Anthony Schueth, MS

The transition in specialty pharmacy from traditional prescription ordering processes to e-prescribing brings challenges and benefits.

Health information technology is a catalyst to transform the ways in which health care is provided and compensated. Electronic prescribing (e-prescribing) is an integral part of that transformation, with nearly 80% of ambulatory physicians sending prescriptions electronically and nearly all pharmacies wired to accept them, according to Surescripts’ National Progress Report.

Although this successful transformation of prescriptions from paper, phone, and fax to e-prescribing systems has taken place over the last decade in retail pharmacy, prescribers have been unable to electronically prescribe specialty medications.

A series of drivers and market forces are converging to facilitate wider adoption of e-prescribing for specialty medications, but this transition will present a much greater challenge than the switch to e-prescribing of traditional drugs.

Today, the e-prescribing ecosphere is built around the ambulatory prescribing of oral solids that are dispensed by retail or mail order pharmacies. Prescription drug eligibility is generally determined before the patient arrives at the provider’s office so that formulary and benefit information can be presented to the prescriber before drug selection. The prescriber is alerted if the selected medication interacts with another the patient is taking. The prescription is then transmitted to the pharmacy of the patient’s choice.

The National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard supports this environment in a profound way. E-prescribing functionality within the 700 e-prescribing-certified electronic health record (EHR) solutions is very good at facilitating the prescribing of traditional medications, and some are better than others when it comes to more complex medications. Nearly 40,000 chain and 21,000 independent pharmacies are able to receive prescriptions electronically, and this “many-to-many” scenario necessitates intermediaries, who are optimized for this environment.

As effective as e-prescribing is today, specialty medications require a different paradigm. Specialty medications tend to be higher-cost therapies that involve unusual or resource-intensive handling or dispensing processes (eg, cold/frozen shipping, adjunct supplies for injections). The majority require focused clinical management.

Because of all of this, specialty medications have traditionally been dispensed by pharmacies that are designed and organized specifically for the medication and therapy they dispense, including unique training for pharmacists and pharmacy staff. These pharmacies may vary by manufacturer or payer. The prescriber may not know which pharmacies are part of the limited distribution network for a given drug and may be unsure of where to send the prescription electronically.

The cost and complexity of these specialty medications often lead to an FDA-required risk evaluation and mitigation strategy (REMS). A REMS may be satisfied by the inclusion of additional patient education material, required additional certification of the prescriber and/or dispenser, ongoing patient monitoring, and/or a limit on the distribution of the medication. However, the prescriber is often not aware of these drug-specific requirements at the time of prescribing.

The prescriber may not be cognizant of implications stemming from the particulars of a patient’s situation, including their pharmacy benefit co-pay and coverage, their payer’s prior authorization (PA) requirements, and what, if any, financial assistance may be available to the patient. Because much of the information needed to make these determinations is not included in the NCPDP SCRIPT Standard, the vast majority of prescriptions for specialty medications are faxed to the pharmacy, often on a drug-specific intake form.

After receiving the faxed form, the pharmacy begins the process of identifying whether there is a REMS requirement, determining coverage, facilitating PA, and researching available patient financial assistance. The pharmacy will be in discussion with the patient, payer/pharmacy benefit manager (PBM), and other stakeholders, often requesting additional information from the prescriber and patient. The pharmacy spends a great deal of time faxing the payer or PBM, most of it in an effort to obtain PA. This process, supplemental to dispensing, can be involved. Manufacturers often offer assistance, either through a third party or within the manufacturer itself (a “hub”).

After dispensing, specialty pharmacies follow up with the patient, generally via telephone, to ensure there are no complications, monitor adherence and persistence, and, in some cases, confirm that the therapy is administered properly. All of this is expensive, time-consuming, and inefficient, and the manual nature serves as an opportunity for error and confusion.

Arguing that there must be a better way, some stakeholders have come together in standards development organizations and other forums to seek ways to leverage technology to ensure that patients are getting their therapies quickly.

The drivers and forces that make a compelling case for the inclusion of specialty e-prescribing in a mainstream health care process include:

According to a report in the Annals of Internal Medicine, patients’ medication nonadherence is a serious problem that results in approximately 100,000 unnecessary deaths and up to $290 billion annually for poor health outcomes, unnecessary hospitalizations, and disability.

According to studies by Surescripts, e-prescribing increases the rate at which patients receive their first fill and facilitates the refill and renewal processes.

 With the growing complexity of patients’ medical needs and medication use, there is an increased risk of errors and adverse drug events. E-prescribing can improve patient safety and quality of care by eliminating illegible prescriptions and transcription errors, reducing miscommunications, implementing warning and alert systems at the point of prescribing, and giving the provider access to the patient’s complete medication history.

 The government’s meaningful use (MU) incentive program for EHR adoption is reaching its third stage. Its carrot-and-stick approach offers incentive payments for providers to adopt EHRs and e-prescribing, and reduces the Medicare payments of those who do not meet participation thresholds. MU stage 3’s proposed e-prescribing threshold for 2018 will rise to 80% of eligible prescriptions for eligible providers.

E-prescribing for specialty medications is 1 way that providers that prescribe a preponderance of specialty medications can meet this threshold.

 According to a 2012 study by the Southeastern Michigan Beacon Community, retail pharmacies are estimated to annually incur $1.1 billion in labor costs in addressing prescription problems.

Although no similar research has been done for specialty pharmacies, it is clear they also incur enormous labor costs while providing their services. Receiving information electronically, including “clean” prescriptions with a prior authorization in place, will reduce the administrative burden that is currently on the specialty pharmacy.

 Specialty medications are a growing and significant part of the nation’s drug spend, which hit $374 billion in 2014, according to a new study from the IMS Institute for Healthcare Informatics. Major drivers included specialty medications to treat hepatitis C (with spending of $12.3 billion), plus therapies to treat cancer, autoimmune disorders, and multiple sclerosis (spending on which, in 2014, rose 16.8%, 24%, and 24.4%, respectively).

The ability of electronic data to support e-prescribing, clinical decision support, and administrative functions, such as benefit review and PA, will help all stakeholders monitor and control pharmaceutical spending and related costs. 

Recognizing the importance of this issue, NCPDP created the Specialty Requirements for ePrescribing Task Group. It follows the model of other NCPDP task groups that were created to address standards-related issues in e-prescribing, such as the special requirements involved in the prescription of controlled substances and in electronic prior authorization (ePA).

As a result of the work of the task group, NCPDP has published guidance to improve the use of fields supported in the currently used version of the SCRIPT Standard that would be of value to specialty pharmacies. The members of NCPDP recently voted to add a range of fields to the SCRIPT Standard to accommodate other information that will greatly enhance the utility and usability of specialty e-prescribing. These include agency and service information, which will allow the provider to indicate the preferred agency (eg, home health) and type of service; hospice indicator; intravenous medication administration information; additional patient demographic and clinical information; order-specific clinical information; and instructions related to delivery of the medication. 

Continuous efforts along these lines by the task group will help fill the gaps in the SCRIPT Standard relative to specialty prescribing. Additional stakeholder input is needed to ensure the emerging standard works for all parties involved in the prescribing and dispensing of specialty medications. For more information about becoming involved, visit www.ncpdp.org.

Some of the modifications that would be required for specialty prescribing include the ability to exchange clinical information, the availability of delivery/destination details on related supplies, and the ability to ensure that the specialty pharmacy can be easily identified. In light of these challenges, opportunities for improvement include:

 There are key pieces of clinical and administrative information that are currently supported by the SCRIPT Standard, yet not widely used. This makes it more difficult and costly to manage specialty medications throughout the continuum of care, affects costs and patient safety, and slows down administrative processes. Systematically adding the diagnosis to prescriptions would eliminate the need for manual entry by pharmacy staff, ensuring that drug-to-diagnosis dispensing is accurate and that the pharmacist has the appropriate clinical information to use when counseling these patient. Patient clinical data—including laboratory values, height, weight, and allergies&mdash;need to be passed to the pharmacy to improve safety. Patient contact information is important to coordinate delivery and clinical services, and to see if they can find ways to help offset the patient’s share of the medication cost. Insurance information is needed to determine eligibility and coverage/co-pay information. The status of a PA request (approved, denied, or pending) also is needed to facilitate the billing and delivery of the specialty medication. These are all elements that can be communicated via the NCPDP SCRIPT Standard today.

 Modifications to e-prescribing functionality in EHRs will be needed to accommodate specialty medications. These include allowing the prescriber to request and obtain PA, split order sets into individual prescriptions, and identify any REMS requirements. Not finding the specialty pharmacy in the e-prescribing work flow may cause delays in treatment initiation, resulting in patient dissatisfaction and additional work for the prescriber. Likewise, specialty pharmacies will need to accommodate the additional information included in the e-prescription and would be wise to standardize and automate other elements of specialty e-prescribing, such as adherence and patient engagement. Optimally, ePA would occur between provider and payer before the prescription is transmitted to the pharmacy. A current challenge is the prescribers’ lack of understanding of PA requirements and other coverage parameters. Work has begun in this arena and needs to be completed. The industry might also consider a work flow where the specialty pharmacies or hubs would request PA on behalf of the patient, a task that is often handled (manually) today.

E-prescribing for specialty medications is evolving of its own volition, yet there are steps that stakeholders can take to accelerate the process, ensuring the evolution is optimally beneficial to the industry. Making e-prescribing for specialty medications a priority for Medicare and Medicaid will drive the entire industry. Both populations will increasingly use specialty medications, which will significantly raise each program’s drug spend. Making e-prescribing for specialty medications a mandatory requirement for Medicare Part D and Medicaid can help reduce costs as well as help track expenditures, improve outcomes, and mitigate safety issues. Past experience has shown that when Medicare and Medicaid implement policy changes, those are often adopted by the private sector. Use of e-prescribing for specialty medications should be the norm for all patients.

Additional work by standards developers and vendors will create needed infrastructure modifications and enhancements. Prescribers and pharmacies need to understand the value proposition for specialty e-prescribing, such as better work flow, reduced overhead, and improved quality of care and patient safety.

The time is right to convert the inefficient paper/phone/fax-based processes for ordering specialty medications to e-prescribing. Although current e-prescribing systems will need to be modified to accommodate the differences in specialty prescribing, the way has been paved. Current systems, standards, and infrastructure can go a long way toward jump-starting e-prescribing of specialty medications. The time is right, and it is the right thing to do. 

		2014 national progress report: more connected than ever before. Surescripts website. http://surescripts.com/docs/default-source/national-progress-reports/surescripts-2014-national-progress-report.pdf. Published 2014.

		Viswanathan M, Golin CE, Jones CD, et al. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. 

		Study: e-prescribing shown to improve outcomes and save healthcare system billions of dollars [press release]. Arlington, VA: Surescripts; February 1, 2012. http://surescripts.com/news-center/press-releases/!content/212_eprescribing.

		Myers E. CMS meaningful use proposed rules overview. Centers for Medicare & Medicaid Services website. www.cms.gov/eHealth/downloads/Webinar_eHealth_May5_MUProposedRules-.pdf. Published May 5, 2015.

		Taylor TN, Lewis NJW, Mac A. Frequency of prescription problems requiring pharmacy—prescriber interactions: a pilot study. Point-of-Care Partners website. www.pocp.com/PDF/prescribing-issues-study-sembc.pdf. Published April 30, 2012.

		IMS Institute for Healthcare Informatics. Medicines use and spending shifts: a review of the use of medicines in the US in 2014. April 2015.

, is managing partner and CEO of Point-of-Care Partners, LLC. He is a coleader of the National Council for Prescription Drug Programs (NCPDP) Specialty ePrescribing Task Group and leads the NCPDP Electronic Prior Authorization Task Group.

 is president, Granada Health, LLC. She is a co-leader of the NCPDP Specialty ePrescribing Task Group.

, is vice president, professional practice and pharmacy policy, at Optum Rx.

Anthony Schueth, MS

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