Permanently the research centers of pharmaceutical laboratories are in search of new drugs that help treat and hopefully cure various diseases. A study was recently released that warns of adverse effects in patients of an experimental Alzheimer’s drug, approved in January in the United States. And of course, when it is published in different media, the questioning of laboratories and the industry in general begins.
What must be understood is that the development and production of a drug goes through different stages before being approved by the health authority and thus can only begin its commercialization. This is where pharmacovigilance comes into play. The World Health Organization (WHO) defines it as “the science and activities related to the detection, evaluation, understanding and prevention of adverse effects of medicines or any other possible drug-related problems”.
In Chile, there is the National Pharmacovigilance Program composed of various health professionals, as well as public and private health organizations and establishments, pharmaceutical laboratories, pharmacies and the Institute of Public Health (ISP). Its objective is to ensure the safety of patients, through the monitoring and evaluation of the benefits v/s risks of the drugs that are in circulation.
In this sense, the pharmaceutical industry has a strong commitment to the safety and efficacy of its products and each of the laboratories has qualified personnel designated to pharmacovigilance, because we know that, although a drug passes all the phases of research, testing and approval to go to market, at that stage is where the product is massified and reaches different patients.
The occurrence of rare or slow-developing adverse reactions can be detected more feasibly during the postmarketing stage. Therefore, pharmacovigilance plays a key role.
In the case we mentioned earlier, the Alzheimer’s drug had been approved in an experimental phase and, of course, some contrary effects are now being measured, but there is still much to investigate and demonstrate. Let’s not think that it is a setback, but an advance for science that brings us closer to finding a cure for this disease.
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