title: Blood Draw Barriers for Treatment with Clozapine and Development of a Point-of-Care Monitoring Device.
abstract: BACKGROUND
  While clozapine (CLZ) is the most effective antipsychotic drug for schizophrenia treatment, it remains underused. In order to understand the barriers of frequent blood draws for white blood cell counts (WBCs) and clozapine levels, we developed a psychiatrist survey and began an integrative approach of designing a point-of-care device that could eventually have real-time monitoring with immediate results.
  
  
  METHODS
  We ascertained barriers related to CLZ management and the acceptance of possible solutions by sending an anonymous survey to physicians in psychiatric practice (n=860). In parallel, we tested CLZ sensing using a prototype point-of-care monitoring device.
  
  
  RESULTS
  255 responses were included in the survey results. The two barriers receiving mean scores with the highest agreement as being a significant barrier were patient nonadherence to blood work and blood work's burden on the patient (out of 28). Among nine solutions, the ability to obtain lab results in the physician's office or pharmacy was top ranked (mean±sd Likert scale [4.0±1.0]). Physicians responded that a point-of-care device to measure blood levels and WBCs would improve care and increase CLZ use. Residents ranked point-of-care devices higher than older physicians (4.07±0.87 vs. 3.47±1.08, p<0.0001). Also, the prototype device was able to detect CLZ reliably in 1.6, 8.2, and 16.3 μg/mL buffered solutions.
  
  
  CONCLUSIONS
  Survey results demonstrate physicians' desire for point-of-care monitoring technology, particularly among younger prescribers. Prototype sensor results identify that CLZ can be detected and integrated for future device development. Future development will also include integration of WBCs for a complete detection device.
authors.forename: Deanna L
authors.initials: DL
authors.lastname: Kelly
authors.forename: Hadar
authors.initials: H
authors.lastname: Ben-Yoav
authors.forename: Gregory F
authors.initials: GF
authors.lastname: Payne
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Winkler
authors.forename: Sheryl E
authors.initials: SE
authors.lastname: Chocron
authors.forename: Eunkyoung
authors.initials: E
authors.lastname: Kim
authors.forename: Christopher
authors.initials: C
authors.lastname: Kitchen
authors.forename: Veronika
authors.initials: V
authors.lastname: Stock
authors.forename: Gopal
authors.initials: G
authors.lastname: Vyas
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Love
authors.forename: Heidi J
authors.initials: HJ
authors.lastname: Wehring
authors.forename: Kelli M
authors.initials: KM
authors.lastname: Sullivan
authors.forename: Stephanie
authors.initials: S
authors.lastname: Feldman
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
authors.forename: Robert P
authors.initials: RP
authors.lastname: McMahon
authors.forename: Reza
authors.initials: R
authors.lastname: Ghodssi
mesh_terms: D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D001291:Attitude of Health Personnel; D003024:Clozapine / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D016903:Drug Monitoring / Q000295:instrumentation / Q000379:methods / Q000523:psychology; D005260:Female; D006403:Hematologic Tests / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology*; D000067716:Point-of-Care Testing; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D011795:Surveys and Questionnaires; D014481:United States
chemical_list: D014150:Antipsychotic Agents; D003024:Clozapine
keywords: Antipsychotic; Clozapine; Medication Underutilization; Point-of-Care; Sensing Lab-on-a-Chip; Therapeutic Drug Monitoring (TDM)