Executive Summary--January 2003  

Introduction

The National Consumers League commissioned Harris Interactive to conduct a survey among 4,263 adult Americans to understand their use of over-the-counter medications (OTCs) including non-steroidal anti-inflammatory drugs, or NSAIDs. (The current estimated population of adults in the U.S. is 209 million (2002 U.S. Census Bureau)  This is one of the largest public opinion studies on over-the-counter medications ever conducted.  The study was conducted by telephone among a nationally representative sample of adults 18 years of age and older.  Results were weighted demographically using figures obtained from the Current Population Survey (CPS) published by the U.S. Census Bureau. 

The margin of error for the total sample is + 1.5% (n=4,263).

The margin of error for people who have taken an OTC over the past year is + 1.6% (n=3,547).

The margin of error for those who take NSAIDs most often is + 2.1% (n=2,279).

Because of the risks associated with over-the-counter medications, including NSAIDs, this study seeks to understand:

• Usage of over-the-counter medications including NSAIDs,

• The extent to which users of over-the-counter medications, including NSAIDs users, read label instructions,

• The extent to which Americans take more than the recommended dose of over-the-counter medications and why they do so,

• Concern about side effects associated with over-the-counter pain relievers including NSAIDs, and

• Whether Americans talk with health professionals about over-the-counter medications.

Use of NSAIDs in America

More than 175 million adult Americans (National Consumers League.  “OTC Pain Meds: What Helps, What Hurts” ) take over-the-counter medications for pain relief – over four-fifths of the U.S. adult population (84%).  Of these, more than 31 million take over-the-counter pain medications daily (15%); another 29 million take over-the-counter medications several times a week (14%).  Non-steroidal anti-inflammatory drugs, or NSAIDs, are the largest part of the over-the-counter pain medication market.  About 110 million Americans who take over-the-counter medications for pain relief take NSAIDs most often.   In fact, Americans are twice as likely to take NSAIDs for pain most often than they are to take acetaminophen-based products including Tylenol.

• Two-thirds (63%) of OTC users take NSAIDs most often when taking over-the-counter pain relievers.

• Ibuprofen-based medicines, such as Motrin or Advil, are the most commonly taken NSAIDs, taken most often by two-fifths (38%) of OTC users.

• One-third (33%) takes Tylenol or acetaminophen (both Non-NSAIDs) most often.

Though typically safe when taken as directed, there are risks associated with taking NSAIDs.  These risks include kidney, liver, and stomach problems—particularly stomach bleeding and ulcers.  Stomach bleeding caused by NSAIDS “accounts for as many as 16,500 deaths and over 103,000 hospitalizations each year in the United States .” (See Table A-4 in Appendix A for a list of medications classified as NSAIDs for this study.)

The Importance of Labels

Given that over-the-counter medications (including NSAIDs) are a part of millions of Americans’ everyday lives, it is all the more important that they use these medications properly.  Labels on over-the-counter medications contain information crucial to proper use of the medication.  Directions for usage, the recommended dosage, and potential side effects are all important items addressed by labels designed to reduce the risk factors associated with improper use of OTCs.  However, while almost all Americans use over-the-counter pain medication, few read the labels on OTCs completely.  By doing this, they potentially put themselves at risk for serious side effects – whether through improper use or potential interactions with other drugs.

• When taking an OTC for the first time, three out of ten (30%) Americans say that they read the dosage recommended on the label.

• One in five (21%) says that they read the directions for usage.

• Less than one in five (16%) read the label for possible side effects of usage.

• One in ten or less reads the label for active ingredients (11%), or for warnings about usage with other non-prescription medications (8%).

Only 16% of Americans who take over-the-counter medications say they read everything on the label the first time they take an OTC; 12% say they don’t read anything at all—perhaps increasing the chance of misuse.

Taking More than the Recommended Dose

Perhaps because they do not read OTC labels completely, or because they choose to ignore warnings, many Americans take more than the recommended dose.  Taking OTCs improperly, in larger doses than directed, or over a prolonged period of time, may increase the risk of serious side effects, such as stomach bleeding, ulcers, liver damage, and kidney damage.  Nonetheless, more than two in five (44%) Americans who use OTCs admit to taking more than the recommended dose.

• One-third (34%) of adults who have taken an over-the-counter medication in the past year admit to having taken the next dose of an OTC sooner than directed on the label. 

• Three out of ten (29%) admit to taking more pills at a single time than directed on the label.

• One in five (19%) says that they have taken more doses per day than directed on the label.

Americans who take NSAIDs most often are significantly more likely than those who take non-NSAIDs most often to take more than the recommended dose of their pain reliever. 

• Half (47%) of adults who take NSAIDs most often sometimes take more than the recommended dose, compared to four out of ten (39%) adults who take non-NSAIDs most often.

The Mistake of Mixing Medications

In addition to taking more than the recommended dose, many Americans mix medications, such as cold or flu medications and OTC pain relievers.  However, many may not realize that cold or flu medications often contain the same active ingredients as those found in over-the-counter pain relievers—in effect increasing the amount of pain medication taken and increasing the risk of potential side effects or drug interactions.  Additionally, many adults fail to heed warnings on over-the-counter pain relievers where alcohol is concerned—even though alcohol is a drug itself and can irritate the stomach lining. 

• Three out of ten (31%) adults who have taken an over-the-counter pain medication in the past year say they have taken a cold or flu medication at the same time as another over-the-counter pain medication. 

• One-third (32%) has consumed alcohol the same day they were taking an OTC.

• Just under half (45%) of those who take NSAIDs most often agree that it is “okay” to take an over-the-counter pain reliever while taking an over-the-counter product for a cold or sinus condition as long as each is taken according to the directions—even though doing this could be dangerous to their health.

Why Americans Exceed Recommended Doses

A significant number of OTC users have exceeded doses recommended on over-the-counter medications.  Reasons cited for taking more than the recommended dose of over-the-counter medications demonstrate the extent of many adults’ lack of understanding about how OTCs work and their limitations.  Most think that taking more than the recommend dose will bring pain relief more quickly—perhaps not realizing that they place themselves at higher risk for serious side effects. 

• Two-thirds (67%) of adults who have taken more than the recommended dose of an OTC have done so because they believed it would bring relief more quickly.

• Two-thirds (67%) said they have done so because they had severe symptoms.

• More than half (57%) did so because they did not get any better taking the recommended dose.

Exceeding the recommended dose of an over-the-counter medication is sometimes indicated when under the supervision of a medical professional.  However, only one in five (19%) OTC users who exceed the recommended dose of their OTC do so because their doctor or nurse told them to. 

• This is higher for those who take NSAIDs most often (21%) compared to those who take non-NSAIDs most often (13%).

Side Effects – Lack of Awareness, Lack of Concern

Though many adults take more than the recommended dose of over-the-counter pain relievers, including half of those who take NSAIDs most often, only half are concerned about possible side effects—side effects such as kidney, liver, and stomach problems including stomach bleeding and ulcers.  In addition to a lack of concern, many OTC users demonstrate a lack of understanding when it comes to the potential side effects of OTC misuse. 

• Half (50%) of adults are either “not too concerned” (25%) or “not at all concerned” (25%) about the potential side effects from taking over-the-counter medications.

  • Half (49%) are either “somewhat” (27%) or “very concerned” (22%) about potential side effects.

• Those who use NSAIDs most often are no more likely to be concerned about potential side effects from taking over-the-counter medications than non-NSAID users.

Though there are many possible side effects associated with misuse of over-the-counter medications, including NSAIDs, few adult OTC users can think of any.   One in five (21%) notes stomach problems as a specific side effect they are concerned about.  This is only slightly higher for those adults who take NSAIDs most often (24%), even though NSAIDs may cause stomach irritation including stomach bleeding and ulcers.

• One in five OTC users (21%) also cite liver damage as a possible side effect they are concerned about; kidney problems are mentioned by only one in ten (12%).

An Opportunity to Inform the Public

A lack of information is the root cause of a lack of concern over the risks associated with over-the-counter medications including NSAIDs.  When presented with specific information about the risks associated with OTCs, most Americans are concerned.  Improving Americans’ understanding about the risks associated with OTCs and NSAIDs might begin with health care professionals.  Less than one in five adults have talked with a health care professional about the risks of kidney or liver damage associated with OTC use (19%), or the risk of stomach bleeding or ulcers (18%). 

• Three-quarters (77%) of adults who have taken an OTC over the past year are concerned that serious side effects, such as stomach bleeding, are associated with some over-the-counter pain relievers.  Those who use NSAIDs most often are significantly less likely to be concerned about this.

• Three-quarters (77%) are concerned that the risk of stomach bleeding increases by as much as three times with the use of some over-the-counter pain relievers. 

• Three-quarters (75%) are concerned that the risk of serious side effects, such as stomach bleeding, increases as the daily dose of certain over-the-counter pain medicines increases.  Those who use NSAIDs most often are significantly less likely to be concerned about this.

• Three-quarters (76%) are concerned that each year 16,500 deaths and 107,000 hospitalizations occur in the U.S. due to side effects associated with some pain medicines.  Those who use NSAIDs most often are significantly less likely to be concerned about this.

At Risk:  Heavy Drinkers

People who consume large amounts of alcohol regularly (“Heavy drinkers” are defined as respondents who consume at least three alcoholic beverages a day for 5+ days per month) are at significantly higher risk of experiencing side effects from over-the-counter medications.  This research demonstrates that they are also significantly more likely to engage in behaviors that put them at risk from OTC misuse.

• Four out of ten (41%) heavy drinkers say they have taken the next dose of an OTC sooner than directed on the label.  This is significantly higher than those who do not drink heavily (32%).

• Just under four in ten (37%) heavy drinkers say they take more pills at a single time than directed by OTC label instructions.  This is significantly higher than those who do not drink heavily (28%).

• Just under three in ten (28%) heavy drinkers say they take more doses per day than directed by OTC label instructions.  This is significantly higher than those who do not drink heavily (18%). 

Most strikingly, two-thirds (65%) of heavy drinkers say they have consumed alcohol the same day they were taking an OTC.  This is almost forty percentage points higher than those who do not drink heavily (27%).   

People who consume alcohol while they are taking an OTC are significantly more likely to be taking an NSAID (35%) as opposed to a non-NSAID (26%). 

Are Men at Higher Risk than Women?

While the majority of both men and women use over-the-counter medications for pain, there are some important differences between the sexes in terms of their attitudes and use of these medicines.  One element behind these differences may lie in why they use OTCs.  Women are more likely to suffer from headaches or migraines, as well as arthritis, whereas men suffer from sports or exercise-related pains more often.  When it comes to the pain medication they use most often, both men and women prefer NSAIDs.

Men and women share many of the same attitudes and behaviors toward OTC use that may put them at higher risk of serious side effects.  However, men are more likely than women to admit to risky attitudes or behaviors; they also say they don’t worry about the potential consequences of their actions.  For example, a majority of both genders fail to completely read the label when taking an OTC for the first time.  Yet, while men are less likely to read the instructions on OTC labels, they are more likely to say that they don’t have to worry about serious side effects or interactions with other drugs – as long as they follow the label’s instructions. 

• Only one in five (19%) women read the entire label when taking an OTC for the first time – just 13% of men read it completely.

  • Conversely, 15% of men don’t read anything on the label (vs. 9% of women).

• Over one-third of men (35%) have had alcoholic drinks and taken an OTC the same day (vs. 28% of women). 

• More men than women think it is “okay” to drink some alcohol with OTCs if they only take the recommended amounts of pain medication (22% of men vs. 15% of women).

Profile of Arthritis Sufferers

People who suffer regularly from arthritis pain represent over 50 million adult Americans.  Women comprise the largest portion of this group.  As a whole, those suffering from arthritis see themselves as being in poorer health compared to the general public and are more likely to suffer from a variety of other pains—most related to their arthritis.  To help alleviate their pain, nearly nine in ten (85%) arthritis sufferers turn to over-the-counter pain relievers and many take OTCs often.  Six in ten (61%) arthritis sufferers who use OTCs take NSAIDs most often.

• Three in ten (29%) report taking OTC medications on a daily basis, and another two in ten (21%) use OTCs several times a week.

Perhaps because they take over-the-counter pain medications frequently, arthritis sufferers are more concerned about potential side effects associated with OTCs than the general public.  Furthermore, half of arthritis sufferers show greater concern when informed about various risks associated with OTC pain medications.

• Half (50%) are “very” concerned when told that the risk of stomach bleeding increases as much as three times with the use of some OTCs.

Regardless of their level of concern, many arthritis sufferers hold potentially dangerous views about the use of over-the-counter medications and fail to discuss potential risk factors with a health professional. 

• Many (43%) think they will avoid any serious risks of side effects as long as they take the recommended dosage or think OTC pain medications are safer than prescription drugs (30%). 

• Just four in ten (39%) report having discussed interactions with other OTCs or prescription medications with a health professional.

• Three in ten have talked about the risk of stomach bleeding or ulcers (29%), or the potential for liver or kidney damage (29%) with a health professional.

• Four in ten (40%) have not discussed any of these concerns with their doctor.