Pharmacovigilance is a dynamic clinical and scientific discipline that has had an important impact on the public health environment. Madalina Huruba, manager (Pharmacovigilance), ELC Group, goes into the history of the discipline and the necessity of an effective pharmacovigilance system.
Impact
With a history of more than 40 years, pharmacovigilance is defined by the World Health Organisation (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems’.
From a regulatory point of view, a need for robust settlements has been identified as a way to build a strong, sustainable system for medicine safety and for public confidence in medicines. The provision of good quality, safe and effective medicines — as well as ensuring their appropriate use — is the responsibility of national governments and is a responsibility that has grown as the industry has expanded. The global pharmaceutical industry, universities and non-governmental organisations (NGOs) now, more than ever, need to join forces to educate rational use of medicines and pharmacotherapy monitoring.
Once a drug reaches the point where it is authorised to be placed on the market, it leaves the secure and protected scientific environment of clinical trials to be used by the general population. At this point, all the data we have on the medicine is gathered from short-term monitoring of a limited number of subjects with limited to no health issues. As a consequence, the need to monitor the effectiveness and safety of the medicine under real-life conditions post-release — with an emphasis on specific population groups and polytherapy — becomes imperative, thus turning effective pharmacovigilance into an essential tool when it comes to patients’ safety.
Indeed, the aims of pharmacovigilance, as noted by the WHO, span improving patient care and safety in relation to the use of medicines, contributing to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, as well as promoting understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public.
Despite its substantial history, pharmacovigilance remains a dynamic clinical and scientific discipline. It is essential that adverse effects and toxicity correlated with the use of medicines are reported, and subject to robust analysis. The trade-off between the benefits and the potential for harm must always be acknowledged and discussed. Pharmacovigilance has therefore had an important impact on the public health environment. Thanks to good guidance and training programmes for healthcare workers, aspects such as exposure to risks linked to medication error and/or preventable ADRs are now acknowledged and managed. Risks linked with diseases, population characteristics, medicine, healthcare systems, empirical treatment and the aftermath are now closely monitored throughout different pharmacovigilance approaches. Pharmacovigilance best practices also allow the documentation and addressing of issues such as counterfeit drugs, substandard medicines, quality standards of donated medicines, as well as ADRs due to medicine interactions, and inappropriate use or dosage.
Today, a number of major categories of medicine-related problems are recognised and assessed. Issues including dependence and addiction, tolerance and rebound, overdose and poisoning as well as indirect adverse effects are now considered in the context of a sustainable pharmacovigilance system. Basic characteristics and distinction of the medicines are taken into account, aiming to contribute to a system that is generally applicable, and also serves as an educational structure for a better understanding of the complex issues that could arise during drug treatment.
One key challenge that has emerged is the issue of monitoring the safe use of medicines in countries with no active regulatory or safety monitoring system in place. In this scenario, the use of medicines in specific communities, such as the treatment of diseases like malaria, leishmaniasis and schistosomiasis, or HIV/AIDS and tuberculosis, becomes a matter of great concern and the subject of coordinated efforts to reduce the risks.
Registers and databases are being created and used as a foundation for statistics that allow medical care providers to oversee potential risks and minimise them. The success or failure of any pharmacovigilance activity depends on the reporting of suspected adverse reactions. WHO has played a vital role in promoting the safety of medicinal products as a clinical and public health issue. Duly, the data collected through spontaneous reporting, national pharmacovigilance centres, and the WHO Programme for International Drug Monitoring has led to changes in the labelling of medicines.
- has become an essential tool in providing the necessary infrastructure for drugs programmes. Furthermore, the cost of an effective pharmacovigilance system is notably smaller when compared to the national expenditure on medicines or the cost of managing ADRs.