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This issue introduces a simple but powerful conceptual model ‘The Systems Cycle of HealthCare’¹, which examines the major elements of healthcare for an individual, and considers how these are inter-related both with each other and with other healthcare systems. As an illustration of its utility, the introductory paper applies the model to self-medication with non-prescription medicines. The model naturally puts the consumer at the centre of this cycle, and the major elements involve the acquisition of knowledge and skills, as well as appropriate access to support, in order to enable safe and effective self-care behaviors. The cycle illustrates that in order to achieve continuous improvement in this cycle we need to measure and analyze the outcomes of self-medication behavior to improve the information database on which the cycle depends. In highlighting this, the model draws attention to a significant gap in current knowledge about self-medication.

It is well recognized that the ‘efficacy’ of a new drug is a narrow concept derived from studies in well defined populations under optimal study conditions. The ‘effectiveness’ of a drug, i.e. its utility in unselected populations exposed to it in uncontrolled ‘real world’ circumstances may be very different, and is rightly regarded as the more relevant measure by those charged with getting value for money from healthcare expenditure. In recent years the move to perform more ‘effectiveness’ studies has been one of the most striking changes in the way new drugs are evaluated. When a medicine moves into the non-prescription setting, the environment of use changes again, and the safety and effectiveness of the drug becomes primarily driven by consumer knowledge and, above all, behavior. When considering the benefit to risk ratio for non-prescription drugs, it is consumer behavior that principally drives both sides of the equation. And yet there is a paucity of real-world data on how populations of consumers actually behave when they take non-prescription medicines and the outcomes that result.

Much attention has been paid to label comprehension for consumer medicines in Europe and the US.  Futher, in the US it is also standard practice to study how well the drug label operates in ‘actual use’ studies performed before OTC approval. However we typically know little about real world outcomes when large populations within a nation actually have access to a new drug for self-care. Are outcomes the same as, better, or worse than when the drug is supplied on prescription for the same indication? What is the real-world OTC pattern of usage and adherence to the drug label? How do consumers actually behave when they have a recognized or an unexpected adverse event? What are the important influencers of consumer behavior in relation to medicines? Often these remain unanswered questions.

With consumer medicines there is a temptation to assume that we know everything important about them. After all these are necessarily well characterized medicines with well known efficacy and safety profiles. Since we continue to collect adverse events after switch, there is also a tendency to assume that this is enough. However unless we actually measure larger population outcomes relating to non-prescription use, misuse and abuse, we have no basis to judge the true benefit to risk in the real world or, if you like, ‘OTC effectiveness’. Unless we have data on the factors that drive consumer behavior, how can we drive continuous improvement in the quality of information and how it is delivered, as envisaged in the ‘Systems Cycle of Self-Care’? For the consumer pharmaceutical industry, the lack of such data could prove costly. If a company does not know the true ‘OTC effectiveness’ of their medicine, they may have trouble defending it in the face of a challenge to OTC status. To expand the role of self-care into new therapeutic areas, and to defend the status of OTC medicines, we need to be prepared to measure outcomes, not just collect adverse experience reports.

The ‘Systems Cycle of Self-Care’ is a potent concept that encourages us to think of the self-care process in a new way. The behavior of consumers drives outcomes, and measuring these elements should inform a virtuous circle built on improved knowledge. It is important that we understand the true ‘effectiveness’ of self-care, and it has never been truer to say that ‘more research is needed’.
Correspondence to: editor@selfcarejournal.com