Policy for drug safety and its impact on the patient safety

Byung-Joo Park

doi:10.5124/jkma.2012.55.9.816

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Park: Policy for drug safety and its impact on the patient safety

Focused Issue of This Month

Drug Safety and Risk Management

Journal of the Korean Medical Association

Journal of the Korean Medical Association 2012; 55(9): 816-818.

Published online: 20 September 2012

DOI: https://doi.org/10.5124/jkma.2012.55.9.816

Policy for drug safety and its impact on the patient safety

Byung-Joo Park, MD^1,^2,³

¹Department of Preventive Medicine, Seoul National University College of Medicine, Korea.

²Medical Research Collaborating Center, Seoul National University Hospital / Seoul National University College of Medicine, Korea.

³Korea Institute of Drug Safety and Risk Management, Korea.

Corresponding author: Byung-Joo Park, bjpark@snu.ac.kr

Received 25 August 2012 Accepted 1 September 2012

(open-access):

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.

References

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2. Waxman HA. The lessons of Vioxx-drug safety and sales. N Engl J Med. 2005. 352:2576–2578.

3. World Health Organization. The importance of pharmacovigilance. 2002.

4. Wood SF, Perosino KL. Increasing transparency at the FDA: the impact of the FDA Amendments Act of 2007. Public Health Rep. 2008. 123:527–530.

5. Permanand G, Mossialos E, McKee M. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clin Med. 2006. 6:87–90.

6. U.S. Food and Drug Administration. The Food and Drug Administration Amendments Act of 2007 (FDAAA). 2007.

7. European Commission. Volume 9A of the Rule Governing Medicinal Products in the European Union ; Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2008.

8. American Society of Hospital Pharmacists. ASHP guidelines on preventing medication errors in hospitals. Am J Hosp Pharm. 1993. 50:305–314.

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