علم داروشناسی که مربوط به تشخیص، ارزیابی، فهم و پیشگیری عوارض جانبی(adverse effects) بویژه اثرات جانبی کوتاه مدت وبلند مدت دارو می باشد. در عوام فارماکوویژیلانس عبارت است از: علم جمع آوری، پایش، تحقیق، ارزیابی و بررسی اطلاعات حاصل از ارایه دهندگان خدمات سلامت و بیماران در خصوص عوارض جانبی دارو، داروهای بیولوژی، داروهای گیاهی و سنتی با توجه به نکات زیر:
- شناسایی اطلاعات جدید درباره خطرات مربوط به دارو
- جلوگیری از صدمات وارده به بیمار
روند جمع آوری اطلاعات از فاز یک آزمایش بالینی قبل از تاییده ورود به بازار شروع و تا بعد از ورود به بازار ادامه می یابد.
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Why pharmacovigilance is needed
The processes involved in the clinical development of medicines are illustrated in Figure 1. Once put onto the market, a medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population. At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. In some cases as few as 500 subjects, and rarely more than 5000, will have received the product prior to its release.
For good reason, therefore, it is essential that new and medically still evolving treatments are monitored for their effectiveness and safety under real-life conditions post release. More information is generally needed about use in specific population groups, notably children, pregnant women and the elderly, and about the efficacy and safety of chronic use, especially in combination with other medicines. Experience has shown that many adverse effects, interactions (i.e. with foods or other medicines) and risk factors come to light only during the years after the release of a medicine (see Table 1).
Figure 1 Clinical development of medicines
Despite its 40-year history, pharmacovigilance remains a dynamic clinical and scientific discipline. It continues to play a crucial role in meeting the challenges posed by the ever increasing range and potency of medicines, all of which carry an inevitable and some- times unpredictable potential for harm.
When adverse effects and toxicity do appear
– especially when previously unknown – it is essential that these are reported, analysed and their significance communicated effectively to an audience that has the knowledge to interpret the information.
For all medicines there is a trade-off between the benefits and the potential for harm. The harm can be minimized by ensuring that medicines of good quality, safety and efficacy are used rationally, and that the expectations and concerns of the patient are taken into account when therapeutic decisions are made. To achieve this is to:
• serve public health, and to foster a sense of trust among patients in the medicines they use that would extend to confidence in the health service in general;
• ensure that risks in drug use are anticipated and managed;
• provide regulators with the necessary information to amend the recommendations on the use of the medicines;
• improve communication between the health professionals and the public;
• educate health professionals to understand the effectiveness/risk of medicines that they prescribe.