Policy for drug safety and its impact on the patient safety

Article information

J Korean Med Assoc. 2012;55(9):816-818
Publication date (electronic) : 2012 September 20
doi : https://doi.org/10.5124/jkma.2012.55.9.816
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 2012 August 25; Accepted 2012 September 01.

References

1. McBride WG. Thalidomide and congenital abnormalities. Lancet 1961. 21358.
2. Waxman HA. The lessons of Vioxx-drug safety and sales. N Engl J Med 2005. 3522576–2578.
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. 123527–530.
5. Permanand G, Mossialos E, McKee M. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clin Med 2006. 687–90.
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. 50305–314.

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