Medication non-adherence - not taking medications as prescribed - contributes to more than 125,000 deaths and 10% of hospitalisations in the USA annually, says Sebastian Seiguer, CEO of emocha Health. It’s a complicated, massive, US$500bn problem with inadequate solutions that miss the mark by focusing on refill rates as an indirect measure of adherence.
One such solution is the auto-refill prescription programme. These programmes initiate prescription refills on a standardised, recurrent basis and are touted as effective ways to address medication non-adherence. Other similar programmes include mail order of medications and automated refill reminder calls and texts.
Medication and prescription programme problems in healthcare
Essentially revenue-driven business models, auto-refill prescription programmes are responding to outdated incentives promoted by the U.S. government. None of these programmes are measured on the health outcomes they should generate if patients were actually taking these medications properly.
The Centers for Medicare and Medicaid Services (CMS) drives the proliferation of auto-refill prescription programmes as an adherence solution through its HEDIS and STARS quality measurement programmes, using an estimate of adherence called Proportion of Days Covered (PDC). PDC looks at a patient’s total medication received and essentially measures the refill rate as a proxy for a patient's medication adherence. CMS adopted PDC when the agency did not yet have the technology to measure medication adherence directly. The organisations that created these indirect measures, the National Committee for Quality Assurance (NCQA) and Pharmacy Quality Alliance (PQA), are now modernising these standards.
For years, we have had the technology to understand adherence through more direct methods, such as biological markers (like cholesterol levels for statins) or even directly observed therapy. While every dose of medication given to a patient in a hospital is dispensed under direct observation, the gold standard for adherence has only been achieved in the outpatient setting for situations where public health is at risk (tuberculosis is an example). But technological innovations have now made direct measurements feasible. So why are we still relying on using PDC as a proxy for medication adherence?
The medication supply chain and wasted medications
Frankly, it's lucrative for the entire medication supply chain, and it's painfully clear that revenues and not patient care are prioritised. PDC creates no incentive to ensure that patients take their medications, and it is well-documented that more than 40% of medications for chronic conditions are not taken at all. This generates artificial demand, which drives up prescription costs for patients and health plans who are paying for unnecessary medications. Drug manufacturers, wholesalers, and pharmacies all enjoy the spoils of massive volumes of wasted medications.
In response, state Medicaid programmes in Minnesota and California have banned or restricted auto-refill programmes for mail and retail pharmacies. Regulators correctly argue that auto-refill programmes contribute to medication waste and stockpiling.
In fact, millions of pounds of prescription medications go unused each year in the USA, and many patients have ample supplies of "leftover" medications. These extra stores can promote antibiotic resistance, lead to environmental pollution, contribute to medication confusion, and in the case of controlled substances, endanger other members of the household. Programmes to “take-back” unused medication have recovered more than US$100mn at a time in unused medications.
So how do we fix this? One solution is investing in programmes and technologies that actually solve the problem. These are programmes that provide high-touch, frequent medication management, ensure the patient has the correct medications, is taking them correctly, and provide data on barriers to adherence such as side effects, adverse events, and social determinants of health. Armed with such data, providers and health plans can deliver prompt interventions to prevent emergency room visits, hospitalisations and death.
Studies in sickle cell disease, asthma, tuberculosis, organ transplant, hepatitis C, and other chronic and infectious conditions show that technology has advanced to make timely outpatient direct adherence measurement and adherence support possible. They also show that adherence rates improve by engaging patients on a near-daily basis. This should come as no surprise - medications actually work when taken every day!
To meaningfully impact medication adherence rates and improve health outcomes, CMS, NCQA, and PQA should implement modern, direct adherence measures. Archaic proxies such as PDC ramp up drug costs, waste life-saving medications, and pose a risk to others. Continuing to push refills without understanding how patients are actually doing is irresponsible, and we can do better.
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