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White Paper on the Value of Over-the-Counter Medicines
 

White Paper on the Value of Over-the-Counter Medicines

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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.

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.

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    White Paper on the Value of Over-the-Counter Medicines White Paper on the Value of Over-the-Counter Medicines Document Transcript

    • OTCmedicinesWhite paper on the benefits Consumer Healthcare Productsof OTC medicines in the Association Clinical/Medical CommitteeUnited States Heinz Schneider [Consumer Healthcare Products AssociationReport of the Consumer Healthcare Products (CHPA)], Rachael Carlisle Roehrig (CHPA), Rosa Coppolecchia (BayerAssociation’s Clinical/Medical Committee HealthCare), Ding Ming (Boeh- ringer Ingelheim Pharmaceuticals),E Jeffrey Garwin (GlaxoSmithKlineExecutive summary as an important value in health care. Consumer Healthcare), Dan QiSelf-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 Consumercare 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), Albertoservices. OTC medicines are an indispens- intrinsic pharmacological activity that Paredes-Diaz (Pfizer Consumerable element of the self-care armamen- results in medical effects. However, unlike Healthcare), Aaron Biesbrocktarium. 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 outletsprevention of many commonly occurring including grocery stores, convenienceconditions including musculoskeletal pain, stores, discount department stores, and Drug Evaluation and Research] overseesheadaches, the common cold, allergies, warehouse outlets. These retailers are OTC drugs to ensure that they are properlyheartburn, dermatitis, obesity, tobacco often closer to an individual’s home or labeled and that their benefits outweighsmoking dependence, and dental car- work place than to the nearest pharmacy. their risks. OTC drugs generally have theseies. 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 isguidelines, 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 neededment guidelines of many leading U.S. medi- options. While surveys show that many for the safe and effective use of thecal 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 2,590health care professionals, and in the wide consumers ultimately have the autonomy adult Americans support the importantuse 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 theimportant features of OTC medicines. 10 most frequently used drugs, includingAccessibility 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 drugstions that require early intervention to ing the health of Americans. FDA’s Web in the top 40 list were an additional 7 drugsobtain 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, andsicians (ACEP) to stock a variety of OTC without a prescription. There are more acne, as well as prevention of dental cariesmedicines, including analgesics, antihista- than 80 therapeutic categories of OTC and sunburn. Indications for which OTCmines, and hydrocortisone cream, in home drugs, ranging from acne drug products medicines have been recently approved inand 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 weightwww.pharmacist.com october 2010 • Pharmacy Today 68
    • OTCmedicinesmanagement. Outside the United States, chronic bronchitis (more than 9 million).4 the illness.7,8,9 Other factors that affect thisOTC medications are available to treat an In the same survey, more than 45 million decision include the effect of the illness oneven 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, andstatus to facilitate self-treatment of condi- prevalence of many conditions treated with cultural and socioeconomic factors.7,8,9,10tions such as hypercholesterolemia, lower OTC medicines is within the range of some In a 2008 survey of 1,005 adults that wasurinary tract infections, bacterial conjunc- of the most common conditions which are commissioned by NCPIE, 650 subjectstivitis, 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 orbroad 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 theirn Cold, cough, and allergy products reflects the high prevalence of the condi- illness due to past experience (90%), then Nighttime sleep-aids tions for which they are used to treat. In a desire to save time, distance, and/or moneyn Gastrointestinal products 2001 survey commissioned by the National (89%), and the belief that the illness isn’tn 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 consumersn Oral health care products medicine, more than three -quarters (78%) take responsibility for their own health.12n Menstrual products did so to relieve pain. Fifty-two percent Based on 1,505 interviews, 40%–54% ofn Nicotine replacement products (52%) of participants reported that they respondents indicated they would use ann Weight loss aids had taken an OTC medicine for a cough, OTC medicine as a first course of actionn 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 waittive. While the risks of OTC medicines are tice guidelines. A search of the National and see approach was the first cause ofaddressed, the main focus of this review Guideline Clearinghouse database identi- action taken by the majority of participantsis 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/backsources, 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 menopausalhealth 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 wasmedicines guidelines include non-narcotic analge- the first action the majority of individualsOTC 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 approachconditions 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 consistentmedicines. OTC medicines are an accepted replacement therapy products, and weight with an earlier study by Stoller et al.13 ofand 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 werepopulation. Attachment 1 describes the care professional recommendations and much more likely to self-medicate than tohigh frequency of occurrence for many of self-care decisions. The use of an OTC consult a physician for headache, runnythe symptoms and conditions for which OTC medicine can either originate from the rec- nose, cough, sore throat, constipation, andmedicines are used. For example, based ommendation of a health care professional diarrhea. In contrast, the same individualson data from the 2008 National Health or from a self-care decision. It is estimated were more likely to consult a doctor thanInterview Survey (NHIS), many Americans that 70% to 90% of all illness episodes to self-medicate for vision problems andsuffered 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 inmigraines 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 8,145lion), hay fever (more than 18 million), and the main issues being perceived severity of pre-school age children were interviewed,69 Pharmacy Today • october 2010 www.pharmacytoday.org
    • OTCmedicinesit 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 healthcommon medications administered were encounters. In a 2006 national survey of kit also includes analgesics/antipyretics, ananalgesics/antipyretics and cough/cold 834 office-based physicians regarding antihistamine, hydrocortisone cream, andmedicines. Women without health insur- the Medicare drug benefit conducted by sunscreen, OTC antidiarrheal medicinesance 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 coughdeterminant 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 healthwhich mothers perceive their children to be that they frequently recommend the use kits are available commercially or can bevulnerable.15 The highest ranked perceived of an OTC medicine as a substitute for a assembled by consumers on their own duevulnerabilities 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 studyditions for which OTC medicines are used OTC medicine for economic reasons. In a of 300 mothers of children 6 months to 12and endorsement of their use in clinical 2003 national survey of 519 cardiologists years found that most mothers keep somepractice 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 houseby 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 fortory Medical Care Surveys (NAMCS) dem- assist patients burdened by out-of-pocket skin problems, such as rash or athlete’sonstrated 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 theysents 9.5% of all medications mentioned.16 to the American Pharmacists Association’s are readily available for conditions whichIn the same study, approximately 65% (APhA’s) 2008 Annual OTC Product Sur- require prompt treatment. An example inof 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 recommendData 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, innames, 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 resultsavailable over the counter.17 An analysis cists’ OTC product recommendations.24 in a significantly shorter duration of painof NAMCS data collected from 1995 to Based on responses from 526 pharmacists, than initiation of treatment more than 12000 found that U.S. physicians made an formulation or active ingredients, self-use hour after pain onset.29 Another exampleestimated 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 thishalf of these recommendations were made important factors influencing their OTC condition, topical antiviral therapy suchby dermatologists and the most frequently product decisions. as the OTC medication docosanol, must berecommended 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 effectivemoisturizers. Shiffman et al.19 found that they can be purchased and kept “at hand” therapeutic outcome.30following the Rx-to-OTC switch of nicotine for future use. OTC medicines are recom- Use of OTC medicines toreplacement therapy products, there was mended for inclusion in home first aid kits, decrease prescriptionan increase in the number of prescriptions as well as travel kits. The American College medicine treatment gapsfor 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. Therecian-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 fromcare 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 nationwidepatients discussed OTC medications with the country, ocean cruises, and overseas survey of 1,025 adult Americans, 20% oftheir 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 aproducts, 9% discussed antacids, and 2% antihistamine, antinausea/motion sickness necessary medical prescription in the pastwww.pharmacist.com october 2010 • Pharmacy Today 70
    • OTCmedicinesyear.31 In the same study, 19% of respon- and follow-up in an OTC setting. convenience in terms of productdents reported that inconvenient office range.40hours prevented them from going to the Convenience value In a 2003 Gallup study, almost halfdoctor, 19% experienced difficulty obtain- of OTC medicines (48%) of adult Americans reported thating 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 Employedrienced 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 bewith the same barriers to use as prescrip- qualitative research in which individuals pressed for time and stressed than theirtion medications. Consequently, the treat- who were asked to describe convenience counterparts who weren’t employed andment gap for a condition may decrease if situations, used words such as “easy to did not have young children. More thanan OTC therapy becomes available. For use,” “near at hand,” “saves,” and “frees- 60% of individuals in these subpopulationsexample, the 1996 introduction of OTC up.”36 When describing convenience situ- reported that they are short of time. Basednicotine replacement therapy products ations the individuals also accentuated on this data, one can expect that familiesin the United States led to a significant the importance of time (e.g., saves times, with children in which both parents areincrease in smoking quit attempts. Based amount of time taken, number of hours a employed are especially short of time. Inon sales data, the number of quit attempts service is available) and space (e.g., sav- 1978, all parents in the household wereusing 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 to2.5 million in 1995 (pre–OTC availability) Various conceptual frameworks for 75%.42to 5.8 million in 1997 (post–OTC availabil- convenience have been developed.37,38,39 In In terms of choice, the phrase “addingity).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, cognitivethat OTC nicotine replacement therapy is for, and benefiting from a product or ser- efforts in terms of knowledge about theused in 26% of quit attempts.33 Potential vice. Therefore, in simplest terms, conve- offered products or services, and trust inbenefits of the increased use of nicotine nience can be described as an individual’s one’s ability to make the right choices.37,38replacement therapy include fewer smok- perception of time and energy (mental and If choices are perceived as too complex bying 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 decisionnificant 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 caregap and no available OTC medicines. time. professionals are frequently consultedApproximately 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 careat least 200 mg/dL, the level the National tant convenience factors described in the The convenience framework described inCholesterol Education Program expert literature: the previous section can be readily appliedpanel 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 includeunaware 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 serviceswho 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 factorstion. In 2007, an FDA advisory committee and energy expenditures to receive a specific to pharmacies include in stockdiscussed 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 timeOTC in the United States.35 The commit- the right place).37,38,39 required to have prescriptions filled.43tee members who voted in favor of an OTC n Choice. If a consumer has more than Several recent studies examined theswitch 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 ofthe 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 orabout consumers’ ability to determine the first decision an individual has to make work was the main reason patients citedappropriateness of lovastatin therapy and is whether to self-perform or purchase for choosing to leave the university-basedto the absence of appropriate monitoring the service.38,39 Consumers also define mammography site for a new site. Another71 Pharmacy Today • october 2010 www.pharmacytoday.org
    • OTCmedicinesstudy analyzed the impact of access conve- including discount department stores, self-care, which is the foundation of thenience, in this case home delivery of anti- grocery stores, and warehouse outlets. health care pyramid. A National Instituteshyperlipidemics, antidiabetics, and antihy- While there are only approximately 54,000 of Health (NIH) guide defines self-care aspertensives, on compliance, as assessed pharmacies in the United States, there are an area that “includes positive steps takenby the medication possession ratio.45 After more than 750,000 retail outlets that sell by individuals to either prevent diseasecontrolling for patient demographics and OTC products.51 Consequently, for many or promote general health status throughdrug 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 orhad significantly higher compliance rates macy, but rather another type of retail out- treatment of minor symptoms of ill-healththan those obtaining these medicines from let. The importance of locational conve- or the self-management of chronic healthretail 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 functionalforms of medicines has also been shown than 1,200 consumers across the United limitations affecting routine activities ofto affect compliance. Patient convenience States.52 Forty-four percent of respondents daily living.”57 Consumer surveys revealis 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 inified release formulations versus conven- convenience of location, while 17% chose matters pertaining to their own health astional 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 2004versus concurrent use of several equiva- Access convenience. The time sav- by the National Lipid Association, morelent single-ingredient products.46,47,48 In ings afforded due to access convenience than half of the participants who were nota study published in 2003, reducing the is another important benefit of OTC medi- being treated for increased cholesterol butnumber of daily doses through use of cines. In a 2008 NCPIE survey of 1,005 were at moderate risk for coronary arteryextended release products was shown to Americans, 77% of participants reported disease stated that they make more healthimprove adherence, patient quality of life, that they self-medicate with OTC medi- decisions on their own now than they didand patient satisfaction in a number of cines because it saves time.11 The time in the previous 5 years.58 These findingsdiseases.48 A systematic review of stud- savings realized with use of OTC medicines are consistent with those of a 2000 surveyies published in 2007 synthesized the versus prescription medicines is primarily in which 59% of Americans reported thatfindings of nine studies which compared derived from avoidance of the need to con- they were more likely to treat their ownadherence with fixed-dose combination sult with a health care provider in order to health conditions currently than they weremedications versus the same medications obtain a prescription. A scheduled doctor a year ago.12administered as single-drug formulations; office visit, including travel, waiting, and The availability of OTC medicinestwo 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 findhypertension, one study was in patients Americans travel less than 30 minutes to trivial or unnecessary. In a 1972 study ofwith human immunodeficiency virus (HIV) see a doctor, 2.5% of the overall popula- 1,458 primary care physicians in the Uniteddisease, and two studies were in patients tion travels more than 1 hour to see their States, 64% of physicians estimated thatwith diabetes.49 Across the nine studies, doctor.55 The poor and near poor are more at least 10% of their patient visits werecombination products reduced the risk of likely than wealthier individuals to travel trivial, unnecessary, or inappropriate.59noncompliance with the recommended longer. In a more recent study conducted in thedosing 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 childrenand OTC medicines about the use of OTC medicines, consum- doctor visits to be unnecessary.60 The mostThe convenience values of OTC medicines ers have full autonomy regarding OTC prod- common causes of visits categorized asare 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 medicinessumers League, individuals who reported from a variety of OTC products, including were not available, the number of trivialthat they were more likely to consider tak- products with different active ingredients physician visits would likely increase. Foring 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 athis 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 werescription medicines, which can only be Health care system not available, there would be an annualpurchased 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 Teminlets which do not employ pharmacists, The OTC availability of medicines facilitates reported that in 1989 there were 1.65www.pharmacist.com october 2010 • Pharmacy Today 72
    • OTCmedicinesmillion fewer doctor visits for colds than save the out-of-pocket costs for doctor rent OTC product labeling standards arein 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 labelingfrom Rx to OTC status during this time the cost of time spent traveling and waiting since they “have already been developedperiod.62 The total resources saved due to at the doctor’s office. Using the U.S. June with health literacy considerations inthis decrease in office visits was estimated 2010 average hourly wage rate of $22.53, mind, utilize a standard format, and haveat $70 million per year, an amount which the 2 to 4 hours that a patient saves from been marketed to the public, increasingincludes the total costs of doctor visits, the avoiding a doctor’s visit would result in an their familiarity and usability.”81costs of transportation, and the costs of average savings of $45 to $90.53,54,74 Temin Two separate studies, each of whichtime 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 theyOTC medications results from improving the drug, cost of the doctor visit to get the use OTC medicines.5,12 However, the samework productivity and reducing unneces- prescription, and value of the time used to studies also found that consumers readsary 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 ingredientsrespiratory infections results in an average first year after topical hydrocortisone was and the safety information. Even if patientscost 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 particularlythree upper respiratory infection episodes second year after the switch. In a study concerning in individuals with low literacyper year, OTC cough and cold medicines concerning the switch of heartburn medi- and those in whom English is not their firstprovide a potential annual savings of $4.75 cations from Rx to OTC status, Mansfield language.81,8billion 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 thenies, 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 initiativesits. Analyses conducted by various health OTC medicines include FDA’s Web pages on “Consumerinsurers demonstrated decreases in drug The benefits of OTC medicines can only Information: Safe Use of Over-the-Countercosts and physician visits after H2 antago- be realized if consumers use them safely Drug Products,”84 the American Academynists, 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 EnglishOTC.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 brochuresOTC 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 inysis published in 2005 reported that the OTC as well as prescription products. English and Spanish;86 and CHPA’s Webaverage retail price of an OTC medicine Furthermore, misconceptions about medi- site, OTCsafety.org,87 which includes thein America was $7, whereas the average cines such as “if 1 pill is good then 2 pills Treat with Care campaign on the safe useprice 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 consumersprescription medicine was $28 USD.71 At also occur with both OTC and prescription in OTC medicine education efforts, manythe time of their introduction to the OTC medicines.76,77,78,79 However, since users of organizations are currently examiningmarket, Alli (orlistat), Zantac (ranitidine), OTC medications are less likely than users ways to use social networking sites andand Miralax (polyethylene glycol), were all of prescription medications to consult with nontraditional media. One example of thispriced between 50% and 90% lower than a health care professional prior to product is CHPA’s StopMedicineAbuse campaignthe original branded prescription medi- use, it is particularly imperative that con- which includes a Facebook page88 and acines.72 Similarly, the cost of a 30-day sup- sumers, including those with low reading Twitter account.89ply of Claritin (loratadine) was $96 when comprehension levels, be able to read and Discussionthe 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 dataof OTC medicines, physicians are likely to all OTC medicines must have a standard- demonstrate that OTC medicines arerecommend the use of an OTC medicine as ized label that provides instructions for an indispensable part of the U.S. healtha substitute for an prescription medicine safe and effective use. This standardized care system. These products alleviate orto assist patients who are burdened with label, known as the OTC Drug Facts for- prevent conditions that affect millions ofout-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
    • OTCmedicinesobesity, 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: 30.3consumers’ decision-making regarding U.S. national medical million people >18 years of age reportthe use of OTC medicines demonstrate the associations and frequencies they were told by a doctor or otherthree main reasons consumers use OTC of selected conditions health professional that they havemedicines: (1) they are familiar with how treated with OTC medicines some form of arthritis4to self-treat a particular condition due to The guidelines listed below were iden- National Headache Foundation (2004past 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 mostwarrant 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, orwith 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 asicines. 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 withcare services, there is limited medical liter- The guidelines either explicitly recom- single-ingredient products fails, OTCature addressing the importance of conve- mend OTC agents or recommend medica- medicines containing acetaminophennience 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 aslishes the convenience of OTC medicines. are available in OTC products. In the lat- options.92OTC medicines offer locational, access, ter scenario, relevant information on the n Frequency of migraines or severeand choice convenience. The ease with agents’ OTC status has been added in headaches: 30.2 million people ≥ 18which OTC medications can be accessed brackets. years of age report they had migrainesenables patients to quickly initiate therapy Analgesics or severe headaches in the past 3for conditions which respond best to early American College of Physicians & months4intervention. 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 otitismay 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 analgesicthe 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 asservices. These services include consulta- OTC.]90 the readily available mainstay of paintions 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 areurgent care centers which are the first they had back pain in the past 3 available OTC.]93contact 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 andFurthermore, OTC medicines save health (2000 evidence-based guideline on hip 11.0 million children under 5 years ofplan spendings on provider reimbursement and knee osteoarthritis): age had acute ear infections in past 12and 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 productscines to be realized, they must be used relief of mild-to-moderate joint pain American College of Chest Physicianssafely and effectively. Since these products in patients with hip and knee osteo- (2006 evidence-based guideline on coughmay 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 recommendedthe benefits and risks of these medicines. thritis with mild to severe pain. [Acet- for short-term symptomatic reliefMany public and private organizations aminophen and several NSAIDs are of coughing in adult patients withhave developed tools to enhance the safe available OTC.] Topical analgesics, chronic bronchitis. A combination ofand 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 treatmentcommon part of people’s daily lives. With- adjunctive treatment or monotherapy of cough due to the common cold inout 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
    • OTCmedicinesn 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.]107n 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 acneAmerican Academy of Allergy, Asthma burn and regurgitation. Proton pump vulgaris):and Immunology & American College inhibitors and H2-antagonists are n Benzoyl peroxide is recommendedof 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 recognizedgic 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 recommendedAllergy, 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 recognizedn 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 months94n 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-basedGasrointestinal 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 atopicn 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 productsn 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 antifungal75 Pharmacy Today • october 2010 www.pharmacytoday.org
    • 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 medicationsn 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 triclosanInfectious 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 [availableand soft-tissue infections): n Cerumenolytic agents, including carb- prescription-only] are recommendedn 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 An 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 thedidiasis): 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 andn 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 lozengesciation (2004 evidence-based guideline n Topical treatment with minoxidil 2% are recommended as first-line therapyon 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 smoke4n 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 obeseeye syndrome): for school-aged children at high risk patients who choose to use adjunctiven 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 18n Frequency of dry eyes: 4.9 million n Frequency of coronal caries: 91% of years and older4 people aged ≥ 50 years121 population aged ≥ 20 years130www.pharmacist.com october 2010 • Pharmacy Today 76
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