The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals

被引:16
作者
Bester, Nicolette [1 ]
Di Vito-Smith, Michelle [2 ]
McGarry, Theresa [2 ]
Riffkin, Michael [2 ]
Kaehler, Stefan [3 ]
Pilot, Richard [4 ]
Bwire, Robert [4 ]
机构
[1] Specialised Therapeut Australia, Melbourne, Vic, Australia
[2] Celgene Pty Ltd, Melbourne, Vic, Australia
[3] Celgene Europe Ltd, Uxbridge, Middx, England
[4] Celgene Corp, Summit, NJ USA
关键词
Abraxane; Australia; Brochure; Education; Health-care professionals; Nab-paclitaxel; Risk management plans; Risk minimization; RESPONSE RATES;
D O I
10.1007/s12325-016-0284-y
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Educational brochures are an important tool for communicating risk to health-care professionals. It is important to evaluate the impact of any risk minimization tool to understand the effectiveness of the strategy. The objective of this study was to assess the effectiveness (i.e., respondents' awareness and understanding of the communication) of a targeted educational brochure distributed to health-care professionals (HCPs) as a risk minimization strategy for the communication of new rare and important adverse events (AEs). A prospective, non-interventional, online survey was performed following distribution of a specifically designed brochure highlighting new and important adverse events to a targeted HCP population, consisting of known users of the target medicine, as represented by a commercial database. Predefined multiple-choice survey questions assessed overall HCP awareness of the brochure and understanding and retention of information in those HCPs who reported receiving the brochure. The educational brochure was sent to a total of 565 HCPs; 121 (21.4%) responded to the survey. The majority of respondents (95.0%) had previously prescribed or dispensed the target medicine. In all, 88 (72.7%) respondents said they had received the educational brochure, of whom 95.5% stated they had at least scanned the main points. More participants who had received the brochure (86.4% to 96.6%) answered the five individual survey questions correctly compared with those who did not (51.5% to 97.0%); this was significant for four out of five questions (P a parts per thousand currency sign 0.005). Significantly more HCPs who received the brochure achieved the predefined pass rate (at least four of five questions answered correctly) compared with HCPs who did not receive the brochure (93.2% vs 57.6%, respectively; P = 0.000003). Distribution of targeted educational brochures may be an effective risk minimization strategy to raise HCP awareness of new rare and important AEs; educational brochures may also be an effective channel for sharing information on how these AEs can be best managed and on the importance and means of reporting AEs. Celgene Pty Ltd, Melbourne, Australia.
引用
收藏
页码:167 / 177
页数:11
相关论文
共 12 条
[1]   Post-Approval Evaluation of Effectiveness of Risk Minimisation: Methods, Challenges and Interpretation [J].
Banerjee, Anjan Kumar ;
Zomerdijk, Inge M. ;
Wooder, Stella ;
Ingate, Simon ;
Mayall, Stephen J. .
DRUG SAFETY, 2014, 37 (01) :33-42
[2]   Response rates in postal surveys of healthcare professionals between 1996 and 2005: An observational study [J].
Cook, Julia V. ;
Dickinson, Heather O. ;
Eccles, Martin P. .
BMC HEALTH SERVICES RESEARCH, 2009, 9
[3]  
Council for International Organization of Medical Sciences (CIOMS), PRACT APPR RISK MIN
[4]  
Edwards B, 2012, DRUG SAFETY, V35, P1027, DOI 10.2165/11635220-000000000-00000
[5]  
European Medicines Agency, Guideline on good pharmacovigilance practices (GVP) Module IX-Signal management (Rev 1)
[6]   Printed educational materials: effects on professional practice and healthcare outcomes [J].
Giguere, Anik ;
Legare, France ;
Grimshaw, Jeremy ;
Turcotte, Stephane ;
Fiander, Michelle ;
Grudniewicz, Agnes ;
Makosso-Kallyth, Sun ;
Wolf, Fredric M. ;
Farmer, Anna P. ;
Gagnon, Marie-Pierre .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2012, (10)
[7]   The Effect of Printed Educational Material from the Coroner in Victoria, Australia, on Changing Aged Care Health Professional Practice: A Subscriber Survey [J].
Ibrahim, Joseph E. ;
Ehsani, Jonathon P. ;
McInnes, Judith A. .
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY, 2010, 58 (03) :585-591
[8]   Surviving Surveys [J].
Mazzarello, Sasha ;
Clemons, Mark ;
Graham, Ian D. ;
Jacobs, Carmel .
JOURNAL OF ONCOLOGY PRACTICE, 2015, 11 (01) :44-46
[9]   Evaluation of the effectiveness of risk minimization measures [J].
Prieto, Luis ;
Spooner, Almath ;
Hidalgo-Simon, Ana ;
Rubino, Annalisa ;
Kurz, Xavier ;
Arlett, Peter .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2012, 21 (08) :896-899
[10]   National survey addressing the information needs of primary care physicians: Side effect management of patients on androgen deprivation therapy [J].
Soeyonggo, Tony ;
Locke, Jennifer ;
Del Giudice, Maria Elizabeth ;
Alibhai, Shabbir ;
Fleshner, Neil Eric ;
Warde, Padraig .
CUAJ-CANADIAN UROLOGICAL ASSOCIATION JOURNAL, 2014, 8 (3-4) :E227-+