PMID- 30356301
OWN - NLM
STAT- MEDLINE
DCOM- 20190403
LR  - 20190403
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 13
IP  - 10
DP  - 2018
TI  - Implementing a simple pharmacovigilance program to improve reporting of adverse 
      events associated with biologic therapy in rheumatology: Preliminary results from 
      the Calabria Biologics Pharmacovigilance Program (CBPP).
PG  - e0205134
LID - 10.1371/journal.pone.0205134 [doi]
LID - e0205134
AB  - INTRODUCTION: Post-marketing surveillance activities (namely pharmacovigilance) 
      are crucial to favor the early detection of unexpected adverse events (AEs) 
      and/or serious adverse reactions (SAEs). Indeed, spontaneous reporting of AEs has 
      been demonstrated to underestimate the number of events in different clinical 
      settings. Aim of the present study is to report the preliminary data of a 
      Regional (Calabria, Italy) Pharmacovigilance Program (CBPP) aimed at improving 
      AEs' reporting associated with biologics use in rheumatology. MATERIALS AND 
      METHODS: We developed a simple, cost-effective pharmacovigilance program based on 
      regular training sessions for physicians (stimulated reporting), periodical phone 
      calls by a clinical pharmacologist aimed at identifying new events and 
      stimulating self-awareness and encouraging reporting to the physician during the 
      subsequent follow-up visit for minor AEs. To test this approach, all consecutive 
      patients undergoing treatment with one biologic agent at eight rheumatology 
      centers during a two-years period were invited to participate. Collected AEs were 
      compared to the number of AEs spontaneously reported for the same molecules in 
      the same centers before starting the protocol. RESULTS: During the study period, 
      399 patients (245 females; mean age: 58 +/- 11 years) were started on treatment 
      with biologics for active RA (n = 211, 52.9%), PsA (n = 119, 29.8%) or AS (n = 
      69, 17.3%) at eight rheumatology centers. A total of 125 AEs (31.3%) and 9 SAEs 
      (2.3%) were reported during the two-years study period. In the control cohort 
      (comprising 368 consecutive patients started on treatment with bDMARDs during a 
      two-years period before CBPP study) only 42 (11.4%) AEs and no SAEs were reported 
      (p < 0.0001). The most common AEs were injection site reactions and skin 
      disorders. CONCLUSIONS: In conclusion, our study provides further evidence of a 
      critical role of active pharmacovigilance in detection, reporting and analysis of 
      AEs in rheumatology.
FAU - Palleria, Caterina
AU  - Palleria C
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - Iannone, Luigi
AU  - Iannone L
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - Leporini, Christian
AU  - Leporini C
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - Citraro, Rita
AU  - Citraro R
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - Manti, Antonia
AU  - Manti A
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - Caminiti, Maurizio
AU  - Caminiti M
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Unit, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli", 
      Reggio Calabria, Italy.
FAU - Gigliotti, Pietro
AU  - Gigliotti P
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Outpatient Clinic, Azienda Ospedaliera Provinciale Cosenza, Cosenza, 
      Italy.
FAU - Grembiale, Rosa Daniela
AU  - Grembiale RD
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - L'Andolina, Massimo
AU  - L'Andolina M
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Outpatient Clinic, Azienda Sanitaria Provinciale Vibo Valentia, Vibo 
      Valentia, Italy.
FAU - Muccari, Giuseppe
AU  - Muccari G
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Outpatient Clinic, Azienda Ospedaliera "Pugliese-Ciaccio", 
      Catanzaro, Italy.
FAU - Naturale, Maria Diana
AU  - Naturale MD
AUID- ORCID: 0000-0002-5599-1265
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - Olivo, Domenico
AU  - Olivo D
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Outpatient Clinic, Azienda Sanitaria Provinciale Crotone, Crotone, 
      Italy.
FAU - Pagano Mariano, Giuseppa
AU  - Pagano Mariano G
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Unit, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli", 
      Reggio Calabria, Italy.
FAU - Pellegrini, Roberta
AU  - Pellegrini R
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Unit, Azienda Ospedaliera "SS Annunziata", Cosenza, Italy.
FAU - Varcasia, Giuseppe
AU  - Varcasia G
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
AD  - Rheumatology Unit, Ospedale Castrovillari, Castrovillari, Italy.
FAU - Abdalla, Karim
AU  - Abdalla K
AD  - Department of Medical and Surgical Sciences, University of Catanzaro "Magna 
      Graecia", Catanzaro, Italy.
FAU - Russo, Emilio
AU  - Russo E
AUID- ORCID: 0000-0002-1279-8123
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
FAU - Ursini, Francesco
AU  - Ursini F
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
AD  - Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
FAU - De Sarro, Giovambattista
AU  - De Sarro G
AD  - Department of Health Sciences, University of Catanzaro "Magna Graecia", 
      Catanzaro, Italy.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20181024
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biological Products)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Antirheumatic Agents/adverse effects
MH  - Biological Products/*adverse effects
MH  - Biological Therapy/*adverse effects
MH  - Drug Substitution
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Pharmacovigilance
MH  - Physicians
MH  - Preliminary Data
MH  - Rheumatology/*methods
PMC - PMC6200211
COIS- The authors have declared that no competing interests exist.
EDAT- 2018/10/26 06:00
MHDA- 2019/04/04 06:00
PMCR- 2018/10/24
CRDT- 2018/10/26 06:00
PHST- 2018/07/06 00:00 [received]
PHST- 2018/09/19 00:00 [accepted]
PHST- 2018/10/26 06:00 [entrez]
PHST- 2018/10/26 06:00 [pubmed]
PHST- 2019/04/04 06:00 [medline]
PHST- 2018/10/24 00:00 [pmc-release]
AID - PONE-D-18-20039 [pii]
AID - 10.1371/journal.pone.0205134 [doi]
PST - epublish
SO  - PLoS One. 2018 Oct 24;13(10):e0205134. doi: 10.1371/journal.pone.0205134. 
      eCollection 2018.