FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

Fracchiolla, Nicola Stefano; Artuso, Simona; Cortelezzi, Agostino; Pelizzari, Anna Maria; Tozzi, Paola; Bonfichi, Maurizio; Bocchio, Federica; Gargantini, Livio; Rosa, Elisa de Oliveira; Vighi, Giuseppe; Prestini, Lucia; Sammassimo, Simona; Frungillo, Niccolò; Pasquini, Maria Cristina; Ragazzi, A; Boghi, Daniele; Pastore, A.; Lanzi, E.; Gritti, Giuseppe; Quaresmini, Giulia; Voltolini, Simone; Gaiardoni, R.; Corti, Consuelo; Vilardo, Maria C.; Targia, Maria Luisa La; Berini, Giacomo; Magagnoli, Massimo; Bacci, C; Consonni, Dario; Rivolta, A; Muti, Giuliana

doi:10.1002/hon.2451

Cited by 5 publications

(13 citation statements)

References 28 publications

(44 reference statements)

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“…Out of the 90 studies, 16 were from France; eight from Italy; seven from the United States and Spain; six from the United Kingdom and Portugal; four from Iran and India; three from China, Sweden, and Mexico; two from Brazil, Denmark, Israel, Korea, the Netherlands, Switzerland, and the United Arab Emirates; and one each from Chile, Germany, Morocco, Nigeria, Saudi Arabia, South Africa, and Thailand. The interventions were designed as before‐after in 50 of the studies, non‐comparative in 17 studies, randomized controlled trial (RCT) and cluster RCT in nine studies, and other in 14 studies. In addition, most of the studies had been developed on HCPs, particularly physicians.…”

Section: Resultsmentioning

confidence: 99%

“…Various computerized registration methods were used alone (n = 8) or in combination with other interventions (n = 14) in these studies and had a nearly significant effect on reporting (an increase of 0.8 to 72.0‐fold). These studies had been conducted in France, the United States, Spain, China, Portugal, Korea, Mexico, Italy, Taiwan, and the UAE…”

Section: Resultsmentioning

confidence: 99%

“…Some studies deployed online registration, such as an online ADR reporting system, a network‐based electronic notification system, online reporting through the website, and a free smartphone app for receiving the SR of pharmacovigilance. A tool for ADR reporting integrated into the hospital information system was another way for computerizing registration and facilitating reporting .…”

Section: Resultsmentioning

confidence: 99%

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Interventions to improve adverse drug reaction reporting: A scoping review

Khalili

Mesgarpour²,

Sharifi

et al. 2020

Pharmacoepidemiology and Drug

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Purpose Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to improve ADR reporting. The aim of this study was to systematically map interventions and strategies to improve ADR reporting among health care professionals. Methods The six‐stage methodological framework of Arksey and O'Malley was used to conduct this scoping review. Ovid MEDLINE, EMBASE, All EBM, and Web of Science were systematically searched from 1999 to February 2019, and the reference lists of the included papers were also searched for gray literature to identify any interventions and strategies that aimed to increase ADR reporting. Two reviewers screened the papers for eligibility based on the inclusion criteria and extracted their key data and analyzed them descriptively. Results Ninety out of 14 501 papers met the selection criteria. Using computerized registration and active surveillance can increase ADR reporting significantly. Educational interventions performed individually or combined with sending reminders and/or feedback, awards, and providing easier reporting channels can improve ADR reporting over a short to medium term. Multiple interventions may have more impact than single‐component interventions. Conclusion Multiple interventions could cause a greater increase in ADR reporting rates than single interventions. Although educational interventions appear to be effective, few studies have reviewed their long‐term effects to ascertain whether the improvements are sustained over time. Studies with a better methodological quality are required on this subject.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Interventions to improve adverse drug reaction reporting: A scoping review

Khalili

Mesgarpour²,

Sharifi

et al. 2020

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

show abstract

“…Recently, an observational study (BIO-Cam) investigated the occurrence of AEs in naïve patients receiving biologic drugs in several settings (including rheumatology), supporting our findings that pharmacovigilance programs may represent a winning strategy to improve the knowledge of safety profile of these new drugs [ 31 ]. Similarly, the project “FarmaREL” produced a significant increase of spontaneous AEs reporting among hematology specialists [ 32 ]. Finally, an observational study conducted by an Italian National Cancer Institute confirmed the essential role of pro-active pharmacovigilance in increasing spontaneous reporting of AEs associated with anticancer targeted-therapies [ 33 ].…”

Section: Discussionmentioning

confidence: 99%

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)

et al. 2018

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IntroductionPost-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 methodsWe 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.ResultsDuring 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.ConclusionsIn conclusion, our study provides further evidence of a critical role of active pharmacovigilance in detection, reporting and analysis of AEs in rheumatology.

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“…Regarding the ratio of AEs reports related to biologic treatments in our region, a considerable improvement has been achieved in the last four years due to active pharmacovigilance programs, as demonstrated in our previous study in rheumatology [ 9 ] and gastroenterology [ 13 ] and generally such as reported in literature [ 25 , 26 ]. In this study, the number of AEs reported seems to be considerably increased (from 7 to 87) compared to the previous two years in the same centres, although the overall number of patients treated subdivided per drug are mandatory to assess confounding variables and confirm improvement.…”

Section: Discussionmentioning

confidence: 62%

Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study

et al. 2020

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Psoriasis is an inflammatory and chronic skin disorder associated with physical and psychological burden impairing patients’ quality of life. In the last decade, biologic drugs have widely changed treatment of moderate-severe psoriasis and their number is increasing overtime. To early identify expected/unexpected adverse events (AEs) with biologic treatments, pharmacovigilance programs are needed. We designed a post-marketing active pharmacovigilance program to monitor and analyse AEs and/or serious adverse events (SAEs) reports. All consecutive patients treated with one biologic drug during a two-years period and satisfying inclusion criteria have been enrolled in five Dermatology tertiary units. Demographic and clinical features of patients, type of treatment used, therapy discontinuation, failures, switch/swap to another biologic, and possible onset of AEs were collected. Overall, 512 patients with a diagnosis of psoriasis (286; 55.9%) or arthropathic psoriasis (226; 44.1%) have been enrolled. Eighty-two (16%) patients with AEs and 5 (1%) with SAEs have been identified. Further, 59 (11.5%) had a primary/secondary failure (mainly on infliximab and etanercept). The adverse events and SAEs were reported with golimumab (4/12), adalimumab (32/167), infliximab (9/48), etanercept (31/175) and ustekinumab (11/73), no adverse events have occurred with secukinumab (0/37). Infliximab and etanercept were significantly associated with primary/secondary failures, whereas no differences have been highlighted for AEs insurgence. On the other hand, ustekinumab seems to be associated with a low rate of AEs (p = 0.01) and no adverse events or failures have been reported with secukinumab (p = 0.04 and 0.03, respectively). Our study, even though limited by a small sample size and a brief follow-up period , provide useful data on widely used biologic drugs and their tolerability, discontinuation rate and the incurrence of severe adverse events. Further studies are necessary to include the recently approved biologic drugs and to increase the sample size for more detailed analysis.

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FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

Cited by 5 publications

References 28 publications

Interventions to improve adverse drug reaction reporting: A scoping review

Interventions to improve adverse drug reaction reporting: A scoping review

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)

Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study

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