Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial
El Hajj et al. Trials
Assessing the effectiveness of a pharmacist- delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial
Maguy Saffouh El Hajj 0
Nadir Kheir 0
Ahmad Mohd Al Mulla 2
Daoud Al-Badriyeh 0
Ahmad Al Kaddour 0
Ziyad R Mahfoud 1 4
Mohammad Salehi 3
Nadia Fanous 2
0 College of Pharmacy, Qatar University , Doha, POBOX 2713 , Qatar
1 Department of Health Care Policy and Research, Weill Cornell Medical College , New York, NY , USA
2 Smoking Cessation Clinic, Medicine Department, Hamad Medical Corporation , Doha , Qatar
3 Department of Mathematics, Statistics and Physics, College of Arts and Sciences, Qatar University , Doha, POBOX 2713 , Qatar
4 Department of Global and Public Health, Weill Cornell Medical College , Doha , Qatar
Background: It had been reported that up to 37% of the adult male population smokes cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is key to reducing smoking-related diseases and deaths. Healthcare providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible healthcare providers and are uniquely situated to initiate behavior change among patients. Many studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist-delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. Methods/Design: A prospective, randomized, controlled trial is conducted at eight ambulatory pharmacies in Qatar. Participants are randomly assigned to receive an at least four-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 min of unstructured brief smoking cessation advice (emulating current practice) given by the pharmacist. Both groups are offered nicotine replacement therapy if feasible. The primary outcome of smoking cessation will be confirmed by an exhaled carbon monoxide test at 12 months. Secondary outcomes constitute quality-of-life adjustment as well as cost analysis of program resources consumed, including per case and patient outcome. Discussion: If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease the smoking burden. Trial registration: Clinical Trials NCT02123329.
Qatar; Tobacco control; Smoking cessation; Pharmacist
The leading preventable cause of ill health today is
cigarette smoking . It is a major risk factor for several
causes of death including heart disease, chronic lung
diseases and lung cancer . It kills one in ten adults
globally and causes more than 5 million deaths annually.
If present trends continue, the number of
smokingrelated deaths is expected to reach more than 8 million
deaths per year by 2030 . The adverse health
consequences of tobacco use not only compromise smokers
quality of life, but also entail significant direct and indirect
economic costs on society. The 2008 World Health
Organization (WHO) report states that the global
healthcare costs attributable to tobacco use reach hundreds of
billions of US dollars each year . Smoking cessation is
key to reducing the number of smoking-related diseases
and deaths. At any age, quitting smoking improves quality
of life (QoL) and confers considerable health benefits
including reduced risk of coronary heart disease, stroke
and smoking-related cancers [5,6]. The World Bank
suggests that if adult tobacco consumption were to decrease
by 50% by the year 2020, approximately 180 million
tobacco-related deaths could be avoided between now and
2050 . Health professionals are in an ideal position to
encourage smoking cessation. A short intervention by
them can considerably increase the smoking cessation rate
. Of all health professionals, pharmacists are the most
easily accessed by the public and are uniquely situated to
initiate behavior change among smokers . They can
provide education and advice without prior appointment
and with no direct or additional cost to individuals .
They regularly interact with patients obtaining medications
for smoking-related diseases. In addition, the increased
availability of pharmacologic smoking cessation aids
including some formulations of nicotine replacement therapy
over the counter in pharmacies in many countries gives the
pharmacists a distinct opportunity to serve as front-line
health providers who can play a major smoking cessation
role . Moreover, available data support the provision of
smoking cessation services in ambulatory and community
pharmacies. Many studies have shown that pharmacists can
be effective providers of tobacco cessation interventions
and can be successful in helping patients quit smoking
[12-20] and that these pharmacy interventions can be
cost-effective or cost-beneficial [21-24]. Additionally, in
many countries there is extensive support at the
professional level for the involvement of pharmacists in smoking
cessation. The Canadian Pharmacists Association
developed a Joint Statement on Smoking Cessation. This
statement promotes the involvement of health professionals
including pharmacists in tobacco prevention and cessation
. The International Pharmaceutical Federation (FIP)
issued a statement of policy on the role of pharmacists
in promoting a tobacco-free future . The European
Forum adopted a pharmacists charter on action against
smoking, which states that pharmacists should consider
smoking cessation as an essential element of their
professional responsibilities . The US Public Health Service
published evidence-based clinical guidelines
recommending that all health care providers, including pharmacists,
should offer smoking-cessation interventions . The
American Society of Health-System Pharmacists (ASHP)
Therapeutic Position Statement on the Cessation of
Tobacco Use strongly encourages pharmacists as well as
other healthcare providers to integrate identification of
tobacco users and delivery of tobacco-cessation
interventions into their routine patient care. As per the ASHP
statement, these interventions should address five key
elements of comprehensive tobacco cessation counseling
(the 5 As): (1) asking patients about tobacco use, (2)
advising users to quit, (3) assessing their readiness to quit, (4)
assisting them with quitting using behavior modification
and smoking cessation medications, and (5) arranging
follow-up care. If comprehensive tobacco-cessation
counseling cannot be provided because of time constraints or
practice site logistics, pharmacists can use a truncated 5 A
model whereby they ask about tobacco use, advise tobacco
users to quit, and then refer patients to smoking cessation
providers or programs .
In Qatar, tobacco use is a major public health problem
that, in addition to the associated morbidity and
mortality, constitutes a huge burden on healthcare services. To
control tobacco use, Qatar has adopted the international
approaches recommended by the World Health
Organization (WHO) and regional plan of Arab countries in the
Gulf. These approaches are based on three strategies:
(1) imposing legislative tobacco control measures, for
example, banning smoking in enclosed public places
and prohibiting selling cigarettes, tobacco or its
derivatives to anyone less than 18 years old, (2) providing
smoking cessation services for free in two
hospitalbased smoking cessation clinics and (3) implementing
antismoking public awareness activities . Despite
these approaches, in Qatar up to 37% of adult males
currently smoke tobacco  and 13.4% of male school
students aged 13 to 15 years smoke cigarettes according
to the 2007 Global Youth Tobacco Survey .
Furthermore, smoking-related diseases are the most prevalent in
Qatar. Ischemic heart disease, as an example, was ranked
as one of the leading causes of burden of disease in Qatar
in 2010 , and Qatar has a higher age standardized lung
cancer incidence rate than many countries in the Gulf
(8.95 per 100,000) . In addition, according to a recent
survey done by Weill Cornell Medical College in Qatar, at
least 1 billion cigarettes are smoked in Qatar each year,
averaging 12,000 per individual, and 65 million US dollars
(USD) are spent on cigarettes annually; 150 million USD
are used to cover the healthcare costs of patients affected
by smoking-related diseases . The potential for
pharmacist-assisted tobacco cessation is therefore huge
and could have a considerable impact on smoking rates,
prevention of tobacco-related diseases and enhancement
of public health in Qatar. Around 700 registered
pharmacists practice in public and private ambulatory care clinics
and in community pharmacies in Qatar. If each of these
pharmacists successfully assists just one tobacco user in
quitting each month, this would result in more than
8500 quitters annually. However, according to a study
conducted by Qatar Universitys College of Pharmacy
and funded by the Qatar Foundation under its
Undergraduate Research Experience Program (UREP), Qatars
ambulatory and community pharmacists are not fully
engaged in smoking cessation activities. Eighty percent
of Qatars ambulatory and community pharmacists rarely,
never or sometimes ask their patients about their smoking
status, and 53% rarely, never or sometimes offer smoking
cessation counseling to nicotine therapy purchasers.
When meeting patients who smoke, only 45% of
pharmacists discuss the adverse health effects of smoking,
41% assist them in quitting and 16% arrange follow-up
sessions with them to assess their progress in quitting
smoking. However, more than 85% of pharmacists are
interested in providing smoking cessation counseling
and believe that it is an important activity . The
pharmacists perceptions regarding the importance of
smoking cessation can be transformed into action if a
smoking cessation model is provided that these
pharmacists can use in routine practice. Unfortunately, an
intensive, patient-specific program of smoking cessation
designed exclusively for implementation in community
and ambulatory pharmacies is not available in Qatar. In
addition, evidence regarding the effect of such a program
is lacking in Qatar.
Also important, in addition to the numerous knowledge
gaps identified above in relation to Qatar, there are also no
data on how cost beneficial the running of smoking
cessation programs like the currently proposed one is, added to
a lacking data on the associated resource implications in
the pharmacy setting from the Qatari perspective.
This proposal describes a study that is currently being
implemented in eight public and private ambulatory clinic
pharmacies in Qatar. Our hypothesis is that a
patientspecific structured smoking cessation program delivered
by smoking cessation-trained ambulatory pharmacists
would be significantly more effective in helping smokers
stop smoking and achieving long-term smoking
abstinence than brief unstructured pharmacist-delivered advice.
We also hypothesize that quitting smoking would lead
to significant improvement in health-related quality of life.
The study objectives are:
Primary: To test the effect of a face-to-face structured
patient-specific smoking cessation program delivered
by trained ambulatory pharmacists on smoking
cessation rates in Qatar
Secondary: To assess the change in health-related
quality of life in quitters vs. non-quitters
Secondary: To explore the resource utilization of
implementing the smoking cessation program as
delivered by the ambulatory pharmacists in Qatar.
This is a cost analysis of the overall cost of running
the proposed patient-specific cessation program,
including cost-effectiveness analyses.
The study is a prospective randomized controlled trial
comparing the effectiveness of a face-to-face structured
patient-specific smoking cessation program conducted
by trained ambulatory pharmacists versus brief
unstructured pharmacist-delivered advice on smoking cessation
The study is implemented in eight public and private
ambulatory pharmacies in the State of Qatar. These
pharmacies are located within large ambulatory clinics
that serve a large proportion of the Qatar population.
To prevent cross contamination with the study, none of
these clinics has established smoking cessation programs.
Each study pharmacy is staffed by at least three
pharmacists. Two pharmacists from each pharmacy are invited to
participate in the study. The study is taking place in a
semiprivate area in the pharmacy. This area is secluded
enough to ensure adequate patient confidentiality.
Study pharmacists training
Prior to starting the study, each study site pharmacist
was sent a copy of the study methodology along with a
written literature review on smoking cessation and asked
to study the material.
Two to three weeks after receipt of the material, the
study pharmacist attended a 2-day (8 h/day) smoking
cessation training workshop that was organized by the Hamad
Medical Corporation (HMC) smoking cessation clinic team
and Qatar University (QU) College of Pharmacy.
The training team consisted of Dr. Ahmed al Mulla
(Public Health and Disease Control Consultant and HMC
smoking cessation clinic head), Dr. Maguy El Hajj (Study
Principal Investigator/Assistant Professor and CPP Chair
at QU College of Pharmacy), Dr. Nadir Kheir (Associate
Professor and CPPD coordinator at QU College of
Pharmacy) and Dr. Mohamad Haniki Nik Mohamed
[Deputy Dean (Academic Affairs) in Kulliyyahof Pharmacy
at the International Islamic University Malaysia (IIUM)].
Dr. Haniki is considered an international authority in the
area of substance abuse, including cigarette smoking.
The HMC smoking cessation clinic is one of the
smoking cessation facilities in Qatar. The clinic is run by highly
qualified smoking cessation consultants and has a
smoking cessation success rate of 40%. In addition to offering
smoking cessation treatment, this clinic contributes to
community education on the dangers of smoking among
the citizens and residents of Qatar and provides
smokingrelated lectures and seminars for all age groups in the
The general objective of this workshop is to provide
the study pharmacists with enough smoking cessation
knowledge and the necessary skills and tools to assess
and treat smokers. A smoking cessation training manual
that was developed by the study training team is
extensively used in the workshop. This manual is also used as
an on-site resource by the study pharmacists in their
smoking cessation program.
The workshop covered the following: smoking
epidemiology and risks, benefits of quitting, a transtheoretical
model for behavior change as applied to smoking cessation,
the necessary elements for documentation in the patient
smoking cessation profile, behavioral modification
techniques, classification of smokers according to their stage of
change (5 stages: precontemplation, contemplation,
preparation, action and maintenance), nicotine replacement
therapy (NRT: nicotine patch, lozenge and gum), patient
counseling techniques, development of a personalized
action plan, use of the exhaled carbon monoxide test,
detailed instructions on the program methodology and
other needed elements.
In addition, the pharmacists training workshop included
training the pharmacists on how to follow the study
protocol exactly. The study team walked the pharmacists
through the study protocol including how to randomly
allocate participants to the intervention and control
groups, how to deliver the intervention and how to deal
with control patients.
During the training workshops, emphasis was also
placed on the importance of behavioral and lifestyle
modifications. Pharmacists were instructed to encourage
smokers who are anticipating quitting to identify the
situations that may increase their risk of smoking such
as having smokers within the household or at the
workplace as well as getting into stressful situations. After
identifying these situations, the pharmacists were
provided with information they could give to smokers
about strategies to improve coping including lifestyle
changes to decrease stress and improve QoL, removing
visual cues for smoking and staying away from these
situations that normally make patients want to smoke
. In addition, the pharmacists were trained to provide
the smokers with information about what to expect during
quit attempts and to address any individual concerns
that the smokers may have . Furthermore, they
were advised to encourage the smokers to notify family
and friends of the plan to quit and to ask for their
Participant counseling and interviewing techniques
were also part of the training workshops. To enhance
learning, the pharmacists applied these techniques using
patient role-plays in small groups. Topics that were
reviewed included counseling skills, verbal and
nonverbal communication skills including use of empathy and
active listening, use of open-ended and priming
questions, verification of patient understanding, overcoming
of communication barriers, communication with difficult
patients, communication with patients not interested in
discussing smoking cessation and use of strategies to
improve medication adherence.
Documentation was an important element of the
workshop. The pharmacists were trained to document the
patients smoking, medical and medication history, basic
demographic characteristics, staging, assessment,
education, counseling, follow-up and the personalized action
plan to quit smoking. In addition, they were instructed on
how to fill in the Fagerstrom test for nicotine dependence
(FTND). The FTND is a six-item questionnaire designed
to assist the healthcare professional in determining a
patients degree of nicotine dependence . This
questionnaire has already been used in smoking-related research
studies in the Middle East area [40,41]. Furthermore,
they were instructed to measure the smokers
healthrelated QoL using the Smoking Cessation Quality of Life
(SCQOL) questionnaire. This instrument was developed
and validated for use in smoking cessation [42,43] and has
already been used in previous studies that tested the
effectiveness of a pharmacist-delivered smoking cessation
program . This questionnaire tackles a total of 13
general and smoking cessation-specific quality-of-life domains
including physical functioning, role-physical, bodily pain,
general health, vitality, social functioning, role-emotional,
mental health, social interactions, self-control, sleep,
cognitive functioning and anxiety .
The study pharmacists were trained to recognize many
opportunities for the promotion of the smoking
cessation program as possible. For example, when dispensing
prescriptions, the study pharmacists were encouraged to
ask patients about smoking and to tell them about the
smoking cessation program. In addition, study site
pharmacists displayed posters and leaflets in their pharmacy
describing the smoking cessation program. Furthermore,
the general practitioners and dentists practicing in the
study ambulatory clinics were sent letters inviting them
to refer their patients who are interested in quitting to
the study pharmacies.
Screening and eligibility criteria
Interested smokers meet with the study pharmacists.
The study pharmacists use a scripted questionnaire to
screen smokers in order to assess their eligibility for the
study. Eligible participants are patients aged 18 years
and older who currently smoke one or more cigarettes
daily for 7 days, are motivated to quit, i.e., in the
preparation stage of the stage-of-change model, able to
communicate in Arabic or English, and are willing to and
capable of attending the scheduled sessions at the study
pharmacies. The motivation to quit is determined by the
pharmacist using the transtheoretical model of behavior
change . Smokers in the precontemplation or
contemplation stages are advised to quit, are provided with
educational materials regarding tobacco cessation and
the health benefits of quitting, and are encouraged to
come back to the pharmacy when they feel they are
ready to commit to quitting smoking.
Exclusion criteria are (1) use of other nicotine or
tobacco products and (2) current use or use in the last 30
days of smoking cessation aids or medications, (3)
planning to leave Qatar in the next 12 months, (4) presence of
any major medical condition that would prevent use of
the nicotine replacement therapy including
hypersensitivity to the products, history of or recent myocardial
infarction, life-threatening arrhythmias, severe or worsening
angina, uncontrolled hypertension and
temporomandibular joint disease (in case of nicotine gum), (5) pregnancy
and (6) psychiatric illness or another debilitating condition
that would interfere with participation in the study.
Following the completion of the screening procedure,
the study pharmacist gives the eligible participant
pertinent background information on the program, explaining
what his or her participation would involve (including
potential benefits, risks, inconveniences, discomforts),
and his or her right to confidentiality. In order to enroll
in the study, the interested participant is asked to sign
an approved consent form. Once the consent form is
signed, the pharmacist collects the participants contact
information and sets an appointment with him or her at
a date and time that is suitable for both of them.
Initial appointment and randomization
One to two days before his or her scheduled
appointment, the study pharmacist contacts the enrolled
participant to remind him or her about the appointment. At
this initial appointment, which takes around 30 min, the
study pharmacist first collects the participants
sociodemographic characteristics, current medical problems and
medications, smoking history (i.e., number of cigarettes
per day, duration of smoking, previous quit attempts,
smoking habits of other family members and the
participants reasons for wanting to quit smoking) and vital
signs (i.e., blood pressure and pulse). In addition, the
pharmacist assesses the smokers level of nicotine
dependence using the Fagerstrom Test for Nicotine Dependence
and measures his or her baseline exhaled carbon monoxide
(CO) level using the exhaled CO test. Furthermore, the
pharmacist administers the smoking cessation
quality-oflife (SCQOL) questionnaires. After baseline data collection,
the smoker is randomly assigned to either the intervention
group or the control group. Randomization is already
anonymously preset by the study statistician for each study
pharmacist. According to the participant number and the
preset list, the participant will be randomized to the
intervention or control group. A new appointment is set with
the participants assigned to the intervention group.
Participants assigned to the control group receive brief
unstructured smoking cessation advice as outlined below.
Participants in both groups do not pay for their participation.
Participants assigned to the treatment group participate in
a face-to-face four-session program at the pharmacy
delivered by the study pharmacist at 2-4-week intervals over 8
weeks. The sessions are set at a date and time that are
convenient for both the pharmacist and participant.
The first session is time-intensive, taking around 30 min.
In this session, the study pharmacist facilitates the
participants preparation to quit. The participant selects a quit
date within the next 2-4 weeks. Based on the
transtheoretical model of change, this would give him or her time to
get prepared to enter the action stage on the quit date.
The pharmacist discusses the benefits of smoking
cessation with the participant and provides him or her with
tailored behavioral and lifestyle strategies. These
strategies take into consideration the participant behaviors,
values and beliefs. For example, if the smoker states that
the hardest time would be at work when others are
taking breaks to smoke, the pharmacist may suggest ways
to spend the time during breaks. As outlined under the
training section, the pharmacist also provides the
participant with information about what to expect during the
quit attempt with suggestions to cope with the early days
of quitting. In addition, the pharmacist encourages the
participant to seek family support during the attempt.
To prevent nicotine withdrawal symptoms, the
participant is also offered, without cost, nicotine replacement
therapy (NRT) as a patch or lozenge depending on his
or her previous experience, preference and adverse effect
profile. Other NRT dosage forms, e.g., an inhaler, nasal
spray and sublingual tablets, are not available in Qatar.
The gum is usually not tolerated by patients. The
participant is not offered the other smoking cessation aids,
including bupropion and varenicline, as they require a
prescription in order to be dispensed in Qatar. Before
dispensing the NRT, the study pharmacist ensures that
the participant does not have any contraindications to
nicotine therapy and is not taking any medication that
would interact with NRT. The NRT is started on the
participants intended quit date. Patient counseling about
NRT is provided to each participant regarding the dosage,
administration, scheduling, duration of therapy, adverse
effects, interactions and proper disposal.
Participants who take the nicotine patch start at 21 mg
if they smoke ten cigarettes or more per day. Otherwise,
they receive a 14-mg patch. Both patches are continued
for 6 weeks before being tapered. The 21-mg patch is
decreased to 14 mg, continued for 2 weeks and decreased to
7 mg for a final 2 weeks. Patients who start with the
14mg patch are tapered to 7 mg for a final 2 weeks .
Participants who take the nicotine lozenge use the 1-mg
pieces. It is continued for 6 weeks as one lozenge every
12 h before being tapered. Then the participant takes one
lozenge every 2-4 h for weeks 7 to 9, then one lozenge
every 4-8 h for week 10-12 .
A personalized action plan is created by the pharmacist
to document the participants quit date, nicotine
replacement therapy dosage schedule and counseling, suggested
behavioral and lifestyle strategies, and date/time of the
next appointment. This plan is signed by both the
participant and pharmacist.
The first follow-up session is scheduled 1 week after of
the participants quit day and takes around 20 min. In
this session, the pharmacist determines the participants
smoking status, measures his or her blood pressure/
pulse/exhaled CO level, and assesses the NRT
tolerability. If the patient succeeds in quitting, the pharmacist
provides reinforcement and addresses problems associated
with quitting such as managing withdrawal symptoms,
coping with cravings, relieving stress, and managing
fear of weight gain and of change in relationships with
other smoking friends or relatives. If the participant
fails to quit smoking, the pharmacist carefully reviews
the participants experience during the attempt to quit
and works through the identified problems. If the
participant does not tolerate the NRT side effects (e.g.,
his or her blood pressure or heart rate increases), the
pharmacist asks the participant to stop the NRT and
refers him or her to the HMC smoking cessation clinic
for further smoking cessation support. This participant
is no longer enrolled in the study.
The second follow-up session is scheduled 2 weeks
after the first follow-up session. The third follow-up
session is set at 4 weeks after the second follow-up session.
These sessions take no more than 10 or 15 min each. In
these sessions the pharmacist assesses the participants
smoking status, blood pressure/heart rate/exhaled CO
level and NRT tolerability and provides NRT refills. In
addition, he or she focuses on maintenance of smoking
abstinence with cognitive-behavioral strategies to prevent
relapse. The pharmacist documents any action taken by
him/her at each follow-up session. After the third
followup session, all participants are instructed to call or visit
the pharmacy for questions or to receive additional
support as needed. For more information on participant flow
during the study, see Figure 1.
Participants in the control group receive 5-10 min of
unstructured brief smoking cessation counseling by the
pharmacist (emulating current practice). In addition,
they are provided with educational materials about
smoking cessation and are offered nicotine replacement
therapy (NRT). Before dispensing the NRT, the study
pharmacist ensures that the participant does not have
any contraindications to nicotine therapy and is not
taking any medication that would interact with NRT.
The choice of the NRT dosage form (patch or lozenge)
depends on the participants previous experience,
preference and adverse effect profile. The NRT dosage
schedule and duration of therapy are similar to those in the
intervention group. Control participants are not asked
to attend any follow-up sessions.
The education materials address the following topics:
the adverse effects of smoking, benefits of smoking
cessation, the methods of quitting, setting the quit date, coping
with nicotine withdrawal symptoms, getting emotional
and social support, and monitoring the blood pressure
and pulse when using NRT and avoiding relapse.
The study team invests a good deal of time orienting
the study pharmacists on their role and training them
on how to deal with the control and intervention groups.
Part of that orientation is on how not to provide any
intervention to the control subset of smokers.
Study pharmacists were provided with assistance in
setting up the study pharmacies and given some time to
familiarize themselves with the study protocol prior to
commencement of the study. Then each pharmacist was
asked to pilot the study in the presence of the study
team. Piloting occurred by screening/recruiting around
four patients in each site and by implementing the study
protocol. Feedback was provided as required to the study
pharmacists on the quality of patient counseling, patient
education and documentation. Very minor adjustments or
refinements were made to the study protocol and study
tools including the patient consent form, Fagerstrom test
for nicotine dependence (FTND) and smoking cessation
quality-of-life (SCQOL) questionnaire as needed.
Continuous quality improvement and evaluation plan
At all stages of the study implementation, the study
pharmacists are closely supervised by the study team.
Supervision is through several mechanisms including
meetings, communication and site visits.
Regular meetings are invaluable for high-quality
supervision. Meetings are used to guide the project toward its
objectives through team involvement. Bi- or triweekly
meetings involving all the team members including the
study pharmacists are held. In these meetings, study
harmacists summarize their activities during the previous
Participants will be screened by the study pharmacists.
Do they meet eligibility criteria?
Intervention group participants will attend a
patient specific structured pharmacist delivered
smoking cessation program that will be
delivered over 4 sessions and that will combine
NRT and behavioral modification strategies
Initial session: 30 minutes long
1st follow-up session: 20 minutes long.
Intolerable NRT side effects?
2nd follow-up session: 10-15 minutes long
3rd follow-up session: 10-15 minutes long
Control group participants will receive 5-10
minutes unstructured brief advice by the
pharmacist + NRT+ smoking cessation
NO FOLLOW-UP SESSIONS in this group
Outcome measurement for both groups
Outcome measurement for both groups
Outcome measurement for both groups
Figure 1 Participant flow during the study.
2-3 weeks, and the study team offers them constructive
feedback, acknowledges their input and suggests new
directions to them. In addition, ad-hoc meetings are
conducted between the study pharmacists and the study team
where necessary to address any irregular issues that might
The study team members are in direct touch with each
other and with the study pharmacists through electronic
communication such as emails.
To maintain quality control in the smoking cessation
study pharmacies, the study team visits each study
pharmacy at least once every 2 to 3 weeks to monitor data
collection, check protocol adherence, ensure the consistency
of program delivery, address any queries that the study
pharmacists might have in implementing the study, review
patients folders for appropriate documentation, provide
any on-site support required and provide individual
pharmacists with feedback on their performance.
Supervision is crucial to:
Model inputs and cost determination
This pharmacoeconomic analysis will be based on
extrapolating data on resources from the randomized controlled
trial; these data will be collected prospectively. Prospective
data collection enhances the accuracy and robustness of
data and limits bias.
The economic analysis is performed from a social
perspective. Direct medical costs will be evaluated to the best
available, including in relation to NRT, CO monitoring
tests and salaries. Direct nonmedical costs will also be
evaluated and will include participants travel costs to
pharmacies (e.g., taxi) and the paperwork and forms. The
indirect costs will be accounted for as well, in relation to
lost productivity (if any), whether for participants or any
unpaid caregivers that participants utilize. Important is
that any protocol-driven costs (e.g., researchers salaries)
will be excluded from the analysis.
The monetary value of resources will be collected from
internal sources at the Qatari clinics. It is worth noting
that costs involved in this study will be based on
wholesale prices, as paid by clinics.
All calculated costs will be in Qatari Riyal, adjusted for
the financial year 2015-2016, utilizing the Qatari Health
Consumer Price Index as appropriate, and no discounts
will be applied given the short timeframe of the analysis.
The economic evaluation will be undertaken via
decision analytic modeling, where a decision tree will be
structured to follow the different options and consequences in
the management pathways. For each of the participants,
the proposed model may include five possible treatment
outcomes depending on whether participants quit
smoking, and if they do, after what duration. Smokers will be
initially assigned to one of two pathways depending on
whether they quit smoking at enrollment. Smokers who
do not quit at enrollment will be further followed until
assigned to one of two pathways, depending on whether
the smoker quits smoking after 3 months or not. If not,
smokers will be followed up until further assigned to one
of two pathways, based on whether they quit smoking
after 6 months or not. Those who do not quit by then will
be followed up until assigned to one of two pathways
depending on whether they quit at 12 months of follow-up
or not, which will be the end of follow-up in any case.
Smokers who quit at enrollment or after 3, 6 or 12 months
will each be followed up separately until the end of the
study. Based on this, in addition to data on resources
consumed and their monetary values, the model will generate
a weighted average cost for patient cessation and
qualityof-life adjustment. As per the general decision analysis
principles, this will be calculated as the sum-product of
the costs of the management outcomes and the respective
The costs of managing the single episode of smoking
cessation will be compared among different management
options and against budgeted costs of
The goal of sensitivity analysis is to indicate the
robustness of the evaluation conclusion against any potential
variations in the model inputs. Deterministic and
probabilistic sensitivity tests will be produced by modifications
on the base case values of several key variables, in
relevance to costs and probabilities, to evaluate the robustness
of the study economic outcome. Base case values will be
substituted by the highest and lowest values within a
reasonable range of values. Where a substitution changes the
study economic conclusion, more values within the range
will replace the base case value. This will be repeated until
the exact variable value that changes the study outcome is
identified. Reporting this as part of the study results not
only indicates the robustness of results, but also boosts
the generalizability of them when being interpreted by
decision makers in other settings, with different model
inputs, e.g., different resource prices.
Uncertainty analysis, by means of Monte Carlo
simulation, will be performed via the @Risk-5.0 analysis tool
(Palisade Corp., NY, USA) to investigate the likelihood
(probability) of a therapys economic advantage. Monte
Carlo is a method whereby simulated input values,
chosen randomly across a range of probability
distributions of a model input, are added into the model. The
model is run for each simulated input, resulting in a
range of outputs characterizing the output uncertainty.
Based on this, a distribution of cost savings will be
generated, indicating the probability of one management
option to have an economic advantage over another.
Ethical considerations and confidentiality
The study protocol and all associated measures, consent
forms and recruitment procedures obtained ethical
approval by Qatar University (QU) and Hamad Medical
Corp. (HMC) institutional review boards (QU-IRB 76/11
and HMC 11113/11). All the participants folders are
stored in a password-protected database on the site
laptop. Only the study pharmacist can access these folders. In
addition, all data are retained in a password-protected
database maintained along with all related study
documentation in a locked cabinet at QU College of Pharmacy.
The study research assistants will call the study
participants in the intervention and control groups to complete
the assessment. To avoid any bias in data collection, the
research assistants will be blinded to the participant
They will measure the following outcome variables at
3, 6 and 12 months after the start of the study (i.e., the
time of the participants enrollment in the study):
Self-reported 7-day point prevalence abstinence,
defined as having smoked no cigarettes for the
previous 7 days at 3, 6 and 12 months
Self-reported 30-day point prevalence abstinence
defined as having smoked no cigarettes in the last
30 days at 3, 6 and 12 months
Self-reported continuous abstinence defined as
having smoked no cigarettes since quit day at 3, 6
and 12 months
Smoking abstinence as objectively verified by the
CO exhaled test at 12 months
Mean change in health-related quality-of-life score
from baseline at 3, 6 and 12 months for quitters vs.
Overall costs of interventions as studied, including
those of utilization for individual recourses consumed
Average and incremental cost-effectiveness ratio of
the study smoking cessation intervention
To objectively determine long-term abstinence, at 12
months, participants who will self-report not smoking
for the previous 7 days will be invited to come to their
study clinic to measure their exhaled CO level. The clinic
nurse who is responsible for measuring the exhaled CO
level will be blinded to the study participant group.
Participants will be considered abstinent if they register less
than 6 ppm on the test. Interpretation of the CO test
results will be made carefully taking into consideration
time since last smoke, time of the day the test is done and
Exhaled carbon monoxide is a well-known indicator of
cigarette smoking. But because of its short half-life (5-6 h),
it only indicates very recent smoking exposure or
abstinence. On the other hand, as a result of its relatively
long half-life, cotinine can detect nicotine exposure for
up to 1 week. However, the use of any NRT formulation
can trigger a false-positive urinary cotinine test.
Therefore, as it is not expensive and is noninvasive, and it
gives the results in a timely manner, the exhaled carbon
monoxide test is commonly used in most smoking
cessation clinical trials .
The CONSORT guidelines will be followed when
analyzing the study data. Demographics and other variables
related to smoking and quality of life will be summarized
using frequency distributions (for categorical variables)
and means with standard deviations (for numeric
variables) and will be compared between the two study arms
using the chi-squared test (or alternatively the Fishers
exact test for small cell counts) for categorical variables
and the independent t-test (or alternatively the Wilcoxon
rank sum test for non-normally distributed variables) for
The main outcome will be continuous abstinence at
12 months as self-reported and verified by the CO test.
The percentages of participants achieving the main
outcome will be computed and compared between the two
groups using the chi-squared test. Moreover, the
difference in the proportions of continuous abstinence at 12
months between the two study arms (with 95%
confidence intervals) will be computed along with the
number needed to treat. Multiple logistic regression will be
used to obtain the odds ratio of the main outcome
between the two study arms adjusting for any imbalances
in demographics or other baseline smoking-related
variables. Moreover, mixed effects logistic regression, with
pharmacy-level random effect, will be considered to
adjust for the possible pharmacy effect if it existed. The
intent-to-treat principal will be used in the analysis
whereby participants who will be lost to follow-up will
be classified as smokers and included in the main
analysis. This includes those who were removed from the
study because they could not tolerate NRT side effects.
A sensitivity analysis following that of Borelli, Hogan
et al. will be done where the outcome has three possible
categories: abstinence, no abstinence and dropout .
The suggested multinomial model will allow assessing
factors affecting abstinence as well as factors affecting
dropout. This will aid in understanding who might need
more support during the intervention. Similar analyses
for the primary outcome will be done at 3 and 6 months
(but do not include verification of abstinence using CO
To assess the participants health-related quality of
life, SCQOL (smoking cessation quality of life) ratings
for each question will be translated into scores. A total
health-related quality of life score and a
domainspecific score will be calculated at baseline, 3 months, 6
months and 12 months for each participant in the
intervention and control groups. The change in the
total and domain-specific quality-of-life score from
baseline will be calculated for each participant at 3, 6
and 12 months and analyzed using linear mixed
models, which will include the quitting (quitters and
non-quitters) factor and time factor (at 3, 6 and 12
months) and their interaction.
There is no interim analysis planned for this trial.
Statistical analyses will be conducted using the Statistical
Package of Social Sciences (IBM-SPSS), version 21. In
all analyses, the level of significance will be set at 5%.
Sample size calculation
For a priori sample size calculation, we assumed a 7-day
point prevalence abstinence at 12 months of 3% for the
control group and 15% for the intervention group based
on the results of one of the previous studies that
assessed the effect of a pharmacist-run smoking
cessation program . With a two-sided alpha of 5% and
90% power, a minimum sample size of 118 participants
was estimated for each group. This sample size was not
adjusted for the potential correlation between outcomes
of patients within each clinic since this is not a clustered
randomized clinical trial, but in this study patients
within each clinic are randomized to the two
intervention groups, and correlations, if they exist, will be very
small; their effect on the power of the study is negligible
. The project has a total of 17 study pharmacists.
Each study site is expected to enroll at least 30
participants (15 participants in the intervention group and 15
participants in the control group). The recruitment
period is over 12 months (48 weeks). Recruiting at least
30 participants at each study site is considered feasible
given that at least 100 patients visit each pharmacy per
day. Assuming each study site will recruit 1 participant
every week, the 30 needed participants will be recruited
in 30 weeks (approximately 8 months). An extra 16
weeks of recruitment time is given to study pharmacists
to account for workload, holidays and sickness.
This study is the first randomized controlled trial
conducted within Qatar and the Middle East (ME) to test
the effect of a pharmacist-delivered smoking cessation
program on smoking cessation rates. Furthermore, it is
the first study in Qatar to assess the change in
healthrelated quality of life after quitting smoking.
Having the economic analysis component in this study
is also of unique significance. To our knowledge, there are
no economic studies that have evaluated the economics of
a smoking cessation program in Qatar or the region. This
component is important as in settings where resources are
scarce, proving that an intervention brings a good return
to the investment can be as important as proving the
Indeed, in consideration of limited resources and tight
departmental budgets, the additional spending
associated with any of the study options should be examined.
This will be performed through determining the
management option that yields benefits that are associated
with most health costs savings. For example, the
structured program in this study is expected to have a
favorable comparative effect profile. But if the value that is
associated with these advantages is not high enough,
having the structured program in settings may not be
the priority practice to implement. Here, the current
study provides a great opportunity for such analysis,
seeing that randomized controlled trials are the ideal source
of data (i.e., highest level evidence) to be used in the
construction of economic analyses.
This study will be of significance to Qatar, the ME and
to some extent the world. It will advance knowledge
about the role that the ambulatory pharmacists in Qatar
and possibly in the ME can play in smoking cessation. It
will show to what extent these pharmacists would be
effective in helping smokers quit smoking. This would be
important for Qatar and the ME given the high number of
cigarette smokers in these countries . This study will
also help in comparing the effect of pharmacist-delivered
smoking cessation programs in Qatar with the effect of
pharmacist-delivered smoking cessation programs in other
countries. Many previous studies conducted in Australia,
Europe and the USA have demonstrated the effectiveness
of pharmacist-run smoking cessation programs [12-20].
Extrapolating the results of these studies to Qatar and the
ME is not readily applicable. The pharmacy practice
environment in these countries differs from that in Qatar. The
pace of improvement in ambulatory pharmacy practice in
Qatar, as other ME countries, is slow. Except for a few
cognitive and patient-oriented activities, ambulatory
pharmacists job is limited to prescription processing and
medication dispensing . Nevertheless, Qatars
pharmacists are increasingly interested in defining a
wellrecognized vocation for themselves in todays healthcare
system and in moving their focus from pharmaceutical
products to patients. This study will be of potential
significance to ambulatory pharmacists in Qatar. It will
put them in a broader perspective than the
productdispensing context. It will promote their role as public
health educators and accessible sources of health
information. Ambulatory pharmacists are an essential part
of the healthcare system in Qatar and are an existing
workforce that needs to be given the opportunity to
contribute to patient care. By direct involvement of these
pharmacists in smoking cessation, this study will help in
improving their professional role and in shifting it to a
more patient-centered focus and will assist them in having
better integration into the healthcare team in Qatar.
WHO: World Health Organization; QoL: Quality of life; FIP: International
Pharmaceutical Federation; ASHP: American Society of Health-System
Pharmacists; UREP: Undergraduate Research Experience Program;
HMC: Hamad Medical Corporation (HMC); QU: Qatar University; CPP: Clinical
Pharmacy and Practice; CPPD: Continuing professional pharmacy
development; NRT: Nicotine replacement therapy; CO: Carbon monoxide;
FTND: Fagerstrom test for nicotine dependence; SCQOL: Smoking cessation
quality of life; SPSS: Statistical Package of Social Sciences; ME: Middle East.
MH is the lead principal investigator on the project, leading its design and
execution. She wrote the project proposal and manuscript. NK is responsible
for the quality-of-life outcome of the study. DB is responsible for the
pharmacoeconomic aspect of the study. AM is responsible for looking over
the administrative issues in HMC, participates in the training of pharmacists
and assists in following up the progress of the study. AK assists in preparing
for the study pharmacists training, setting up the study sites, coordinating
between members of the study team, and assessing the study outcomes in
participants. NF is responsible for maintaining the quality checkup of data
collection and participants recruitment done by the centers. She ensures the
availability of the study materials and medications in all centers throughout
the data collection period. ZM and MS will help in analyzing the study data.
All authors read and approved the final manuscript.
This publication was made possible by a grant from the Qatar National
Research Fund under its National Priorities Research Program (NPRP). Its
contents are solely the responsibility of the authors and do not necessarily
represent the official views of the Qatar National Research Fund.
We would like to thank Qatar Primary Health Care (PHC) and Qatar
Petroleum (QP) administration and pharmacists for their support and
participation in the project.
1. Lande G . Nicotine addiction. [http://emedicine.medscape.com/article/ 287555-overview]
2. The World Health Organization. The top 10 causes of death Fact sheet [http://www.who.int/mediacentre/factsheets/fs310/en/index2.html]
3. The World Health Organization: Tobacco [http://www.who.int/mediacentre/ factsheets/fs339/en/index.html]
4. The World Health Organization . WHO Report on the Global Tobacco Epidemic , 2008 The MPOWER package [http://whqlibdoc.who.int/ publications/2008/9789241596282_eng.pdf]
5. Center for Disease Control and Prevention: Smoking and Tobacco Use Cessation and Interventions [http://www.cdc.gov/tobacco/data_statistics/ fact_sheets/cessation/quitting/index.htm]
6. Roth MT , Andrus MR , Westman EC . Outcomes from an outpatient smoking cessation clinic . Pharmacotherapy . 2005 ; 25 ( 2 ): 279 - 88 .
7. The World Health Organization: Tobacco Free Initiative [http://www.who.int/ tobacco/research/economics/cessation/en/index.html]
8. Canadian Pharmacists Association. Joint Statement on Smoking Cessation- Tobacco the Role of Health Professionals in Smoking Cessation [http://www.pharmacists.ca/cpha-ca/assets/File/cpha-on-the-issues/ PPSmokingCessation.pdf]
9. Hudmon KS , Prokhorov AV , Corelli RS . Tobacco cessation counseling: pharmacists' opinions and practices . Patient Educ Couns . 2006 ; 61 : 152 - 60 .
10. Aquilino ML , Farris KB , Zillich AJ , Lowe JB . Smoking-cessation services in Iowa community pharmacies . Pharmacotherapy . 2003 ; 23 ( 5 ): 666 - 73 .
11. Sinclair HK , Bond CM , Stead LF . Community pharmacy personnel interventions for smoking cessation . Cochrane Database Syst Rev . 2004 , Issue 1. Art . No.: CD003698 . doi: 10.1002/14651858.CD003698.pub2.
12. Maguire TA , McElnay JC , Drummond A. A randomized controlled trial of a smoking cessation intervention based in community pharmacies . Addiction . 2001 ; 96 ( 2 ): 325 - 31 .
13. Vial RJ , Jones TE , Ruffin RE , Gilbert AL. Smoking cessation program using nicotine patches: linking hospital to the community . J Pharm Pract Res . 2002 ; 32 : 57 - 62 .
14. Carroll P , Rois R , Sarson D , Flynn J. A community pharmacy based smoking cessation program using transdermal nicotine replacement therapy: actions and outcomes . Aust Pharmacist . 2000 ; 19 : 51 - 5 .
15. Sinclair HK , Bond CM , Lennox AS , Silcock J , Winfield AJ , Donnan PT . Training pharmacists and pharmacy assistants in the stage-of-change model of smoking cessation: a randomized controlled trial in Scotland . Tob Control . 1998 ; 7 : 253 - 61 .
16. Zillich AJ , Ryan M , Adams A , Yeager B , Farris K. Effectiveness of a pharmacist-based smoking-cessation program and its impact on quality of life . Pharmacotherapy . 2002 ; 22 : 759 - 65 .
17. Dent LA , Harris KJ , Noonan CW . Randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation . Ann Pharmacother . 2009 ; 43 ( 2 ): 194 - 201 .
18. Smith MD , McGhan WF , Lauger G . Pharmacist counseling and outcomes of smoking cessation . Am Pharm . 1995 ; NS35( 8 ): 20 - 9 .
19. Kennedy DT , Giles JT , Chang ZG , Small RE , Edwards JH . Results of a smoking cessation clinic in community pharmacy practice . J Am Pharm Assoc (Wash) . 2002 ; 42 : 51 - 6 .
20. Dent LA , Scott JG , Lewis E. Pharmacist-managed tobacco cessation program in Veterans Health Administration community-based outpatient clinic . J Am Pharm Assoc (Wash DC) . 2004 ; 44 : 700 - 15 .
21. Crealey GE , McElnay JC , Maguire TA , O'Neill C. Costs and effects associated with a community pharmacy-based smoking-cessation programme . Pharmacoeconomics . 1998 ; 14 ( 3 ): 323 - 33 .
22. McGhan WF , Smith MD . Pharmacoeconomic analysis of smoking cessation interventions . Am J Health Syst Pharm . 1996 ; 53 ( 1 ): 45 - 52 .
23. Sinclair HK , Silcock J , Bond CM , Lennox AS , Winfield AJ . The cost-effectiveness of intensive pharmaceutical intervention in assisting people to stop smoking . Int J Pharm Pract . 1999 ; 7 : 107 - 12 .
24. Tran MT , Holdford DA , Kennedy DT , Small RE . Modeling the cost-effectiveness of a smoking cessation program in a community pharmacy practice . Pharmacotherapy . 2002 ; 22 ( 2 ): 1623 - 31 .
25. FIP Statement of Policy: the Role of the Pharmacist in Promoting a Tobacco Free Future . [https://www.fip.org/files/fip/news/tobacco-final2.pdf]
26. European Forum Pharmacists' Charter on Action against Smoking [http://www.europharmforum.org/file/13612]
27. 2008 PHS Guideline Update Panel, Liaisons, and Staff . Treating tobacco use and dependence : 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary . Respir Care . 2008 ; 53 ( 9 ): 1217 - 22 .
28. Hudmon KS , Corelli RL . ASHP therapeutic position statement on the cessation of tobacco Use . Am J Health Syst Pharm . 2009 ; 66 : 291 - 307 .
29. Al-Kuwari MG . Tobacco control in Qatar . Middle East J Fam Med . 2008 ; 6 ( 6 ): 11 - 3 .
30. Al-Mulla A , Bener A. Cigarette smoking habits among Qatari population . Public Health Med . 2003 ; 4 ( 3 ): 41 - 4 .
31. Global Youth Tobacco Surveillance, 2000 - 2007 [http://www.cdc.gov/mmwr/ preview/mmwrhtml/ss5701a1.htm]
32. Bener A , Zirie M , Kim EJ , Buz R , Zaza M , Nufal , et al. Measuring burden of diseases in a rapidly developing economy: state of Qatar . Glob J Health Sci . 2013 ; 5 ( 2 ): 134 - 44 .
33. Ibrahim WH , Rasul KI , Khinji A , Ahmed MS , Bener A. Clinical and epidemiological characteristics of lung cancer cases in Qatar . East Mediterr Health J . 2010 ; 16 ( 2 ): 166 - 70 .
34. Smoking-Addressing a National Epidemic [https://qatar-weill.cornell.edu/ media/intoHealth/SmokingEpidemic.html]
35. El Hajj M , Al-Nakeeb R , Al-Qudah R. Smoking cessation counseling in Qatar: community Pharmacists' attitudes, role perceptions, and practices . Int J Clin Pharm . 2012 ; 34 ( 4 ): 667 - 76 . doi: 10.1007/s11096- 012 - 9663 -x.
36. Smoking cessation clinic [http://stopsmoking.hamad.qa/ar/clinic/clinic.aspx]
37. Sackey JA . Smoking cessation counseling strategies in primary care . [http://www.uptodate. com/contents/smoking-cessation-counselingstrategies-in-primary-care?source=search_result&search=Smoking+cessation +counseling+strategies+in+primary+care& selectedTitle=1~150]
38. Kennedy DT , Small RE . Development and implementation of a smoking cessation clinic in community pharmacy practice . J Am Pharm Assoc . 2002 ; 42 ( 1 ): 83 - 92 .
39. Heatherton TF , Kozlowski LT , Frecker RC , Fagerstrm KO . The Fagerstrm test for nicotine dependence: a revision of the Fagerstrm tolerance questionnaire . Br J Addict . 1991 ; 86 ( 9 ): 1119 - 27 .
40. Al Mohamed HI , Amin TT . Pattern and prevalence of smoking among students at King Faisal University , Al Hassa, Saudi Arabia . EMHJ. 2010 ; 16 ( 1 ): 56 - 64 .
41. Asfar MD , Vander MW , Maziak W , Hammal F , Eissenberg T , Ward KD . Outcomes and adherence in Syria's first smoking cessation trial . Am J Health Behav . 2008 ; 32 ( 2 ): 146 - 56 .
42. Olufade AO , Shaw JW , Foster SA , Leischow SJ , Hays RD , Coons SJ . Development of the smoking cessation quality of life questionnaire . Clin Ther . 1999 ; 21 ( 12 ): 2113 - 30 .
43. Smoking Cessation Quality of Life (SCQoL) Questionnaire [http://qol.thoracic. org/sections/instruments/pt/pages/scqol.html]
44. Hudmon KS , Berger BA . Pharmacy applications of the transtheoretical model in smoking cessation . Am J Health Syst Pharm . 1995 ; 52 : 282 - 7 .
45. DRUGDEX Evaluations: Nicotine [http://www.micromedexsolutions.com/ home/dispatch]
46. DRUGDEX Evaluations: Nicotine polacrilex [http://www. micromedexsolutions.com/home/dispatch]
47. Jatlow P , Toll BA , Leary V , Krishnan-Sarin S , O'Malley SS . Comparison of expired carbon monoxide and plasma cotinine as markers of cigarette abstinence . Drug Alcohol Depend . 2008 ; 98 ( 3 ): 203 - 9 .
48. Borelli B , Hogan J , Bock B , Pinto B , Roberts M , Marcus B. Predictors of quitting and dropout among women in a clinic-based smoking cessation program . Psychol Addict Behav . 2002 ; 16 ( 1 ): 22 - 7 .
49. Though the smoke: Tobacco use in the Middle East [http://www.ispu.org/ Getpolicy/34/1846/Publications.aspx]
50. Kheir N , Zaidan M , Younes H , El Hajj M , Wilbur K , Jewesson PJ . Pharmacy education and practice in 13 Middle Eastern countries . Am J Pharm Educ . 2008 ; 72 ( 6 ): 1 - 13 .