Access to OTC medicines is often presented as a cost-saving mechanism that allows members of the public to self-treat minor ailments rather than consult a doctor; however, there are also roles for various of these medicines in the management of chronic diseases. In the present study the focus was on utilization of OTC medicines applicable to the management of a selection of chronic diseases prevalent among medical scheme beneficiaries ≥40 years of age, formally registered with an appropriate DMP. As shown in Table 2, 22.5% of beneficiaries were in the metabolic category, 1.5% were categorised as respiratory, 0.12% as cardiovascular and 0.5% as glaucoma. This distribution is similar to that reported by CMS for the same conditions.
The analysis of chronic disease group according to gender and ethnicity (Figure 1) showed results at odds with national data. The higher rate of females in the cardiovascular group differs from that shown in the CMS report which reflected a male:female ratio of 1.4:1, while the prevalence of diseases among ethnic groups differs from national statistics. It is important to note that the various disease prevalence rates were not based on surveys or screening programmes that would have identified actual prevalence rates and/or asymptomatic/undiagnosed disease. Furthermore, recording of chronic diseases in the medical schemes environment is typically influenced by health-seeking behaviour of different groups. This has been studied in the South African context, showing that female gender, higher levels of education and ethnicity (whites in particular) are directly related to access to health services and treatment. Also important is that this study focused on DMP-registered chronic conditions; in the absence of registration the condition would not have been identified and recorded.
Utilization of OTC medicines accessed directly by beneficiaries is shown in Figure 2. In keeping with their disease, 5% of respiratory patients accessed fluticasone and one-third accessed bronchodilators. The latter is of some concern since theophylline (the dominant bronchodilator in this study) is not regarded as mainstream treatment for asthma, although it might have a role in disease that is difficult-to-control. Aspirin was accessed by a very small percentage of respiratory patients, possibly reflective of avoidance because of the effect of aspirin as a trigger for asthma. Between 17 and 22% of patients with diagnosed metabolic and cardiovascular conditions accessed bronchodilators. Here there is the possibility that they accessed the medication for self-treatment of a side-effect of treatment for their underlying disease. A beta-blocker prescribed for a cardiovascular patient with heart failure or arrhythmia is known to cause bronchoconstriction in some, resulting in use of a bronchodilator for management of the symptom.[22-23] Bronchodilators contained in ‘cough mixtures’ may also have been accessed by hypertensive patients in the metabolic group who had a cough resulting from treatment with an angiotensin-converting-enzyme (ACE) inhibitor. The similar utilization between subjects in the metabolic and control groups has raised the question of undiagnosed disease in the latter. This is highly likely given that all three conditions within the metabolic group (hypertension, Type 2 diabetes and hyperlipidaemia) are known to be undiagnosed on a large scale, both nationally and globally. In this regard, studies in the sub-Saharan region have shown a 15-76% rate of undiagnosed hypertension, while globally 45.8% have undiagnosed diabetes.[25-26] Around 15% of glaucoma patients accessed aspirin and bronchodilators. While neither medicine has a place in mainstream management of glaucoma, data have shown that the different types of glaucoma may benefit from these medicines.[27-29] Several thousand beneficiaries in this study had a chronic disease registered for management by a medical scheme DMP which should have overseen all elements necessary for disease control, including funding of OTC/acute medicines. These requirements are detailed in legislation and in the CMS Accreditation Standards for Managed Care Organizations.
Prescription of OTC medicines by doctors for beneficiaries in the four groups is shown in Figure 3. In the respiratory group there was again high prescription of fluticasone and bronchodilators. Both medicines should have been funded from the risk pool, and one must question what the DMP was actually managing. Higher-scheduled medicines are the mainstay of treatment for the respiratory conditions, therefore the resort to OTC medicines, theophylline in particular, suggests that disease control might have been inadequate. In comparison with the minimal aspirin utilization rate when patients self-medicated, the 20% prescription rate by doctors was fairly high, particularly since there is the known role for aspirin as an asthma trigger. This is worthy of further investigation. However in the cardiovascular group there was appropriately-high prescription of aspirin, consistent with guidelines for secondary prevention in conditions such as ischaemic heart disease, vascular disease and arrhythmias. Despite its low cost, aspirin should also have been funded as a chronic medication. The prescription of aspirin to almost 40% of patients in the metabolic group was also in line with guidelines, for example for diabetics with risk factors for cardiovascular disease. The prescription of bronchodilators for 20% of metabolic group patients could again have been for treatment of side effects such as an ACE-inhibitor cough. The control group had a 40% prescription rate for aspirin and 22% rate for bronchodilators, possibly for ‘undiagnosed’ disease, but in this category of doctor-prescribed medicines it is more likely that doctors were treating a condition that had been diagnosed but not registered with the medical scheme. The high prescription rate of aspirin and 20% rate of bronchodilators to glaucoma patients were possibly for the reasons already mentioned for the beneficiary-accessed medicines.
A number of concerns arise out of this study, the first being that OTC medicines were accessed for the treatment of DMP-registered conditions and not fully funded out of the chronic medicines benefit. In some cases the OTC medicine was entirely appropriate (e.g. aspirin for cardiovascular patients), in others it was perhaps less-appropriate (e.g. theophylline for asthma patients who could/should have been better managed with first-line drugs), and in a third category it might have served as a ‘flag’ warranting further investigation (aspirin for glaucoma patients). The CMS is clear on the criteria for accreditation of managed care organizations and their DMPs, but precisely how these programmes operate is variable.[4-6] Diabetes management is typically multi-dimensional with programmes offered by medical schemes or outsourced to a dedicated service provider that enrols patients, schedules regular access to doctors, nurses, nutritionists and biokineticists, and provides medicines and laboratory tests relating to diabetes control. On the other hand, hypertension is the most prevalent condition but DMP management is usually limited to approval of chronic medicines, access to brochures, and the occasional telephone call from the medical scheme. Whether a comprehensive or a more-basic DMP it is well within the capability of medical scheme administrators and their DMPs to interrogate claims data and maximise the value[30,31]. Claims for medicines other than the mainstream higher-scheduled drugs would be identified and if linked in any way to the particular chronic condition a call could be made as to whether disease was inadequately controlled or medicines administered to treat side effects of other drugs. Beneficiaries and/or their doctors could also be contacted for information as to why particular OTC medicines were being accessed, whether for supplementary disease control or to treat side effects such as cough or wheezing. Interrogation of the use of aspirin and bronchodilators by and for glaucoma patients might shed interesting light on the condition and its management, while a review of OTC claiming patterns in apparently-healthy beneficiaries would likely alert and inform medical schemes of the need to screen for undiagnosed conditions such as hypertension and diabetes. Table 3 condenses data from the study into various categories, showing whether OTC medicines in this study were accessed directly by beneficiaries or prescribed by a doctor, and whether beneficiaries were DMP-registered or apparently free of the chronic conditions studied. The 30% of beneficiaries with a registered disease who directly accessed OTCs were likely those whose disease was under-treated or were self-medicating for side effects of recommended treatment. The 72.5% for whom OTC medicines were prescribed by doctors were likely in similar categories (under-treated or treated for side-effects). In both cases the DMPs were falling short in their responsibilities, while the CMS should also be held to account for poor oversight of DMPs that they have accredited. The 30.1% of control beneficiaries who directly accessed OTCs likely included those with undiagnosed disease. This category should be managed by medical schemes through ‘wellness days’ that offer screening for common conditions such as diabetes, hypertension, hyperlipidaemia, asthma and cardiac dysfunction. For the 53.7% of control beneficiaries for whom the OTC medicines were prescribed by doctors one may speculate that the doctors were aware of the various conditions, but between themselves and their patients had failed to have the diseases registered with the medical schemes. Recognizing that DMPs are paid for by beneficiaries, management failures such as the above are breaches, not only of trust but also of contracts between beneficiaries and their medical schemes.