Efficacy and Safety of Medicines

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Presentation transcript:

Efficacy and Safety of Medicines

Efficacy versus Effectiveness Medicines need to balance efficacy and safety. A medicine is beneficial when it produces the desired effect (efficacy) with an acceptable level of side effects (safety). Efficacy relates to how well a treatment works in laboratory studies or clinical trials. Effectiveness, on the other hand, relates to how well a treatment works in practice after a medicine is publicly available.

Benefit versus Risk The benefit of taking a medicine must exceed the risks of taking it. Even though no therapy 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.

Pharmacovigilance Efficacy and safety still need to be monitored after a medicine becomes available to patients. This is called ‘pharmacovigilance’. 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’.

Efficacy and Safety Monitoring 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). As side effects are reported, more information will become available on the safety of a medicine.

Long-term efficacy and safety Today, before a medicine is made available to patients, it has typically been tested (depending on the disease) on at least 5000 persons for a limited time period. The long-term efficacy and safety of the medicine must be monitored and continuously evaluated while on the market, under ‘real-life’ conditions.

References 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).