A Study on Current Status of Clinical Trial Pharmacy in Domestic Clinical Trial Institution

Yoo-Jeong Jang; Wonku Kang; Joomi Lee; Hae Won Lee; Min Soo Park; Young-Ran Yoon

doi:10.12793/jkscpt.2013.21.1.71

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Jang, Kang, Lee, Lee, Park, and Yoon: A Study on Current Status of Clinical Trial Pharmacy in Domestic Clinical Trial Institution

Original Article

J Korean Soc Clin Pharmacol Ther 2013;21(1):71-81.

Published online: 11 January 2013

DOI: https://doi.org/10.12793/jkscpt.2013.21.1.71

A Study on Current Status of Clinical Trial Pharmacy in Domestic Clinical Trial Institution

Yoo-Jeong Jang^1,², Wonku Kang², Joomi Lee^1,³, Hae Won Lee^1,³, Min Soo Park^4,⁵, Young-Ran Yoon^1,^3,²

¹Clinical Trial Center, Kyungpook National University Hospital

²College of Pharmacy, Yeungnam University

³Department of Biomedical Science, Kyungpook National University Graduate School

⁴Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine

⁵Korea National Enterprise for Clinical Trials

E-mail: minspark@yuhs.ac

Received 12 December 201230 May 2013 Accepted 1 June 2013

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background:

There is a lack of research on the status of clinical trial pharmacy and clinical trial pharmacist (CTP) in Korea. This study was aimed to investigate the current status of clinical trial pharmacy and clinical trial pharmacists.

Methods:

The survey was performed using the 41-item questionnaire designed to investigate information on the following; (1) current status of clinical trial pharmacy designated by Korea Food and Drug Administration, (2) current status of working condition, management, and satisfaction index of CTP. Data collected was analyzed by t-test and x².

Results:

Among the CTPs who responded, 92.7 % belonged to department of pharmacy, and 7.3 % to clinical trial center. 90.2 % of the respondents were women. Forty-two point seven percents of the respondents had more than 3 years of experience in the clinical trial field. 36.6 % answered that the current number of CTPs in the institution was ‘2’. Sixty-three point four percents answered that they subsumed an additional post. Regarding the question on “whether the equipment and working environment of your clinical trials pharmacy is adequate”, 65.1 % of the respondents answered as ‘Inadequate’. Ninety-eight point eight percents answered that work-related education is needed. Ninety-three point nine percents answered that the quality of clinical trials is related to the improvement of the working environment of CTP.

Conclusion:

Clinical trial pharmacy’s facility and number of actually working CTP were insufficient. Proper and continuous education and training for CTPs are needed to improve the quality of clinical trials conducted in Korea, with strong institution support and timely regulation change.

Keywords: Clinical trial pharmacist, Clinical trial pharmacy, Current status, Education

REFERENCES

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Figure 1.

Training and education course of other clinical trial participants.

Table 1.

General characteristics of clinical trial pharmacist

Characteristics	N(%)
Gender
Male / Female	8(9.8) / 74(90.2)
Age(years)
20-29	7(8.5)
30-39	44(53.7)
40-49	23(28.0)
50-59	6(7.3)
>60	1(1.2)
Location of institution
Seoul, Incheon, Gyeonggi	39(47.6)
Other provinces	43(52.4)
Number of bed
< 200	2(2.4)
200 - 499	16(19.5)
500 - 999	50(61.0)
1000 - 1499	9(11.0)
≥ 1500	4(4.9)
Belong to
Department of pharmacy	76(92.7)
Clinical trial center	6(7.3)
Experience of pharmacist(years)*
≤ 5	17(20.7)
6 - 10	23(28.0)
11 - 15	17(20.7)
> 16	24(29.3)
Job type
Regular	77(93.9)
Irregular, full time	3(3.7)
Irregular, part time	1(1.2)
Experience of clinical trial pharmacist(months)
< 6	7(8.5)
6 - 11	11(134.)
12 - 23	16(19.5)
24 - 35	11(13.4)
≥ 36	35(42.7)

N(%) denotes the number (percentage). * Mean ± SD is 11.7 ± 6.5 years.

Table 2.

Education about clinical trial pharmacist’s performance

Education related contents	N(%)
Need of education program
Yes / No / Missing	81(98.8) / 0(0.0) / 1(1.2)
Type of required education*
Certifiable GCP^† training	57(31.1)
Regulation	53(59.0)
Hands-on training of clinical trial pharmacy	72(39.3)
Other	1(0.5)
Opportunity of education
No opportunity	7(8.5)
Regularly	19(23.2)
Irregularly	49(59.8)
Other	6(7.3)
Missing	1(1.2)
Supporting for education outside*
Transportation fee	33(22.9)
Registration fee	63(43.8)
Time arrangement	43(29.9)
No supporting	5(3.5)

N(%) denotes the number (percentage). * Multiple responses. ^† Good clinical practice.

Table 3.

Working status of clinical trial pharmacist

Working related contents	N(%)
Number of clinical trial pharmacists in institution
1 / 2 / 3 / 4 *	14(17.1) / 30(36.6) / 20(24.4) / 7(8.5)
More than 5 persons	11(13.4)
Separation of duties ^†
For each task sharing	15(18.3)
For each department	2(2.4)
Main and back up	45(54.9)
Other	4(4.9)
Composition of pharmacist
All of dedicated clinical trial pharmacists	15(18.3)
Dedicated + adjunct	14(17.1)
All of adjunct pharmacists	52(63.4)
Criteria of clinical trial pharmacist designation ^‡
Previous experience as clinical trial pharmacist	28(30.8)
Pharmacist working career	18(19.8)
Regular rotation^§	20(22.0)
Other	25(27.5)
Adequacy of current working pharmacist personnel
Yes / No	32(39.0) / 50(61.0)

N(%) denotes the number (percentage). * Persons. ^† If, more than 2 pharmacists. ^‡ Multiple responses. ^§ Circulation work by pharmacy department’s turn.

Table 4.

Reported adverse events and adverse drug reactions

		Number of project
		<50	≥50, <100	≥100, <150	≥150, <200	≥200
Number of clinical trial pharmacists in institution	1	10(20.4%)	3(15.8%)	0(0%)	0(0%)	0(0%)
	2	19(38.8%)	6(31.6%)	4(57.1%)	1(50.0%)	0(0%)
	3	12(24.5%)	6(31.6%)	2(28.6%)	0(0%)	0(0%)
	4	4(8.2%)	3(15.8%)	0(0%)	0(0%)	0(0%)
	≥5	4(8.2%)	1(5.35)	1(14.3%)	1(50.0%)	4(100%)
P value^*		0.056

^* X² test.

Table 5.

Actual condition of clinical trial pharmacist’s working

Actual condition of clinical trial pharmacist’s working	N(%)
Number of project
<50	49(59.8)
≥50, <100	19(23.2)
≥100, <150	7(8.5)
≥150, <200	2(2.4)
≥200	4(4.9)
Cycle of survey stock and expiration date
Every 3 months	17(20.7)
Every 6 months	9(11.0)
Every 1 year	2(2.4)
Not at all	2(2.4)
When needed	44(53.7)
Contact cycle with PI *
Every 1 or 2 month	7(8.5)
Every 3-6 month	14(17.1)
Every 1 year	11(13.4)
Not at all	6(7.3)
When needed	40(48.8)
SOP^† Revision cycle
No SOP	5(6.1)
Every 1 year	17(20.7)
Every 2 years	8(9.8)
Every 3 years	4(4.9)
No established criteria	44(53.7)
Having enough time for communicating and counseling clinical trial patients/participants
Not at all	7(8.5)
Not really	41(50.0)
Average	20(24.4)
Somewhat	12(14.6)
Very much	0(0.0)

N(%) denotes the number (percentage). * Principal investigator. ^† Standard operating procedure.

Table 6.

Actual condition of clinical trial pharmacy’s facility

Actual condition of Clinical trial pharmacy’s facility	N(%)
Separation of clinical trial pharmacy(Space)
Yes / No	40(48.8) / 42(51.2)
Having restrict access device*
Have / Do not have	79(96.3) / 3(3.7)
Having enough space for drug storage and work
Not at all	10(12.2)
Not really	40(48.8)
Average	26(31.7)
Somewhat	3(3.7)
Very much	3(3.7)
Having enough facility for maintaining the temperature and humidity
Not at all	5(6.1)
Not really	29(35.4)
Average	30(36.6)
Somewhat	12(14.6)
Very much	6(7.3)

N(%) denotes the number (percentage). * Clinical trial pharmacy or Storage cabinet.

Table 7.

Relationship with other clinical trial participants

Relationship with other clinical trial participants	N(%)
Relationship with investigators
Not at all	0(0.0)
Not really	3(3.7)
Average	58(70.7)
Somewhat	13(15.9)
Very much	5(6.1)
Relationship with IRB *
Not at all	0(0.0)
Not really	1(1.2)
Average	62(75.6)
Somewhat	11(13.4)
Very much	5(6.1)
Relationship with CRCs^†
Not at all	0
Not really	0
Average	45(54.9)
Somewhat	20(24.4)
Very much	14(171.)
Relationship with sponsors
Not at all	0(0.0)
Not really	3(3.7)
Average	58(70.7)
Somewhat	16(19.5)
Very much	2(2.4)
Most amicable relationship for performance
Investigator	25(30.5)
IRB	4(4.9)
CRC	28(34.1)
Sponsor	15(18.3)

N(%) denotes the number (percentage). * Institutional review board. ^† Clinical research coordinators.

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