This report examines the role of OTC medicines in the U.S. health care system as reflected through professional treatment guidelines, medication use data, as well as clinical and consumer research.

1. OTCmedicines
White paper on the benefits Consumer Healthcare Products
of OTC medicines in the Association Clinical/Medical
Committee
United States Heinz Schneider [Consumer
Healthcare Products Association
Report of the Consumer Healthcare Products (CHPA)], Rachael Carlisle Roehrig
(CHPA), Rosa Coppolecchia (Bayer
Association’s Clinical/Medical Committee HealthCare), Ding Ming (Boeh-
ringer Ingelheim Pharmaceuticals),
E
Jeffrey Garwin (GlaxoSmithKline
Executive summary as an important value in health care. Consumer Healthcare), Dan Qi
Self-care constitutes the foundation of the This report emphasizes the convenience (McNeil Consumer Healthcare),
healthcare pyramid and allows the health value offered by OTC medicines, a key Paul Starkey (Merck Consumer
care system to focus its strained resources benefit of these medications that is sel- Care), Edwin Hemwall (Merck Con-
on the diagnosis and treatment of serious dom addressed in the literature. Like pre- sumer Care), Robert Chaponis (No-
diseases, new research, and innovative scription medicines, OTC medicines have vartis Consumer Health), Alberto
services. OTC medicines are an indispens- intrinsic pharmacological activity that Paredes-Diaz (Pfizer Consumer
able element of the self-care armamen- results in medical effects. However, unlike Healthcare), Aaron Biesbrock
tarium. prescription medicines which can only be (The Procter & Gamble Company),
Americans rely on over-the-counter purchased at pharmacies, OTC medicines Aman Bhatti (Reckitt Benckiser)
(OTC) medicines for the treatment and are available at a variety of retail outlets
prevention of many commonly occurring including grocery stores, convenience
conditions including musculoskeletal pain, stores, discount department stores, and Drug Evaluation and Research] oversees
headaches, the common cold, allergies, warehouse outlets. These retailers are OTC drugs to ensure that they are properly
heartburn, dermatitis, obesity, tobacco often closer to an individual’s home or labeled and that their benefits outweigh
smoking dependence, and dental car- work place than to the nearest pharmacy. their risks. OTC drugs generally have these
ies. This report examines the role of OTC Consequently, OTC products provide loca- characteristics:
medicines in the U.S. health care system as tion convenience. Another convenience n Their benefits outweigh their risks.
reflected through professional treatment offered by OTC products is that they save n The potential for misuse and abuse is
guidelines, medication use data, as well the patient time since they do not require low.
as clinical and consumer research. consultation with a health care provider for n Consumer can use them for self-diag-
The important role of OTC medicines in a prescription. OTC medicines also provide nosed conditions.
the treatment of many conditions is dem- the convenience value of choice by offer- n They can be adequately labeled.
onstrated by their presence in the treat- ing consumers a wide variety of treatment n Health practitioners are not needed
ment guidelines of many leading U.S. medi- options. While surveys show that many for the safe and effective use of the
cal associations, in the high frequency at individuals consult a physician or phar- product.”
which the medicines are recommended by macist about the use of OTC medicines, The findings of a Slone survey of 2,590
health care professionals, and in the wide consumers ultimately have the autonomy adult Americans support the important
use of the products by consumers. to make the final choice regarding the use role OTC medicines have in America’s
Accessibility and convenience are of OTC medicines. health care system.2 In this survey, 6 of the
important features of OTC medicines. 10 most frequently used drugs, including
Accessibility facilitates the use of OTC Introduction the top 4, were drugs available OTC. Fur-
medicines for the treatment of condi- OTC medicines are essential for maintain- thermore, among the remaining 30 drugs
tions that require early intervention to ing the health of Americans. FDA’s Web in the top 40 list were an additional 7 drugs
obtain optimal therapeutic effect, such as page on the Regulation of Nonprescription available OTC.
migraine headaches or cold sores. This Products states:1 Traditional uses of OTC medicines
“at hand” benefit also is reflected in the “Over-the-counter (OTC) drugs play an include the treatment of mild to moder-
recommendations of the Centers for Dis- increasingly vital role in America’s health ate pain, symptoms of the common cold,
ease Control and Prevention (CDC) and care system OTC drug products are those hay fever, heartburn, diarrhea, constipa-
the American College of Emergency Phy- drugs that are available to consumers tion, hemorrhoids, gingivitis, eczema, and
sicians (ACEP) to stock a variety of OTC without a prescription. There are more acne, as well as prevention of dental caries
medicines, including analgesics, antihista- than 80 therapeutic categories of OTC and sunburn. Indications for which OTC
mines, and hydrocortisone cream, in home drugs, ranging from acne drug products medicines have been recently approved in
and travel first aid kits. to weight control drug products. As with the United States include smoking cessa-
Convenience has been recognized prescription drugs, CDER [Center for tion, emergency contraception, and weight
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2. OTCmedicines
management. Outside the United States, chronic bronchitis (more than 9 million).4 the illness.7,8,9 Other factors that affect this
OTC medications are available to treat an In the same survey, more than 45 million decision include the effect of the illness on
even wider range of diseases. For example, adult Americans were current smokers, normal behavior, duration of symptoms,
in the United Kingdom, medications were more than 74 million were overweight, understanding of the cause of the symp-
“switched” from prescription (Rx) to OTC and more than 59 million were obese. The toms, worry or fear of symptoms, and
status to facilitate self-treatment of condi- prevalence of many conditions treated with cultural and socioeconomic factors.7,8,9,10
tions such as hypercholesterolemia, lower OTC medicines is within the range of some In a 2008 survey of 1,005 adults that was
urinary tract infections, bacterial conjunc- of the most common conditions which are commissioned by NCPIE, 650 subjects
tivitis, and benign prostatic hyperplasia.3 treated with prescription products; in the indicated that they typically self-medicate
Currently in the United States, OTC 2008 NHIS, the prevalence of hypertension health conditions such as heartburn, colds,
medicines are available in the following was more than 56 million and the preva- allergies, headaches, cough, and rashes or
broad therapeutic classes: lence of diabetes was more than 18 million. hives. The main reasons for self-medicat-
n Analgesics and antipyretics Consumer use of OTC medications ing were familiarity with how to treat their
n Cold, cough, and allergy products reflects the high prevalence of the condi- illness due to past experience (90%), the
n Nighttime sleep-aids tions for which they are used to treat. In a desire to save time, distance, and/or money
n Gastrointestinal products 2001 survey commissioned by the National (89%), and the belief that the illness isn’t
n Dermatological products Council on Patient Information and Edu- serious enough to require consulting a doc-
n Other topical products (including vagi- cation (NCPIE), 598 of the 1,011 adult tor (78%).11
nal antifungals, anorectal medicines, Americans surveyed (59%) indicated that A survey conducted in 2000 by Roper
products for head lice, products for they had taken an OTC medicine in the past Starch on behalf of CHPA examined the
hair loss, ophthalmics, and otics) 6 months.5 Among those who took an OTC extent to which American adult consumers
n Oral health care products medicine, more than three -quarters (78%) take responsibility for their own health.12
n Menstrual products did so to relieve pain. Fifty-two percent Based on 1,505 interviews, 40%–54% of
n Nicotine replacement products (52%) of participants reported that they respondents indicated they would use an
n Weight loss aids had taken an OTC medicine for a cough, OTC medicine as a first course of action
n Vaginal contraceptives and emergency cold, flu, or sore throat; 45% for allergy or for headaches, skin problems, heartburn/
contraceptives sinus relief; 37% for heartburn, indiges- indigestion, common cold symptoms,
The purpose of this report is to exam- tion, or other stomach problems; 21% for or allergy/sinus symptoms; 26%–34%
ine the role of OTC medicines in the U.S. constipation, diarrhea, or gas; 12% for reported they would wait to see if the symp-
health care system, particularly the ben- infections such as athlete’s foot or yeast toms would go away; and only 4%–13%
efits these products provide from a medi- infections; and 10% for skin problems. of participants indicated they would con-
cal, convenience, and economic perspec- OTC recommendations in clinical prac- sult a physician first. Conversely, the wait
tive. While the risks of OTC medicines are tice guidelines. A search of the National and see approach was the first cause of
addressed, the main focus of this review Guideline Clearinghouse database identi- action taken by the majority of participants
is on the benefits of OTC products. An fied numerous clinical practice guidelines (32%–46%) for upset stomach/nausea,
emphasis is placed on data from U.S. from U.S. medical associations or govern- constipation/ diarrhea, muscle/joint/back
sources, since many factors relevant to mental agencies that either explicitly rec- pain, minor eye problems, pre-menstrual/
OTC medicines are specific to the local ommend OTC medicines or recommend menstrual problems, and menopausal
health care environment. the use of active ingredients that are avail- problems, followed by the use of OTC med-
able in OTC products (see Attachment 1). icines (26%–35%), and doctor consulta-
Health benefits of OTC OTC medicines recommended in these tion (9%–19%). Consulting a doctor was
medicines guidelines include non-narcotic analge- the first action the majority of individuals
OTC medicines for treatment and sics, antihistamines, proton pump inhibi- took for teeth and gum problems (36%),
prevention of common health tors, H2-antagonists, laxatives, topical followed by the wait and see approach
conditions hydrocortisone, topical emollient agents, (31%), and OTC medicine use (17%).
Frequency of conditions treated with OTC fluoride oral health care products, nicotine These findings are generally consistent
medicines. OTC medicines are an accepted replacement therapy products, and weight with an earlier study by Stoller et al.13 of
and often first-line therapy for many of the loss aids. 667 elderly people living in community set-
most common conditions affecting the U.S. OTC medicine use based on health tings. The elderly subjects surveyed were
population. Attachment 1 describes the care professional recommendations and much more likely to self-medicate than to
high frequency of occurrence for many of self-care decisions. The use of an OTC consult a physician for headache, runny
the symptoms and conditions for which OTC medicine can either originate from the rec- nose, cough, sore throat, constipation, and
medicines are used. For example, based ommendation of a health care professional diarrhea. In contrast, the same individuals
on data from the 2008 National Health or from a self-care decision. It is estimated were more likely to consult a doctor than
Interview Survey (NHIS), many Americans that 70% to 90% of all illness episodes to self-medicate for vision problems and
suffered from low back pain (more than 61 are addressed with self-treatment.6 The urination disorders.
million), arthritis (more than 51 million), decision process between self-medication The use of many OTC medicines in
migraines or severe headaches (more than and professional consultation appears to children is usually initiated by parents.
30 million), sinusitis (more than 30 mil- be affected by many factors, with one of In a study in which the mothers of 8,145
lion), hay fever (more than 18 million), and the main issues being perceived severity of pre-school age children were interviewed,
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3. OTCmedicines
it was reported that more than half of the discussed antidiarrheals.20 In the same medication, antibiotic ointment, hydrocor-
children (54%) were given an OTC medi- study, 37% of physicians asked questions tisone cream, calamine lotion, and sun-
cine during the past 30 days.14 The most about OTC medications during patient screen.26 CDC’s recommended travel health
common medications administered were encounters. In a 2006 national survey of kit also includes analgesics/antipyretics, an
analgesics/antipyretics and cough/cold 834 office-based physicians regarding antihistamine, hydrocortisone cream, and
medicines. Women without health insur- the Medicare drug benefit conducted by sunscreen, OTC antidiarrheal medicines
ance were significantly more likely to give the Kaiser Family Foundation, physician– such as loperamide or bismuth subsalicy-
OTC medicines to their children. An earlier patient discussions about the burden of late, mild laxatives, antacids, deconges-
study of 300 mothers of children 6 months out-of-pocket prescription costs were found tants (alone or in combination with anti-
to 12 years old showed that the major to be a trigger in many cases for physician histamine medications), as well as cough
determinant for keeping OTC medicines recommendations of OTC medicines.21 In suppressant/expectorant medications,
handy is the nature of health problems to this study, 38% of physicians reported and throat lozenges.27 Prepackaged health
which mothers perceive their children to be that they frequently recommend the use kits are available commercially or can be
vulnerable.15 The highest ranked perceived of an OTC medicine as a substitute for a assembled by consumers on their own due
vulnerabilities were scratches on arms or prescription medicine in order to assist to the OTC availability of its components.
legs (infection), cough for two days, fever of patients with their out-of-pocket prescrip- Consistent with these recommenda-
101ºF, and sore throat. tion costs. Furthermore, 39% of physicians tions, many households store some OTC
Considering the high prevalence of con- said that they sometimes recommend an medications at home for future use. A study
ditions for which OTC medicines are used OTC medicine for economic reasons. In a of 300 mothers of children 6 months to 12
and endorsement of their use in clinical 2003 national survey of 519 cardiologists years found that most mothers keep some
practice guidelines, it is not surprising that and internists conducted by researchers OTC medications in the home.15 The medi-
OTC medicines are widely recommended from the University of Chicago, physicians cations most commonly kept in the house
by physicians. An analysis of data collected reported that the recommendation of an were fever remedies (>90% of mothers),
from the 1997 to 1999 National Ambula- OTC medicine was a likely strategy used to cough remedies (>50%), and remedies for
tory Medical Care Surveys (NAMCS) dem- assist patients burdened by out-of-pocket skin problems, such as rash or athlete’s
onstrated that physicians recommended an prescription costs.22 foot (>30%).
estimated 88 million OTC products annu- Consumers frequently consult phar- An important aspect of the “at hand”
ally during office-based visits; this repre- macists about OTC medicines. According benefits of OTC medicines is that they
sents 9.5% of all medications mentioned.16 to the American Pharmacists Association’s are readily available for conditions which
In the same study, approximately 65% (APhA’s) 2008 Annual OTC Product Sur- require prompt treatment. An example in
of non-narcotic analgesics prescribed in vey, pharmacists make approximately 31 this area is acute headache for which pro-
office-based practices were OTC products. OTC recommendations per week and an fessional treatment guidelines recommend
Data from the 2006 NAMCS showed that 3 average of 83% of individuals purchase an the early use of OTC analgesics to maxi-
of the 20 most frequently mentioned drug OTC medicine that their pharmacist rec- mize their effectiveness.28 For example, in
names, i.e., ibuprofen, acetaminophen, ommended.23 A survey published in 2002 patients with migraines, initiation of treat-
and omeprazole, were active ingredients investigated factors influencing pharma- ment within 1 hour of pain onset results
available over the counter.17 An analysis cists’ OTC product recommendations.24 in a significantly shorter duration of pain
of NAMCS data collected from 1995 to Based on responses from 526 pharmacists, than initiation of treatment more than 1
2000 found that U.S. physicians made an formulation or active ingredients, self-use hour after pain onset.29 Another example
estimated 36 million recommendations of the product, scientific evidence, and of a condition which requires prompt treat-
for OTC topical skin products.18 More than positive consumer feedback were the most ment is herpes simplex labialis. For this
half of these recommendations were made important factors influencing their OTC condition, topical antiviral therapy such
by dermatologists and the most frequently product decisions. as the OTC medication docosanol, must be
recommended products were hydrocorti- ‘At hand’ benefits of OTC medicines initiated within a few hours of the appear-
sone preparations, anti-infectives, and skin One of the benefits of OTC medicines is that ance of the first symptoms for an effective
moisturizers. Shiffman et al.19 found that they can be purchased and kept “at hand” therapeutic outcome.30
following the Rx-to-OTC switch of nicotine for future use. OTC medicines are recom- Use of OTC medicines to
replacement therapy products, there was mended for inclusion in home first aid kits, decrease prescription
an increase in the number of prescriptions as well as travel kits. The American College medicine treatment gaps
for such products, with more than 10 mil- of Emergency Physicians (ACEP) recom- The term “treatment gap” refers to the num-
lion physician recommendations in 2004. mends that every home have a first aid kit ber of people with a condition or disease
There is a paucity of data on physi- which contains OTC medicines, including who need treatment but do not get it. There
cian-patient interactions regarding OTC analgesics such as acetaminophen, ibupro- are many economic, practical, and psycho-
medicines. A 1995 study of 414 primary fen, and aspirin, cough and cold medicines, logical barriers that prevent patients from
care visits at the University of New Mexico allergy medicines, hydrocortisone cream, receiving medical care and obtaining pre-
Health Sciences Center found that 58% of and decongestant tablets.25 For trips across scription medicines. In a 2008 nationwide
patients discussed OTC medications with the country, ocean cruises, and overseas survey of 1,025 adult Americans, 20% of
their physicians; 38% of patients discussed flights the ACEP recommends a traveler’s individuals reported that cost of prescrip-
analgesics, 10% discussed cold or allergy first aid kit which contains analgesics, an tion drugs prevented them from obtaining a
products, 9% discussed antacids, and 2% antihistamine, antinausea/motion sickness necessary medical prescription in the past
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4. OTCmedicines
year.31 In the same study, 19% of respon- and follow-up in an OTC setting. convenience in terms of product
dents reported that inconvenient office range.40
hours prevented them from going to the Convenience value In a 2003 Gallup study, almost half
doctor, 19% experienced difficulty obtain- of OTC medicines (48%) of adult Americans reported that
ing a medical appointment, 18% reported In Webster’s Dictionary, convenience is they felt short of time, and one-third (33%)
that the cost of physician visits prevented defined as “anything that adds to one’s reported that they experience stress fre-
them from seeing a doctor, and 13% expe- comfort or saves work; useful, handy, or quently in their daily lives.41 Employed
rienced difficulty finding a physician. helpful device, article, service, etc.” This individuals and parents of children under
OTC medications are not associated definition is consistent with findings from 18 years of age were more likely to be
with the same barriers to use as prescrip- qualitative research in which individuals pressed for time and stressed than their
tion medications. Consequently, the treat- who were asked to describe convenience counterparts who weren’t employed and
ment gap for a condition may decrease if situations, used words such as “easy to did not have young children. More than
an OTC therapy becomes available. For use,” “near at hand,” “saves,” and “frees- 60% of individuals in these subpopulations
example, the 1996 introduction of OTC up.”36 When describing convenience situ- reported that they are short of time. Based
nicotine replacement therapy products ations the individuals also accentuated on this data, one can expect that families
in the United States led to a significant the importance of time (e.g., saves times, with children in which both parents are
increase in smoking quit attempts. Based amount of time taken, number of hours a employed are especially short of time. In
on sales data, the number of quit attempts service is available) and space (e.g., sav- 1978, all parents in the household were
using nicotine replacement therapy prod- ing a trip, locational proximity, one-stop employed in 59% of families with children,
ucts is estimated to have increased from shopping). while in 1998, this number increased to
2.5 million in 1995 (pre–OTC availability) Various conceptual frameworks for 75%.42
to 5.8 million in 1997 (post–OTC availabil- convenience have been developed.37,38,39 In In terms of choice, the phrase “adding
ity).32 The increased utilization inferred general, all of these frameworks address to one’s comfort” from Webster’s conve-
from sales data has since been confirmed the time and energy or effort consumers nience definition comes into play. Deci-
in population surveys, which indicate spend deciding on, accessing, transacting sion-making requires both time, cognitive
that OTC nicotine replacement therapy is for, and benefiting from a product or ser- efforts in terms of knowledge about the
used in 26% of quit attempts.33 Potential vice. Therefore, in simplest terms, conve- offered products or services, and trust in
benefits of the increased use of nicotine nience can be described as an individual’s one’s ability to make the right choices.37,38
replacement therapy include fewer smok- perception of time and energy (mental and If choices are perceived as too complex by
ing attributable deaths, increased life physical) related to purchasing or using a consumer, he or she may feel uncomfort-
expectancy for current smokers, and sig- products or services. The time dimension able about them and delegate the decision
nificant health care cost savings. may refer to time saved by utilizing a prod- to somebody perceived as more qualified
Hypercholesterolemia is a condi- uct or service or to the ability to obtain a or more capable in the area of question.
tion for which there is a large treatment product or service at a more convenient This is one of the reasons why health care
gap and no available OTC medicines. time. professionals are frequently consulted
Approximately 50% of Americans have a Time and energy, or effort, are the about OTC medicines (see Section 3.1.3).
total serum cholesterol concentration of main determinants of the following impor- Role of convenience in health care
at least 200 mg/dL, the level the National tant convenience factors described in the The convenience framework described in
Cholesterol Education Program expert literature: the previous section can be readily applied
panel considers borderline-high risk.34 n Locational convenience. Goods or ser- to health care services and products.
However, approximately 50% of patients vices may be provided at a place that is Convenience factors that can affect satis-
with increased cholesterol levels are closer to a consumer’s home or work- faction with health care services include
unaware of their condition, and approxi- place, thereby saving him or her time access features such as a convenient loca-
mately 60% of men and 70% of women and energy.37 tion of physician and pharmacy services
who know they have hypercholesterolemia n Access convenience. Access conve- and the availability of services during non-
are not receiving treatment for the condi- nience involves an individual’s time business hours. Some convenience factors
tion. In 2007, an FDA advisory committee and energy expenditures to receive a specific to pharmacies include in stock
discussed the possibility of making the product or service (being able to get a availability of prescribed medications, abil-
lipid-lowering drug lovastatin available product or service at the right time at ity to request refills by telephone, and time
OTC in the United States.35 The commit- the right place).37,38,39 required to have prescriptions filled.43
tee members who voted in favor of an OTC n Choice. If a consumer has more than Several recent studies examined the
switch cited public health issues associ- one option for receiving a service or importance of convenience in health care.
ated with hypercholesterolemia and the product, he can make choices on the A study conducted at the University of Cin-
large number of untreated individuals as basis of time and effort required to cinnati regarding mammography screen-
factors supportive of a switch. However, receive these services. Berry et al. ing services illustrates the importance of
the majority of committee members voted use the term “decision convenience” location convenience of a health care ser-
against OTC approval due to concerns in this context and point out that the vice.44 In this study, distance to home or
about consumers’ ability to determine the first decision an individual has to make work was the main reason patients cited
appropriateness of lovastatin therapy and is whether to self-perform or purchase for choosing to leave the university-based
to the absence of appropriate monitoring the service.38,39 Consumers also define mammography site for a new site. Another
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5. OTCmedicines
study analyzed the impact of access conve- including discount department stores, self-care, which is the foundation of the
nience, in this case home delivery of anti- grocery stores, and warehouse outlets. health care pyramid. A National Institutes
hyperlipidemics, antidiabetics, and antihy- While there are only approximately 54,000 of Health (NIH) guide defines self-care as
pertensives, on compliance, as assessed pharmacies in the United States, there are an area that “includes positive steps taken
by the medication possession ratio.45 After more than 750,000 retail outlets that sell by individuals to either prevent disease
controlling for patient demographics and OTC products.51 Consequently, for many or promote general health status through
drug use behaviors, individuals receiving Americans, the closest place to purchase health promotion or lifestyle modification;
their medicines through home delivery an OTC medicine is not the nearest phar- medical self-care for the identification or
had significantly higher compliance rates macy, but rather another type of retail out- treatment of minor symptoms of ill-health
than those obtaining these medicines from let. The importance of locational conve- or the self-management of chronic health
retail pharmacies. nience when purchasing medications was conditions; and steps taken by laypersons
The convenience of certain dosage demonstrated in a 2001 survey of more to compensate or adjust for functional
forms of medicines has also been shown than 1,200 consumers across the United limitations affecting routine activities of
to affect compliance. Patient convenience States.52 Forty-four percent of respondents daily living.”57 Consumer surveys reveal
is one of the factors that leads to improved in this survey reported that the main rea- that there is an increasing trend for indi-
medication adherence with depot and mod- son they used their regular pharmacy was viduals to seek more active involvement in
ified release formulations versus conven- convenience of location, while 17% chose matters pertaining to their own health as
tional formulations and improved adher- a pharmacy based on price, and 13% well as the health of other family members.
ence with fixed-combination medicines chose a pharmacy based on service. In an internet survey conducted in 2004
versus concurrent use of several equiva- Access convenience. The time sav- by the National Lipid Association, more
lent single-ingredient products.46,47,48 In ings afforded due to access convenience than half of the participants who were not
a study published in 2003, reducing the is another important benefit of OTC medi- being treated for increased cholesterol but
number of daily doses through use of cines. In a 2008 NCPIE survey of 1,005 were at moderate risk for coronary artery
extended release products was shown to Americans, 77% of participants reported disease stated that they make more health
improve adherence, patient quality of life, that they self-medicate with OTC medi- decisions on their own now than they did
and patient satisfaction in a number of cines because it saves time.11 The time in the previous 5 years.58 These findings
diseases.48 A systematic review of stud- savings realized with use of OTC medicines are consistent with those of a 2000 survey
ies published in 2007 synthesized the versus prescription medicines is primarily in which 59% of Americans reported that
findings of nine studies which compared derived from avoidance of the need to con- they were more likely to treat their own
adherence with fixed-dose combination sult with a health care provider in order to health conditions currently than they were
medications versus the same medications obtain a prescription. A scheduled doctor a year ago.12
administered as single-drug formulations; office visit, including travel, waiting, and The availability of OTC medicines
two studies were in patients with tuber- visit time, consumes approximately 2 to 4 reduces the need for many physician visits,
culosis, four studies were in patients with hours of a patient’s time.53,54 While most including those that physicians would find
hypertension, one study was in patients Americans travel less than 30 minutes to trivial or unnecessary. In a 1972 study of
with human immunodeficiency virus (HIV) see a doctor, 2.5% of the overall popula- 1,458 primary care physicians in the United
disease, and two studies were in patients tion travels more than 1 hour to see their States, 64% of physicians estimated that
with diabetes.49 Across the nine studies, doctor.55 The poor and near poor are more at least 10% of their patient visits were
combination products reduced the risk of likely than wealthier individuals to travel trivial, unnecessary, or inappropriate.59
noncompliance with the recommended longer. In a more recent study conducted in the
dosing schedule by 26%. Choice of products. While many con- UK, general practitioners considered 6%
Domains of convenience sumers consult health care professionals of adult doctor visits and 15% of children
and OTC medicines about the use of OTC medicines, consum- doctor visits to be unnecessary.60 The most
The convenience values of OTC medicines ers have full autonomy regarding OTC prod- common causes of visits categorized as
are of key importance to consumers. In a uct purchases and use. In most therapeu- unnecessary were skin problems and mus-
2007 study sponsored by the National Con- tic drug categories, consumers can select culoskeletal symptoms. If OTC medicines
sumers League, individuals who reported from a variety of OTC products, including were not available, the number of trivial
that they were more likely to consider tak- products with different active ingredients physician visits would likely increase. For
ing an OTC product for lowering choles- and products with similar active ingredi- example, if only a small percentage of indi-
terol than an prescription medication most ents, but with different formulations, pack- viduals who currently self-treat their head-
often cited convenience as the reason for age sizes, and prices.56 In a 2000 survey ache or backache would chose to visit a
this selection.50 of 1,505 Americans, 80% of participants physician instead of self-medicating with
The following section discusses the responded that having a range of choices an OTC analgesic, this would result in mil-
convenience factors associated with use of OTC medicines helps them treat and pre- lions of extra doctor visits each year.
of OTC medicines. vent health conditions on their own.12 A 2008 study of heartburn sufferers
Locational convenience. Unlike pre- estimated that if OTC medications were
scription medicines, which can only be Health care system not available, there would be an annual
purchased at pharmacies, OTC medicines benefits of OTC medicines increase of approximately 6 million heart-
are available at various types of retail out- Societal perspectives burn-related doctor office visits.61 Temin
lets which do not employ pharmacists, The OTC availability of medicines facilitates reported that in 1989 there were 1.65
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6. OTCmedicines
million fewer doctor visits for colds than save the out-of-pocket costs for doctor rent OTC product labeling standards are
in 1976, a difference attributed to FDA visits (including insured consumer’s co- considered as a reference for future stan-
approving the switch of cold medicines payments) and transportation, as well as dardized prescription medicine labeling
from Rx to OTC status during this time the cost of time spent traveling and waiting since they “have already been developed
period.62 The total resources saved due to at the doctor’s office. Using the U.S. June with health literacy considerations in
this decrease in office visits was estimated 2010 average hourly wage rate of $22.53, mind, utilize a standard format, and have
at $70 million per year, an amount which the 2 to 4 hours that a patient saves from been marketed to the public, increasing
includes the total costs of doctor visits, the avoiding a doctor’s visit would result in an their familiarity and usability.”81
costs of transportation, and the costs of average savings of $45 to $90.53,54,74 Temin Two separate studies, each of which
time spent travelling and waiting A study by combined three factors to assess the included more than 1,000 adult Ameri-
Lipsky and colleagues demonstrated that economic implications of the OTC avail- cans, found that 90% to 95% of consum-
the majority of cost savings from taking ability of topical hydrocortisone: price of ers read the Drug Facts label when they
OTC medications results from improving the drug, cost of the doctor visit to get the use OTC medicines.5,12 However, the same
work productivity and reducing unneces- prescription, and value of the time used to studies also found that consumers read
sary physician visits.63 The study found that go to the doctor.75 He estimated that con- the label selectively and often pay insuf-
the use of OTC medicines to treat upper sumers saved more than $200 million the ficient attention to the active ingredients
respiratory infections results in an average first year after topical hydrocortisone was and the safety information. Even if patients
cost savings of $9 per episode. Assuming switched from prescription (Rx) to OTC read the label, they may not comprehend it.
that adult Americans have an average of status and more than $400 million the Poor label comprehension is particularly
three upper respiratory infection episodes second year after the switch. In a study concerning in individuals with low literacy
per year, OTC cough and cold medicines concerning the switch of heartburn medi- and those in whom English is not their first
provide a potential annual savings of $4.75 cations from Rx to OTC status, Mansfield language.81,8
billion per year. et al. found that consumers saved approxi- Several government and nongovern-
Since OTC medicines are generally mately $160 in out-of-pocket drug costs ment organizations have developed pro-
not covered by health plans, from the and $14 in physician visit costs annually.61 grams that use various forms of commu-
perspective of health insurance compa- nication to educate consumers about the
nies, Rx-to-OTC switches reduce costs Conditions for safe safe and effective use of OTC medicines.
for drugs as well as costs for doctor vis- and effective use of Ongoing consumer education initiatives
its. Analyses conducted by various health OTC medicines include FDA’s Web pages on “Consumer
insurers demonstrated decreases in drug The benefits of OTC medicines can only Information: Safe Use of Over-the-Counter
costs and physician visits after H2 antago- be realized if consumers use them safely Drug Products,”84 the American Academy
nists, loratadine, omeprazole, and vagi- and effectively. Intentional or unintentional of Family Physicians’ (AAFP’s) Web site,
nal antifungal products became available nonadherence to the usage instructions www.FamilyDoctor.org, which is in English
OTC.64,65,66,67,68,69,70 of medicines in terms of incorrect dos- and Spanish and contains a comprehen-
Consumer perspectives ing and duration of treatment or failure sive OTC Guide;85 APhA’s patient brochures
OTC medicines are generally priced much to heed warnings and precautions is a addressing self-treatment of selected com-
lower than prescription products. An anal- challenge which applies to all medicines, mon conditions, which are available in
ysis published in 2005 reported that the OTC as well as prescription products. English and Spanish;86 and CHPA’s Web
average retail price of an OTC medicine Furthermore, misconceptions about medi- site, OTCsafety.org,87 which includes the
in America was $7, whereas the average cines such as “if 1 pill is good then 2 pills Treat with Care campaign on the safe use
price of a name-brand prescription medi- should be twice as good” and the inability of OTC cough and cold medicines in chil-
cine was $96, and the price of a generic to understand directions on the label can dren. In order to engage more consumers
prescription medicine was $28 USD.71 At also occur with both OTC and prescription in OTC medicine education efforts, many
the time of their introduction to the OTC medicines.76,77,78,79 However, since users of organizations are currently examining
market, Alli (orlistat), Zantac (ranitidine), OTC medications are less likely than users ways to use social networking sites and
and Miralax (polyethylene glycol), were all of prescription medications to consult with nontraditional media. One example of this
priced between 50% and 90% lower than a health care professional prior to product is CHPA’s StopMedicineAbuse campaign
the original branded prescription medi- use, it is particularly imperative that con- which includes a Facebook page88 and a
cines.72 Similarly, the cost of a 30-day sup- sumers, including those with low reading Twitter account.89
ply of Claritin (loratadine) was $96 when comprehension levels, be able to read and Discussion
the drug was available by prescription and understand the product labeling. Evidence-based treatment guidelines,
$22 following the switch to OTC avail- Unlike prescription container labels health care professionals’ recommenda-
ability.71 Due to the economic advantage which do not have a standardized format, tion patterns, and consumer usage data
of OTC medicines, physicians are likely to all OTC medicines must have a standard- demonstrate that OTC medicines are
recommend the use of an OTC medicine as ized label that provides instructions for an indispensable part of the U.S. health
a substitute for an prescription medicine safe and effective use. This standardized care system. These products alleviate or
to assist patients who are burdened with label, known as the OTC Drug Facts for- prevent conditions that affect millions of
out-of-pocket prescription costs.73 mat, was established by FDA in 1999.80 Americans, including headaches, musculo-
By using OTC medications, consum- According to the conclusions of a 2008 skeletal pain, the common cold, heartburn,
ers not only save on drug costs, they also Institute of Medicine workshop, the cur- diarrhea, dermatitis, heartburn, allergies,
73 Pharmacy Today • october 2010 www.pharmacytoday.org

7. OTCmedicines
obesity, tobacco addiction, and tooth car- Attachment 1: Therapeutic [Several topical analgesics are avail-
ies. agents available in OTC able OTC.]91
Numerous studies that have examined products recommended by n Frequency of arthritis diagnosis: 30.3
consumers’ decision-making regarding U.S. national medical million people >18 years of age report
the use of OTC medicines demonstrate the associations and frequencies they were told by a doctor or other
three main reasons consumers use OTC of selected conditions health professional that they have
medicines: (1) they are familiar with how treated with OTC medicines some form of arthritis4
to self-treat a particular condition due to The guidelines listed below were iden- National Headache Foundation (2004
past experience, (2) they have concluded tified through a search of the National guideline on primary headache; conclu-
that their illness is not serious enough to Guideline Clearinghouse database (NGC; sions reflect clinical experience and most
warrant a doctor’s visit, and (3) it saves www.guideline.gov), a public resource for recent medical literature):
money and time when they self-medicate evidence-based clinical practice guide- n OTC aspirin, acetaminophen, or
with an OTC medicine. The latter aspect lines provided by the Agency for Health- NSAIDs such as ibuprofen, naproxen,
reflects the convenience value of OTC med- care Research and Quality (AHRQ), U.S. and ketoprofen are recommended as
icines. Although convenience is recognized Department of Health and Human Ser- first-line therapy for episodic tension-
as being an important parameter of health vices. type headache. If treatment with
care services, there is limited medical liter- The guidelines either explicitly recom- single-ingredient products fails, OTC
ature addressing the importance of conve- mend OTC agents or recommend medica- medicines containing acetaminophen
nience as it relates to OTC medicines. The tions without specifying their prescription and/or acetaminophen with the addi-
information presented in this report estab- or OTC status, but the active ingredients tion of caffeine are recommended as
lishes the convenience of OTC medicines. are available in OTC products. In the lat- options.92
OTC medicines offer locational, access, ter scenario, relevant information on the n Frequency of migraines or severe
and choice convenience. The ease with agents’ OTC status has been added in headaches: 30.2 million people ≥ 18
which OTC medications can be accessed brackets. years of age report they had migraines
enables patients to quickly initiate therapy Analgesics or severe headaches in the past 3
for conditions which respond best to early American College of Physicians & months4
intervention. Patients who perceive a doc- American Pain Society (2007 evidence- American Academy of Pediatrics &
tor’s visit as inconvenient, and therefore based guideline on low back pain): American Academy of Family Physi-
do not seek out prescription medications, n Acetaminophen and nonsteroidal anti- cians (2004 guideline on acute otitis
may use an OTC medicine which can be inflammatory drugs (NSAIDs) are media):
obtained locally without a prescription. recommended as first-line medication n Acetaminophen and ibuprofen are
The healthcare system benefits from options for most patients suffering recommended as effective analgesic
the OTC availability of medicines due to the from low back pain. [Acetaminophen treatment for mild to moderate otal-
reduction of unnecessary use of healthcare and several NSAIDs are available gia. These medicines are described as
services. These services include consulta- OTC.]90 the readily available mainstay of pain
tions by primary care physicians, nurse n Frequency of low back pain: 61.7 mil- management for acute otitis media.
practitioners, community clinics, and lion people ≥ 18 years of age report [Acetaminophen and ibuprofen are
urgent care centers which are the first they had back pain in the past 3 available OTC.]93
contact for most people looking to receive months4 n Frequency of acute ear infections:
treatment for cough and cold symptoms. American College of Rheumatology 21.8 million people of all ages and
Furthermore, OTC medicines save health (2000 evidence-based guideline on hip 11.0 million children under 5 years of
plan spendings on provider reimbursement and knee osteoarthritis): age had acute ear infections in past 12
and prescription medicines. n Acetaminophen is recommended months94
In order for the benefits of OTC medi- as an initial therapy option for the Cold, cough, and allergy products
cines to be realized, they must be used relief of mild-to-moderate joint pain American College of Chest Physicians
safely and effectively. Since these products in patients with hip and knee osteo- (2006 evidence-based guideline on cough
may be purchased without the guidance arthritis. NSAIDs are recommended suppressants and pharmacologic protus-
of a health care professional, it is impor- as an alternate therapeutic approach sive therapy):
tant that consumers be educated about in patients with knee or hip osteoar- n Dextromethorphan is recommended
the benefits and risks of these medicines. thritis with mild to severe pain. [Acet- for short-term symptomatic relief
Many public and private organizations aminophen and several NSAIDs are of coughing in adult patients with
have developed tools to enhance the safe available OTC.] Topical analgesics, chronic bronchitis. A combination of
and effective use of OTC medicines. e.g., methylsalicylate or capsaicin brompheniramine and pseudoephed-
In conclusion, OTC medicines are a cream, are recommended as either rine is recommended for treatment
common part of people’s daily lives. With- adjunctive treatment or monotherapy of cough due to the common cold in
out them, the health of Americans would in individuals with knee osteoarthritis adults. [Dextromethorphan, brom-
likely decline. who have mild to moderate pain, do pheniramine, and pseudoephedrine
not respond to acetaminophen, and are available OTC.]95
do not wish to take systemic therapy.
www.pharmacist.com october 2010 • Pharmacy Today 74

8. OTCmedicines
n Frequency of cough: 26.7 million doc- n Frequency of indigestion, nausea, and hydrocortisone, emollient agents, and
tor visits annually due to cough96 vomiting: 8 million people of all ages coal tar are available OTC.]107
n Frequency of chronic bronchitis: report they had of indigestion, nau- n Frequency of dermatitis: 8.2 million
9.8 million people ≥ 18 years of age sea, and vomiting during the last 12 people of all ages report they has der-
report they were told by a doctor or months94 matitis during the past 12 months94
other health professional in the past American College of Gastroenterology n Frequency of atopic dermatitis
12 months that they had a chronic (2005 evidence-based guideline on gas- (eczema): 10%–20% of infants and
bronchitis4 troesophageal reflux disease): young children, 1%–3% of adult pop-
n Frequency of common cold: American n Antacids, proton pump inhibitors, and ulation108
population experiences an estimated H2-antagonists are recommended for American Academy of Dermatology
1 billion colds each year97 patient directed therapy for heart- (2007 evidence-based guideline on acne
American Academy of Allergy, Asthma burn and regurgitation. Proton pump vulgaris):
and Immunology & American College inhibitors and H2-antagonists are n Benzoyl peroxide is recommended
of Allergy, Asthma and Immunology recommended as mainstay of gastro- as effective topical therapy of acne
(2008 evidence-based guideline on aller- esophageal reflux disease therapy. vulgaris. Salicylic acid is recognized
gic rhinitis): [Antacids, proton pump inhibitors and as a treatment option. [Benzoyl per-
n Oral second-generation antihista- H2-antagonists are available OTC.]101 oxide and salicylic acid are available
mines are recommended over first- n Frequency of gastroesophageal reflux OTC.]109
generation antihistamines for treat- disease: estimated lifetime prevalence n Frequency of acne: 5 million people of
ment of allergic rhinitis. Oral and of 25% to 35% of the population102 all ages94 and an estimated 80 percent
topical decongestants and intranasal n Frequency of heartburn/gastroesoph- of all people between the ages of 11
cromolyn sodium are recommended ageal reflux disease: annual preva- and 30110
as treatment options. [Agents from lence is estimated at 60%104 American Academy of Dermatology
all classes mentioned are available American Gastroenterological Asso- (2009 evidence-based guideline on pso-
OTC.]98 ciation (2008 evidence-based guideline riasis):
n Frequency of hay fever: 18 million peo- on gastroesophageal reflux disease): n Topical corticosteroids, including
ple ≥ 18 years of age report they were n Proton pump inhibitors and H2 over-the-counter hydrocortisone
told by a doctor or other health profes- antagonists are recommended as preparations, are recommended as
sional in the past 12 months that they treatment for patients with gastro- a cornerstone of treatment for the
had hay fever4 esophageal reflux disease. Antacids majority of patients with psoriasis,
American Academy of Allergy, Asthma are acknowledged as the most rapidly particularly those with limited dis-
and Immunology & American College of acting agents whose efficacy can be ease. Emollients are recommended
Allergy, Asthma and Immunology (2005 sustained by combining them with a as standard adjunctive therapy. Sali-
evidence-based guideline on sinusitis): proton pump inhibitor or an H2 antag- cylic acid and coal tar are recognized
n Topical and oral nasal decongestants onist. [Proton pump inhibitors, H2 as treatment options. [All ingredients
are recommended for treatment of antagonists, and antacids are avail- mentioned are available OTC.]111
acute or chronic sinusitis. [Agents able OTC.]105 n Frequency of psoriasis: 2.9 million
from these two classes are available n Frequency of gastroesophageal reflux people of all ages report they had pso-
OTC.]99 disease: see above riasis during the past 12 months94
n Frequency of sinusitis: 30.6 million American Gastroenterological Asso- American Academy of Allergy, Asthma
people ≥ 18 years of age report they ciation (2000 guideline on constipation): and Immunology; American College
were told by a doctor or other health n Fiber and saline agents such as milk of Allergy, Asthma and Immunology;
professional in the past 12 months of magnesia are recommended for the & Joint Council of Allergy, Asthma
that they had sinusitis4 initial management of constipation and Immunology (2004 evidence-based
Gasrointestinal products followed by bisacodyl, lactulose, and guideline on atopic dermatitis):
American College of Gastroenterology polyethylene glycol. [Except lactulose n Emollients available in form of lotions,
(1997 evidence-based guideline on acute all ingredients mentioned are avail- creams, and ointments are recom-
infectious diarrhea in adults): able OTC.]106 mended as first-line therapy of atopic
n Loperamide is recommended as the n Frequency of frequent constipation: dermatitis. Topical corticosteroids,
drug of choice when nonspecific ther- 3.1 million people of all ages report applied to area of eczema, are recog-
apy is desired for diarrhea. Bismuth they had frequent constipation during nized as effective treatment. [Emol-
subsalicylate is recommended as the the past 12 months94 lients and topical hydrocortisone are
preferred agent when vomiting is a Dermatological products available OTC.]112
major manifestation of enteric infec- American Academy of Dermatology n Frequency of atopic dermatitis: see
tion. [Loperamide and bismuth sub- (2004 evidence-based guideline on atopic above
salicylate are available OTC.]100 dermatitis): Other topical products
n Frequency of diarrhea: an estimated n Topical corticosteroids and emollients American Academy of Dermatology
99 million adults experience acute are recommended as standard of care (1996 guideline on superficial mycotic skin
diarrhea or gastroenteritis each for atopic dermatitis. Coal tar recog- infections):
year100 nized as a treatment option. [Topical n Topical treatment with antifungal
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9. OTCmedicines
products is recommended for nonin- American Academy of Ophthalmology n Frequency of root caries: 18% of pop-
flammatory tinea corporis, tinea cru- (2008 evidence-based guideline on con- ulation aged ≥ 20 years130
ris, tinea faciei, tinea manuum, and junctivitis): American Academy of Periodontol-
tinea pedis. [Topical antifungals that n Topical OTC antihistamine/vasocon- ogy (2001 evidence-based guideline on
are available include clotrimazole, strictor agents are recommended for plaque-induced gingivitis, chronic peri-
ketoconazole, miconazole, terbin- the treatment of mild allergic conjunc- odontitis, and other clinical conditions):
afine, and tolnaftate.]113 tivitis.122 n Topical antibacterial medications
n Frequency of mycotic skin infections: n Frequency of episodes of watery, itchy including products containing a com-
Tinea pedis (athlete’s foot) is esti- eyes (most likely allergy-linked): 40% bination of thymol, menthol, eucalyp-
mated to occur in up to 15% of the of adult population123 tol, and methyl salicylate [available
population114 American Academy of Otolaryngol- OTC], products containing triclosan
Infectious Diseases Society of America ogy—Head and Neck (2008 evidence- [available OTC], and products contain-
(2005 evidence-based guideline on skin based guideline on cerumen impaction): ing chlorhexidine gluconate [available
and soft-tissue infections): n Cerumenolytic agents, including carb- prescription-only] are recommended
n Topical bacitracin and neomycin are amide ear drops, are acknowledged as as therapy options for treatment and
mentioned as options for the treat- a treatment option. [Carbamide ear prevention of plaque-induced gingivi-
ment of impetigo. Mupirocin is consid- drops are availabe OTC.]124 tis.132 The guideline refers to a volun-
ered the best topical agent for impe- n Frequency of earwax impaction: 12 tary seal standard established by the
tigo. [Bacitracin zinc and neomycin million people annually123 American Dental Association (ADA)
are available OTC, mupirocin is avail- American Academy of Pediatrics (2002 for the assessment of the safety and
able by prescription only.]115 guideline on head lice): effectiveness of dental products.133 A
n Frequency of impetigo: affects n Topical permethrin is recommended number of OTC products containing a
approximately 1% of children116 as the treatment of choice for head lice variety of active ingredients (includ-
Infectious Diseases Society of America in children. Pyrethrine plus piperonyl ing triclosan, stannuous fluoride, and
(2009 evidence-based guideline on can- butoxide is acknowledged as an alter- essential oils) have been awarded the
didiasis): native treatment option. [All ingredi- ADA seal for an indication of preven-
n Six topical antifungal agents are ents mentioned are available OTC.]125 tion of plaque and gingivitis.
recommended for treatment of vul- n Frequency of head lice infections: n Frequency of gingivitis: more than
vovaginal candidiasis. [Four of the Among children 3 to 12 years of age 50% of adults have gingivitis on an
recommended agents are available approximately 6 to 12 million have average of 3–4 teeth134
OTC, i.e., clotrimazole, miconazole, head lice each year.124 One large study Smoking cessation products
butoconazole, and tioconazole].117 showed that 3.6% of elementary Agency for Healthcare Research and
n Frequency of vaginal yeast infection: school children had nits without head Quality, Centers for Disease Control
Nearly 75% of adult women have at lice and 1.6% had lice.126 and Prevention, et al. (2000 evidence-
least one vaginal yeast infection in American Academy of Dermatology based guideline on tobacco use and depen-
their life time118 (1996 guideline for androgenetic alope- dence):
American Gastroenterological Asso- cia): n Nicotine gums, patches, and lozenges
ciation (2004 evidence-based guideline n Topical treatment with minoxidil 2% are recommended as first-line therapy
on hemorrhoids): solution is recommended as an effec- options which reliably increase long-
n Topical corticosteroids are recog- tive therapeutic option. [Minoxidil is term smoking abstinence rates. [All
nized as useful medical therapy for availabe OTC.]127 products mentioned are available
managing perianal skin irritation and n Frequency of androgenetic hair loss: OTC.
topical analgesics are recognized as 50% of men128 or 35 million men129 n Frequency of current smokers: 46 mil-
useful for symptomatic relief of local Oral healthcare products lion people ≥ 18 years of age report
pain and itching. [Topical hydrocorti- American Academy of Pediatric Den- they have smoked at least 100 ciga-
sone and topical analgesics are avail- tistry (2008 evidence-based guideline on rettes in their lifetime and still cur-
able OTC.]119 fluoride therapy): rently smoke4
n Frequency of hemorrhoids: 8.5 million n Fluoride toothpaste twice daily is rec- Weight loss products
people of all ages report they had hem- ommended for in home use as a pri- American College of Physicians (2005
orrhoids during the past 12 months94 mary preventive measure. Fluoride evidence-based guideline on obesity in pri-
American Academy of Ophthalmology mouth rinses or brush-on gels are mary care):
(2008 evidence-based guideline on dry recommended as a prevention option n Orlistat is recommended for obese
eye syndrome): for school-aged children at high risk patients who choose to use adjunctive
n Aqueous enhancement using artificial for caries. [Fluoride toothpastes, gel drug therapy. [Orlistat is available
tear substitutes, gels and ointments and rinses are available OTC.]130 OTC.]135
is recommended for mild dry eye syn- n Frequency of caries in permanent n Combined frequency of overweight
drome. [Topical products for dry eye teeth: 42% of population aged 6–19 and obesity: 68% of Americans ≥ 20
syndrome are available OTC.]120 years131 years of age136 or 134 million adults 18
n Frequency of dry eyes: 4.9 million n Frequency of coronal caries: 91% of years and older4
people aged ≥ 50 years121 population aged ≥ 20 years130
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10. OTCmedicines
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