Pharmaceutical Industry Faces Tougher Quality Validation Expectations

| URAC Staff
Architectural drawings

While ill-chosen ground was the biggest culprit, flawed measuring only made Italy’s famous Leaning Tower of Pisa worse. Early in the construction, when builders noticed the tower wasn’t holding level, they tried to compensate by shortening supports on one side. Their failure to adequately measure the size and weight of the altered building materials inadvertently sped the leaning.

Builders, system designers and other professionals have learned a lot since then about the importance of quality, research and measurement in any endeavor. Pharmacies are by no means an exception. In fact, the market and regulatory landscape is putting increasing pressure on them to demonstrate these qualities, says Marybeth Farquhar, PhD, MSN, RN, vice president of quality, research & measurement at URAC.

“Everyone is talking about quality, and that includes the pharmacy space,” she says. “Right now, I think that a lot of the pharmacies have not been subject to the quality checks available for them to determine whether they are adding value to the system, or whether they aren't,” Farquhar explains.

With federal healthcare spending moving toward a value-based model as opposed to volume measures, “they want to see the value for the dollar that they're spending,” according to Farquhar. That new demand means “pharmacies are going to have to be able to show that they, indeed, are high quality organizations, and that they do add value to the customer experience,” she says.

Pharmacy Benefit Management (PBM) administrators are applying additional pressure on pharmacies, Farquhar says, “by requiring pharmacies to provide information about their quality. They're asking for a show of quality by attaining accreditation in some instances, particularly specialty pharmacy.”

Regulators and the broader marketplace are beginning to demand a higher level of data measurement integrity, says Eleni Theodoropoulos, director of quality & measurement at URAC.  She leads URAC’s Measures Advisory & Research Group – a multi-disciplinary team of external stakeholders that evaluates new measures for introduction, inclusion, or retirement for 10 of URAC’s accreditation programs. 

Up to now, many of those measures have been made with what Theodoropoulos calls “the honor system.” However, that might not cut it anymore. The data validation component is a way to have an independent party evaluate the accuracy of each measure, and the effectiveness for each organization within each of those particular measures, according to Theodoropoulos.

For example, when looking at a specific drug class, or a specific medication adherence measure, “you're looking at how well they're performing,  and by adding in the validation component, an independent evaluator would confirm that these measures are constructed properly, reported accurately, and are meeting all the requirements of the measures so they can be compared against their competitors appropriately,” she says.

New measurement requirements demand new ways of measuring, Theodoropoulos says. Sometimes, it boils down to common sense, e.g. making sure that you're measuring the correct thing. That said, it’s not always as easy to do as it may sound.

“If you're looking at a specific drug class, you need only look at that drug class – you’re not necessarily going outside of those bounds, Theodoropoulos says. “Understanding what it is you're trying to measure, and what it is you're trying to accomplish with that measure is very helpful.” Otherwise, minutiae takes over and data analysts “start splitting these proverbial, theoretical hairs that are just way off base,” she explains.

Don’t assume the original data is accurate either, cautions Farquhar. Too often, those inputting data will enter in numbers that don't make sense at even a casual glance. “They should be able to recognize the fact that, ‘oh we juxtaposed a number’, or ‘we got a negative result and that shouldn't be’,” she says.

“If you can’t measure it, you can’t improve it,” Farquhar says.

URAC’s quality, research and measurement team will run a one-day workshop, Mastering Pharmacy Quality Measures, in Washington, D.C., that goes into the details of pharmacy measures on March 27, 2019. The workshop will be followed by a two-day URAC Pharmacy Accreditation Standards workshop on March 28-29, 2019.

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