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					       6.17: Tobacco Use Cessation



Priority Medicines for Europe and the World
 "A Public Health Approach to Innovation"




            Background Paper




   Tobacco Use Cessation:
 Importance and Implications




               By Warren Kaplan
           With materials provided by
               Dr. Samira Asma
           Centers for Disease Control
                       USA

           Coordinated by Derek Yach
                Yale University

                12 October 2004




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                                              6.17: Tobacco Use Cessation



                                                         Table of Contents

Introduction........................................................................................................................................... 3
What is the Size and Nature of the Disease Burden? ...................................................................... 4
  Health Consequences of Smoking .................................................................................................. 4
What is the Control Strategy? ............................................................................................................. 5
  Importance of smoking cessation in reducing disease burden .................................................. 5
Why Does the Disease Burden Persist? ............................................................................................. 6
  Need for Intervention to Increase Cessation ................................................................................. 6
  Evidence Base for Effective Intervention ....................................................................................... 6
What Can Be Learned from Past/Current Research into Pharmaceutical Interventions?.......... 7
  Nicotine replacement Therapy-Available Technologies ............................................................. 7
  Nicotine Replacement Products and Government Policies ........................................................ 9
  Policies and Problems for the Availability of NRTs .................................................................... 9
  Accessibility of NRT Products ...................................................................................................... 12
    a.    Geographical Accessibility .............................................................................................. 12
    b.    Financial Accessibility ...................................................................................................... 13
What Are the Opportunities for Research Into New Pharmaceutical Interventions? .............. 13
Discussion/Summary ......................................................................................................................... 15
References ............................................................................................................................................ 16



                                                                  Appendix




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                             6.17: Tobacco Use Cessation



Introduction
Cigarette smoking and other tobacco use imposes a huge and growing global public health
burden. Every year, tobacco use is currently estimated to kill nearly five million people
worldwide, accounting for one of every five deaths among males over age 30 and one in
twenty deaths among females over age 30. Based on current smoking patterns, annual
tobacco deaths will rise to ten million by 2030. During the 21st century as a whole, we are
likely to see 1 billion tobacco deaths, most of them in developing countries. In contrast the
20th century saw 100 million tobacco deaths and most of them were in developed countries.

Much of tobacco’s substantial death toll is avoidable. Numerous studies from high-income
countries, and a growing number from low and middle-income countries, provide strong
evidence that tobacco tax increases, dissemination of information about health risks from
smoking, restrictions on smoking in public places and in workplaces, comprehensive bans on
advertising and promotion, and increased access to cessation therapies are all effective in
reducing tobacco use and its consequences. Cessation by the 900 million current smokers in
developing countries is central to meaningful reductions in tobacco deaths over the next five
decades. Price and non-price interventions are, for the most part, highly cost-effective.
Potentially, tens or hundreds of millions of premature deaths would be avoided if these
interventions could be widely applied.

There is overwhelming evidence for the health benefits, effectiveness and cost-effectiveness
of quitting smoking and of treatment for tobacco dependence, a disorder recognized by the
tenth version of WHO’s International Classification of Diseases.1 Treatment for tobacco
dependence is safe and efficacious. However, despite availability of cost-effective treatment
for tobacco dependence, the public health sector in many countries, is not investing in
smoking cessation services, nor in the development of an infrastructure that will motivate
smokers to quit and support them on doing so. Furthermore, in most countries, provisions
for treatment, training of health care providers, education and information on wide use of
cessation therapies, as well as financial resources are limited and rarely incorporated into
standard health care. Also, smoking cessation is not seen as a public health priority and is
not necessarily approached as a key tobacco control strategy in governmental and
institutional workplans. Beside specific interventions for smoking cessation, a general
supportive environment that will stimulate smokers to quit is not usually considered a
component of smoking cessation policies.

This paper examines the relevant set of policies on information, availability, accessibility and
affordability of Nicotine Replacement therapy (NRT) products from the pharmaceutical
policy perspective for developed and developing countries.




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                             6.17: Tobacco Use Cessation



What is the Size and Nature of the Disease Burden?
Tobacco use is the single largest preventable cause of death worldwide. Every year, nearly 5
million people die from tobacco-related illnesses.2 The prevalence of tobacco use worldwide
is estimated at 29%, and it is rising.3 The global rate of tobacco use is significantly higher for
men (47%) than women (12%),3 but the tobacco industry has targeted women in their
promotional strategies. In many regions of the world this targeting has proved effective,
resulting in alarming rates of increase in tobacco use among women in both developed and
developing countries.3, 4 In Denmark, Germany, and Sweden, more women aged 14 to 19
years than ever now smoke, even in the midst of national declining rates. Similarly, in some
countries in Asia, smoking among women aged 18 to 24 years has increased. The number of
women smokers will likely triple over the next generation.4 The prevalence of smoking
among youth is also increasing. Data from the Global Youth Tobacco Survey show that one
out of five children in the world smokes his or her first cigarette by age 10 years. The
prevalence of tobacco use among schoolchildren aged 13 to 15 years ranges greatly
throughout the world, from 10% to as high as 60%.5

Health Consequences of Smoking

Smoking harms nearly every organ of the body, causing many diseases and reducing the
health of smokers in general. Forty years after the first Surgeon general’s report in 1964, the
list of diseases and other adverse effects caused by smoking continues to expand.
Epidemiologic studies are providing a comprehensive assessment of risks faced by smokers
who continue to smoke across their lifespan. Laboratory research now reveals how smoking
causes disease at the molecular and cellular levels. Fortunately for former smokers, studies
show that the substantial risks of smoking can be reduced by successfully quitting at any
age.6

Tobacco use was a known or probable cause of more than twenty-five specific diseases and is
an important cause of, and risk factor for, chronic disease.6 Independently and often in
combination, these risk factors are the major causes of cancer, cardiovascular disease,
diabetes, respiratory disease, and other chronic diseases.7 The list of disease caused by
smoking has been expanded to include abdominal aortic aneurysm, acute myeloid leukemia
cataract, cervical cancer, kidney cancer, pancreatic cancer, pneumonia, periodontitis, and
stomach cancer.6 Prolonged smoking causes lung cancer, other cancers (i.e., cancer of
kidneys, cervix and bone marrow), chronic respiratory and cardiovascular diseases (in
particular ischemic heart disease), and many other diseases. Smoking diminishes health
generally. Adverse health effects begin before birth and continue across the life span.
Smoking also causes cataracts and contributes to the development of osteoporosis, thus
increasing the risk for fracture in the elderly.7 In populations in which cigarette smoking has
been common for several decades, about 90% of lung cancer, 15% to 20% of other cancers,
75% of chronic bronchitis and emphysema, and 25% of deaths from cardiovascular disease at
ages 35 to 69 years are attributable to tobacco use.8 Tobacco-related cancer constitutes 16% of
the total annual incidence of cancer cases – and 30% of cancer deaths – in developed
countries, and 10% of deaths in developing countries.7
Chronic diseases are expected to account for an increasing share of the disease burden, rising
from 43% in 1998 to 73% by 2020.8 The expected increase is likely to be most rapid in
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                            6.17: Tobacco Use Cessation


developing countries. For example, in India, the number of deaths from chronic causes each
year is projected to almost double, from 4.5 million in 1998 to about 8 million in 2020. 2 The
steep projected increase in chronic diseases worldwide is largely driven by the rapidly
increasing numbers of people presently exposed to tobacco via smoking or secondhand
smoke (SHS) as well as to other risk factors.

What is the Control Strategy?
Importance of smoking cessation in reducing disease burden

Quitting smoking has immediate as well as long terms benefits, reducing risks for disease
caused by smoking and improving health in general.6 Smoking cessation is a priority for
preventing disease and reducing its burden.8 At any age, quitting confers substantial and
immediate health benefits including reduced cardiovascular disease risks,7 improved lipid
profiles and platelet reactivity9 and reduced risk of stroke7 and smoking-attributable
cancers.10 The World Bank suggests that, if adult consumption were to decrease by 50% by
the year 2020, approximately 180 million tobacco related deaths could be avoided.10 Thus
promotion of smoking cessation and treatment of tobacco dependence can have great impact
in reducing the burden of disease and improving population health. (See Appendix 6.17.1)

According to the Commission on Macroeconomics and Health, smoking is on a short list of
specific conditions-including HIV/AIDS, malaria, tuberculosis, childhood infectious disease,
maternal and perinatal conditions, and micronutrient deficiencies-that needs to be a priority
in low income countries to save million of lives, reduce poverty, spur economic
development, and promote global security.11 In addition, cessation interventions are
described specifically in the WHO Framework Convention on Tobacco Control (FCTC).
Signing the FCTC and its ratification will obligate countries to work on cessation as part of a
comprehensive effort in tobacco prevention and control.12

In recent years governments at all levels have adopted a variety of macro-level interventions.
These include tobacco tax increases, restrictions on smoking in public places, limits on youth
access to tobacco products, bans on advertising and other promotions, counter advertising,
efforts to increase information about the harmful consequences of tobacco use. Most of these
interventions aimed at reducing the demand (consumption) for tobacco products and are
considered preventive policies.

Demand for smoking cessation interventions is increased in an environment that discourages
and denormalizes tobacco use. Smoke-free indoor air policies, tobacco taxation to increase
price, and public information campaigns increase interest in stopping smoking. Banning the
use of misleading labeling on tobacco products, for example, ‘light’ and ‘mild’, can also help
prevent smokers from relapsing and increase quitting.13 The impact of a smoking cessation
program is the product of its effectiveness and population reach (e.g., the proportion of
smokers in the population who use it). Brief low-intensity interventions that focus on
education and increasing motivation to quit and produce a low but measurable success rate,
and have a higher potential for population impact. Most smokers that have quit in Western
countries have done so without any therapies or even doctor’s advice. 7 In contrast, multi-
session, high-intensity treatments targeting nicotine-dependent smokers requiring individual
treatment are characterized by a higher success rate, but reach only a small fraction of the
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                            6.17: Tobacco Use Cessation


population. This balance of the two approaches may differ across time, between countries
and within countries. As prevalence falls, dependence in remaining smokers is likely to be
high. In countries with a high smoking rate and low population awareness of the risks of
tobacco use, awareness of the hazards of smoking and the benefits of cessation, plus focused
efforts that reach large numbers (e.g., quit phone lines) are the priority. In countries or
populations where smoking prevalence has started to fall and awareness of the health risks
of tobacco is higher, higher intensity clinical interventions may be needed.

Near term reductions in smoking-related mortality depend heavily on smoking cessation.
There are numerous behavioral smoking cessation treatments available, including self-help
manuals, community-based programs, and minimal and intensive clinical interventions.14 In
clinical settings, pharmacological treatments, including nicotine replacement therapies
(NRT) and bupropion, have become much more widely available in recent years in high-
income countries.14 , 15

Why Does the Disease Burden Persist?
Need for Intervention to Increase Cessation

Tobacco dependence is recognized as a disease in the WHO’s International Classification of
Diseases (ICD-10) and the American Psychiatric Association’s Diagnostic and Statistical
Manual (DSM-IV).15 In developed countries, a large proportion of smokers want to stop
smoking and many try to stop16 but the corresponding proportions in developing countries
are low.17, 18, 19 Smokers who try to quit often find it difficult because of the addictive
properties of nicotine.20 Because of the low rate of quitting and the inherent difficulties in
stopping, governments need to encourage smokers to quit and to provide more assistance to
those who need help.

Evidence Base for Effective Intervention

The evidence base for both the effectiveness and cost effectiveness of clinical smoking
cessation interventions is strong in Europe and the US.21, 22 A similar evidentiary base is not
available for developing countries.14 In the US there is also a strong evidence base for the
effectiveness of community based and population based interventions such as running
sustained mass media campaigns, raising tobacco prices, reducing the cost of treatment, and
establishing telephone quitlines.23, 24

Current research from Western countries provides mixed evidence on the impact of
community-based behavioral interventions without NRT on successful smoking cessation.15
However, community interventions may be more effective and more cost-effective (due to
lower labor costs) in low income countries. In India, studies among 37,000 tobacco smokers
and chewers found that cohorts who received health professional advice, information and
cessation camps had quit rates of 9% to 17%, in contrast to 3% to 9% among cohorts who did
not receive these interventions.18

Promoting smoking cessation, creating an environment supportive of non-smoking, and
providing appropriate services has produced encouraging results in the UK.25, 26, 27 Although
in 2000 the WHO recommended that the treatment of tobacco dependence be considered a
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                            6.17: Tobacco Use Cessation


public health priority,28 much more needs to be done to promote smoking cessation
worldwide.

What Can Be Learned from Past/Current Research into Pharmaceutical
Interventions?
Nicotine replacement Therapy-Available Technologies

In recent years, given the addictive nature of tobacco, tobacco control interventions have
given an increasing importance for the tobacco addiction treatments, such as the nicotine
replacement therapy products (NRTs). The recent World Bank tobacco report “Curbing the
Epidemic: Governments and Economics of Tobacco Control” also addressed the importance
of the NRT products as one of the efficient tobacco control policies. Moreover, the report
recommends that governments include nicotine addiction treatments into tobacco control
policies.

Nicotine replacement therapy (NRT) aims to replace the nicotine from cigarettes by other
means of delivery nicotine skin patches, chewing-gum, lozenges, sublingual tablets,
inhalators or nasal spray. NRT provides a background level of nicotine that reduces craving
and withdrawal. The evidence is strong and consistent that pharmacological treatments
significantly improve the likelihood of quitting, with success rates two to three times those
when pharmaceutical treatments are not employed.14, 15, 29

A recent overview suggested the 2-3% of smokers abstained at 6 months with brief clinical
advice to stop. Adding NRT to such advice increased quit rates to 6%, and intensive support
plus NRT raised quit rates to 8% at 6 months.

The products currently licensed in the UK listed in Table 1 (NICE 2002).




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                             6.17: Tobacco Use Cessation


        Table 1. Nicotine Replacement Therapies Technology Available in the UK

                   NRT                                   Dose/Brand/Manufacturer

Nicotine transdermal patches                     5mg, 10mg, 15 mg (Nicorette, Pharmacia)
                                                 7mg, 14mg, 21mg per 24 hours
                                                  (NICOTINELLE TTS 10, TTS 20 &TTS 30
                                                  Novartis Consumer Health)
                                                 7mg, 14mg, 21mg (NiQuitin CQ,
                                                  GlaxoSmithKline (GSK))
Nicotine chewing gum                           2mg, 4mg (Nicorette, Phamacia) (Nicotinell,
                                               Novartis Consumer Health)
Nicotine sublingual tablet                     2mg (Nicorette, Microtab, Pharmacia)
Nicotine lozenge                               1 mg (Nicotinell, Novartis Consumer Health)
Nicotine inhalation cartage plus               10mg (Nicorette, Inhalator, Pharmacia)
mouthpiece
Nicotine nasal spray                           0.5mg per puff metered nasal spray (Nicorette
                                               and Pharmacia
Nicotine lozenge                               2mg and 4mg (NiQuitin CQ, GSK)


While successful in treating nicotine addiction, the markets for NRT and other
pharmacological therapies are highly regulated. In turn, pharmaceutical treatments are less
affordable and less available than nicotine-containing tobacco products that are distributed
in a relatively unrelated market. Recent evidence indicates that the demand for these
products is related to economic factors, including their price.30 Policies that decrease the cost
of NRT and increase their availability, such as mandating private health insurance coverage
of NRT, including NRT coverage in public health insurance programs, and subsidizing NRT
for uninsured or underinsured individuals, would likely lead to substantial increases in the
use of these products. Given their demonstrated efficacy in treating smoking, these policies
could generate significant increases in smoking cessation and the health benefits that result
from cessation.

NRT expenditures per capita vary widely between income group countries as well as
between the US and other high-income countries. The US spends $2.11 per capita or $10.88
per smoker on NRT products in 1996, whereas other high-income countries on average
spend $0.42 per capita or $1.63 per smoker. Middle-income countries’ expenditures on NRT
are significantly less than that of other-income countries. Upper-middle income countries
spend $0.03 per capita or $0.16 per smoker on NRT products. Lower-middle income
countries’ spending are $0.003 per capita or $0.03 per smoker.




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                            6.17: Tobacco Use Cessation


Nicotine Replacement Products and Government Policies

A successful tobacco control policy on addiction treatment strongly depends on smoker’s
demand for NRT products and government’s policies on availability and accessibility of
these products. Most smokers start smoking at an early stage of their lives and later regret
that they are smokers. For example, a survey from Indonesia indicates that over 80% of
smokers want to quit smoking. Moreover, most smokers who say they want to stop, their
efforts to quit have failed, often despite of frequent attempts.31

Policies and Problems for the Availability of NRTs

Patent policies, designed to give returns to research and development expenditures, are
politically charged issues. Almost all industrialized and developing countries now recognize
patents on both pharmaceutical products and process- usually for 20 years.

Given the monopolistic elements of the pharmaceutical market, price control policies on
drugs are commonly found in countries at all income levels. The primary objective of the
price controls is to control drug prices and expenditures. With regard to NRT and such
pricing policies, there is not sufficient time series data to compare the trend on NRT
expenditures for countries with and without price control policies. Second, countries did not
include NRT products in their essential drug lists and also there is no reimbursement system
for the NRT products in any country, as they are mostly available over the counter.
Therefore, NRT products are not subject to any price control policies at all.

Given the market share of NRT products in pharmaceutical expenditures, especially in
developing countries, including NRT products into essential drug list may increase the
availability of these products. Most low and middle income countries have financial
constraints to purchase drugs in the international level. When the NRT products are
included in the essential drug lists, Ministries of health and finance should work together so
that budgetary funds and foreign exchanges are available.

Although information on the regulation of advertising of the NRT products for the
developed and developing countries is not available, only few developing countries allow
NRT products to be advertised directly to consumer. For example, in Australia, 2mg gums
are allowed to be advertised in 1997, and nicotine patches in 1998. Studies show that direct
advertising in Australia32 and the US has increased the sales of these products. Some
available information shows that most countries treat NRT products as medical drugs and
do not permit advertising or permits with restrictions. Some restrictions on advertising of
NRT products also create hurdles on availability of these drugs. In other words, permitted
advertising with specific restrictions may create negative impact on consumers to purchase
these products. For example, warning labels of NRT products in Italy, an advertising
requirement, is one of the examples that may handicap marketing products in the country.
All OTC products are required to provide a voice-over warning. NRT requires the following
warning (that takes between 12-15 seconds to be read, thus effectively reducing the effect of
the advertising in half (most commercials are 30 second ones):



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                              6.17: Tobacco Use Cessation


"This is a medicine for the reduction of smoking dependence. Read the Leaflet carefully and pay
particular attention to the contraindications. Avoid smoking during the treatment. Do not use if you
suffer from heart diseases, or if you are pregnant or breast feeding."

In terms of distribution restriction, Japan is very unique. It restricts NRT sales only to
smokers who suffer from a tobacco attributable disease. In other words, NRT products are
not available for smokers unless they are ill. In general, globally, NRT products are legally
available either by prescription or over the counter. Consumers are required to get
prescriptions from a physician to access the NRT products when the sales are restricted to by
prescription only. The structure of the over- the-counter sales is more complex. Over-the-counter
(OTC) NRT products are sold either in only by pharmacy or by general sales. For example, in
the US, NRT products are available not only in pharmacies but also in other stores (grocery
stores, supermarkets, etc). Consumers have an easy access to these products since they are
widely available to the public. On the other hand, over-the-counter sales in most countries are
restricted to pharmacy only. In most cases, consumers request these products from
pharmacists since they are restricted. With well-trained pharmacists, this type of sale is likely
to provide consumers safe products with therapeutic effectiveness, and lower costs in
comparison to other products in low-and middle-income countries where self-prescription is
common.

Currently developing countries face two problems which may alter the availability of NRT
products; (1) few pharmacies to cover the population, and (ii) few trained pharmacists. For
example, in Indonesia, over 200 pharmacies are providing drugs to 200 million people. This
may be one of the reasons for a pharmaceutical company to withdraw NRT products from
Indonesia six months after entering the market.

Trained pharmacists are also the only source of information for smokers in low-income
countries regarding the availability of NRT products, because (1) the access to physician care
is low, and (2) since NRTs are considered medical drugs, they are likely to be subject to
advertising ban in some countries. Therefore, the importance of trained pharmacists and the
number of pharmacies to cover the majority of population are important issues for the
availability of NRT products.

Table 2 provides information of the legal status of NRT products in selected European
countries and Japan. NRT nasal spray is sold by prescription in most countries, except
Germany. In general, patches and gums are sold over the counter by pharmacy only.




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                          6.17: Tobacco Use Cessation


                 Table 2: Availability of NRT Products in European Countries

    MARKET           DOSAGE FORM                        LEGAL STATUS

Austria                     Patch           Pharmacy Only
Austria                  Nasal spray                                 Prescription
Belgium                     Patch           Pharmacy Only
Belgium                  Nasal spray                                 Prescription
Canada                      Patch                                    Prescription
Czech Republic              Patch           Pharmacy Only
Denmark                     Patch           Pharmacy Only
Denmark                  Nasal spray                                 Prescription
Denmark                   Inhalator         Pharmacy Only
Estonia                     Patch           Pharmacy Only
Finland                   Inhalator         Pharmacy Only
Finland                     Patch           Pharmacy Only
Finland                  Nasal spray                                 Prescription
France                      Patch                                    Prescription
Germany                     Patch           Pharmacy Only
Germany                    Plaster          Pharmacy Only
Germany                  Nasal spray        Pharmacy Only
Germany                   Injection         Pharmacy Only
Greece                      Patch         Lower doses for pharmacy, higher doses for
                                          prescription only
Greece                   Nasal Spray                               Prescription
Greece                     Inhaler                                 Prescription
Hungary                     Patch                                  Prescription
Ireland                  Nasal spray                               Prescription
Ireland                     Patch           Pharmacy Only
Italy                       Patch           Pharmacy Only
Italy                     Inhalator         Pharmacy Only
Italy                     Solution?         Pharmacy Only
Japan                       Patch                                  Prescription
Latvia                      Patch           Pharmacy Only
Lithuania                   Patch           Pharmacy Only
Netherlands                 Patch           Pharmacy Only
Netherlands                Inhaler                                 Prescription
Netherlands              Nose-spray                                Prescription
Norway                      Spray                                  Prescription
Norway                    Inhalator         Pharmacy Only
Norway                      Patch           Pharmacy Only
Poland                      Patch                                  Prescription
Portugal                    Patch                                  Prescription
Portugal                 Nasal spray                               Prescription
Portugal                  Inhalator                                Prescription
Russia                      Patch           Pharmacy Only
Spain                       Patch           Pharmacy Only
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                                6.17: Tobacco Use Cessation


     MARKET              DOSAGE FORM                                LEGAL STATUS

Sweden                           Patch                Pharmacy Only
Sweden                        Nasal spray                                           Prescription
Sweden                         Inhalator              Pharmacy Only
Switzerland                   Nasal spray                                         Prescription (?)
Switzerland                      Patch                                             Prescription
UK                            Nasal Spray                                          Prescription
UK                               Patch                Pharmacy Only
UK                              Inhaler               Pharmacy Only


Accessibility of NRT Products

It is critical to make cessation products more affordable to those who, so far, have been
unable to afford them. It might be worthwhile to organize a campaign similar to that
undertaken for AIDS treatment in Africa, which placed significant international pressure on
pharmaceuticals companies to reconsider their pricing policies for AIDS drugs in poor
African countries where the pandemic was escalating. Similarly, there is an argument to be
made for making available cheap generic variants of NRT products and for the relaxation of
patent laws for cessation products on the basis of extremely high death toll exacted by
smoking and other tobacco use. The WHO FCTC addresses the accessibility and affordability
of treatment for tobacco dependence when it states that parties shall endeavour to
“collaborate with other Parties to facilitate accessibility and affordability for treatment of
tobacco dependence including pharmaceutical products pursuant to Article 22. Such
products and their constituents may include medicines, products used to administer
medicines and diagnostics when appropriate”.13
a.      Geographical Accessibility
NRT products face the similar distribution and access problems as general drugs. Health
care financing system, pharmaceutical policy and distribution systems of a country play a
significant role on geographical accessibility.

In low-income countries, self prescription is common. Drugs registered for sale by prescription only
are, in practice, often obtainable as easily as over-the-counter drugs. Private providers consist of small
hospitals, clinics, individual physicians, and traditional healers. Drugs are purchased from
pharmacies, health facilities, or drug peddlers. NRTs are, if available, sold mostly at pharmacies only.
Expanding households’ geographic access to drugs is usually the main concern of pharmaceutical
policy in low-income countries.

In middle-income countries, government regulatory capacity tends to be greater and more of
the population has contact with organized health care delivery- both public and private.
Drugs are purchased directly from pharmacies. Self-prescription is common, but a higher
proportion of the population has regular contact with formal health providers, particularly
large, organized providers. Having sufficient pharmacies to cover most of the population is
still a problem for middle-income countries. Pharmacies are usually located in highly
populated areas, which make it difficult for smokers to access these products.



                                                 6.17-12
                             6.17: Tobacco Use Cessation


In most industrialized countries, health care delivery systems are highly organized; therefore
there is no issue of geographical access. Drugs are available in general sales through over the
counter and prescription.
b.     Financial Accessibility
Financial accessibility of the NRT products depends on the country’s health financing
system. Although most pharmaceutical drugs are subject to pricing policies, NRT products
are not. One of the reasons is that NRT products are not included in the most essential drug
lists in any country. Most countries have essential drug lists and one of their characteristics is
to provide information to providers regarding which drugs are reimbursed by an insurance
company. Up-to-date, NRT products are not reimbursed by either insurance companies or
governments, except a few insurance companies in the United States.

What Are the Opportunities for Research Into New Pharmaceutical
Interventions?
The current National Institutes of Health database (www.clinicaltrials.gov) provides more
information on smoking-cessation pharmaceutical interventions in clinical trials in the
United States (Table 3).


                              Table 3: NRT in USA Clinical Trials

      Clinical Trial           Sponsoring              Name of the drug      Phase of     Number
                               Organization                                    trial          of
                                                                                           patients
Combinations of             Department of          Bupropion                 Phase I      -
Pharmacologic Smoking       Veterans Affairs       Mecamylamine
Cessation Treatments                               Nicotine Patch
Tobacco Cessation in        NIDA                   Nicotrol                  Phase I      -
Postmenopausal Women
(Part II) - 2
Comparing Smoking      NIDA                        Nicotine transdermal      Phase II     270
Treatment Programs for                             system
Lighter Smokers - 1
Effect of Combined     NIDA                        Bupropion                 Phase II     34
Pharmacotherapy/Behav
ioral Treatment on
Smoking Cessation For
Methadone Maintenance
Therapy Patients - 2
Effect of Combined     NIDA                        Bupropion                 Phase II     34
Pharmacotherapy/Behav
ioral Treatment on
Smoking Cessation For
Methadone Maintenance
Therapy Patients - 2
Pharmacologic Relapse  NIAAA                       NRT patch                 Phase II     292

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                               6.17: Tobacco Use Cessation


       Clinical Trial            Sponsoring            Name of the drug   Phase of    Number
                                 Organization                               trial        of
                                                                                      patients
Prevention for Alcoholic                           Bupropion
Smokers                                            (Wellbutrin)
Quit Smoking                  Department of        Mecamylamine           Phase II    -
                              Veterans Affairs     Nicotine Patch
Fluoxetine as a Quit          Department of        Nicotine transdermal   Phase III   240
Smoking Aid for               Veterans Affairs     system
Depression-Prone              Eli Lilly and
Smokers                       Company
Smoking Cessation             NIDA                 Nicotine transdermal   Phase III   585
Treatment with                                     system
Transdermal Nicotine
Replacement Therapy - 1
Behavioral Counseling for     NIAAA                NRT patch -            Phase IV    144
Alcohol Dependent                                  Mood management
Smokers (nicotine patch)
Behavioral/Drug               NIAAA                Naltrexone (Revia)     Phase IV    200
Therapy for Alcohol-                               Nicotine replacement
Nicotine Dependence                                patch
(naltrexone/nicotine
patch)
Bupropion and Weight          NIDA                 Bupropion              Phase IV    450
Control for Smoking
Cessation - 1
Bupropion as a Smoking        NIAAA                Bupropion              Phase IV    200
Cessation Aid in                                   (Wellbutrin)
Alcoholics
Combination Nicotine          NIAAA                NRT patch and gum      Phase IV    175
Replacement for Alcoholic
Smokers
Smoking Cessation in          NIAAA                NRT patch              Phase IV    112
Alcoholism Treatment
Timing of Smoking             NIAAA                NRT patch              Phase IV    500
Intervention in Alcohol
Treatment (nicotine patch)
Tobacco Dependence in         NIAAA                Naltrexone (Revia)     Phase IV    166
Alcoholism Treatment                               NRT patch
(nicotine patch/naltrexone)
Maintenance Treatment for     NIDA                 Bupropion                          750
Abstinent Smokers - 1
Mood and Smoking: A           Department of        NRT                    -           128
Comparison of Smoking         Veterans Affairs
Cessation Treatments
Naltrexone and Patch for      Department of        Naltrexone             -           -
Smokers                       Veterans Affairs     Hydrochloride
                                                   Transdermal

                                             6.17-14
                               6.17: Tobacco Use Cessation


       Clinical Trial           Sponsoring               Name of the drug      Phase of        Number
                                Organization                                     trial            of
                                                                                               patients
                                                     Nicotine
Nicotine Replacement          Oncken, Cheryl,        NRT (2 mg gum)            -               268
Treatment for Pregnant        MD
Smokers                       Hartford Hospital
                              University of
                              Connecticut
                              Duke University
Tobacco Dependence in         NIAAA                  Naltrexone (Revia)        -               200
Alcoholism Treatment                                 NRT patch
(nicotine patch/naltrexone)
Use of Sibutramine in         NHLBI                  Sibutramine                               -
Smoking Cessation

NIDA: National Institute on Drug Abuse
NIAAA: National Institute on Alcohol Abuse and Alcoholism
NHLBI: National Heart, Lung, and Blood Institute

The database provided by the Pharmaceutical Research and Manufacturers of America
(www.phrma.org) provides some further information on pharmaceutical interventions in
Table 4.


              Table 4: Additional Information on NRTs in clinical development


nicotine and                  Elan Pharmaceuticals        Phase III                Smoking
mecamylamine                  South Francisco, CA                                  Cessation
transdermal patch
none / nicotine and
mecamylamine
transdermal patch33
SR141716                      Sanofi-Aventis              Phase III/Phase II       Obesity
none / cannabinoid            New York, NY                /Phase II                Schizophrenia
receptor (CB1)                                                                     Smoking
antagonist                                                                         Cessation
(Acomplia ®
(rimonabant))34



Discussion/Summary
The risks of medications are frequently evaluated against a condition in which there is no
medication and no risk. By this standard, approved smoking cessation medications are
remarkably low in risk. However, the comparison and risk benefit should be judged against
a condition that kills 50% of those afflicted. By this standard, the risks of treatment

                                               6.17-15
                                6.17: Tobacco Use Cessation


medications are virtually nil, which is why the US Clinical Practice Guideline (1996 and 2000
versions) recommends that all smokers be offered medication therapy. This perspective is
increasingly being taken by expert committees, including just recently a new
NCI/NIDA/FDA panel (August 2004, unpublished).



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