Biosimilar Details Engineering Integration – Pharmacy Know-how Report

Douglas Hackenyos, PharmD, BCOP

Oncology Pharmacy Medical Coordinator
Section of Pharmacy
UConn Well being
Farmington, Connecticut

As of August 2020, the Fda has authorised 9 antineoplastic biosimilars—biologics that are very related to and have no clinically meaningful distinctions from an accredited reference solution with regard to security, purity, and potency.1

As additional biosimilars hit the market place, overall health care establishments deal with expanding problems in properly controlling their use. This write-up is the next in a 3-section collection focusing on administration and uptake of biosimilars in oncology follow. Biosimilar item assortment was reviewed in the to start with installment, and this posting focuses on biosimilar info technology integration. The 3rd write-up will emphasize the part of the pharmacist in supplier and affected person education about biosimilars. (Section 1 is out there in this article.)

Digital Health File Construct

Effective incorporation of biosimilars into the electronic wellness document (EHR) commences with perfectly-built making blocks: electronic prescriptions or medication data. It is important to understand that biosimilar merchandise have distinct Countrywide Drug Codes (NDCs), billing codes, and names that will not allow for them to be interchanged as are standard brand-title and generic medicines. Biosimilar digital treatment documents (eMARs) must incorporate the distinctive NDC, HCPCS J code, generic name (with 4-letter suffix), and manufacturer identify related with each individual exceptional product or service. In depth biosimilar builds decrease glimpse-alike/seem-alike (LASA) errors that could crop up with buy entry, verification, planning, and administration (Table). LASA warnings also might be added to each individual develop so they surface on the eMAR and drug labels.

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Desk. Guidelines for Reducing Look-Alike/Seem-Alike Medication Errors With Biosimilars
Buy Entry
  • Discrete treatment records for each biosimilar with complete generic title, 4-letter suffix, and brand name title
  • Default purchase sets/treatment pathways to formulary product or service choice
Verification
  • Discrete medication information for each and every biosimilar with full generic identify, 4-letter suffix, and brand name name
  • Decrease require for substitution upon verification
Preparation
  • Barcode scanning
  • Segregated inventory places for reference, biosimilar, and subcutaneous product formulations
Administration
  • Barcode scanning
  • Discrete treatment data for just about every biosimilar with total generic title, 4-letter suffix, and manufacturer identify
  • Segregated inventory areas in automatic dispensing cupboards

Biosimilar Buy Sets

In addition to their numerous other benefits, digital purchase sets and oncology remedy pathways can help biosimilar uptake considerably. A most popular formulary biosimilar may perhaps be set as the default agent in a prepare to bolster use and avoid service provider confusion at order entry. Statements extra to procedure options and electronic consent varieties can be applied to even more highlight formulary preferences and encourage affected individual instruction connected to biosimilars. Defaulted remedy plans also may possibly support in streamlining the prior authorization referral course of action and make the preferred biosimilar assortment very clear to authorization workers.

Default choice of a favored formulary products in just a remedy program also will have to be well balanced with a have to have for flexibility. Preferably, options must be created to accommodate 3rd-get together payor tastes and nonpreferred products supplied by specialty pharmacies or manufacturer assistance courses. Complex EHRs may perhaps make it possible for for “toggling” involving biosimilars and reference items within just a procedure strategy to allow for pharmacist substitution of the demanded item. Initiatives to lessen or avoid use of model names in oncology remedy pathway titles, prepare parameters, and other buy set fields outside the house of the specific treatment purchase may perhaps make future substitutions or product or service conversions extra successful.

Dispensing Technological innovation

Technological innovation in just the pharmacy can dramatically strengthen an institution’s capability to incorporate biosimilars into observe. Inventory management devices with electronic barcode scanning can assist pharmacy workers differentiate concerning biosimilars and reference products as quickly as drugs enter the pharmacy. Biosimilar solutions could be assigned segregated locations applying stock administration technological innovation to avoid confusion all through stocking and buying of physical stock. Barcode scanning, image capturing, and dose compounding verification engineering also can lower planning problems that may consequence from LASA biosimilar products. Dose preparation and verification engineering also may well assistance avoid preparation faults that may perhaps result from variations in the planning of particular solutions. For instance, vial sizes, reconstitution instructions, and the have to have for sterile drinking water for injection (SWFI) compared to bacteriostatic SWFI differ amongst solitary- and multidose trastuzumab items.2,3 Inventory administration and dose preparation may possibly be additional intricate by the want to stock several biosimilars as nicely as subcutaneous formulations for any supplied reference merchandise barcoding engineering is essential to keep away from faults in this sort of situations.

Treatment Administration Technological innovation

Engineering tremendously facilitates safe and sound administration of all medications which include biosimilars. The use of barcode scanning and good infusion pumps can minimize mistakes that might arrive with numerous solution possibilities. Several institutions are opting to limit develop and servicing operate for their sensible pump libraries by working with a one entry below a generic identify to deal with both of those reference and biosimilar goods with equivalent administration guidelines. Some eMARs also may permit the addition of intranet hyperlinks to drug information and facts and affected individual instruction methods for biosimilar items for uncomplicated obtain at the level of care.

Summary

Implementation of a most well-liked oncology biosimilar solution is a elaborate course of action that rewards enormously from the use of information technology devices. Comprehensive eMAR builds and technology associated in dispensing and administration will assistance uptake and minimize faults associated to biosimilar use. With 3rd-occasion payor preference being a big element in figuring out biosimilar product range, it is vital to sustain adaptability in eMAR and oncology procedure pathway design and style.

References

  1. Food and drug administration. Biosimilar products information and facts: Fda-approved biosimilar goods. bit.ly/2G3Pnes-PPN. Accessed September 17, 2020.
  2. Kanjinti (trastuzumab-anns) [prescribing information]. Amgen, Inc 2019.
  3. Herceptin (trastuzumab) [prescribing information]. Genentech, Inc 2018.

Dr. Hackenyos reported no related money associations.