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Health benefits of an adverse events reporting system for chronic pain patients using long‐term opioids
Author(s) -
Planelles Beatriz,
Margarit César,
Ajo Raquel,
Sastre Yolanda,
Muriel Javier,
Inda MaríadelMar,
Esteban María D.,
Peiró Ana M.
Publication year - 2019
Publication title -
acta anaesthesiologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.738
H-Index - 107
eISSN - 1399-6576
pISSN - 0001-5172
DOI - 10.1111/aas.13243
Subject(s) - medicine , tramadol , pharmacovigilance , adverse effect , opioid , fentanyl , concomitant , pain ladder , polypharmacy , pregabalin , emergency medicine , emergency department , chronic pain , anesthesia , intensive care medicine , analgesic , physical therapy , psychiatry , receptor
Background Safety data from long‐term opioid therapy in the real world has been poorly studied in chronic non‐cancer pain ( CNCP ). The aim was to design a pharmacovigilance data recording system and assess whether participation in this recording system improves pain management, enhancing patient′s health status. Methods A pharmacovigilance data recording system was conducted during 24 months. Data were self‐reported by patients (pain, adverse events [ AE s] and healthcare resources use) and physicians (morphine equivalent daily dose [ MEDD ] prescribed and suspected adverse drug reaction [ ADR s]). Outcomes from patients with (case) or without (controls) suspected ADR s and cases follow‐up were also compared with Spanish Pharmacovigilance System data. Results A total of 753 patients were recruited in 897 visits. Fentanyl and tramadol were the most prescribed opioids, 89% with concomitant drugs, pregabalin being the one with the most potential drug interactions. Cases presented significantly higher pain intensity ( VAS 67 ± 26 vs 59 ± 30 mm, P < 0.05), number of AE s (8 ± 6 vs 5 ± 3 AE s/patient, P < 0.01), polypharmacy related to pain (65% vs 34%, P < 0.01) and MEDD (139 ± 130 vs 106 ± 99 mg/d, P < 0.01) than controls. Furthermore, cases presented significant higher changes in pharmacological pain therapy due to pain, unplanned emergency visits and hospital admission than controls. Physicians notified 168 suspected ADR s mostly related to neurological or psychiatric events and 8% of them were previously unknown. Conclusions This data recording system provided important information to achieve a better control of CNCP pharmacological pain therapy, improving patient's health status and reducing costs to the Health System.