Applied Project: A Deeper Look at Patient Compliance And...

Applied Project Dunn, S

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Applied Project:

A Deeper Look at Patient Compliance

And

Smoking Cessation

Sherry Dunn

APRJ-699

Word Count: 14,735

Submission Date: 20/11/2013

Applied Project Supervisor: Dr. Ana Azevedo

Applied Project Coordinator: Dr. Teresa Rose


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Abstract

Recognizing the importance of patient compliance, this paper provides a conceptual

model through literature reviews that identify critical factors that could improve

compliance. This paper focuses on secondary sources such as available literature, and

web results. The learning is applied specifically to the field of smoking cessation. The

findings identify methods to improve outcomes for all key stakeholders while increasing

market size, and market share of a particular product. This paper categorizes the

findings of the literature review in a conceptual model with independent variables and a

mediating link to patient compliance. The independent variables consist of patient

education, marketing variables, and individual background variables. The adoption of

smoking cessation methods are categorized as mediating or intervening variables.

Patient education must be delivered through various touch points with the healthcare

professional being a central source of the information. The message is to be delivered

consistently during teachable moments. Personalized tools and delivery methods

increase the likelihood of the message resonating with the patient. The end user must

be made aware of the products and methods that are available to them to increase

compliance.

The likelihood of increased patient compliance with a specific drug is highly dependent

on the 4P‘s of marketing (product, price, promotion, and place). The marketing and

promotion of a drug could be catered to the various types of patients looking to quit

smoking. Personalization of information is also important when considering the

individual demographics, backgrounds, and conditions of patients. Some factors such

as age and gender cannot be influenced, while understanding the emotional and

physical nature of the addiction allows for more customized programs. All of the above

mentioned independent variables are further influenced and enhanced by adoption of

smoking cessation methods or programs such as individual counseling and

assessment.

Based on the findings of the literature review, the recommendations of the paper in

each category are as follows:

Marketing Variables: there is a requirement for continuous product, indication, and

format innovation to provide patients with personalized options as well as renewed hope

when trying to quit smoking. Implementation of pricing strategies such as increased

public access to products, subsidization by the pharmaceutical industry, and lobbying

for greater private coverage will increase compliance rates of smoking cessation

products and serve as a differentiator for certain products. In addition, loyalty products


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will keep patients motivated to continue on a therapy line. Promotional activity should

focus on both direct to consumer advertising (DTC), as well as focus on healthcare

professionals. Smoking cessation products should be available in locations where

patients are most likely to make a quit attempt such as during hospital visits and

immediately after a hospital stay. Implementation of programs such as mailing products

and information to individuals who recently had a hospital stay could ensure greater

compliance success. Products with temporary abstinence indication should be sold in

airports, and at sporting events, conferences, and contests.

Patient Education: physician advice and counseling is an important factor in patient

compliance and yet healthcare professionals do not have the required time to

successfully fulfill this strategy. They must be made aware of and connected to

smoking cessation programs that offer structured support and education for patients.

The unique needs and individual motivations of patients must be assessed by a

physician in order to properly support the quit attempt by an individual. . Tools to make

assessments and motivate patients to quit such as spirometers, motivational

assessments, and change models must be provided and made accessible to healthcare

professionals for use with patients. Part of the education program is patient familiarity

with available smoking cessation products, services, and options. The information

could be communicated through direct to consumer (DTC) advertising, healthcare

professional messaging, and through peer communication methods such as social

media. The provision of feedback systems associated with each product would allow

patients to provide valuable information to the manufacturer that would be used for

product improvements in the future. Smoking cessation drug manufacturers should

work with a range of healthcare professionals including dentists, family physicians, and

specialists to ensure consistent message delivery and utilization of value added tools

and methods.

Individual background variables: Age, gender, health conditions, and pregnancy play an

important role in the decision to quit. Although they cannot be altered, a thorough

understanding of each of these groups would allow for better targeted programs and

messaging. Counseling programs should be customized towards female patients with

greater receptivity to emotional support. Specific programs and tools should be made

available to target each of the individual health conditions at the point of care.

Adoption of smoking cessation methods or programs: The pharmaceutical industry

should works closely with a variety of groups. It should be mandated that the

development of programs connect various healthcare professionals, patients, and

advocacy groups.


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Table of Contents Abstract ........................................................................................................................... 2

Introduction ..................................................................................................................... 5

Research Purpose and Research Questions .................................................................. 6

Literature Review and Review of Relevant Theory ......................................................... 8

Research Design and Data Collection........................................................................... 21

How to Increase Compliance in Smoking Cessation (Results & Analysis) .................... 22

Recommendations ........................................................................................................ 35

Conclusion .................................................................................................................... 37

References .................................................................................................................... 39

Appendix ....................................................................................................................... 44

Appendix 1 ................................................................................................................. 44

Appendix 2 ................................................................................................................. 46

Appendix 3 ................................................................................................................. 47


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Introduction Johnson & Johnson Inc. (JnJ) is one of the largest pharmaceutical companies in the

world with consistent reporting of annual profits. The organization is decentralized;

working out of 60 countries, over 250 operating companies and consists of three distinct

divisions (Our Company, 2013). The divisions consist of Consumer Healthcare,

Pharmaceutical, and Medical Devices and Diagnostics. The organization focuses on

both organic and inorganic growth. Innovation, growth of the customer base, and

increase in productivity are considered some of the organic strategies. The inorganic

growth consists of mergers and acquisitions. Many JnJ products are household names

such as Nicorette®, Nicoderm®, Listerine®, Tylenol®, Johnson‘s® baby products, and

Polysporin®. The organization is primarily focused on product offerings, although

services are a part of the differentiation factor. There is significant focus on the four Ps

of product, price, promotion, and place. Product differentiation could be based on form

(size, shape, and physical structure), features, customization, performance quality,

conformance quality, durability, reliability, and style. This paper will be focused on the

organic growth of the organization. More specifically, the analysis will relate the findings

to a specific disease state and product offering: smoking cessation and nicotine

replacement therapies (NRTs) NICORETTE® and NICODERM® brands. The analysis

will review current strategies in place by the organization to increase patient

compliance, as well as potential areas of focus for continued success.

Smoking is the number one preventable cause of death worldwide. The annual cost of

smoking in United States is $193 billion due to direct cost to health care ($96 billion)

and loss of productivity ($97 billion) combined. (prevention, Smoking-Attributable

Mortality, Years of Potential Life Lost, and Productivity Losses — United States, 2000–

2004, 2008) Smoking is responsible for more than 440,000 deaths each year which

works out to one out of every five deaths in the U.S (including exposure to secondhand

smoke). Smoking causes heart and chronic obstructive pulmonary disease, stroke,

multiple cancers, complications of pregnancy, and many other diseases that, on

average, shorten the lifespan of a smoker by 14 years. About 70 percent of smokers

want to stop smoking, and nearly half of all smokers make an attempt to quit each year.

However, only about a third of smokers use counseling and/or medication during their

quit attempt, and about 5% are successful without formal help. (prevention, Quitting

smoking among adults-United States, 2001-2010, 2011)This is likely one important

reason why nearly one in five U.S. adults still smoke. Smoking is a topic that garners

much conversation on why it is so difficult to quit, but the major reason is the

physiological element that highlights the strong addictive characteristics of nicotine.

Nicotine is responsible for the physically rewarding nature of tobacco products. The

addictive properties of nicotine are comparable to that of alcohol, cocaine, or heroin.

(Services, 2010) Consider tobacco dependence not only an addiction, but also a chronic


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disease that requires intervention, education, and ongoing management to prevent

relapse and remission. (Fiore MC, 2008)

Some of the physiological effects of smoking include arousal (including a rise in blood

pressure and heart rate), cognitive effects (improved concentration and heightened

mood), and the release of numerous neurotransmitters (dopamine, serotonin,

norepinephrine, etc.). These physical changes result in rewarding and pleasurable

effects. In fact, smokers often self-regulate these effects by titrating their nicotine levels

through their smoking habits.

Research Purpose and Research Questions The goal of this paper is to answer two questions:

The primary question is: What are the critical factors that could influence patient

compliance?

Once these factors have been uncovered, the author will focus on answering a

secondary question: How to increase patient compliance in smoking cessation?

The findings of the paper will be relevant and applicable to other pharmaceutical

products. The paper will also uncover strategies around the four Ps and patient

compliance. Regardless of the product or disease state, patient compliance is a

significant success factor.

Patient compliance or adherence is defined as the voluntary cooperation of a patient in

their treatment regimen recommended by healthcare professionals. Persistence of a

given therapy is the length of time that a patient adheres to the treatment.

The pharmaceutical industry invests billions of dollars in research and development on

an annual basis with the hopes of lucrative returns. They are interested in patient

compliance and persistence in order to increase the profitability of marketed drugs.

With increased rates of forecasted sales, more products would meet launch hurdle

rates. Increased profits would encourage additional investment in research and

development for new drugs.

Increasing the sales of a product and impacting patient compliance rates also has

significant impact on the research and development of future drugs. It is important for

researchers to know if patients are not responding to a current medication due to lack of

efficacy versus lack of compliance.

Healthcare costs continue to rise with forecasts of exponential increases in the coming

years with the growth in the aging populations. Governments have a desire to reduce


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costs through prevention or better health solutions which are impacted by patient

compliance to drug therapies.

The deliverables of this paper will consist of:

Using the literature review, a conceptual model will be developed by uncovering

the critical factors influencing patient compliance.

The second section of the paper will apply the learning specifically to smoking

cessation. Recommendations will include the categories of four Ps of product,

price, promotion, and place as well as other areas categorized as identified in the

literature review.

The findings will result in increasing market size, and market share of a product. The

knowledge domain of the research paper will focus primarily on the marketing aspect

and will also incorporate concepts of strategic management.


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Literature Review and Review of Relevant Theory There may be multiple reasons for a patient not adhering to a product therapy ranging

from forgetting to take a medication to cost implications (Loden & Schooler, 2000, p.

88).

Patient compliance and adherence have a significant contribution to patient outcomes in

terms of the success of their treatment, prevention of further complications, and reduced

rates of hospitalization, and mortality. Estimates indicate that half of patients take their

medication incorrectly (Loden & Schooler, 2000, p. 88), and that approximately 44,000

to 98,000 patients die annually in the US due to medication errors (Byrns, 2005, p. 67).

Compliance is important not only in improving patient health; it also has an immense

impact on improving the economic health of the pharmaceutical industry (Ellwood,

lichtenfeld, Parker, Tuncer, Solis, & etal., 2007). This subject has been addressed in

the past through various approaches that have not yielded success. Some examples of

such programs include:

The one size fits all approach is where a single strategy has been used for a wide

population with the hopes of significantly impacting compliance rates. It is important to

recognize that reasons for noncompliance differ from patient to patient. Therefore, in

designing programs for improving patient adherence, one has to keep in mind flexibility

and the ability to customize programs depending on the needs of individual patients

(Gellad, Grenard, & McGlynn, 2009).

Pharmaceutical companies need to keep in mind that one-directional communication is

often problematic. Two-way dialogue with the patients is critical in order to ensure that

their needs are addressed (Honigberg, Gorden, & Wisniewski, 2011).

The sole reliance on technology has also proven unsuccessful since it has been found

to be too complex for some users. Programs that are introduced to patients should be

simple enough for patients and the rest of the healthcare team to understand and utilize

them in a timely manner (Atreja, Bellam, & Levy, 2005).

Indirect, impersonal direct mails have been widely used in the past with minimal return

on investment. Programs should focus on the needs of the patients and personalized

where possible.

The acceptance of the adherence program by various stakeholders is important. When

patients hear the same message consistently from various sources, it increased their

chances of success. The message and process therefore require it to be simple

enough for everyone to follow and there needs to be a buy-in from all parties involved in

order for it to help improve the medication compliance. (Medicine, 2011)


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Changes that will improve compliance are multifaceted. They involve industry, health-

care teams, patient advocacy groups, patients, and finally caregivers. Compliance

improvement methods could be categorized in 4 areas:

a) Making improvements to medications

b) Improving the technology

c) Focusing on the needs of patients

d) Working with the medical professionals

Making improvements to medications

Price is one of the key factors influencing compliance. Establishing programs that could

improve costs for various patient groups would make a significant difference in

optimizing patient compliance (Hubbard & Daimyo, 2010). Methods to reduce cost

could include reducing co-pays by providing vouchers, or spreading the cost over a

longer period of time. In addition, working with insurers when designing their

formularies could help place medications in lower cost brackets and therefore, a lower

out of pocket cost for the patients. Price barriers should be discussed between patients

and their healthcare professionals in order to provide alternatives or allow for the

switching of medications to lower price options that may be covered by a formulary plan.

Improving the packaging of the medications can also help with increasing patient

compliance. Blister packs and the use of reminder packaging are some of the ways that

allow patients to habitually take their medications as required. Availability of different

medication dosage forms will improve the delivery options of the medications and could

play an important role in improving compliance. Examples of innovative delivery options

are: transdermal patches that are not invasive and are able to deliver medications

effectively and changing the frequency of dosing to a less frequent option (once daily

instead of few times daily or even once monthly instead of once a day). (Musaus &

Bahr, 2012; Wertheimer & Thomas, 2005)

Improving the technology

Establishing a universal medical record system in which all the health care providers

could see patients‘ health information and medication records will help improve

compliance and minimize the duplication of medications. Such a system will enable

healthcare providers to monitor and address compliance issues with their patients.

(McGuire, 2010)

Sending instant messages to patients as a reminder to take their medications could be

a useful method to improve adherence as well. Instant messages are secure and could


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be used for sending medical reminders. Another method is to send a signal from the

cap of the medication bottle when it is opened and medication is taken by the patient

into a system that keeps up with their daily medication regimen. Through this system, if

a predefined period of time has elapsed and the patient has not taken the medication, a

message may be sent to a family member, physician, or pharmacist to remind the

patient to take their medication. (Bender, et al., 2010)

Setting up call centers to respond to inquiries about the medication, provide counseling,

or general advice have been shown to produce benefits. These services could also be

provided as an outreach to patients that are using the product for the first time or where

the healthcare professional has identified the need for additional follow-ups with the

patient. (H, E, Jette, John, Jeanne, & Kathleen, 1996)

Developing websites that are dedicated to a certain medication or disease state,

complete with question-answer sections could improve patient compliance. These

websites could be a way of delivering important messages to a target audience and

could be followed up with newsletters and instant reminder messages. These could be

specifically useful for patients starting a new medication. These websites could play an

important role in increasing the knowledge of patients for the specific medication and

familiarize them with drug interactions and the importance of the ―do‘s‖ and ―don‘ts‖ of

their specific treatment. (Raynor, et al., 2007) The technological methods described

also serve as a promotional vehicle of a specific medication and result in increased

consumption.

Focusing on the needs of patients

Patient education plays an important role in improving compliance. Education is

multilayered and includes information on the mechanism of action, importance of the

particular medication for their condition, drug interactions as it pertains to their regimen,

and correct administration. Direct one on one counseling and focusing on answering

individual concerns and questions of patients are most effective as compared to a

broader once size fits all approach. (McDonald, Garg, & Haynes, 2002)

Direct to consumer (DTC) marketing is another way of positively influencing compliance

rates. Television and radio advertising, newspaper prints, and web promotions are all

among the direct to consumer marketing vehicles. They help promote the product being

viewed in a positive light by showcasing the key benefits and as a reminder for patients

to be more compliant. (Marta, 2005)

Discount/assistance programs are important components as well. As previously noted,

the high cost of medications is among one of the reasons for non-compliance.

Providing patients with discounted prescription cards would help alleviate this obstacle.


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Cost reduction measures not only boost compliance but can increase brand loyalty.

Since the discount card is used each time a prescription is filled, it is easy to keep track

of the product usage and if a prescription has not been filled within a certain time period,

a reminder could easily be generated. (Giufrrida & Torgerson, 1997)

Influencing the beliefs of patients about a product or disease is instrumental in

increasing compliance. Providing information about their condition and importance of

the medications prescribed to them could help the situation by improving their

knowledge and therefore increase the likelihood of them taking their medications.

Patient beliefs could be uncovered and influenced through motivational interviewing

where concerns could be uncovered and addressed. Motivational interviewing is a

counseling technique that focuses on the needs of the patient. Through discussion,

reasoning, and personalized feedback, the goal is to change the behaviour of an

individual. The technique avoids confrontation, aggressive interactions, or threatening

comments about the health of the patient. . A meta-analysis of 14 studies, with over

10,000 smokers has provided positive results when the technique is administered by

general practitioners or trained counselors. (Lai, Cahill, Ying, & Jin-Ling, 2010)

Putting a patient in charge of their own health means getting them involved in the

process and allows for the understanding of cause and effect. For example, patients

measuring their own blood sugar every day when they are starting their diabetes

medications could provide them with an opportunity to see the positive changes in blood

sugar when they have ceased smoking and are compliant with their medication regimen

and vice versa. This way, they will believe in the power of their medication and lifestyle

choices to positively influence their quality of life. (Medicine, 2011)

Obtaining feedback could prove to be instrumental in increasing compliance. It would

be beneficial for the pharmaceutical industry to build a system in which others, such as

care givers, could utilize in order to send messages to the end user of the product.

Allowing a way for patients to provide feedback and communicate their needs and

concerns about a product for the industry to evaluate is an efficient way of establishing

a two- way dialogue. This can improve the experience of the patient about their

particular medication and therefore, increase their compliance.

Family members/caregivers can get involved in situations when patients are unable to

manage their own medications such as adolescents or patients with dementia. In these

situations, educating the family members on the importance of the medication for the

condition and the consequences of the noncompliance could be instrumental in

improving compliance. (Brown & Bussell, 2011)

The role of gender has been studied without conclusive evidence regarding its influence

on smoking cessation. There is however a number of behavioural and physiological


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factors that manifest differently in women as compared to men. These factors include

concern of weight gain, need for social support, self-confidence, depression, and

differences in the readiness to quit (stages of change). (Gritz, Nielsen, & Brooks, 1996)

The role of gender amongst adolescent smokers is the subject of a study by Branstetter,

Blosnich, Dino, Nolan, and Horn (2012). Within this age group clear differences in

smoking variables, cessation success, and variables influencing smoking behavior were

observed. Female adolescence in this study were more likely to be surrounded with

more smokers in their lives, including parents, siblings, and romantic partners. Having a

parent or parents who smoke had a strong indirect effect on the motivation of a female

to quit, whereas there were no direct or indirect effects for male smokers. As compared

to adolescence males, females had greater confidence that they would have the support

of those around them while making a quit attempt. Males scored a higher nicotine

dependence score as evaluated by time to first cigarette in the morning. (Branstetter,

Blosnich, Dino, Nolan, & Horn, 2012)

The Lung Health Study (Bjornson, et al., 1995) analyzed gender differences through a

special intervention group consisting of 3923 participants. The end points were 12 and

36 sustained abstinence rates for each gender. All patients in the program were offered

12 sessions of counseling assistance with their quit attempts, as well as a 12 week

smoking cessation program. The findings of the study were that men had higher

sustained quit rates that were statistically significant. However, the study also found

that demographics and smoking history had a large influence on the outcome. Men in

the study were more likely to have smoked for a longer period of time prior to the quit

attempt, they had more than three quit attempts prior to the study, and had successfully

quit for more than 6 months in the past. Although women in the study were more likely

to have used nicotine replacement therapy chewing gums in the past, they were less

likely to have quit for any length of time in the past. Those who had quit for less than 6

months in the past were less likely to have sustained abstinence during this study. One

of the noteworthy outcomes of this paper was that there were no gender differences

amongst participants who did not live with a smoker within the same household.

Women were more likely to live with another smoker, such as parents or a partner.

When participants did live in the presence of another smoker, women were more likely

to struggle with quitting compared to men. Amongst each gender group, individuals

who had higher education, were married, older, had made past quit attempts with longer

duration, had not used a nicotine replacement chewing gum in the past, and/or had a

higher body mass index were more likely to achieve sustained smoke free at each of

the 12 and 36 month time points. Overall, this study demonstrated gender differences

associated with smoking cessation but also pointed to the importance of emotional and

physical dependence. Some of the characteristics that have a correlation with higher


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success such as education could be influential in increasing a patient‘s likelihood of

success while other factors such as age and marital status are not adaptable.

(Bjornson, et al., 1995)

The Role of Medical Professionals

Healthcare professionals have a vital role in motivating patients to quit smoking. It has

been shown that even brief interventions from a healthcare professional will have a

significant positive impact on quit rates (Eckert & Funker, 2001). A study in 2011 by

Eckert and Funker (2001) looked at uncovering the role of healthcare professionals in

the motivation of smoking cessation. The paper focused on answering the following

questions:

- How often do physicians address smoking cessation

- Methods for quitting advised by healthcare professionals

- The impact of gender, age, and number of cigarettes smoked, in cessation

- The impact of healthcare professionals advice on the patients‘ desire to quit

The study uncovered a number of interesting opportunities that could have an impact on

patient compliance. A clear correlation was uncovered between the advice of a

physician to quit and patients‘ motivation to cease smoking. The research looked at the

odds ratio which is explained as the likelihood of an event occurring due to chance

versus related to a certain variable. An odds ratio equal to 1 is interpreted as no

correlation to the variable, whereas an odds ratio greater than one is indicative of an

association of the outcome with the variable in question. There was a fourfold increase

in the odds ratio between the desire to quit of patients who had a conversation with the

physician on the topic as compared to those who did not. Therefore, this demonstrates

the high correlation between physician counseling and the resulting desire of patients to

quit. Although 88% of the physicians asked patients about their smoking habit, only

34% of them advised the patient to stop smoking. Healthcare professionals discussed

the topic of smoking cessation more frequently with patients that were in poor health,

females, older patients, and those who saw their physician more than once in the a

twelve month period. The interaction between the physician and the patient was

however found to be independent of the number of cigarettes consumed by the patient.

There were two factors that correlated strongly with the desire to stop smoking: the

number of cigarettes and the advice of a physician. The odds ratio demonstrates that

the higher the number of cigarettes a patient smoked per day, the higher the likelihood

for their personal desire to quit smoking. The discussion and advice of the physician as

related to the importance of quitting smoking also had a key role with patients It is

noteworthy that only 50% of those advised to quit were recommended to use a specific

method of cessation. Only 39% of the strategies included a nicotine replacement


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therapy while the remainder was recommendation for support groups, acupuncture,

further consultation, self-reading materials, and ―cold turkey‖ (use of no

product/material). Although an exact and absolute linkage of the cause and effect

cannot be made for the results of the study, the findings of this paper present several

areas of opportunity. Physicians could be equipped with specific strategies to assist

patients with cravings and also to increase the frequency and incidence of the smoking

cessation conversations. (Eckert & Funker, 2001)

Training physicians and providing them with resources is critical. Patients who

communicate well with their physicians are able to be more involved in their own care

and therefore, more compliant with their medications than the ones that do not have a

good relationship with their doctors. Physicians need to be trained in good bedside

manners and communicating with patients effectively in order to improve the

compliance of patients. Pharmaceutical companies could help by providing educational

pieces and helpful discussion aids. (Kerse, Buetow, G, Gregory, Coster, & Arroll, 2004)

Physicians could personalize interactions with patients through assessing their

motivation to quit. ―The Stages of Change‖ assessment model‖ (Prochaska & Velicer,

The Transtheoretical Model of Health Behavior Change, 1997) assists physician in

evaluating the readiness of an individual to quit smoking. The tool allows for the

message to be targeted to the needs of the specific patient (Prochaska & DiClemente,

Stages and Processes of Self-Change of Smoking: Toward an Integrative Model of

Change, 1983). The model classifies a patient into one of five categories with specific

characteristics and their motivation for quitting: precontemplation, contemplation,

preparation, action, and maintenance and relapse.

In addition, the Fagerstrom test indicates the patient‘s level of nicotine dependence

(West, 2004). This would allow for the specific product, method, or program to be

adapted based on the nicotine dependence level of the patient.

A well noted obstacle for the provision of smoking cessation counseling by healthcare

professionals is the time constraints within their medical practice. As such, studies have

focused on the role of providing healthcare professionals with a financial incentive for

providing smoking cessation counseling. One such study by Rosaki (2003) analyzed

the impact of financial incentive on the healthcare providers‘ motivation to adhere to the

smoking cessation counseling guidelines. Both the study and control group included a

patient registry with a proactive telephone support system for smoking cessation as an

added support mechanism for the smoker. In this study the patients in the control group

were given a printed version of smoking cessation guidelines. The outcome of the

study was a statistically significant improvement in smoking cessation rates in the study

group versus the control group (i.e., patients in clinics without physician incentives).


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The patients who were part of the study group accessed the telephone support system

for counseling more often than the control group (p<0.001). This study demonstrated

the positive impact of a financial incentive in driving smoking cessation programs with

physicians, however additional studies would be required to analyze the optimal level of

incentive for the greatest return, as well as specific conditions that would increase the

success rate of such programs. (Roski, et al., 2003)

Intervention by various healthcare professionals has been shown to have a substantial positive effect on smoking cessation (Lawrence, et al., 2008). The Surgeon General‘s report in 1990 pointed to the benefits of a conversation with patients about the importance of quitting smoking (U.S. Department of Health and Human Services, 1990). The involvement and role of healthcare professionals is important due to the ―teachable

moments‖ that they have with smokers. Teachable moments are defined as the

naturally occurring time frames when individuals have greater receptivity to a message

and to a change in behavior (McBride, Emmons, & Lipkus, 2003). The impact of

teachable moments and their potential in patient compliance was the topic of a 2003

meta-analysis study by McBride, Emmons, & Lipkus. The paper summarized the

evidence related to teachable moments for smoking cessation and provided

recommendations to improve the process. Leveraging the opportunity to provide

counseling at an appropriate time leading to an increase in success rates is a cost

effective strategy that could be applied to various disease states. Smoking cessation is

of particular interest due to the vast impact of cigarette smoke to a large number of

health factors such as pregnancy, diabetes, heart conditions, and respiratory health.

The study found that despite the inherent risk of smoking, patients are more receptive to

the message by healthcare professionals under certain conditions. The study identifies

three criteria for an event to be considered a teachable moment:

1) The event must heighten the perception / awareness of the risk to the individual

and the outcome of their actions

2) The interaction elicits a strong emotional response from the patient

3) The self-concept or social role of the patient is redefined as a result of the

interaction

Teachable moments have been identified as particularly effective related to reproductive

health, pediatric care, asthma management and dental care. In each of these

instances, the healthcare professional has the opportunity to provide personalized

feedback, advice, counseling, and a plan of action. The discussion is tailored to the

particular needs of the patient and the harm of smoking as it relates to their situation.

The healthcare professionals are also able to follow-up and confirm the progress

through assessment tests, or a spirometry test which measures the level of oxygen in

the lungs. The impact of teachable moments related to cessation rates under four


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different health occurrences were reviewed: routine health visits or inquiries due to

acute illness, the delivery of test results by a healthcare professional, pregnancy

interactions, and hospitalization. The meta analysis revealed that cessation rates are

significantly higher during pregnancy and hospitalization, therefore presenting the

greatest impact of teachable moments. During pregnancy when a mother has a strong

desire to protect the baby, cessation rates have been reported at 39%, or eight times

higher than the average population (Fingerhut, Kleinman, & Kendrick, 1990). Patients

are often diagnosed with various diseases during a hospital stay. Amongst hospitalized

patients, cessation rates range 15-78% while the cessation of the average population is

reported at 5%. Long term cessation rates are highest amongst cardiac patients and

cancer patients. Cancer patients could be further categorized with higher cessation

amongst head, neck and lung cancer sufferers. The higher success rates within

hospitalized smokers could be attributed to the fact that they are under higher

monitoring and scrutiny during a hospital visit by the healthcare professionals and also

due to the various bans against smoking within many hospital premises. There are a

number of weaknesses related to the results of this study. The differences in cessation

rates identified in the study could not be fully accounted by teachable moments due to a

number of other circumstantial or confounding factors such as the target population,

various cessation strategies, timing of follow-up measurements, as well as age, and

gender of the subjects. Also, the various studies being compared lacked consistency in

terms of the time elapsed since the teachable moment and measurement of cessation.

Finally, in many of the reviewed studies, cessation rates were self-reported leading to

possible questions about the accuracy of the data. For example, there was a concern

that in the case of pregnant mothers, and hospitalized patients, the individuals may

have felt pressured to report higher cessation rates.

The results of this meta-analysis are still highly beneficial in targeting smoking cessation

efforts in certain environments or patients where there is greater motivation to quit

smoking. Despite the lack of clarity of specific causation behind the results, the

evidence clearly indicates higher cessation during certain health events. These

circumstances therefore provide opportunities of increasing cessation rates. (McBride,

Emmons, & Lipkus, 2003)

Pharmacists

The intervention of a pharmacist in educating and counseling the patient is also highly

beneficial in increasing compliance. Pharmacists are knowledgeable professionals who

receive special training in medication counseling and could positively influence patients‘

decisions on taking their medications. They also have direct accessibility to many

focused educational materials which could be provided to patients. Patients are also

able to directly and instantly ask questions and get answers to specific inquiries. Given


Page 17

the high level of accessibility, interaction and influencing potential of the pharmacist, it is

imperative to provide them with information and resources about different discount

programs available, vouchers, and patient resources. (Beney, Bero, & Bond, 2009)

Dentists

The Canadian Dental Hygienists Society has published a position statement regarding

the important role that hygienists possess with helping patients quit smoking (Canadian

Dental Hygienists Association, 2004). Dental professionals are responsible for

monitoring of their patients‘ oral health. Given the relationship of smoking and the

deterioration of the oral health of patients, the involvement of dentists and hygienists

with this addiction makes logical sense. There are a number of reasons that contribute

to the critical role that dental professionals have in assisting patients with smoking

cessation. Smoking is one of the top reasons for the development of oral cancer and the

screening of oral cancer is within the scope of the work of dental professionals. There

are certain sectors of the population such as men, teenagers, and young adults that are

more likely to see a dentist/hygienist on a regular basis as compared to other healthcare

professionals. These groups of patients are more likely to see their dental professionals

on a regular basis as compared to other healthcare workers. During a dental

appointment there are a number of opportunities or ―teachable moments‖ when the

patient is a captive audience and may be more likely to listen to the recommendations

of the hygienist/dentist. In Canada the professional dental hygiene association

encourages and supports members in the pursuit of providing smoking cessation

counseling to patients by providing a monetary incentive through the inclusion of a fee

code for smoking cessation counseling. Despite the important role of dental

professionals as related to smoking cessation and the support of the association,

evidence suggests a lack of engagement of hygienists on the topic. Lack of education

is reported by 44% of hygienists as the main reason for not addressing the topic with

patients. (Canadian Dental Hygienists Association, 2004)

Providing educational opportunities for dental professionals on the topic of smoking

cessation and methods of intervention is an area of opportunity. The pharmaceutical

industry in conjunction with various professional associations can take advantage of this

need stage. Education could be provided through dental schools, continuing education

seminars, and on-line learning modules.

Recognizing the importance of patient compliance, the American Heart Association

conducted a multi-level compliance literature review as well as the recruitment of an

expert panel (Miller, Hill, Kottke, & Ockene, 1997). The association recognizes the

importance of providing more effective health treatment interventions in an effort to

reduce health concerns and improve outcomes. Patient compliance is a form of risk


Page 18

reduction with influence on patient outcomes, societal well-being, and healthcare cost

reduction. The presented strategies are important due to the pressures to reduce

healthcare costs, while increasing quality of care and patient outcomes. The

deliverables of the research consisted of assessing the available compliance models

that were previously studied and/or practiced. Based on the information available,

determination was made if there was sufficient information to make recommendations

on how compliance could be increased, and finally a recommendation related to areas

of future research that would assist in the improvement of compliance. The most

important output of the research paper for the purpose of this discussion is the

emphasis placed on three core target audiences that are deemed imperative for patient

compliance: the patient, providers, and healthcare organizations. Based on the findings

of the literature review, best practices, and the advisory panel, the paper makes a series

of recommendations as outlined in Appendix 1. The requirements for compliance

consist of education, behavioural strategies, assessment methods, methods to promote

required behaviours by patients, providers, and organizations, and the integration of

efforts from multiple sources. Future research should focus on methods to monitor

compliance and implementation strategies. (Miller, Hill, Kottke, & Ockene, 1997)

The literature on smoking cessation provides an opportunity for addressing specific

areas to improve patient compliance. The information presented in the literature could

be categorized in a conceptual model with specific factors that influence patient

compliance (Appendix 2). The independent variables consist of patient education,

marketing variables, and individual background variables. Based on the literature,

these variables have a significant relationship to smoking cessation and hence patient

compliance. In addition, adoption of smoking cessation methods or programs could be

categorized as a mediating or intervening variable. This variable provides a mediating

link between the other independent variables and patient compliance. Simply adopting

the mediating variable of a smoking cessation program does not lead to patient

compliance, but rather in connection to the above mentioned independent variables the

relationship is strengthened. Therefore, adoption of smoking cessation methods or

programs could mediate the relation between the independent variables and patient

compliance.

Patient Education Variables

Patient education could be provided through various sources. HCP advice and

counseling during teachable moments have been demonstrated to be effective

(McBride, Emmons, & Lipkus, 2003). Various healthcare professionals, including

general and family physicians, dentists, pharmacists, and nurse practitioners have a

vital role to play. They must consistently deliver the message about the importance of


Page 19

cessation, as well as provide important information, education, tools, and support for the

patient.

In order to personalize the information and ensure that it resonates with patients,

various assessment tools should be utilized. These tools could include spirometry tests,

stages of change assessment, and the Fagerstrom test for smoking dependence.

Patients must be educated about the methods and options available to them for

smoking cessation and encouraged to take charge of their health. Information about

each product‘s unique features, benefits, adverse effects, contraindications, and

success rates would allow patients to make informed decisions.

The availability of educational materials could further encourage and assist patients

during their journey to quitting smoking.

Marketing Variables

The 4 Ps, consisting of product, price, promotion, and place are important areas of

attention for the success of any pharmaceutical drug. Patients looking to quit smoking

often undergo a number of quit attempts before finally succeeding. As a result, new and

innovative products often provide new hope to help patients set forth on a quitting

journey. A variety of products are required to meet various levels of dependence, stage

of change, and patient preference. Product dosage, packaging and delivery methods

could be part of the consideration of pharmaceutical companies. The price is also an

important consideration factor. Programs that focus on reducing the overall cost burden

for certain patients help improve accessibility. Patients should be made aware of the

various programs, as well as product options through promotional and educational

sources. Finally, the availability and accessibility of the product needs to be addressed.

Individual Background Variables

Awareness of the patient profile is important in providing personalized information.

Although some factors such as age, and gender could not be influenced, understanding

the motivation and type of addiction (emotional and physical) would allow for a more

robust program. Health conditions have been shown to influence cessation attempts.

Reproductive health, pediatric care, asthmas management, dental care, hospitalization,

and pregnancy all provide opportunities where there is heightened receptivity to

smoking cessation and therefore the prospect to increase patient compliance.

Adoption of Smoking Cessation Methods or Programs

Smoking cessation products help patients overcome cravings and withdrawal

symptoms, hence increasing the chances of success. Nicotine replacement therapies


Page 20

and oral medications can double cessation rates. The combination of smoking

cessation medications as well as individual counseling further increase success rates as

well as address patient motivation, and overcoming of smoking slips. The counseling

could take various forms such as provided in group sessions, and/or individual

programs. Ongoing assessment and monitoring is important to assist patients on their

journey to success.


Page 21

Research Design and Data Collection

Answering the two research questions:

The primary question: What are the critical factors that could influence patient

compliance?

Once these factors have been uncovered, the author will focus on answering a

secondary question: How to increase patient compliance in smoking cessation?

The conceptual model has been researched and developed in the following way:

- Focus on secondary sources such as available literature, and web results. The

data collection of the paper is based primarily on literature reviews.

- Search topics include patient compliance, 4Ps (product, price, promotion and

placement), patient motivation, and mature product growth

- One of the outcomes of the literature review has been identifying the critical

variables that influence patient compliance which are then applied to a

framework. The analysis of the identified variables has formed the critical

factors, and mediating variables.


Page 22

How to Increase Compliance in Smoking Cessation (Results & Analysis) This proposal identifies 3 independent variables and 1 mediating variable to improve

smoking cessation compliance rates with the aid of the pharmaceutical industry:

Marketing Variables




Marketing variables

The marketing variables could be categorized into the 4 Ps of price, product, promotion

and place.

Marketing Variable: Product

Most smokers make multiple quit attempts during their lifetime before they are finally

successful. The high relapse rates of 50-60% within the first year (Tonstad S, 2006),

translate into patients trying many different types of quit aids. Smokers often try to quit

―cold turkey‖ (without the use of any aids) followed by the use of multiple products

during their quit journey. These groups of consumers are very receptive to new

innovative products that offer them new hope for success. It is therefore important to

introduce patients with new line extensions, innovation, and variety of product options.

Consumers would find some products better suited for them based on their smoking

habits. For example, smokers that are accustomed to the hand to mouth motion

associated with cigarettes may find the NRT inhaler to be beneficial. The product

addresses the hand to mouth motion while providing nicotine through a cartridge in the

device.

(Nicorette Inhaler, 2012)

Other patients may prefer the oral gratification associated with the NRT gum or

lozenges. These product options also occupy the patient and provide an oral

gratification therefore preventing the compensation of the habit with food consumption

which could lead to weight gain.


Page 23

(Nicotine Chewing Gum, 2012) (No Smoke Lozenge, 2012)

Patients who prefer a discrete format with consistent delivery of nicotine throughout the

day, have the option of the nicotine patch. This product is suited for patients who

normally smoke throughout the day.

(Nicotine Patches, 2012)

Currently there are a range of products on the market including lozenges, nasal sprays,

mouth sprays, gums, patches, as well as prescription oral medications. Each of these

products provides unique benefits to patients based on their addiction level, life style,

and preferences.

There is still a lot of opportunity for improving patient compliance for those who are

trying to quit through the use of technology.

Additional opportunities for expanding reach and compliance through technology

include:

The development of call/text centers based on the patient‘s medication, that would send

individualized reminders to patients to take/apply their medication for that day and also,

include an encouraging statement for the patient each day.

Development of websites that would provide information on smoking cessation (this

already exists) which also include an online live agent to answer questions and

concerns would be another helpful way for patients who want to go through smoking


Page 24

cessation. The current company/product websites provide non-personalized

information and therefore there is opportunity for improvement.

Educating patients goes a long way especially when it comes to smoking cessation.

Smoking has a behavioral and a psychological component both of which requires

patient education in order to know how to modify their thinking and behaviour.

Patients need to be educated on what their body is going through while they are on the

program. They also need to communicate about their preferences when it comes to

medications. For example, knowing if they have found a preference for a certain format

or dosage form or if their lifestyle prevents them from taking their medication at certain

time of the day would be beneficial. This will help the physician with prescribing of

medications and with improved compliance. Therefore, focusing on answering the

individuals concerns and questions plus education goes a long way in ensuring

compliance with the program.

Marketing Variable: Price

There are several smoking cessation medications on the market today that have proven

to be useful for smoking cessation. However, they are very costly unless price is of no

concern to the patient. The leading smoking cessations agents are: Chapmix®

(Varenicline) is approximately $200 monthly, Nicoderm® patch $50 weekly, Nicorette®

gum $40 weekly, Nicorette® Inhaler (Nicotine inhalation system) $234 monthly,

Nicotrol® NS (Nasal spray) $ 73 monthly (not available in Canada) , Nicotine lozenge $

35 weekly, and Zyban® (Bupropion SR) is $40 monthly. In Canada, some of these

products are covered through provincial programs, and some private insurance

programs also offer partial or full cost coverage. However, these programs are not

available to the entire population and there are many restrictions and qualification

guidelines.

Price barriers should be discussed with patients at the time that the product is being

prescribed. Healthcare professionals may be able to switch the product depending on

the patient‘s budget or particular financial situation. In addition, individual employers

and the drug manufacturers could negotiate with insurers about adding these products

to their formulary or establishing lower co-pay for their employees. This will eliminate a

barrier that some patients have to face when considering a way of improving

compliance with smoking cessation products.

Pricing programs would provide benefits to the pharmaceutical company by increasing

usage, compliance, and patient loyalty for a given brand. Pharmaceutical companies

should partner with various advocacy groups, key opinion leaders, and employers to


Page 25

lobby for coverage of smoking cessation products through private and public insurance

plans.

Smoking cessation purchase plans targeted to specific products would serve as a

differentiator. These programs would consist of free products or discounts for patients

who continue their therapy for a specified number of weeks or months. Other incentives

could focus on a specific patient group by distributing discount cards to certain

healthcare professionals such as dentists/hygienists, oncologists, and obstetricians.

In order to decrease the cost burden for smokers with private coverage, pharmaceutical

companies could cover the co-pay portion up to a predefined amount of the total cost of

the medication.

Marketing Variable: Promotion

Pharmaceutical companies should promote the availability of the various products,

counseling, and assistance programs to healthcare professionals and also through

direct to consumer advertising. Work should also be done by the companies with the

specific counseling programs to provide the latest medication information, clinical

studies, and most importantly the provision of support and educational tools.

Awareness of the availability of programs and products is important for both patients

and healthcare professionals. The goal of promotional activities in this category should

be focused on informing consumers and healthcare professionals of the services

available, introduction of new products to provide smokers with renewed hope, as a

form of competition with other products on the market, and to encourage consumers to

attempt quitting. . The target group of patients and healthcare professionals need to be

made aware of the various products, tools, and services that are available to help them

break free from the addiction of smoking. The promotions should cater to the needs of

the patient and the physician separately. While the patient is interested in the

availability of products and services, the healthcare professional is interested in

additional information regarding efficacy rates, side effects, availability, drug

interactions, and how to quickly and easily convey the information to patients.

Communication to patients could be through direct to consumer (DTC) advertising and

could be accomplished through tactics such as television, radio, magazines, public

location billboards, as well as through advocacy groups. Healthcare professionals could

learn about the product through continual medical education (CMEs), medical journals,

and conferences. Promotional programs geared at the specific needs of various patient

profiles and physician types would increase the likelihood of the information resonating

with the audience. Increasing the number of patients who access the smoking

cessation programs would inevitably result in an increase demand for smoking


Page 26

cessation products; therefore increase sales and profits for the pharmaceutical

companies.

Marketing Variable: Place

The availability of the smoking cessation products and services to the end user is very

important. Making products accessible when patients are most prepared to make a quit

attempt could have a significant positive impact on outcomes. Currently, nicotine

replacement therapies are offered to patients at most hospitals, however upon being

released from the facility, there is no consistent method of follow-up with the patient.

The recommendation is for an established follow-up program which includes

accessibility of smoking cessation products and counseling for patients at their

residence. The program could include phone follow-ups to encourage, motivate, and

help the patient to stay smoke- free. Given that patients may have mobility issues or

may not be physically able to leave their home immediately after a hospital

stay/procedure, a NRT mailing program could help ensure accessibility to the required

product. In addition, nicotine replacement therapies should be made available in

locations where smoking is forbidden. Some NRT products have the indication for

temporary abstinence. These products could replace a single cigarette, with the hope

that patients will eventually develop the determination to quit completely. The products

with the temporary abstinence indication should be made available for purchase in

locations such as airports, sporting events, conferences, and concerts.

The availability of the product and counseling at the right time and place would increase

the likelihood that a patient would remain smoke- free.

Patient Education Variable: HCP Advice/Counseling

The provision of patient education including smoking cessation advice and counseling

has been established in part, however in order for this initial step to be effective

everyone involved in the care of the patient needs to work together. The level of

involvement of healthcare professionals in smoking cessation and the programs offered

varies significantly across the country. Specifically, physicians need to be working with

a smoking cessation program. Physician‘s often do not have the required time to spend

with patients regarding smoking cessation. The majority of physicians are able to

provide a very limited amount of counseling time, followed by a prescription for a

medication. Smoking cessation involves more work than just a few minutes of

counseling followed by a prescription or recommendation of medications. Regular

follow-ups and maintenance programs are required that allow for two way

communication, and consistent delivery of the cessation message. There are many


Page 27

programs that are available nationwide that provide counseling for patients who want to

proceed with smoking cessation. These programs include call centers and face- to-

face counseling. Physicians need to be aware of the programs that are available in

their area and work with their patients to have them linked with these programs. These

counselors are reachable by phone many hours of the day as well as face- to- face

appointments. Usually, a patient meets with them on a weekly basis to discuss how

their smoking cessation is progressing, and obtain answers to any questions or

concerns. Counselors often have the goal of providing strategies for the patient to avoid

smoking. For example, they discuss and educate patients about smoking triggers and

what to do to avoid them, as well as other options for the substitution of cigarette

without increasing the caloric intake when patients feel the needs for a distraction or the

need to overcome a craving. Weight gain is not a side effect of smoking cessation,

however, many patients face this problem since their sense of taste works better and

they start tasting the flavours of the food they are consuming. Daily calls from

counselor to enquire about how the patient is progressing on a specific day and also to

answer any question, or concerns patients may have faced that day would be optimal.

Counseling programs have the potential to assist patients with overcoming both the

physical and emotional dependence associated with smoking. It provides needed

encouragement for patients who are feeling that they are not progressing and or those

who may have relapsed.

Patient Education Variables: Assessment Methods

Influencing the belief of a patient is very important when it comes to smoking cessation.

Patients need to believe in and have full confidence in their cessation program;

otherwise they will d not be successful. Therefore, other than motivational interviewing,

patients need to also be put in charge of their own care and see the changes in their

own body. For example, patients need to write down when they took/applied their

medication on a daily basis. They also need to be asked to measure their blood

pressure once a week and write the value down. All of this information should be

communicated to the physician during regular visits. This way, they can see the

improvements in their blood pressure or lung capacity as their bodies and overall health

improve. During every appointment the physician should also assess their respiratory

rates and include the results to the file of the patient. Through these sources of

information, patients not only see the improvements being made to their bodies, but

also, it will ―make a believer out of them‖ to be compliant with their medications. In order

to make the transfer of the information possible, pharmaceutical companies should work

with patients and healthcare professionals to provide them with support and educational


Page 28

tools. Patient diaries, health information applications, daily information tools and

spirometry devices would be some of the examples.

Smokers‘ reasons for smoking and their motivations to quit vary significantly and hence

require an individualized approach to cessation. There is a well-documented and

accepted method of assessing patients‘ motivation to quit known as the ―The Stages of

Change Model‖ originally developed by James O. Prochaska, which has been published

in numerous peer-reviewed journals and many books (Prochaska & Velicer, The

Transtheoretical Model of Health Behavior Change, 1997). Although the model could

be applied for general health behavior change, it has been used extensively in smoking

cessation assessments to tailor programs based on the needs of individuals. The

stages of change consist of five distinct steps: precontemplation, contemplation stage,

preparation stage, action stage, and maintenance and relapse. By personalizing the

interaction and meeting the needs of individual patients the clinician has the opportunity

to move a patient through the various stages of change. It has been noted that moving

a patient a single stage has the potential to double their chances of quitting 6 months

later (Prochaska & Goldstein, 1991).

Precontemplation Stage

Many smoking cessation programs are based on individuals who are motivated to quit

and yet there are many patients that are content with smoking and do not see a problem

with their habit. These smokers are not interested in having a conversation about

smoking cessation, or the products available to help them quit. They are ‗happy‘

smokers that may be in denial about the health risks of the habit or they may not have

thought about the long- term consequences of the addiction. The role of healthcare

professionals is to cater the conversation based on the consequences of the habit for

the specific smoker. For example, a dentist/hygienist could discuss the cosmetic

consequence of the habit such as discoloration of the teeth. MacDonald (2004) studied

the role of the stages of change to influence participation rates in smoking cessation

programs. Classified ads were placed in newspapers targeted to each stage of change.

The message for precontemplation recruits was ―Are you a smoker who wants to keep

smoking? We are designing a booklet for smokers who do not want to quit smoking‖

(McDonald P. W., 2004, p. 50). By customizing the messages, the program was able to

successfully recruit patients in the precontemplation stage. Product advertising to this

group of patients should focus on temporary abstinence in locations where smoking is

forbidden.

Contemplation Stage

Patients in the contemplation stage feel that they‘ve reached a crossroad and a decision


Page 29

needs to be made. They assess the advantages and disadvantages of quitting,

including giving up an enjoyed behavior, as well as the cost and struggles of cessation.

Patients‘ response to the question ―are you thinking about quitting‖ often reveals mixed

thoughts and emotions. The most important message a healthcare professional could

provide is that smoking cessation is the single most important change an individual

could make to improve their health. Although patients in this stage know that they need

to quit smoking, their quit dates are often set in the distant future, often in the next year

(Prochaska & DiClemente, Stages and Processes of Self-Change of Smoking: Toward

an Integrative Model of Change, 1983). The patient should then be provided with tools

and options for a planned cessation path. A quit date should be planned with the

patient and/or further counseling sessions with the goal of setting a quit date.

Preparation Stage

In the preparation stage individuals have decided that the harm of smoking outweighs

the benefits. They are actively preparing to quit smoking and may take small steps

towards quitting. These modifications may include reducing the daily number of

cigarettes or changing the brand of cigarettes to a lighter version. Awareness of

nicotine replacement therapies that have an indication for smoking reduction would be

beneficial for these patients. For example, the patient could continue to smoke but

replace one cigarette every day with a nicotine replacement therapy (NRT) chewing

gum, or inhaler. Gradually the number of NRT products used would be increased on a

daily/weekly/monthly basis while the number of cigarettes would be reduced. With this

option the patient would not have to make a full commitment to quitting and yet at the

preparation stage start reaping the benefits of heading towards full cessation.

Action Stage

When a smoker makes the firm decision to quit smoking, the action stage has

commenced. Individuals in this stage are actively trying to quit and set short and long

term goals. Struggles in the form of cravings and slips are very common during this

phase. As a result, healthcare professionals, support groups, and pharmaceutical

companies can play a vital role in supporting the patient. Awareness of the possible

obstacles allow for better preparation. The availability of tools, services, and products

should be positioned as options to help the individual.

Maintenance and Relapse

Once the patient has successfully quit smoking they must remain smoke- free. This is

at times a struggle for smokers as they try to overcome temptations and slips. Many

individuals go through the stages of change numerous times before successfully quitting

and remaining smoke- free. Stressful situations, boredom, and social pressures could


Page 30

serve as triggers to go back to smoking. Once again, messaging tailored to individuals

at this stage of change would provide them with options. Examples could include

having NRT products on hand to combat difficult situations. Those who have

successfully quit need to be continuously congratulated for the important

accomplishment in combating a strong addiction.

The evaluation of a patient‘s stage of change allows for the messaging, tools,

information and product to be tailored to their needs and increases the likelihood of the

message resonating with him/her. Patients‘ level of dependence to cigarettes should

also be evaluated through qualitative and quantitative methods. This evaluation could

consist of an interview by a healthcare professional or a quantitative test. The most

common quantitative measurement is the Fagerstrom test for nicotine dependence

(Appendix 3). The results of the test provide an indication of the outcome of the

smoking attempt. Individuals with high dependence score high on the test and

conversely a low score indicates low dependence to cigarettes.

The most important questions in determining the level of dependence is the number of cigarettes smoked per day and the time to first cigarette of the day. Based on these questions, and by determining a patient‘s level of dependence, specific options and products would be offered. For example for a patient with a high Fagerstrom score and therefore high dependence, a NRT product with consistent delivery of nicotine throughout the day with consistent blood nicotine levels would be ideal. These patients should avoid sharp drops and increases in nicotine levels that result in stronger cravings.

Patient Education Variables: Knowledge of Methods of Smoking Cessation

Awareness of products, services, and options that are available to individuals trying to

quit smoking is extremely important. Smoking cessation aids and counseling have been

shown to double the chances of success. Adapting the message and the benefits of

each product and service to the various types of quitters and at each of the stages of

change would allow for better consumer receptivity. The message could be

communicated through direct to consumer (DTC) advertising, healthcare professional

messaging, and through peer communication methods such as social media.

In addition, each product needs to have a feedback system, where patients who take a

certain medication give feedback and provide improvement suggestions to the industry.

This is an important way for the pharmaceutical industry to make improvements on their

products as they are coming up with new innovations.

Withdrawal symptoms in patients attempting to quit tobacco will occur because of

nicotine addiction and may include anxiety, difficulty concentrating, irritability, insomnia,


Page 31

and increased appetite. (JR, 2007) These withdrawal symptoms as well as other

possible negative effects from quitting such as weight gain or depression are some of

the most common reasons why patients may relapse or require multiple quit attempts.

In fact, about 50% to 60% of initially successful quitters relapse within a year. (Tonstad

S, 2006) It is important to describe to patients the withdrawal symptoms they should

expect upon quitting, and explain why these symptoms occur (e.g., the body is

physically dependent on the rewarding effects of nicotine). By understanding the basic

physiology of why it is so difficult to quit smoking, patients can better prepare for the

potential challenges of quitting and may be more interested in using smoking cessation

medications. Patients should be reassured that although handling withdrawal symptoms

can be tough, most symptoms are the worst during the first week and usually subside

within a month. Behaviors associated with the use of cigarettes are often more difficult

to break than the physical symptoms of nicotine dependence. (NL., 2010) Habits and

routines developed in concert with the use of tobacco (such as smoking after a meal,

while driving, during stress, or while drinking coffee or alcohol) result in conditioned

behaviors that are especially difficult to change. Therefore, it is critical to use smoking

cessation strategies involving products and services that address both the physical and

behavioral aspects of tobacco dependence to help patients succeed. (Hudmon KS,

2012) Unfortunately, most smokers try to quit without any formal treatment and instead

try to go "cold turkey‖. Therefore, there are many different program initiatives that have

been talked about and established recently. In the United States, every state has a

smoking cessation program established through their health department. In addition

different private and public businesses are offering their employees benefits that include

smoking cessation packages. The big problem is; smokers still smoke and their

numbers are increasing. Within Canada there are various smoking cessation programs

that are offered at the provincial level that patients should be made aware of. Programs

include but are not limited to:

British Columbia (BC Smoking Cessation Program, 2012): Within the province the cost

of smoking cessation products are covered for residents trying to quit. The program

compensates the cost of both prescription drugs (bupropion and varenicline) and over

the counter nicotine replacement therapies (Thrive™ nicotine chewing gum, and

Habitrol® nicotine patches). Patients are eligible for up to 12 continuous weeks of either

the prescription products or the over the counter options once each calendar year.

Alberta (The Pharmacy Benefact, 2012): A smoking cessation program is offered

through Alberta Blue Cross for a restricted group of residents who meet the criteria.

Individuals who qualify can take advantage of 24 weeks of varenicline (Champix®)

therapy per consecutive 12-month period, in addition to individual counseling.


Page 32

Ontario (Pharmacy Smoking Cessation Program, 2011): Individuals who qualify for the

Ontario Drug Plan (ODB) could receive individualized assessment and counseling

services through community pharmacists. The program spans through a one year

period and includes an initial consultation meeting and a number of follow-up sessions.

The pharmacist is compensated with $40 for the first consultation, $15 for primary

follow-up counseling, and $10 for secondary follow-up sessions. In addition, ODB

patients can receive varenicline (Champix®) or bupropion (Zyban®) in conjunction with

counseling for 12 weeks per 365 days. The Ontario government offers a range of other

initiatives to support and promote smoking cessation including contests (Driven to Quit

Challenge), help lines, student programs (Leave the Pack Behind), and aboriginal

tobacco programs (Toward A Smoke-Free Ontario, 2012).

Quebec (Prescription Drug Insurance): The full cost of all over the counter and

prescription smoking cessation products are covered for the residents. The products

must be obtained through a healthcare professional prescription. All drugs are covered

for a maximum of 12 consecutive weeks every 12 month period. In addition there are a

number of other services and programs such as counseling and contests to increase

patients‘ chances of success.

Pharmaceutical companies have a role to play in informing patients and physicians

about the products and services that are available to those trying to quit smoking. As

well, the companies should work with provincial and federal government groups to

increase accessibility.

Patient Education Variables: Knowledge of Educational Materials

In addition to promoting products for smoking cessation, tools and materials provide

patients with knowledge of their stage of quitting and what could be expected.

Pharmaceutical companies should provide value- added tools. For example, patient

diaries help keep track of the number of cigarettes per day, triggers, and mood and

emotions throughout the day. The diary would provide the patients and their physicians

with additional information regarding the properties of the addiction. Other beneficial

resources would include literature on what patients should expect at every stage of the

process, what to do in the event of a slip, and contact information for additional support

and information.

Patient Education Variable: Working with the medical professionals

Other than dentists who can influence smoking cessation while taking care of patient‘s

oral health, pharmacists could play an important role in this process as well.


Page 33

Pharmacists are accessible health care professionals for the patients. They are

knowledgeable on the available products and can provide counseling on the medication

use for the patients as well as answering questions and addressing their concerns.

They can also collaborate with physicians in providing them information about other

medications a patient may be taking that may interact with the smoking cessation

product. Physicians can coordinate the smoking cessation of a patient by following the

clinical practice guideline which delineates five key components for tobacco cessation

interventions. (Fiore MC, 2008) These components, referred to as the 5 A‘s, offer a

practical method for implementing tobacco counseling in clinical practice. The 5 A‘s are

as follows: Ask – systematically identify all tobacco users at every visit; Advise –

strongly urge all tobacco users to quit; Assess – determine willingness to make a quit

attempt; Assist – aid the patient in quitting (provide counseling and medication); Arrange

– ensure follow-up care.

Industry needs to provide more opportunity for education of their products to different

healthcare professionals so they can be more aware of the full range of benefits on

available products. This will be beneficial when choosing medications for a particular

patient as well as answering patient‘s questions and addressing their concerns.

Providing tools and resources that meet the needs of each type of healthcare

professional would further facilitate and encourage patient discussions.


Age, gender, health condition, and pregnancy all play an important role in the decision

to quit smoking. Although these variables could not be altered, in developing a

marketing plan it is important to have a thorough understanding of the customer.

Female patients are influenced by emotional, as well as the physical addiction to

cigarettes. As a result, they should be encouraged to seek counseling to address any

concerns. In addition, knowing that females are more likely to have another smoker in

their household, cessation options should focus on household programs. Group

sessions would concentrate on encouraging all members of the household to make a

cessation attempt.

Certain health conditions such as reproductive health, pediatric care, asthma

management, dental care, hospitalization, and pregnancy provide a higher receptivity to

cessation. Specific programs and tools should be made available to target each of

these health conditions. Although pharmaceutical companies cannot target their

smoking cessation products to pregnant women due to healthcare regulations,

physicians are able to weigh the cost and benefits and make an informed

recommendation. Product availability, messaging, and tools at the point of care would


Page 34

present a great opportunity for top of mind awareness. Each of the conditions provides

teachable moments and opportunities to progress the patient along the stages of

change.


Patient compliance may be further influenced through the adoption of smoking

cessation methods or programs. Offering patients medications that meets their

individual needs, along with counseling, and group support programs could have a

significant impact on patient compliance. Given the high relapse rates, patients require

constant assessment and monitoring to stay on track to full cessation. Pharmaceutical

companies have a role to play in connecting the various groups and programs, while

offering effective and innovative products.


Page 35

Recommendations Based on the findings of the literature review and the development of the marketing

plan, the following key recommendations are made to the pharmaceutical industry to

increase compliance for smoking cessation: There is a requirement for focus on the

three marketing variables, patient education, and attention to individual backgrounds.

Further enhancement of programs is achieved through the adoption of smoking

cessation methods.

Marketing variables

Strategies around the 4 P‘s of marketing consisting of product, price, promotion, and

place must be implemented. A variety of smoking cessation products must be offered

to meet the varying needs of patients and also provide new hope for those who have

had unsuccessful quit attempts in the past. Cost effective solutions offered through

public and private programs and pharmaceutical subsidy initiatives increase product

accessibility. Product promotion through dual channels of healthcare professionals and

directly to consumer increases awareness and heightens the importance of the

decision. Products must be made available to patients when they are most receptive to

the message and towards making a quit attempt. Availability of products during hospital

stays and post release from hospital, as well as in locations where smoking is forbidden

would have the greatest impact on patients.

Patient Education

Smoking cessation advice from healthcare professionals has an important role in patient

compliance. Healthcare professionals should be supplied with tools and made aware of

programs that will aid patients in their journey to quit. Assessment methods such as

motivational interviewing and the stages of change allow customized conversations and

programs that meet the needs of individual patients. At every interaction with a

healthcare professional, patients must be encouraged to set a quit date. Educational

material for both patients and physicians should be accessible in both print and online.

Individual Backgrounds

Although patient conditions and backgrounds could not be influenced or altered,

awareness of differences allows for programs to be customized, meeting patient needs.

Smoking cessation messaging should be altered for female and male audiences,

meeting their motivation to quit, as well as health conditions when there is greater

desire for cessation.

In conjunction with the above mentioned recommendations, there must be a focus on

the adoption of smoking cessation methods and programs. Offering patients specific


Page 36

medications, individual/group counseling, and therapies will increase the likelihood of

success. Patients must be continuously monitored and assessed in order to manage

progress and course correct programs/products as required.


Page 37

Conclusion

Patient compliance is voluntarily cooperating with a drug regimen and persisting on the

therapy for the full duration which benefits a number of key stakeholders. The dosage

and administration of a pharmaceutical product as outlined in a product monograph are

aimed at producing optimal results. Patients, healthcare professionals, government

groups, and the pharmaceutical industry are beneficiaries of the results of compliance.

Through compliance, patients obtain optimal outcomes, healthcare professionals

achieve their mandate of health improvements, and public healthcare costs are

reduced. The increase in compliance also results in the pharmaceutical industry

benefiting from lucrative returns on investments. Patient compliance results in

increased sales, further research and development of new drugs, as well as

improvements to current marketed products.

Smoking cessation is an interdisciplinary problem, and therefore, it needs an

interdisciplinary group of individuals to work with each other in order for the program to

be a successful one and provide the ultimate benefit to patients. Pharmaceutical

companies are in a unique position to work with the entire key stakeholder universe to

reach the desired outcome of increased patient compliance. It is important to focus on

the common goals of the public and private systems which consist of increasing

smoking cessation access to the entire population and focus on increasing smoking

cessation rates.

The goal of this applied project has been to answer two key research questions:

What are the critical factors that could influence patient compliance?

How to increase patient compliance in smoking cessation?

To answer the first research question, the researcher reviewed the existing academic

literature and introduced a conceptual model that describes key independent variables

and mediating variables that significantly contribute to patient compliance. These

variables consist of the 4 P‘s of marketing, patient education, and individual

backgrounds. Within each of these variables, recommendations have been made

specific to increasing compliance rates in smoking cessation. In addition, a mediating

variable of adoption of smoking cessation methods or programs is identified to further

enhance the above mentioned variables.


Page 38

In addition, to answer the second question, this applied project advanced a marketing

plan containing a number of recommendations including the availability of smoking

cessation products to offer patients with new hope, provision of assessment tools to

customize the patient‘s journey to quitting, and product feedback mechanisms to

enhance future improvements.

The available literature highlights that improving patient compliance is a

multidimensional, multifaceted issue that takes many factors into account. Patients,

caregivers, healthcare professionals, and the pharmaceutical industry all have to work

together to address concerns and answer questions in order to improve compliance.


Page 39

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Appendix

Appendix 1

Patient Compliance: Summary of Recommendations for Patients, Providers and

Healthcare Organizations

Actions by Patients Specific Strategies

Patient’s involvement in the preventative and treatment aspects of the program is critical. • Decision to assess risk factors • Decide to control risk factors. • Set goals with assistance from the provider • Acquire the necessary skills associated with the behavior change • Assess and monitor progression towards the desired end result • Monitor progress toward goals. • Deal with any potential obstacles There must be communication between providers and patients about preventative steps and treatment services.

• Comprehension of the reasons for the steps being taken and desire to reach the end results for reasons that are important to the individual. Understand rationale, and importance of commitment. • Focus on effective communication skills • Utilization of methods to remind the patient about the behavior change. Use reminder systems. • Patients should self-monitor their actions. • Implement problem-solving skills, and leverage social support networks. • Ongoing reminders of the reasons why certain steps are being taken.

Actions by Providers Clear communication by providers is critical • Message about behavior and therapy must be clear and direct • Patient inclusion in decisions about prevention, treatment goals and related strategies. • Incorporate behavioral strategies into counseling. Documentation and response to patients' progress toward goals. • Develop evidence-based practice. • Patient compliance assessment at each visit. • Reminder systems to ensure identification and follow-up of patient status.

Specific Strategies • Verbal and written instruction, including rationale for treatments. • Develop skills in communication/counseling. • Use tailoring and contracting strategies. • Negotiate goals and a plan. • Anticipate barriers to compliance and discuss solutions. • Use active listening. • Develop multi-component strategies (i.e., cognitive and behavioral). • Determine methods of evaluating outcomes. • Use self-report or electronic data. • Use telephone follow-up.

Actions by Healthcare Organizations Specific Strategies


Page 45

Healthcare organizations must • Develop an environment that supports prevention and treatment interventions. • Provide tracking and reporting systems. • Provide education and training for providers. • Provide adequate reimbursement for allocation of time for all healthcare professionals. Healthcare organizations must adopt systems to rapidly and efficiently incorporate innovations into medical practice.

• Develop training in behavioral science, office set-up for all personnel. • Use preappointment reminders. • Use telephone follow-up. • Schedule evening/weekend office hours. • Provide group/individual counseling for patients and families. • Develop computer-based systems (electronic medical records). • Require continuing education courses in communication, behavioral counseling. • Develop incentives tied to desired patient and provider outcomes. • Incorporate nursing case management. • Implement pharmacy patient profile and recall review systems. • Use electronic transmission storage of patient's self-monitored data. • Obtain patient data on lifestyle behavior before visit. • Provide continuous quality improvement training.

Source: Adapted from (Miller, Hill, Kottke, & Ockene, 1997)


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Appendix 2 Conceptual Model for Patient Compliance

Marketing Variables.Product

.Price.Promotion

.Place


.HCP Advice/Counseling.Assessment tests

.Knowledge of methods for smoking cessation.Educational Materials


.Age.Gender

.Health Condition

Patient Compliance

Adoption of Smoke Cessation Methods or

Programs.Medications

.Individual Counseling.Group Support programs

.Therapies.Assessment &Monitoring


Page 47

Appendix 3 Fagerstrom Test for Nicotine Dependence

Source: West, 2004

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