PMID- 30109708
OWN - NLM
STAT- MEDLINE
DCOM- 20200210
LR  - 20200210
IS  - 1399-6576 (Electronic)
IS  - 0001-5172 (Linking)
VI  - 63
IP  - 2
DP  - 2019 Feb
TI  - Health benefits of an adverse events reporting system for chronic pain patients 
      using long-term opioids.
PG  - 248-258
LID - 10.1111/aas.13243 [doi]
AB  - 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 [AEs] 
      and healthcare resources use) and physicians (morphine equivalent daily dose 
      [MEDD] prescribed and suspected adverse drug reaction [ADRs]). Outcomes from 
      patients with (case) or without (controls) suspected ADRs 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 AEs (8 +/- 6 vs 5 +/- 3 
      AEs/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 ADRs 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.
CI  - (c) 2018 The Acta Anaesthesiologica Scandinavica Foundation. Published by John 
      Wiley & Sons Ltd.
FAU - Planelles, Beatriz
AU  - Planelles B
AD  - Pain Unit, Alicante Department of Health-General Hospital, Alicante, Spain.
AD  - Neuropharmacology on Pain (NED), Research Unit, Department of Health of 
      Alicante-General Hospital, ISABIAL, Alicante, Spain.
FAU - Margarit, Cesar
AU  - Margarit C
AD  - Pain Unit, Alicante Department of Health-General Hospital, Alicante, Spain.
AD  - Neuropharmacology on Pain (NED), Research Unit, Department of Health of 
      Alicante-General Hospital, ISABIAL, Alicante, Spain.
FAU - Ajo, Raquel
AU  - Ajo R
AD  - Neuropharmacology on Pain (NED), Research Unit, Department of Health of 
      Alicante-General Hospital, ISABIAL, Alicante, Spain.
FAU - Sastre, Yolanda
AU  - Sastre Y
AD  - Pain Unit, Alicante Department of Health-General Hospital, Alicante, Spain.
FAU - Muriel, Javier
AU  - Muriel J
AD  - Neuropharmacology on Pain (NED), Research Unit, Department of Health of 
      Alicante-General Hospital, ISABIAL, Alicante, Spain.
FAU - Inda, Maria-Del-Mar
AU  - Inda MD
AD  - Neuropharmacology on Pain (NED), Research Unit, Department of Health of 
      Alicante-General Hospital, ISABIAL, Alicante, Spain.
FAU - Esteban, Maria D
AU  - Esteban MD
AD  - Operative Research Center, Miguel Hernandez University, Elche, Spain.
FAU - Peiro, Ana M
AU  - Peiro AM
AUID- ORCID: 0000-0002-2385-3749
AD  - Pain Unit, Alicante Department of Health-General Hospital, Alicante, Spain.
AD  - Neuropharmacology on Pain (NED), Research Unit, Department of Health of 
      Alicante-General Hospital, ISABIAL, Alicante, Spain.
AD  - Clinical Pharmacology Unit, Alicante Department of Health-General Hospital, 
      Alicante, Spain.
LA  - eng
GR  - BF4-15-04/Spanish Pain Foundation/International
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180814
PL  - England
TA  - Acta Anaesthesiol Scand
JT  - Acta anaesthesiologica Scandinavica
JID - 0370270
RN  - 0 (Analgesics, Opioid)
RN  - 39J1LGJ30J (Tramadol)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*adverse effects/therapeutic use
MH  - Chronic Pain/*complications/drug therapy
MH  - Female
MH  - Fentanyl/adverse effects/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Outpatients
MH  - Pain Management
MH  - Pharmacovigilance
MH  - Physicians
MH  - Retrospective Studies
MH  - Self Report
MH  - Tramadol/adverse effects/therapeutic use
OTO - NOTNLM
OT  - chronic non-cancer pain
OT  - opioids
OT  - patient's reports of adverse events
OT  - pharmacovigilance data recording system
OT  - suspected adverse drug reaction
EDAT- 2018/08/16 06:00
MHDA- 2020/02/11 06:00
CRDT- 2018/08/16 06:00
PHST- 2017/07/26 00:00 [received]
PHST- 2018/06/14 00:00 [revised]
PHST- 2018/07/19 00:00 [accepted]
PHST- 2018/08/16 06:00 [pubmed]
PHST- 2020/02/11 06:00 [medline]
PHST- 2018/08/16 06:00 [entrez]
AID - 10.1111/aas.13243 [doi]
PST - ppublish
SO  - Acta Anaesthesiol Scand. 2019 Feb;63(2):248-258. doi: 10.1111/aas.13243. Epub 
      2018 Aug 14.