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)

Palleria, Caterina; Iannone, Luigi Francesco; Leporini, Christian; Citraro, Rita; Manti, Antonia; Caminiti, Maurizio; Gigliotti, Pietro; Grembiale, Rosa Daniela; L’Andolina, Massimo; Muccari, Giuseppe; Naturale, Maria Diana; Olivo, Domenico; Mariano, Giuseppa Pagano; Pellegrini, Roberta; Varcasia, Giuseppe; Abdalla, Karim; Russo, Emilio; Ursini, Francesco; Sarro, Giovambattista De

doi:10.1371/journal.pone.0205134

Cited by 10 publications

(23 citation statements)

References 31 publications

(31 reference statements)

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“…Spontaneous reporting of suspected AEs, and above all programs of active pharmacovigilance, can provide a rapid and early detection of adverse events potentially related to drugs but a high under reporting rate, with an overall estimate of only 6–10% of all AEs described, is widespread [ 9 , 15 ].…”

Section: Discussionmentioning

confidence: 99%

“…The Calabria Biologics Pharmacovigilance Program (CBPP) is a multicentre pharmacovigilance study as previously described [ 9 , 13 ]. Briefly, CBPP is a multicenter pharmacovigilance study aimed at improving the continuous monitoring of safety of treatment with biologic drugs in clinical practice.…”

Section: Methodsmentioning

confidence: 99%

“…Nevertheless, surveillance on adverse events on biologic drugs, as well as other drug classes, is far from being optimal and underreporting is still pervasive, and frequently the spontaneous reporting of AEs underestimates the real number of events [ 9 , 10 ]. Active pharmacovigilance activities may be more useful for the detection and reporting of serious and unexpected AEs [ 8 , 11 ] although some limitations must be considered [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

“…Aim of this active post-marketing study was to monitor and analyse AEs occurring with biologic drugs using the data from the dermatologic area of the active Calabria Biologics Pharmacovigilance Program [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…The ADRs most documented in different studies are those related to infections [14,15,[19][20][21], general manifestations or those associated with the administration of biotech drugs [12,22,23] and those related to the skin or subcutaneous tissues [4,12,23,24]. However, the present study found that the most common ADRs were those related to the respiratory tract, diverging with what was found in other studies where their frequency was much lower (16.8 vs. 3.8-10.8%) [4,12,24], probably because we included in this category infections such as pneumonia and bronchitis, among others, which increased the proportion of respiratory tract-related ADRs.…”

Section: Discussionmentioning

confidence: 99%

Adverse drug reactions associated with the use of biological agents

Machado‐Alba

Jiménez-Morales

Moran-Yela

et al. 2020

Preprint

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IntroductionBiotech drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with serious adverse drug reactions (ADRs).ObjectiveTo identify the ADRs associated with the use of biotech drugs in Colombia.MethodsThis was a retrospective study of ADR reports from 2014 to 2019, contained in the database of the pharmacovigilance program of Audifarma SA. The ADRs, groups of associated drugs, and affected organs were classified.ResultsA total of 5,415 reports of ADRs associated with biotech drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most commonly affected organ system (16.8%), followed by the skin and adnexa (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%).ConclusionsThere has been an incremental increase in the reporting of ADRs associated with the use of biotech drugs in the pharmacovigilance program, related to the strengthening and appropriation of the patient safety culture and improvement in the quality of the generated information. It is important to empower physicians and entire health teams to ensure the traceability of ADRs and to perform interdisciplinary interventions derived from pharmacovigilance at the individual and population levels.

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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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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)

Cited by 10 publications

References 31 publications

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

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

Adverse drug reactions associated with the use of biological agents

Interventions to improve adverse drug reaction reporting: A scoping review

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