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KMID : 1011320110040010022
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Journal of Pharmacoepidemiology and Risk Management
2011 Volume.4 No. 1 p.22 ~ p.39
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Development of Counseling Protocol for Drug Side Effects: Korea Food and Drug Administration Pharmacovigilance Research Network Regional Pharmacovigilance Centers
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Choi Nam-Kyong
Kim Ye-Jee
Park Jung-Won
Lee Joong-Yub
Lee So-Hee
Kim Jeong-Eun
Kim Bo-Ri
Hwang Ye-Won
Kim Kyung-Sun
Kim Ja-Young
Park Hye-Jin
Kim Grace
Kim Hye-Min
Park Byung-Joo
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Abstract
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Objective: We developed a counseling protocol for drug side effects to provide the standard of adverse events counseling for researchers of Pharmacovigilance Research Network (PVNet) Regional Pharmacovigilance Centers (RPVC).
Methods: We organized a task force team (TFT) which was constituted of PVNet researchers and Korea Food and Drug Administration officials. Pre-existing materials related to counseling of drug side effects in each RPVCs were reviewed in order to establish the goal, core contents and determine the format of the protocol. Members of TFT made a draft to take their own part, and then the final version was developed by agreements.
Results: We presented the entire process of counseling for drug side effects in sequence, including information on actions after counseling. Main contents were composed of i) purpose, ii) scope, and target subjects iii) route of visit, iv) counselor, v) collect adverse event-related information, vi) providing counseling, vii) documentation, viii) case evaluation, and ix) follow-up. In addition, we included the appendix to provide more specific information as follows; flowchart, document, ADR card, causality assessment tool, and examples of counseling.
Conclusion: This protocol will improve the quality of counseling for drug side effects in PVRCs as well as regional cooperation clinics or pharmacies.
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KEYWORD
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Pharmacovigilance, Regional pharmacovigilance center, Adverse drug reaction, Counseling protocol, Patient education
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