Identification of potential drug name confusion errors in the Sentinel System.

PURPOSE: In July 2015, the US Food and Drug Administration (FDA) published a drug safety communication regarding errors in prescribing and dispensing of the antidepressant Brintellix (vortioxetine) and the antiplatelet Brilinta (ticagrelor) that arose due to proprietary drug name confusion. Brintellix is indicated for major depressive disorder; Brilinta is indicated to reduce cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or history of myocardial infarction. Brintellix was renamed to Trintellix in May 2016. Using Brilinta and Brintellix as a proof-of-concept feasibility use case, we assessed whether drug name confusion errors between the pair could be identified in electronic health care data via the combination of a claims-based algorithm and limited manual claims data review. METHODS: Using data from the Sentinel System, we defined potential errors as Brintellix users without an on- or off-label indication for Brintellix, without a dispensing for a drug with the same indications as Brintellix, and with an on- or off-label indication for Brilinta between -365 and +30 days after index Brintellix dispensing; the reverse was done for Brilinta. We manually reviewed claims profiles of potential cases. RESULTS: We identified 27 (0.1%) potential errors among 21 208 Brintellix users; 16 appeared to be likely errors based on claims profile review. Fifty-one (0.3%) of the 16 779 Brilinta users were identified as potential errors, and four appeared to be likely errors. CONCLUSIONS: A claims-based algorithm combined with manual review of claims profiles could identify potential drug name confusion errors, and narrow down likely errors that warrant further investigation.

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with HER2-positive (HER2+) metastatic breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Approval was based on data from SOPHIA, a multicenter, randomized, open-label, active controlled study comparing margetuximab with trastuzumab, in combination with chemotherapy. The primary efficacy endpoint was progression-free survival (PFS) by blinded independent central review. SOPHIA demonstrated a 0.9-month difference in median PFS between the two treatment arms [5.8 vs. 4.9 months, respectively; stratified HR, 0.76 (95% confidence interval: 0.59-0.98; P = 0.0334)]. Overall survival (OS) was immature at the data cut-off date of September 10, 2019. Infusion-related reactions (IRR) are an important safety signal associated with margetuximab plus chemotherapy. In SOPHIA, 13% of patients treated with margetuximab plus chemotherapy reported IRRs, of which 1.5% were grade 3. The most commonly reported adverse drug reactions (>10%) with margetuximab in combination with chemotherapy were fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, IRR, palmar-plantar erythrodysesthesia, and extremity pain. Overall, the favorable risk-benefit profile for margetuximab when added to chemotherapy supported its approval for the intended indication.

Use of Proprietary Names by Prescribers When Prescribing Over-the-Counter (OTC) Drug Products.

BACKGROUND: To identify if proprietary names are used by health care practitioners when prescribing over-the-counter (OTC) drug products. These findings can inform evaluation of proposed proprietary names for both prescription and OTC drug products. METHODS: QuintilesIMS OTC International Market Tracking (QuintilesIMS OTCIMS) was used to identify top OTC drug products sold to the consumers from US retail store outlets in year 2011. QuintilesIMS's Vector One: National (VONA) was used to identify prescribers' use of proprietary names by examining drug use data from 2003 to 2011 for the top OTC products identified from QuintilesIMS OTCIMS. RESULTS: Of the 29 OTC drug products that have drug utilization data available, the data showed prescribers' use of proprietary names every year from 2003 to 2011 for 24 OTC drug products, and from 2004 to 2011 for 2 OTC drug products. The drug use data showed the use of proprietary name in some years but not all years from 2003 to 2011 for the remaining 3 OTC drug products. For the OTC drug products studied, prescribers used proprietary names for OTC products when prescribing them, and the use of proprietary names on prescriptions can vary during a 9-year period. CONCLUSION: This research identified that prescribers do prescribe OTC drug products using proprietary names. This prescribing practice confirms the need for the pharmaceutical industry, industry consultants, and regulators to consider the proprietary names of OTC drug products when formulating and evaluating new proprietary names for drugs.