Pharmacovigilance: regulation for patient safety

It is now generally agreed that part of the evaluation process of drug safety This needs to happen in the post-marketing (approval) phase, so as not to lose important innovations in an unduly restrictive regulatory network. The decision of whether and how this should be done is in the hands of regulators and pharmacovigilance.

First and foremost, the stronger the national pharmacovigilance and adverse drug reaction (ADR) reporting system, the more likely it is that balanced regulatory decisions will be made for the prompt release of new drugs, promising therapeutic advances.

The role of pharmaceutical companies in patient safety is crucial.

The legislation governing the regulatory process in most countries allows for the establishment of conditions for registration, such as the requirement for thorough pharmacovigilance in the first years after the drug is released to the market. In Brazil, the RDC 200/2017 Brazilian health regulatory agency Anvisa requires the submission of Risk Minimization Plans and Pharmacovigilance Plans when registering medications. Even after commercialization begins, companies must continue their vigilance: both in effectively capturing signals and in processing this data.

To achieve this, companies must implement the Good Pharmacovigilance Practices outlined by... RDC 406/2020 e IN 63/2020 from Anvisa.

However, careful safety monitoring is not limited to new medicines or significant therapeutic advances. It has an important role to play in the introduction of generic medicines and in the review of the safety profile of older medicines already available. This is because new safety issues may have arisen in the latter.

In a developing country, these latter considerations are probably more important than the benefits that a modern therapeutic entity might bring to an already limited healthcare service. While spontaneous reporting remains a cornerstone of pharmacovigilance in the regulatory environment and is indispensable for identifying signals, the need for more active surveillance has also become increasingly clear. Without information on use and extent of consumption, spontaneous reports do not make it possible to determine the frequency of an ADR attributable to a product or its safety in relation to a comparable product. And the role of the healthcare professional in this process is extremely important, as regulated by the... REs 730 e 734/2022from the CFF (Brazilian Federal Council of Pharmacy) when describing the role of the Pharmacist in Pharmacovigilance in the industry or in another health unit.

Therefore, pharmacovigilance is only possible with the action of the healthcare professional and their knowledge of regulation.

More systematic and consistent epidemiological methods that take into account the limitations of spontaneous reporting are needed in post-marketing surveillance. This way, it is possible to better address important safety issues.

There are other aspects of drug safety that have been largely neglected until now. Therefore, it is important to include them in the monitoring of latent and long-term drug effects. These include:

• identification of drug interactions;
• measuring the environmental impact of medicines used in large populations
• assessment of the contribution of "inactive components" (excipients) to the safety profile;
• Systems for comparing safety profiles of drugs in the same therapeutic class.
• Monitoring the adverse health effects of pharmaceutical residues in animals, e.g., antibiotics and hormones.

Pharmacovigilance programs need strong links with regulators. This ensures that authorities are well-informed about safety issues in daily practice, as these may be relevant to future regulatory actions. In this way, regulators understand that pharmacovigilance plays a specialized and fundamental role in ensuring the ongoing safety of medicines.

And you? Do you know how to easily and practically consult pharmacovigilance regulations? The App LegalPharma There's a specific menu for the topic!!!!

Source: The Importance of Pharmacovigilance / World Health Organization – Brasília: Pan American Health Organization, 2005. (Monitoring the safety of medicines).