Adherence with regulatory resolutions on prevention of NSAIDs-related gastrointestinal injury in Italy

Abstract

Background The rate of gastrointestinal (GI) complications with non-steroidal antiinflammatory drugs (NSAIDs) or low-dose aspirin (LD-ASA) varies according to risk factors. For at risk patients, the Italian regulatory resolution enforce prophylaxis with proton pump inhibitors (PPIs) or misoprostol. Objective This study evaluated the consistency with such resolution in patients receiving NSAIDs or LD-ASA and assessed whether patients continued to receive GI protection with PPIs for an adequate time following NSAID discontinuation. Setting An observational retrospective study was conducted using data from Health District of Pisa. Methods The analysis was performed on patients receiving prescription of NSAIDs or LD-ASA, with or without concomitant PPIs or misoprostol, accordingly with the presence of risk factors (2008-2010). Prescription data were retrieved from the database of reimbursement claims for dispensed drugs, while history of past GI diseases was obtained from primary or secondary discharge diagnosis. Main outcome measure The consistency rates of PPI and misoprostol prescriptions with Italian regulatory rules in patients receiving chronic NSAIDs or LD-ASA. Results 6869 patients, receiving NSAIDs or LD-ASA during the observation period, were eligible for the analysis. For NSAIDs or LD-ASA, gastroprotection rates in patients without risk factors were: 8 and 6 % in 2008; 10 and 8 % in 2009; 9 and 6 % in 2010; while the proportions of patients with one or more risk factors not receiving gastroprotection were: 12 and 17 % in 2008; 25 and 22 % in 2009; 15 and 17 % in 2010. In patients discontinuing chronic NSAIDs, 62 % were maintained on protection with PPIs, but only 28 % continued the PPI treatment for an adequate time (60 ± 7 days). Conclusions The present analysis, although restricted to prescription patterns in a single health district, suggests scarce levels of consistency with Italian regulatory resolution on the prophylaxis of GI adverse events associated with chronic NSAIDs or LDASA.

Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions

“…Preventable cases were detected in all age groups, including infants, adolescents, and elder. This result was expected considering that previous studies have evidenced a widespread inappropriate use of NSAIDs involving both young and elder users in the Italian population (Motola et al, 2004; Scarpignato et al, 2015; Cardile et al, 2016; Montagnani et al, 2016). Moreover, this result is in line with the drug utilization data published by AIFA which evidenced a higher use of preventive measure for gastrolesivity among patients with an age greater or equal to 65 years old that were concurrently exposed to multiple gastrolesive drugs (The Medicines Utilisation Monitoring Centre., 2015).…”

“…As the result of initiatives to improve the identification of medication errors in the individual case safety reports (ICSRs) promoted by World Health Organization (Pal et al, 2015), and recently strengthen in Europe (European Medicine Agency, 2011, 2013), committees were introduced in Italy to meet these new regulatory tasks (Bencheikh and Benabdallah, 2009; Sessa et al, 2016a,d). Although on the Italian national territory evidence was provided regarding the association between inappropriate use of NSAIDs and the risk of experiencing serious and non-serious ADRs (Montagnani et al, 2016; Rafaniello et al, 2016), no studies were conducted to assess the magnitude of their preventability, highlighting the need of gain further insight on this aspect. This is even more important considering that on the National territory, several NSAIDs were sold as over-the-counter medications, which dispensing profile is well known to lead to abuse in their usage, with harms being increasingly recognized (Cooper, 2013).…”

Effective and safe proton pump inhibitor therapy in acid-related diseases – A position paper addressing benefits and potential harms of acid suppression

“…In Europe, the most common inappropriate use of PPI is for the prevention of gastric damage in co-therapy with agents that have a low gastrotoxicity, if any, or in patients without GI risk factors for significant gastroduodenal damage [30, 31, 425–427] as well as in the prevention of stress-induced bleeding [14, 428–430]. PPIs are often started as an inpatient treatment and continued (often long-term) on discharge for non-indicated reasons [14, 431, 432].…”

“…For instance, despite all guidelines supporting the use of gastroprotection with PPIs in at-risk patients treated with NSAIDs [26–28], low prescription rates of gastroprotective medications have been reported, although these rates have increased progressively (for review see [28]). In Italy, three studies [29–31] reported a substantial misuse of gastroprotection in primary care. In particular, an underuse rate of 25 − 30 % or an overuse (young patients without any concomitant risk factor) as high as 57.5 % were observed.…”

Inquérito domiciliar sobre a prevalência do uso de inibidores da bomba de prótons

“…Um estudo europeu mostra que os IBPs continuam sendo prescritos fora das diretrizes de tra-tamento, como prevenção de dano gástrico e hemorragias gástricas decorrentes ocasionadas pelo estresse. Outro motivo é a utilização para pacientes internados que após alta hospitalar continuam com o tratamento, muitas vezes a longo prazo, por razões não indicadas 15,16,17,18 . Thomas e colaboradores avaliaram prescrições de mais de 20.000 pacientes que receberam IBPs de forma inadequada após a internação hospitalar ao longo de um período de 4 anos com custo de aproximadamente 3.000.000 de dólares 19 .…”