title: Effectiveness of a risk-minimization activity involving physician education on metabolic monitoring of patients receiving quetiapine: results from two postauthorization safety studies.
abstract: Following Good Pharmacovigilance Practices Module XVI, two complementary studies were performed that included process and outcome measurements of the effectiveness of physician education on metabolic monitoring of patients receiving quetiapine. A multinational survey of 800 European Union physicians was utilized to assess the receipt of educational materials and also to assess the degree of monitoring as reported by physicians. Recall of receipt of educational materials ranged from 16.0 to 69.0% across the participating countries; however, physicians reported that 64.5% of patients were being monitored, with the majority reporting performance of three or more of four key metabolic-monitoring activities. Higher rates of monitoring were reported by those who reported receiving materials. Assessment of outcomes in a separate retrospective analysis of electronic medical record data showed lower levels of monitoring performed by specialist physicians. The monitoring activities observed were assessed as acceptable on the basis of the established performance of UK physicians, who are incentivized to deliver preventive screening.
authors.affiliation: aMedical Evidence & Observational Research, Global Medical Affairs, AstraZeneca Pharmaceuticals LP bDepartment of Statistical Science, AstraZeneca Pharmaceuticals LP cGlobal Regulatory Affairs, AstraZeneca Pharmaceuticals LP dPatient Safety, AstraZeneca Pharmaceuticals LP, Gaithersburg, Maryland (Former) eAdelphi Values, Boston, Massachusetts (Former) fAdelphi Research, Doylestown, Pennsylvania gUS Medical Affairs, AstraZeneca Pharmaceuticals LP, Wilmington, Delaware, USA hAstraZeneca R&D, Mölndal, Sweden iReal-World Evidence Solutions, IMS Health, London, UK.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Brody
authors.forename: Charles L
authors.initials: CL
authors.lastname: Liss
authors.forename: Heather
authors.initials: H
authors.lastname: Wray
authors.forename: Ramon
authors.initials: R
authors.lastname: Iovin
authors.forename: Carmen
authors.initials: C
authors.lastname: Michaylira
authors.forename: Anushini
authors.initials: A
authors.lastname: Muthutantri
authors.forename: Philip
authors.initials: P
authors.lastname: Damstetter
authors.forename: Catherine
authors.initials: C
authors.lastname: Datto
authors.forename: Leigh
authors.initials: L
authors.lastname: Jefferies
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects*; D004502:Education, Medical, Continuing / Q000379:methods*; D057286:Electronic Health Records; D005062:European Union; D040261:Harm Reduction; D006801:Humans; D001523:Mental Disorders / Q000150:complications / Q000188:drug therapy; D008660:Metabolism / Q000187:drug effects*; D008991:Monitoring, Physiologic / Q000379:methods*; D060735:Pharmacovigilance; D010820:Physicians; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D000069348:Quetiapine Fumarate / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D011795:Surveys and Questionnaires
chemical_list: D014150:Antipsychotic Agents; D000069348:Quetiapine Fumarate