Article
Although specialty pharmacy has mirrored health care IT’s explosive growth and market innovation over the past several decades, the industry has not advanced significantly in dispensing software.
Information technology (IT) has revolutionized the health care industry, allowing pharmacy services to expand dramatically over the past 30 years. Virtual dispensing platforms have improved efficiency and patient outcomes; automated prescription dispensing robots cut the time to fill scripts and improve accuracy of fills; pharmacy applications connect patients with their health care in ways that improve treatment engagement and adherence—the list can go on and on.
Patients can meet with their health care providers virtually and predictive analytics have helped providers get drugs into the hands of patients who need them the most. The world of health care IT has revolutionized how we experience health care, and it will continue to do so well into the future.
The specialty pharmacy market has experienced a similar transformation over the past few decades, beginning from a single pharmacy supporting dispensing of transplant medications to becoming one of the fastest growing market sectors in all of health care. The number of drugs receiving orphan disease state indications has exploded since the Orphan Drug Act of 1983 was passed and there are thousands of drugs expected to receive similar approvals over the next 30 years.
Specialty pharmacies have revolutionized patient care in many ways. They have developed ironclad patient service models that are tailored to fit specific patient and manufacturer needs. Patients can receive unparalleled support throughout their treatment from pharmacies specializing in a certain disease’s medications, and there is no doubt that specialty pharmacy is here to stay.
Before specialty pharmacies can dispense these medications, they must reach a contractual agreement with the respective manufacturers. These partnerships can be labeled as “exclusive,” “semi-exclusive,” or “limited” distribution, depending on the number of specialty pharmacies a manufacturer partners with.1
Manufacturers may choose to establish these relationships due to the intricacies of drug administration, transportation, or cost, for example. The term used to classify these types of medications is “specialty drug.” The National Association of Specialty Pharmacy defines a specialty drug as “more complex than most prescription medications and are used to treat patients with serious and often life threatening conditions…the complexity of these medications may be due to the drug itself, the way it is administered, the management of its side effect profile, the disease or condition it is used to treat, special access conditions required by the manufacturer, payer authorization or benefit requirements, patient financial hardship, or any combination of these.”2
Manufacturers are likely to elect some variation of limited distribution because it allows them to control how their product is distributed—and the patient experience associated with it. The partnership between manufacturers and specialty pharmacies has certainly evolved since the inception of the first specialty pharmacy model in the early 1990s.3
At that time, paperwork for high-cost, high-maintenance drugs was a new concept and proved to be a challenge for patients from a health literacy and time sensitivity standpoint. For example, patients who required immediate access to immunosuppression to prevent organ rejection may have had difficulty knowing precise doses based on drug levels or insurance information for coverage of the cost.
These difficulties may have resulted in delay of care, poor patient experiences, and life-threatening patient outcomes. Specialty pharmacies took notice and began to offer services to complete the paperwork in a timely fashion, with the clinical expertise, and familiarity of the paper forms.3
One effort towards gaining efficiency in the specialty pharmacy exists in dispensing of the medications themselves. Currently, many specialty drugs require dose titration or escalation to reach the desired efficacy.
To communicate these adjustments, the pharmacist must enter duplicate prescriptions, verify duplicate orders, and dispense multiple medication vials that appear the same based on the manufacturer’s instructions. The format is cumbersome and not intuitive for the patient to understand, which leads to additional adherence outreach and excessive telephone communication.
Furthermore, superfluous steps introduce room for error, which is a patient safety risk. The Institute for Safe Medication Practices (ISMP) reported in May of 2021, labeling- and packaging-related medication events are one of the most frequently reported errors reported.1 They go on to discuss, “most of these reports are associated with the immediate container label or carton label, rather than the official product labeling or packing.”1
To mitigate this risk and improve the process, manufacturers may consider optimizing drug packaging by consulting with health care clinicians, such as specialty pharmacists, prior to drug launch. A well-designed preset titration package (such as a Z-Pak) can eliminate process inefficiencies through reducing prescription count and the need for patient adherence phone calls. Through this collaboration, pharmacists and manufacturers could also improve digital marketing/patient education to aid in the communication of instruction, compliance, and monitoring.
The manual process of paperwork input can be labor intensive due to the importance of ensuring accuracy and up-to-date patient information. If information provided on the manufacturer treatment forms is difficult to interpret, illegible, missing, or incorrect, the pharmacist must reach out to the patient, representative, or provider to clarify.
The additional time required to complete this task is an inefficient utilization of resources. Not only does this take time away from the pharmacy’s workflow, but also delays time to the patient’s receipt of the drug by days or weeks.
Because the current process demands rework and duplication of efforts, it would be mutually beneficial to establish a solution. A potential area for improvement may be within manufacturer and specialty pharmacy communication.
Rather than a manufacturer independently developing new patient treatment forms independent of any feedback from their limited distribution specialty pharmacy partners, there should be collaboration with the specialty pharmacy and manufacturer in the development of the paperwork prior to launch of the new drug. Furthermore, such forms could be designed to integrate or align with the specialty pharmacy’s software, thereby streamlining the process. The required information would be collected upfront, and the system could be completely digitalized.
Although specialty pharmacy has mirrored health care IT’s explosive growth and market innovation over the past several decades with the adoption of various IT solutions, the industry has not advanced significantly in dispensing software. Although it is true that many pharmacies possess up to date and often proprietary patient service software platforms that help drive patient and prescriber outreach, insurance investigation and verification, and a host of other services surrounding specialty patient therapy, the programs responsible for actually setting up and filling specialty drug prescriptions is often outdated, not owned and operated in house, and designed for purposes other than specialty pharmacy.
Examples of commonly used dispensing software in specialty pharmacy are RX30, which was launched in 1977 for retail pharmacies, RXhome, launched in 1989 to support hospital drug dispensing, and CPR+, launched in the mid 1990s to support hospital pharmacies. Although each of these software systems can successfully support specialty pharmacy dispensing activities, several issues exist with the software as they relate to specialty pharmacy.
The first issue is that the software is old. Specialty pharmacies typically use various software applications for various reasons and old dispensing software does not integrate well with them in most cases.Improper integration can lead to various process redundancies as issues arise from improper information transfers between applications.
For example, data reporting from pharmacies to manufacturing clients is ubiquitous and extremely important. Many manufacturers will levy billing penalties on pharmacies if their report accuracy falls below certain contractually mandated levels.
Reporting errors can exist due to improper dispensing software integration with data reporting applications, requiring dedicated data quality control processes, report restatements, and potentially causing accuracy rates to fall, resulting in those aforementioned billing penalties. Old software applications will only get worse with integration as health care IT solutions grow more modern and advanced. Additionally, the developers can discontinue their support of these older dispensing platforms, just as Windows or Apple may choose to no longer support various older versions of operating systems.
Another important issue is that these dispensing platforms were developed for hospital or retail pharmacies and not specialty pharmacies. Because of this, pharmacy staff usually have to work around the software instead of with the software to carry out daily tasks. The software is not designed for specialty pharmacy needs.
Simply taking a verbal prescription from the prescriber and entering it into these systems can become a 20-plus step task that is fraught with potential areas to create mistakes. Data entry error rates can become unacceptably high as too much time is spent inputting prescriptions.
Correcting these errors costs SPs extra time and can lead to a higher rate of medication errors making it through to the patient. Other issues that arise can include commonly prescribed specialty medication titrations needing to be entered as multiple separate prescriptions, requiring pharmacist verification for each prescription, or multiple tabs being required to check each detail of a prescription instead of aggregating every detail on the same page to improve workflow. Specialty pharmacies simply have to work around the obstacles that these systems present.
Finally, these old dispensing software platforms are expensive. Subscription fees to connect employees with these platforms are expensive.
Every employee that that is connected to these platforms can cost specialty pharmacies thousands of dollars per year. Specialty pharmacy is growing rapidly, adding to the overall cost of these subscription fees. This cost and the costs created by process redundancy and inefficiency will increase as increased volume puts an additional strain on existing dispensing software systems.
Despite the explosive advancement of both specialty pharmacy and health care IT, there is still a glaring unmet IT need in specialty pharmacy for dispensing software. Specialty pharmacy stakeholders realize this, but can do very little to affect change.
Software developers have yet to create modern efficient dispensing platforms specifically for specialty pharmacy. Some specialty pharmacies that are large enough in size have turned in house to develop their own proprietary dispensing platforms that they own and can change at any time to fit their evolving needs.
They can also market their system to other pharmacies to create an additional revenue stream. Those pharmacies that address this issue can gain a leg up on their competition and finally this puzzling gap between the fast-growing specialty pharmacy and health care IT markets can be bridged.
About the Authors
Daniel Paul earned his Bachelor of Science in Biology from Allegheny College and his Doctor of Pharmacy degree from Duquesne University in Pittsburgh. He is currently earning a Master of Pharmacy Business Administration (MPBA) at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Dan has spent the last 2.5 years working in Specialty Pharmacy, initially as a clinical pharmacist and most recently as the Manager of Pharmacy Operations.
Mackenzie Goltz (Magid) earned her Doctor of Pharmacy degree from The University of Kansas and her Master of Pharmacy Business Administration (MPBA) degree at the University of Pittsburgh School of Pharmacy/Joseph M. Katz Graduate School of Business, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Mackenzie completed a PGY1 Pharmacy Residency and PGY2 Solid Organ Transplant Pharmacy Residency at Duke University Hospital, where she currently practices as a clinical pharmacist.
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