Hartigan-Go Kenneth
Bureau of Food and Drugs, Department of Health, 27 Woodpecker St. Greenmeadows, Brngy Ugong Norte, Quezon City 1110, Philippines.
Toxicology. 2002 Dec 27;181-182:103-7. doi: 10.1016/s0300-483x(02)00263-9.
Pharmacovigilance is the study of adverse drug reactions (ADR, events-AE). It affords a unique vantage point from which to detect problem drugs and drug use. The ADR reporting system in the Philippines was established in August 1994 and was recognized as a national centre member of the World Health Organization International Drug Monitoring (currently known as the Uppsala Monitoring Centre) by February 1995. The pharmacovigilance system in the Philippines developed a number of communication and training packages with the intention of advocating safer medicines and rational drug use. Although unpopular with western-trained medical doctors, people do utilize traditional folk medicines. There have been few ADR reports, perhaps in part because the AE are unrecognized; sometimes, the AE is misconstrued as part of the healing action; and practitioners of these remedies are unlikely to report them. People who resort to herbal medicines are usually from the poor segment of the population, and are likely to believe in unscientific claims and unlikely to report what they suffered. The promotion of herbal medicines as natural safe alternatives neglects the possibility of AE. Although unregulated, traditional Chinese medicines are allowed in the Philippines if used by ethnic Chinese. The regulation of health supplements has also been inefficient. Both of these factors have provided gaps for the entry of harmful products. Pharmacovigilance programmes are useful in the detection of false claims and substandard medicines. Examples of the Philippine ADR monitoring experience are cited.
药物警戒是对药物不良反应(ADR,不良事件-AE)的研究。它提供了一个独特的视角,从中可以发现有问题的药物和药物使用情况。菲律宾的ADR报告系统于1994年8月建立,并于1995年2月被确认为世界卫生组织国际药物监测(现为乌普萨拉监测中心)的国家中心成员。菲律宾的药物警戒系统开发了一些沟通和培训材料,旨在倡导更安全的药物和合理用药。尽管受过西方培训的医生对此并不欢迎,但人们确实会使用传统民间药物。ADR报告很少,部分原因可能是不良事件未被识别;有时,不良事件被误解为治疗作用的一部分;而且这些疗法的从业者不太可能报告。使用草药的人通常来自贫困人群,他们可能相信不科学的说法,也不太可能报告自己的遭遇。将草药宣传为天然安全的替代品忽视了不良事件的可能性。尽管不受监管,但如果华裔使用,菲律宾允许使用传统中药。保健品的监管也效率低下。这两个因素都为有害产品的进入提供了漏洞。药物警戒计划有助于发现虚假宣传和不合格药品。文中列举了菲律宾ADR监测经验的例子。