Abbreviations Buy this Book!

HEALTH PROMOTION
AND DISEASE
PREVENTION
Lisa Anne Boothby, Pharm.D., BCPS; and Paul L. Doering, R.Ph.,
M.S., FAPhA
Reviewed by Magaly Rodriquez de Bittner, Pharm.D., BCPS, CDE, FAPhA; Glen T. Schumock,
Pharm.D., M.B.A., FCCP, BCPS

Learning Objectives empowered to take actions that improve their quality of life.
Health advocates regard health promotion as a step toward
autonomous decision-making for people who benefit from
1. Discuss the implications of the human genome project such measures as fluorinated drinking water, dietary
and the advent of pharmacogenomics for disease
additives (e.g., folic acid supplementation in grains and
prevention and health promotion initiatives for
vitamin D in milk), mass testing and vaccination programs
substance abuse prevention.
(e.g., tuberculin and rubella), and many others. Although
2. Outline the Food and Drug Administration’s (FDA)
these interventions seem beneficent in nature, controversies
five-part strategic action plan, Protect and Advance
America’s Health. arise frequently, especially when people are not given a
3. Determine when pharmacotherapies are indicated for choice, and when public policy enforced by government
disease treatment and/or disease prevention and when weigh benefits and risks for an entire population based on
they are not indicated because of excessive risk or data derived from epidemiological studies. Epidemiological
contraindications. data are subject to bias and limited by confounders; thus,
4. Counsel an alcoholic pregnant woman in her first sometimes associations are observed and not confirmed by
trimester about the risks to her unborn fetus of subsequent prospective experimental studies (e.g., hormone
continued alcohol consumption. replacement therapy results from the Women’s Health
5. Analyze the design, efficacy, and cost of model Initiative vs. the Nurses Health Study).
substance abuse prevention programs. Healthy People 2010 is a comprehensive, nationwide
6. Recommend drug therapy regimens for disease health promotion and disease prevention agenda that is
prevention or health promotion when appropriate. designed to guide efforts to improve the health of all people
7. Describe the clinical pharmacist’s role in disease state in the United States during the first decade of the 21st
management programs for disease prevention and century. Its purpose is to promote health and prevent illness,
health promotion. disability, and premature death, and is a continuation of the
Healthy People 2000 agenda of similar scope and purpose.
Using the public health philosophical doctrine, the health of
Introduction the individual is closely linked to the health of the
community and, hence, the health of the nation. The
Health promotion is the process of enabling people to Healthy People 2010 document provides general goals for
increase control of and improve health, and disease 10 leading health indicators (e.g., tobacco use, substance
prevention is the therapeutic or educational intervention abuse, overweight and obesity, responsible sexual behavior,
provided by the medical community based on access to health care, and immunizations). The document is
evidence-based medicine and public policy. Health further subdivided into 28 focus areas with quantifiable
promotion requires action by many individuals and groups goals whenever possible.
not usually identified with the care of the sick or prevention Two comprehensive review articles recently reviewed
of disease. With health promotion initiatives, patients are the pharmacist’s role in helping the nation achieve the

Babb VJ, Babb J. Pharmacist involvement in Healthy People 2010. J Am Pharm Assoc (Wash) 2003;43:56–60.

Pharmacotherapy Self-Assessment Program, 5th Edition 165 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

during pregnancy which represents preventable, modifiable

Abbreviations in this risk factors for neonatal morbidity and mortality. Neonatal
mortality continues to rise in the United States despite the
Chapter relative wealth of the nation. Pharmacists also can
contribute to tobacco use cessation initiatives because
FAS Fetal alcohol syndrome
FDA Food and Drug Administration tobacco use has been identified as the No. 1 preventable
cause of morbidity and mortality in this country. In
addition, obesity is occurring in epidemic proportions,
Healthy People 2010 goals. Some interventions outlined in
according to the Centers for Disease Control and
the first article included the conduct of screening programs Prevention, and pharmacists are in a unique position to
and provision of specialized services that focus on impact this disease state.
hypertension, diabetes, asthma, patient education, smoking Another important role of the clinical pharmacist is to
cessation, or general drug management. Collaborative provide accurate drug information, which is especially
practice agreements between pharmacists, physicians, and important in an age where the 10-second sound bite on the
other health care professionals are emphasized. Because the evening news leaves patients frightened and confused.
community pharmacist is the most accessible health care Hormone therapy is a subject that has been in both the
provider, pharmacists have a unique opportunity to motivate medical and lay press and has resulted in confusion over the
patients toward achieving these goals, and pharmacy as a role of such therapy. In the past, hormone supplementation
profession has been pursuing provider status through was embraced as a major disease prevention and health
collaborative practice agreements for many years, subject to promotion initiative. With new research forcing
individual state laws and regulations that govern the scope reevaluation of the role of hormone therapy, pharmacists
of pharmacists’ practice. In addition, because of the must remain abreast of new developments to guide their
emphasis on self-care and the availability of medical recommendations. Pharmacists need to provide accurate
information on the Internet, patients are becoming more information to patients to assist them in making personal
informed about available drug therapies; however, they choices about whether to take hormones. This chapter also
often do not understand the information they find. Thus, the includes a brief introduction to the emerging science of
role of the pharmacist in verifying the validity and pharmacogenomics with particular focus on its implications
applicability of medical information on the Internet for future disease prevention and health promotion
becomes paramount. initiatives.
An American College of Clinical Pharmacy white paper
described the challenges and opportunities for pharmacists
with Healthy People 2010 initiatives, and divided the focus Government Initiatives in
areas into four categories: category 1 included areas where
the pharmacist’s role is well established; category 2 Public Health
included areas where pharmacists are active but have yet to
establish a leadership role; category 3 included areas where The impetus for public health research and interventions
pharmacists primarily have a supportive role but have yet to is based on epidemiological studies that document
achieve a leadership role because of barriers that include increasing trends of certain diseases and/or modifiable risk
inadequate training and insufficient manpower; and factors for diseases in various genders, subgroups, or ethnic
category 4 included areas where little or no role exists for groups. Cultural and/or genomic links to various disease
pharmacy in these areas. This chapter examines examples states have been identified. Based on these national trends,
of public health programs targeted toward the most the United States government has created federally funded
imminent, modifiable threats to the public health. Some programs to try to decrease modifiable risk factors in certain
initiatives also are emphasized; this chapter focuses on risks patient populations. Clinical pharmacists have an important
to public health that clinical pharmacists have yet to role in many of these programs as discussed in the following
embrace as disease prevention initiatives and those that section.
have new evidence to support potential
pharmacotherapeutic interventions, the majority of which Developing Disease Prevention Programs
are characterized by the American College of Clinical Community health disease prevention and health
Pharmacy as category 3 focus areas. This chapter helps promotion programs cannot be successful unless health care
readers increase awareness and delineate the pharmacist’s practitioners have a thorough understanding of the
role in disease prevention and health promotion initiatives, dynamics of the targeted community. Planning a health
and perhaps encourage pharmacists to capitalize on their promotion and disease prevention program is a systematic
unique position as a community health resource in ways not process. One philosophical dogma is that communities can
previously pursued. develop the capacity to deal with their own problems.
Pharmacists could contribute substantially more to Another is that people want to change and have the ability
substance abuse prevention, especially substance abuse to do so. Thus, the community members must be involved

Calis KA, Hutchinson LC, Elliot ME, et al. Healthy People 2010: challenges, opportunities, and a call to action for America’s pharmacists. Pharmacotherapy
2004;24:1241–94.

Health Promotion and Disease Prevention 166 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

in the planning and developing processes for lasting changes Table 1-1. REACH 2010 Disease State Targets
to occur. Target Disease
The first step in creating a disease prevention and health
promotion program is assessing the needs of the target Breast and cervical cancer
Cardiovascular diseases
population by gathering data. Then, the data are analyzed Child and adult immunizations
and prioritized based on needs that were identified. Next, Diabetes
the needs are validated, and goals and objectives are chosen Elder care
to measure progress with the initiatives. Once these are HIV/AIDS
drafted, the intervention is implemented. Then the actual Infant mortality
outcomes are compared with the expected outcomes, and AIDS = acquired immune deficiency syndrome; HIV = human
adjustments are made as necessary to obtain the best immunodeficiency virus.
possible results.
The Centers for Disease Control and Prevention uses a Excellence in Curriculum Integration through Teaching
methodology referred to as scenario planning to anticipate Epidemiology is a collection of teaching materials
possible future public health problems to address chronic developed by the Centers for Disease Control and
disease prevention and control programs. Scenario planning Prevention to introduce students to public health and
is a method that is used to anticipate possible alternative epidemiology. This program is targeted toward high school
futures. It allows planners to anticipate problems and to students, but could be used for exceptional elementary
consider their potential alternative consequences. Using an school students as well. Students will learn about the
example from public health, an unhealthy diet and physical scientific method of inquiry, basic biostatistics, and
inactivity are considered to be key risk factors for outbreak investigation. Excellence in Curriculum
cardiovascular disease. Scenarios are presented to allow Integration through Teaching Epidemiology adapts readily
public health professionals to evaluate the following three to team-teaching across a variety of subjects, including
consequences: interventions to promote a healthful diet plus mathematics, social studies, history, and physical education.
an active lifestyle, interventions that promote a healthful Racial and Ethnic Approaches to Community Health
diet without interventions to promote an active lifestyle, and 2010 is a federal initiative to eliminate racial and ethnic
interventions to promote an active lifestyle without disparities in conjunction with the Healthy People 2010
interventions to promote a healthy diet. This methodology initiatives. Funding was awarded to community coalitions
allows the Centers for Disease Control and Prevention to in 18 states to help address racial and ethnic disparities in
allocate human and monetary resources for disease the United States. Some of these disease state targets are
prevention and health promotion initiatives that are listed in Table 1-1.
discussed further in the next section. The Department of Health and Human Services has
selected six focus areas in which racial and ethnic minorities
Centers for Disease Control and Prevention experience disparities in health access and outcomes: 1)
Initiatives infant mortality, 2) cancer screening and management, 3)
The Centers for Disease Control and Prevention has cardiovascular disease, 4) diabetes, 5) human
embraced numerous health promotional initiatives that immunodeficiency virus infection and acquired immune
include adopting healthy behaviors, such as eating deficiency syndrome, and 6) immunizations. These disease
nutritionally sound foods, being physically active, and states or conditions have been chosen in consultation with
avoiding tobacco use, to protect and control the devastating experts in the field of public health because they affect
effects of chronic disease. Some of these programs include multiple racial and ethnic minorities. Thus, programs have
the National Multicultural Campaign Promoting Healthy been developed during the past 4 years to target these
Lifestyles Among Tweens program, the Racial and Ethnic disease prevention and health promotion initiatives.
Approaches to Community Health 2010 program, and the The term “health disparities” refers to a difference in
Excellence in Curriculum Integration through Teaching incidence, prevalence, mortality, and burden of diseases and
Epidemiology programs. In the National Multicultural other health conditions that exist among specific
Campaign Promoting Healthy Lifestyles Among Tweens populations of the United States. According to the National
campaign, Congress directed the Centers for Disease Institutes of Health, the ethnic groups that need to be
Control and Prevention to create a healthy movement targeted with these programs include African Americans,
campaign for youths. The program is a planned, Pacific Islanders, Hispanics/Latinos, Native Americans, and
5-year, national, multicultural campaign to promote Native Alaskans. The National Institutes of Health has
physical activities among tweens (9–13-year-olds) and the awarded grants to three biomedical research institutions to
people who influence them. National Multicultural establish Comprehensive Centers on Health Disparities.
Campaign Promoting Healthy Lifestyles Among Tweens The goal is to encourage innovative and effective research
materials available from the Centers for Disease Control and strategies that ultimately will reduce the burden of diseases
Prevention include interactive computer activities, stickers, that disproportionately affects minority populations. The
posters, and temporary tattoos given as rewards to development of sustainable, effective, and culturally
participating youths. appropriate prevention and intervention strategies targeted
Centers for Disease Control and Prevention. National Center for Chronic Disease Prevention and Health Promotion. Goals for 2010. February 19, 2004.
Available at http://www.cdc.gov/reach2010/goals.htm. Accessed November 20, 2004.

Pharmacotherapy Self-Assessment Program, 5th Edition 167 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

toward minority populations continue to be a priority for regulatory activities to improve patient and consumer safety.
these government-funded initiatives. Some specific objectives to accomplish this goal include
A glaring health disparity is evident when examining the partnering with other government agencies and health care
rate of occurrence of birth defects in different groups. Birth providers and embracing technologies such as bar coding.
defects continue to occur with more frequency among The third goal is to better inform consumers so that the
minority and less affluent populations. The cause of this choices they make on a daily basis will improve their own
higher frequency is multifactorial, and may be because of health and welfare. The fourth goal is to protect the nation
limited health care access, inadequate nutrition, from terrorism and its many forms, including protecting the
occupational exposures, pollution, substance use/abuse, or nation’s food supply, and to speed the availability of new
any combination thereof. To further understand the counter measures against national threats in the form of
causative factors, with the hope of designing future biological or chemical warfare. The fifth goal is to promote
community health models, the March of Dimes awards a strong FDA that can protect and advance America’s health
several grants for research into the prevention of birth through the employment of outside experts and
defects. These grants encourage proposals for behavioral collaborators, and to improve employee retention within the
research to identify and prevent cognitive and behavioral FDA.
risk factors that affect outcomes of pregnancy, the perinatal One strong FDA initiative that is beginning to bear fruit
period, and subsequent child development. For example, is to improve the regulation of dietary supplements. For
pharmacogenomics research is being conducted to example, ephedra is an alkaloid that has been found in many
determine the possible genetic links to the triggering of dietary supplements promoted for weight loss. Evidence
premature birth, because babies born at 32 weeks or earlier suggests that ephedra is not effective for long-term weight
are 40 times more likely to develop cerebral palsy. Even loss, yet it increases the risk for cardiovascular events and
moderately prolonging gestation can have a tremendous other adverse health outcomes. Its active ingredient,
effect on disease prevention. Clinical pharmacists often are ephedrine, can be chemically modified to methamphetamine
involved in pharmacogenomics research, especially as it in clandestine laboratories. The FDA deemed
relates to drug metabolism. However, current disease ephedra-containing nutritional supplements misbranded and
prevention and health promotion initiatives in this area have adulterated based on several observational studies that
been minimal and should be a more pronounced focus for documented an increased risk of ischemic stroke and other
research initiatives in the future.
adverse cardiovascular outcomes in patients who used
One observational study was conducted to determine if
ephedra for weight loss. Patients with preexisting
pharmacy interventions to increase periconceptional folic
cardiovascular disease who used ephedra for weight loss
acid supplementation was associated with increased
were associated with increased cardiovascular risk. The
multivitamin use in a sample of women during childbearing
FDA banned the sale of ephedra because it was deemed to
years. The effectiveness of two interventions was
pose an unreasonable risk to public health.
evaluated: a pharmacy mailing vials containing 100 folate-
containing multivitamins and an educational intervention Another FDA initiative involves a Nonprescription Drug
delivered by primary care providers. A total of 3438 women Task Force that is charged with evaluating the safe and
were interviewed after the interventions. A small, effective use of nonprescription drugs. One recent
significant increase in the percentage of women using investigation that this committee has undertaken is to
multivitamins was found in the group that received determine the risk of misuse of ipecac syrup as a
information and prenatal vitamins at the beginning of the nonprescription drug, and its marginal therapeutic role for
intervention period (p=0.006), but this increase was not managing poisonings. Many health care practitioners have
sustained after the interventions ended. No other significant expressed their desire to have ipecac syrup restricted to
changes were observed, and this increase in multivitamin prescription drug status to increase monitoring and decrease
use pales in comparison to other, larger scale governmental availability to the untrained user. Several large scale
initiatives, such as folic acid supplementation in flour and pharmacoepidemiological studies demonstrated that ipecac
grains. But it shows that pharmacists can have an impact on syrup is used rarely in the community for therapeutic
vitamin use, and results of this study could provide ideas for purposes. When community and hospital pharmacists are
future programs. Furthermore, it demonstrates the need for consulted in cases of drug overdose, most pharmacists defer
continued educational initiatives provided by pharmacists if to the poison control center for treatment recommendations.
benefits of initial teachings are to be sustained. For acute poisonings, the poison control center refers most
patients and their families to the emergency department.
Food and Drug Administration Initiatives and Ipecac syrup is rarely the treatment of choice for acute
Regulations overdoses because of its slow onset of action, variable
The Food and Drug Administration (FDA) has drafted a duration of action, and lack of efficacy for removing many
strategic action plan, Protect and Advance America’s Health offending drugs. The use of ipecac syrup complicates
that encompasses five broad priority goals to address new poison management because it cannot be used
challenges that face the agency. The first goal is to embrace concomitantly with activated charcoal or gastric lavage.
efficient, scientific-based risk management. This goal Thus, the availability of ipecac syrup as a nonprescription
requires that the most current biomedical, statistical, drug does not decrease the number of emergency
managerial, and economic science be used. The second goal department visits, but often complicates emergency
is to enhance postmarket monitoring, communication, and department visits.

Health Promotion and Disease Prevention 168 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

Also problematic is the abuse of ipecac syrup by patients position to distribute some of these materials and to be
with eating disorders. Although not as frequently abused as available to provide advice and counsel those who may have
prescription-controlled drugs, abuse of ipecac syrup may concerns.
predispose patients to dehydration and associated electrolyte Several FDA initiatives are continuing and have already
abnormalities. Thus, benefits of nonprescription availability been described in the American College of Clinical
may not outweigh the risks of inappropriate use. The FDA Pharmacy white paper on Healthy People 2010. Readers are
is still accepting comments about this issue and has yet to referred to the white paper for a comprehensive review of
make a final decision. the Healthy People 2010 objectives because they have
To improve the safe and effective use of nonprescription important ramifications for public health.
drugs, the FDA has ordered manufacturers to improve
product labels. The goal is to improve the way consumers
use nonprescription medicines, a need made clear after a Pharmacogenomics and
survey revealed that most patients do not read or understand
nonprescription drug labels. It is hoped the new labels will Disease Prevention
prove to be easier for laypersons to read and understand.
The FDA has long been concerned about the casual way Pharmacogenomics (which is the focus of an entire
in which Americans use nonprescription pain relievers and chapter in this book) focuses on the genetic variations
the risks that such use may pose. In January 2004, the FDA affecting drug response. The challenge of the field is to
launched a national education campaign to provide advice understand which genetic variants are biologically relevant,
on the safe use of over-the-counter pain relief products. The to understand how the combined interaction of genetic
nationwide campaign focuses on the over-the-counter pain variants contributes to disease, and to determine how to
and fever reducers that contain acetaminophen and achieve optimal drug therapy selection based on
nonsteroidal anti-inflammatory drugs, including products pharmacogenomics findings. This area of research has the
containing aspirin, ibuprofen, naproxen sodium, and potential to impact disease prevention and health promotion
ketoprofen. initiatives substantially in both therapeutic and ethical
Because acetaminophen is found in more than 600 over- realms. Understanding 1) why certain patients abuse drugs
the-counter and prescription products, such as pain and others do not and 2) why certain babies are born with
relievers, cough suppressants, and drugs that treat colds, major malformations and others are not despite their
patients could ingest more of this ingredient than is safe. To seemingly similar modifiable risk factors are just two
minimize the risks of an accidental overdose, consumers are examples of pharmacogenomics research that may affect
encouraged to avoid taking multiple drugs that contain the disease prevention. Both legal and ethical dilemmas arise
same active ingredient at the same time. The risk for when scientific knowledge progresses faster than public
acetaminophen liver damage may be increased in consumers policy, because acquiring knowledge without means for
who drink three or more alcoholic beverages per day, and action does not necessarily improve patient care. For
the FDA embarked on an educational campaign to raise example, in California, comprehensive newborn screening
awareness of the dangers of these familiar drugs. is mandated. However, a recent case describes how
Nonsteroidal anti-inflammatory drugs can cause ineffective public policy can undermine the effectiveness of
gastrointestinal bleeding with an increased risk in patients such programs. A baby underwent state-mandated newborn
who are older than 60 years of age, those taking prescription screening and was found to have abnormally low levels of
drugs with anticoagulant properties or corticosteroids, or thyroxine and thyrotropin, findings consistent with the
those with a history of gastrointestinal bleeding. presence of congenital hypothyroidism. The physician was
Nonsteroidal anti-inflammatory drugs also may increase the not notified of these results because the state had chosen not
risk of renal diseases in consumers with preexisting kidney to divulge the actual values and instead had opted to report
disease or those taking diuretics. as abnormal only these results in which thyroxine levels
The FDA’s consumer educational initiative includes: 1) were low and thyrotropin levels were high. As a result, the
an over-the-counter pain reliever brochure to be distributed diagnosis of congenital hypothyroidism and subsequent
in pharmacies and by health care providers; 2) a “matte treatment were seriously delayed, resulting in permanent
release” newspaper article to be distributed to 10,000 harm. When the child’s family sued the state, the California
community papers across the country; 3) a reprint of “Use Supreme Court ruled that the state program could not be
Caution With Pain Relievers”, an FDA Consumer magazine held liable, in part to avoid diverting funds that would have
article that will be distributed at national health care been used for other state purposes. By contrast, if a private
conferences and available for reprinting in health-related diagnostic laboratory had given the same report, especially
publications; and 4) two print public service advertisements without providing the actual results that would have enabled
that will be sent to about 100 major magazines. The the newborn’s physician to make an independent
campaign provides advice on how to avoid inadvertently assessment, the laboratory almost certainly would have been
taking more than the recommended doses of over-the- held responsible. In this example, the fault was not with the
counter pain relieves, and outlines underlying health screening program, but with its implementation. This begs
conditions that increase risk. Pharmacists are in a key the question as to whether the public health is actually

Clayton EW. Ethical, legal, and social implications of genomic medicine. N Engl J Med 2003;349:562–9.

Pharmacotherapy Self-Assessment Program, 5th Edition 169 Health Promotion and Disease Prevention
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improved by mere knowledge, for it is public policy nicotine dependence occurs only after long-term, heavy
decisions that permit actions that improve public health. smoking. In the McGill study, 17% of adolescents, 19% of
weekly smokers, and 66% of daily smokers who had
smoked during the previous 3 months were tobacco-
Tobacco Use dependent.
The link between pharmacogenomics and tobacco
Tobacco, a substance sold legally in the United States, is dependence was evaluated prospectively in adolescents. A
a well-known carcinogen when smoked or chewed, and it protective association between the tyrosine hydroxylase
has adverse effects on the fetus when used during gene and tobacco smoking in adolescents was found.
pregnancy. Tobacco use, particularly cigarette smoking, is Adolescents positive for the K4 allele of the tyrosine
the leading preventable cause of death in the United States hydroxylase gene were less likely to smoke tobacco as
and is responsible for about 440,000 deaths each year. One adolescents. Further study may elucidate the means to
of the national health objectives for 2010 is to reduce the identify interventions that target high-risk populations, as
prevalence of cigarette smoking among adults to less than well as the possibility to learn from low-risk populations.
12%. During 2001, the median adult current smoking Pharmacist-managed smoking cessation programs have
prevalence was 23.4% (range: 13.3–30.9%) for the United been described in great detail in the pharmacy literature.
States and Washington, D.C., and 12.5% (range: These interventions are perhaps even more important in
9.8–31.4%) for Guam, Puerto Rico, and the Virgin Islands. pregnant patients, because maternal smoking increases the
During 1996–2001, the prevalence of current smoking was risk of spontaneous abortion, low birth weight, premature
relatively stable in 41 states and Washington, D.C., and the delivery, sudden infant death syndrome, and learning and
proportion of current smokers who were “some day” behavioral problems in offspring. In addition, prospective
smokers (i.e., smoked cigarettes occasionally, but not every data from the National Collaborative Perinatal Project found
day) increased significantly in 31 of those states and that children of mothers who smoked more than a pack of
Washington, D.C. Because the only safe alternative to cigarettes during pregnancy were at an increased risk of
smoking is cessation, interventions should target all smokers developing nicotine dependence. Furthermore, children of
to help them quit smoking completely. two smoking parents are associated with higher nicotine
In women who use tobacco products during pregnancy, dependence scores.
higher nicotine concentrations are found in the fetus/neonate A multimodal approach to smoking cessation in pregnant
than the mother. Nicotine use is associated with increased women was more effective than counseling alone when
maternal and fetal heart rate, preterm birth, decreased birth smoking cessation rates were measured at 37 weeks’
weight, and an increased risk of abortion and stillbirth. gestation. This multimodal approach involved initial
A prospective, observational study was conduced in 24 individual smoking cessation counseling supplemented by
pregnant women. Maternal heart rate, blood pressure, fetal an invitation to join a smoking cessation program with
heart rate, and fetal aortic and umbilical vein blood flow nicotine replacement therapy as a voluntary option. All
increased after nicotine exposure. Pulsatility indices of the pregnant women involved in the study received standard
fetal aortic and umbilical artery blood velocity waveforms smoking cessation counseling. Despite evidence for
decreased with increasing maternal nicotine levels. These effectiveness of smoking cessation programs, a recent
results suggest that maternal nicotine intake is associated survey of 354 programs reported that less than 50%
with changes in fetal blood flow that may contribute to provided training on smoking cessation/reduction methods,
decreased fetal birth weight. Despite these known risks, and 28% said that smoking cessation counseling had a high
women continue to smoke during pregnancy. Is it because priority in comparison to other objectives. Thus, public
they are unaware of the health risks to themselves and their policy must put greater emphasis and encouragement on
fetuses, or is it because of nicotine dependence and evidence-based interventions.
addiction, and can public policy address these issues?
Current research seeks to understand the process and
mechanism of nicotine dependence. Primary Prevention of
Much research in smoking cessation is targeted toward
adolescents because this age typically is when tobacco use Chronic Disease
begins. A recent report from the continuing McGill
University Study on the natural history of nicotine For the past 12 years, the prevalence of patients with one
dependence found an association between nicotine or more major risk factors for heart disease and stroke has
dependence symptoms and increased smoking in increased. As a result, the national burden of heart disease
adolescents. This result challenges previous dogma that and stroke may increase substantially during the next 10

Andres RL, Day MC. Perinatal complications associated with maternal tobacco use. Semin Neonatol 2000;5:231–41.
O’Loughlin J, DiFranza J, Tyndale RF, et al. Nicotine-dependence symptoms are associated with smoking frequency in adolescents. Am J Prev Med
2003;25:219–25.
Olsson C, Anney R, Forrest S, et al. Association between dependent smoking and a polymorphism in the tyrosine hydroxylase gene in a prospective
population-based study of adolescent health. Behav Genet 2004;34:85–91.
Klerman LV, Spivey C. Smoking-related activities in prenatal care programs. Am J Prev Med 2003;25:129–35.

Health Promotion and Disease Prevention 170 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

years. Nationally sponsored prevention programs to when sweetener intake is more than 25% of the total
increase awareness of and reduce high blood pressure, high nutrition consumed, according to the Institutes of
blood cholesterol, smoking, diabetes, and obesity are more Medicine’s suggested maximal intake level. Yet, in the
important now than ever and should remain a public health United States, one in four children surpasses this level.
priority. See the Annotated Bibliography for information Polyols (sugar alcohols) add sweetness with reduced energy
regarding the latest clinical practice guidelines for and functional properties to foods/beverages and promote
preventing these chronic diseases. The Prevention of dental health. Five non-nutritive sweeteners have
Cardiovascular Disease chapter in the Cardiology book of FDA-approved labeling (acesulfame-K, aspartame,
PSAP-V discusses the role of the pharmacist in disease neotame, saccharin, and sucralose) at estimated intakes
prevention and health promotion, highlighting below the acceptable daily intake (level that a person can
pharmacotherapy as appropriate. This chapter focuses on safely consume everyday during a lifetime without risk).
obesity because obesity is of epidemic proportions in the Although evidence does not support an association between
United States and continues to rise, and it affects the elevated intake of nutritive sweeteners and increased obesity
development of cardiovascular disease as well as the risk, or non-nutritive sweetener consumption and behavioral
development of many other chronic diseases. disorders, the American Dietetic Association recommends
that consumers enjoy both nutritive and non-nutritive
sweeteners as part of their healthful dietary program.
Obesity Sometimes, for several reasons, behavioral modification,
education, and non-nutritive sweetener supplementation is
During the past 30 years, the prevalence of obesity in the not enough to promote weight loss in specific patients. In
United States has increased from 14.5% to 30.9%. If current these obese patients, pharmacotherapy along with behavioral
trends continue, obesity will surpass tobacco smoking as the and lifestyle interventions is necessary to promote weight
No. 1 preventable cause of death in the United States. loss. Surgical therapy also may be used when the benefits
During the past 30 years, mean carbohydrate intake per outweigh risks. Medicare is evaluating stomach bypass
person increased and total dietary fat consumption surgery for coverage because this modality has proven to be
decreased, which is consistent with the current more effective for long-term weight loss than other
recommendations of the United States Dietary Guidelines. therapeutic modalities, although many questions still remain.
Because of this increasing obesity prevalence, an expert
advisory committee appointed by the United States Pharmacotherapy for Obesity
Department of Health and Human Services and the United Preventing and treating obesity can decrease obesity-
States Department of Agriculture is conducting a review of related sequelae. Of the drug therapies used in this
the dietary guidelines for Americans that is expected to be setting—metformin, acarbose, orlistat, sibutramine,
published in 2005. In the meantime, the United States diethylpropion, phentermine, and others—orlistat and
Preventive Services Task Force recommends that clinicians sibutramine are the only drugs with FDA-approved
screen all patients for obesity and offer intensive counseling indications for long-term use. These drug therapies promote
and behavioral interventions at each appointment or modest weight loss when combined with lifestyle and
interview. Body mass index between 25 kg/m2 and behavioral interventions. Drug therapy must be continued
29 kg/m2 is considered overweight and a body mass index to maintain weight loss and weight loss typically peaks after
greater than 30 kg/m2 is defined as obesity; obesity is further 6 months. For these reasons, many insurance companies do
divided into three classes to assess severity and treatment not cover the costs of drug therapies for obesity treatment.
strategies. Evidence-based medicine confirms that Public policy must address the ethics of denying obesity
decreasing weight, even modestly, is beneficial; a 3–5 kg treatment, knowing that obesity is one of the most prevalent
weight loss can improve glucose metabolism, have a causes of preventable death in the United States. More
beneficial effect on lipid levels, and decrease blood pressure insurance companies, including Medicaid, cover drug
in obese patients if maintained for more than 1 year. therapy for erectile dysfunction than drug therapies for
The five As, (assess, advise, agree, assist, and arrange) obesity treatment.
are used as a framework for behavioral counseling for Drug therapy for obesity is contraindicated during
obesity. These same interventional strategies are used in pregnancy for several reasons, including the lack of safety
smoking cessation counseling, and are discussed in great data for mother and fetus. Table 1-2 shows the patient types
detail in the public health literature. Incorporating in whom pharmacotherapy is indicated. Orlistat is a
non-nutritive sweeteners is one intervention that is used by nonsystemic inhibitor of gastrointestinal lipases that are
many Americans to decrease daily caloric consumption. necessary for dietary fat breakdown. This inhibition
These sweeteners are contained in several consumer prevents absorption of dietary fats from the intestines. At 18
products from soft drinks to diet aids. The American months follow-up, 33% of patients randomized to orlistat
Dietetic Association has addressed public health concerns lost more than 10% of their baseline body weight versus
about non-nutritive sweeteners. Dietary quality suffers 25% of patients randomized to placebo. Successful
Centers for Disease Control and Prevention. Trends in intake of energy and macronutrients—United States, 1971–2000. MMWR Morb Mortal Wkly Rep
2004;53:80–2.
Whitlock EP, Orleans T, Pender N, Allan J. Evaluating primary care behavioral interventions: an evidence-based approach. Am J Prev Med 2002;22:267–84.
Also available at http://www.ahrq.gov/clinic/3rduspstf/behavior/behsum1.htm. Accessed November 20, 2004.

Pharmacotherapy Self-Assessment Program, 5th Edition 171 Health Promotion and Disease Prevention
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Table 1-2. Indications for Pharmacotherapy for Obesity Metformin commonly is prescribed for women with
Indicationa insulin resistance that manifests as type 2 diabetes,
1. Patients at risk for disease from their level of obesity
prediabetes, or polycystic ovary syndrome. Polycystic ovary
2. Patients committed to losing weight syndrome is a common cause of infertility and recurrent
3. Patients who understand the risks for long-term therapy pregnancy loss. It also is associated with central adiposity
4. Patients who understand the success rates and increased cardiovascular risk that commonly is referred
5. Patients with BMI greater than 30 to as metabolic syndrome. Metformin has an array of
6. Patients with BMI greater than 27b complex actions yet to be fully elucidated. Hypoglycemia is
7. Women with a waist circumference greater than 35 inchesb rare and modest weight loss is promoted. Although
8. Men with a waist circumference greater than 40 inchesb metformin is not effective enough as a sole treatment for
9. Patients with no contraindications to the drugs
aPatients need to have indications 1–4, plus at obesity, it is useful as an adjunct for insulin-resistant obese
least one of 6–9.
bWith two or more associated comorbidities. patients to prevent the development of diabetes. Women have
BMI = body mass index. been able to take metformin throughout pregnancy without
adverse consequences to the mother or the baby. See the
treatment with orlistat results in improvements in Annotated Bibliography for clinical practice guidelines
cardiovascular risk factors that include obesity, lipid profile, endorsed by the American Heart Association; National Heart,
blood pressure, waist circumference, and fasting insulin and Lung, and Blood Institute; and the American Diabetes
glucose levels. More patients with impaired glucose Association for managing metabolic syndrome.
tolerance who are treated with orlistat have normal glucose Patients often ask the community pharmacist about the
tolerance after 2 years compared with a matched placebo efficacy of various nonprescription drugs and nutritional
group. Half as many patients progressed to a diabetic state. supplements. The majority of these products do not have
Diets high in fat (greater than 30% of total caloric intake) evidence to support long-term safety or efficacy. This is the
can increase the adverse effects associated with orlistat that perfect opportunity for clinical pharmacists to advise
include fecal urgency, incontinence, oily spotting, and patients that nonprescription drugs and nutritional
flatulence. These adverse effects may become less frequent supplements are of limited value for weight loss, and to
or diminish in patients who consume a high-fiber diet. emphasize effective lifestyle modifications for weight loss
Psyllium 3 times/day with orlistat and taken with meals may that include a calorie-restricted, well-balanced diet, and the
decrease gastrointestinal symptoms. Orlistat decreases benefits of increased physical activity in the form of aerobic,
absorption of fat-soluble vitamins, particularly vitamin E anaerobic, and weight bearing exercise 3–5 times/week.
and vitamin D, especially in obese adolescents treated for
3–6 months. Orlistat also decreases vitamin K absorption Surgical Treatments of Obesity
Gastric bypass, vertical banded gastroplasty, and
from the intestines and, thus, attenuates warfarin efficacy in
adjustable gastric banding can result in substantial weight
anticoagulated patients; increased monitoring and dose loss (28–40 kg). This effective intervention is reserved for
adjustments may be necessary to prevent bleeding patients with class 3 obesity or those with class 2 obesity
complications. The pharmacist is invaluable in counseling and one other obesity-related illness. Some patients (about
patients about methods to decrease the severity of these 25%) will require subsequent operations. Vitamin
common adverse effects. supplementation is necessary. Some authors suggest an oral
Sibutramine is a nonamphetamine appetite suppressant multivitamin, whereas others suggest intramuscular B12,
that also has slight antidepressant properties. Its folate, vitamins A and D, and others.
pharmacological action involves the blocking of neuronal The long-term sequelae of these procedures remain
uptake of norepinephrine, serotonin, and (weakly) unknown, and short-term severe complications are rare
dopamine. Its approved indications include weight loss in (0.5–1.5% mortality). To identify the factors that increase
adolescents and patients 16 years of age and older; it also is mortality after either open or laparoscopic Roux-en-Y
effective for patients with hypertension and diabetes who gastric bypass, a retrospective analysis was conducted in the
have additional risk factors for cardiovascular disease. bariatric outcomes database at a university teaching hospital
Sibutramine is well tolerated, but it can cause increased (n=2000). A multivariate logistic regression analysis was
blood pressure, heart rate, and palpitations in some patients. used to identify factors related to perioperative mortality.
Factors examined included age, gender, body mass index,
Thus, cardiovascular risks must be considered, and adverse
preoperative weight, hypertension, diabetes mellitus, sleep
effects must be monitored along with weight loss progress. apnea, obesity hypoventilation syndrome, venous stasis
Drug therapy should be discontinued if ineffective or ulcers, intestinal leak, small bowel obstruction, and
adverse effects are intolerable. A recent randomized, pulmonary embolus. Results indicated that independent risk
prospective, clinical trial demonstrated that low-dose factors associated with perioperative death included leak,
metoprolol improved compliance rates and decreased the pulmonary embolus, preoperative weight, and hypertension.
cardiovascular adverse effects without adverse metabolic Thus, surgery should not be reserved as a desperate last
sequelae combined with sibutramine therapy in patients who measure for weight loss when the benefits of long-term
may otherwise discontinue treatment. weight loss are weighed with the risks of surgery.
Fernandez AZ Jr, Demaria EJ, Tichansky DS, et al. Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity.
Ann Surg 2004;239:698–702.

Health Promotion and Disease Prevention 172 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

Differences in absorption of drug therapies in patients health care providers. The main tools of the campaign are
after gastric bypass remain unknown. Clinical pharmacists fact sheets about menopause and hormone therapy and a
should help gastric bypass patients choose appropriate purse guide that provides questions for discussion with a
multivitamin supplements, as well as counsel patients on the health professional.
importance of long-term adherence to vitamin Future research may focus on understanding the
supplementation. Gastric bypass patients consume distribution and regulation of estrogen receptors in vascular
low-calorie diets that do not provide sufficient vitamins and tissue; genomic interactions of estrogens and progestins;
minerals per American Dietary Association and the interaction between inflammatory cytokines,
recommendations for preventive health. Also, the surgical coagulation proteins, platelets, and the endothelium.
procedure bypasses part of the small intestine, which Genetic variations of estradiol metabolism have been
decreases nutrient absorption from food and the described as significant contributors to disease susceptibility
bioavailability of drugs taken orally. In general, drugs with that include recurrent pregnancy loss (typically at least three
a narrow therapeutic window taken orally require more or more), preeclampsia, endometriosis, breast cancer, and
frequent monitoring and dose adjustments after gastric hormone therapy-related complications including
bypass procedures, but little information has been published thrombosis. The research should result in an increased
to assess the clinical significance of altered drug and ability to target hormone therapy to those best suited for
nutrient absorption. In the future, as bariatric surgery intervention.
(obesity management) becomes more prevalent, clinical Clinical pharmacists have the necessary skills to evaluate
pharmacists should publish case reports and observational, critically the medical literature, and to interpret the data
cohort studies that assess the clinical significance of altered appropriately for patients, health care providers, and the
nutrient and drug therapy absorption, especially in patients press as appropriate. Clinical pharmacists work in
who receive drugs with a narrow therapeutic window. collaboration with physicians and other health care
practitioners to evaluate the appropriateness of hormone
Hormone Therapy therapy for patients, together weighing benefits and risks in
each individual case. The risks of osteoporosis,
thromboembolism, and breast cancer for one symptomatic
The FDA has launched a collaborative campaign to perimenopausal patient may be totally different from
inform women that hormone therapy is no longer another. Clinical pharmacists explain benefits and risks of
appropriate for primary or secondary prevention of hormone therapy during counseling sessions and provide
cardiovascular disease, according to the Women’s Health recommendations or prescriptions for hormone therapy,
Initiative, the Heart and Estrogen/Progestin Replacement
depending on the pharmacists’ scope of practice.
Study, and Heart and Estrogen/Progestin Replacement
Study 2. Proven benefits of hormone therapy include
reduction of hot flashes, vaginal dryness, and bone loss.
These benefits must be weighed against the confirmed
Preterm Labor
increased risk of stroke, heart disease, and breast cancer.
In January 2003, based on the findings of the Women’s Preterm birth occurs in about 11.5% of all live births,
Health Initiative, the FDA advised women and health care resulting in 500,000 premature infants per year. Despite
professionals that menopausal hormone therapy—estrogen improvements in medical care, the preterm birth rate
and estrogen with progestin—is associated with an increased by 10% in the United States during the past 10
increased risk of heart disease, heart attacks, strokes, and years. This rate is highest for African-American women,
breast cancer. The warning emphasized that these products followed by Native Americans, Hispanics, Caucasians, and
are not labeled or intended for heart disease prevention. Asians. Premature births result in significant neonatal
The FDA also has modified the approved indications of morbidity and mortality; surviving neonates often must
these menopausal hormone therapies to clarify that these endure long-term neurological manifestations. With
drugs should be used only when the benefits clearly substantial economic consequences resulting in a cost of
outweigh risks. $12 billion (United States dollars) per year, research is
With a clearer picture of who should and who should not continuing to seek solutions to this significant source of
take hormones, the next challenge is in communicating the morbidity and mortality.
importance of weighing benefits and risks for potential Premature labor is defined as regular uterine contractions
users. In the spring of 2003, Congress directed the FDA to that occur before 37 weeks of gestation and are associated
develop and execute an informational campaign targeting with cervical changes. One cause of premature labor is
women through partnerships with organizations nationwide. postulated to be an imbalance between estrogen and
Working in collaboration with the National Institutes of progesterone because both hormones in combination are
Health and other Department of Health and Human Services thought to prevent uterine contractions. Trauma and
agencies, the FDA has developed science-based inflammation of the cervix both have been associated with
informational materials on its latest guidance on preterm labor. Although the causes of premature labor
menopausal hormone therapies (estrogens and estrogens remain poorly understood and currently are being
with progestins), and is working closely with women’s researched, risk factors, diagnosis, treatment, and
health organizations, community-based organizations, and consequences of premature labor for both mother and
other experts to get this information out to women and neonate have been identified.

Pharmacotherapy Self-Assessment Program, 5th Edition 173 Health Promotion and Disease Prevention
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Modifiable risk factors in the mother include family Candidates for hydroxyprogesterone caproate therapy
stress, domestic abuse, tobacco use, sexually transmitted must have a history of preterm birth, be free of fetal
diseases, illicit substance abuse, inadequate nutrition, low anomalies per ultrasound diagnosis, and must be between 15
preconception body mass index, and slow prenatal weight and 20 weeks’ gestation. Patients with a history of
gain. Patients with these characteristics should be referred hypertension or a seizure disorder are not candidates.
to the appropriate support services for follow-up strategies Intramuscular injections are given weekly until 36 weeks’
to prevent preterm birth, even though few prevention gestation or delivery. If an injection is missed or forgotten,
methods have been proved. There is conflicting evidence it should be administered as soon as remembered and the
whether treating bacterial or viral infections prevents schedule readjusted to be weekly thereafter. In this study,
premature labor, but prophylactic antibiotics in patients with injections were administered by the nurse and directly
intact membranes are not recommended outside of clinical observed; patients can be taught to administer their own
trials. Despite vast medical advances in neonatal care, the injections. Patients should be followed up in clinic and
fetus cannot survive outside the uterus before 22 weeks’ monitored as a high-risk pregnancy.
gestation. Therefore, supportive measures for the mother
are used, and tocolysis rarely is initiated at this stage. Tocolytic Therapy
Educational initiatives geared toward women at high risk for Although halting uterine contractions in preterm labor is
preterm labor can make a difference. A recent landmark not a labeled indication, nifedipine is used to do just that.
clinical trial demonstrated that preventing the start of This treatment is preferred to the once popular
preterm labor with hydroxyprogesterone caproate in certain β-sympathomimetic drugs because it is associated with
patients can be more effective than trying to stop preterm fewer maternal adverse effects. Compared to both
labor with tocolytic therapy once it begins. It is ironic that magnesium sulfate and β-sympathomimetic drugs,
at the time of this writing, hydroxyprogesterone caproate is nifedipine also has been associated with better neonatal
not available commercially from a manufacturer; thus, outcomes and is discontinued less often because of adverse
pharmacists compound hydroxyprogesterone caproate as a effects. Fewer neonates are transferred to neonatal intensive
care units when nifedipine tocolysis is used versus
sterile, pyrogen-free injectable solution for intramuscular
β-sympathomimetic drugs. In the studies analyzed,
injection. Pharmacists teach patients how to administer the
nifedipine doses ranged from 30 mg/day to 160 mg/day.
intramuscular injections; how to dispose of needles; and
Clinical pharmacists in hospitals should encourage the
counsel patients about the benefits and risks of therapy,
use of nifedipine tocolysis as opposed to
including the importance of drug therapy adherence to
β-sympathomimetic drugs or magnesium. Institutionally
obtain optimal outcomes. approved standard order forms and clinical pathways
endorsed by the medical staff help to improve prescribing
Hydroxyprogesterone Caproate patterns. The combination of education, policy changes,
A recent randomized, double-blind, placebo-controlled and clinical interventions provided by clinical pharmacists
trial evaluated the efficacy of 17-α-hydroxyprogesterone are more effective than education alone.
caproate for preventing preterm labor in high-risk women.
Women were enrolled if they had a documented history of
spontaneous preterm delivery. The
(17-α-hydroxyprogesterone caproate) or placebo was
drug Recurrent Pregnancy Loss
administered weekly after randomization, starting at 15–20 Polycystic ovary syndrome is the most common form of
weeks’ gestation. Results indicate that intramuscular infertility and is responsible for both poor conception rates
administration of 17-α-hydroxyprogesterone caproate at and pregnancy loss. First trimester spontaneous abortions
250 mg/week in high-risk women resulted in an 18.6% can occur as frequently as 50% in patients with this
absolute risk reduction in preterm delivery before 37 weeks’ syndrome. The mechanism involves both insulin resistance
gestation (p<0.05). For every five patients treated with and an increase in endothelin-1, a marker of vasculopathy.
17-α-hydroxyprogesterone caproate, one preterm birth Although the specific mechanism of action remains
before 37 weeks’ gestation is prevented. Similarly, for every unknown, both retrospective and prospective, observational
10 patients treated, one preterm birth before 35 weeks’ studies have shown that metformin administration
gestation is prevented, and 12 high-risk patients were treated throughout pregnancy is associated with a decrease in
to prevent one preterm birth before 32 weeks’ gestation is spontaneous abortions and without known adverse fetal
prevented. Additional beneficial results were observed in sequelae in patients with polycystic ovary syndrome.
infants born to women who received Metformin during pregnancy also has been associated with
17-α-hydroxyprogesterone caproate, including decreased a decreased rate of gestational diabetes in these women.
occurrence of enterocolitis, intraventricular hemorrhage, Children of mothers who received metformin throughout
and need for supplemental oxygen. As previously discussed, pregnancy have been followed up to 6 months without signs
17-α-hydroxyprogesterone caproate is not available of motor and social developmental sequelae.
commercially, necessitating pharmaceutical compounding In addition to polycystic ovary syndrome,
in hospitals and special compounding pharmacies. antiphospholipid syndrome is another frequent cause of

King JF, Flenady VJ, Papatsonis DN, Dekker GA, Carbonne B. Calcium channel blockers for inhibiting preterm labour. Cochrane Database Syst Rev
2003;(1):CD002255.

Health Promotion and Disease Prevention 174 Pharmacotherapy Self-Assessment Program, 5th Edition
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recurrent pregnancy loss. Antiphospholipid syndrome is a To ensure adequate folic acid consumption in women of
condition characterized by a hypercoagulable state childbearing years, especially because more than 50% of
secondary to autoantibodies that bind to anionic pregnancies are not planned, grains in the United States, as
phospholipid-protein complexes. The diagnosis of well as several other countries, are now fortified with folic
antiphospholipid syndrome is based on finding of “moderate acid. After this folic acid addition in 1998, a 54% reduction
to high” anticardiolipin antibody titers and/or a positive in open neural tube defects was observed. Women in
lupus anticoagulant test with a syndrome of episodes of intermediate- to high-risk categories for neural tube defects
thrombosis in arteries or veins, pregnancy loss, and/or (previous pregnancy affected by neural tube defect, family
thrombocytopenia. In patients with systemic lupus history, insulin-dependent diabetes, and epilepsy treatment
erythematosus, the prevalence of anticardiolipin antibodies with valproic acid or carbamazepine) should be advised that
ranges from 12% to 30% and 15% to 34% for lupus high-dose folic acid (4–5 mg/day) supplementation is
anticoagulant. Patients with recurrent thromboses require recommended.
lifelong anticoagulation; patients with recurrent Community pharmacists who dispense insulin or
spontaneous abortions require anticoagulation with heparin antiepileptic drugs to women of childbearing years should
or low-molecular-weight heparin and aspirin throughout counsel them about the elevated folic acid requirements to
most of gestation. Once diagnosed and adequately treated, prevent neural tube defects. Also, pharmacists working in
women given low-molecular-weight heparin and aspirin had collaboration with physicians and other health care
a higher rate of live births than those treated with practitioners in primary care settings should educate all
intravenous immunoglobulin alone, aspirin alone, or women of childbearing years about the importance of folic
placebo. acid supplementation, regardless of whether the patients are
Low-molecular-weight heparin typically is the planning to conceive in the near future. Colorful signs
anticoagulant of choice for pregnant patients with should be posted in waiting areas in community pharmacies
antiphospholipid syndrome. A prospective, clinical trial and clinics reminding women and practitioners about folic
evaluated the efficacy of enoxaparin for preventing acid supplementation.
spontaneous abortions in patients with a history of recurrent
spontaneous abortions. Twenty-six of the 37 pregnancies
(70%) in treated patients resulted in live births, compared
Preventing Drug-induced
with 21 of 48 (44%) in untreated patients (p<0.02; odds ratio
= 3.03; 95% confidence interval = 1.12–8.36). The
Birth Defects
beneficial effect was seen mainly in women with no
About 150,000 babies are born each year with birth
previous live births (p<0.008; odds ratio = 9.75; 95% defects. The parents of one out of every 28 newborns are
confidence interval = 1.59–52.48). For pregnant patients confronted with the news that their baby has a birth defect.
with thrombophilic defects, recurrent miscarriages during The causes of about 60–70% of birth defects currently are
and after the second trimester, preeclampsia, or intrauterine unknown; hence, prevention efforts are difficult if not
growth restriction, 40 mg once daily of subcutaneous impossible. Drugs and environmental chemicals account
enoxaparin or heparin is recommended. For pregnant for an estimated 2–3% of all birth defects. Pharmacists can
patients, those with antiphospholipid syndrome and those emphasize the importance of a woman’s prepregnancy visits
with a history of long-term anticoagulation therapy, 1 mg/kg to her health care provider. A prepregnancy visit is
subcutaneous enoxaparin 2 times/day or subcutaneous especially crucial for women with medical problems, such
heparin is recommended. Patients are taught to administer as diabetes, high blood pressure, and epilepsy or any other
the subcutaneous injections of 17-α-hydroxyprogesterone condition for which drugs are required. This visit would be
caproate in the thigh at alternating sites. a good time to ensure that all vaccines are up to date.
Another risk factor for recurrent pregnancy loss is All women who could become pregnant should take a
hyperhomocysteinemia. A meta-analysis of case control daily multivitamin containing 400 mcg of the B vitamin,
studies found an association between recurrent pregnancy folic acid. A woman who is pregnant or planning pregnancy
loss and hyperhomocysteinemia. Hyperhomocysteinemia should avoid alcohol, smoking, and drugs of abuse because
may be related to a hereditary defect within the methionine- these can cause birth defects and other pregnancy
homocysteine pathway. It also may be acquired as a result complications. Pharmacists who maintain good patient
of a deficit of vitamin B12 and vitamin B9. Elevated profiles are in a position to monitor the drugs a woman may
homocysteine levels greater than 18 micromol/L are be taking and to suggest she should check with her health
considered a risk factor for recurrent pregnancy losses. care provider about continuing the therapy.
Supplementation with 400 mcg/day folic acid 4 weeks There are more than 4 million chemical mixtures (e.g.,
before conception and for the first 12 weeks of gestation drugs, cleansers, and pest control agents) in homes and
decreases homocysteine levels and the onset of businesses in this country, with little information on the
spontaneous/recurrent miscarriage. effects of most of them during pregnancy. Certain drugs and

Carp H, Dolitzky M, Inbal AJ. Thromboprophylaxis improves the live birth rate in women with consecutive recurrent miscarriages and hereditary
thrombophilia. J Thromb Haemost 2003;1:433–8.
Brouwer IA, van Dusseldorp M, Thomas CM, et al. Low-dose folic acid supplementation decreases plasma homocysteine concentrations: a randomized trial.
Am J Clin Nutr 1999;69:99–104.

Pharmacotherapy Self-Assessment Program, 5th Edition 175 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

chemicals are known to increase the risk of birth defects, for patients with all of these characteristics: 1) not pregnant,
and pharmacists should be aware of these. Efforts can be 2) uses two forms of contraception if fertile, and 3) is
undertaken to prevent drug-induced birth defects. compliant with the contraceptive methods chosen. To
Phenytoin is one drug with known adverse effects on the prescribe isotretinoin, the prescriber must obtain a supply of
fetus. Fetal abnormalities associated with its use during yellow self-adhesive isotretinoin qualification stickers. To
pregnancy include facial dysmorphism, epicanthal folds, obtain these stickers, prescribers must agree to educate
hypertelorism, broad flat bridge of the nose, upturned tip of patients about the risks of isotretinoin use; they must discuss
the nose, and prominent lips. This syndrome, collectively the need for two forms of contraception while patients are
referred to as the fetal hydantoin syndrome, occurs in taking isotretinoin and for 1 month after drug therapy
11–17% of exposed pregnancies. Other anticonvulsant discontinuation. The prescriber obtains the first pregnancy
drugs have been implicated. A recent retrospective, case- test when the decision is made to pursue qualification of the
control study (n=128,049) did not detect a difference in patient for isotretinoin therapy. The second pregnancy test
major malformation incidence among newborns exposed to (a confirmation test) is conducted during the first 5 days of
various anticonvulsant drugs (e.g., phenytoin, the menstrual period immediately preceding the beginning
carbamazepine, or phenobarbital), but the total incidence of of isotretinoin therapy. For patients with amenorrhea, the
growth retardation, midface hypoplasia, and hypoplasia of second test should be done at least 11 days after the last act
the fingers was greater in those exposed to anticonvulsant of unprotected sexual intercourse.
therapy than those not exposed to anticonvulsant drugs in Each month of therapy, the patient must have a negative
mothers with no seizure history. Developmental delays also result from a urine or serum pregnancy test. A pregnancy
have been observed more often in children exposed to test must be repeated every month for therapy continuation.
monotherapy and polytherapy with anticonvulsant drugs in Patients must receive written warnings about the rates of
utero than nonexposed children. possible contraception failure (included in patient education
kits). The patient must sign an informed consent form and
Pregnancy and Live Vaccines an informational sheet that describes the isotretinoin survey
Rubella, also known as German measles, was associated and information for participation. The prescriber may then
with major fetal abnormalities in the early 1940s. A survey prescribe isotretinoin and place a yellow isotretinoin
determined that offspring of all mothers infected with
qualification sticker on the prescription. This sticker
rubella before week 7 of pregnancy were abnormal; 80% of
signifies that the patient has had two negative urine or serum
those infected between weeks 7 and 12; 65% between weeks
pregnancy tests with a sensitivity of at least 25 mIU/ml
13 and 16; and 4% at week 17 or greater. Heart, eye, and
before receiving the initial prescription.
central nervous system defects were all associated with
Despite all the precautions taken to prevent isotretinoin-
exposures during weeks 3–12 and deafness between weeks
induced malformations, there are still birth defects caused
3 and 16. Isolation of the measles virus, development of the
vaccine, and mass vaccination has virtually eradicated by prenatal exposure to this drug. With the growing
congenital rubella syndrome. The Centers for Disease problem from underground sources (e.g., rogue Web sites),
Control and Prevention recommends that vaccines should women may obtain drugs illegally and unwittingly harm
not be administered to women who are pregnant or might their babies by ingesting this drug. The manufacturer of
become pregnant within 4 weeks after vaccination because isotretinoin created an internal watch group that discovered
of the risk for fetal vaccinia. 108 Internet sites in the United States and abroad that
illegally offer its acne drug, isotretinoin, for sale. A bottle
Isotretinoin of 60 capsules of isotretinoin 20 mg could be purchased for
A well-known teratogen, isotretinoin, is a retinoid that is the price of $123.20 from a Web site traced to the South
a synthetic analogue of vitamin A. Retinoic acid Pacific Island nation of Vanuatu. Pharmacists should be on
embryopathy is characterized by malformations of the fetal the lookout for patients showing an interest in obtaining
cranium and face, heart, thymus, and central nervous isotretinoin in this manner and cautioned strenuously
system. Microtia and anotia with atresia or stenosis of the against pursuing this source of supply.
external auditory canal are the most commonly observed
fetal anomaly. Because all retinoic acid derivatives are Thalidomide
teratogenic in both humans and animals, isotretinoin has Thalidomide is a drug initially marketed in Germany
been contraindicated in pregnancy after it was first brought starting in the 1950s as a nonprescription sedative,
to market in the early 1980s. Yet, accidental exposures have antinausea, and antiemesis drug. It was available in several
occurred, and the incidence of observed malformations is other countries including Great Britain, Sweden, Belgium,
between 20% and 80%. By 1999, 2.5 of 1000 women of and Canada. Thalidomide has caused more than 6000 major
reproductive age had been exposed to isotretinoin. Thus, fetal malformations, not including the abortions or fetal
public policy changes were needed to protect the public. deaths attributable to the drug. A highly specific syndrome,
The program designed to protect the public from known as phocomelia, results in the reduction of upper
isotretinoin’s known teratogenicity is called the System to limbs, and sometimes results in digits emerging from the
Manage Accutane-Related Teratogenicity. Isotretinoin is shoulder. Other skeletal and nonskeletal malformations also
contraindicated in women during childbearing years, except occur. The mechanism is still poorly understood today

Holmes LB, Harvey EA, Coull BA, et al. The teratogenicity of anticonvulsant drugs. N Engl J Med 2001;344:1132–8.

Health Promotion and Disease Prevention 176 Pharmacotherapy Self-Assessment Program, 5th Edition
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because the teratogenesis witnessed in humans is not easily Table 1-3. Characteristics of Children with Fetal
reproduced in animals. Alcohol Syndrome
Thalidomide was reintroduced into the market for Characteristic
treating erythema nodosum leprosum, prompting the
development of a safeguard program called System for Small for gestational age or small in stature in relation to peers
Facial abnormalities such as small eye openings
Thalidomide Education and Prescribing Safety. However,
Poor coordination
the majority of thalidomide use today is off label for its Hyperactive behavior
immunomodulatory and anti-inflammatory properties. It Learning disabilities
has demonstrated benefits in a variety of diseases, including Developmental disabilities (e.g., speech and language delays)
aphthous and genital ulcers, cancer cachexia, human Mental retardation or low IQ
immunodeficiency virus infection, tuberculosis, and chronic Problems with daily living
graft versus host disease. Thalidomide also is being studied Poor reasoning and judgment skills
in clinical trials for treatment of renal cell carcinoma, and Sleep and sucking disturbances in infancy
liver and thyroid cancers. IQ = intelligence quotient.
Much like the System to Manage Accutane-Related
Teratogenicity program, the System for Thalidomide a permanent, lifelong condition that affects every aspect of
Education and Prescribing Safety program was designed to a child’s life and the lives of the child’s family. However,
protect patients from the teratogenic effects of thalidomide. FAS is completely preventable, provided the woman does
With this program, only prescribers and pharmacists not drink alcohol while she is pregnant.
registered with the program are allowed to prescribe and In 1981, public health concern about drinking during
dispense thalidomide. Pregnancy must be avoided by using pregnancy was first voiced by the Office of the Surgeon
two reliable forms of contraception simultaneously or by General in the form of a public health advisory. Women
continuous abstinence from heterosexual sexual contact. A who were pregnant or planning a pregnancy were warned to
pregnancy test must be conducted within 24 hours before abstain from alcohol use because of the potential risks to the
beginning thalidomide therapy. The prescriber must not fetus. The United States Department of Health and Human
issue a prescription for thalidomide for a woman of Services issued additional advisories in 1990, 1995, and
childbearing potential until a written report of a negative 2000. Despite the clear links between the consumption of
pregnancy test has been obtained. Because thalidomide is alcohol during pregnancy and adverse outcomes, pregnant
present in the semen of patients receiving the drug, men women continue to consume alcohol. Although the overall
taking thalidomide must use a latex condom during any rate of alcohol use (at least one drink) among pregnant
sexual contact with women of childbearing potential, even women has declined after 1995, frequent (seven or more
after vasectomy. Pregnancy tests should occur every 4 drinks per week) and binge (five or more drinks on any one
weeks thereafter. If menstrual cycles are irregular, the occasion) drinking continues to occur. One in 30 women
pregnancy testing should occur every 2 weeks. Pregnancy who know they are pregnant reports “risk drinking” (seven
testing and counseling should be performed if a patient or more drinks per week or five or more drinks on any one
misses her period or if there is any abnormality in menstrual occasion). One in seven women of childbearing age
bleeding. If pregnancy occurs during thalidomide (18–44 years of age) who report not being pregnant engages
treatment, thalidomide must be discontinued immediately. in “risk drinking.”
All inadvertent exposures should be reported to the Celgene During 1999, about 500,000 pregnant women reported
pregnancy registry program. Patients must receive both oral having one or more drinks during the preceding month, and
and written warnings before thalidomide is dispensed. an estimated 130,000 pregnant women per year in the
Thus, the role of the pharmacist is to ensure that the patient United States consume alcohol at levels shown to increase
complies with all requirements for thalidomide treatment, the risk of having a baby with FAS or other prenatal alcohol-
and that the patient has been counseled on all of the benefits related conditions.
and risks associated with it. Patients must be counseled on As previously discussed, FAS and other prenatal alcohol-
the safe maintenance of their supply of thalidomide to related conditions are completely preventable by ensuring
prevent family members or others from illegally obtaining that a woman does not drink alcohol while she is pregnant
this drug without knowledge of the potential sequelae. or when she could become pregnant. If a woman is drinking
during pregnancy, benefits from stopping can still occur.
Fetal Alcohol Syndrome The sooner a woman stops drinking, the better it will be for
Ethanol is one of the most prevalent human teratogens both her baby and her.
with a myriad of fetal adverse effects collectively referred to
as the fetal alcohol syndrome (FAS) and characterized by How to Counsel Pregnant Alcoholic Women
growth retardation, central nervous system damage, and About 20–25% of women drink some alcohol during
facial dysmorphology. Cognitive delays and motor deficits pregnancy, even though no universally safe level of alcohol
also are attributed to this syndrome. Short palpebral fissure consumption has been identified. About 50% of pregnant
is observed in the neonate, along with midfacial hypoplasia, women spontaneously reduce or discontinue alcohol
long flat filtrum, and a long convex upper lip with a thin consumption while pregnant. By implication, this means
vermilion border. See Table 1-3. that the other 50% continue to drink, some maintaining
Problems caused by FAS often lead to difficulties in drinking behaviors consistent with alcoholism. Counseling
school and problems socializing. Fetal alcohol syndrome is such patients would be similar to counseling the

Pharmacotherapy Self-Assessment Program, 5th Edition 177 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

nonpregnant patient, but women may not know the abstain from alcohol; 3) sexually active women should not
seriousness of the risk at which they are placing their babies. drink if they could be pregnant; and 4) women at risk for an
The pharmacist should explore the knowledge and attitudes alcohol-exposed pregnancy should see a physician.
of the patient, which may help tailor an individualized Another media campaign is taking place at the University
treatment approach likely to be effective. Pharmacists of Iowa where reduction of prenatal alcohol use in rural
should teach patients that there is no safe level of alcohol areas is targeted at women enrolled in the Women, Infants,
intake and that cumulative exposure of the baby to alcohol and Children program. Through formative research, project
increases risk. At the same time, women should be advised staff is producing commercial-quality materials (a broad-
that it is never too late to quit drinking. based 30-second television commercial for dissemination on
Patients with a strong physical addiction to alcohol three channels; an 8-minute video for localized distribution
should be referred to a practitioner with skills and in Women, Infants, and Children clinics; and a printed
experience in dealing with alcohol withdrawal and pamphlet for distribution in Women, Infants, and Children
detoxification. Specialized programs for dealing with clinics) to increase awareness about the dangers of alcohol
alcoholic expectant mothers are available at select places in use during pregnancy. Women, Infants, and Children clinics
the country. Traditional after care programs, such as in rural Iowa will be paired and randomly assigned to usual
Alcoholics Anonymous, or similar programs would be care or awareness intervention groups.
necessary. Regular contact with the patient should be A project based at the University of Texas at San Antonio
maintained to monitor for relapse and to institute a sobriety is exploring characteristics regarding alcohol use and
plan for the duration of the pregnancy and beyond. pregnancy, and plans to demonstrate the effectiveness of a
Clinical pharmacists in hospital settings provide social action approach to prevent alcohol-exposed
recommendations for treating acute alcohol withdrawal pregnancies among Latinos in San Antonio. The project
during pregnancy. Benzodiazepines typically are not will investigate the values, attitudes, and behaviors of
prescribed during pregnancy, but are the class of drugs Latinos regarding motherhood and pregnancy, patterns of
usually prescribed for acute alcohol withdrawal in alcohol use and familial patterns, sexual activity, and
nonpregnant patients. Barbiturates, such as phenobarbital knowledge of FAS. The study will pilot-test a social action
and secobarbital, are more likely options for acute alcohol intervention model that aims to alter normative drinking
withdrawal during pregnancy. A new drug therapy to help behavior and/or sexual behavior.
maintain abstinence from alcohol after detoxification is Health professionals, including pharmacists, have a
acamprosate. There are no data to support the safety or responsibility to their patients and to society to effectively
efficacy of acamprosate in pregnant women. Thus, counsel pregnant women and those at risk for becoming
psychosocial therapeutic modalities should be used to pregnant of the dangers of prenatal alcohol use. Prevention
maintain abstinence from alcohol for the pregnancy of FAS and other alcohol-related birth defects requires the
duration. Clinical pharmacists can educate patients and active involvement of all health professionals with whom
other health care practitioners about acamprosate use the patient may come into contact. Yet, in one recent survey,
postpartum. Clinical pharmacists can alleviate fears by only 1% of obstetric physicians reported asking about
explaining that acamprosate does not affect the mesolimbic alcohol use at every prenatal visit and 70% reported time
dopaminergic pathways and, thus, is not associated with a limitations as a barrier to assessment.
known abuse potential. The recommended dosage of Many health professionals receive little or no training on
acamprosate is 666 mg orally 3 times/day. substance abuse issues and when they do, the message often
is not clear. Despite public health recommendations that
Targeted Media Campaigns to Reduce FAS pregnant women abstain from drinking during pregnancy, a
The media can be powerful tools to create awareness, recent review of 81 obstetrical textbooks found that only
change attitudes, and motivate individuals and communities 17% consistently recommended that pregnant women
to engage in healthy behaviors. Campaigns can be targeted should not consume alcohol. Although there was a slight
to specific audiences, taking into account the specific upward trend toward recommendations for abstinence in
attributes and requirements of particular groups. The more recent texts, only 24% of the 29 texts published after
targeted media campaign can be used to enhance current 1990 made this recommendation. Fifty-three percent of all
prevention efforts related to FAS and other prenatal alcohol- texts and 52% of texts published after 1990 contained a
related effects. sentence condoning drinking at some level. The remaining
One example of a targeted media campaign is a program texts (30%) contained no recommendations. Many texts,
aimed at African-American women, 18–35 years of age, at even those published recently, have not embraced public
risk for pregnancy. The primary purpose of the campaign is health recommendations and, in some instances, contradict
to increase knowledge and change attitudes about alcohol them.
use during pregnancy. The campaign was designed to For some time now, it has been known that the incidence
deliver four core messages: 1) drinking alcohol during of alcoholism is affected by genetic factors. A recent study
pregnancy harms unborn babies; 2) pregnant women should of identical twins demonstrated that not only alcoholism,

Ingersoll K, Floyd L, Sobell M, Velasquez MM; Project CHOICES Intervention Research Group. Reducing the risk of alcohol-exposed pregnancies: a study
of a motivational intervention in community settings. Pediatrics 2003;111:1131–5.
Loop KQ, Nettleman MD. Obstetrical textbooks: recommendations about drinking during pregnancy. Am J Prev Med 2002;23:136–8.

Health Promotion and Disease Prevention 178 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

but also certain medical complications of alcoholism typically become more involved with marijuana and then
including alcoholic psychosis and cirrhosis, also are advance to other illegal drugs, while continuing their abuse
genetically influenced. It is thought that 50% of the overall of tobacco and alcohol. Studies also have shown that early
variance in these traits is because of additive genetic factors. initiation of drug abuse is associated with greater drug
Susceptibility to FAS is not because of a mutation in a single involvement in the long term, whether with the same or
gene, but rather of the action of both genes and different drugs.
environmental risk factors including exposure to alcohol. Scientists have proposed several hypotheses as to why
Identifying the precise genes that might contribute to the individuals first become involved with drugs and then
risk of a complex disorder such as FAS is not an easy task. escalate to abuse. One explanation is a biological cause,
Using the case-control approach, researchers can evaluate such as having a family history of drug or alcohol abuse,
the role of a particular candidate gene on a disease which may genetically predispose a person to drug abuse.
phenotype. To study the genes responsible for FAS, two Another explanation is that starting to abuse a drug may lead
samples would need to be studied: a group of FAS patients to affiliation with more drug-abusing peers which, in turn,
and a control group of non-FAS patients. The goal would be exposes the individual to other drugs. Many other factors
to find a sample of individuals whose mothers consumed may be involved.
similarly large amounts of alcohol. Ideally, the two groups Research has shown that the key risk periods for drug
would be matched (e.g., ethnically) so that they differ only abuse occur during major transitions in children’s lives.
in the presence or absence of FAS. The allele frequencies at These transitions include significant changes in physical
a marker within or near the candidate gene of interest are development (e.g., puberty) or social circumstances (e.g.,
then compared in the two groups, and evidence of divorce or relocation) when children experience heightened
differences in allele frequencies between the two groups vulnerability for problem behaviors. Children often
typically is interpreted as causal evidence that the candidate experience the first big transition when they leave the
gene contributes to disease susceptibility. In the mixed sanctuary of the family and begin their schooling. New
ancestry population of the Western Cape Province in South academic and social circumstances accompany the move
Africa, this approach has found that the ADH2*2 allele is from elementary school to middle or junior high school.
significantly more common in controls compared to the Learning to get along with a broader group of peers and
children with FAS and their mothers. Thus, the ADH2*2 having greater pressure to earn good grades create an
allele is protective against FAS, as is the ADH2*3 allele. environment where children are likely to encounter drug use
The isoenzyme forms containing the β2 and β3 subunits and for the first time.
encoded by the variant ADH2*2 and ADH2*3 alleles In high school, there are new social, psychological, and
metabolize alcohol faster than those encoded by the educational challenges. Children are more likely to
ADH2*1 allele that encodes for the β1 subunit. In the encounter greater availability of drugs, drug abusers, and
future, perhaps it will be possible to develop methods to test social circumstances involving drugs. A particularly risky
a patient’s genotype, thereby identifying a high-risk period occurs in late adolescence when students move away
population for developing FAS. In this way, specific from home for the first time to live without parental
programs targeting these individuals could be developed. supervision, perhaps to attend college or other schooling.
Substance abuse, particularly of alcohol, remains a major
public health problem for college populations. Life is filled
Preventing Substance with all types of transitions, but the news is not all bad:
research has shown that some new lifestyles, such as
Abuse Among Children marriage and parenthood, serve as protective factors—the
new roles become more important than being involved with
and Adolescents drugs in some cases.
Pharmacists consider themselves to be knowledgeable
Abuse of alcohol, tobacco, and other drugs is considered about drugs and pride themselves on being able to deliver
by some to be the nation’s No. 1 health problem. There are “antidrug” messages, focusing primarily on information
more deaths, illnesses, and disabilities from substance abuse about the drugs themselves. Information refers to facts
than from any other preventable health condition. The about drugs and their effects, as well as drug laws and
economic cost of substance abuse to the United States policies. However, drug information alone has not been an
economy each year is staggering, estimated at more than effective drug abuse deterrent. Combining information with
$414 billion. Reducing the abuse of drugs and other skills, methods, and services produces more effective
substances would result in enormous cost-savings to the results. Table 1-4 describes the type of content included in
health care system, not to mention the immeasurable effective prevention programs. Skills development training
benefits to those whose pain and suffering would be is aimed at building and improving behaviors in important
prevented. areas, such as communication within the family, social and
Considerable research has been conducted to determine emotional development, academic and social competence in
how the problem of drug abuse starts and how it progresses. children, and peer resistance strategies in adolescents.
Studies indicate that some children are already abusing
drugs by 12 or 13 years of age. Early abused drugs include Risk Factors and Protective Factors
tobacco, alcohol, inhalants, marijuana, and pharmaceutical Many factors have been discovered that help identify
drugs. If drug abuse persists into later adolescence, abusers individuals more likely to abuse drugs compared with those

Pharmacotherapy Self-Assessment Program, 5th Edition 179 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

Table 1-4. Content Areas for Effective Drug Abuse Prevention Programs
Program Types Information Skills Development Methods Services
Community Drug trends Social skills Tolerance policies Drug-free zones
School Drug effects Resistance skills Norms change School counseling
and assistance
Family Drug abuse Parenting skills Home drug testing Family therapy
symptoms Curfew

less likely to get involved. Factors associated with greater specific to the population or audience characteristics, such
potential for drug abuse are called “risk” factors, and those as age, gender, and ethnicity,
associated with reduced potential for abuse are considered Family-based prevention programs should enhance
“protective” factors. It would seem intuitive that if people family bonding and relationships and include parenting
could work to eliminate or decrease the risk factors or skills; practice in developing, discussing, and enforcing
improve the protective factors, then the likelihood of family policies on substance abuse; and training in drug
individuals becoming involved in drugs would be education and information. Prevention programs can be
diminished. Indeed, research shows this to be the case. designed to intervene as early as preschool to address risk
Table 1-5 provides a framework for identifying risk and factors for drug abuse, such as aggressive behavior, poor
protective factors in five settings or domains. As the first social skills, and academic difficulties
two examples suggest, some risk and protective factors are Prevention programs for elementary school children
mutually exclusive. That is, the presence of one means the should target improving academic and social-emotional
absence of the other. For example, in the individual domain, learning, such as early aggression, academic failure, and
early aggressive behavior is a risk factor that indicates the school dropout, to address risk factors for drug abuse.
absence of impulse control, a key protective factor. Helping Education should focus on skills, such as self-control,
a young child learn to control impulsive behavior is a focus emotional awareness, communication, social problem-solving,
of some prevention programs. Prevention programs should and academic support, especially in reading. Programs for
be aimed at changing the balance between risk and middle or junior high and high school students should
protective factors so that protective factors outnumber the increase academic and social competence with the following
risk factors. skills: study habits and academic support, communication,
peer relationships, self-efficacy and assertiveness, drug
Table 1-5. Risk Factors and Protective Factors for resistance skills, reinforcement of antidrug attitudes, and
Substance Abuse strengthening of personal commitments against drug abuse.
Risk Factors Domains Protective Factors Prevention programs aimed at general populations at key
Early aggressive behavior Individual Impulse control transition points, such as the transition to middle school, can
Lack of parenteral supervision Family Parental monitoring produce beneficial effects even among high-risk families
Substance abuse Peer Academic competence and children. Community prevention programs that
Drug availability School Antidrug use policies combine two or more effective programs, such as
Poverty Community Strong neighborhood family-based and school-based programs, can be more
attachment
effective than a single program alone. Community
prevention programs reaching populations in many settings
Long-term research studies have led to the development (e.g., schools, clubs, faith-based organizations, and the
of some guiding principles common to effective prevention media) are most effective when they present consistent,
programs. These can be used to guide prevention community-wide messages in each setting.
practitioners in setting up programs to decrease drug use Prevention programs should be long-term with repeated
among children and adolescents. The earlier an intervention interventions (i.e., booster programs) to reinforce the
is made to change the risk factors (e.g., aggressive behavior original prevention goals. Research shows that the benefits
and poor self-control), the greater its effect. Prevention from middle school prevention programs diminish without
programs should address all forms of drug abuse, alone or in follow-up programs in high school. Teacher training on
combination, including the underage use of legal drugs (e.g., good classroom management practices, such as rewarding
tobacco or alcohol); the use of illegal drugs (e.g., marijuana appropriate student behavior, are necessary in effective
or heroin); and the inappropriate use of legally obtained prevention programs. These techniques help to foster
substances (e.g., inhalants, prescription drugs, or students’ positive behavior, achievement, academic
nonprescription drugs). Programs also should address the motivation, and school bonding. Peer discussion groups and
type of drug abuse problem in the local community, target parent role-playing allow for active involvement in learning
modifiable risk factors, and strengthen protective factors about drug abuse and reinforcing skills.
that might be present. To improve program effectiveness, Research-based prevention programs can be
prevention programs should be designed to address risks cost-effective. For example, in a recent study, investigators
performed cost-effectiveness and cost-benefit analyses on

Hawkins JD, Catalano RF, Arthur MW. Promoting science-based prevention in communities. Addict Behav 2002;27:951–76.

Health Promotion and Disease Prevention 180 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

data from two long-term interventions previously shown to Treatment of Opiate Dependence with
be effective in preventing substance abuse. Both Buprenorphine
interventions were found to be cost-beneficial by preventing Typically, opioid dependency is treated initially with
adult cases of alcohol abuse, thereby saving future costs for detoxification, usually in an inpatient setting. Some
treatment of alcohol abuse. For each $1 invested in one of individuals remain drug-free, but a large number of
these programs, there was a benefit of $9.60 in prevention. patients require long-term maintenance therapy. Until
recently, the cornerstone of opioid-dependency treatment
For the other program, $5.85 of benefit was derived from
was methadone or levomethadyl acetate. However, federal
each $1 invested. For each family in the first program, there restrictions limited distribution of these drugs to a small
was a benefit of $5,923, and for the second program a number of “methadone clinics” with limited provision for
benefit of $2,697 per family was observed. take-at-home dosing of methadone or levomethadyl
Drug Abuse Resistance Education (DARE) is a because of concern about the diversion of these drugs to
long-standing and highly acclaimed drug abuse prevention illicit use.
program that was estimated to reach 26 million school In October 2003, the FDA-approved labeling of two
children in the United States in 2004. It is the most widely new formulations of buprenorphine indicated for treating
implemented drug use prevention program in the United opiate dependence. The first of these formulations
States and has considerable community support. According contained only buprenorphine, and is intended for use at
to its organizers, this program, founded in 1983 in Los the beginning of treatment for opiate abuse. A second
Angeles, is now being implemented in almost 80% of the product contains both buprenorphine and naloxone, and is
nation’s school districts and in more than 54 countries around the formulation used for maintenance treatment of opiate
addiction. Naloxone was added to buprenorphine, so that
the world. Drug Abuse Resistance Education is a police
the formulation cannot be ground up and injected
officer-led series of classroom lessons that teaches children
intravenously, lest the naloxone negate the
from kindergarten through 12th grade how to resist peer pharmacological actions of buprenorphine. These drugs
pressure and live productive drug-free and violence-free lives. represent the first therapy available for in-office
Despite the excellent reputation of this program, research prescribing for opioid dependence; yet, not every
has questioned its effectiveness in changing drug abuse physician is permitted to prescribe these new drugs. To
behaviors. A recent study was conducted to evaluate the qualify, physicians must be board certified in addiction
effect of the middle and junior high school Drug Abuse medicine/psychiatry or have other special credentials, and
Resistance Education and an enhanced program called Drug physicians are required to obtain 8 hours of authorized
Abuse Resistance Education Plus on drug use and violence. training before they can prescribe drugs for office-based
The study was a randomized, controlled trial of 24 schools treatment of opioid dependence. They also must agree to
and neighborhoods, primarily in Minneapolis-St. Paul, treat no more than 30 opioid-dependent patients at any one
Minnesota. The research included all 7th-grade students in time, and they must obtain special Drug Enforcement
24 schools in the academic year 1999–2000. The outcomes Administration numbers indicating that they are
authorized to prescribe under the provisions of the Drug
measured were self-reported tobacco, alcohol, and
Addiction Treatment Act of 2000.
marijuana use; multidrug use; violence; and victimization. In a multicenter, randomized, placebo-controlled trial,
These outcomes were assessed at the beginning and end of 326 people addicted to opiates were assigned to
7th grade and at the end of 8th grade. There were no office-based treatment with sublingual tablets consisting
significant differences between children who attended a of buprenorphine (16 mg) in combination with naloxone
Drug Abuse Resistance Education program and children (4 mg), buprenorphine alone (16 mg), or placebo given
who did not. There were significant differences among boys daily for 4 weeks. The primary outcome measures were
undergoing the expanded version of the program and those the percentage of urine samples negative for opiates and
who did not, with positive results for tobacco, alcohol, and the patients’ self-reported craving for opiates. Safety data
multidrug use and victimization. Researchers concluded were obtained on 461 people addicted to opiates who
that Drug Abuse Resistance Education Plus significantly participated in the open-label phase of buprenorphine and
enhanced the effectiveness of the Drug Abuse Resistance naloxone (at daily doses of up to 24 mg and 6 mg,
Education curriculum among boys and was more effective respectively) and another 11 people who received this
combination only during the trial.
than the delayed program controls, underscoring the
The double-blind trial was terminated early because
potential for multiyear, multicomponent prevention both buprenorphine and naloxone in combination and
programs, and demonstrating gender differences in response buprenorphine alone had greater efficacy than placebo.
to intervention programs. The proportion of urine samples that were negative for
Are there prevention programs that do work? In the opiates was greater in the combined treatment and
Annotated Bibliography is a reference that will direct the buprenorphine groups (17.8% and 20.7%, respectively)
interested reader to a Web site discussing such prevention than in the placebo group (5.8%; p<0.001 for both
programs. comparisons with each buprenorphine group); the active

Spoth RL, Guyll M, Day S. Universal family-focused interventions in alcohol-use disorder prevention: cost effectiveness and cost-benefit analyses of two
interventions. J Stud Alcohol 2002;63:219–28.

Pharmacotherapy Self-Assessment Program, 5th Edition 181 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

treatment groups also reported fewer opiate cravings

(p<0.001 for both comparisons with placebo). Rates of
Annotated Bibliography
adverse events were similar in the active treatment and
1. Department of Health and Human Services, Centers for
placebo groups. During the open-label phase, the Disease Control and Prevention. Health Promotion.
percentage of urine samples negative for opiates ranged Available at http://www.cdc.gov./node.do/id/0900f3ec80059b1a.
from 35.2% to 67.4%. Results from the open-label follow- Accessed November 20, 2004.
up study indicated that the combined treatment was safe and Adopting healthy behaviors, such as eating nutritious
well tolerated. The authors concluded that the combination foods, being physically active, and avoiding tobacco, can
of buprenorphine and naloxone and buprenorphine alone are prevent or control the devastating effects of many diseases.
safe and reduce the use of and craving for opiates among The Centers for Disease Control and Prevention is committed
people addicted to opiates who receive these drugs in an to programs that reduce the health and economic
office-based setting. consequences of the leading causes of death and disability and
that ensure a long, productive, healthy life for all people. This
Physicians will use sublingual buprenorphine alone
Web site provides information about health promotion efforts
during induction and will give a small supply of the product that would be useful to pharmacists who need resources to
directly to the patient (clinical studies used buprenorphine- help start health promotion campaigns. Topics are divided
only tablets for the first 2 days). Community pharmacists into the following areas: adolescent health, aging and elderly
typically will see prescriptions for the combination of health, bone health, breastfeeding, correctional health, faith-
buprenorphine and naloxone. If patients present based and community initiatives, global health, health-related
prescriptions for either drug from more than one prescriber quality of life, men’s health, minority health, nutrition, oral
for the same time period, the pharmacist should assume that health, physical activity, pregnancy, reproductive health,
school health, tobacco, and women’s health. There are many
diversion or abuse is occurring, refuse to fill the
helpful links to other electronic sources of information, such
prescriptions, and notify both prescribers. Likewise, as the link to a subpage called, “preventing chronic disease.”
prescriptions for the single-entity product should be verified This is a useful source of information; however, it does not
with prescribers, as the combination is preferred for long- provide extensive referencing for it content, which is the case
term therapy. with many Web sites.

2. The March of Dimes Birth Defects Foundation. Birth Defects:

Conclusions, Challenges, Strategies for Prevention and Ensuring Quality of Life.
Available at http://www.marchofdimes.com/professionals/.
and More Questions Accessed November 20, 2004.
The March of Dimes supports education, research, and
Pharmacists have an opportunity to provide public policies that promote the health and welfare of babies.
pharmaceutical care and clinical pharmacy services in This Web page contains an excellent overview of the
problems of birth defects and efforts under way to prevent
conjunction with interdisciplinary teams to optimize drug
them. There are sections on the background on birth defects,
therapy regimens. They also have the expertise to research major legislation aimed at preventing birth defects, and a
the etiology, behaviors, and other potentially modifiable risk discussion on federally sponsored birth defects research and
factors associated with diseases, especially those that affect services. Although this resource provides an excellent
public health and that may benefit from existing or future overview of efforts to prevent birth defects, its greatest value
pharmacotherapeutic interventions. Pharmacists teach and is the links to other resources. Special sections focus on drug-
promote disease prevention and health promotion to induced birth defects (e.g., those caused by isotretinoin and
laypersons, patients, pharmacy students, and other health alcohol); an overview of the mechanisms of drug-induced
dysmorphosis would be a welcomed addition. There are
care professionals as opportunities arise. Disease extensive bibliographies on a variety of patients for a
prevention and health promotion are as important, if not pharmacist who is interested in more detail. There also are
more important than the treatment of already existing continuing education programs that focus on genetics,
disease. The examples discussed in this chapter are some of resources that link to perinatal statistics, and patient education
the most imminent risks to public health today. Educational materials.
interventions, grants, research, and other initiatives should
focus on these disease states to improve public health as a 3. World Health Organization Technical Report Series No. 916.
whole, and to empower patients to make a difference for Diet, Nutrition, and the Prevention of Chronic Diseases. Available
their own health and welfare. at http://www.who.int/hpr/NPH/docs/who_fao_expert_report.pdf.
Accessed November 20, 2004.
The concept that it is easier to prevent than treat disease
is an intuitive one. Yet, the real work begins when These recommendations, drafted at a joint meeting of the
World Health Organization and the Food and Agricultural
modifiable risk factors and pharmacogenomics variables
Organization of the United Nations, are part of the World
that affect pharmacotherapy decision-making and disease Health Organization Technical Report Series. This report
state management are identified. More research is needed to focuses on modifiable risk factors, interventions to decrease
learn what interventions can be made, and how these risk, and evidence-based medicine from clinical trials. It
modifiable risk factors can be decreased. follows a template for each disease that consists of the

Boatwright DE. Buprenorphine and addiction: challenges for the pharmacist. J Am Pharm Assoc 2002;42:432–8.

Health Promotion and Disease Prevention 182 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

following: background, trends, diet, physical activity, The original conference identified six major components of
strength of evidence, disease-specific recommendations, and the syndrome: abdominal obesity, atherogenic dyslipidemia,
references. Some diseases addressed include obesity, diabetes elevated blood pressure, insulin resistance with or without
mellitus, cardiovascular disease, hypertension, stroke, glucose intolerance, a proinflammatory state, and a
osteoporosis, and cancer. It also addresses genetic prothrombotic state. The follow-up conference on
susceptibility to chronic disease and gives recommendations management was structured around therapies for these
for diet, nutrition, and physical activity. The report is 149 components.
pages long and, at times, can be tedious to read. It is well Because of the increasing frequency of obesity in the
referenced, allowing the interested reader to access primary United States, metabolic syndrome also has increased. Adult
literature and more detail on a given subject. Particularly Treatment Panel III introduced metabolic syndrome into its
useful is the chart at the end of the report that summarizes the clinical guidelines to achieve cardiovascular disease risk
strength of evidence for nutritional strategies in preventing reduction beyond low-density lipoprotein-lowering therapy.
obesity, type 2 diabetes, cardiovascular disease, cancer, dental All pharmacists, especially those working in primary care
disease, and osteoporosis. clinics and adult internal medicine programs, should find this
report useful. The report is quite lengthy, but fortunately there
4. United States Department of Health and Human Services, are summaries and overviews that condense the information
Substance Abuse and Mental Health Services Administration, into a useable format.
Center for Substance Abuse Prevention. Bringing Effective
Prevention to Every Community. Available at 6. Kalter H. Teratology in the 20th century: environmental
http://www.mentalhealth.samhsa.gov/cmhs/specialpopulations/. causes of congenital malformations in humans and how they
Accessed November 20, 2004. were established. Neurotoxicol Teratol 2003;25:131–282.
The Substance Abuse and Mental Health Services This article is the most comprehensive reference that puts
Administration is the federal agency charged with improving the issue of congential malformations in humans in a clinical
the quality and availability of prevention, treatment, and perspective. It establishes a common set of definitions and a
rehabilitative services to reduce illness, death, disability, and system of classification of malformations. The author created
costs to society that result from substance abuse and mental a historical approach to the study of environmental causes of
illnesses. A workplace resource center on the Web site birth defects. The author is able to maintain a writing style
provides centralized access to information about drug-free that is captivating. The article begins with a discussion of
workplaces and related topics. Also included are two Web congenital malformations caused by x-irradiation and rubella.
casts featuring two model drug abuse prevention programs. There is a fascinating historical account of a thalidomide
The Centers for the Application of Prevention Technologies episode as it relates to teratogenic effects of drugs. There are
teaches people how to apply skills that have proven sections that discuss the difficulty in studying teratogenic
effectiveness for substance abuse prevention. This Web site is effects of drugs as well as interesting accounts of the
a comprehensive resource for the pharmacist who may wish purported teratogens: doxylamine-pyridoxine, blighted
to become involved in substance abuse prevention. It potatoes, female sex hormones, and diethylstilbestrol.
provides an evidence-based approach to evaluate what does There is discussion of environmental hazards, such as
and what does not work to reduce the burden of substance iodine deficiency, organic mercury, Agent Orange, and such
abuse in our country. environmental disasters as the radiation leak at Chernobyl.
The style of this article is such that it is difficult to read just a
5. Grundy SM, Hansen B, Smith SC Jr, Cleeman JI, Kahn RA; small section. It is clear that the author has conducted years
American Heart Association; National Heart, Lung, and of research to compile this paper. Without question, this is an
Blood Institute; American Diabetes Association. Clinical indispensable reference for anyone interested in the subject of
management of metabolic syndrome: report of the American drug-induced birth defects.
Heart Association/National Heart, Lung, and Blood
Institute/American Diabetes Association conference on 7. Griffin KW, Botvin GJ, Nichols TR, et al. Effectiveness of a
scientific issues related to management. Circulation universal drug abuse prevention approach for youth at high
2004;109:551–6. risk for substance use initiation. Prev Med 2003;36:1–7.
The metabolic syndrome consists of a constellation of Targeting school aged children for substance abuse
factors that raise the risk for cardiovascular disease and type prevention continues to be an important disease prevention
2 diabetes. The National Cholesterol Education Program’s initiative but has met with mixed success. This study
Adult Treatment Panel III report identified metabolic evaluated the effectiveness of a program designed to prevent
syndrome as a multiplex risk factor deserving of more clinical the use of alcohol, tobacco, and other drugs of abuse in school
attention. Subsequently, the National Heart, Lung, and Blood age children. A strength of this particular study is that instead
Institute, in collaboration with the American Heart of targeting all of the students in these middle schools, only
Association, convened a conference to examine scientific the students deemed to be at high risk for developing
issues related to the definition of metabolic syndrome. This substance abuse problems received the substance abuse
paper summarizes a second conference devoted to clinical intervention. Twenty-nine innercity middle schools
management of metabolic syndrome, which was sponsored by participated in the substance abuse prevention program.
the American Heart Association in partnership with the General social skills, antidrug norms, and drug refusal skills
National Heart, Lung, and Blood Institute and cosponsored by were taught to students identified as high risk for substance
the American Diabetes Association. use initiation (n=426). The high-risk students who received
The second conference considered the following issues: 1) the educational interventions reported less tobacco use, less
pathogenesis and presentation of metabolic syndrome, 2) alcohol use, less inhalant use, and less polydrug use at 1 year
management of underlying risk factors, 3) management of after education versus high-risk students who did not
metabolic risk factors, and 4) unresolved issues and research participate in the program. Whether these differences in
challenges. substance abuse continue long term remain to be seen.

Pharmacotherapy Self-Assessment Program, 5th Edition 183 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

Although this research looked at programs in innercity middle

schools, the paper would be useful for pharmacists working in
substance abuse prevention who want to incorporate an
evaluation component of the program.

8. Svikis DS, Reid-Quinones K. Screening and prevention of

alcohol and drug use disorders in women. Obstet Gynecol
Clin North Am 2003;30:447–68.
Effective drug abuse prevention programs often need to
target special populations at risk. For example, many
treatments are available for women with substance use
disorders. Some of these available treatments include
psychosocial interventions, cognitive-behavioral therapy, and
12-step recovery programs. Drug therapies, such as
acamprosate, buprenorphine, methadone, and naltrexone, also
are available to be used in combination with cognitive
interventions. This comprehensive review article describes
the clinical trials that have documented the efficacy of
pharmacotherapy and cognitive therapy in combination to
decrease substance abuse. Although a challenging
proposition, physicians and pharmacists can use this review
article to identify effective interventions to decrease the onset
and recidivism of substance abuse problems with their
patients. The article encourages more primary care
practitioners to screen for substance abuse, and intervene
quickly and efficiently. This paper looks at new strategies to
enhance practitioner feelings of self-efficacy about their
ability to identify and intervene early in the progression from
alcohol use to abuse to dependence.

9. Substance Abuse and Mental Health Services Administration.

Model Programs: Effective Substance Abuse and Mental
Health Programs for Every Community. Available at
http://modelprograms.samhsa.gov/template.cfm?page=
default. Accessed November 20, 2004.
This PSAP chapter talked about the elements of an “ideal”
or model program for delivering substance abuse prevention
messages. Can there possibly be programs that meet or
exceed these standards? Indeed, programs have been
identified as model programs, described as well-implemented,
well-evaluated programs. The Substance Abuse and Mental
Health Services Administration of the United States
Department of Health and Human Services maintains this
Web site identifying such “model programs.” To be
acknowledged by the Substance Abuse and Mental Health
Services Administration as a model program requires review
by the National Registry of Effective Programs according to
rigorous standards of research. In return for being recognized
as model programs, program developers have coordinated and
agreed with Substance Abuse and Mental Health Services
Administration to provide quality materials, training, and
technical assistance for nationwide implementation. This site
would be particularly useful for those who wish to begin
providing prevention services without having to start from
scratch.

Health Promotion and Disease Prevention 184 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

Please start new

PSAP-V answer
sheet before
continuing.

SELF-ASSESSMENT
QUESTIONS

Questions 1 and 2 pertain to the following case. A. A positive association was found between
One hundred thirty male, Mexican-American alcoholics alcoholism in Mexican Americans and the serotonin
who met Diagnostic and Statistical Manual of Mental transporter-linked polymorphic region S allele.
Disorders, Fourth Edition, criteria for alcohol dependence B. A positive association was found between
were recruited for a study. Two hundred fifty-one Mexican- alcoholism in Mexican Americans and the
Americans were in the control group. Peripheral blood dopamine dopamine type 2 receptor TaqI A allele.
samples were collected, and deoxyribonucleic acid was C. No positive association was found between
isolated, amplified, and sequenced for genotypic analysis. alcoholism in Mexican Americans and the serotonin
The table below lists the results of genotypic analysis. transporter-linked polymorphic region S allele.
Genotype and allele frequency of dopamine type 2 D. A positive association was found between
receptor TaqI A, B, and -141C insertion/deletion alcoholism in Mexican Americans and the
polymorphisms; serotonin transporter-linked polymorphic dopamine type 2 receptor TaqI B allele.
region; and gamma aminobutyric acid A receptor β3 subunit
gene in Mexican Americans. 2. You are a clinical pharmacist employed by the National
Institute on Drug Abuse. Based on this clinical data
1. Based on the results in the table, which one of the from the case, which one of the following is the best
following can be concluded from this study? next step in the interest of public health?
n Genotype (%) Frequency (%)
DRD2 TaqI A A1/A1 A1/A2 A2/A2 A1_A2/A2_A2 A2
Nonalcoholic patients 251 81 (32.3) 121 (48.2) 49 (19.5) 170 (67.7) 43.6
Alcoholic patients 130 42 (32.3) 64 (49.2) 24 (18.5) 88 (67.7) 43.1
DRD2 TaqI B B1/B1 B1/B2 B2/B2 B1_B2/B2_B2 B2
Nonalcoholic patients 251 92 (36.7) 123 (49.0) 36 (14.3) 159 (63.3) 38.8
Alcoholic patients 130 52 (40.0) 57 (43.8) 21 (16.2) 78 (60.0) 38.1
DRD2 TaqI -141C Ins/Del Del/Del Ins/Del Ins/Insa Ins/Del_Ins/Ins Ins
Nonalcoholic patients 251 7 (2.8) 70 (27.9) 174 (69.3) 244 (97.2) 83.3
Alcoholic patients 130 6 (4.6) 18 (13.9) 106 (81.5)a 124 (95.4) 88.5
5-HTTLPR L/L L/S S/S L/S_S/Sb Sc
Nonalcoholic patients 251 63 (25.1) 111 (44.2) 77 (30.7) 188 (74.9) 52.8
Alcoholic patients 130 19 (14.6) 62 (47.7) 49 (37.7) 111 (85.4)b 61.5c
GABRb3 G1/G1a G1/nG1 nG1/nG1 G1/nG1_nG1/nG1 nG1
Nonalcoholic patients 251 22 (8.8) 81 (32.2) 148 (59.0) 229 (91.2) 75.1
Alcoholic patients 126a 12 (9.5) 41 (32.6) 73 (57.9) 114 (90.5) 74.2
ap=0.007; χ2 = 9.888.
bp=0.018; χ2 = 5.574, nonalcoholic patients versus alcoholic patients.
cp=0.021; χ2 = 5.316, nonalcoholic patients versus alcoholic patients.
5-HTTLPR = serotonin transporter-linked polymorphic region; DRD = dopamine type 2 receptor; GABRb3 = gamma aminobutyric acid A receptor β3 subunit
gene; Ins/Del = insertion/deletion polymorphisms.

Pharmacotherapy Self-Assessment Program, 5th Edition 185 Health Promotion and Disease Prevention
Abbreviations Buy this Book!

A. Choose goals and objectives for public health 3 times/day for epilepsy. His physician recommends
initiatives based on these data. that he undergo a gastric bypass procedure because all
B. Use scenario planning to anticipate future public other modalities for weight loss have failed in R.L., and
health issues. he is at high risk for cardiovascular comorbidities
C. Prioritize public health needs to determine because of obesity. Which one of the following is the
prevention programs necessary. best clinical pharmacy intervention after surgery?
D. Gather and analyze more data before planning A. Assess liver function tests and R.L.’s complaints of
public health initiatives. muscle aches.
B. Assess R.L. for hyperglycemia, hypoglycemia, or
3. B.J. is a 24-year-old woman who has been a patron of drug-induced diarrhea.
your community pharmacy for several years. Recently, C. Assess blood pressure, heart rate, and add low-dose
she delivered a healthy baby boy weighing just more aspirin or an angiotensin-converting enzyme
than 8 pounds. With all good intentions, B.J.’s mother inhibitor.
has taken it on herself to prepare her daughter’s house D. Assess phenytoin serum concentrations and R.L.’s
for the new baby. She prepared a checklist of things for seizure history.
her daughter to do. Among these things was the
recommendation to purchase a 2-ounce bottle of ipecac 7. Which one of the following patients is the best
syrup from the pharmacy. When B.J. asks for this candidate for orlistat drug therapy?
product, you tell her that ipecac syrup is no longer
A. Patients with body mass index greater than 40 and
recommended to be kept in the home. Which one of the renal dysfunction.
following is the best explanation as to why ipecac syrup B. Patients with polycystic ovary syndrome, recurrent
should not be kept in the home? spontaneous abortion history, and insulin resistance.
A. It has abuse potential similar to benzodiazepines C. Patients with hyperlipidemia, high-fiber diet, and
and opiates. body mass index greater than 27.
B. Its use does not decrease emergency department D. Patient with irritable bowel syndrome and an eating
visits or improve patient outcome. disorder.
C. Cardiac monitoring is necessary because of central
nervous system stimulation and arrhythmias. 8. Which one of the following is the best candidate for
D. Its rapid action requires monitoring by a health care sibutramine drug therapy?
practitioner in a hospital. A. Patient with body mass index greater than 40 and
renal dysfunction.
4. The Food and Drug Administration (FDA) recently B. Patient with polycystic ovary syndrome, recurrent
revised the requirement for labeling of nonprescription spontaneous abortion history, and insulin resistance.
drugs. Which one of the following is the best C. Patient with uncontrolled hypertension, high-fiber
explanation for this revision? diet, and body mass index greater than 27.
A. Encourage laypersons to use nonprescription drugs D. Normotensive patient with dysthymia and body
more frequently. mass index greater than 27.
B. Research suggests laypersons do not understand
nonprescription drug labels. 9. You are volunteering at your local community health
C. Nonprescription drugs are not safe when used per fair and staffing a booth with a sign that reads, “Ask the
label instructions. Pharmacist.” A patient asks if she should continue to
D. Pharmacists do not understand nonprescription drug take her estrogen and progestin supplement for “her
labels. heart”. She says her physician told her it will prevent
cardiovascular disease. Which one of the following is
5. In early 2004, the FDA banned the sale of the best response?
ephedra-containing dietary supplements. The agency A. Hormone therapy is only marginally effective for
deemed that ephedra posed a risk to the public health. primary prevention.
Patients taking which one of the following drugs are at B. Hormone therapy is no longer appropriate for
an increased risk for the adverse effects attributable to primary prevention.
ephedra? C. Short-term compared to long-term hormone therapy
A. Amoxicillin 500 mg 3 times/day for 7 days. is associated with more cardiovascular risk.
B. Orlistat 120 mg 3 times/day. D. Stop taking hormone therapy immediately because
C. Fluoxetine 20 mg/day. of increased cardiovascular risk.
D. Carvedilol 25 mg 2 times/day.
A randomized, double-blind, placebo-controlled,
6. R.L. is a 47-year-old Hispanic man who is 5'7" and multicenter study was conducted in 463 women with a
265 pounds. His current drugs include atorvastatin 10 history of spontaneous preterm delivery. Women were
mg once daily for hyperlipidemia, metformin 1000 mg enrolled between 16 and 20 weeks’ gestation, and randomly
2 times/day for type 2 diabetes, metoprolol XL 50 mg assigned in a 2:1 ratio to receive weekly injections of
once daily for hypertension, and phenytoin 125 mg 250 mg of 17-α-hydroxyprogesterone caproate or weekly

Health Promotion and Disease Prevention 186 Pharmacotherapy Self-Assessment Program, 5th Edition
Abbreviations Buy this Book!

injections of inert placebo. Injections were continued to risk for future children with FAS.
week 36 or delivery. The following data were collected: B. Fetal alcohol syndrome can be diagnosed with
amniocentesis and ultrasonography.
Pregnancy- Progesterone Placebo C. Mothers of children with FAS typically are of low
related Relative Risk socioeconomic status.
Complications (95% CI) D. Alcohol exposure during the first trimester causes
No. (%) No. (%)
FAS.
Delivery before
37 weeks’ gestation 111 (36.3) 84 (54.9) 0.66 (0.54–0.81) Question 14 pertains to the following table, which presents
Indicated because 21 (6.9) 15 (9.8) 0.70 (0.37–1.32) results from an evaluation of a substance abuse prevention
of complications program. Substance use was compared at the end of each
CI = confidence interval. “wave” of multidisciplinary interventions.

10. Which one of the following statements is most correct Variable Wave 2 Wave 3 Wave 4
according to recently published data regarding the risk Decrease in self-reported substance abuse
of delivery before 37 weeks’ gestation? compared to baseline (percentage)
Recent Substance Use 6% 10%b 16%c
A. Patients in the placebo group had a decreased risk of
Alcohol 15%b 15%a 23%c
preterm delivery. Cigarettes 4% 10%a 7%
B. Patients in the hydroxyprogesterone group had a Marijuana 1% 6% 18%c
decreased risk of preterm delivery. ap<0.05.
C. Patients in the placebo group had more pregnancy- bp<0.01.
related complications. cp<0.001.
D. Patients in the hydroxyprogesterone group had
more pregnancy-related complications.
14. Which one of the following statements is the best
11. Dr. Watkins is a general practitioner who works in a interpretation of these data?
remote county in one of the southwestern states. He is
A. Alcohol, cigarettes, and marijuana use was
treating a patient with premature labor at 29 weeks’
decreased at study completion.
gestation. Dr. Watkins asks you, the clinical pharmacist
B. Alcohol and marijuana use was decreased at study
for obstetrics and gynecology, why you have
recommended nifedipine monotherapy. Which one of completion.
the following is the best response to his question? C. Recent substance use and cigarette use decreased
throughout the study.
A. Nifedipine is more effective than terbutaline. D. No conclusions can be drawn from these data.
B. Nifedipine is available intravenously and orally.
C. Combining tocolytic drugs increases the rate of Questions 15–17 pertain to the following case.
maternal pulmonary edema. A.N. is a healthy 25-year-old who is 4 months pregnant.
D. Magnesium sulfate is associated with less maternal She is having difficulty quitting smoking but expresses a
and fetal adverse effects. sincere desire to quit. She comes to see her pharmacist and
asks if smoking cessation aids, such as bupropion or
12. You are a pharmacist volunteering your time in a
nicotine patches, are an option for her.
medical clinic for homeless people. In the waiting
room, you overhear two young women arguing about
15. Which one of the following is the best response?
drinking alcohol during pregnancy. One woman
contends that it is safe, just as long as you do not drink A. Nicotine replacement therapy has been associated
“excessively.” The other woman believes differently. with congenital malformations.
Based on the current scientific evidence, which one of B. Nicotine replacement is contraindicated in
the following statements is most correct regarding pregnancy.
alcohol consumption during pregnancy? C. Nicotine does not cross the placenta to a significant
A. No amount of alcohol is safe during pregnancy. degree.
B. Moderate alcohol during the second trimester is not D. Nicotine replacement poses similar risks to the fetus
harmful. as smoking tobacco.
C. Less than two alcoholic beverages per day is not
harmful. 16. A.N.’s doctor is not comfortable prescribing nicotine
D. Alcohol consumption has not been definitively replacement therapy to help her quit smoking. The
associated with fetal anomalies. physician asks you for an alternative recommendation.
Which one of the following is the best response?
13. According to substance abuse specialists, which one of A. Nicotine replacement therapy is contraindicated, so
the following statements about fetal alcohol syndrome bupropion is her best choice.
(FAS) is the most accurate? B. Behavioral modification therapy without nicotine
A. Mothers of children with FAS have an increased patches is her best option.

Pharmacotherapy Self-Assessment Program, 5th Edition 187 Health Promotion and Disease Prevention
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C. Both behavioral modification and nicotine 20. A friend of yours works for a local community service
replacement therapy is her best option. agency that is applying for a grant to establish a drug
D. Bupropion is classified as pregnancy category C; abuse prevention program for children and adolescents.
therefore, it is not an option for A.N. Knowing that you are a pharmacist, your friend asks for
your help in completing the grant application. For the
17. According to clinical practice guidelines, which one of application section called “program description”, he has
the following most accurately describes A.N.’s risks of proposed that you and he formulate a plan in which the
tobacco smoking on the fetus? county pharmacy association would develop a
A. Smoking increases the risk of spontaneous abortion. speaker’s bureau through which pharmacists could go
B. Smoking decreases the risk of low birth weight. to local elementary schools and middle schools to
C. Smoking increases the risk of major teratogenesis. explain the dangers of drugs. Which one of the
D. Smoking is more harmful to the mother than the following is the best response that you can give your
fetus. friend?
A. Research what constitutes effective prevention
18. A.J. is a 22-year-old Caucasian woman with a past programs and change accordingly.
medical history of heroin abuse for 4 years, cocaine B. Begin calling all the pharmacists that you know and
abuse for 5 years, and alcohol abuse for 8 years. You ask for volunteers who would be willing to do these
are the clinical pharmacist at the emergency department programs.
she went to about 24 hours ago with an acute heroin C. Advise him to discontinue substance abuse
overdose, as evidenced by respiratory depression, prevention as these programs are futile.
pinpoint pupils, ventricular dysrhythmias, and mental D. Order enough books about the adverse effects of
status changes leading to unconsciousness. Opiate abused drugs so that the pharmacists can present
concentrations consistent with toxicity were confirmed factual information to scare potential substance
through drug screen. Intravenous naloxone 2 mg was abusers.
administered every 3 minutes for three doses until A.J.
regained consciousness; it was ordered as needed for
symptom recurrence. After 24 hours of intravenous
fluids and psychosocial support, A.J. was discharged
with follow-up by social services. Which one of the
following prescriptions is the best discharge drug to
prevent opiate abuse?
A. A 30-day supply of acetaminophen-codeine orally
3 times/day.
B. A 30-day supply of extended-release oxycodone
10 mg orally 3 times/day.
C. A 30-day supply of methadone 10 mg/day.
D. A 30-day supply of buprenorphine 8 mg sublingually
daily.

19. M.J. is a 32-year-old Caucasian woman in the

ambulatory care clinic with a history of nausea and
vomiting and general malaise occurring throughout the
past 3 weeks. As the clinical pharmacist, you have been
asked to do a drug history on M.J. At some point during
your discussion, she tells you she thinks she is pregnant.
As you talk with her, you notice a strong smell of
residual alcohol on her breath, perhaps indicating a
heavy night’s drinking the evening before. When you
inquire about her drinking habits, she tells you that she
has a drink only occasionally. Which one of the
following is the best thing you can do?
A. Perform a urine test to determine if she has used
alcohol in the past 24 hours.
B. Recommend disulfiram or acamprosate for alcohol
abstinence.
C. Give her the phone number to the local Alcoholics
Anonymous chapter.
D. Explain the dangers of alcohol consumption during
pregnancy.

Health Promotion and Disease Prevention 188 Pharmacotherapy Self-Assessment Program, 5th Edition