Sigrid Piening1, Pieter A de Graeff2,3, Sabine M J M Straus3,4, Flora M Haaijer-Ruskamp2, Peter G M Mol2,3. 1. Department of Clinical Pharmacology, FB20, University of Groningen, University Medical Center Groningen, PO Box 196, 9700 AD Groningen, The Netherlands. sigridpiening@gmail.com 2. Department of Clinical Pharmacology, FB20, University of Groningen, University Medical Center Groningen, P.O. Box 196, 9700 AD, Groningen, The Netherlands. 3. Dutch Medicines Evaluation Board, Utrecht, The Netherlands. 4. Department of Medical Informatics, Erasmus Medical Center, Rotterdam, The Netherlands.
Abstract
BACKGROUND: The usefulness and the impact of Direct Healthcare Professional Communications (DHPCs, or 'Dear Doctor letters') in changing the clinical behaviour of physicians have been debated. Changes in the current risk communication methods should preferably be based on the preferences of the healthcare professionals, to optimize the uptake of the message. OBJECTIVE: The aim of this study was to assess whether safety issues are communicated more effectively with an additional e-mail sent by the Dutch Medicines Evaluation Board (MEB) than with the DHPC only. METHODS: A randomized controlled trial was conducted amongst ophthalmologists and hospital pharmacists in the Netherlands, who were the target group of a DHPC that was issued for pegaptanib, a drug that is administered intra-ocularly in patients with macular degeneration. The intervention group (N = 110) received the pegaptanib DHPC, as well as the MEB e-mail. The control group (N = 105) received the traditional paper-based DHPC only. Two weeks later, the study population received an invitation to fill out an online questionnaire. Questions were asked about the respondents' knowledge and attitude regarding the pegaptanib issue, and any action they had consequently taken. Additional questions were asked about their satisfaction with the DHPC and the e-mail, and their preferred source of such information. RESULTS: Forty respondents (18.6%) completed the questionnaire. Eighty-one percent of the respondents in the intervention group (N = 21) and 47% of the control group (N = 19) correctly indicated that a serious increase in intra-ocular pressure could be caused by pegaptanib injections (Fishers' exact test, p = 0.046). Nine respondents in the intervention group versus none of the control group respondents indicated that they had taken action in response to the pegaptanib safety issue (Fishers' exact test, p = 0.01). The majority of both the intervention group and the control group confirmed that they would like to receive an MEB e-mail with safety information about drugs in the future (90 and 95 %, respectively). CONCLUSION: The results of this study indicate that an additional e-mail might strengthen the uptake of the safety information provided to healthcare professionals, who prefer to receive an e-mail from the MEB as a source of such information, as well as the DHPC. This study may serve as a starting point for new strategies to improve risk communication regarding safety issues associated with drugs and its impact on prescribing.
RCT Entities:
BACKGROUND: The usefulness and the impact of Direct Healthcare Professional Communications (DHPCs, or 'Dear Doctor letters') in changing the clinical behaviour of physicians have been debated. Changes in the current risk communication methods should preferably be based on the preferences of the healthcare professionals, to optimize the uptake of the message. OBJECTIVE: The aim of this study was to assess whether safety issues are communicated more effectively with an additional e-mail sent by the Dutch Medicines Evaluation Board (MEB) than with the DHPC only. METHODS: A randomized controlled trial was conducted amongst ophthalmologists and hospital pharmacists in the Netherlands, who were the target group of a DHPC that was issued for pegaptanib, a drug that is administered intra-ocularly in patients with macular degeneration. The intervention group (N = 110) received the pegaptanibDHPC, as well as the MEB e-mail. The control group (N = 105) received the traditional paper-based DHPC only. Two weeks later, the study population received an invitation to fill out an online questionnaire. Questions were asked about the respondents' knowledge and attitude regarding the pegaptanib issue, and any action they had consequently taken. Additional questions were asked about their satisfaction with the DHPC and the e-mail, and their preferred source of such information. RESULTS: Forty respondents (18.6%) completed the questionnaire. Eighty-one percent of the respondents in the intervention group (N = 21) and 47% of the control group (N = 19) correctly indicated that a serious increase in intra-ocular pressure could be caused by pegaptanib injections (Fishers' exact test, p = 0.046). Nine respondents in the intervention group versus none of the control group respondents indicated that they had taken action in response to the pegaptanib safety issue (Fishers' exact test, p = 0.01). The majority of both the intervention group and the control group confirmed that they would like to receive an MEB e-mail with safety information about drugs in the future (90 and 95 %, respectively). CONCLUSION: The results of this study indicate that an additional e-mail might strengthen the uptake of the safety information provided to healthcare professionals, who prefer to receive an e-mail from the MEB as a source of such information, as well as the DHPC. This study may serve as a starting point for new strategies to improve risk communication regarding safety issues associated with drugs and its impact on prescribing.
Authors: K C Reber; S Piening; J E Wieringa; S M J M Straus; J M Raine; P A de Graeff; F M Haaijer-Ruskamp; P G M Mol Journal: Clin Pharmacol Ther Date: 2012-12-27 Impact factor: 6.875
Authors: Stacie B Dusetzina; Ashley S Higashi; E Ray Dorsey; Rena Conti; Haiden A Huskamp; Shu Zhu; Craig F Garfield; G Caleb Alexander Journal: Med Care Date: 2012-06 Impact factor: 2.983
Authors: S Piening; K C Reber; J E Wieringa; S M J M Straus; P A de Graeff; F M Haaijer-Ruskamp; P G M Mol Journal: Clin Pharmacol Ther Date: 2012-05 Impact factor: 6.875
Authors: Esther de Vries; Elisabeth Bakker; Remy D C Francisca; Stijn Croonen; Petra Denig; Peter G M Mol Journal: Drug Saf Date: 2022-03-29 Impact factor: 5.228
Authors: Meredith Y Smith; Andrea Russell; Priya Bahri; Peter G M Mol; Sarah Frise; Emily Freeman; Elaine H Morrato Journal: Drug Saf Date: 2018-04 Impact factor: 5.606
Authors: Sumitra Shantakumar; Beth L Nordstrom; Susan A Hall; Luc Djousse; Myrthe P P van Herk-Sukel; Kathy H Fraeman; David R Gagnon; Karen Chagin; Jeanenne J Nelson Journal: J Patient Saf Date: 2019-03 Impact factor: 2.844