Problems and adverse reactions related to opioid analgesics in Colombia
*Correspondencia: Dra. Melissa Reyes Rueda. Servicio de Medicina del Dolor y Cuidados Paliativos. Instituto Nacional de Cancerología. Calle 1, N.o 9-85. 111511. Bogotá, Colombia. E-mail: melireyesrueda@gmail.com
Introduction: The prevalence of pathologies that generate chronic pain is high (10-40%), as is the use of opioids. In Colombia, these drugs rank among the first in terms of prescriptions and the number of deaths related to their consumption is rising (0.71/1,000,000 inhabitants). This study seeks to characterise opioid-related problems (ORP) and the variables associated with their resolution.
Materials and methods: It is a study based on secondary information. Incidences were calculated using Ministry of Health data and characteristics related to non-recoverable adverse reactions (ADRs) were determined.
Results: Altogether 4,437 problems were identified in 3,063 patients (39.51%, male), adults (45 years old; IQR: 29-62). The most common opioids were tramadol (46.49%, 5 mg; IQR: 5-5) and morphine (19.65%, 3 mg; IQR: 2.6-5). The majority of ORP were ADRs (93.15%) and of these, 32.28% were severe. Women had proportionally more gastrointestinal and neurological disorders, while men had a higher frequency of vascular, psychiatric, urinary and haematological problems (p < 0.05). These reactions did not resolve in 8.39%, and prognosis was associated with oral administration - odds ratio (OR): 9.24; 95% confidence interval (CI 95%): 6.36-13.42; severity (OR: 3.96; CI 95%: 2.71-5.76); age (OR: 1.01; CI 95%: 1.001-1.01); weak opioids (OR: 0.57; CI 95%: 0.4-0.84); and neurological-cardiovascular reactions (OR: 0.36; CI 95%: 0.21-0.61).
Conclusions: Interventions to optimise the prescription of opioids should be encouraged to prevent ADRs with poor prognosis. Studies should be conducted to further investigate the impact of gender and route of administration on the occurrence of ADRs, as well as the severity of skin and gastrointestinal problems, which may be underestimated.
Materiales y métodos Es un estudio basado en información secundaria. Se calcularon las incidencias con datos del Ministerio de Salud y se determinaron las características relacionadas con reacciones adversas (RAM) no recuperables.
Resultados Se identificaron 4.437 problemas en 3.063 pacientes (39,51%, hombres), adultos (45 años; RIC: 29-62). Los opioides más comunes fueron tramadol (46,49%, 5 mg; RIC: 5-5) y morfina (19,65%, 3 mg; RIC: 2,6-5). La mayoría de los PRM fueron RAM (93,15%), y de éstas, el 32,28% fueron graves. Las mujeres presentaron proporcionalmente más alteraciones gastrointestinales y neurológicas, mientras que los hombres tuvieron una mayor frecuencia de problemas vasculares, psiquiátricos, urinarios y hematológicos (p < 0,05). Estas reacciones no se resolvieron en el 8,39% y el pronóstico se asoció con la administración oral odds ratio (OR): 9,24; intervalo de confianza al 95% (IC 95%): 6,36-13,42, gravedad (OR: 3,96; IC 95%: 2,71-5,76), edad (OR: 1,01; IC 95%: 1,001-1,01), opioides débiles (OR: 0,57; IC 95%: 0,4-0,84) y reacciones neurológicas-cardiovasculares (OR: 0,36; IC 95%: 0,21-0,61).
Conclusiones Se sugiere fomentar intervenciones para optimizar la prescripción de opioides y así prevenir RAM con pobre pronóstico. Deben realizarse estudios que profundicen en el impacto del sexo y la vía de administración sobre la ocurrencia de RAM, así como la gravedad de los problemas cutáneos y gastrointestinales, que podría subestimarse.