The regulation of off-label uses in the EU, EU Member States, and UK
Andrea Parziale in 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
Trevor F. Cox in 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.
Adverse reactions and the proliferation of risk
Kevin Dew in Public Health, Personal Health and Pills, 2018
The fast tracking of drugs and the use of expedited reviews has led to more reliance on the post-marketing assessment of new drugs and reporting of adverse reactions to them (Weatherall 2006) – that is, to a greater reliance on pharmacovigilance mechanisms. Pharmacovigilance is the activity of ‘analysing and managing the risk posed by medications once they have come on to the market’ (Lopez-Gonzalez et al. 2009). We have to be vigilant in assessing the effects of pharmaceuticals. Fatal adverse drug reactions (ADRs) may be as high as the fourth leading cause of death in the US (Lazarou et al. 1998) constituting an important public health problem in terms of mortality, morbidity and cost (Lopez-Gonzalez et al. 2009). As a result of increasing concern to detect adverse drug events, many countries have developed pharmacovigilance systems to collect and monitor data on adverse reactions (Lopez-Gonzalez et al. 2009). The World Health Organization (WHO) Uppsala Monitoring Centre was set up in 1978 as yet another attempt to respond to the thalidomide tragedy (Uppsala Monitoring Centre 2018). It collects and assesses information from the pharmacovigilance systems of WHO member countries, and had received over 9 million case reports of suspected ADRs by 2014 (Uppsala Monitoriing Centre 2014). This is only a fraction of likely reportable ADRs, as 98 per cent of all reports come from high income countries. Given the high rate of ADRs pharmacovigilance activities are important.
Fifteen years of patient reporting –what have we learned and where are we heading to?
Published in Expert Opinion on Drug Safety, 2019
Florence van Hunsel, Linda Härmark, Leàn Rolfes
Until now, patients have mostly been involved in pharmacovigilance as reporters of ADRs. This is in many ways a one-way communication, and we think it is important to make the interaction with patients a two-way communication, to have a dialogue with patients in matters regarding pharmacovigilance. To find out how this interaction can be established, national pharmacovigilance center should enhance their collaboration with patient organizations. Working with patient organizations can be a way for pharmacovigilance centers to have better access to the target group [36] and those active in the patient organization are also very committed. However, working with patient organizations requires time and effort on both sides. A recent European wide study shows that there is varying interest among patient organizations to be involved in pharmacovigilance. Financial restraints and lack of sources and support from National Competent Authorities are seen as the main barriers for patient organizations to being involved in pharmacovigilance [37].
Medication safety knowledge, attitudes and practices among community pharmacists in Lebanon
Published in Current Medical Research and Opinion, 2018
Aline Hajj, Souheil Hallit, Elsy Ramia, Pascale Salameh
Overall, the majority of the responders (employers or employees) had good knowledge concerning the concept and purpose of pharmacovigilance as well as about Adverse Drug Events (ADE). They believe that pharmacovigilance allows the detection, assessment, understanding and prevention of adverse effects and therefore contributes to patient safety and public health as defined by both WHO and FDA3,31. In fact, this system allows assessing the benefits, harm, effectiveness and risk of drugs and medicines which are the primary advantages of ADE reporting as described previously26,32. The majority of the pharmacists knew how to define correctly ADR3 and admitted that they can be reported with any pharmaceutical product or even related to drug related interactions.
Assessment of suspected adverse drug reactions in elderly patients with diabetes mellitus based on a Portuguese spontaneous reporting database: analysis of reporting from 2008 to 2018
Published in Expert Opinion on Drug Safety, 2021
Cristina Monteiro, Samuel Silvestre, Ana Paula Duarte, Gilberto Alves
Due to the limited evidence to justify clinical decisions regarding optimal therapy in older patients and to minimize or prevent adverse drug reactions (ADRs) in this population, studies to analyze suspected ADRs in older patients are of high importance. Therefore, many studies in this scope can be found in the literature, involving, for instance, antidiabetic drugs [1,12,13]. However, retrospective studies on spontaneously reported ADRs using national pharmacovigilance data are very scarce and usually cover diabetic patients belonging to all age groups [7,14,15]. In fact, the knowledge of the most common medications and ADRs induced in elderly patients with diabetes is important to increase the safety of their use. For this, the databases used in pharmacovigilance are important tools to increment this knowledge, and consequently to increase the drug’s safety, having the advantage of identifying hazards associated with medicinal products used in real-world context. Thus, this study intended to analyze the suspected ADRs in older patients with diabetes mellitus reported to the Portuguese Pharmacovigilance System (PPS) in an eleven-year period. In addition, it was assessed if they were known and preventable, the drugs mostly involved and the outcome of each case. With this type of knowledge, generated from real-world pharmacovigilance data, we intend to minimize the risk of harm that may occur and prevent drug-related hospital admissions as well as the morbidity and mortality associated to drugs used by elderly patients with diabetes.
Related Knowledge Centers
- Adverse Drug Reaction
- Adverse Effect
- Adverse Event
- Clinical Trial
- Pharmacy
- Medication
- Preventive Healthcare
- Medical Error
- Health
- Efficacy