Project Focus| Drug and Vaccine Safety

Developing New Knowledge on Real-Life Benefit-Risk of Medicines in Resource Limited Areas

Despite the highly controlled process of clinical development, the overall effects of medicines cannot be fully predicted before the product is brought to the larger population after marketing authorisation. Once the medicine is authorised, it is utilised under real-life conditions where the benefit-risk balance may change. Such reversal may be due to the lacking knowledge on very rare adverse drug reactions, the inappropriate management of drug interactions, its administration to never studied sub-populations, its off-label or inappropriate use, the difference between measured and perceived benefit and all kind of medication errors. This may lead to incidences and have a deleterious effect on risk perception and trust in medicines of the population.

Hence, drug and vaccine safety monitoring needs to continue after marketing authorisation. Low-income countries are facing a high burden of infectious and, increasingly, of non-communicable diseases. In view of this enormous challenge and the prevailing lack of resources the effort to establish a well-functioning pharmacovigilance system understandably is a second priority.

However, the consequential low participation in spontaneous reporting of adverse drug reactions and the resulting under-reporting and non-recognition of new safety signals poses additional risks. Therefore, conducting drug and vaccine safety surveillance is an essential cornerstone for the safe and appropriate use of medicines in resource limited areas.

Our objective is to contribute to the knowledge on real-life benefit-risk of medicines and to improve the safe use and acceptance of medicines, focusing on health systems and populations in resource limited areas.