By Pooja Babbrah, Senior Consultant
Biosimilars are starting to enter the market in the United States and are expected to quickly become mainstream in the near future because of their significant cost-savings and patient care implications. There are a number of issues the industry must address as biosimilars become more widespread. One that requires high-priority attention is how to indicate to the prescriber that a substitution has been made either for a biosimilar over another drug or one biosimilar over another. Why is this important? Patient safety is at stake.
This issue is taking on heightened importance now that nearly two-thirds of states have enacted or are considering enacting legislation requiring that physicians be notified when a biosimilar substitution is made. Biosimilars are made from living organisms and are different in chemical composition than conventional medications. They vary in how and where they are administered most are infused in hospitals, special ambulatory centers and even patients homes. The physician must have information about which specific product was dispensed to a patient to ensure care quality and to protect the patients safety in case an adverse event occurs. Despite legislative efforts to ensure that the provider is notified of the substitution, such legislation is silent as to how such notification should be done.
There are four possible electronic transactions that could be used to indicate to a prescriber that a substitution was made and which biosimilar was dispensed. These transactions are used by electronic health record (EHR) systems to communicate between prescribers and pharmacies. NCPDP SCRIPT standard contains three transactions that might be used to indicate a biosimilar substitution: RxFill, RxChange and medication history. The fourth possibility is consultation with state prescription drug monitoring programs (PDMPs), which are state-specific databases containing information about dispensed controlled substances.
What are the pros and cons of each? Is there one best option? Lets take a look.
RxFill or fill status notification. This transaction is sent to the prescriber from the pharmacy and indicates the status of the prescription (dispensed, partially dispensed or not dispensed).
RxChange. This transaction is sent by the pharmacy to the prescriber when the pharmacy would request approval to switch from a drug originally prescribed to something different. RxChange would typically be utilized in situations in which an insurer has a preferred alternative drug, if the drug is not covered by the patients insurer or if a quantity change from a 30- to 90-day supply has been requested. RxChange is a bidirectional transaction, involving a query from the pharmacy and a response by the prescriber.
Medication history. This NCPDP SCRIPT query transaction is sent from a doctor to an intermediary (such as Surescripts), which in turn requests a patients medication history from various payers. The intermediary gathers the responses, which are then downloaded into a patients medication history file in the EHR.
PDMPs. Prescription drug monitoring programs are state-run databases that contain information about all controlled substance prescriptions dispensed in each state (except Missouri, which lacks a PDMP). The information is supplied by pharmacies on varying timetables (such as daily, weekly or monthly). Most states encourage prescribers to check the database before prescribing a controlled substance to help address the epidemic problems of prescription drug overdose and doctor shopping. New York mandates checking with the PDMP for nearly all controlled substance prescriptions and other states are expected to follow its lead. PDMP content, technical aspects and accessibility (such as who has access to the database and for what purpose) vary by state.
Whats our pick? The Point-of-Care Partners team has been heavily involved in issues involving ePrescribing and biosimilars. While all four options described here to notify prescribers of a biosimilar substitution have some appeal, we believe RxFill is the best option. This transaction was designed to do what we need it to do, is part of the ePrescribing process, and the standards infrastructure has been expanded to accommodate biosimilars. It is available for use now by EHRs in all states. Let us know if we can help you understand the changes to standards, EHRs, pharmacy systems and work flows posed by the introduction of biosimilars in the US market.