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- Safety Assessment of Medications in Elderly: Contribution of the Pharmacovigilance SystemPublication . Monteiro, Cristina Sofia de Jesus; Alves, Gilberto Lourenço; Duarte, Ana Paula CoelhoAs a result of the industrialisation and technological and scientific advances in healthcare, there has been a substantial increase in aging of the population worldwide, and Portugal is no exception. In fact, in Portugal, the average life expectancy is increasing and therefore the number of elderly people. Additionally, the proportion of elderly patients with multiple comorbidities is rising, which in turn leads to an increase in medication use and in the risk of adverse drug reactions (ADRs). In fact, ADRs in elderly can be considered a public health problem, having high costs and being a relevant cause of hospitalization and mortality. Pharmacovigilance is the science concerned with the detection, analysis, evaluation, understanding, and prevention of ADRs. It is a fundamental area for the continuous monitoring of the safety of medicines, particularly relevant in the initial periods of the widespread marketing of new drugs, due to relative scarcity of drug safety information available at the time of marketing authorization, which arises, at this stage, essentially based on pre-marketing clinical trials. Pharmacovigilance allows the identification of problems related to the use of drugs, which are often detected in the post-marketing phase. This is essential to prevent and minimize potential iatrogenic risks to the health of patients. Therefore, monitoring the iatrogenicity of medication that particularly affects elderly patients is fundamental to maximize the safety information of medicines in this special population. Additionally, there is an increasing prevalence of elderly patients with diabetes mellitus and musculoskeletal diseases, whereby is important the knowledge generated from real-world pharmacovigilance data to minimize the risk of harm that may occur with drugs used for the treatment of these conditions. The central aim of this work was to characterize the ADRs profile in elderly patients spontaneously reported to the Portuguese Pharmacovigilance System (PPS). Additionally, this work also intended to characterize the ADRs in elderly diabetic patients and to evaluate the safety of non-steroidal anti-inflammatory drugs (NSAIDs) in this age group. For this propose, firstly, all spontaneous ADRs reported to the PPS from 2013 to 2017 were examined. However, considering the aim of this study, ADRs referring to patients aged 65 and over were analysed in higher detail and compared with those reported in non-elderly adults. Secondly, a retrospective analysis of suspected ADRs reports from PPS between 2008 to 2018 was performed, involving patients aged ≥65 years with diabetes mellitus. Finally, it was carried out a comprehensive literature review of NSAIDs safety in elderly patients and, in parallel, considering the same period of time (i.e., 2008-2018), the suspected ADRs related to these drugs reported to a database of pharmacovigilance, for people aged ≥65, were analysed. Reports were analysed in terms of gender of the involved patients, seriousness and type of ADRs, according to the “System Organ Class” from the Medical Dictionary for Regulatory Activities terminology. In the reports with fatal outcome a deeper analysis in terms of “Preferred Term” for each report was performed. In the general analysis of spontaneous reports in the elderly, the most frequent suspected ADRs fall within the categories of general disorders and administration site conditions, and skin and subcutaneous tissue complaints. Regarding the therapeutic agents involved, the antineoplastic drugs were the most commonly implicated. In addition, the antineoplastic and antithrombotic drugs were the most represented pharmacotherapeutic groups of suspected drugs involved in patient’s death. In the analyses of ADRs in elderly diabetic patients, the most frequent were hypoglycaemia and lactic acidosis, and the drugs specifically indicated for glycaemic control were the most frequently involved. Finally, in the literature review performed on NSAIDs safety in elderly patients, most studies concluded that the risk of a gastrointestinal adverse event with the use of cyclooxygenase-2 (COX-2)-selective NSAIDs seems to be lower when compared with conventional NSAIDs. In addition, celecoxib was considered the safest of all other NSAIDs. However, the risk of gastrointestinal events in patients aged ≥75 years taking selective COX-2 inhibitors was higher when compared with younger patients. Additionally, diclofenac was associated with relevant renal adverse events in patients aged 75 years or older as well as in those with some renal impairment. Regarding cardiovascular events the incidence was lower with coxibs than with conventional NSAIDs and celecoxib led to a lower incidence of these events when compared with etoricoxib. In the analysis performed in PPS data most of suspected ADRs had diclofenac as suspected drug. The suspected ADRs most frequently reported fall within the categories of skin and subcutaneous tissue disorders. Serious gastrointestinal ADRs occurred mostly in patients taking more than one NSAID and/or another concomitant drug that increases the incidence of these events, in the absence of gastroprotection. The majority of serious ADRs related to renal and cardiac disorders occurred in patients with history of renal disorders or diabetes mellitus and hypertension, respectively. All the studies performed with the data belonging to PPS concluded that the majority of ADRs were serious, occurred predominantly in female and were expected. Hence, an accurate identification of ADRs, especially the detection of preventable ADRs, is an important starting point to improve drug safety in elderly. Therefore, studies targeting elderly patients are needed to improve the safety information of these drugs in this special population, considering their multiple medical conditions, thus highlighting the importance of active pharmacovigilance. In this context, it is important to emphasize that pharmacovigilance databases are important tools to evaluate issues related to the safety of drugs in older people, enabling to improve the knowledge on the safety profile of medicines in these patients.