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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
2
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
3
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
4
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.
5
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
6
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.
7
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
8
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
9
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.
10
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)
11
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
12
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.
13
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
14
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.
15
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
16
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.
17
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?
18
- 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.
19
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
20
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
21
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
22
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
23
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.
24
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,
25
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
26
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
27
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.
28
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.
29
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
30
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
31
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.
32
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.
35
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[Article in French]
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alliancehpsr_lebanon_atmps

  • 1. 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
  • 2. 2 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
  • 3. 3 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
  • 4. 4 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.
  • 5. 5 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
  • 6. 6 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.
  • 7. 7 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
  • 8. 8 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
  • 9. 9 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.
  • 10. 10 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)
  • 11. 11 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
  • 12. 12 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.
  • 13. 13 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
  • 14. 14 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.
  • 15. 15 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
  • 16. 16 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.
  • 17. 17 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?
  • 18. 18 - 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.
  • 19. 19 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
  • 20. 20 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
  • 21. 21 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
  • 22. 22 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
  • 23. 23 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.
  • 24. 24 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,
  • 25. 25 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
  • 26. 26 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
  • 27. 27 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.
  • 28. 28 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.
  • 29. 29 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
  • 30. 30 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
  • 31. 31 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.
  • 32. 32 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. 33 time to allow for modification of the final list of research questions based on the prioritization exercise.
  • 34. 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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