Identification of Priority Policy Research Questions in the area of Access to and Use of

Medicines in EMRO Countries: Focusing on Iran, Pakistan and Lebanon

Country level work in Lebanon

Final report

Version: 20 July 2011

Submitted by:

Samer Jabbour, MD, MPH

Senior Lecturer

Department of Health Management and Policy

Faculty of Health Sciences

American University of Beirut

and

Rouham Yamout, MD, MPH

Research Associate

Faculty of Health Sciences

American University of Beirut

To:

Dr. Maryam Bigdeli

World Health Organization

Alliance for Health Policy and Systems Research

Geneva, Switzerland

Project Duration:

March 2011– June 2011

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CONTENTS ACRONYMS USED IN THIS REPORT

THE RESEARCH TEAM IN LEBANON

1. ABSTRACT

2. EXECUTIVE SUMMARY

3. BACKGROUND, RATIONALE AND OBJECTIVES

4. METHODS

5. RESULTS – LITERATURE REVIEW

6. RESULTS – KEY INFORMANT INTERVIEWS

7. RESULTS – PRIORITY POLICY RESEARCH QUESTIONS

8. DISCUSSION AND LIMITATIONS

9. ACKNOWLEDGEMENTS

10. REFERENCES AND ADDITIONAL BIBLIOGRAPHY

11. APPENDICES

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ACRONYMS USED IN THIS REPORT AKU: Aga Khan University ATM: Access to and use of medicines AUB: American University of Beirut AUB/FHS: American University of Beirut/Faculty of Health Sciences AUB/FHS/HMPD: American University of Beirut/Faculty of Health Sciences/Department of Health Management and Policy AUB/FM: American University of Beirut/Faculty of Medicine AUBMC: American University of Beirut Medical Center CSO: Civil society organizations EMR: Eastern Mediterranean Region GoL: Government of Lebanon KII(s): Key Informant Interview(s) MENA: Middle East and North Africa MoPH: Ministry of Public Health in Lebanon TUMS: Tehran University of Medical Sciences WHO: World Health Organization WHO/EMRO: World Health Organization/Regional Office for the Eastern Mediterranean WHO/AHPSR: World Health Organization/Alliance for Health Policy & Systems Research YMCA Young Men’s Christian Association

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THE RESEARCH TEAM IN LEBANON The PI for Lebanon has brought together a research team that brings important skills and resources to the ATM research project. The team has comprised the following individuals, all of whom based at AUB: Principal investigator

− Samer Jabbour, MD, MPH: Senior lecturer, AUB/FHS/HMPD. Co-investigators

− Fadi EL-Jardali, MPH, PhD: Associate Professor, AUB/FHS/HMPD (co-investigator). Fadi is a well-known health systems researcher. He has carried out important research in the EMR in collaboration with WHO/AHPSR. Specifically he was the PI for the study ‘Identification of Priority Research Questions Related to Health Financing, Human Resources for Health, and the Role of the Non-State Sector in Low and Middle Income Countries of the Middle East and North Africa Region.’ Fadi therefore brings a rich experience in research prioritization.

− Ghassan Hamadeh, MD: Professor and Chair, Department of Family Medicine, AUB/FM & AUBMC (co-investigator). Ghassan is a prominent research and advisor to health policymakers in Lebanon. For many years, Ghassan has served in multiple capacities in Lebanon in the area of ATM including in developing a list of essential medicines for the MoPH and in advising the MoPH including the current minister of health on various issues related to medicines.

− Rouham Yamout, MD, MPH: Research Associate, AUB/FHS. Rouham bring a 20-plus year experience in practicing medicine in various communities in Lebanon. Additionally, she is a researcher in public health with skills in both qualitative and quantitative research. Research assistants and students

− Reem El Soussi, MPH & Rawane Chaaban, MPH: Research Assistants, AUB.

− Nadia Irfan, Najla Khatib, Loubna Sinno: Graduate students/MPH candidates in AUB/FHS/HMPD): These students have participated in the ATM research project and carried out a separate sub-study on comparing the views of two sets of practitioners, towards fulfilling the requirements for a research project as part of their MPH degree curriculum.

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1. ABSTRACT This report describes the conduct and summarizes the results of a study carried out in Lebanon, aimed at identifying policy-relevant priority research questions in the area of access to and use of medicines. This study is part of a global study conducted in 19 countries with the support of the World Health Organization’s Alliance for Health Policy and Systems Research. The Lebanon study is itself a part of a regional study carried out, besides Lebanon, in Iran and Pakistan. Access to medicines is an important concern in Lebanon as evidenced by high expenditures on medicines as part of total health expenditures in Lebanon. There are important equity concerns in access to medicines considering that most expenditure on medicines is out-of-pocket. While branded medicines are widely available in Lebanon, accessibility is limited by high prices. Financing for medicines is fragmented. Over half of the population has no insurance coverage for medicines. Existing social insurance schemes are cumbersome and discourage access. Private insurance coverage for medicines is very low. This study has three components. The first focuses on literature review. A comprehensive search strategy is pursued to identify journal articles and relevant “gray” literature. The second focuses on interviews with key informants whose work directly concern access to medicine. Priority policy concerns and corresponding research questions are identified from literature review and key informant interviews. The third focuses on validation and prioritization among policy research questions that emerged from the first two components. Literature review shows that the research evidence base on access to medicines is rather weak. Prior studies have addressed issues such as prescribing behaviors and interventions to improve them, patterns of consumer use and consequences of irrational use such as antimicrobial resistance and drug-related hospitalization, and pharmacy manpower. Many valuable “gray literature” documents are identified covering a broad range of issues including good governance for medicines, medicines prices, and analyses of the medicines market. Interviews with key informants identified a large number of policy concerns; a correspondingly large number of policy research questions have emerged. These cover all aspects of ATM including financing, rational prescribing and use, affordable pricing and health and supply systems. A list of 57 research questions was submitted to a meeting of key informants and others. Participants first classified questions according to importance. A list of the 22 questions considered important or possibly important by at least two thirds of participants was generated. Participants ranked these questions according to five criteria (relevance, urgency, feasibility, applicability and ethical acceptability). The top five questions that emerged include: 1) Assessment of quality of medicines on the market and role of counterfeit medicines and black market; 2) A study of attitudes of physicians and of the public towards generic substitution and the opportunities for implementing relevant policies; 3) Evaluation of the role of civil society organizations and non-governmental organizations in improving access to medicines especially for the poor, vulnerable groups and hard-to-reach populations; 4) Is access to medicines a priority for policymakers, for professional

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associations, and for consumer advocates?; and 5) What happens at the dispensary? Dispensing medicines or delivering primary health care? Adherence to generics in PHC and dispensaries.

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2. EXECUTIVE SUMMARY

2.1. The context and objectives

Lebanon is an upper middle income country with a population of 4.22 million and a GNI per capita of around $8060. While average health indicators are favorable, there are inequalities in development indicators among different sub-regions. The political system is a confessional democracy. The state has been weakened by civil war but civil society tradition and non-state action are strong. The economic system, which relies mostly on services, is liberal, based on free market, including for medicines. Lebanon’s economy relies mostly on the service sector. The official unemployment rate is about 9% but is suspected to be much higher. Health expenditures account for about 8.9% of GDP, and is primarily private, with secondary and tertiary care consuming the major component (80%). The public sector is weak, has limited facilities and is not highly trusted by the population. The primary health care system relies primarily on the private and non-profit, non-governmental sector although the public network is expanding. There are six public or semi-public health coverage schemes in Lebanon, with varied coverage and reimbursement policies. The MoPH covers the cost of ambulatory and hospital-based treatments that are not covered by private insurance plans or that are particularly onerous such as cancer or HIV treatments but does not cover medicines purchased to treat acute conditions in outpatient settings. Medical doctors and pharmacists are required to obtain a License of Practice but are exempted from re-licensing or continuing education (Lebanon EMRO, 2006) and bodies to audit, control and monitor medical practice are inefficacious. Lebanon has an over-supply of physicians and pharmacists (WHO, 2006). Access to medicines is an important concern as evidenced by high expenditures on medicines as part of total health expenditures. There are important equity concerns in access considering that most expenditures on medicines is out-of-pocket. While branded medicines are widely available, accessibility is limited by high prices. Financing for medicines is fragmented. Over half of the population has no insurance coverage for medicines. Existing social insurance schemes are cumbersome and discourage access. Private insurance coverage for medicines is very low. There is insufficient knowledge about many of the complex issues related to access to medicines. Because the research agenda for understanding access to medicine is potentially large, we need to prioritize the most important research questions. This study aims to develop a list of the most important policy-relevant research questions. 2.2. Methods

This study has three components. The first component focuses on literature review. We employed a multi-pronged and comprehensive search strategy has been developed to identify published journal articles and published as well as unpublished (gray literature) documents. Documents were considered of interest to this research if they focused on issues of ATM, discussed ATM in one or more part of the document, or discussed issues of direct relevance to ATM. The research team developed an expanded MeSH terms/keyword list to capture more domains of the ATM framework (according to WHO 2004) and conducted a systematic review using the following electronic databases: PUBMED/MEDLINE, EMBASE, SCIRUS, IMEMR (WHO EMRO’s Index Medicus for the Eastern Mediterranean Region), the Lebanese Corner at the Saab Medical Library of the American University of Beirut and the 13 first pages of Google

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Scholar. We reviewed the abstracts of 104 articles from peer reviewed journals and ended up with a list of 44 journal articles relevant to access to medicines in Lebanon. In addition we searched websites (e.g. MoPH, WHO-EMRO), databases (WHO Medicines Bookshelf version 6 [2010], and national resources (e.g. the National Health Information Library of the WHO country office in Lebanon). In addition, we asked key informants to supply us with any documents of potential interest, and gathered a large number of documents covering a broad range of topics. Two researchers independently reviewed abstracts of relevant journal articles and documents to identify ATM policy concerns and research questions. The second component focuses on interviews with key informants whose work directly concern access to medicine. The research team conducted in-depth interviews with 29 key informants from diverse professional backgrounds, fields of work, and perspectives. The interviews were based loosely on a modified ‘Semi-structured interview guide’ developed by the research team at TUMS, while giving the informants the needed space to move about the ATM sphere freely and gave the researchers the needed structure to explore ATM issues from various angles. The researchers used the WHO-2004 ATM framework to explore ATM policy concerns and corresponding research questions. Interviews were recorded, transcribed and analyzed thematically to identify relevant policy concerns and research questions. Informed consent was obtained and privacy and confidentiality were insured. In the third component, priority policy concerns and corresponding research questions are identified from literature review and key informant interviews. Research questions were consolidated into a list of 57 questions which were submitted to a validation-prioritization meeting of informants and other participants. The participants initially validated the questions according to a dichotomous assessment (important or possibly important vs. not important). The first 22 questions that were perceived to be important or possibly important by at least two thirds of participants were retained. The participants then ranked the 22 questions according to five criteria (urgency, relevance, feasibility, applicability, and ethical acceptability). 2.3. Findings and discussion

Literature review shows that the research evidence base on access to medicines is rather weak. Prior studies have addressed issues such as prescribing behaviors, patterns of consumer use and consequences of irrational use such as drug-related hospitalization and antimicrobial resistance, and pharmacy manpower. Many valuable “gray literature” documents are identified covering a broad range of issues including good governance for medicines, medicines prices, and analyses of the medicines market. Major issues raised in these documents include high expenditures on medicines (25%) as part of total health expenditures with out-of-pocket spending accounting for 67.8% of such expenditures, importation from high-income countries and high prices of medicines, and low rates of generic prescribing coupled with aggressive marketing of branded medicines by pharmaceutical companies, lack of modern medicine regulatory authority structure, and vulnerability to corruption in the medicines sector. Literature review identified many research gaps that need to be addressed. For example, prior studies have addressed one or more aspect of the ATM but no studies have examined ATM in a comprehensive manner or situation issues within a broader framework of ATM; studies of

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interventions that evaluate policy options or more technical matters are lacking; and many studies did not link the specific questions at hand with the policy and regulatory environment, structural barriers, and the political economy of ATM, which key informants later identified as crucial for approaching, and thus for improving, ATM. Interviews with key informants also identified a large number of policy concerns some of which can be considered as ‘general’ concerns, such as limited thinking of the medicines problem in terms of access and equity and the role of the state vs. non-state actors, while others can be considered as ‘thematic’ concerns based on the WHO 2004 ATM framework. Perhaps the most consistent finding from KIIs is that informants find it difficult to identify and articulate research questions in relation to the numerous policy concerns that they voice. This indicates the need for the researcher to play a greater role in elucidating research questions based on voiced policy concerns. However, such a role comes with its own challenges in terms of the biases that a researcher can introduce in formulating research questions. The list of 22 questions that has emerged from the validation phase of the validation-prioritization meeting represents a diversity of topics. However, most questions concern descriptive rather than intervention studies. Among the three groups of policy/decision makers, professionals/practitioners and consumers/patients, the middle group has received the most attention in the list of research questions. Only a few questions concern the identification of actual limitations to access with pricing and equity dimensions receiving limited attention. Participants have prioritized the determinants aspects of ATM over the interpersonal, cultural, and knowledge aspects. However, the interest in the determinants of the medicines situation was mostly in proximal determinants rather than in structural determinants such as the political economy or the regulatory framework of ATM. 2.4. Lessons learned

The research team has learned many lessons in the process of conducting this study. In relation to the literature review, we used an expanded search strategy to identify journal articles. This strategy needs to be compared with strategies used by research teams from other countries and needs to be validated in future ATM studies. In relation to the identification of gray literature and published and unpublished documents, a useful strategy can perhaps be referred to as “multi-seeking” with some informants supplying the name of a document while the document itself can be secured from another source. In relation to the interviews with key informants, we found that a priori identification of a list of informants may not be sufficient and some flexibility is needed in adding additional names as suggested by informants. There is a need for substantial flexibility in conducting the interviews based on the semi-structured interview schedule. It was useful to provide key informants with the WHO 2004 document outlining the ATM framework and this did not adversely impact the responses of informants. In relation to the validation-prioritization meeting, we found the number of participants, at 12, to be optimal and allowed discussions on contentious issues. However, a three-hour meeting may not be adequate to conduct optimal prioritization of research questions when a large number of questions are put forth. There is a need for more time for participants to digest, reflect on, discuss and modify the research questions. Furthermore, there was a need for more time to allow for modification of the final list of research questions based on the prioritization exercise.

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3. BACKGROUND, RATIONALE AND OBJECTIVES

3.1. The social, political and economic context with focus on ATM-relevant aspects

Lebanon has a population of 4.22 million. Life expectancy at birth in Lebanon is 72 years and adult literacy rate is 90%. Lebanon has universal access to drinking water and quasi-universal access to sanitation. This means that Lebanon has a reasonably developed infra-structure and services. Nevertheless, there are well-recognized inequalities in development indicators among different sub-regions that reflect inequitable distribution of resources and services particularly in the North and South governorate. Such inequity impacts ATM. The political system is confessional with governance based on a consensual democracy allocating quotas to each of the 18 confessional communities. Such a system has inhibited the establishment of a reliable social contract and has encouraged corruption. The confessional system is at least partially blamed for several features that impact ATM, for example the lack of unification of the six social insurance schemes under one umbrella and securing better ATM for all. However, the absence of a national social strategy has favored the development of intra-communal social solidarity and a strong civil society tradition. The civil society plays an important role in health care service delivery including in ATM as will be discussed later. The economic system is liberal, relying on free market. The free market logic underlies, for example, the argument that any medicine can enter the market under the specific condition of being of lower price than existing medicines of the same composition and explains the presence of almost 6000 registered medicines on the market. Lebanon is a middle-income country with the GNI/capita of around $8060. Lebanon has limited industry and agriculture; and most of the economy (61%) relies on the service sector, especially tourism, on remittances from immigrant workers, and merchandise trade. The official unemployment rate is about 9% among adults but much higher rates of undeclared or hidden unemployment are suspected. This presents a challenge to ATM in the absence of insurance coverage schemes.

3.2. The health system with focus on ATM-relevant aspects

ATM is intimately linked with the health system, particularly the health care system, and its policies. ATM reflects the strengths and weaknesses of health system governance, prioritization of equity in policymaking, and the role of primary health care in the health system. ATM is closely linked with professional practice. The health care system in Lebanon is considered an important component of the economy. Previously documented to consume about 12% of GDP, the health sector is now said to consume about 8.9% of GDP (World Health Report 2010). The health care system is pluralistic and fragmented with multiple financing agents (Mohamad Ali Osseiran et al., 2005; De and Shehata, 2001). Numerous funding schemes exist in Lebanon, with varied coverage and reimbursement policies and different contracts with the private providers. There are six public/semi-public funds: the National Social Security Fund (the NSSF) covers the employees in the private sector and mostly purchases services from the private sector. The Civil Servants Cooperative (CSC)

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covers the employees in the public sector. (Deeb et al., 2005; De and Shehata, 2001). Those two funds have a common policy of reimbursing enrollees for medicines purchased in the outpatient setting, paying 70 % of the price paid by enrollees. Three Security Forces coverage schemes (Internal Security Forces [ISF], General Security Forces [GSF], and State Security Forces [SSF]), that cover the full expense of health care for those eligible and their dependents, including prescribed drugs, at full price, sometimes directly at the point of purchase. During the last two decades, Lebanon has witnessed the explosion of mutual funds, numbering 71 (Sfeir 2007). These are autonomous non-profit organizations where membership is voluntary and is based on the principle of mutual aid (the healthy finances the healthcare of the sick) (De and Shehata, 2001). However those funds generally do not cover medicines prescribed in outpatient settings. Last the Ministry of Public Health covers hospital inpatient expenditures of 45% of the population that are uninsured mostly relying on buying services from the private sector; it subsidizes 85% of the cost of hospitalization in private hospitals and provides inpatient services at heavily discounted prices in public hospitals. The MoPH also provide quasi-free chronic medication through a program operated by the YMCA (Hamra, et al., 2009). The ministry also covers the cost of some treatments that are not covered by private insurance plans or that are particularly onerous such as chemotherapy, renal dialysis, transplants and open-heart surgery (Deeb et al., 2005). In addition, MoPH covers ambulatory treatments of disabling conditions such as HIV/AIDS, schizophrenia, multiple sclerosis and others (Hamra et al 2009) but do not cover drugs purchased to treat acute conditions in outpatient setting. Despite the efforts for strengthening the public sector while equipping it, it still lacks favorable public appraisal and the trust of the population. In terms of the public-private mix, the private sector dominates the health sector. The private health sector has undergone remarkable growth since the eruption of civil war in 1975 due to the retreat of the role of the state and has continued its growth despite the formal end of the civil war in 1990. The public health service delivery sector is weak. A limited number of public hospitals are in operation. The MoPH and MOSA own and operate a number of low-cost primary health care facilities. The MoPH certifies centers in its PHC network, which include in addition to MoPH-owned centers, PHC centers operated by MOSA, the Lebanese Red Cross, secular and faith-based NGOs, to ensure the delivery of a basic package of services. The PHC system remains weak although the network of PHC centers, both public and private, seems to be expanding. Specialist care remains a major component of outpatient service delivery. Provision of outpatient/primary care is primarily in the private sector. However, the non-governmental sector plays a key role through faith-based, communal and sectarian NGOs. These NGOs work on the principle of non-profit and provide highly discounted services but seldom provide services for free. They rely on donations and technical assistance from international organizations and governments of other countries. As for secondary and tertiary care, over 80% of services are in the private sector, which owns 90% of hospital beds (Deeb et al., 2005; De and Shehata, 2001). The private sector offers high quality specialist care and high-tech diagnostic and treatment services. Medical doctors, other healthcare providers, and pharmacists cannot practice without a License of Practice from the MoPH. But this license does not preview regulations for re-licensing or

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requirements for formal continuing education program (Lebanon EMRO, 2006). Moreover, Lebanon suffers from an over-supply in physicians and reaches the highest in the region physician density (3.25 per 1000 compared to a regional average of 1.14 per 1000) (WHO, 2006). The over-doctoring results in more competition between doctors and encourages the tendency of doctors to opt for aggressive treatments to guarantee the satisfaction of their patients; The over-prescription of antibiotics in one example of this trend. Two third of pharmacists work in pharmacies and 10.3% of them are prospectors in drug companies, and are often the only source of information for physicians cloistered in their private practice. The pharmacy practice is rather well regulated, but bodies to audit, control and monitor the work of the pharmacists are inefficacious in a context of favoritism and corruption. Moreover, pharmacists are often asked to consult the clients that wish to cutoff the expenses of a medical consultation. The practice of pharmacist performing medical consultations and prescribing drugs is common, especially in underprivileged areas. Drug importers are also submitted to strong regulations. However, those regulations become quickly formal, and the rules of free market, including manipulations and speculations, control more the turnover of drugs. The situation of medicines and of access to medicines is discussed in section 5.1. (Literature review in the Results section of this report) based on a review of journal articles and published and unpublished documents and gray literature 3.3. Rationale and objectives for the current study

Access the medicines is a key aspect of improving health for any population. However, in many middle income countries, such as Lebanon, there is insufficient information about many of the complex issues related to access to medicines. Because the research agenda for understanding access to medicine is very large, we need to prioritize the most important research questions. This study aims to develop a list of the most important policy research questions in the area of access to and use of medicines. This information might help public health leaders, practitioners and researchers to devise plans to meet these priorities. The identified policy research priorities might help focus public spending on research in the area of access to and use of medicines. This would reduce waste and produce results that can potentially have a larger impact on policy making. The specific objectives of this study are: − Identify journal articles, published and unpublished documents and gray literature that are relevant to

ATM.

− Identify ATM policy concerns based on literature review and interviews with key informants.

− Identify ATM policy research questions based on literature review and interviews with key

informants and prioritize among these questions through a meeting of key informants.

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4. METHODS

4.1. Literature review

The research team has developed a multi-pronged and comprehensive search strategy to identify published journal articles and documents as well as unpublished (gray) documents. The strategy focuses on identifying publications and documents in several categories (listed below). Documents within each of the following categories were sought. Documents were considered of interest to this research if they focused on issues of ATM, discussed ATM in one or more part of the document, or discussed issues of direct relevance to ATM.

− Peer-reviewed journal articles identified through a search of multiple databases.

− Documents of the Lebanese parliament, the Government of Lebanon, the MoPH, of ministries and of governmental agencies other than MoPH

− Publications and documents of the WHO, WHO/EMRO in Cairo or WHO country office in Lebanon

− Publications and documents of other international agencies (e.g. UNDP, UNICEF, World Bank)

− Books on devoted to one or more aspects of ATM in the Arab world, MENA, EMR or Lebanon

− Books on health systems or public health in the Arab world, EMR, MENA, or Lebanon where ATM is discussed

− Reports and studies about the pharmaceutical industry or market in Lebanon

− Other publications, for example as identified by key informants. In addition to improving our understanding the issues of and surrounding ATM in Lebanon, the purpose of the search strategy was to create a mini-library of documents of interest to ATM which can aid future research on ATM in Lebanon. 4.1.1. Journal articles

The TUMS-based research team was responsible for identifying ATM-specific journal articles from EMR countries and has followed a consistent search strategy in PubMed to identify journal articles published in English for each country (see the PubMed search strategy for Lebanon in Appendix 1-A). This search strategy retrieved only four (4) articles (since 2000) of which three (3) articles were directly related to ATM. The Lebanon team modified this search slightly and removed the time filter (Appendix 1-B), still only nine (9) article could be retrieved. As this did not seem to represent the body of potentially-relevant literature on ATM in Lebanon, the Lebanon team felt the need to expand the search strategy and use multiple databases to retrieve a larger number of articles. Although it was obvious that this approach might reduce the specificity of the search strategy, the rationale was that the conceptual framework of ATM, for example according to WHO 2004, is quite broad and encompassing and many articles, even if not specific to ATM, can enlighten a better understanding of the health system issues of direct relevance to ATM. The research team developed an expanded MeSH terms/keyword list to capture more

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domains of the ATM framework (according to WHO 2004) and conducted a systematic review using the following electronic databases: PUBMED/MEDLINE, EMBASE, SCIRUS,

IMEMR (WHO EMRO’s Index Medicus for the Eastern Mediterranean Region), and

Google Scholar. We reviewed abstracts and excluded irrelevant articles. For Google Scholar, we searched the first 13 pages of around 36,000 articles obtained. For each step of literature search we retained articles that have not been found during a previous search to avoid redundancy in the list. In addition to the aforementioned search strategy, we attempted to identify additional journal articles by searching the following national resources: The National Health Information Library, supported by the WHO country office in Lebanon, and the online database of the Lebanese Corner at the Saab Medical Library of the American University of Beirut, a resource on all health-related publications concerning Lebanon.

4.1.2. Document review

To identify documents, whether published or unpublished, of interest to ATM we carried out a multi-pronged strategy. We searched websites (e.g. MoPH, WHO-EMRO), databases (WHO Medicines Bookshelf version 6 [2010], Lebanese Corner at the Saab Medical Library of the American University of Beirut), and other national resources (e.g. the National Health Information Library of the WHO country office in Lebanon). This led us to identify only a limited number of documents. In addition, we asked key informants to supply us with any documents of potential interest to ATM. Key informants supplied the research team with a large number of documents covering a broad range of topics. 4.2. Key informant interviews

The research team conducted in-depth interviews with 29 key informants whose work directly concern ATM to solicit their views on the most important policy and research issues concerning ATM. 4.2.1. Inclusion criteria

We initially identified 15 key informants as the target for interviews but ended up conducting interviews with 29 informants, following the advice provided by other informants. Although saturation in responses was reached after the first 15 interviews, the later set of interviews were useful in addressing specific issues and in clarifying particular questions in ATM. We identified informants whose work encompasses the various domains of ATM. In many cases, informants served in multiple roles. For example, some informants served in professional associations or NGOs but were also practitioners of medicine, pharmacy or nursing. Some practitioners were also educators in their fields. A key strategy in identification of key informants was to ensure diversity of professional backgrounds, fields of work, and perspectives. Informants came from the public sector, the private sector, professional associations, civil society groups/NGOs and consumer groups, and from among practitioners. Appendix 2 presents the complete list of informants along with their affiliations.

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4.2.2. Conduct of key informant interviews

Key informants identified based on the aforementioned criteria were called by telephone or contacted by email to explore their interest in participating in the study. If they expressed interest, we sent the consent form (Appendix 3) by email, fax or delivered it in person and the WHO-2004 paper explaining the ATM framework. On the interview day, informants were asked to go over the consent document and encouraged to seek any clarification from the investigator. Informants were then asked to complete the informed consent document if they voluntarily agree to participate. Interviews were recorded on a digital recorder and later transcribed. One to three members of the research team conducted the interviews, which lasted from 30 minutes to 90 minutes depending on informant’s time availability. Informants were told that the interviewers would be exploring ATM in Lebanon according to the WHO-2004 framework and that there will be an attempt to cover the four domains of the ATM framework but that the interview can expand well beyond that. For informants who seemed unfamiliar with the terminology of ATM and the various domains of ATM framework, the researcher briefly reviewed the WHO-2004 framework prior to the start of the interview. It was felt that this allowed interviews to be more focused and allow more productive use of time. The informants did not seem biased in particular directions by this approach. The interviews used loosely the ‘Semi-structured interview guide’ developed by the research team at TUMS (Appendix 4). The researchers felt that the interview guide, although comprehensive and useful, did not allow for the flexibility and fluidity that informants demanded. Consequently, the interviews were largely based on asking the informants about their views of which are the most important policy concerns, and corresponding research questions, in ATM and then moved to explore the ATM issues more in-depth using the leads provided by the informants, the WHO 2004 framework and the semi-structured interview guide. This method gave the informants the needed space to move about the ATM sphere freely and gave the researchers the needed structure to explore ATM issues from various angles. The initial focus was to elicit from each informant a list of policy research questions and priorities in the area of ATM. However, this proved difficult as informants commonly focused on the actual obstacles and policy aspects of ATM issues rather than on identification of related research questions. In some cases, prodding by the interviewing researcher proved useful in identifying specific research questions. In other cases, this proved difficult and it became clear to the researchers that they would need to identify research questions based on the policy concerns expressed by informants. 4.2.3. Privacy and confidentiality

Several measures were taken to ensure the privacy and confidentiality of informants. Consent forms lacked any personal identifiers. During the recoded interviews, informants were asked not to provide any identifiers, such as names or names of the institution or their positions. If such information was provided, it was not transcribed or deleted from transcription. The recordings

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were downloaded to a password-protected computer immediately after the interviews and deleted from the digital voice recorder. Only one person of the research team had access to the recording. Once successfully transcribed and checked by the PI, the digital recordings were permanently removed from computers. The consent documents are locked in a safe place with access restricted only to the PI. All those documents will be permanently destroyed once the study report is submitted and the articles and papers published. 4.3. Analysis of data and identification of research questions

Two researchers (SJ and RY) independently reviewed the literature, both journal articles and documents, to identify ATM areas that have been covered in prior research and to retrieve new policy-relevant research questions. When a research question was explicitly expressed, it was added unmodified to the list of research questions. When a research question was not explicitly expressed but could be inferred from policy concerns about ATM appearing in the literature, the two researchers developed the corresponding research questions(s) and modified the question(s) until a consensus is reached about the wording of research questions. Identified research questions were categorized in one of the four domains as per the WHO 2004 framework. An additional category comprised research questions encompassing cross-cutting and general issues. The research questions emanating from the literature review are listed in Appendix 6-A. Similarly, the transcribed interviews were analyzed to identify policy concerns and research questions. Just as the case for literature review, when a research question was explicitly expressed, it was added unmodified to the list of research questions. When a research question was not explicitly expressed but could be inferred from policy concerns about ATM stated by the informants, the researchers developed the corresponding research questions(s). The first step was to list all possible questions emerging from the analysis of all transcripts. This exercise was performed by two research assistants. In the second step, two researchers (SJ & RY) independently reviewed the list of questions, merged similar questions, and excluded the research questions that seemed incoherent. During these two steps, identified research questions were categorized in one of five categories corresponding to the four domains of ATM as presented in the WHO-2004 framework, and one general cross cutting category encompassing such research questions that pertain to all the four aspects such as corruption, governance, or free market. We included a research question, where expressed explicitly or inferred implicitly from a policy concern, even if such a question was cited only once by one informant during the two steps of identification. This process was meant to allow the inclusion of as many research questions as possible. The research questions emanating from the analysis of KII are listed in Appendix 6-B. The principal investigator then reviewed all research questions that have emerged from literature review and key informant interviews, and consolidated and shortened the research questions, excluding those deemed redundant, inadequate, or poorly corresponding to the domain of ATM. In the final step, two researchers reviewed all research questions and reached consensus about the research questions in their final reworded and merged form. This resulted in a list of 57 questions (Appendix 6-C) which were to be submitted to the validation-prioritization meeting.

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4.4. The validation-prioritization meeting All key informants were invited to participate in the validation-prioritization meeting. Key informants unable to participate were asked to recommend representatives of their institutions/organizations if possible. The final list of participants is presented in Appendix 2. Both the participants and the researchers felt that the number of participants was adequate and allowed for engagement in discussions and for completing the prioritization tasks within the allotted time of three hours. The objectives of the validation-prioritization meeting were to review the research questions that have emerged from literature review and key informant interviews, remove the questions that were not thought to be priorities, modify questions as needed and rank questions according to pre-specified evaluative criteria. Although the research questions from literature review and key informant interviews had been categorized thematically in the previous step (see 3.3. above), the 57 questions were presented to the participants in one list. The rationale behind this was to avoid force-fitting the questions into pre-defined categories, i.e. according to the WHO 2004 framework, and allow the participants to discuss and propose alternative frameworks for approaching ATM and thus priority research. The meeting comprised two main steps: a. Step 1: Validation exercise: Each participant was given a print-out of the 57 research

questions and asked to grade the 57 research questions according to importance (0 if they deem the question unimportant, and 1 if deem it important or possibly important) and to identify the questions that required modification. The participants were also encouraged to propose new questions that deemed important to include in the list of priorities and those they considered inadequate or illegitimate. After having reworded a number of questions, the grades were added up. All the questions that obtained a score of more than 8, signifying that more than 2/3 of participants, or 9 participants at least, considered them important, passed to the second round of prioritization ranking.

b. Step 2: Prioritization exercise: Among the original 57 questions that emerged from the

validation exercise, 22 questions achieved the cut-off score and were submitted to the participants for prioritization. Each participant was given a print-out of the list of 22 questions and asked to give a score each question on five evaluative/ranking criteria for prioritization. A statement of explanation was provided for each criterion. The participants provided a critique of criteria and requested modification. The final list of criteria was:

- Relevance: Would the research study address one or more of the important issues in ATM?

- Urgency: How soon should the research study be done? - Feasibility: Can the research study be done using available resources? - Applicability: What are the practical implications of the research study on changing

policy? Would the political climate allow it to be done?

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- Ethical acceptability: Would the research study violate ethical principles? For each criterion, the participant were asked to give the research question a score from 1-10 (10 representing a high priority for the research question on the concerned ranking criterion). The final list of 22 questions ranked according to these criteria is presented in Appendix 6-D.

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5. RESULTS – LITERATURE REVIEW

5.1. Literature review

5.1.1. Journal articles

Using the expanded search strategy, we reviewed the abstracts of 104 journal articles and identified a total of 44 journal articles as relevant to ATM (Appendix 5-A). Among these, no articles specifically discussed the issue of access and no articles examined ATM in a comprehensive manner that includes the four domains of the WHO 2004 framework. As common in ATM research globally, the area of rational selection and use has received attention from researchers in Lebanon. Saab et al (2001) described that “In 1966, Lebanon had around 19,000 drug formulations registered in the Ministry of Public Health. The government decreased that number to 5400 in 1992 through numerous interventions.” They described the process of development of a list of essential drugs for primary care by an ad hoc committee set up by the Lebanese government. Several studies have looked at prescribing behaviors, in general or for specific conditions. In a university health center, Hamadeh et al (2001) studied prescribing practices and found low rate of generic and essential drug prescribing and frequent prescribing in respiratory or ear infections (about 50% of encounters). Bizri et al (2002) reviewed available data at the time on patterns of antibiotic prescribing in ambulatory care. In a four-country (Lebanon, Morocco, Spain and USA) study of medical management of menopause, Sievert et al (2008) reported that physicians were generally well informed and that prescription patterns and perceived benefits of hormone therapy appeared to reflect local medical culture rather than simply physician characteristics. El Sayed et al (2008) described that pediatricians prescribed antibiotics to infants at least once in 21.4% of cases diagnosed as the common cold and 45.5% of cases of acute bronchiolitis. Antibiotics misuse was more common among infants born to mothers with lower educational levels. Pediatricians tend to prescribe antibiotics in dispensaries more often than in private clinics. Abi Rizk et al (2010) reported that primary care physicians prescribed antibiotics for pharyngitis at high rates (42% with 68% in winter and 38% in summer) and “No physician used all the criteria in the score adopted by the CDC to decide on the prescription of antibiotic or throat culture.” A few studies have looked at prescribing practices in hospital settings. Azzam et al (2002) reported that antimicrobial prophylaxis for surgical procedures was appropriate. Kanafani et al (2005) found that antibiotic prescribing for acute cholecystitis was erratic and costly in the absence of international guidelines on appropriate use. Nassar et al (2009) found high rates of appropriate prescribing among obstetricians for a specific indication. The area of management of post-operative pain was, however, sub-optimal as reported by Madi-Jebara et al (2009). Several studies described development of practice guidelines and other interventions to improve prescribing practices for managing specific conditions. Azar (2000) proposed practice guidelines for managing hypertension in diabetics. El-Hajj Fuleihan et al. (2005) proposed Lebanese guidelines for managing osteoporosis. These guidelines were updated in 2007 (El-Hajj Fuleihan

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et al., 2007; El-Hajj Fuleihan et al., 2008). Riachy et al. (2010) reported that an intervention using clinical guidelines aimed at improving the use of nebulizers in a university hospital did not succeed in lowering inappropriate prescriptions. Zgheib et al. (2011) described the introduction of “rational prescribing” sessions, using team-based learning format, to medical students at AUB. Several studies have looked into medication use patterns. Naja et al. (2000) carried out a first pharmaco-epidemiological study on benzodiazepine consumption, as such medicines were available without a prescription at the time. Benzodiazepine use during the past month was found in 9.6% of subjects and described as “particularly high”. Benzodiazepine dependence was found in 50.2% of users. Makhlouf Obermeyer et al (2002) analyzed medication use in the 1999 National Household Health Expenditures and Utilization Survey and found that education and employment were associated with lower rates of medication use while higher socioeconomic status was associated with higher use rates. The researchers highlighted three areas for further research and interventions: the higher use of antibiotics in rural areas, the greater use of psychotropic drugs by women, and the possible obstacles to obtaining needed medications for those with lower incomes. Among elderly Lebanese, Saab et al (2006) documented that about 60% were taking at least one inappropriate medication and identified correlates of inappropriate use. Solberg (2008) reported increasing use of medication to treat mental health challenges which may be related to Lebanon’s recent history of conflict. In a multi-country study involving Lebanon, Scicluna et al. (2009) documented the highest rates of self-medication in Lebanon (37%). Lebanon had the highest percentage (60%) of people keeping antibiotics at home. There was a significant association between antibiotic hoarders and intended users of antibiotics for self-medication. Because irrational use of medicines is common, several studies have reported on consequences. As antibiotics are accessible without a prescription, several studies have documented the consequences in terms of microbial resistance (Araj et al., 1994; Araj 1999; Araj & Kanj 2000), including in specific conditions such as tuberculosis (Hamze & Araj, 1997; Araj et al 2006), haemophilus influenzae (Santanam et al., 1990) and streptococcus pneumonia (Araj, et al., 1999; Harakeh et al., 2006; Uwaydah et al 2006). Major (1997) and Major et al. (1998) studied the incidence of drug-related hospitalization in a tertiary medical center and its association with self-medicating behavior. They found that among adults and children admitted, 10.2% and 7.9% had drug-related illnesses, respectively. Adverse drug reactions accounted for 7.0% and 5.7% and therapeutic failures for 3.2% and 2.2% of adult and pediatric admissions, respectively. Self-medication was commonly practiced (52.6% of adults and 41.6% of children). Interestingly, female sex increased the risk of adverse drug reaction in adults, whereas self-medication decreased the risk. In children, the risk of adverse drug reaction was increased in lower socioeconomic groups. Kassab et al (2005) reported the first-year results of a national system of adverse drug reactions. They found that antimicrobial agents were the most common drugs involved in such reactions (43%). Articles concerning the health and supply systems highlighted a few interesting aspects. Kyriacos et al (2008) studied the quality of amoxicillin formulations in Lebanon, Jordan, Egypt

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and Saudi Arabia and found that 56% of amoxicillin capsules did not meet the United States Pharmacopeia (USP) requirements. They identified several factors that might jeopardize the quality status of medicines: lack of effective quality assurance system during manufacture in both Arab and export countries, and uncontrolled storage conditions, especially unsuitable pharmacy premises. Use of substandard antibiotic preparations increases the risk of therapeutic failure and the emergence of drug-resistant microorganisms. The practice of pharmacy received important attention. Dib et al (2004) described pharmacy practice and outlined the challenges. Bou Antoun and Salameh (2006) carried out a survey among community and pharmaceutical company pharmacists in Lebanon to evaluate their satisfaction with professional status and willingness to work as clinical pharmacists. The first group was more satisfied and more willing to engage in clinical pharmacy. Salameh and Hamdan, (2007) carried out a survey of a pharmacist and a nurse in each of 59 hospitals in two regions of Lebanon on the drug circuit starting from prescription to administration. There were gaps in all hospitals that could lead to drug errors. Salameh et al (2007) noted that clinical pharmacy is not professionally applied in Lebanese hospitals despite the accreditation requirements and showed that the majority of physicians and nurses thought that interventions by clinical pharmacists would be beneficial. Khachan et al. (2010) described pharmacy education in Lebanon but did not describe aspects relevant to ATM. 5.1.2. Published and unpublished documents and gray literature

Using the previously discussed search strategy and supplemented with documents provided by key informants, the research team has assembled a library of documents of direct relevance to ATM (Appendix 5-B). It is beyond the scope of this report to review all such documents. Therefore we focus in this section on observations about key aspects of the ATM situation in Lebanon. These observations supplement the evidence-based review of research published in peer reviewed journal articles (see section 5.1.1. above) and can inform the agenda for essential research on ATM. Expenditures on medicines (ATM) are an important concern in Lebanon. Different resources estimate that medicines account for 25% of total health expenditures (Hamra et al 2009; Shebaro 2011). Reported market sales in 2007 exceeded USD900 million (Ammar 2009, p. 102). The Lebanese pharmaceutical market is expected to reach USD1.1 billion in 2015 (Shebaro 2011). This means that the medicines bill in Lebanon, which has a population of only 4.22 million, comes third in the region after such populous countries as Egypt and Saudi Arabia. About 80% of medicines are sold in pharmacies, 14% consumed in hospitals and 6% purchased directly by the MoPH, the Army and the Internal Security Forces (Ammar 2009, p. 103). An important proportion of spending on medicines is out-of-pocket (OOP), accounting for 67.8% of total spending on medicines (rate calculated from Table IV-2, Ammar 2009, p. 104) and for 31.01% of total household spending on health in 2005 (which increased from 25.35% in 1998) (Ammar 2009, p. 104). Between 1998 and 2005, while spending on medicines by “intermediaries” increased by 34.2%, household spending on medicines increased only by 0.7% indicating that “cheaper sources of supply have become available for at least a part of the

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population” (Ammar 2009, p. 104). In 2005, household annual spending on medicines was estimated between USD100 and USD 125 per capita (Ammar 2009, p. 102; Hamra et al 2009). However, there are indications that this figure is underestimated (Hamra et al 2009). Lebanon is the leading importer of pharmaceuticals in the region. There are between 85 and 142 agents (importers) (Shebaro 2011; Hamra et al 2009) who import some 5,995 drugs from more than 558 factories in 32 countries constituting between 92% and 94% of the products available in the market (Hamra et al 2009; Shebaro 2011). Among all registered medicines in 2008, 79.42% came from European countries, 9.59% from Arab countries, 5.75% from USA and 5.24% from other countries (Ammar 2009, p. 102). The local pharmaceutical manufacturing industry is still small but is expanding. In 2010, medicines manufactured by seven local factories made up from 6 to 9% of all medicines consumed (Hamra et al 2009; Shebaro 2011). Prices of medicines are a major concern. In a study of prices of 32 medicines based on an international standardized methodology, Karam (2004) found that the public sector purchases medicines at reasonable prices for poor patients and provides medicines for free in public health facilities but availability in the public sector is “very low” and “poor patients are forced to buy expensive medicines from private pharmacies.” In the private sector, availability is very good but that “almost all the surveyed medicines are over-priced if compared with the international reference price and the prices of innovator brands are up to 5 times more expensive than the prices of their generic equivalents.” On the WHO_EMRO (2011) website it is noted that the Lebanese spend three to six times more on the prices of the essential medicines they need than they should. Karam (2004) also notes that a “big part of price problem is the current price structure including profit margins, expenses and fees as well as the incremental calculation method.” Hamra et al (2009) note that the profit component of prices designated for pharmacies is considerable, reaching 22.5% of the original price, which encourage pharmacists to promote for more expensive products. High rates of importation from European countries and USA (over 85% according to Ammar 2009, p. 102) contribute to the high prices of medicines, especially in a context of devaluation of the national currency versus the Euro (Ammar 2009, p. 102). A major contribution to the medicines situation is low rates of generic prescribing. Karam (2004) notes that Lebanon is a “brand name” country. She notes that “innovator brands drugs are possibly

used more extensively as there are “no incentives to prescribe and sell generic equivalents.” Ammar (2009, p. 104) attributes this to “absence of any framework for medical prescription accountability”. The well-known oversupply of physicians, especially specialists, and pharmacists in Lebanon contributes to high rates of prescribing and dispensing of branded medicines. Hamra et al (2009) note that pharmacists are not allowed to substitute a prescribed product with a cheaper or generic one. Almost all publications acknowledge the role of aggressive promotion by pharmaceutical companies and the incentives for physicians to prescribe branded medicines. For example, physicians commonly reply on pharmaceutical companies to finance their continuous education by sponsoring their trips to international conferences (Shebaro 2011). The heavy promotion of brands creates trade name affinity, discouraging doctors from prescribing generics (Hamra et al 2009). The MoPH has proposed a code of ethics for promotion of pharmaceutical products and

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has recently revised it and re-circulated it to stakeholders but this document has not been formally adopted by any stakeholder yet. At the policy level, Hamra et al (2009) note that Lebanon lacks a “modern medicine regulatory authority structure in place or a national medicine policy or policy document that lays out a vision for the future of the sector and that defines political, technical, economic and health related parameters that form the framework for pharmaceutical legislation”. While there is large political interest in the pharmaceutical sector, there is “insufficient will and commitment” to carry out reform. There are common media reports of corruption in the medicines sector but there are no studies that document or measure the level of such corruption. In their study of governance in the public pharmaceutical sector, Hamra et al (2009) evaluated vulnerability to corruption of the policy, structures, and procedures in place at the time of the survey. They found that “the area of medicine distribution received the highest score and is minimally vulnerable to corruption; medicines registration, inspection, and procurement are marginally vulnerable to corruption; and the promotion and selection functions had the lowest scores and are moderately vulnerable to corruption.” 5.2. Research questions emanating from the literature review

It is apparent from the aforementioned literature review that there is important evidence for policy action to improve ATM. Nevertheless, the review indicates that evidence is lacking in many key areas. The research questions that emanate from the literature review are provided in Appendix 6-A.

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6. RESULTS – KEY INFORMANT INTERVIEWS

6.1. Policy concerns – thematic analysis

The transcriptions of interviews with key informants provide a rich material for understanding the various concerns regarding ATM. As expected, concerns reflect the positions and interests of stakeholders with different stakeholders voicing diverse and sometimes opposing concerns. It is an important exercise, indeed a research question, to map out the ATM concerns in relation to stakeholder positions and interests. However, as this is beyond the scope of this report, we focus in this section on highlighting a few general points which are of particular relevance to a future agenda of ATM research in Lebanon and then move to provide a thematic analysis using the WHO 2004 ATM framework. 6.1.1. General points

The concept of ATM. All informants identified the situation of medicines are a challenge of profound public health dimensions. However, very few informants expressed and voiced this challenge in terms of “access”. Access therefore was not prioritized as a concept in the interviews. While many informants highlighted important and specific challenges that limit ATM such as high prices of medicines in the private sector or interrupted supplies in the public sector, very few informants explicitly expressed such concerns in terms to equity, which lies at the heart of the concept of access. Equity did not come up as a central theme in the discussions of ATM. The approach to ATM. Most informants identified concerns with ATM that impact people and patients. However, only a few informants stressed the need to make the perspectives of people and patients the central aspect of approaching the subject of ATM. One informant brought up the concern that the WHO 2004 framework for ATM focuses on the policy level and is directed to policymakers and suggested alternatively the use of the framework of Frost and Reich (2009) which approaches ATM from the perspective of users by focusing on attributes that concern them directly: availability, affordability and acceptability. This informants wondered how the ATM research agenda would be different if ATM is approached from the perspective of health as a basic human right to all. The importance of the political and economic context to understanding and improving ATM. Irrespective of the sometimes-opposing positions of different informants, the majority of informants emphasized that ATM must be understood in relation to the political set-up and the economic free market and the prominent role of special interests and confessional parties. Medicines in Lebanon are treated as consumption goods rather than as public goods and are submitted to free market laws and profit making. Several informants were quick to highlight that they don’t see improvements in the ATM situation, or the point of carrying out research on ATM, unless the political governance are first addressed as the broader governance framework directly impacts and determines governance of medicines. These informants stress that the main problem in ATM does not emanate from lack of resources but rather in poor governance. The governance of health system and the regulation of drugs’ market are subjected, as all the other sectors of governance, to sectarian quotas, favoritism, and corruption. Many informants implied,

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or explicitly stated, that the absence of a social contract governing health and social matters, based on health as a right, is the major obstacle to equitable access to medicines in Lebanon. The party(ies) which are most responsible for ensuring ATM. Informants pinpointed to the fragmentation in the governance, financing, and supply of medicines. Almost all informants stress the need for a stronger role for the state and especially the MoPH. The MoPH already plays a key role, seen for example in policy development and regulation or in supply such as through the YMCA-administered program to ensure availability of medicines for chronic conditions in PHC centers and in dispensaries or through the free provision of expensive medicines for conditions such as HIV/AIDS, multiple sclerosis and cancer. However, the role of the MoPH is undermined by powerful interests. How to strengthen the role of the MoPH in improving ATM within the current political set-up remains an open question. The important role of non-state parties in improving the ATM situation. Informants have acknowledged that non-state parties have played an important role in ensuring access, for example through the dispensaries and through health centers operated by CSOs and NGOs, and that this role must continue even as they stress the priority of strengthening the role of the MoPH in ATM. A large segment of the poor and the marginalized primarily secure their needs to medicines through these alternative supply system outside the market rules as the network of dispensaries and CSO/NGO health center of the governmental centers belonging to MoPH and MOSA. In reality, the main activity of many health centers and dispensaries is provision of essential drugs at quasi-free or heavily discounted rates. However, informants also see the need for more supervision and better coordination of the work of CSOs and NGOs in the area of provision of medicines in order to make their contributions more effective. Many health centers and dispensaries suffer from recurrent stock-outs, bureaucracy and favoritism. A large number of dispensaries are not currently under adequate supervision and many act as stores for dispensing medicines without proper medical supervision. Many are suspected of providing dated or improperly stored drugs, of distributing donations of doubtful quality and origin, and of dispensing medicines in “small bags” that promote irrational use. The role of practitioners and their professional associations. Informants have acknowledged the important role of practitioners and professional associations and emphasized that practitioners and associations can do much more to improve access. However, for this to happen, practitioners must be protected and given the mandate and the proper incentives to play such a role. The current incentive structure directs practitioners away from rational prescribing and dispensing of medicines. 6.1.2. Application to the WHO-2004 framework

Here we summarize some of the recurrent concerns expressed by key informants using the WHO’s 2004 ATM framework. Financing: Of the four areas, concerns were expressed the least often in this area. Spending on medicines, as a proportion of total health expenditures, is much higher than in many other high middle-income countries and is unacceptably high. Out-of-pocket expenditures for medicines are

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the primary source of financing posing a challenge to access. There is significant fragmentation of financing as seen for example in the absence of a common medicines financing framework for all six social insurance organizations. Affordable prices: The prices of medicines, and consequently affordability, indicate that there are major challenges. Prices are much higher than would be expected, and are much higher than prevailing prices in other countries in the region. The free market logic cannot alone explain this situation. Presumed open competition has not led to reducing prices of medicines. The regulations stipulating that new imported medicines must be cheaper than medicines of the same compound that exist in the market, has not led to need reductions in the prices of medicines. Manipulations of the market expressed among other practice in artificial emptying of the MoPH stocks, and speculations expressed among other means in hiding certain crucial drugs to encourage black market and over-pricing were cited as examples. Rational selection and use: This is a key ATM challenge. There are almost 7200 medicine formulations on the market of which almost 5900 are registered by the MoPH. This well exceeds the needs of the country, leads to wastage and over-spending on advertisements and creates the opportunities for corruption. An essential medicines list has not been updated in many years. However, even if such a list were to be updated and provided, its impact is not clear in the absence of strong governance, regulatory capacity, and implementing and sanctioning bodies. For example, even the NSSF could not maintain its position in imposing a restricted list of reimbursable drugs. Medicines are neither rationally prescribed nor rationally dispensed. Physicians’ prescribing practices are unduly influenced by pharmaceutical promotions and self-interest. There is no prescribing accountability. Many physicians draw their knowledge from pharmaceutical companies’ prospectors, and they depend on them to acquire continuous learning as alternative systems, either supported by public funds or by professional associations are very weak. Clinical practice guidelines are very few. The over-supply of physicians and pharmacists tends to increase irrational prescribing and dispensing of medicines. Rational use of medicines by the public is also a major problem. There is common misconception about generics and the superiority of medicines from expensive sources such as manufacturers in Europe. Some informants felt that cultural particularities in Lebanon encourage use of branded medicines; other informants disagrees stating that irrational use is more related to the lack of a strong governance and the nature of the political and health system. Many people purchase medicines without prescriptions or consume medicines prescribed by the multiple providers, especially specialists, they might seek for consultation. Health and supply systems: Supply systems are reasonably well developed in Lebanon especially that much of such services are in the private sector and are for-profit. Informants did not think of important concerns about inadequate storage, or inadequate transportation of medicines. However, they expressed serious concerns about the quality of medicines on the market and the presence of counterfeit drugs. The closure of the central laboratory is a major impediment to improve quality of medicines. Some medicines that have been withdrawn from the market in

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North America or Europe may remain on the market in Lebanon for a while. There are regular interruptions in the supply of medicines supported by the MoPH, especially expensive medicines for conditions such as HIV/AIDS, multiple sclerosis and cancer. The problem is less pronounced in the supply of medicines for chronic conditions through the program administered by YMCA. Geographical access of the population to health care and medicines is not usually seen as a major problem. However, much of the dispensing of medicines in dispensaries and PHC centers is not necessarily well linked to provision of care and users may get their medicines in these outlets but have their actual care elsewhere, especially by private providers.

6.2. Research questions emanating from key informant interviews

Appendix 6-B presents the list of research questions that emerged from the KII and which are identified through the method described earlier.

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7. RESULTS – PRIORITY POLICY RESEARCH QUESTIONS

As discussed under “Methods”, the researchers combined the research questions emanating from the literature review and from the KII into one list. The researchers aimed to reduce the large volume of questions and produce a list of around 50-60 questions. As a result, a list of 57 questions was generated and submitted to the validation and prioritization meeting (Appendix 6-C). While questions were initially categorized according to four domains of the WHO 2004 ATM framework, it was decided to remove the categories and just provide a single list. The rationale for this approach was to avoid imposing categories on participants as they prioritized questions in the validation-prioritization meeting. Furthermore, the researchers hoped that this would allow discussions among participants to suggest whether the WHO 2004 framework was appropriate or whether there are alternative frameworks that need to be considered. After the first round we retained the 22 questions deemed important by more than two thirds of the participants. Those questions were submitted to the ranking exercise. The participants were asked to rate each question for a scale from 1 to 10 by each of five criteria. We then added up the scores of all 12 participants. Appendix 6-D shows the rank of the 22 questions. The five questions that receive the highest scores are (in descending order): 1. Assessment of quality of medicines on the market and role of counterfeit medicines and

black market. 2. A study of attitudes of physicians and of the public towards generic substitution and the

opportunities for implementing relevant policies 3. Is access to medicines a priority for policymakers, for professional associations, and for

consumer advocates? 4. Evaluation of the role of civil society organizations and non-governmental organizations in

improving access to medicines especially for the poor, vulnerable groups and hard-to-reach populations.

5. What happens at the dispensary? Dispensing medicines or delivering primary health care? Adherence to generics in PHC and dispensaries.

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8. DISCUSSION AND LIMITATIONS 8.1. Main research findings

We focus our discussion here on issues of most relevance to a future agenda for ATM research in Lebanon. 8.1.1. Research gaps identified in literature search

Our search, both journal articles as well as gray literature and published and unpublished documents, show that there is already substantial literature that describes the main challenges in ATM in Lebanon. Such literature provides the basis for action to improve the medicines situation. However, the research evidence is weak in several areas:

− Prior studies have addressed one or more aspect of the ATM but no studies have examined ATM in a comprehensive manner;

− Research studies on specific issues have not situated these issues within a broader framework of ATM;

− Descriptive research dominates and studies of interventions that evaluate policy options or more technical matters are lacking;

− Studies have focused on various aspects of ATM but the central component, i.e. access, is not directly and explicitly the focus of attention especially if considered from an equity lens. Indeed, the equity dimension is neither researched nor discussed as often or as deeply as it deserves;

− Studies have not adequately evaluated ATM from a population perspective. Many studies focused on clinical settings and thus have limited generalizability at the national level.

− Most descriptive studies have prioritized processes related to ATM, for example prescribing behaviors, rather than outcomes;

− Many studies did not link the specific questions at hand with the policy and regulatory environment, structural barriers, and the political economy of ATM, which key informants later identified as crucial for approaching, and thus for improving, ATM.

These gaps in research evidence mean that the agenda for ATM research in Lebanon is, for all practical purposes, wide open and indicates the need for serious investments in ATM research. 8.1.2. Research needs emerging from key informant interviews

Perhaps the most consistent finding from KIIs is that informants find it difficult to identify and articulate research questions in relation to the numerous policy concerns that they voice. This indicates the need for the researcher to play a greater role in elucidating research questions based on voiced policy concerns. This process, however, can have negative consequences as researchers may bring their own biases and positions into the identification and prioritization of research questions. How researchers elucidate research questions from policy concerns should

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itself become the focus of future research that critically examines the process and outcomes of the choices that researchers make. The research questions that have come out of KIIs are comprehensive and concern all aspects of ATM. However, the area where the fewest number of research questions have emerged is financing of medicines while the area with the largest number of research questions is rational selection and use. Considering that financing has profound effects on all other aspects of ATM, it is possible that the identified ATM research questions under-estimate the research needs in ATM financing. This has obvious impact on the identified policy research priorities. 8.1.3. Consolidation of research questions to be submitted for prioritization

The researchers have consolidated the research questions that emerged from literature search and from KIIs into a list of 57 questions which were submitted to the validation-prioritization meeting. Such consolidation carries several potential disadvantages. First, there is the loss of information with potentially important research questions not making it to the list. Second, consolidation may lead to the development of dense and composite research questions, as was actually the case for a few questions, that would become difficult to prioritize by participants in the validation-prioritization meeting. Third, consolidation necessarily means the introduction of another layer of intervention by the researchers, which adds to their interventions in formulating research questions from policy concerns voiced by key informants. However, the process of consolidation of research questions was unavoidable due to the long list of research questions that emerged from literature review and from KIIs. The researchers have tried to minimize potential problems associated with consolidation through having two researchers, SJ and RY, work to develop consensus on how to consolidate the questions and formulate the final questions to be submitted to the validation-prioritization meeting. 8.1.4. Prioritization of policy research questions in the validation-prioritization meeting

The researchers have submitted to the participants in the validation-prioritization meeting a single list of 57 questions that were NOT categorized by theme. The rationale was threefold: to avoid force-fitting the 57 questions into a single framework such as the WHO 2004 framework; to avoid biasing the participants who might feel the need to prioritize within categories/theme; and to allow discussions among the participants in the meeting about the framework of analysis for the data at hand and for the situation in Lebanon. Indeed, participants wondered why the researchers had not categorized the questions according to themes and this stimulated a lively discussion about the need for a framework for approaching the ATM research agenda and what frameworks might actually emerge from the research questions. Some participants proposed that the right to health might well serve as a framework for approaching the ATM research agenda. The limited time did not allow for developing specific proposals for alternative frameworks. As discussed previously, the participants in the validation-prioritization meeting have validated the 57 research questions submitted to them according to a simple dichotomy of importance (important or possibly important vs. not important). The researchers have selected the questions perceived as important by at least two thirds of participants. The purpose was to reduce the

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number of questions that needs to be prioritized to around twenty. This process resulted in 22 questions submitted to final prioritization. One can argue that the process of validating research questions according to a simple dichotomy of importance and reducing the questions from 57 to 22 resulted in the loss of many important research questions from consideration. This is a real limitation but is unavoidable as prioritization among 57 questions would have proved too difficult to do. Indeed, prioritization among the final 22 questions itself was challenging in the allotted time. The list of 22 questions that has emerged from the validation phase represents a diversity of topics. Several observations can be made about this list. First, most questions concern descriptive rather than intervention studies, perhaps reflecting the dominance of descriptive over intervention research questions in the 57 questions submitted to the validation-prioritization meeting. Because the aim of this research project is to impact policy, researchers and policy makers interpreting this list must evaluate each question carefully to identify the actionable/intervention dimension of such a question. The researchers in this study have elected not to rephrase every descriptive research question into an actionable/intervention research question as this would have introduced yet another layer of intervention by the researchers. However, such rephrasing perhaps needs to be done when future research teams and policy makers decide on an agenda for ATM research for Lebanon. Second, among the three groups of policy/decision makers, professionals/practitioners and consumers/patients, the middle group has received the most attention in the list of research questions. This perhaps reflects the combination of several factors: many participants in the meeting were professionals/practitioners; policy and decision makers could not participate due to the demands of appointment of a new minister of health right before the meeting; the limited representation of consumer groups; and/or the lack of representation of actual consumers in the meeting. Third, and in relation to the previous observation, only a few questions concern the identification of actual limitations to access. For example, while prices of medicines are uniformly acknowledged to be a problem in Lebanon, questions on pricing did not make it to the list. Furthermore, the equity dimension was weak in the list as it was in the literature search and during the KIIs. The implication of this observation is that researchers and policy makers must evaluate the list critically, re-evaluate the rank of questions in light of policy concerns and priorities and supplement the list with research questions that correspond to such concerns and priorities. Finally, the list of research questions reflect the logic that participants have followed, without instructions from the researchers, of prioritizing the determinants aspects of ATM over the interpersonal, cultural, and knowledge aspects. Nevertheless, the interest in determinants was mostly in proximal determinants rather than in structural determinants such as the political economy or the regulatory framework of ATM. A few participants in the meeting emphasized the need for more research on structural determinants and the regulatory framework. This implies again the need for researchers and policy makers to evaluate the list critically with an eye towards addressing research questions on structural determinants of ATM.

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8.2. Lessons learned

The research team has learned many lessons in the process of conducting this study. In relation to the literature review, the researchers have felt the need to employ an expanded search strategy to identify journal articles of interest to ATM. This has proved useful in identifying articles that would not been identifiable using terms specific to access. This search strategy needs to be compared with strategies used by research teams from other countries and needs to be validated in future ATM studies and be modified as needed to reflect a desired balance of sensitivity and specificity. In relation to the identification of gray literature and published and unpublished documents, the key informants have supplied the bulk of the documents. One strategy that can, and should, be used in the future to identify relevant gray literature can perhaps be referred to as “multi-seeking”. Some informants, including mid-level managers have identified documents which they have authored or co-authored but which they did not comfortable sharing. In this case, an informant is encouraged to supply the name of the document while the document itself can be secured from another source, including a more senior manager. In relation to the interviews with key informants, several observations are important to consider and all center around the need for flexibility. First, we found that a priori identification of a list of informants may not be sufficient and some flexibility is needed. Some of the key informants identified other names, which we did not have as part of the initial list of informants, as potentially important informants. The latter provided important new insights. This was the case even when the research team felt that saturation was reached (at around 15 informants). Second, there is a need for substantial flexibility in conducting the interviews based on the semi-structured interview schedule. Many informants were comfortable and fluent in discussing the ATM issues based on their professional and lived experiences and there was little room to ask many of the questions in the interview schedule. Third, it was useful to provide key informants with the WHO 2004 document outlining the ATM framework and this did not adversely impact the responses of informants or “force-fit” such responses into a framework as the informants ultimately decided what they wanted to say or discuss based on their experiences. In relation to the validation-prioritization meeting, several lessons are instructive. First, the number of participants, at 12, was felt to be optimal and allowed a smooth conduction of the meeting including the discussions by informants with opposing views on contentious issues such as the role of corruption and the pharmaceutical companies. Second, the strategy of asking several key informants to send representatives of their organizations proved useful despite the initial concern of the research team that these representatives may not have served as key informants and thus may not have had the opportunity to think through the ATM issue carefully. In this regards, it proved useful to send these representatives the WHO 2004 ATM framework document so at least they know the domains that will be discussed in the meeting. Third, a three-hour meeting may not be adequate to conduct optimal prioritization of research questions when a large number of questions are put forth. There is a need for more time for participants to digest, reflect on, discuss and modify the research questions. Furthermore, there was a need for more

33

time to allow for modification of the final list of research questions based on the prioritization exercise.

34

9. ACKNOWLEDGEMENTS

We are grateful to the key informants and participants in the validation-prioritization meeting who have graciously given their time for this study and have supplied important insights and documents. Ms. Rawan Chaaban and Ms. Reem El Soussi, both research assistants, served competently and with diligence especially in carrying out tedious . We thank Ms. Jana Rahal, secretary of the Department of Health Management and Policy in the Faculty of Health Sciences at the American University of Beirut, for providing outstanding administrative support. Ms. Aida Farha, librarian in the Saab Medical Library at the American University of Beirut, provided excellent librarian services.

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Hamadeh, G.N., Dickerson, L.M., Saab, B.R. & Major, S.C. (2001) Common prescriptions in ambulatory care in Lebanon, Annals of Pharmacotherapy, 35(5):636-40.

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Kassab, I.A., Bouchi, N., Bagheri, H. & Geahchan, A. (2005), [Setup of a national system of adverse drug reaction reporting in Lebanon: results of the first year of activity], Thérapie, 60(6):583-7. [Article in French]

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Pharmacy Teaching and Learning, 2(3):186-191.

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Kyriacos, S., Mroueh, M., Chahine, R.P. & Khouzam, O. (2008), Quality of amoxicillin formulations in some Arab countries, Clinical Pharmacy and Therapeutics, 33(4):375-9.

Lebanon EMRO (2006). Health Systems Profile- Lebanon. Regional Health Systems Observatory. Available on:http://gis.emro.who.int/healthsystemobservatory/main/Forms/CountryInfo.aspx?Country=LEBANON

Madi-Jebara, S., Naccache, N., Abou-Zeid, H., Antakly, M.C. & Yazbeck, P. (2009) [A national survey of postoperative pain management in Lebanon], Annales Françaises d’Anesthesie et de

Réanimatologie, 28(5):496-500. [Article in French]

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Therapeutics, 64(4):450-61.

Major, S. (1997), Drug related illness leading to hospitalization at the American University of Beirut-Medical Center, Le Journal Médical Libanais, 45(4):245.

Makhlouf-Obermeyer, C., Schulein, M., Kasparian, C. & Ammar, W. (2002), Medication use, gender, and socio-economic status in Lebanon: analysis of a national survey, Le Journal Médical

Libanais, 50(5-6):216-25.

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Psychiatrica Scandinavia, 102(6):429-31.

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Maladies Respiratoires, 27(9):1049-54 [french].

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Salameh, P., Najjar-Aad, M., Semaan, M., El Hawzi, R., Bechara, M., El Kadi, B. et al. (2007), [Drug circuit in Lebanese hospitals], Revue d' Epidemiologie et de Santé Publique, 55(4):308-13. [Article in French]

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Clinical Pharmacology, 51(7):1101-11.

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and Fibrinolysis, 2006 Nov;17(8):647-50.

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11. APPENDICES

11.1. Appendix 1: Search strategies

A. PubMed Search Strategy used by the TUMS-based research team (limit 2000 and newer)

- #1- ((((((((((((((((iran[Affiliation]) OR pakistan[Affiliation]) OR lebanon[Affiliation])

OR Egypt[Affiliation]) OR Afghanistan[Affiliation]) OR Sudan[Affiliation]) OR

Yemen[Affiliation]) OR Jordan[Affiliation]) OR Tunisia[Affiliation]) OR

Morocco[Affiliation]) OR Syria[Affiliation]) OR Palestine[Affiliation]) OR Iraq

[Affiliation]) OR Djibouti[Affiliation]) OR Libya[Affiliation]) OR Somalia[Affiliation])

- #2- ((((((((((((((((((((middle east[Title/Abstract]) OR Iran[Title/Abstract]) OR

Tehran[Title/Abstract]) OR low income countries[Title/Abstract]) OR middle income

countries[Title/Abstract]) OR Pakistan[Title/Abstract]) OR Lebanon[Title/Abstract]) OR

Egypt[Title/Abstract]) OR Afghanistan[Title/Abstract]) OR Sudan[Title/Abstract]) OR

Yemen[Title/Abstract]) OR Jordan[Title/Abstract]) OR Tunisia[Title/Abstract]) OR

Morocco[Title/Abstract]) OR EMRO[Title/Abstract]) OR Syria[Title/Abstract]) OR

Palestine[Title/Abstract]) OR eastern Mediterranean[Title/Abstract]) OR Iraq

[Title/Abstract]) OR Djibouti[Title/Abstract]) OR Libya[Title/Abstract]) OR

Somalia[Title/Abstract])

- #3- (#1)OR (#2)

- #4- ((((drug$[Title/Abstract]) OR medicines[Title/Abstract]) OR

medication$[Title/Abstract]) OR pharmaceutical$[Title/Abstract])

- #5- ((((((((((use[Title/Abstract]) OR access[Title/Abstract]) OR available[Title/Abstract])

OR availablity[Title/Abstract]) OR affordable[Title/Abstract]) OR

affordability[Title/Abstract]) OR utilisation[Title/Abstract]) OR

utilization[Title/Abstract] OR prescription$ [Title/Abstract]) OR prescribe$

[Title/Abstract])

- #6- (#3) AND (#4) AND (#5)

Number of retrieved articles: 4

B. Modification of the PubMed search strategy used by the TUMS-based research team for the

Lebanon study (no time limit)

- #1- (((Lebanon[Affiliation]) OR Lebanese[Affiliation]) NOT Dartmouth[Affiliation]

- #2- ((((drug$[Title/Abstract]) OR Medicines[Title/Abstract]) OR

medication$[Title/Abstract]) OR pharmaceutical$[Title/Abstract]) OR

preparation[Title/Abstract]

- #3- ((((((use[Title/Abstract]) OR access[Title/Abstract]) OR rational[Title/Abstract]) OR

affordab$[Title/Abstract]) OR prescription[Title/Abstract]) OR

prescribing[Title/Abstract]

- #4- (#1) AND (#2) AND (#3)

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Number of retrieved articles: 9

C. Search strategy for the systematic literature review followed by the Lebanon team

Database Search terms #

1 PubMed ((Lebanon[MeSH Terms]) NOT Dartmouth [Affiliation]) AND pharmaceutical[MeSH Terms]

4

2 PubMed

(("pharmaceutical preparations"[MeSH Terms] OR ("pharmaceutical"[All Fields] AND "preparations"[All Fields]) OR "pharmaceutical preparations"[All Fields]) OR ("medication systems"[MeSH Terms] OR ("medication"[All Fields] AND "systems"[All Fields]) OR "medication systems"[All Fields]) OR ("pharmaceutical preparations"[MeSH Terms] OR ("pharmaceutical"[All Fields] AND "preparations"[All Fields]) OR "pharmaceutical preparations"[All Fields] OR "drugs"[All Fields]) OR medicines[All Fields] OR ("pharmaceutical preparations"[MeSH Terms] OR ("pharmaceutical"[All Fields] AND "preparations"[All Fields]) OR "pharmaceutical preparations"[All Fields] OR "medication"[All Fields])) AND "lebanon"[MeSH Terms]

56

3 PubMed (("prescriptions"[MeSH Terms] OR "prescriptions"[All Fields] OR "prescription"[All Fields]) OR prescribing[All Fields]) OR Treated[Title] AND ("lebanon"[MeSH Terms] OR Beirut[All Fields])

55

4 PubMed

("therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields]) AND ("guideline"[Publication Type] OR "guidelines as topic"[MeSH Terms] OR "guidelines"[All Fields]) AND "lebanon"[MeSH Terms]

29

5 PubMed ("pharmacy"[MeSH Terms] OR "pharmacy"[All Fields] OR "pharmacies"[MeSH Terms] OR "pharmacies"[All Fields]) AND practice[All Fields] AND "lebanon"[MeSH Terms]

6

6 Embase Drugs/Lebanon 68

7 Scirus

(Drugs OR Medicines OR Medications OR Pharmaceutical) AND (Use OR utilisation OR utilization OR access OR financing OR supply OR Storage OR labeling OR Affordability OR Affordable OR cost effective) AND Lebanon (Keyword)

54

8 SML LEB (drug in Title) Or (medicines in Title) Or (pharmaceutical in Title) 343

9 IMEMR (Drugs OR Pharmaceuticals OR medicines OR Prescription OR Prescribing) AND (Lebanon Or Lebanese)

63

10 Google Scholar

(Drugs OR Medicines OR Medication OR Pharmaceutical) AND (Use OR utilisation OR utilization OR access OR financing OR supply OR Storage OR labeling OR Affordability OR Affordable OR cost effective) AND (Lebanon OR Lebanese OR Beirut)

36,000

entries

IMEMR: Index Medicus for the Eastern Mediterranean Region (WHO Regional Office for the Eastern Mediterranean) LEB SML: Lebanese Corner at Saab Medical Library of the American University of Beirut Total number of potentially relevant and non-overlapping abstracts reviewed: 104

11.2. Appendix 2: Key informants and participants in the validation-prioritization exercise

Name Organization Type of organization Title

Charaf Abou Charaf Lebanese Order of Physicians Professional association President

Walid Ammar Ministry of Public Health Governmental Director General

Zouhair Berro Consumer Rights Defense Association NGO President

Husni Shebaro Independent Independent Consultant

Nadia Dalloul Dalloul Pharmacy Private practice Pharmacist

Hala El Hout Ministry of Public Health Governmental Director, Central Laboratory

Noureddine El-Kouche

Rafic Hariri Foundation NGO General Manager

Abdo Ephrem Lebanese Society of General Practice Professional association President

Rola Ghandour# § Lebanese Society of General Practice Professional association Secretary

Leila Habr National Social Security Fund Social insurance Head, Medical Staff

Mona Haidar Lebanese American University – School of Medicine

Academia Coordinator, Social Medicine

Walid Hallassou MedNet Private sector – health care benefit management co.

Deputy General Manager

Ghassan Hamadeh American University of Beirut - School of Medicine

Academia Professor, Chair, Associate Dean

Rasha Hamra Ministry of Public Health Governmental Director of PR & Health Education Departments. Responsible for GGM program

Rabih Hassouneh #,§§

Lebanese Order of Pharmacists Professional association Secretary

Ghassan Issa Arab Resource Collective NGO General Coordinator

Salam Jalloul SANAD, the Home Hospice Association of Lebanon

NGO Executive team member and Physician

Rita Karam Ministry of Public Health Governmental Head, Import/Export Department

Cynthia Kheir YMCA NGO Pharmacist

Ziad Mansour WHO Country Office in Lebanon International agency Program Coordinator

Mirna Metni National Social Security Fund Social insurance Pharmacist

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Name Organization Type of organization Title

Marie-Claire Mouhawej

SANDAL, the Home Hospice Association of Lebanon

NGO Executive team member & Palliative care nurse

Maha Naous Ministry of Public Health Governmental Head, Central Drug Warehouse

Ziad Nassour Lebanese Order of Pharmacists Professional association President

Armand Pharès Lebanese Pharmaceutical Importers Association

Private sector President

Alissar Rady WHO Country Office in Lebanon International agency National Professional Officer

Bassem Saab American University of Beirut – Faculty of Medicine

Academia Professor

Rima Sassine-Kazan Order of Nurses in Lebanon Professional association Treasurer & Council member

Ismail Sukkarieh Private practice Private practice Gastroenterologist, former parliamentarian

Rita Wahab Soins Infirmiers et Développement Communautaire

NGO General Secretary, Vivre Positif

Antoine Wakim Independent Independent Member of Board of Directors of National Social Security Fund and ex-CEO, SNA (insurance company)

Marlene Zakhia# YMCA NGO Director, Medical Service

participated in the validation-prioritization meeting

# Participated in the validation-prioritization meeting but did not serve as a key informant § Represented the Lebanese Society of General Practice at the validation-prioritization meeting §§ Represented the Lebanese Order of Pharmacists at the validation-prioritization meeting

11.3. Appendix 3: Consent form

Consent Form to participate in the research project:

Identification of Priority Policy Research Questions in the area of Access to and Use of

Medicines

Protocol No.: FHS.SJ.03

Principle Investigator: Dr. Samer Jabbour

American University of Beirut Faculty of Health Sciences, Van Dyck Hall Beirut, Lebanon /(01) 350000 Ext. 4648 or (03) 826512 Email: sjabbour@aub.edu.lb Institutional Review Board: Ms. Lina El-Onsi American University of Beirut DALE Hall Tel: 1 374374, ext: 5445 Email: le08@aub.edu.lb Site where the study will be conducted: Department of Health Management and Policy and Center for Research on Population and Health, Faculty of Health Sciences and. American University of Beirut. Introduction

Many thanks for taking the time to review this form. I am Samer Jabbour. I am a researcher in the Faculty of Health Sciences, American University of Beirut. I am conducting a study to identify research priorities in the area of access to and use of medicines in Lebanon. This is part of a multi-country and multi-regional study supported by World Health Organization’s Alliance for Health Policy and Systems Research. Description of the Study This study aims to identify policy research questions in the area of access to and use of medicines. The study has two components. First, we plan to interview 15-20 key informants. The interviews will be recorded without personal identifiers using a digital voice recorder, transcribed anonymously, and analyzed to compile policy concerns and develop a comprehensive list of possible policy research questions. Second, all informants are invited to a meeting to prioritize among the identified policy research questions. The meeting will be recorded without personal identifiers using a digital voice recorder, and transcribed anonymously. The results of the prioritization exercise will be joined with results from other countries in this region and other regions to identify common policy research priorities for low and middle income countries and

45

which would guide future work on the World Health Organization and other agencies in this area. The study will start in March 2011 and finish in June 2011. Participant Selection

You are selected to participate in this study because your work directly or indirectly concerns the area of access to and use of medicines in Lebanon; can inform us about the policy research priorities that must be addressed in order to develop better policies and regulations to improve access to and use of medicines; and you are willing to take part in the study. Your rights as a participant

The interview will take one to one and a half hour of your time. Your participation in this study is totally voluntary. You have the right to withdraw your consent, withdraw from the study or stop communication at any time without penalty. Your decision not to participate will not influence your relationship with AUB. During the interviews, you can refuse to answer any questions addressed to you without the need to provide justification for such refusal. You can participate in the first phase or second phase or both. Benefits

There are no direct benefits to you from your participation in this study. Your answers will help in formulating policy research priorities related to access to medicines. Risks

Acknowledging that there may be unforeseeable risks, your participation in this study does not involve any physical or emotional risks to you beyond the risks of daily life. Confidentiality

To secure confidentiality of your responses, your name and other identifying information will not be attached to your answers. Consent documents are anonymous. Informants are asked not to avoid mentioning any identifying information during the taped interviews and prioritization meeting of informants. If any such information is inadvertently tape-recorded, it will not be transcribed. The recorded tapes of interviews and prioritization meeting of informants will be destroyed after transcription is completed. Data access is limited to the principal Investigator and research assistants working directly on this project. Both have password-protected computers. The folders will data will be stored will have an additional specific password protection. Your privacy will be maintained in all published and written data resulting from this study. Your name or other identifying information will not be used in our reports or published papers. Consent

I have read and understood all aspects of the research study and all my questions have been answered. I voluntarily agree to be a part of this research study and I know that I can contact the

principal investigator at 4648 in case of any questions. If I feel that my questions have not been

46

answered, I can contact the Institutional Review Board at 5440 (Ms. Lina El-Onsi). I understand that I am free to withdraw this consent and discontinue participation in this project at any time, even after signing this form, and it will not affect my care or benefits. I know that I will receive a copy of this signed informed consent. (Please check the box). I agree to participate in the study Date: _____________________ Name of the interviewer(s): __________________________________ Date of the interview: _______ Time: from ________ to ________ Signature of the interviewer(s): ______________________________

47

11.4. Appendix 4: Interview guide (modified after the guide provided by Dr. Arash

Rashidian et al)

Introduce yourself to the informant. Give a summarizing statement about the project and the purpose of the interviews. Clarify that the interview will be digitally-recorded and transcribed without identifying information. Review the consent document and ask for consent prior to proceeding. Ask the informant not to provide any identifying information during the interview. 1-How do you define 'access to medicines'? What are the different dimensions of such

access?

2- In your view what are the key issues relating to access to medicines in Lebanon (if not

mentioned by the informant, the interviewer can explore issues such as affordability to pay,

insurance coverage, drug quality, rational drug use and/or health system financing in

'access to medicines')? (note to the interviewer: you may need to ask about issues one by one.)

• If the informant seems well knowledgeable about the key issues, explore the policy concerns

and corresponding research questions under each key issue. Then use a snow-bowling

technique to explore other issues that come up in the discussion and identify relevant policy

concerns and research questions.

• If the informants seems uncomfortable with the opening questions or does not appear

knowledgeable about the issues, please to ask specific questions as below.

3-What do you think of the health system performance in Lebanon in relation to access to

medicines?

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

4-What are the challenges in access to medicine at the level of health sector policy

(stewardship and governance function)?

(examples of governance issues may include: national drug list, pricing, import or production

regulation, generic or brand policy, subsidizing, quality control, pharmaceuticals share of total

health expenditure …)

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

48

5- What are the challenges in Lebanon's health insurance system in securing access to

medicines? (Including insurance coverage, the decisions to cover medicines, depth of

coverage…)

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

6- What are the challenges in production, procurement and supply chain for access to

medicine? What factors may improve this system? (Factors influencing public and private

sectors, drug pricing, pharmacies' geographical distribution and geographical access to

medicines, healthcare networks, hospital pharmacies, ..)

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

7- Thinking of the role of other sectors in access to medicines, what are the challenges at

the national and international level? (e.g. think of the positive or negative roles that the

following may have: ministries of finance, commerce and industry; authorities that issue

standards, medical councils or unions, pharmaceutical societies, NGOs, patient groups, medical

societies, WTO, WHO, donors in your country …)

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

8- What do you think are the factors that affect access to medicine at the individual,

household and community levels? (e.g. demand for medicines, care-seeking behaviour,

knowledge and preferences of users, beliefs, socio-cultural constraints, financial barriers for

individuals, households and communities)

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

9- What are the barriers and challenges in access to medicines related to provider

(physicians, pharmacist...) behaviors? (e.g. induced demand, rational drug use, reimbursement

methods, retailing behaviour, generic substitution policy, pharmacy revenue, OTCs, herbal

medicines, drug counterfeits and fraud …)

49

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

10- Is there anything else you would like to add? Are there other research priorities you

would like to propose?

Thank you very much for your participation in this study.

11.5. Appendix 5: Literature review

Appendix 5-A: Journal articles

1st Author Year Title

Zgheib et al 2011 Using Team-based Learning to Teach Clinical Pharmacology in Medical School: Student Satisfaction and Improved Performance

Abi Rizk et al 2010 Determinants of antibiotic use and throat culture in managing pharyngitis among primary health care physicians in Beirut

Ghosn 2010 Crackdown on pharmacies in Lebanon spurs blame game

Khachan et al 2010 Pharmacy education in Lebanon

Riachy et al 2010 Application of a hospital audit to the use of nebulizers: the Case of the Hôtel-Dieu de France-Lebanon

Bou Antoun & Salameh

2009 Satisfaction of pharmacists in Lebanon and the prospect for clinical pharmacy

El Sayed et al 2009 Prospective study on antibiotics misuse among infants with upper respiratory infections, European

Nassar et al 2009 Prescribing practices among Lebanese obstetricians for prenatal corticosteroids to enhance fetal lung maturity

Scicluna et al 2009 Self-medication with antibiotics in the ambulatory care setting within the Euro-Mediterranean region; results from the ARMed project.

Kyriacos et al 2008 Quality of amoxicillin formulations in some Arab countries

Naccache et al 2008 Pain management and health care policy

Sievert et al 2008 The medical management of menopause: a four-country comparison care in urban areas

Solberg 2008 Lebanese turn to drugs to treat mental-health problems

El-Hajj Fuleihan et al 2007 First update of the Lebanese guidelines for osteoporosis assessment and treatment

Salameh et al 2007 Pharmacy manpower in Lebanon: An exploratory look at work-related satisfaction

Salameh et al 2007 Drug circuit in Lebanese hospitals

51

1st Author Year Title

Araj et al 2006 Nationwide study of drug resistance among acid-fast bacilli positive pulmonary tuberculosis cases in Lebanon

El Accaoui et al 2006 A review of the off-label use of recombinant activated factor VII in a developing country tertiary care center,

Harakeh et al 2006 Antimicrobial-resistance of Streptococcus pneumoniae isolated from the Lebanese environment

Saab et al 2006 Inappropriate medication use in elderly lebanese outpatients: prevalence and risk factors

Salameh et al 2006 Clinical pharmacy in lebanon: a pilot study regarding health care professionals' opinion

Uwaydah et al 2006 Penicillin-resistant Streptococcus pneumoniae in Lebanon: the first nationwide study

El-Hajj Fuleihan et al 2005 Lebanese guidelines for osteoporosis assessment and treatment: who to test? What measures to use? When to treat?

Kanafani 2005 Antibiotic use in acute cholecystitis: practice patterns in the absence of evidence-based guidelines

Kassab et al 2005 Setup of a national system of adverse drug reaction reporting in Lebanon: results of the first year of activity

Nassar et al 2005 Gynecologists' attitudes towards hormone therapy in the post "Women's Health Initiative" study era

Dib et al 2004 Pharmacy practice in Lebanon

Azzam et al 2002 Survey of antimicrobial prophylaxis for surgical procedures in Lebanese hospitals

Makhlouf Obermeyer et al

2002 Medication use, gender, and socio-economic status in Lebanon: analysis of a national survey

Bizri et al 2001 The current status of antibiotic prescribing in ambulatory care the Lebanese experience

Hamadeh et al 2001 Common prescriptions in ambulatory care in Lebanon

Saab et al 2001 List of essential drugs for primary care in Lebanon

Araj & Kanj 2000 Current status and changing trends of antimicrobial resistance in Lebanon,

Araj et al 2000 Comparative study of antituberculous drug resistance among Mycobacterium tuberculosis isolates recovered at the American University of Beirut Medical Center: 1996-1998 vs 1994-1995

Azar 2000 A practical guideline for management of hypertension in patients with diabetes

52

1st Author Year Title

Naja et al 2000 A general population survey on patterns of benzodiazepine use and dependence in Lebanon

Araj et al 1999 Drug-resistant Streptococcus pneumoniae in the Lebanon: implications for presumptive therapy

Araj 1999 Human brucellosis: a classical infectious disease with persistent diagnostic challenges

Major et al 1998 Drug-related hospitalization at a tertiary teaching center in Lebanon: incidence, associations, and relation to self-medicating behavior

Araj 1997 Antibiotics: A need for regional surveillance and a control program.

Hamze & Araj 1997 Drug resistance among Mycobacterium tuberculosis isolates in Lebanon

Major 1997 Drug related illness leading to hospitalization at the American University of Beirut-Medical Center

Araj et al 1994 Antimicrobial susceptibility patterns of bacterial isolates at the American University Medical Center in Lebanon,

Santanam et al 1990 Prevalence of antimicrobial resistance in Haemophilus influenzae in Greece, Israel, Lebanon and Morocco

Appendix 5-B: Published and unpublished documents and gray literature

Year Author Lang Type Title

2011 Shebaro, H English WORD DRUG MARKET ANALYSIS LEBANON 2010

2011 Harb, R English Article in Daily Star Misuse of antibiotics leading to hardier diseases: WHO

2010 Karam, R English PDF Registration and interpretation of drugs in Lebanon (Volume I & II)

2010 Karam, R English PDF Lebanese Drug Market Study

2010 WHO – Lebanon English PDF COOPERATION STRategy at a glance

2010 WHO, World health report English PDF HEALTH SYSTEMS FINANCING -The path to universal coverage

2010 FDA English PDF GUIDANCE FOR CLINICAL INVESTIGATORS&SPONSORS

2010 Sukkarieh, I Arabic Book Medicines…Mafia or the crisis of a regime? Part – 1

2010 Sibai, A., & Hawalla, N English PDF WHO STEPS Chronic Disease Risk Factor Surveillance

2009 MoPH English PDF Lebanon National Drug Index - Addendum to the second edition

2009 Ammar W English Book Health beyond politics

2009 Hamra R et al English PDF MEASURING TRANSPARENCY TO IMPROVE GOOD GOVERNANCE IN THE PUBLIC PHARMACEUTICAL SECTOR

2008 Raidy, C Arabic PPP LECTURE VARIATIONS OF IMPORTED DRUGS /PPP

2008 Raidy, C Arabic PPP LECTURE VARIATIONS OF LOCAL DRUGS /PPP

2008 MoPH English Book Lebanon National Drug Index - second edition

2008 Sukkarieh, I Arabic PDF The right to Health, for UNDP, the national plan for Human Rights

2007 Karam, R English PDF Current licensing procedure for generics in Lebanon

2007 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE – BAHRAIN

2007 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –LYBIA

2006 Hamadeh, G English PDF PROPOSAL FOR UPGRADING THE DRUG REGULATORY SYSTEM at the Ministry of Public Health

2006 Boustani, M English PDF Proposal For The Improvement Of the MOH Chronic Drug Distribution System In Lebanon Prepared for Community Health Consultants

2006 Phares, L & Karam, R English PDF PROPOSAL FOR UPGRADING THE DRUG REGULATORY SYSTEM at the Ministry of Public Health

2006 Harvey, K English PPP LECTURE- ROLE OF DRUGS & THERAPEUTIC COMMITTEES

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE – EGYPT

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE – IRAN

54

Year Author Lang Type Title

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE – IRAK

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –JORDAN

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –KUWAIT

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –LEBANON

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –MOROCCO

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –OMAN

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –QATAR

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE -SAUDI ARABIA

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –SUDAN

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –SYRIA

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –TUNISIA

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –UAE

2006 WHO- Regional HSO English PDF HEALTH SYSTEM PROFILE –YEMEN

2005 WHO English PDF International Health Regulations

2005 WHO/DMP/RGS English PDF MARKETING AUTHORIZATION OF PHARMACEUTICAL PRODUCTS WITH SPECIAL REFERENCE TO MULTISOURCE (GENERIC) PRODUCTS: A MANUAL FOR DRUG REGULATORY AUTHORITIES

2005 Seiter English PDF Lebanon Health Sector Development Project. Technical Discussion Paper

2005 3rd Italo-Lebanese Conf. English Proceedings Pharmaceutical Policy Development Pricing – Registration – Local Production Final Report

2004 Mossialos, E et al English Book chap Regulating pharmaceuticals in Europe: an overview

2004 Seiter WB English PDF Pharmaceutical policy reform in Lebanon.

2004 Seiter WB English PDF The pharmaceutical sector in Lebanon: Issues, stakeholder views, policy options for reform

2004 Karam, R English PDF Medicine prices in Lebanon: A new approach for measurement

2004 Mansour Z English Paper WHO mission for drug pricing in Lebanon.

2004 WHO English PDF Equitable access to essential medicines:a framework for collective action

2003 Ammar, W English Book Health system and reform in Lebanon

2002 Karam, R English PDF Cost comparison of the drugs in Lebanon and some European countries

2002 Mansour Z English Paper WHO mission for drug pricing in Lebanon.

2001 NSSF- Lebanon French List Liste des medicaments agrees par la CNSS

2000 Arbid B Arabic Book Health - Reality and solutions: Towards rationalization of health spending and correcting

55

the path of health policy

Year Author Lang Type Title

1999 Aydenian H, et al English

PDF Estimating drug requirements in different types of health centers

1999 WHO English

PDF Effective drug regulation. What can countries do? Essential drugs and other medicines

1996 MoPH & UNICEF English

Book Essential drugs for PHC vol1,

1996 MoPH Arabic

Book Essential drugs in primary health care - Part 1

1994 Abdel Hadi A & Issa G Arabic

PDF Drug issues in the Arab countries: Essential drugs and the rational use of drugs - Challenges and initiatives

1986 Nasif ED French

PhD thesis A proposed implementation plan for the epi of Lebanon

1985 Mroueh, A & Kronfol, N English

Book Health services in Lebanon - Part 2

Appendix 5-C: Regulatory documents

Year Type Concern Document Title

2001 Report import Parliamentary report 2001 Drugs - 3dr part

1998 Law Financing R Act 673 transport a fund within MoPH

1995 Decree Governance K Decree 6381 fees of the members of technical commission

2002 Decision Ethics, human rights LEBANON LAW OF PATIENTS RIGHTS ق 574 ر�� ����ن� �� ا������ ة وا���ا�� ا��

2004 Resolution import E MR 212 Re-regulation of the import procedures

2003 1- Law import H Act 530 condition of registration, import, marketing and classification of pharmaceutical products

2003 Agreement Import-export 33.HEALTH AGREEMENT SYRIA & LEBANON - 2003

�� ا���زة��� !�/ ا�.وا-�� و ا�,*�� ا����)�ت %*�دل �)�ل �' %&�ون ! و%�آ�ل أ! ام �� ا���ر�0 ا�& !�� ا�)��1ر�0 و ا��*����� ا�)��1ر�0

2000 Decree import J Decree 17710 formation of a commission in the MoPH to regulate the import of natural medicines and food supplements

1999 Decree import M Letter 6381 Letter from the minister of PH to the syndicate of drug importers

1998 Resolution import H MR 539 related to the import pf pharmaceutical products

1994 Resolution import 0 MR 968 related to the condition of import, export, production, sale, distribution medicinal plants, vitamins, minerals and food supplements that have a pharmaceutical form

1993 Resolution import G MR 233 Regulation of drug registration

2009 Decree Local industry 4.GMP LEBANON DECREE- 2009 Production guideline to ensure quality of locally manufactured drugs

2009 Decree Local industry GMP LEBANON DECREE- 2009 ARABIC

Production guideline to ensure quality of locally manufactured drugs in Arabic

2009 Decree Local industry GMP LEBANON DECREE- 2009 Control of local production by guidelines

2001 Resolution Local industry N MR 543 Form a committee to study latest global evidence related to the production and trade of drugs, and to propose legislation projects for the re-regulation for the registration, import, and export of drugs in Lebanon

1985 Decision Local industry 6.GMP LEBANON - 1985 ار 8 و67 و �5دو�0 ا�)�. ا��3��4 أ�2ل 35/1 ر�� �

1983 LAW Local industry 3.LAW OF DRUG MANUFACTURER NO.106-83

�9م� ا�دو�0 �3��4 إ�>�ء 106 ر�� ا:' ا�8

1983 Decree Local industry Q Decree 106 establishment of drug manufactories

1961 Decree Local industry P Decree 12063 related to the establishment of drug manufactories

2010 Decision Pharmacies DIRECTIVE NO.45.1 22.01.2010 CLOSE 11 PHARMACIES

measures taken against fraudulous pharmacies

2010 Ammend. Pharmacists AMENDMENT- LAW OF PHARMACY -INVOICE

Regulation of drug sale

2010 Decision Pharmacists DECISION NO. 29-1 -2010 - INVIOCE- Regulation of phamacy work

57

EXP.& BATCH

2000 Law pharmacists 19940801 Law 367-English Version-Argus

governing the practice of the profession of pharmacist

1998 Law pharmacists T Act 83-5 everything about the regulation of the pharmacy profession

1995 Decree Pharmacists L Decree 6382 defining fees for the acquisition of a permission to practice the profession of pharmacist, or launching or run a pharmacy or a drug manufacture

1994 Law pharmacists 19940801 Law 367 (Pharmacy Practice) related to the pharmacist profession practice

1994 Law pharmacists A Act 367 regulation of the profession of pharmacist

1994 Law pharmacists 1.LAW OF PHARMACY LEBANON - ARABIC

�<او�� ����ن ��1� �*��ن �' ا��4.��

1994 Law pharmacists 2.LAW OF PHARMACY LEBANON - ENGLISH

Regulation of pharmacists profession

1994 Law pharmacists 3.LAW OF PHARMACY - FRENCH Regulation of pharmacists profession

1994 Law Pharmacists LAW OF PHARMACY LEBANON No.367-1994 - ENGLISH

Regulation of pharmacists profession

1994 Ammend. Pharmacists AMENDMENT - LAW OF PHARMACY MEDICAL

Regulation of pharmacists' profession

1994

Ammend.

Pharmacists AMENDMENT- NATURAL PRODUCTS NO. 29.1.2010

Regulation of pharmacists' profession

1994

Ammend.

Pharmacists AMENDMENT- LAW OF PHARMACY COUNTERFEIT 1.7.2010

ND Decision Pricing customs tables Custom amounts

ND Rules Pricing Jadawel ��-? @0��% ا��)�ز ا��&A��/ ا��*�3 9& ا�� ا�����رد ����� Pricing rules ا��*����� !���� ة - �*��ن �' ا�&��م

ND Rules Pricing Price structure V W Y pricing structure middle east countries Pricing rules

2008 Decision Pricing Initial 208 regulation of drug pricing either imported oe produced locally

2006 Decision Pricing 20060202 Pricing decision 51-1 Pricing Decision

2005 Decision Pricing 20050609 Pricing Decision 306-1 Bases of drug pricing

2005 Decision Pricing Karar 306 Bases of pricing of medicines

2005 Decision pricing decision 306 modifications related to the bases of drug pricing

2005 Decree Pricing PRICE DECREE 306-1 - 9.6.2005 Bases of drug pricing in Arabic

2004 Decree Pricing F Marsum 128311 Exemption from taxes of the chronic drug program b/w MoPH and YMCA

2004 Law Pricing- comparison Jordan pricing act related to drug pricing in Jordan

2002 Law Pricing 20021214 Law 480 Permission to sell drugs at lower prices

2002 Law pricing B Act 480 pharmacist free to sell at lesser prices

2001 Law Pricing LAW OF CUSTOMS LEBANON - 2001 the general custom law in Lebanon

2001 Decision Pricing E Karar 119 reduce taxes and importation fees on medications

1999 Resolution pricing C MR 503 About the processes of pricing

58

1983 Decision Pricing B Karar 208 bases of drug pricing

1970 Decision Pricing A Karar 361 regulation of drug pricing either imported or produced locally

2011 Decision Registration MoPH LOCAL DRUG REGISTRATION BIOEQUIVALENCE DATA

Modification of previous decision in what concerns registration of locally produced drugs. In Arabic

2010 Decree registration LEBANON DRUG RECALL 2010 decrees concerning drug registration of all marketed drugs in Lebanon 2010

2009 Decree registration LEBANON DRUG RECALL 2009 decrees concerning drug registration of all marketed drugs in Lebanon 2009

2008 Decree registration 20081030 Applicative Decree 571 for Law 530

condition of registration, import and marketing and classification of drugs

2008 Decree Registration 1.DRUG REGISTRATION & CLASSIFICATIONS MARSOUM 571 .2008

B�*,% م����� ا��C��C ا���د%�/ أ�Dوا� /� وا��9 اد %�)�@ 8 وط) ٥٣ ر�� ا����ن B0��%و H��4%٦٠ و ٥٤ و ٥٣ و ٥٢ وا���اد (ا�دو�0 و /� و%&.N0%6 ٣٦٧ ا����ن

�<او��) ��1� (ا��4.��

2008 Decree Registration LEBANON DRUG RECALL 2008 decrees concerning drug registration of all marketed drugs in Lebanon 2008

2004 Decision registration E MR 212 reg Decision about regulation of drug registration

2003 Law registration 20030724 Law 530 authorization to import and marketing

2002 Decision registration 20020213 Decision 96-1 modification of previous decision

2000 Law Registration S Act 193 about illicit drugs trade – Quality control

1998 Decision registration 19980825 Decision 539-1 (revision-update of decision 90-1)

related to the import of pharmaceutical products

1992 decree registration 19920313 Decision 90-1 (Parellel import ministerial decree)

parallel import related to the import of (special) pharmaceutical products

1991 Resolution Registration- I MR 114 related to the import and production of pharmaceutical products

1983 Decision registration 19830503 Pricing Decision 208-1 Pricing Decision

Guidelines/ codes/ decisions

ND Powerpoint Local industry FDA’S CLINCAL STAGES- PPT FDA production standards

ND Guidelines Clinical labs LEBANON CLINICAL LABORATORY GUIELINES

Guidelines for Licensing Clinical Laboratories

2008 Ethical codes LEBANON DRUG ETHICAL STANDARDS

���Cق وا�� ا�&� ا� 2. و���Qت �*��ن �' ا�دو�0 �� وP0 ا����NO ا��&��0

2008 Guidelines Ethics LEBANON CODE OF ETHICS وا�� ا�&� ا� 2. و���Qت �*��ن �' ا�دو�0 �� وP0 ا����NO ا��&��0

2004 Guidelines Ethics Pharmaceutical companies

LEBANON GOOD ETHICS OF PHARMA. MARKETING

�*��ن �' ا�دوB0��% �0 ����ر�9ت ا���7' ا����Cق

2007 Guidelines Local industry HOW TO PASS FDA & EU INSPECTIONS & GMP

How to Pass EU and FDA Inspections & GMP Compliance Auditor Course

2009 Guidelines Local industry 17.GMP GUIDELINES LEBANON 2009 guidelines for drugs production

ND Guidelines Quality control WHO CERTIFICATION SCHEME + GUIDELINES ON THE IMPLEMENTATION OF THE WHO

59

MODEL C.P.P CERITIFICATE CERTIFICATION SCHEME ON THE QUALITY OF PHARMACEUTICAL PRODUCTS MOVING IN INTERNATIONAL COMMERCE

ND Guidelines Registration GUIDELINES FOR REGISTRATION FOR BIOLOGICALS

GUIDELINES FOR APPLICATION FOR REGISTRATION OF BIOLOGICALS

ND Guidelines 4.PRICE REGULATIONS contains 11 documetns from which 2 PDF

ND Guildelines Registration TYPE I & II VARAITIONS - DEFINITION Definition of the variations after the first entry of the drug into the Lebanese market

Handouts/

2006 Directives Pricing PRICE DIRECTIVE NO.51.1 - 21.1.2006 PRICE DIRECTIVE

2005 Directives Pricing PRICE DIRECTIVE NO.306-1-2005 PRICE DIRECTIVE

ND Handout import reg application application form to register a new drug

ND Handout import comparison of reg pricing req registration requirement in the middle east countries

2004 Handout import questionnaire enlglish documents required for the registration of a pharmaceutical product in Lebanon. Decree 212

ND handout import D doc Documents needed for registration of a new Pharmaceutical product in Lebanon

2011 handout Import 2.REGISTRATION REQUIREMENTS OF IMPORTED DRUGS 2011

REGISTRATION REQUIREMENTS OF IMPORTED PHARMACEUTICAL PRODUCT LEBANON – 2011

ND Handout Local Industry ANNEX 3 PLANT PROFILE Plant profile

ND Handout Local Industry ANNEX 5 - A APPLICATION LOCAL MANUF. DRUG ARABIC

ND Handout Local Industry ANNEX 5 - A APPLICATION OF LOCAL MANUF. ENGLISH

ND Handout Local Industry ANNEX 5 - B APPLICATION OF LOCAL LICENCE. ENGLISH

ND Handout Local Industry ANNEX 5 - B APPLICATION OF LOCAL UNDER LICENCE –Arabic

ND Handout Local Industry ARAB GMP REGULATIONS ا��.و�� ��! ات ��3��4 ا�)�.ة �����ر�9 ا���-.ة ا��*�دئ �' ا�&A� ا��4.?��� ا����ND Handout Local industry GMP INSPECTION CHART FDA production standards

ND Handout Pricing PRICING DATA REQUIRED BY THE LEBANESE M.O.H

List of documents required to price a product

2008 Handout Pricing 3.PRICING DATA REQUIRED BY M.O.H LEBANON

Needed documents to price a pharmaceutical product

ND Handout Pricing EMRO WHOLESALER & RETAILER MARK-UPS

WHOLESALER & RETAILER MARK-UPS in the region, including jordan, Kuwait, syria, Pakistan, Sudan Yunisia Yemen

ND Handout Pricing M.O.H PRICE SEGMENTS Total Cumulative Markup “FOB & CIF” Prices Lebanon

ND Handout registration Screen shot internet registration of drugs

Handout registration 1.DRUG REGISTRATION IMPORTED DRUGS + CHECK LIST

contains 27 documents, from which 3 PPT and 2 PDF

ND Handout Registration ANNEX 7 Requirements to Register imported Biological and Generic Locally Manufactured pharmaceutical products

60

ND Handout Registration ANNEX 9 TYPE I VARAITIONS - LOCAL- ENGLISH

TYPE I VARAITIONS LOCALLY MANUFACTURED PRODUCTS

ND Handout Registration ANNEX 11 TYPE II - Ar ات A����� ا���4&� ا���)�� ������ (TYPE II VARIATIONS) تN0.&% �STا� ����Cا�

ND Handout Registration ANNEX 11TYPE II - En TYPE II VARAITIONS LOCAL MANUFACUTURED PHARMACEUTICAL PRODUCTS

ND Handout Registration MoPH LOCAL DRUG REGISTRATION APPLICATION

Registration of a locally produced drug, Arabic

ND Handout Registration MoPH LOCAL DRUG REGISTRATION APPLICATION UNDERLICENCE

Registration of a locally produced drug under license, Arabic

2008 handout registration DRUG REGISTRATION REQUIREMENTS. 571 - 27.10.2008 - ENGLISH

List of documents to be submiteed for drug registration

2011 handout registration 1.REGISTRATION CHECK LIST - 2011 REGISTRATION REQUIREMENTS CHECK LIST 2011

2011 handout Registration 3.MoPH BIOLOGICALS DRUG REGISTRATION CHECK LIST

Pharmaceutical product registration file

ND Handout Registration ANNEX 8 TYPE I VARAITIONS - IMPORT - ENGLISH

TYPE I VARAITIONS IMPORTED REGISTERED PHARMACEUTICAL PRODUCTS -- conditions of variations for Austria, Australia, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Norway, Netherlands, Spain, Sweden, Switzerland, UK, USA

ND Handout Registration 7.PRICING DATA FROM OFFICIAL INTERNET

Conditions of accepting documents printed out from internet sources.

2001 Handout regulation of import - pricing

G Muzakara 1711 conditions of acceptance of original bill

ND Handout 2.DRUG REGISTRATION APPLICATIONS FORMATS 2011

contains 24 PDF

2010 List Import DRUG IMPORT BY AGENT 2010 List of agents importing drugs and the number of drugs they import

2011 List License 1.OPL LISTMED PHARMACOLOG 09.04.2011

the latest list of licensed drugs in Lebanon and their number

2010 List Pharmaceutical companies

LIST OF LARGEST PHARMACEUTICAL COMPNIES 2010

LIST OF LARGEST PHARMACEUTICAL COMPNIES 2010

2011 List Pricing 1.M.O.H PRICE LIST 04.01.2011 latest official prices of drugs on the Lebanese market

2011 List Registration LEBANON NUMBER OF REGISTERED MEDICINES 1964 - 2010

Number of registered medicine from 1964- 2010

2011 List NSFF 1.LISTE CNSS 2011 + SUPP.19+430+14032011

list of pharmaceutical products reimbursed by the CNSS

2010 List YMCA list YMCA DRUG LIST 2010 YMCA drug list

Official documents

61

ND Questionnaire Import 4.ANNEX 2 COMPANIES PROFILE Questionnaire to pharmaceutical companies inquiring about the institutions they are affiliated to

ND Questionnaire Import 5.ANNEX 3 PLANT PROFILE Questionnaire to pharmaceutical companies inquiring about the plant profile of manufacturers

2011 Application Import 6.STATEMENT RELATION BETWEEN THE PARTIES

Application of a Laboratory

no date

Handout import F Questionnaire Documents needed for import from foreign manufacture

2011 Application Import 6.COMPANY STATEMENT REGARDING THE RELATED PARTIES

Application of a pharmaceutical company

ND permission Local industry 1.PERMIT TO LICENSE A MANUFACTURER

U�7 V�O �5دو�0 ��4&� إ�>�ء %

ND permission Local industry 2.PERMIT TO LICENSE A MANUFACTURING PLANT

1. U�7 V�O �5دو�0 ���C�9? 3�4ر ا��

ND Application Pricing ANNEX 10 TYPE II VARAITIONS - IMPORT ENGLISH

TYPE II VARAITIONS IMPORTED PHARMACEUTICAL PRODUCTS for change of dosage dosage,

ND Application Pricing APPLICATION FORM DRUG PRICING �0.% ات ا9&�ر �.اول A� ا�,*�� ا����

ND Application Pricing M.O.H PRICE APPLICATION FORM Pricing application form

ND Certificate Pricing 8.PRICE CERTIFICATE OF NEIGHBORING COUNTRIES

certify about the price of sale in neighbouring countries

ND Certificate Pricing 4.M.O.H PRICE CERTIFICATE The chain of pricing of a product from the export point to the retail point

ND Certificate Pricing 6.COMPARATIVE STUDY TABLE - 6 - BY IMPORTER

Study of Comparative Prices in the Currency of the Country of Origin

ND Certificate pricing 7.M.O.H PRICE CERTIFICATE certify that the imported product comply with all the legal requirements for sale in original country

ND Application Registration ANNEX 4 PAGES 1&2 APPLICATION IMPORT ARABIC

U�7 @�(�% A��������رد �2.?�'

ND Application Registration ANNEX 4 PAGES 1&2 APPLICATION IMPORT ENGLISH

Application for the Registration of Imported pharmaceutical Product

ND Application Registration ANNEX 4 PAGES DRUG REGISTRATION APPLICATION

U�7 @�(�% A��������رد �2.?�'

ND Application Registration ANNEX 6 REG. OF IMPORTED BIOLOGICAL ENGLISH

Application for the Registration of Imported pharmaceutical Product

ND Application Registration APPLICATION FORM DRUG REGISTRATION

U�7 @�(�% A��������رد �2.?�' detailed with chemical composition and bioequivalence

2010 Application Registration APPLICATION FORM DRUG VARATION

Application form to perform vhange in the composition, dosage of a drug already in the market

62

2010 Certificate Registration 9.STATEMENT FOR VARAITIONS

Company confirmation that there will be no changes in the registration status, product name, manufacturing procedure, formulation, active and non active ingredients, drug specifications, labelling and quality control of the product.

2012 Application Registration APPLICATION FORM MEDICAL DECIVE

request of classify a product as a drudg

2012 Application Registration APPLICATION FORM VITAMINS Registration of a food supplement and vitamine

2010 Technical report

specification WHO EXPERT COMMITTEE ON PHARMA SPECIFICATIONS 2010

WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS

63

11.6. Appendix 6: Research questions

Appendix 6-A: Research questions emanating from literature review

Research question

Study of drug resistance, clinical comparison over time of resistance, and assessment of factors influencing it.

Determinants of medication purchasing and use behaviors among the public.

The relationship between emergence of resistant strains and poor prescribing and user behaviors.

Prevalence and incidence of drug-related complications at a national level. Comparison with regional and international numbers, linked with the characteristics of drug market regulation.

Study of off-label use of medicines.

Study of physician prescribing behaviors and the link with characteristics of clinical practice.

Evaluation of adherence of providers to treatment guidelines in their prescribing practices, the factors reinforcing or hindering adherence.

Evaluation of the drug reporting system, and assessment of obstacles.

Evaluation of the impact of audits on physicians' compliance with prescribing guidelines.

Assessment of the impact of different interventions to regulate the medicines market and promote rational prescribing, dispensing and use of medicines. Comparison of outcomes before and after the intervention.

Assessment of medication use behaviors in major groups of illnesses.

Evaluation of curricula of medical students in relation to access to medicines.

What is the link between prescribing legislation and use patterns of psychotropic drugs and narcotics

Determinants of medicines use behaviors. How does family income influence medicines use?

Assessment of quality control of medicines in the market.

Are counterfeit drugs an important issues in the Lebanese market? Tracing the path of entry of counterfeit drugs.

Evaluation of cost effectiveness of generic vs. branded medicines

Study of prescribing behaviors and determinants of non-compliance with evidence-based guidelines

The influence of cultural factors on prescribing and use behaviors

Evaluation of regulatory laws in prescription

Comparative studies between generic and brand drugs in the goal of advertising for the use of generics and optimize cost effectiveness of medication

Determinants of patterns of self-medication

Evaluation of guidelines in terms of cost effectiveness of different treatment strategies

64

Assess the perceptions of pharmacists regarding access to medicines

Assessment of population needs for medicines through epidemiologic studies

Evaluation of budget allocation for medicines and assessment of impact on ATM

Comparative studies of prices of medicines and of expenditures on medicines with other countries in the region and with countries of similar level and level of development

Study of the processes for selection and registration of medicines, and the factors influencing these processes

In relation to the import of medicines, assess the cost-effectiveness of the import of medicines. Are the alternatives valid?

Assess whether selection of coverage of medicines by social insurance funds is rational and explore alternatives to improve the rational selection

Assessment of public and professional perceptions about generics and their cost effectiveness

Comparative studies of clinical and cost-effectiveness between generics, branded generics and originator brands

Among local pharmaceutical manufacturing companies, assess adherence to good manufacturing practices (GMP)

Assess the efficiency of the medicines distribution network (through the PHC centers and dispensaries) and its reach to underserved areas and how the network impacts ATM

Evaluate the program for distribution of medicines for chronic condition by YMCA in terms of the process, wastes and corruption, overuse and misuse by beneficiaries, reach to intended users, and user satisfaction.

Explore the sources and outcomes of conflict of interests of different stakeholders in the health workforce

Assess the satisfaction of different health professionals with the way medicines are handled.

Evaluate the influence of over-supply of physicians and pharmacists on ATM. Assess the relationship between over-supply of physicians and poor prescribing practices and assess the relationship between over-supply of pharmacists and poor dispensing practices

Assess the quality of user-pharmacist interactions in pharmacies and in dispensaries

Study the marketing strategies of pharmaceutical companies, and link it with the rational selection and use of medicines.

Compare the marketing strategies of multinational pharmaceutical companies, and those of local companies and link it with the prescribing behavior of doctors, and with purchasing behavior of patients.

65

Appendix 6-B: Research questions emanating from key informant interviews

Rational selection and use

Explore perceptions of providers and patients about the use of generic drugs

Explore the medicines seeking/purchasing behaviors of consumers. Compare and contrast between different Lebanese communities and SES categories

Secondary data analysis to identify trends of medicines purchasing behavior

Assessment of prescribing behaviors of providers and the determinants of such behaviors

What are the factors that impact physicians’ prescribing behaviors?

Medicines purchasing behaviors and their determinants and associated factors

Population needs assessment to guide rational selection of medicines

Assessment of central control of prescriptions, dispensing and promotion of medicines

Production of treatment guidelines to guide selection of medicines

Assessment of adherence of providers to treatment guidelines

Explore the factors influencing the misuse of antibiotics/ antidepressants/sedatives, etc…

What should a unified structured prescription form include? How can this form be applied and monitored?

Cost analysis of the unified prescribing form

What are the barriers faced by NSSF in enforcing rational use of medicines? How can these barriers be overcome?

What are the possible mechanisms that can be used to control dispensing of drugs?

How can we control the aggressive marketing of drugs?

Explore the marketing practices of pharmaceutical companies and the impact on access to medicines

Do doctors and hospitals follow the treatment and prescribing guidelines? How can adherence be ensured?

Explore the appropriate mechanisms to implement generic substitution of branded medicines

What standards can be followed to update the essential drug list?

Identify the factors that affect the population’s basic knowledge of medicines

Explore the methods of increasing providers and patients' awareness regarding rational use of medicines

How can international guidelines be adapted for management of diseases and thus improvement of prescribing behaviors?

Explore the adherence by practitioners to the code of ethics and professionalism among physicians

Why do people take medications without consulting a physician? And how this can be overcome?

Explore self-medication and its determinants and correlates

To what extent do drug representatives adhere to the code of ethics for promotion of pharmaceutical products?

The knowledge of physicians about laws related to prescriptions.

Explore barriers to improving knowledge of physicians about prescribing behaviors and the adherence of physicians to the prescription laws.

Explore the household pattern of medicines usage

66

What are the guidelines for substitution of drugs by generics and how they can be implemented and monitored?

Assess factors influencing follow up on patients taking medicines for chronic conditions.

Affordability

Study the cost effectiveness of generics. Are generics cost effective in Lebanon considering the phenomenon of branded generics?

How can we ensure sustainability of high quality services regarding education and drugs?

Assess processes and explore ways of improvement of medicines price control

Price analysis of imported and locally manufactured drugs, especially chronic medication.

Assess processes of better pricing tenders, for example as is done by the Army, to reduce procurement prices of medicines purchased by the MoPH

How to develop guidelines for fair pricing

Pricing studies: Price structure in the country of origin.

Assess transparency in pricing mechanisms

Trace the sources of price increase

Study the Lebanese drug market

Anticipate the influence of the generic drugs on the cost of essential medicines

Pharmaco-economic study (multidisciplinary)

Is the price appropriate? Should consumers have multiplicity of choices or a standard list?

Forecast changes in the population needs for free or subsidized medicines and explore ways of securing medicines to address the growing needs

Assessment of barriers facing increasing availability and use of generics in the market

Assess the relationship b/w the affordability/prices and the rational use of drugs?

Compare the process of registration of medicines between Lebanon and other countries in the region.

Assess the adherence of pharmacies to the laws and regulations concerning pricing of medicines including discounts offered to consumers

Explore the patterns of marketing generics as branded medicines

Assess time trends in the medicines bills as part of health expenditures in light of the introduction of generic drugs

Assess the relationship between the price of medicines and the profits of pharmacists

Assess the measures to be taken to increase competition and decrease monopoly of medicines

Explore the options to support locally manufactured medicines and the impact this may have on decreasing the prices of medicines

Assess the impact of the economic exchange policy with other Arab countries on ATM

Assess the GMP of local manufacturers of medicines and the standards and qualifications of factories and raw materials

Explore ways of encouraging and improving local production of medicines

Compare the compliance of insured versus non-insured people to use of prescribed medicines

What causes fluctuation in the prices of medicines? How can such fluctuation be controlled?

Assess the medicines bill of tertiary care and compare with international figures

Comparative prevalence of chronic diseases, expenditures on health, including medicines, by different income groups

67

Explore the agreements between international manufacturers and Lebanese importers, how these impact the prices of medicines and ways to reduce the prices by making the agreements more transparent

Assess critically the MoPH-YMCA program of purchase and provision of medicines for chronic conditions.

Financing

Review eligibility criteria for coverage by MoPH and NSSF to ensure that only people in need are covered

Assess the satisfaction of enrollees in the NSSF and other insurance schemes in relation to reimbursement for medicines purchased OOP first by enrollees.

Assess the changes in medicines coverage by social and private insurance and the use of such data for budget and planning purposes

Assess the compliance of insurance companies to covering cancer medicines during the whole treatment period

Assess the impact of donations by foreign agencies on the medicines market, and assess measures to face the current trend of decreasing donations of medicines

Compare ATM between different social insurance schemes (the Army, NSSF, Internal Security Forces)

What is the national insurance model that would be most effective in improving the ATM situation?

Explore way of collaboration between the private and public sectors, in terms of insurance coverage for medicines

Explore possibilities of expanding NSSF coverage to improve ATM such as through covering child vaccination

Explore the MoPH coverage scheme reaches intended needy patients and leads to improving ATM for such patients

Explore perception of the public about cheaper medicines from PHC centers and dispensaries

Compare treatment costs by diseases between users in the private versus public sectors

Explore the justifiability of the MoPH’s high expenditures on cancer treatments as part of the MoPH’s total medicines bill

Develop quality control guidelines that impact the MoPH’s expenditures on cancer medicines

Study patterns of consumer abuse of medicines coverage by social and private insurance, and explore ways to minimize such abuse.

Assess the reasons of the high OOP expenditures on medicines in Lebanon and explore ways of reducing it

Health and supply system

What is named a generic? Are branded generics really generics as seen through the lens of ATM?

Draft national guidelines for management of selected conditions and diseases and use this to develop the essential drug list to ensure cost effectiveness

Assess the marketing of generics and the patterns of marketing generics as trade medicines?

What is the list of drugs that a pharmacist can prescribe without a physician’s order?

Study the market of antibiotics and sedatives in light of the common practice of self-

68

medication and assess adherence by pharmacists to requirements for prescription

Study the medicines market in general

Are pharmacists aware of the laws and regulations related to prescriptions? What the barriers to adherence to such laws and regulations?

Explore ways of introducing and ensuring sustainability of high quality services in pharmacies regarding education of consumers on rational use of medicines

Retrieve the standards of reliable quality-control in the national control laboratory

Assessment of the quality of medicines entering Lebanon

Retrieve and adopt standards for classifying products as pharmaceuticals

Study counterfeit drugs and non-regulated medicines in the market

Explore the regulations regarding registering medicines

Explore the conditions under which medicines are allowed to enter Lebanon without undergoing registration and how this practice is used or abused and whether it really improves ATM

Establishment of a pharmaco-vigilance system and the conduct of pharmaco-vigilance studies

Study mechanisms to determine appropriate number of medicines that meet the needs of the Lebanese population

Assess monitoring and evaluation of medicines distribution in dispensaries

Study whether and how people are able to access medicines under private insurance schemes

Prioritizing exercise of the recommendations of WHO

Evaluation of the effectiveness of the WHO recommendations in improving the medicines situation in the Lebanese health system

Accreditation of dispensaries and PHC centers run by NGOs

Evaluation of the equipment and presence of specialized doctors in dispensaries far from Beirut

Assess duplication and explore ways to avoid it (in dispensaries)

List of all drugs on the Lebanese market including donations and those distributed by dispensaries

Patients perceptions of access to dispensaries

Set standards for transportation and storage of drugs and ways of controlling such transportation

How can MoPH monitor the chain of supply that includes importers, wholesalers and pharmacists

How can we ensure that all products including locally manufactured and imported generics and generics have bioequivalence?

Assessment of the influence of political power on the current lack of a functioning central control laboratory and explore ways out of the current situation.

Assessment of the registration process from the perspective of importers and companies.

Assess the effectiveness of PHC-based health system experiments in improving the ATM situation and explore ways of how can this be applied at the national level.

How to control and monitor clinical trials done on patients through agreements between physicians and pharmaceutical companies?

Assess emergency preparedness of dispensaries

What are the generics that are supervised by original countries and subject to the control

69

laboratory and how they can be prioritized in the Lebanese market?

General

The impact of corruption on the market of medicines

Assess the trends in morbidity and health seeking behaviors to inform the medicines policy, selection, guidelines, and eligibility criteria for coverage

What are the rules and practices for registering a medicine? Are they consistent with international standards?

The presence of conflict of interests and its influence on the drug access

Explore people's voices regarding medicines, and their needs as they state them

Identify indicators to raise accountability in selection and delivery of medicines

Assess the impact of the use of a magnetic card to rationalize utilization of medicines

Assess the relative contribution of each element of the ATM framework in shaping accessibility to medicines

Assess the causes of monopolies of medicines

How can we draft a national health policy without the influence of politicians

What are the economic, social, political, and sectarian determinants of access to medicine?

Assess the effectiveness of possible collaboration of MoPH, pharmacists and NGOs with educational institutions on improving ATM.

How continuous education of physicians can be ensured without the interference of pharmaceutical companies?

How can people’s awareness on their health rights be raised?

What are the laws regarding medicines in Lebanon and what are the physicians and pharmacists views on it?

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Appendix 6-C: Research questions submitted to the validation-prioritization exercise

1. Is access to medicines a priority for policymakers, for professional associations, and for consumer advocates?

2. Assessment of quality of pharmacy services at the different levels of the health system (public as well as private pharmacies, different geographical areas).

3. Current and future projection of health needs assessment at the population level to guide rational selection of medicines.

4. Assessment of adherence of pharmaceutical manufacturing to good manufacturing practices (GMP)

5. Evaluation of the current procedures of inspection and quality control of pharmaceutical products.

6. Assess the impact of the good governance for medicines (GGM) program on access to medicines

7. Assess the perceptions and current practices of different members of the health care team (physicians, nurses pharmacists, community educators) in facilitating or impeding rational use of medicines at the community level.

8. Evaluate the process of registration and pricing of medicines and compare between Lebanon and other countries in the region.

9. The equity dimension: Assessment of patterns of use and access to medicines between different socioeconomic groups including insured vs. un-insured population groups.

10. Public and professional perceptions of ATM as part of the right to health.

11. Exploration of the political economy (e.g. influence of special interests, different power relations and sectarian politics) of the situation of medicines and the role of corruption

12. Assessment of options for cost-savings such as through introducing a unified list of medicines (formularies) and improving prescribing behaviors for different social insurance organizations and joint procurement of medicines by NGOs and assess the impact on affordability.

13. The cost savings of developing a system for coding of pharmaceutical products according to international guidelines for coding of consumer products.

14. Evaluation of the role of civil society organizations and non-governmental organizations in improving access to medicines especially for the poor, vulnerable groups and hard-to-reach populations.

15. Evaluation of the impact of electronic health information system and electronic card on improving efficiency, reducing potential corruption, and improving access to medicines

16. Study of consumer behaviors such as purchasing patterns, intake patterns, selection patterns, and home storage and use of medicines

17. Prescribing behaviors of physicians, and adherence to international prescribing indicators, and explanatory factors of such behaviors

18. Barriers to development of a national policy for medicines

19. Mapping the capacity of researchers and research institutions to carry out essential research on access to medicines

71

20. What happens at the dispensary? Dispensing medicines or delivering primary health care? Adherence to generics in PHC and dispensaries

21. Consumer satisfaction with medicines services at different points of service in the health system (both public and private)

22. Price analysis and surveillance and monitoring of prices of medicines in Lebanon compared with prices in other countries in the region.

23. A study of the lost value of medicines purchases due to various factors in the medicines supply chain (higher than needed procurement prices, poor distribution, irrational prescribing, irrational use)

24. The patterns of use of supplements for medicinal purposes by the public and corresponding physician prescribing

25. Sources of information for physicians and their influences on their prescribing behaviors

26. A study of attitudes of physicians and of the public towards generic substitution and the opportunities for implementing relevant policies

27. Assess the coverage of medicines by private insurers and practices in sustaining medicines coverage in the event of emergence of a costly disease.

28. Assess the impact of medicines donations on access to medicines and the supply system

29. Feasibility of pharmaco-vigilance studies

30. Exploring conflict of interest in both the public and private sector and its impact on access to medicines

31. Cultural factors influencing consumers’ preferences for originator brands vs. generics

32. Developing and testing a framework for physician prescribing accountability (which has three components: scientific, ethical, and regulatory)

33. Consumers’ unmet needs due to current restrictions on access to medicines (e.g. narcotics and pain control)

34. Impact of irregularity in medicines supply (e.g. through MoPH central pharmacy, or YMCA) on adherence to medicines and on proxy health outcomes

35. Rational selection and use of medicines in hospitals and potential for savings for smaller and medium size hospitals from adherence to formularies

36. Assessment of quality of medicines on the market and role of counterfeit medicines and black market.

37. The proportion of emergency room visits and hospitalizations that results of irrational prescribing or irrational use of medicines

38. Impact of delay in reimbursement by NSSF on ATM among NSSF beneficiaries on finances of families and on increasing rates of hospitalization. What are the equity dimensions for such delays (among low and middle income households)? How do NSSF beneficiaries solve their medicines needs?

39. The impact of the institutional policy framework (e.g. at the hospital level) in influencing prescribing behaviors

72

40. Assessment of barriers to adoption of code of ethics for drug promotion proposed by the Ministry of Public Health among different stakeholders.

41. The impact of developing disease management protocols (e.g. for management of hypertension) and prescribing guidelines (which drugs to start with, which ones to add) for improving the rational use of medicines.

42. Impact of audits on physicians’ prescribing behaviors.

43. Developing and testing different incentive structures to improve physician prescribing behaviors

44. The impact of social networks (e.g. access to specialists among family and friends) on irrational use of medicines

45. Who are the users of dispensaries and PHC network? Are they the poor and low income household? How important are the medicines to their use of these dispensaries and PHC network?

46. Assessment of the availability and affordability of medicines in dispensaries and PHC network.

47. Challenges facing pharmaceutical manufacturing and options for reform.

48. Assessment of sustainability of access to medicines during emergencies

49. Differentials in access to medicines vs. access to health services.

50. The potential role of professional associations (physicians, pharmacists, nurses) working together to improve rational prescribing, dispensing and use.

51. The role of medical education and residency training on developing irrational prescribing behaviors.

52. Obstacles to and opportunities for empowering consumers to improve their access to medicines.

53. The impact of alternative administrative structures (e.g. a separate drug agency similar to Jordan FDA within MoPH or independent) on improving registration, pricing and monitoring of medicines.

54. Pharmacoeconomic studies on various pharmaceuticals

55. Change in availability of medicines due to fluctuating currency exchange rates and the impact on adherence to medical therapy.

56. Study of access to medicines among special populations such as those supported by the MoPH (for cancer, HIV…), refugees, and Bedouins.

57. Reasons for professional perception of low quality of generics or low-priced branded generics

73

Appendix 6-D: Research questions submitted to the ranking exercise and the results of ranking according to five

evaluative criteria –

1= Urgency, 2= Feasibility, 3= Applicability, 4= Ethical acceptability, 5=Relevance, T=Total score

Possible score for each criterion = 0-10 (10 being most important). Total score = the combined score from all evaluative criteria

Research question 1 2 3 4 5 T

Assessment of quality of medicines on the market and role of counterfeit medicines and black market. 112 63 62 88 103 340

A study of attitudes of physicians and of the public towards generic substitution and the opportunities for implementing relevant policies

90 80 74 83 92 336

Is access to medicines a priority for policymakers, for professional associations, and for consumer advocates? 88 75 77 102 81 321

Evaluation of the role of civil society organizations and non-governmental organizations in improving access to medicines especially for the poor, vulnerable groups and hard-to-reach populations.

92 71 76 106 82 321

What happens at the dispensary? Dispensing medicines or delivering PHC? Adherence to generics in PHC & dispensaries

98 70 65 87 87 320

The potential role of professional associations (physicians, pharmacists, nurses) working together to improve rational prescribing, dispensing and use.

85 87 73 97 73 318

The equity dimension: Assessment of patterns of use and access to medicines between different socioeconomic groups including insured vs. un-insured population groups.

97 77 64 103 79 317

Prescribing behaviors of physicians, and adherence to international prescribing indicators, and explanatory factors of such behaviors

93 65 64 85 91 313

The role of medical education and residency training on developing irrational prescribing behaviors. 91 68 65 99 84 308

Assessment of sustainability of access to medicines during emergencies 85 70 68 99 85 308

74

Research question 1 2 3 4 5 T

Reasons for professional perception of low quality of generics or low-priced branded generics. 95 70 68 90 74 307

Impact of delay in reimbursement by NSSF on ATM among NSSF beneficiaries on finances of families and on increasing rates of hospitalization. What are the equity dimensions for such delays (among low and middle income households)? How do NSSF beneficiaries solve their medicines needs?

108 59 50 75 89 306

Developing and testing different incentive structures to improve physician prescribing behaviors 95 61 61 76 81 298

Barriers to development of a national policy for medicines 94 63 63 87 77 297

Evaluation of the current procedures of inspection and quality control of pharmaceutical products. 87 65 58 98 84 294

The impact of developing disease management protocols (e.g. for management of hypertension) and prescribing guidelines (which drugs to start with, which ones to add) for improving the rational use of medicines.

73 72 66 93 83 294

Impact of irregularity in medicines supply (e.g. through MoPH central pharmacy, or YMCA) on adherence to medicines and on proxy health outcomes

75 73 63 83 72 283

Developing and testing a framework for physician prescribing accountability ( scientific, ethical, and regulatory) 77 67 64 82 69 277

Evaluation of the impact of electronic health information system and electronic card on improving efficiency, reducing potential corruption, and improving access to medicines

81 65 52 88 78 276

Assessment of barriers to adoption of code of ethics for drug promotion proposed by the Ministry of Public Health among different stakeholders.

77 59 54 88 69 259

Assessment of options for cost-savings; introducing a unified list of medicines (formularies)/ improving prescribing behaviors for different social insurance organizations and joint procurement of medicines by NGOs and assess the impact on affordability.

77 60 61 77 52 250

Current and future projection of health needs assessment at the population level to guide rational selection of medicines.

67 51 47 73 84 249