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Readers Write: Why EHRs Will Have Different Documentation Requirements for Biosimilar Dispensing, Administration, and Outcomes

July 11, 2016 Readers Write No Comments

Why EHRs Will Have Different Documentation Requirements for Biosimilar Dispensing, Administration, and Outcomes
By Tony Schueth


While a second biosimilar recently being approved in the United States does not a tsunami make, biosimilars are nonetheless expected to quickly become mainstream. In response, stakeholders are beginning to work on how to make them safe and useful within the parameters of today’s healthcare system because, biosimilars – like biologics – are made from living organisms, which makes them very different from today’s conventional drugs.

In fact, biosimilars are separated into two categories: biosimilars and interchangeables, both of which are treated differently from a regulatory standpoint. These differences will create challenges and opportunities in how they are integrated in electronic health records (EHRs) and user workflows as well as how patient safety may be improved.

EHRs must treat biosimilars differently than generics. As a result, EHR system vendors will need to make significant changes to accommodate the unique aspects of biosimilar dispensing, administration and outcomes.

Patient safety is a priority for development and use of all medicines. Manufacturers must provide safety assessments and risk management plans as part of the drug approval process by the Food and Drug Administration (FDA). Even so, biologics and biosimilars are associated with additional safety considerations because they are complex medicines made from living organisms. Even small changes during manufacturing can create unforeseen changes in biological composition of the resulting drug. These, in turn, have implications for treatment, safety, and outcomes. In order to address these issues, information about what was prescribed, administered, and outcomes must be documented in the patient’s medical record.

Substitution also is an issue because dispensed drugs may be very different than what was prescribed. As a result, it is important for physicians to know whether a substitution has been made and capture information about the drug that was administered in the patient’s medical record, especially when it comes to biologics and biosimilars. This is important for treatment and follow-up care, as well as in cases where an adverse event (AE) or patient outcome occurs later on.

Four drivers make the unique documentation requirements of biosimilars in EHR a priority.

  1. Utilization is expected to grow rapidly because of biosimilars’ lower-cost treatment for such chronic diseases as cancer and rheumatoid arthritis. It is easy to envision the availability of four biosimilars each for 20 reference products that could be available in 2020, given projected market expansions. That amounts to 100 biologics that will need to be addressed separately. As more biosimilars are approved and enter the market, it will become increasingly challenging and important to accurately identify and distinguish the source of the adverse events (AEs) from a biosimilar, its reference biologic, and other biosimilars.
  2. Physicians will need this information once biosimilars come on line and their use becomes widespread. Adverse complications — particularly immunologic reactions caused by formation of anti-drug antibodies – may occur at much later after the drug was administered. Physicians report more than a third of adverse events to the FDA, but need to know what was administered to the patient when the pharmacist performs a biosimilar substitution.
  3. Outcomes tracking and patient safety are growing priorities in healthcare. They are key pieces of the move toward value-based reimbursement and are a focus of public and private payers. Identifying, tracking, and reporting adverse events are expected to become key metrics for assessing care quality and pay-for-performance incentives.
  4. States are ahead of the curve when it comes to substitution. More than 30 are considering or have enacted substitution legislation for biosimilars, which creates urgency in how such information is captured and documented in EHRs. Some states require the pharmacy to communicate dispensing data to the prescriber’s EHR.

Because of the unique properties of biosimilar dispensing, administration and outcomes, many adjustments will be needed for documentation into EHRs used by physician offices in independent practices and integrated delivery systems (IDS). For example:

  • EHRs must be able to comprehensively record data on what was administered or dispensed for an individual patient, as well as what was prescribed. Modifications will be needed for tracking adverse event reports in various administration locations, including the physician’s office; an affiliated entity (e.g., practice infusion center); the patient’s home; or non-network providers.
  • Changes in drug data compendia will be needed to account for new naming conventions that soon will be put in place by the FDA and substitution equivalency.
  • Tracking the manufacturer and lot or batch numbers (similar to vaccine administration) can facilitate more accurate tracing of an AE back to the biologic. Fields will need be added to record the NDC code, manufacturer, and lot number of biosimilars that have been dispensed. 
  • NCPDP SCRIPT’s Medication History and RxFill transactions — already available for electronic prescribing in EHRs— can include the NDC and the recently added manufacturer and lot number as part of the notification to the prescriber. Although not widely used today, RxFill provides a compelling method to notify providers that a substitution occurred in the pharmacy.
  • EHRs will need to address barriers related to the use of biosimilars, such as creation of too many alerts; the usability of how the information is presented to the clinician; lack of consistency in the display of drugs and drug names; and conformance of screen features and workflow within and between systems.
  • IDS systems need to be interoperable and have a seamless transfer of information. This can be a challenge in trying to meld together multiple disparate health information technology systems and EHRs from different vendors.

The time is right for industry, hardware and software developers, and other stakeholders to address the opportunities and challenges posed by entrance of biologics and biosimilars into the US market. As patient safety issues arise, the EHR community must be in a position to capture and exchange needed information. Otherwise, states and other regulators could develop alternative tracking methods. Examples include state vaccine registries or prescription drug monitoring programs, which track controlled substances dispensing and vary from state to state. These programs have become complicated mechanisms for healthcare providers to address.

Tony Schueth is CEO and managing partner of Point-of-Care Partners of Coral Springs, FL.

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