Table A3.

Selected Survey Results from the American Society of Clinical Oncology Survey on REMS

Survey Question	No.	%
What type of organization best describes your practice?
Academic	571	44
Private practice	417	32
Other, please specify	127	10
Hospital, nonacademic	122	9
Private practice, staff model (eg, Kaiser)	42	3
Government agency	32	2
Total	1,311	100
Are you familiar with Risk Evaluation and Mitigation Strategies (REMS)? (Respondents who answered “no” were not included in the following question)
Yes	1104	84
No	207	16
Total	1311	100
Do you prescribe medications that require one or more REMS elements and/or do you participate in aspects of a REMS program in a clinical setting? (Respondents who answered “no” were not included in the following four questions)
Yes	937	85
No	168	15
Total	1105	100
In your experience, what is the impact of REMS with respect to patient safety?
Some elements enhance, while some do not enhance patient safety	457	49
Does not enhance patient safety	381	41
Meets the goal of enhancing patient safety	99	11
Total	937	100
What is the administrative impact of REMS with respect to clinical practice?
The impact of the administrative requirements outweigh any potential benefit	526	56
There is impact, but the benefits to patients with respect to safety outweigh the resources needed to administer various REMS programs	239	26
The impact of REMS interferes with patient safety measures already implemented in the clinical setting	129	14
No impact on my clinical practice	43	5
Total	937	100
What steps has your practice taken to manage the impact of REMS programs? (Check all that apply)
Staff/staff time has been added to the practice in order to account for REMS administrative requirements	502	56
My staff and/or I spend less time with my patient in order to have the resources to manage the REMS programs	375	42
There are drugs I will not prescribe due to aspects of the associated REMS program	309	35
REMS materials make it easy for my practice to update educational materials, consent forms and important patient talking points	126	14
Other, please specify	86	10
Fewer new patient have been accepted in order to have the resources to manage the REMS programs	58	6
Have you attempted to quantify the impact in FTEs, change in prescribing patterns, time away from patients, or decreased patient load?
No	827	93
Yes	67	7
Total	894	100

	Somewhat Trusted		Very Trusted
	No.	%	No.	%
To what extent do you view the following stakeholders as a trusted source of information regarding the clinical management of a safety issue at the practice level? (All respondents were asked this question)
Peer-reviewed scientific journal	263	20	1011	77
Professional society notifications	370	28	856	65
FDA notifications	399	30	831	63
Colleagues	757	58	362	28
Industry (manufacturer) notifications/Dear Doctor letters	708	54	242	18
Health system notifications	558	43	146	11
Group Purchasing Organizations (or others in the supply chain) notifications	265	20	45	3
Patient	166	13	20	2
News, including mass media and trade press	123	9	6	0

Survey was administered during May 2011 and received a total of 1,311 complete responses.

Abbreviations: FDA, US Food and Drug Administration; REMS, Risk Evaluation and Mitigation Strategies.