J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 7, Number 12, December 2015, pages 956-960

Japanese Physicians’ Views on Drug Post-Marketing Surveillance

Figure

Figure 1. Respondents’ views on the acceptability to collect and provide data in various issues without obtaining informed consent in the current framework of post-marketing surveillance.

Tables

**Table 1.** Annual and Total Number of Times Post-Marketing Surveillance (PMS) of Drugs and Medical Devices Was Conducted in Tokushima University Hospital During the Study Period
	PMS
	Drug	Medical device	Total
2009	62	3	65
2010	49	5	54
2011	51	4	55
2012	38	3	41
2013	47	8	55
Total	247	23	270

**Table 2.** Number of PMS Reports, Electronic Data Capturing Responses, and Responses to Queries
	0	1 - 5	6 - 10	11 - 15	> 16	No response
PMS reports	48 (46.6%)	40 (38.8%)	5 (4.9%)	0	9 (8.7%)	1 (1.0%)
Electronic data capturing responses	77 (74.7%)	17 (16.5%)	2 (1.9%)	1 (1.0%)	5 (4.9%)	1 (1.0%)
Responses to queries	60 (58.2%)	34 (33.0%)	5 (4.9%)	1 (1.0%)	2 (1.9%)	1 (1.0%)

**Table 3.** Respondents’ Views on the Importance of PMS and the Associated Workload as Well as Feedback of PMS Results to Physicians
	Strongly disagree (score 1)	Disagree (score 2)	Neutral (score 3)	Agree (score 4)	Strongly agree (score 5)	No response
PMS is important	2 (1.9%)	4 (3.9%)	34 (33.0%)	32 (31.1%)	31 (30.1%)	0
The workload of PMS is a burden	0	0	10 (9.7%)	29 (28.2%)	26 (25.2%)	38 (36.9%)
The workload of PMS has been increasing	17 (16.5%)	3 (2.9%)	17 (16.5%)	15 (14.6%)	12 (11.7%)	39 (37.9%)
Feedback of PMS results to physicians is satisfactory	14 (13.6%)	14 (13.6%)	27 (26.2%)	10 (9.7%)	9 (8.7%)	29 (28.2%)

**Table 4.** Relationship Between Experience of Voluntary Reporting and Views on PMS
	Mean with SDs of scores
	Voluntary reporting experience	No experience	P
PMS is important	4.09 ± 0.91 (n = 33)	3.71 ± 0.98 (n = 70)	0.07
The workload of PMS is a burden	4.46 ± 0.71 (n = 26)	4.10 ± 0.68 (n = 39)	0.04
The workload of PMS has been increasing	3.16 ± 1.70 (n = 25)	2.95 ± 1.30 (n = 39)	0.58