Impact of Safety-Related Regulatory Action on Clinical Practice

Piening, Sigrid; Haaijer‐Ruskamp, Flora; Vries, Jonie T. N. de; Elst, Menno E van der; Graeff, Pieter A. de; Straus, Sabine M. J. M.; Mol, Peter G. M.

doi:10.2165/11599100-000000000-00000

Cited by 88 publications

(110 citation statements)

References 61 publications

Supporting

Mentioning

106

Contrasting

Order By: Relevance

“…6 In a survey of over 1000 Dutch doc tors and pharmacists, almost onethird reported taking action following a direct healthcare professional communication. 3 This might be considered a disappoint ing figure, but the authors argued that in some other areas, achieving a behav ioural impact by a single act of com munication in onethird of the targeted audience would be seen as a success. A much larger survey (with over 3000 respondents) across nine European countries found that healthcare profes sionals are generally familiar with the safety communication tools (ie direct healthcare professional communications and national competent authority com munications) and these tools are consid ered useful.…”

Section: Discussionmentioning

confidence: 99%

Perceptions of the Drug Safety Update newsletter

Wilcock¹,

Praed²

2017

Prescriber

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

Perceptions of the Drug Safety Update newsletter

Wilcock¹,

Praed²

2017

Prescriber

View full text Add to dashboard Cite

show abstract

“…This was a descriptive correlational study using a structured questionnaire adapted from earlier study by Piening et al (2012) and based on 3 process indicators in the Banerjee model; awareness, which measured the coverage and awareness, understanding/knowledge which assessed respondents' understanding of the information contained in the DHP letters and behavior which measures the extent of deviation from accepted behavior (Banerjee et al, 2014;Piening et al, 2012). The questionnaire was pretested using 20 respondents who were not included in the final analysis.…”

Section: Questionnaire Designmentioning

confidence: 99%

“…They are also used to communicate new or emerging safety information on medicines to health workers and the content and wording of these letters are extremely important in achieving the intended purpose. Review of the literature suggested that letters to health workers may or may not be effective in communicating safety information leading to change in behavior (Dusetzina et al, 2012;Piening et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

Sabblah¹,

Darko²,

Asamoa-Amoakohene³

et al. 2016

Afr. J. Pharm. Pharmacol.

View full text Add to dashboard Cite

Dear Healthcare Professional (DHP) letter is a risk minimization tool used to inform health workers about new and emerging safety information during the marketing period of medicinal products. DHP letters in some cases may not be effective because targeted audience may not be aware of these letters or even understand them. The objectives of this study were to assess the effectiveness and relevance of DHP letters as effective risk minimization tool and to seek opinion of health workers about the most effective way of communicating safety information. A descriptive correlational study of 913 health workers selected by convenient sampling through face-to-face interviews from Apr. to June, 2014 was conducted, with a response rate of 83.15%. The data was analyzed using descriptive analysis and Pearson-chi square test (χ 2 ) with STATA version 13. A p-value of < 0.05 was considered significant during the analysis. Of the 913 respondents only 350 (38.34%) were aware of at least one of the letters distributed in 2013 and 314 (89.71%) out of these admitted that these letters have influenced their way of prescribing, dispensing and administering the medicines involved. One hundred and ninety-two (54.82%) of the respondents rated the level of understanding of the language used as good and there was no significant difference in the health workers rating of the language used in the letters (p=0.40). Health workers suggested electronic methods such as short messaging service to their mobile phones 56.81% (438), e-mail 91 (85.85%) and posting the letters on the Food and Drugs Authority's website 26.85% (207). The results suggest that DHP letters issued by the Food and Drugs Authority (FDA) are effective in changing behavior of those who receive them but they are received late or not at all. The FDA should therefore explore other means of communicating safety information such as electronic means as suggested by the health workers.

show abstract

“…This applies to formal risk management plans as well as to risk minimization action otherwise taken for a medicine and interactions between healthcare professionals and patients. Drug Safety has increasingly been a forum for discussing risk communication,[2–11] and given that applying communication science to pharmacovigilance is relatively new, we thank the journal editors for now dedicating a whole edition to this topic.…”

mentioning

confidence: 99%