Vial Sharing of High-Cost Drugs to Decrease Leftovers and Costs: A Retrospective Observational Study on Patisiran Administration in Bologna, Italy.

Waste of high-cost medicines, such as orphan drugs, is a major problem in healthcare, which leads to excessive costs for treatments. The main objective of this study was to evaluate the impact of a vial-sharing strategy for patisiran, an orphan drug used for the treatment of hereditary transthyretin-mediated amyloidosis, in terms of a reduction in the discarded drug amount and cost savings. The retrospective observational study was conducted in a tertiary referral center (Emilia-Romagna, Italy), between February 2021 and November 2022. Data on drug waste were calculated as "(mg used-mg prescribed)/mg prescribed" for each session. We found a statistically significant (-9.14%, p < 0.001, 95% CI 5.87-12.41) absolute difference in mean discarded drug rates per session based on the study phase (before and after vial-sharing introduction) at the two-sample t-test. The absolute difference corresponded to a percentage decrease in the average reduction in the discarded drug rate with vial sharing of 82.96% per session. On an annual scale, the estimated cost savings was EUR 26,203.80/year for a patient with a standard body weight of 70 kg. In conclusion, we demonstrated that a patisiran vial-sharing program undoubtedly offsets some of the high costs associated with this treatment. We suggest that this easy-to-introduce and cost-effective approach can be applied to the administration of other high-cost drugs.

The impact of statin therapy on in-hospital prognosis and endothelial function of patients at high-to-very high cardiovascular risk admitted for COVID-19.

Statins may protect against adverse outcomes from Coronavirus disease 2019 (COVID-19) through their pleiotropic effects. Endothelial dysfunction seems to be implicated in the pathophysiology of COVID-19, and can be attenuated by statins. This study assessed the role of preadmission statin therapy and its interaction with endothelial function, measured using flow-mediated dilation (FMD) at hospital admission, in predicting in-hospital outcomes among patients with COVID-19 having high-to-very high cardiovascular (CV) risk. We conducted a retrospective cohort study of hospitalized patients with COVID-19 having high-to-very high CV risk, including a subgroup of patients who underwent FMD assessment. Among 342 patients, 119 (35%) were treated with statins at study baseline. Preadmission statin therapy was independently associated with a 75% risk reduction of intensive care unit admission/in-hospital death (adjusted hazard ratio 0.252, 95% confidence interval 0.122-0.521, p < 0.001). In the subgroup of patients with an FMD assessment (245 patients, 40% statin-treated), preadmission statin therapy was independently associated with higher FMD values (ß = 0.159, p = 0.013). However, preadmission statin therapy × FMD interaction was not associated with in-hospital outcomes (F = 0.002, pinteraction = 0.960). Preadmission statin therapy is associated with better in-hospital outcomes among patients with COVID-19 having high-to-very high CV risk, independent of the endothelium-protective effects of these drugs.

The HACOR Score Predicts Worse in-Hospital Prognosis in Patients Hospitalized with COVID-19.

Non-invasive respiratory support (NIRS) is widely used in COVID-19 patients, although high rates of NIRS failure are reported. Early detection of NIRS failure and promptly defining the need for intubation are crucial for the management of patients with acute respiratory failure (ARF). We tested the ability of the HACOR score¸ a scale based on clinical and laboratory parameters, to predict adverse outcomes in hospitalized COVID-19 patients with ARF. Four hundred patients were categorized according to high (>5) or low (≤5) HACOR scores measured at baseline and 1 h after the start of NIRS treatment. The association between a high HACOR score and either in-hospital death or the need for intubation was evaluated. NIRS was employed in 161 patients. Forty patients (10%) underwent intubation and 98 (25%) patients died. A baseline HACOR score > 5 was associated with the need for intubation or in-hospital death in the whole population (HR 4.3; p < 0.001), in the subgroup of patients who underwent NIRS (HR 5.2; p < 0.001) and in no-NIRS subgroup (HR 7.9; p < 0.001). In the NIRS subgroup, along with the baseline HACOR score, also 1-h HACOR score predicted NIRS failure (HR 2.6; p = 0.039). In conclusion, the HACOR score is a significant predictor of adverse clinical outcomes in patients with COVID-19-related ARF.

Initial treatment of hypertension and adherence to therapy in general practice in Italy.

BACKGROUND: Antihypertensive agents are among the most used therapeutic classes. The approach to the pharmacological treatment of hypertension is guided by international recommendations and adherence to treatment is known to result in effective prevention of cardiovascular risk. AIM: The aim of this study was to evaluate the pattern of use of antihypertensive agents in general practice in terms of drug choice for the initial treatment of hypertension and adherence to treatments among newly recruited patients. METHODS: We collected the data of all antihypertensive drugs prescribed by general practitioners (GPs) and reimbursed between January 1998 and December 2002 by a Local Health Authority of Emilia Romagna (Ravenna district, 350,000 inhabitants). We selected subjects aged 40 years and older, permanently living in the area during the whole period of the study, who received their first prescription of antihypertensives between January and December 1999, with no prescription of antihypertensive agents in the previous year. For each patient, we documented the starting regimen and evaluated adherence to treatment in terms of persistence during the years (patients were defined persistent if they received at least one prescription per year) and in terms of daily coverage (patients were defined covered if they received an amount of drugs consistent with a daily treatment). Finally, switches or addition of other therapeutic classes during the 3-year period were identified. RESULTS: A cohort of 6,043 subjects receiving their first antihypertensive treatment in 1999 was obtained. Regarding the starting regimen, monotherapies with angiotensin converting enzyme inhibitors (n = 1,597; 26%) or calcium channel blockers (n = 1126; 19%) were the most frequently prescribed. Of the patients, 21% started with a drug combination regimen. Regarding adherence to treatment, 18% of the cohort received only one prescription throughout the 3 years, 13% received more than one prescription but stopped the therapy during the first year, 69% were persistent during the second year and 60% also during the third year. Only 34% were covered during the first year and 24% also during the second year, whereas only 20% of the patients resulted covered throughout the 3 years. Among persistent patients, 41% maintained the same antihypertensive regimen throughout the 3 years, 25% added other drugs to the initial treatment and 34% switched to completely different regimens. CONCLUSIONS: Our findings reflect the lack of convergence among guidelines on the drug class(es) to be considered as first choice in the initial treatment of hypertension. Although an intervention in this field may have important implications in terms of cost savings, the ongoing debate does not allow us to draw definite conclusions on whether measures should be taken by the National Health Authority. However, the lack of adherence to antihypertensive treatment is undoubtedly a matter of concern for public health and should be addressed with appropriate interventions.

Drug-induced anaphylaxis : case/non-case study based on an italian pharmacovigilance database.

OBJECTIVE: To identify the number of cases of anaphylaxis reported in association with different classes of drugs and compare it with other reports contained in the same database. METHODS: The data were obtained from a database containing all of the spontaneous reports of adverse drug reactions (ADRs) coming from the Italian regions of Emilia Romagna, Lombardy and the Veneto, which are the main contributors to the Italian spontaneous surveillance system. The ADRs reported between January 1990 and December 2003 with a causality assessment of certainly, probably or possibly drug related (according to the WHO criteria) were analysed using a case/non-case design. The cases were defined as the reactions already coded by the WHO preferred terms of 'anaphylactic shock' or 'anaphylactoid reaction' (this last term also included anaphylactic reaction) and those with a time of event onset that suggested an allergic reaction and involved at least two of the skin, respiratory, gastrointestinal, CNS or cardiovascular systems; the non-cases were all of the other ADR reports. The frequency of the association between anaphylaxis and the suspected drug in comparison with the frequency of anaphylaxis associated to all of the other drugs was calculated using the ADR reporting odds ratio (ROR) as a measure of disproportionality. RESULTS: Our database contained 744 cases (including 307 cases of anaphylactic shock with 10 deaths) and 27 512 non-cases. The percentage of anaphylaxis cases reported in inpatients was higher than that among outpatients (59.1% vs 40.9%). This distribution is significantly different from that of the other ADR reports that mainly refer to outpatients. After intravenous drug administrations, anaphylactic shock cases were more frequent than anaphylactoid reactions or other ADRs, but more than one-third of these reactions were caused by an oral drug. Blood substitutes and radiology contrast agents had the highest RORs. Among the systemic antibacterial agents, anaphylaxis was disproportionally reported more often for penicillins, quinolones, cephalosporins and glycopeptides, but diclofenac was the only NSAID with a significant ROR. As a category, vaccines had a significantly lower ROR, thus indicating that anaphylaxis is reported proportionally less than other ADRs. CONCLUSIONS: Anaphylaxis is a severe ADR that may also occur with commonly used drugs. It represents 2.7% of all of the ADRs reported in an Italian spontaneous reporting database.