Pharmacovigilance is … Vigilance
Tóm tắt
The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error are all aspects of the safety of medicines that we have monitored for decades, though without perhaps paying enough attention to their special aspects. There are many new stakeholders taking serious interest in pharmacovigilance outside the regulatory sphere and they often focus on improving individual patient care, rather than the more traditional concentration on broad public health. The same stakeholders are also drawing attention to other iatrogenic outcomes that should be recognised, evaluated and their outcomes compared and contrasted with medication, such as harm from medical devices. The vigilance methods used for medication are very much applicable to all these new fields, though more and different expertise will be needed to evaluate outcomes.
Tài liệu tham khảo
Monitoring. Found in Wikipedia at http://en.wikipedia.org/wiki/Monitoring. Accessed 11 May 2015.
Moore N, Biour M, Paux G, Loupi E, Begaud B, Boismare F, Royer RJ. Adverse drug reaction monitoring: doing it the French way. Lancet. 1985;8463:1056–8.
Bencheikh RS, Benabdallah G. Medication errors: pharmacovigilance centres in detection and prevention. Br J Clin Pharmacol. 2009;67(6):687–90.
Meyboom RH, et al. Pharmacovigilance in perspective. Drug Saf. 1999;21(6):429–47.
Clancy CM, Eisenberg JM. Outcomes research: measuring the end results of health care. Science. 1998;5387:245–6.
Ellwood P. Outcomes management. A technology of patient experience. NEJM. 1988;318(23):1549–56. doi:10.1056/NEJM198806093182329 (PMID 336796).
Edwards IR. The WHO world alliance for patient safety: a new challenge or an old one neglected? Drug Saf. 2005;28(5):379–86.
Rhalem N, Aghandous R, Chaoui H, Eloufir R, Badrane N, Windy M, et al. Role of the poison control centre of Morocco in the improvement of public health. Asia Pac J Med Toxicol. 2013;2:82–6.
Wysowski DK. Surveillance of prescription drug-related mortality using death certificate data. Drug Saf. 2007;30(6):533–40.
Benabdallah G, et al. The involvement of Pharmacovigilance Centres in medication errors detection: a questionnaire-based analysis. Int J Risk Saf Med. 2011;23(1):17–29.
Banerjee AK, Okun S, Edwards IR, Wicks P, Smith MY, Mayall SJ, et al. Patient-reported outcome measures in safety event reporting: PROSPER Consortium guidance. Drug Saf. 2013;36(12):1129–49. doi:10.1007/s40264-013-0113-z.
Milmo S. Extending the Scope of Pharmacovigilance comes at a price. International BioPharm. 2014 http://www.biopharminternational.com/extending-scope-pharmacovigilance-comes-price. Accessed 17 Dec 2014.
Lindquist M. Data quality managemen t in pharmacovigilance. Drug Saf. 2004;27(12):857–70.