Greater patient input into drug product design could significantly improve outcomes and save health systems millions, by reducing medication-related errors and unnecessary hospitalisations. This was the take-away message of a talk by Professor Sven Stegemann of the Technical University of Graz, Austria, delivered to Semalytix employees on July 8. Prof. Stegemann is professor for patient-centric drug design and has a long history working for pharmaceutical companies in drug development and manufacturing.
The message resonates particularly loudly during today’s COVID-19 pandemic. The crisis has stretched many healthcare providers to the limit and compelled more patients – especially elderly patients - to stay at home and attempt to manage their medications alone for long periods, with little or no physician support.
As populations age, more people are having to manage not just one, but multiple chronic diseases. This means they must remember to take several different medications each day, often at different times, with or between meals. “In the last twenty years, the prevalence of poly-pharmacy – the need to take more than five drugs per day, and often up to 12 or more – has risen to 70% among over-60 year olds,” Prof. Stegemann pointed out.
With that rise has come an increase in medication errors, contributing to the approximately 39% of hospital emergency room visits considered to be avoidable. Over-burdened patients struggle to take the right drug at the right time, faced with hard-to-open pillboxes, illegible package-inserts and a range of virtually indistinguishable white tablets that are difficult to handle, and which may even need to be cut in half. Sometimes, patients simply give up, or just take the one or two tablets that they immediately recognise. “Most medication errors happen at the patient level, and are both predictable, and preventable,” Stegemann said.
Better designed, more user-friendly products could address many of these medication errors. “There are lots of small, relatively simple changes that can be made” to tablet, blister-pack and pill-box design, he said, which has barely moved on at all since the 1950s – unlike almost any other consumer product.
Listening to patients and observing how they actually take their medicines in the home-setting - the kind of real-world research that Prof. Stegemann and his team are engaged in - can help identify many of those changes. (Asking patients what they want isn’t enough: many don’t know, won’t say, or won’t acknowledge that they are struggling.) “Patient-centric design is really important,” stressed Stegemann.
The science and technology that drives drug development must, in the final product, be melded with psycho-social considerations that reflect how humans actually behave. We are all driven to reduce physical and cognitive demand – to keep our lives as simple as possible. So, as patients, we want pill-taking to be easy. Taking medicines has to be manageable in order to be effective, with as few ‘dosing moments’ as possible during the course of the day.
The challenge is that drugs are developed for a single disease, not to be taken as part of a cocktail of therapies. Dosing regimens are calculated to ensure optimal pharmaco-kinetics, not to fit around lunch. Coordinating pill size and dosages across multiple manufacturers around the globe would be difficult.
But a more effective compromise between scientific rigor and meeting patient expectations is entirely feasible. It requires more real-world research into the needs, expectations and behaviours of different patient groups, and perhaps some coordinated guidance around testing product usability and acceptability in home-settings. The toughest part, perhaps, is that it demands that scientists and drug developers – accustomed to dealing with complexity – actually keep things simple.
Patient-centric product design isn’t the sole solution to medication errors, Stegemann cautioned. But it is an important contributor – and one that has been largely overlooked, despite the pharmaceutical industry’s vocal attempts to achieve greater patient-centricity. (Only about a third of patients can actually read package inserts on their medicines).
As regulators continue to push for more patient-focused drug development – FDA guidelines are expected next year – the time is ripe to involve patients to a much greater extent in determining what medicines look and feel like, and how they are taken. This must begin to happen at the very early stages of determining product profile. “Pharmaceutical firms must think, early on, about what kind of patients they will have, and what that means” for their product design, Stegemann told the Semalytix employees. “Target product profiles should extend to include target patient profiles.”