Drug safety and pharmacovigilance remains a dynamic clinical and scientific discipline. Pharmacovigilance is defined by the World Health Organization (WHO) as ’the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It receives information from spontaneous reporting of adverse reactions from healthcare professionals, clinical trials, published medical literature, pharmaceutical companies, healthcare and population statistics and information on the consumption of medicinal products. In some countries, adverse drug reactions (ADRs) rank among the top 10 leading causes of mortality. In order to prevent or to reduce harm to patients and thus improve public health, mechanisms for evaluating and monitoring the safety of medicines in clinical use are vital.
The WHO established its Program for International Drug Monitoring in response to the thalidomide disaster detected in 1961. There exist different pharmacovigilance programs around the globe. Their principal aims are to improve patient/public care and safety in relation to the use of medicines; to contribute to the assessment of effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use; to promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public.
Nowadays, pharmacovigilance is facing lots of challenges to develop better health care systems. Major challenges are globalization, web-based sales and information, broader safety concerns, public health versus pharmaceutical industry economic growth, monitoring of established products, developing and emerging countries, attitudes and perceptions to benefit and harm. In order to face these challenges all parties like public health administration, health professionals, the pharmaceutical industry, government, drug regulators, the media, consumers must strive towards the highest ethical, professional and scientific standards in protecting and promoting safe use of medicines. Policies must be regulated to describe the benefit, harm, effectiveness and risk of medicines so that governments and healthcare personnel may account for.
For future consideration, pharmacovigilance should extend knowledge of safety by encouraging adequate and balanced input of information, constructive basic training, strong collaboration among healthcare professionals and pharmaceutical companies, and clear governmental decisions. All outcomes must be employed based on pre-specified standards to promote the optimum target of ‘good pharmacovigilance practice’.
Audience take away:
• To define pharmacovigilance and recite its aims.
• To highlight recent challenges faced by pharmacovigilance programs and demonstrate suggested solutions.
• To recognize that the provision of good quality and safe and effective use of medicine is the responsibility of governments, healthcare personnel, pharmaceutical companies, researchers and NJOs.
• To infer the need of establishing good pharmacovigilance practices.