990, maternal deaths by almost a quarter. Pace accelerated after Millennium Development Goals were set, yet few countries on track to meet ambitious targets SEATTLE — Since the start of an international effort to address maternal and child mortality, millions of lives have been saved globally, a new study by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington shows.(more)
يهدف هذا الدليل إلى توضيح المستندات اللازمة وآليات تسجيل الدواء في مختلف مراحلها بغية تسهيل مهمة اصحاب العلاقة وترشيد علاقتهم مع الوحدات المعنية في الوزارة وإزالة اي سوء تفاهم مع الموظفين. تستند الإجراءات المتّبعة إلى المرسوم التطبيقي رقم 571 الذي يحدّد شروط تطبيق أحكام القانون رقم 530 الصادر بتاريخ 16/7/2003 (شروط تسجيل وإستيراد وتسويق وتصنيف الأدوية) وأحكام القانون رقم 367 تاريخ 1/8/1994 (مزاولة مهنة الصيدلة) وتعديلاته، لا سيّما المواد 52، 53، 54 و60 منه. يقسم هذا الدليل إلى خمسة أجزاء هي: تسجيل مستحضر صيدلاني جديد، التعديلات الحاصلة في بيانات التسجيل للمستحضرات الصيدلانية المسجلة، تصنيف مستحضرات، العلم والخبر، وآليات إعتراض على قرار اللجنة الفنية للأدوية او على قرار لجنة التسعير.
يهدف هذا الدليل إلى تجديد المستندات اللازمة والشروط المفروضة والمراحل التي تمر بها المعاملات الإدارية في دائرة إستيراد وتصدير الأدوية بغية تسهيل مهمة أصحاب العلاقة والموظفين على حدٍ سواء وهو يأتي تطبيقاً لقرار معالي وزير الصحّة الأستاذ علي حسن خليل رقم 1/1635 تاريخ 9 تشرين الأول 2013 والمتعلّق باعتماد دليل إجراءات المعاملات الإدارية في مصلحة الصيدلة والدوائر التابعة لها.
The study was conducted in response to the growing need for country-level trends in chronic disease risk factors. Findings are addressed to a highly diversified audience, including researchers, policy makers, and program planners.
Using adapted standardized questions and protocols, the study followed the WHO STEPwise approach to surveillance of non-communicable disease risk factors...
The Ministry of Public Health (MOPH) Contingency Plan (CP) is a tool that describes the level of preparedness and the arrangements made in terms of Health Response in anticipation of a crisis to ensure appropriate health and humanitarian assistance and protection.
لقد صدرت الطبعة الثالثة من دليل المواطن بعد جهود ومثابرة فريق عمل الوزارة بالتعاون والتنسيق مع جميع رؤساء الوحدات الإدارية.
لقد تلازم تحضير هذا الكتيّب مع مشروع توحيد ومكننة جميع نماذج الإستمارات العائدة للمعاملات الإدارية في الوزارة وتم نشر هذه الإستمارات على موقع الوزارة الإلكتروني لتسهيل الحصول عليها من قبل المواطن.
إن الهدف من هذا الدليل هو أولاً وأخيراً تقديم خدمة أفضل للمواطن من خلال رفع مستوى المعرفة لديه وتمكينه من معرفة المتطلبات الواجب توفرها تلبيةً لحاجة لديه حفاظاً على جهده ووقته.
إن هذه الخطوات تصب كلها في في زيادة فعالية القطاع العام من خلال تحديث أساليب العمل من جهة ومن جهة أخرى في محاربة الفساد عن طريق توعية المواطن وزيادة الشفافية في العمل.
This special box on Lebanon has been copied verbatim from the recently released (November 22nd) “World Health report 2010 on Health Care Financing”
Box 4.2. Lebanon’s reforms: improving health system efficiency, increasing coverage and lowering out-of-pocket spending
In 1998 Lebanon spent 12.4% of its GDP on health, more than any other country in the Eastern Mediterranean Region. Out-of-pocket payments, at 60% of total health spending, were also among the highest in the region, constituting a significant obstacle to low-income people. Since then, a series of reforms has been implemented by the Ministry of Health to improve equity and efficiency.
The key components of this reform have been: a revamping of the public-sector primary-care network; improving quality in public hospitals; and improving the rational use of medical technologies and medicines. The latter has included increasing the use of quality-assured generic medicines. The Ministry of Health has also sought to strengthen its leadership and governance functions through a national regulatory authority for health and biomedical technology, an accreditation system for all hospitals, and contracting with private hospitals for specific inpatient services at specified prices. It now has a database that it uses to monitor service provision in public and private health facilities.
Improved quality of services in the public sector, at both the primary and tertiary levels, has resulted in increased utilization, particularly among the poor. Being a more significant provider of services, the Ministry of Health is now better able to negotiate rates for the services it buys from private hospitals and can use the database to track the unit costs of various hospital services.
Utilization of preventive, promotive and curative services, particularly among the poor, has improved since 1998, as have health outcomes. Reduced spending on medicines, combined with other efficiency gains, means that health spending as a share of GDP has fallen from 12.4% to 8.4%. Out-of-pocket spending as a share of total health spending fell from 60% to 44%, increasing the levels of financial risk protection.
Non-Communicable Diseases and Behavioral Risk Factor Survey
Comparison of Estimates Based on Cell Phone Interviews with Face to Face Interviews
Developing countries have been experiencing a shift in disease type and prevalence,generally referred to as the epidemiologic transition. Infectious diseases, once dominant inlow-income countries, are now being replaced by non-communicable diseases (NCDs)which include cardiovascular disease (CVD), hypertension, dyslipidemia, diabetes,overweight and obesity, osteoporosis, and some types of cancer. NCDs account for almost 70% of the global burden of disease and 60% of global mortality (Strong et al., 2005).
Overall, NCDs are the largest cause of mortality in people of working age, thus affecting anation’s economic development through loss of income and investments. NCDs also addeconomic strain on a country due to the high-cost of treatments...
A reliable Health Information System is a crucial aspect of a surviving healthcare system in view of the fact that good quality health information is essential to move towards evidence-based and timely policy formulation. Due to the fact that the majority of health information exists in the Ministry Of Public Health, ...
Despite political crises, economic austerity and military conflicts, the health sector in Lebanon did not loose ground. Studies reveal that over the last decade, the health status of the population has been improving along with lessening inequities in terms of both accessibility and health outcomes. Evidence shows also that during the same period, the GDP share of health expenditures decreased significantly, mostly as a result of a meaningful reduction in households’ out-of-pocket spendings.
How can progress be made in times of widening political and confessional discord, economic recession and devastating wars? This book pays tribute to those guided by science, professional ethics and human values, who despite the insecurity and hard working conditions, persevered in contributing to alleviate pain, reduce morbidity and mortality, improve quality of life and promote social progress.
Health beyond politics is not just a book on health, it is most of all about resilience. It holds one’s responsibility in taking part in building a modern healthy society.
The “Citizen’s Charter” program sets a framework for the relationships between the citizen and the public administrations and serves as a prelude to other specialized charters covering the different public administration sectors, namely those related to health, education, environment, public funds, public safety and heritage.
The underlying reasons behind issuing the charters include improving the citizen’s relationship with the public administration, promoting democracy in the public sector, achieving transparency, protecting the citizen from the arbitrary use of authority, and enforcing the accountability system.
While focusing on the rights and obligations of citizens, these charters serve not only as informative tools but also contribute to setting up detailed principles with specific application machineries
The quality of hospital care in Lebanon has witnessed a paradigm shift since May 2000, from a traditional focus on physical structure and equipment to a broader multidimensional approach, emphasizing managerial processes, performance and output indicators. In the absence of an effective consumer voice, the impetus for change has come from the Ministry of Public Health, which has supported the development of an accreditation programme for hospitals. This paper describes and analyses the experience of Lebanon in introducing this programme. It looks at the application of normative measures on private institutions that have been used to operating in a loosely controlled environment with little accountability.
تلعب وزارة الصحة العامة دوراً هاماً في مجال التمويل الصحي بغية ضمان إيصال الخدمات الى الجميع خاصة الفقراء والفئات المستضعفة وذلك تحقيقاً للعدالة الصحية. إلا أن الدور الأهم للوزارة يبقى في تنظيم القطاع الصحي. ولقد بذلك هذه الوزارة جهوداً كبيرة لتعزيز قدراتها التنظيمية، إلاّ أن ذلك وإن نجح نسبياً يبقى دون المستوى المطلوب لإرتباطه الوثيق بالوضع الإداري العام. إن الضمانة الأساسية لإستقامة الأمور إن في أجهزة الدولة أو في مؤسسات القطاع الخاص هي المواطن الواعي الذي يدرك واجباته وحقوقه، فيقوم بما هو مطلوب منه ليستكمل معاملته وفقاً للقانون، ومن ثم يطالب بحقه كاملاً دون منه من أحد. هنا تبرز أهمية هذا الدليل الذي يوضع للمواطن من ناحية ما يتوجب عليه إتمامه للتقدم بطلبه، ومن ناحية أخرى ما سيؤول إليه هذا الطلب وضمن أية مهلة.
EVALUATION OF THE IMPACT OF HIV PREVENTION INTERVENTIONS ON KNOWLEDGE, ATTITUDES, BELIEVES AND PRACTICE OF THE LEBANESE POPULATION CONCERNING AIDS
Joseph G. Kahhaleh, MD, MPH, Abdo R. Jurjus, PhD, Mustapha El Nakib MD, MPHSponsored by National Aids Program-Lebanon, in Collaboration with the World Health Organization-EMRO
This cross sectional study, performed between January 2004 and July 2004, was conducted on a national representative sample of 3200 of the Lebanese population age (15 – 49). Data showed that about 2/3 (n=2138) of the population reported as sexually active. 52% (n=1665) had ever married. Of the sexually active respondents (including the married population) 13.0% (n=278) reported having regular partners other than spouse and only 25.0% (n=259) of those who had regular partners used condoms in their last sexual intercourse. However, 16.8% (n=360) of the sexually active had sex with non-regular partners, 26.4% (n=95) of these partners were met for the first time and, 71.7% (n=258 out of 360) of them have used a condom in their casual sexual encounter.
The HIV/AIDS disease has influenced the lifestyles of only 24.1% (n=758 out of 3142) of the sample population. The perception of risk of catching HIV was low in this study: 13.7% as compared to 19.3% in 1996.
Most 59.6% (n=1872) of the population expressed positive attitudes towards the HIV/AIDS persons and were willing to take care of a family member with HIV/AIDS, 69.2% (n=2173) agreed that HIV/AIDS people to be allowed to continue their work, 74.1% (n=2329) wanted the proper medical treatment for the HIV/AIDS patients. On the other hand, 29.1% (n=914), compared to 13.6% in 1996 study, agreed to keep HIV positivity as a secret.
The knowledge of the population about preventive practices against HIV/AIDS has regressed since 1996 but its actual rate is still good compared to very good in 1996 study. In addition, the overall rates of misconceptions increased. Condoms were then more available in the country and more accessible. However, the rate of condom use is still the same and relatively low. The indicator on non-regular sexual partners was 16.9% in 1996 compared to 22.4% now coupled with more than 30% lack of condom use. The percentage of persons self-reporting symptoms suggestive of STD amounted to 9.1% (n=121), i.e. higher than 5% in 1996, this result needs to be confirmed by an STD prevalence study.
Finally, the perception of risk, attitudes and behaviors of people towards HIV/AIDS patients regressed from 1996; more work is needed to introduce positive changes in the lifestyle and adoption of safer sexual behavior.
Health spending in Lebanon is growing rapidly and faster than GDP. The current financing and delivery arrangements, extensively described in this book, are responsible for the resulting poor value for money. Reform is needed to adapt the health system with financial constraints and changing demographic and epidemiological profiles, and to produce the desired health outcomes. Lebanon's experience in introducing reform measures within a pluralistic health system, is interesting for many EMR countries, which consider enhancing the private sector role in health care provision and financing. This book provides evidence that, in the absence of proper regulation, the public financing of private services feed the escalation of health expenditures, while private insurance takes full advantage of the weak regulation capability of the public administration. It provides an analysis of the health care market and assesses the impact of the supply and different payment mechanisms on the demand and the cost of medical services.
This book does not only target experts and health professionals but is also a useful reference for students in medical and public health schools. It exposes them to different approaches for evaluating a health system, comparing utilization rates and incurred expenses between financing agencies, and calculating national health accounts. Finally, it introduces different reform components, proposes their gradual integration and gives the global picture of change for the future.
The National Cancer Registry (NCR) is an in information system designed for the collection, storage, management, and analysis of data on cancers throughout Lebanon. The major purposes of the Registry are:
To establish and maintain a cancer incidence reporting system;
To be an informational resource for the investigation of cancer and its causes... .