Compliance Through Direct-to-Consumer Advertising?

For decades manufacturers have focused their promotional spending on marketing to physicians and professionals. Since the U.S. Food and Drug Administration permitted branded promotional advertising to consumers, drug companies have been spending heavily on Direct-to-Consumer Advertising (DTCA) in selected therapeutic classes. Studies show DTCA has helped expand awareness of diseases, augment incidence of treatment, and increase utilization for some classes of drugs. With certain classes (like allergy) and brands (like Viagra) the impact of DTCA is apparent. However, a point of contention is whether DTCA has a significant impact on patient behavior beyond creating brand awareness. Attitudinal studies have suggested a positive relationship between patient compliance--the degree to which an individual follows a specific recommendation by a physician to treat a disease or condition--and DTCA, but problems of isolating and measuring the impact of DTCA on compliance persist.

Isolating the impact of DTCA on compliance

Understanding the effect of DTCA on behavior such as compliance is confounded by macro and individual level factors, including:

Demographic change: For chronic conditions, demographic changes like population aging have a strong effect on drug utilization and sales, as well as on compliance. Persons over 65 years use a relatively larger portion of their household spending on prescription drugs than younger people; they have also been found to be more compliant than younger people. A slightly different but related factor is that every year new people are diagnosed with chronic conditions. This includes older people who were previously undiaqnosed as well as any new people who are diagnosed with a chronic condition for the first time. This brings new consumers into a franchise. For example, the number of arthritis sufferers has increased from 38 million in 1990 to 43 million in 1997, thereby impacting the utilization and sales of arthritic drug therapies. Prescription drug spending increases are similar in the US, Canada and Europe, which highlights the influence of demographic change (as the US and New Zealand are the only two countries currently allowed by law to advertise prescription drugs to consumers).

Increased Health Coverage: The increase in insurance coverage, from 25% of the total national prescription billing in 1990 to 44% in 2000, probably plays a role in the increase in drug spending in the U.S. Insurance coverage has also been cited as one of the causes of compliance to drug therapies. Consumers may be more likely to fill and refill a prescription if the financial burden associated with the treatment is absorbed in whole or in part by their insurer.

Professional Promotion (sampling and detailing): This is the mainstay of all prescription drugs marketing and difficult to take out of any study on DTCA outcomes. While promotional spending in the pharmaceutical industry grew in absolute terms in the last decade, the spending-to-sales ratio remained fairly constant. DTCA is the fastest growing area of promotional spending (increasing by 145% between 1997 & 2001), but still relatively small compared to spending on research and development and the rest of the promotional mix ($2.7 billion, $30.3 billion, and $16.4 billion in 2001, respectively). Promotions directed at physicians are still the largest part of the promotional mix (about 80% in 2001), and drugs with the highest sales growth are usually also the most heavily promoted to physicians. Furthermore, there seem to be synergies between professional promotion and DTCA: in one study, 70% of physicians said they are more likely to prescribe the brand name medication requested if they had a free sample available.

Measuring the impact of DTCA on compliance

Behaviors are complex and often difficult to measure: assessing compliance or adherence to a therapy regime is no exception. Compliance criteria and metrics can be highly variable, further complicating the ability to compare studies or to formulate convincing conclusions. For example, in clinical trials bioassays are the measure of choice where possible, followed by pill counts. Pill counts tend to overestimate compliance compared to bioassays, but are considered to be more accurate than self-report measures such as patient interviews, questionnaires, and drug diaries. Compliance studies in clinical trials usually deal with the same drug, but population surveys can often involve drug switching within a drug class or across drug classes. For example, patients with elevated cholesterol may switch from one brand of statin to another, or arthritis sufferers may change their cox-2 medication to a NSAID. Thus to be relevant to manufacturers, effects of DTCA need to be studied for single drugs rather than a therapy regime. The challenge is to find a definition relevant to the class, yet consistent enough to be comparable across drug classes.

Compliance also needs to be defined differently for different therapeutic classes. For instance, the concept of compliance in chronic conditions has to be defined differently from compliance in acute conditions (where drugs are taken as needed). Further, there are classes with many sub classes (pain and arthritis, hypertension), and those with over-the-counter and generic competition. And of course, there are classes that use DTCA and those that do not.

Attitudinal studies have been suggestive in associating DTCA with compliance as a direct cause or spillover effect, however the true relationship is not very well understood. Various hypotheses exist for the impact of DTCA on compliance. For example, DTCA may serve to reassure patients about the safety of their medications; a survey in Prevention magazine revealed 30% to 50% of respondents who were exposed to DTCA and were taking a drug said they felt better about taking their drugs. Further, studies have shown that in 25% to 30% of cases DTCA reminds consumers to take their medication, refill their prescriptions and stay on their drug therapy regimes. Conversely, it is possible that DTCA may deter compliance. Some consumers, empowered by much more readily available medical information, may feel comfortable making changes in their dosage schedules without their doctor's consent. DTCA may also attract marginal patients who are not very sick to begin with and therefore do not follow through on their therapy. Neither of these possible scenarios has been studied in detail.

Influencing compliance with DTCA

Confounding elements (such as demographic change, increases to health coverage, and professional promotions), and measurement issues (including difficulties in producing comparable metrics and identifying elements of cause and effect) create a dilemma for researchers wishing to isolate and measure the impact of DTCA on compliance. The solution to this dilemma is derived from the fact that compliance is a behavior that can change over time. Therefore, the ideal data is longitudinal, preferably from first diagnosis through drop off from medication altogether. A longitudinal prescription drug purchase panel, such as Ipsos PharmTrends, is one of the rare datasets where such studies can be successfully conducted. Current analysis suggests at least six factors that could help with understanding compliance:

• Patient involvement in their treatment
• Demographics (age, income, education and marital status)
• Transaction costs (out-of-pocket monetary costs for drug and insurance coverage)
• Comorbidity (number of ailments suffered as a measure of overall health)
• Purchase channels
• Marketing efforts (including DTCA)

Ongoing analysis can help companies identify opportunities (for example, the impact of scripts on compliance), offer diagnostics to help focus marketing efforts (such as answering whether sampling affects compliance in a particular class), evaluate promotional spending against consumers, and other relevant topics. With comprehensive datasets, manufacturers can unleash the power of DTCA to affect health outcomes.