“When a biological proper drug name is used, it is highly recommended to express the full name with the suffix. Some argue that the use of brand names and batch numbers in Europe contributes to a smoother integration of biosimilars into the market, making them more readily accepted and accessible into healthcare systems. Instead, biosimilars in the European Union (EU) are identified by their brand names and batch numbers for pharmacovigilance purposes. In contrast, the European Medicines Agency (EMA) generally does not use suffixes for biosimilars. In April, an unnamed specialty pharmacy raised concerns with the ISMP that look-alike packaging with the different presentations of Humira, can lead to confusion and this necessitates barcode scanning. There are nine FDA approved Humira biosimilars, as of September 2023. Moreover, it’s worth noting that this practice is specific to the US. However, this additional name introduces another layer of potential look- and sound-alike risk with other products already on the market,” says Jennifer Young, PharmD, a Medication Safety Specialist at the ISMP. “The manufacturers of biosimilars also often assign unique brand names, which may help distinguish a biosimilar from the reference product. For example, Pfizer’s biosimilar of the AbbVie drug Humira (adalimumab) is called Abrilada (adalimumab-afzb). This suffix is intended to make each product name unique and easily distinguishable from the reference biologic and other biosimilars. The US Food and Drug Administration (FDA) introduced the use of a distinct four-letter suffix to be added to the INN of each biosimilar. New biosimilars will have a unique brand name, however the INN name is kept the same as the reference biologic. When it comes to the naming of biosimilars, things get a little more complex. “Safety alerts such as caution in use publications or drug safety updates (DSUs) can be used to warn healthcare professionals of observed problems,” he says. New chemical and biological entities are named by the World Health Organization (WHO), through the International Non-proprietary Name (INN) programme.Īdrian Evans, a UK Medicines and Healthcare products Regulatory Agency (MHRA) British Pharmacopoeia Specialist highlights the measures in place by the agency to address safety issues related to medication names once a drug is on the market. For example, paracetamol is the non-proprietary name for the painkiller, its chemical name is acetaminophen, and Tylenol is an example of a brand name. “The big safety concern is the fact that the patient may end up getting the wrong medication because of that confusion.” The impact of confusing drug names on patient safetyĭrugs have three types of names: chemical, non-proprietary, and a trade or brand name. Rita Jew, PharmD, president of the ISMP, says confusing drug names can have implications on patient safety. For example, Amicar (aminocaproic acid), a blood clot drug, and Omacor (Omega-3-acid ethyl esters), used to treat lipid disorders such as hypertriglyceridemia. Earlier this year, one such nonprofit agency, The Institute for Safe Medical Practices (ISMP) released a list of the most confusing drug names, which contains look-alike and sound-alike (LASA) name pairs of medications. And even international bodies need to be on board.
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