Efficacy relates to how well a treatment works in clinical trials or laboratory studies. Effectiveness, on the other hand, relates to how well a treatment works in practice after a medicine is generally available.
Even though no technology is completely safe, the perception of acceptable risk level may vary between patients, healthcare professionals and regulatory authorities.
Experience has shown that some patients are more willing to accept higher risks than regulators and healthcare professionals.
The World Health Organisation (WHO) defines pharmacovigilance as ‘[…] the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’.
Today, before a medicine is made available to patients, it has typically been tested (depending on the disease) on at least 5.000 persons for a limited time period.
If a patient experiences any side effects, it is recommended that they talk to a healthcare professional. This includes any possible side effects not listed in the package leaflet. In many EU member states, side effects can be reported directly via the national reporting system available on the websites of the National Competent Authority (NCA).
- World Health Organization (2002). The importance of pharmacovigilance: Safety monitoring of medicinal products. Geneva: World Health Organization. Retrieved 23 June, 2015, from http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf?ua=1.
- World Health Organization (2004). Pharmacovigilance: Ensuring the safe use of medicines. Geneva: World Health Organization. Retrieved 23 June, 2015, from http://apps.who.int/medicinedocs/en/d/Js6164e/ (Retrieved 23 June, 2015).
- Presentation: Efficacy and Safety of Medicines
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A presentation describing the efficacy and safety of medicines, which can be adapted for own use.