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The regulation of off-label uses in the EU, EU Member States, and UK
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
The authorisation phase is followed by the so-called pharmacovigilance phase (also known as “phase IV” of pharmaceutical development).21 The WHO defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem”.22 While phase I to III clinical trials assess the efficacy and safety of any medicinal product before it is put into circulation, the information produced during the pre-authorisation phases cannot capture all possible adverse reactions to product use.23 This is due to several different reasons. First, experimental subjects are limited in number. Thus, clinical trials cannot reproduce all possible conditions that can be found in clinical practice. Also, certain special groups of patients might not be represented, and information about drug interaction might not be available. Secondly, the duration of the test is relatively short. Therefore, clinical trials cannot catch long-term effects of medicine use. These factors prevent the discovery of all the adverse reactions a drug may produce before it is put onto the shelves. This is why pharmacovigilance is needed.24
Designing and Running a Clinical Trial
Published in Trevor F. Cox, Medical Statistics for Cancer Studies, 2022
Pharmacovigilance is the detection, assessment and reporting of adverse effects of medicines. Plans have to be drawn up as to how this will happen within the trial. During the course of a trial, patients can experience one or more of the following, Adverse Event (AE), e.g. mild nausea when the patient does not usually suffer from nauseaAdverse Reaction (AR), e.g. a rash which is related to the drug being takenSerious Adverse Event (SAE), e.g. severe nausea leading to hospitalisationSerious Adverse Reaction (SAR), e.g. kidney damage caused by the drugSuspected Unexpected Serious Adverse Reaction (SUSAR), e.g. death of a patient when this was unexpected; SUSARs have to be reported promptly to the MHRA and the relevant ethics committee.
Ayurveda
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
Subhadip Banerjee, Sayan Biswas, Pulok K. Mukherjee
Pharmacovigilance is the practice of monitoring, evaluating and communicating drug safety with insightful suggestions that is subject to the reliability and cooperative responsibility of all parties, such as consumers, health professionals, researchers, academic, media, pharmaceutical industry, drug regulators, governments and international organisations. The main aim of pharmacovigilance is to spread the safety monitoring and detection of any adverse drug reactions that have previously been unrecognised in the evaluation of a clinical trial. These quality issues can be addressed to some degree by improved regulation requiring GMP standards for manufacturing. Pharmacovigilance is an indispensable tool for increasing reliable information on the safety of AM. The existing systems were developed for synthetic medicines and require some modification to address the specific differences of AM. Organised pharmacovigilance is indispensable to gather reliable information on the safety of herbal medicines for the development of appropriate guidelines for their safe and effective use (Mukherjee et al. 2010).
Vismodegib (ERIVEDGE) pregnancy prevention programme: assessment of risk awareness
Published in Journal of Dermatological Treatment, 2022
Gabriel Schnetzler, Miguel Cuberos, Reinhard Bucher, Katja Stassen, Roberto Mingrino
According to 2012 European Medicines Agency (EMA) Good Pharmacovigilance Practice Module V guidance, the overall aim of conducting a risk management plan (RMP) for a particular medicinal product is to ensure that the benefits of the product exceed the risks by the greatest achievable margin (11). Thus, all pharmaceutical companies are required to submit an EU RMP to the EMA when applying for a marketing authorization; the EU RMP includes routine risk-minimization measures (RMMs), such as pack-size restrictions, suitable wordings in patient information leaflets, and summary of product characteristics for all medicinal products. Most safety concerns are usually adequately addressed by routine RMMs, but additional RMMs (aRMMs) may be necessary to address specific safety issues (12). Apart from detailing RMMs and aRMMs, the EMA requires that EU RMPs include a plan for the periodic monitoring of these measures to ensure that risk information is being communicated effectively (12).
Collaboration between patient and pharmacovigilance organizations to gain insight into adults’ experiences with drug use and ADRs for the treatment of ADHD
Published in Expert Opinion on Drug Safety, 2019
Gerda Weits, Linda Härmark, Jenny Hartman, Agnes Kant
Patient involvement in pharmacovigilance is more than patient reporting. Patients should also be actively engaged in pharmacovigilance decision-making and were therefore also included in the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA), the central decision-making body concerning pharmacovigilance issues in Europe [7,8]. EMA holds public hearings when the evaluation of a drug safety issue is discussed. The relevant risk minimization options will be enhanced by listening to patients’ views. To maximize the input of patient participation, it is important to increase the capacities and capabilities of well-informed patients and patient organizations so that they can be effective advocates and advisors. The consortium project ‘European Patients’ Academy on Therapeutic Innovation’ (EUPATI) helps patients and patient organizations in this matter by providing scientifically reliable, objective, and comprehensive information on medicine research and development [9].
Pharmacological treatment of pediatric Gaucher disease
Published in Expert Review of Clinical Pharmacology, 2018
Punita Gupta, Gregory Pastores
Overall, ERT as a modality is very safe for all ages and all GD subtypes. Safety has been documented in clinical trials, through pharmacovigilance programs by each of the manufacturers, and via disease or drug registries. Death or irreversible damage due to severe drug-related adverse events has not been reported. Only a few cases have developed anaphylactic reactions, typically during the first or second infusion, and most reported adverse events (AEs) are mild to moderate in severity and transient and do not lead to discontinuation of therapy. Allergic reactions are efficiently managed by use of premedication, by slowing the infusion rate or by switching to another ERT. Anti-drug antibodies have been reported in 1 to 53% of treated patients (see Table 1), but usually, they were not associated with anaphylactic reaction or with suppressed response to ERT [39].