Safety assessment of essential medicines for elderly people: a bibliographic survey

Abstract

Certain medicines are considered potentially inappropriate (PIM) for elderly people as they increase the risk of adverse drug events (ADE) and because safer alternative therapies are available on the market. In this context, in order to identify the instruments that assess the quality of medical prescriptions for elderly and to determine which drugs are considered PIM, a bibliographic survey was conducted in PUBMED, LILACS and PAHO databases, in February and March/2010. The search strategy included the use of health descriptors and a manual search in the references cited by selected papers. During the period of data collection, 15 instruments were identified. In 2012, with the publication of the update of Beers criteria, this instrument was included in the study. We identified 163 PIM of 25 therapeutic classes, of which 125 (76.7%) are marketed in Brazil. Of these, 31 (24.8%) are essential medicines (RENAME 2012), of which 13 have safer therapeutic equivalents and 19 (15.2%) are over-the-counter drugs. Data suggest the need for inclusion of safer alternatives for the elderly in the national list of essential medicines and the pharmaceutical care for early detection of ADE in this age group, in order to contribute to the safe use of medicines.Uniterms: Aged/medicines prescription. Medication/errors. Medicines/inappropriate prescribing. Medicines/adverse effects/control. Medicines/safety use. Medication/risk assessment/control. Pharmaceutical care.Determinados medicamentos são considerados potencialmente inapropriados (MPI) para idosos, por aumentarem o risco de ocorrência de eventos adversos a medicamentos (EAM) e por existirem alternativas terapêuticas mais seguras. Neste contexto, com o intuito de identificar os instrumentos que avaliam a qualidade das prescrições médicas para idosos e verificar quais medicamentos são considerados MPI, levantamento bibliográfico foi realizado nas bases de dados PUBMED, LILACS e PAHO em fevereiro e março de 2010. Para a seleção dos manuscritos utilizaram-se descritores em saúde e busca manual nas referências bibliográficas dos artigos identificados. No período da coleta de dados, foram identificados 15 instrumentos. Em 2012, com a publicação da atualização da lista de Beers, este instrumento foi incluído no estudo. Foram identificados 163 MPI de 25 classes terapêuticas, dos quais 125 (76,7%) são comercializados no Brasil. Destes, 31 (24,8%) são medicamentos essenciais (RENAME 2012), sendo que para 13 deles há equivalentes terapêuticos mais seguros e 19 (15,2%) são medicamentos isentos de prescrição. Os dados sugerem a necessidade de inclusão de medicamentos mais seguros para idosos na lista nacional de medicamentos essenciais e do monitoramento farmacoterapêutico para a detecção precoce de EAM nesta faixa etária para contribuir com o uso seguro de medicamentos.

Drug administration adjustments for elderly patients with dysphagia: A case report

“…However, it is not the safest drug in this clinical population due to the increased risk of thrombocytopenia and QTc prolongation. 17 Consequently, given these clinical considerations, such as when available specific pharmaceuticals are not optimal for specific patient needs, as indicated here by clinical condition and age, 28 it is imperative to make drug adjustments that are based upon known physicochemical properties and stability, especially when oral intake is compromised by dysphagia, for instance. 17…”

Safety assessment of omeprazole use: a review

“…We take the view that the duration of exposure is likely to increase the likelihood of adverse events, since polypharmacy alone is a risk factor for occurrences of adverse events. 24 Outcomes of therapeutic ineffectiveness and symptom worsening were identified. It was noted that some patients did not respond to omeprazole treatment 13,32,64,70 and that for others, their symptoms worsened.…”

“…4 Thus, there have been studies reporting on the risks (adverse events) of use of omeprazole, such as: (a) gastric proliferative changes; 5 (b) increased creatinine and urea levels, leading to acute interstitial nephritis [6][7][8] and increased risk of developing chronic kidney disease; 9 (c) increased risk of asthma concomitant with gastroesophageal reflux; 10 (d) increased risk of infection by Clostridium difficile; [11][12][13] (e) decreased absorption of vitamin B; 14 (f) steatorrhea caused by cystic fibrosis; 15 (g) fracture with decreased calcium absorption; 16,17 (h) gynecomastia; 18 (i) hypomagnesemia; 19 (j) hyponatremia; 20 (k) spontaneous bacterial peritonitis; 21 l) pneumonia; 22 (m) anaphylactic reactions to omeprazole; 23 and (n) risk of celiac disease. 24 In addition, studies that evaluated the prevalence of hospital admission due to adverse drug events have cited omeprazole among the drugs that were possibly related to hospitalization, thus also suggesting that off-label use of omeprazole occurs frequently. 23,24 Off-label use of drugs consists of their use for unapproved indications and usually occurs among polymedicated patients Side Effects and Adverse Reactions" OR "Risk Assessment" OR "Treatment Outcome" OR "Off-Label Use").…”

“…24 In addition, studies that evaluated the prevalence of hospital admission due to adverse drug events have cited omeprazole among the drugs that were possibly related to hospitalization, thus also suggesting that off-label use of omeprazole occurs frequently. 23,24 Off-label use of drugs consists of their use for unapproved indications and usually occurs among polymedicated patients Side Effects and Adverse Reactions" OR "Risk Assessment" OR "Treatment Outcome" OR "Off-Label Use"). All descriptors used in these search strategies are Medical Subject Headings (MeSH terms).…”

Over-the-counter medications potentially inappropriate for the elderly

“…Seeking to identify the instruments that assess the quality of prescriptions written for the elderly and which drugs could be considered PIM for this age group, Varallo et al 20 (2014) conducted a review of publications on the subject and identified 15 in-struments, including a version of the Beers' criteria before 2015 7 . They considered 15.2% of the over-thecounter drugs sold in Brazil to be PIM for the elderly, a number close to that found by this editorial (14.3%).…”