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Authors
Abstract(s)
Introdução: As reações adversas a medicamentos (RAM) constituem um problema de saúde
pública e são especialmente graves numa população polimedicada e mais frágil como a
população idosa. Em Portugal, há uma elevada taxa de notificações de RAM referentes à
população idosa, o que levanta a necessidade urgente de se efetuarem estudos de
farmacovigilância nesta área. As enxaquecas e cefaleias primárias são um problema de saúde
com elevada incidência em toda a população, mas há casos específicos de cefaleias
secundárias devido à utilização de medicação, quer seja por sobredosagem, interações
medicamentosas ou mesmo uma resposta prejudicial e não intencional a um medicamento
usado de acordo com autorização de introdução no mercado. A farmacovigilância é um
processo essencial para avaliar e aumentar a segurança dos fármacos, através da
identificação dos fatores de risco e do levantamento de queixas, tentando prevenir a
ocorrência de RAM noutros doentes. Métodos: Foi feita uma pesquisa na base de dados
nacional de farmacovigilância do INFARMED, incluindo todas as notificações referentes a
doentes com idade igual ou superior a 65 anos com o termo LLT ‘headache’ do dicionário
MedDRA, recebidas entre 01/01/2007 e 31/12/2017. Os casos com informação incompleta e
os duplicados foram eliminados. A população foi avaliada quanto à distribuição por género e
idade, bem como a respetiva taxa de polimedicação. As notificações de reações adversas
foram analisadas quanto à classe do(s) medicamento(s) suspeito(s), de acordo com a
classificação ATC (Anatomical Therapeutic Chemical) da Organização Mundial de Saúde, ao
grau de gravidade, relação de causalidade atribuída entre o fármaco e a reação adversa, e
evolução do caso. Foram ainda analisadas as outras reações adversas notificadas que
acompanhavam as cefaleias. Resultados: Neste período de 11 anos foram analisadas 155
notificações que tinham cefaleias como reação adversa. A população analisada era constituída
maioritariamente por doentes do sexo feminino (75%) e da faixa etária dos 65-74 anos (54%).
Cerca de 43% dos doentes estavam a tomar 5 ou mais fármacos simultaneamente, resultando
numa taxa de polimedicação bastante elevada. As classes farmacoterapêuticas dos
medicamentos suspeitos mais comummente reportados foram antivíricos (9%),
antidislipidémicos (8.4%), anti-depressores (6.5%), analgésicos estupefacientes (5.8%) e
bifosfonatos (5.2%). É de realçar que quase metade das notificações (46%) foram consideradas
graves. Foram relatadas diversas outras reações adversas além das cefaleias, de entre as
quais as mais comuns foram tonturas (18.7%), alterações de visão (15.5%) e náuseas (15.5%).
Discussão e conclusões: De acordo com os resultados deste estudo, deve existir maior
cuidado ao prescrever analgésicos estupefacientes, anti-depressivos e anti-dislipidémicos
nesta população, optando por medidas não farmacológicas ou por outras classes de
medicamentos. Nos doentes idosos é necessário ter-se atenção às doses dos medicamentos,
que devem ser ajustadas, devido às alterações fisiológicas que ocorrem com o avançar da
idade. Sugere-se ainda a elaboração de estudos clínicos na população idosa, antes ou após a comercialização dos medicamentos, tendo em conta que neste momento os idosos raramente
são incluídos nos ensaios clínicos, e é necessário avaliar a segurança dos fármacos para estes
doentes. Também os profissionais de saúde, em todos os níveis de cuidados, devem estar
alertados para a necessidade de monitorizar a terapêutica e notificar eventuais RAM,
promovendo o bem-estar dos doentes idosos e o uso seguro do medicamento.
Background: Adverse drug reactions (ADR) are a public health concern and are specially serious in the elderly population, which is usually polymedicated and more fragile than others. In Portugal there is a high rate of ADR reports referring to the elderly, which brings us the urgent need to make new pharmacovigilance studies about this special population. Migraines and primary headaches are a health problem with high incidence across the general population, but there are cases where secondary headaches can happen due to medication use, either because of overdosing, drug-drug interactions or due to a harmful and unintended response to a medicinal product used under a marketing authorization. Pharmacovigilance is a key process to assess and increase the safety of drugs, through identification of the risk factors and safety signs, with the goal of preventing ADR. Methods: We performed a search on the national pharmacovigilance database, including all ADR reports related to patients aged 65 and older, with the LLT term ‘headache’ from the MedDRA dictionary, received between 01/01/2007 and 31/12/2017. Incomplete or duplicate reports were eliminated before analysis. The population was assessed as to gender and age distribution, and also the rate of polymedication. ADR reports were evaluated on the pharmacotherapeutical classes of the suspect drugs, according to the ATC (Anatomical Therapeutic Chemical) of the World Health Organization, severity and outcome of the ADR, and its causality relationship with the drugs. ADR reported other than but simultaneously with headaches were also evaluated. Results: We analysed 155 ADR reports during a period of 11 years. The majority of the population was from the female sex (75%), and was between 65-74 years old (54%). 43% of the patients were taking 5 or more drugs at the same time, which gives us a rather high polymedication rate. The pharmacotherapeutical classes of drugs most represented were antivirals (9%), antidislypidemics (8.4%), antidepressants (6.5%), narcotic painkillers (6.8%), and bisphosphonates (5.2%). We must point out that almost half of the reports (46%) were considered serious. There was a number of ADR besides headaches, of which the most common were dizziness (18.7%), visual disturbances (15.5%) and nausea (15.5%). Discussion and conclusions: According to this study, narcotic painkillers, antidyslipidemics and antidepressives should be avoided, and we should insist on non-pharmacological measures or other drug classes as alternatives. Because of the physiological changes that happen with ageing, we should take caution and adjust the doses and drug classes we use in these patients. We suggest there should be clinical trials done on the elderly population, before or after marketing, because at the moment these patients are often left out from the trials, and there is information lacking on the safety of drugs for this population. Also, all health care providers should be prepared to monitor drug therapies, promoting patients’ well-being and the safe use of medications.
Background: Adverse drug reactions (ADR) are a public health concern and are specially serious in the elderly population, which is usually polymedicated and more fragile than others. In Portugal there is a high rate of ADR reports referring to the elderly, which brings us the urgent need to make new pharmacovigilance studies about this special population. Migraines and primary headaches are a health problem with high incidence across the general population, but there are cases where secondary headaches can happen due to medication use, either because of overdosing, drug-drug interactions or due to a harmful and unintended response to a medicinal product used under a marketing authorization. Pharmacovigilance is a key process to assess and increase the safety of drugs, through identification of the risk factors and safety signs, with the goal of preventing ADR. Methods: We performed a search on the national pharmacovigilance database, including all ADR reports related to patients aged 65 and older, with the LLT term ‘headache’ from the MedDRA dictionary, received between 01/01/2007 and 31/12/2017. Incomplete or duplicate reports were eliminated before analysis. The population was assessed as to gender and age distribution, and also the rate of polymedication. ADR reports were evaluated on the pharmacotherapeutical classes of the suspect drugs, according to the ATC (Anatomical Therapeutic Chemical) of the World Health Organization, severity and outcome of the ADR, and its causality relationship with the drugs. ADR reported other than but simultaneously with headaches were also evaluated. Results: We analysed 155 ADR reports during a period of 11 years. The majority of the population was from the female sex (75%), and was between 65-74 years old (54%). 43% of the patients were taking 5 or more drugs at the same time, which gives us a rather high polymedication rate. The pharmacotherapeutical classes of drugs most represented were antivirals (9%), antidislypidemics (8.4%), antidepressants (6.5%), narcotic painkillers (6.8%), and bisphosphonates (5.2%). We must point out that almost half of the reports (46%) were considered serious. There was a number of ADR besides headaches, of which the most common were dizziness (18.7%), visual disturbances (15.5%) and nausea (15.5%). Discussion and conclusions: According to this study, narcotic painkillers, antidyslipidemics and antidepressives should be avoided, and we should insist on non-pharmacological measures or other drug classes as alternatives. Because of the physiological changes that happen with ageing, we should take caution and adjust the doses and drug classes we use in these patients. We suggest there should be clinical trials done on the elderly population, before or after marketing, because at the moment these patients are often left out from the trials, and there is information lacking on the safety of drugs for this population. Also, all health care providers should be prepared to monitor drug therapies, promoting patients’ well-being and the safe use of medications.
Description
Keywords
Cefaleias Farmacovigilância Idoso Polimedicação Reação Adversa A Medicamentos