Sticking to the regimen

January 1, 2006
Colin Armstrong

Colin Armstrong, Ph.D., is director of health psychology services at the Vanderbilt Dayani Center for Health and Wellness at Vanderbilt Medical Center in Nashville, TN. His work has been published in a variety of professional journals, and he is a frequent speaker at conferences and corporate events. Colin regularly teaches workshops and seminars on the topics of medication adherence, exercise motivation and adherence, stress and worry management, and developing a more positive attitude. He can be reached at Colin.Armstrong@Vanderbilt.edu or (615) 343-2808. For a complete list of references used in this article, please contact him.

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LeAndrea Barham

LeAndrea Barham is an executive clinical specialist in the HIV division of a large pharmaceutical company. She has held various positions in the industry for eight years and lives in Nashville, TN. You can contact her at leandrea@comcast.net.

Pharmaceutical Representative

The problem of medication nonadherence.

Medicationadherence (or compliance) is a critical issue in our healthcare system.Between 1993 and 2003, the Food and Drug Administration approved morethan 300 new medicines, vaccines and biologics aimed at the preventionor treatment of over 150 different medical conditions, according to theWashington-based Pharmaceutical Research and Manufacturers of America.It is estimated that approximately 1,000 medications are now at somepoint in the development pipeline. While these astonishing advancesoccur in the discovery and testing of new medications, a largeproportion of patients will not adhere to their medication regimen tothe extent that full therapeutic benefits can be realized.

This article was written to provide pharmaceutical sales reps with anintroduction to the magnitude of the problem of medicationnonadherence. Certainly for some readers, the information in thisarticle will be a review. However, for others it will provide thebackground information necessary to converse more effectively withtheir healthcare providers and a greater appreciation of the impact ofnonadherence.

What's the difference?

There are four terms all pharmaceutical reps should be familiar with:adherence, compliance, persistence and concordance. It should be notedthat there is a fair amount of disagreement in the literature about theuse of these terms, and your company may wish you to use terminologydifferently than described below.

"Adherence" and "compliance" are the terms used most widely byproviders in the United States. In describing a patient'smedication-taking behavior, "noncompliant" gradually replaced termssuch as "untrustworthy" or "unreliable." It now appears as though theterm "adherence" is gradually replacing "compliance," although bothhave limitations.

According to the World Health Organization, "adherence" reflects "theextent to which a person's behavior -- taking medication, following adiet and/or executing lifestyle changes, corresponds with agreedrecommendations from a healthcare provider." Note that the use of theterm "compliance" is not improper; it is the underlying meaning thatcan be problematic. Many providers and theorists feel that the terms"noncompliance" and "noncompliant patient" have often been used in amanner that simply does not recognize the complexity of the issue. Forexample, the term "non-compliant patient" does not fully recognize theinfluence of factors that are well beyond the patient's control. Inaddition, some professionals feel that "compliance" denotes a passiverole for the patient, while "adherence" better captures the fact thatpatients play an active role in making decisions about their care,whether one chooses to recognize that role or not. Finally, the term"noncompliant patient" has sometimes been used in a derogatory manner(similar to "resistant patient"), and many feel that "adherence" betterrecognizes that failure to engage in health-promoting behaviors isactually the norm in our society, not the exception.

"Persistence" is a more recent term that refers specifically to theconcept of continuous therapy -- the patient filling the initialprescription, refilling the prescription on schedule and taking themedication until it is discontinued. In short, "persistence" describesthe patient staying on the medication. In fact, some professionalssimply consider adherence to have two components: compliance (takingthe medication as directed) and persistence (staying on themedication).

The term "concordance" was proposed by the Royal Pharmaceutical Societyof Great Britain in 1997 as part of a national campaign to improvemedication-taking behaviors by emphasizing the shared decision-makingbetween provider and patient. "Concordance" does not apply directly tothe patient's medication-taking behavior. Instead, it refers to theprocess of consultation between patient and provider, which isdescribed as "a negotiation between equals." Although the reasonsbehind the initiative are admirable, the term "concordance" is notcurrently used widely outside of Europe.

We will use the word "adherence" for the remainder of this article. Asdefined earlier, "adherence" is a broad term that can be applied to themany health-promoting behaviors that healthcare providers may addressin their practice (like dietary changes, exercise, taking medicationand checking blood pressure daily). In specifying that the patient'sbehavior corresponds with "agreed recommendations" from a healthcareprovider, "adherence" recognizes the shared role between provider andpatient in decision-making. In the interest of brevity, the term"nonadherence" will be used in this article, rather than "poormedication adherence."

Be aware that some of your providers may use the terms "compliance,""adherence," "persistence" and (to a lesser extent) "concordance" assynonyms, while others may hold strong views on the differences amongthe terms. In the end, the terminology used is not nearly as importantas one's view of the patient's role in decision making and appreciationof the wide range of factors that influence adherence.

Forms of nonadherence

As medication adherence reflects the extent to which the patient'smedication-taking behavior "corresponds with agreed recommendationsfrom a healthcare provider," medication nonadherence can take a variety offorms.

Note that any form of medication nonadherence may directly underminepersistence. For example, if a patient is taking the medicationincorrectly and thus is not receiving the full benefit, that patientmay be less likely to refill his prescription.

Estimates of medication nonadherence vary widely in the literaturebased upon several factors, including medication-specific factors (likedosing frequency), disease-specific factors (like acute versus chronicdisease and severity of symptoms), the studies' operational definitionof adherence (for example, what percentage of missed doses would becategorized as nonadherence?) and how adherence was measured (forexample, patient questionnaires, medication diaries, patient or familyreports, electronic monitoring, pill counts, prescription refillrecords, biological markers, or drug levels in biological fluids).

Across medical conditions, typically 20% to 80% of patients fail toadhere to the prescription regimen to the extent that full therapeuticbenefits can be realized. According to research done in 1979,approximately 50% of patients on medications for chronic conditions donot properly adhere to their medication regimen. Note that high ratesof nonadherence have been reported even when the consequences are quitesevere. For example, researchers in 1999 pointed out that in a givenyear, up to 20% of heart transplant patients are nonadherent toprescribed medications, notably immunosuppressants.

The human and economic costs

The total worldwide human and economic costs of medication nonadherenceare impossible to estimate. The WHO described poor medication adherenceas a "worldwide problem of striking magnitude" in that it "causesmedical and psychosocial complications of disease, reduces patients'quality of life and wastes healthcare resources." That body has alsoidentified poor medication adherence as the "primary reason forsub-optimal clinical benefit" from medications.

The economic costs of medication nonadherence are enormous. In 1994, areport from the Task Force for Compliance indicated that medicationnonadherence in the United States accounts for up to $100 billion inhealthcare and productivity costs. According to statistics from theDallas-based American Heart Association, 10% of all hospital admissionsare the result of medication nonadherence, at a cost of $15 billion peryear. It has been estimated that 23% of all nursing home admissions aredue to medication nonadherence. However, that figure comes from a 1984article in the American HealthcareAssociation Journal, and the proportion of nursing homeadmissions attributable to nonadherence may now be higher. The authorsof this article are not economic experts. However, certainly it must becheaper and more humane to prevent hip fractures among the elderly thanto allow them to suffer the resulting hardships.

Recently, Frank Lichtenberg of New York's Columbia University evaluatedWHO data covering virtually all human diseases and concluded thatbetween 1986 and 2000, the average life expectancy in the 52 countriesstudied increased by almost two years. He also found that 0.8 years(40%) of that increase could be attributed to the launch of newpharmaceuticals.

If you consider developed and developing nations, acute and chronicmedical conditions, and both communicable diseases and diseases of ourlifestyle, what other health-promoting behavior can have the samepositive impact as that seen with the initiation of and adherence toappropriate medications? On the other hand, nonadherence to appropriatelyprescribed medications can increase patient suffering and death,contribute to the spread of communicable diseases, decrease workforceproductivity, lead to incorrect scientific and clinical conclusions,and drive up healthcare costs.

Pharmaceutical reps should be aware of the staggering toll medicationnonadherence has taken on our healthcare system. With your directaccess to physicians, nurses and pharmacists, you are in a position toassist these fellow professionals in their efforts to supportmedication adherence. You may find that your customers are veryinterested in learning about how to better support adherence (viaeducational material that you can leave with them, speaker programs onhow to support adherence, etc., consistent with your company'spolicies). Your company may already have adherence support programs inplace that may benefit your customers, and if not, such programs may bein development. To assist your customers, you will want to come armedwith information. We hope this article has sparked your interest inlearning more about medication adherence. A follow-up article in theMarch issue of PharmaceuticalRepresentative will take a closer look at the forms ofmedication nonadherence, as well as how reps can position their drugsas solutions to nonadherence problems.

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