RESUMO
The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal products, including older medicines such as generic medicinal products with a well-established safety profile. For the latter, the risk management plans no longer contain important risks, considered important safety concerns, on the basis that routine pharmacovigilance activity would not allow their further characterisation. Society assumes that unexpected adverse reactions causally related to pharmacological activity are very unlikely to be detected for such well-established medicines, but important risks can still occur. For these products, a change in the safety profile which is brand or source specific and usually local in nature, associated with failures with the adequate control of quality of manufacturing or distribution are important safety issues. These may be the consequence of manufacturing and pharmacovigilance quality systems that are not fully integrated over the product life cycle (e.g. inadequate control of quality defects affecting one or multiple batches; inadequate impact assessment of change/variation of manufacturing, quality control testing, storage and distribution processes; inadequate control over the distribution channels including the introduction of counterfeit or falsified products into the supply chain). Drug safety hazards caused by the above-mentioned issues have been identified with different products and formulations, from small molecules to complex molecules such as biological products extracted from animal sources, biosimilars and advanced therapy medicinal products. The various phases of the drug manufacturing and distribution of pharmaceutical products require inputs from pharmacovigilance to assess any effects of quality-related issues and to identify proportionate risk minimisation measures that often have design implications for a medicine which requires a close link between proactive vigilance and good manufacturing practice. To illustrate our argument for closer organisational integration, some examples of drug safety hazards originating from quality, manufacturing and distribution issues are discussed. PLAIN LANGUAGE SUMMARY: Monitoring the manufacturing and quality of medicines: the fundamental task of pharmacovigilance Pharmacovigilance is the science relating to the collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products. The collection and assessment of adverse reactions are particularly important in the first decade after marketing authorisation of a drug as the information gathered in this period could help, for example, to identify complications from its use which were unknown before its commercialization. However, when it comes to medicines that have been on the market for a long time there is general acceptance that their safety profile is already well-established and unknown adverse reactions unlikely to occur. Nevertheless, even older medicines, such as generic drugs, can generate new risks. For these drugs a change in the safety profile could be the result of inadequate control of their quality, manufacturing and distribution systems. To overcome such an obstacle, it is necessary to fully integrate manufacturing and pharmacovigilance quality systems in the medicine life-cycle. This could help detect safety hazards and prevent the development of new complications which may arise due to the poor quality of a drug. Pharmacovigilance activities should indeed be included in all phases of the drugs' manufacturing and distribution process, regardless of their chemical complexity to detect quality-related matters in good time and reduce the risk of safety concerns to a minimum.
RESUMO
BACKGROUND: The digital world has undergone an essential metamorphosis in recent years, making the easy sharing of information possible, including those related to pharmacovigilance and the safety aspects of pharmaceutical and other healthcare products. These new interactive ways pose both opportunities and challenges to healthcare/pharmaceutical companies. The Pharmacovigilance Working Group "Ernesto Montagna" of the Italian Society of Pharmaceutical Medicine (SIMeF) decided to carry out a survey to gain a better understanding of the role of pharmacovigilance in digital activities. METHODS: The Pharmacovigilance Working Group "Ernesto Montagna" sent a questionnaire via Computer-Assisted Web Interview (CAWI) technology to the members of the Pharmacovigilance Working Group (N = 257). The questionnaire was composed of 11 questions in four clusters exploring: (i) digital channels and projects implemented by the healthcare/pharmaceutical companies; (ii) governance tools in place for digital channels and projects; (iii) management of adverse events collected from digital channels and projects; (iv) impact of artificial intelligence on pharmacovigilance activities. RESULTS: Ninety-three members of the Group "Ernesto Montagna" completed the questionnaire. The results show that, in the panorama of Italian healthcare/pharmaceutical companies, digital activities are ongoing, but there are still areas of uncertainty: on when a pharmacovigilance team should be involved, on the governance tools and on the guidance to be used to ensure effective governance of digital projects. CONCLUSION: In a scenario which is evolving very quickly, a critical factor is the availability of specific and updated regulations. Scientific societies, such as SIMeF and Farmindustria, the Italian national Pharma-Companies Association, could give a valuable contribution to the development of appropriate guidance together with the competent authorities. PLAIN LANGUAGE SUMMARY: Results of an Italian survey on pharmacovigilance and digital world Background: The digital world allows and makes the sharing of information easy, including information related to the health status of patients and side effects of drugs. Healthcare/pharmaceutical companies are faced with both opportunities and challenges provided by such new ways of interaction among patients and healthcare professionals. The Pharmacovigilance Working Group "Ernesto Montagna" of the Italian Society of Pharmaceutical Medicine (SIMeF) carried out a survey to gain a better understanding of the role of pharmacovigilance in digital activities.Methods: The Pharmacovigilance Working Group "Ernesto Montagna" distributed a questionnaire to the 257 members of the Pharmacovigilance Working Group. The questionnaire was composed of 11 questions exploring: (i) digital channels and projects implemented by the companies; (ii) governance tools in place for digital channels and projects; (iii) management of adverse events collected from digital channels and projects; (iv) impact of artificial intelligence on pharmacovigilance activities.Results: Ninety-three members completed the questionnaire. The results show that digital activities are ongoing in the Italian healthcare/pharmaceutical companies. Despite this, there are still areas of uncertainty, in particular: on when pharmacovigilance team should be involved and on the tools and guidance to be used to ensure effective governance of digital projects.Conclusion: In a scenario that is evolving very quickly, an important factor is represented by the availability of straightforward and updated pharma-regulations and guidelines. Scientific societies like SIMeF and Farmindustria, the Italian national Pharma-Companies Association, could give a valuable contribution to the development of appropriate guidance together with the qualified authorities, in order to coordinate and standardize the approach among pharmaceutical companies.