The Benefits of REMS Standardization and Multidimensional Communication Health Care Systems

You are a specialty pharmacist verifying a prescription for one of your patients. Sometimes you receive faxed prescriptions or the rare verbal order, but this current prescription was received electronically.

This is no surprise to you, since the majority of the prescriptions that you dispense are received electronically. After all, e-prescribing (eRx) is the primary mode for prescription submission these days, accounting for 1.7 billion prescriptions in 2017.

As part of the verification process, you check the standard prescription components for accuracy, such as patient demographics, secondary identifiers, strength, dosage form, directions, quantity, and refills. The prescribed medication and dose seem to be correct based on the patient’s indication.

As a specialty pharmacist, you are aware that the medication you are about to verify has additional safety requirements. You check the directions and comment fields on the eRx to see if the prescriber free-texted the information, but unfortunately there is nothing to be found.

You pick up the phone and make an outbound call to the prescriber’s office and wait on hold until you are finally transferred to the right department. The receptionist asks if you would be willing to leave a message for the prescriber, so you leave your request and put the prescription aside for future follow-up.

Hopefully the prescriber returns your call soon so that you can finish dispensing the medication to the patient. Otherwise, you send a follow-up message within a day or so requesting the information again. In the meantime, you contact the patient and explain that there is a delay in their order. They are frustrated and don’t fully understand what the holdup is since we have a valid prescription from the prescriber.

This scenario might sound a bit exhausting to you, but it is a common occurrence in pharmacy practice these days—especially when it comes to Elements to Assure Safe Use (ETASU) and risk evaluation and mitigation strategies (REMS). ETASU and REMS requirements were derived from the FDA Amendments Act of 2007.

These requirements were a means to ensure that the benefits of a medication outweighed its risks for the patient. The goal of REMS is to inform patients and prescribers of these serious risks and to provide mitigation strategies for these risks.

It is the pharmacist’s responsibility to ensure that ETASU and REMS data are present and documented accordingly prior to dispensing of a patient’s prescription. If this information is missing or incomplete, a pharmacist is not authorized to dispense the prescription to the patient. The FDA describes ETASU as including 1 or more of the following:

• Health care providers who prescribe the drug have particular training or experience or are specially certified.
• Pharmacies, practitioners, or health care settings that dispense the drug are specially certified.
• The drug may be dispensed only to patients in certain health care settings, such as in hospitals or infusion centers.
• The drug is dispensed to patients with evidence or other documentation of safe-use conditions (for example, liver enzyme tests or pregnancy tests).
• Each patient using the drug may be subject to certain monitoring or each patient using the drug must be enrolled in a registry.

As you can imagine, it may be difficult for a specialty pharmacist to keep track of the different requirements for each drug product. However, compliance to these requirements is critical both for patient safety and for the pharmacy’s ability to continue to dispense the medication.

To aid with compliance, some pharmacy management systems have been technologically enhanced to ensure appropriate documentation of applicable requirements prior to dispense. Although this can help to standardize the documentation of ETASU and REMS requirements internally, the missing piece still lies within the lack of standardization across health care entities and the ability to communicate within a multi-dimensional system.

As the specialty pharmacy industry continues to quickly grow, more medications are being released with REMS requirements. At the time of writing, there are 74 products containing these requirements.

There has been an increased focus on the standardization of these requirements, beginning in 2011 with the creation of the FDA’s REMS Integration Initiative. The goals of the initiative are to “develop guidance on how to apply statutory criteria to determine when a REMS is required, improve standardization and assessment of REMS, and improve the integration of REMS into the existing and evolving health care system.”

The initiative focuses on the following 4 projects:

1) Benefit Risk Information—establishing best practices for counseling patients.

2) Prescriber Education—incorporation of continuing education into REMS programs.

3) Pharmacy Systems—Structured product labeling.

4) Practice Settings—Enhancement of REMS information repository.

Although the pharmacy systems project will aid in the formatting of REMS requirements, it does not solve for the lack of an integrated communication platform between health care providers. The ability to capture and transmit ETASU and REMS between prescribers, pharmacists, and manufacturer hubs would be a groundbreaking achievement for the pharmacy industry.

This functionality could greatly enhance the efficiency, organization, and compliance across the health care organization. I believe this topic will continue to be a focal point for the health care industry over the next several years.

Currently, some vendors offer REMS data collection services, such as Cardinal Health and Pharmaceutical Product Development. Although an integrated system capable of multidimensional communication between providers has yet to emerge.

Some ideas are promising, such as transmission of REMS data through electronic prescribing or claim submission through the REMS administrator, similar to completing an online claim adjudication. But again, this functionality will not support the communication needs previously outlined.

A foreseeable challenge to implementation of such a program would be the lack of standardization and uniformity surrounding the current REMS programs for today’s drug products. The range of requirements is wide, and the mode for collecting the requirements also differ. For example, some manufacturers require information to be obtained via phone while others offer a web portal.

The information documented also ranges from prescriber and patient identification numbers to dispense authorization numbers. Depending on the program, some identification numbers remain the same for each prescriber and patient, while others change with each dispense. If the desired technology is developed, it will need to account for these varying requirements.

Successful creation of this technology would be beneficial to specialty pharmacies in many ways. First, it will offer a standardized formatting for viewing and collecting REMS data. Second, it will aid in systematic efforts to prevent the dispensing of products prior to ensuring that all requirements have been fulfilled.

Most specific to the technology I have described, it will allow for communication between the pharmacy, prescriber, and manufacturer hub. Let’s revisit our earlier scenario. If this type of communication was available, there are a variety of ways in which the situation may have played out.

• Situation 1: The prescriber attempts to send the electronic prescription to the pharmacy without the required REMS information. An alert is received communicating the missing information to the prescriber. The prescriber gathers the required information, enters it into the e-prescribing software, and successfully submits the prescription to the pharmacy.
• Situation 2: The pharmacist notices incomplete REMS information received on the prescription. In a few simple clicks, they can send the prescription back to the prescriber with a note of the clarification required. They can also send this information to the manufacturer hub, if necessary, for status updates on the order.
• Situation 3: The prescriber sends the prescription electronically with the required REMS information. The specialty pharmacist verifies the prescription after confirming accuracy of prescribing information and documentation of REMS information. Unfortunately, a prior authorization is required. If the manufacturer has a bridge supply or starter supply program, with a single click the pharmacy can send the pending prior authorization status to the manufacturer hub indicating the possible need for an interim patient supply.
• Situation 4: The prescriber sends the prescription electronically with the required REMS information. The specialty pharmacist verifies the prescription after confirming accuracy of prescribing information and documentation of REMS information. With a click, the pharmacy can send a status update to the manufacturer HUB indicating the receipt of a completed prescription.

As you can see, there are many possibilities that could be created with the interfacing of these health care systems. Although there are technological advances happening today with respect to electronic medical records, such as creating interfaces between providers, this functionality is not yet developed for communication between prescribers, manufacturer hubs, and pharmacies.

In a world of digital convenience and electronic benefits, we could expect to see this functionality present in some form over the next several years. With this technology interface, the health care system could experience enhanced communication, efficiency, and regulatory compliance, which makes patient safety the ultimate benefit.

About the Author

Michelle Byrne earned her Doctor of Pharmacy degree from Duquesne University and earned her Master of Science in Pharmacy Business Administration (MSPBA) program 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. Michelle has worked in the specialty pharmacy industry for the past 9 years, starting as a clinical pharmacist and working in leadership roles within her organization. Michelle’s current role is Pharmacy Manager, Quality & Regulatory and Pharmacist-in-Charge for her site within the Specialty Operations division of her organization.