Data Standardization Crucial to Success of Specialty Pharmacy

Measures to standardize specialty pharmacy data should be put in place to improve the industry.

Much like data gathered from a traditional retail pharmacy, data from specialty pharmacies are valuable to health care stakeholders. While the retail side of the industry has had significantly longer to perfect their data aggregation process, the specialty side has been lacking.

Traditional pharmacy data generally focuses on the product itself, including the pharmacy that purchased the drug, when they re-ordered it, and payer information. Specialty pharmacy data differs largely due to various software platforms and complicated disease states.

Order forms for specialty pharmacies are more likely to include patient information, who their physician is, the physician’s specialty, and information related to diagnosis. These forms also generally include dosage information regarding how much, and how often the drug is to be administered, in addition to which formulation the patient is to take the drug in.

Other significant information is gathered through patient-pharmacist interaction either at the pharmacy or over the phone. Through free text or check-off boxes, the pharmacist is able to document conversations with the patient and any concerns that were raised. This information is usually sent back to the physician’s office, which provides the benefit of continuous feedback and collaboration among providers.

Due to the growing importance of pharmacists in disease management, this constant communication between pharmacists and other health care providers has proven beneficial.

During conversations with patients, pharmacists may record adverse events in their software platform, which are then transmitted to the manufacturer. If the manufacturer is flooded with reports of this event, they may choose to update the safety warnings so that other patients are aware of the risks associated with a specific drug.

Patient adherence is another significant area that is affected by specialty pharmacy data. For example, if a pharmacist calls to inform the patient that they should pick up their refill, but the patient is not running low, the pharmacist can speculate that this particular patient has not been adherent to their treatment. The pharmacist can then investigate the issue, and make suggestions to improve adherence. Certain pharmacies even receive financial incentives from manufacturers to keep their patients adherent to treatments, since nonadherence can result in thousands of dollars wasted.

There is also much more involvement with insurance companies on the specialty side. While insurance companies occasionally limit the use of branded drugs when a generic is available, it happens less often now than it used to. On the other hand, a majority of prescriptions filled at a specialty pharmacy have prior authorization or step therapy requirements, which leads to more data that must be decoded.

A crucial difference between traditional and specialty pharmacies in terms of data is how they are gathered. Specialty pharmacies usually send their information to data aggregators, who then make sense of the information transmitted. Meanwhile, retail pharmacies typically do not have data aggregators involved since their data are already largely standardized.

“What’s different in data gathering than traditional pharmacies, is you get real-time or more frequent time around what the behaviors of a particular product in terms of insurance of payer acceptance,” Dan Steiber, RPh, editor-in-chief of Specialty Pharmacy Times.

Immediacy of data is crucial for manufacturers, since certain specialty products may require post-approval marketing surveillance, where the manufacturer must report data to the FDA to ensure there are no concerns with efficacy or safety. These products may require collaborative monitoring between health care providers that is then consolidated, sent to the manufacturer, and passed on to the FDA.

“Even though a drug gets approved with a higher side effect profile, there’s a checks and balances system driven by specialty pharmacy data that the manufacturer gathers,” Steiber said. “If they see any anomalies, they have to report it to the FDA and tweak what the overall processes are.”

Although specialty pharmacy data are significant and provides many benefits, it is largely unstandardized, which is where data aggregators come into play. These aggregators make sense of data sets coming in from different pharmacies for different drugs that treat different diseases. Even within the same disease state, processes and treatments vary greatly, which reinforces the need for standardized data.

Specialty pharmacies tend to operate off of 2 or more different software platforms that encompasses patient management and drug dispensing. This provides a barrier for standardization since data being reported by the platforms is unstandardized, and requires the assistance of an aggregator.

Although technology has advanced greatly, specialty pharmacy platforms must be standardized to allow for variability for the pharmacy, but provide clinically meaningful data for the manufacturer. However, stakeholders have been slow to collaborate to form standards for specialty data.

Besides pharmaceutical companies, specialty pharmacies, payers, and aggregators, prescribers must be included in the standardization process. If the newly-created standard process proves to be a lot of heavily lifting for the physician, they may shy away from that specific product and prescribe a competing drug.

“What we are advocates of at Specialty Pharmacy Times is looking at creating efficiencies that will improve patient outcomes in the system,” Steiber said. “We are more than willing to be advocates to enable the different stakeholders to collectively come up with some other processes there.”

Not only will standardized data benefit the industry and provide stakeholders with valuable information without needing to translate it, patients will benefit as well. Implementing a feedback loop into data will allow pharmacists to continuously improve the quality of care they are providing. This may involve suggesting patients take a medication at a certain time due to new clinical evidence that may help patients improve their overall health.

Additionally, if patients are experiencing improved health quicker due to standardization, this will likely lead to reduced costs due to mitigated adverse events. It may also prevent patients from requiring drug therapy for certain conditions if it is properly managed.

“Rather than putting resources, and energy in having to reformat information because standards don’t exist, Specialty Pharmacy Times believes that there’s a need to bring the different stakeholders in an open information sharing environment to discuss where the gaps are. We are in the process of leveraging our resources as SPT, to create more awareness and to bring these various stakeholders together though live meetings, video events, round table discussions supported by print and multimedia venues. At the upcoming Asembia conference, we will be holding an accredited educational session covering the topic also,” Steiber concluded. “We believe that process will yield some efficiencies. Standards tend to take a long time to develop, and tends to be a very collaborative process. That way when they finally come out, the overall groups are aligned. That could take months or years, but if as a group we are aligning around best practices, we might be able to shorten that cycle.”