BackgroundSince 2009, the Surgical Block Pharmacy has been involved in the management of medical devices (MD) via centralisation, the use rationalisation and the production of procedural kits (standardised MD sets including sutures, syringes and scalpels, associated with one or more surgical procedure).Since June 2016, the production of kits has been implemented with eye surgery, first cataract surgery and intravitreal injections, and, since January 2017, with all types of eye surgery.Kit composition is periodically reviewed by the pharmacist through the analysis of unused MD returned to the pharmacy.PurposeTo optimise kit contents, to improve logistics and to streamline daily delivery processes.Material and methodsWe analysed unused MD returned to the pharmacy from the ophthalmic operating room for every kit in the first 4 months of 2017.MD returned to the pharmacy were analysed via a query of the logistic software.Our focus was concentrated on the most critical kits, identified by unused MD returned ≥50%.Once the critical MD was identified, we estimated whether the quantity was to be reduced or the MD should be removed.Subsequently, the change was proposed to the operating room staff, to be accepted and approved by the head physician.At the same time, kit content was re-evaluated, if necessary with the addition of other MD.ResultsTwenty-five different types of kits were prepared for eye surgery.Fifteen kits had unused MD returned to the Pharmacy ≥50% and all were analysed.Contents of 11 kits (73%) were revised: in particular, 30 MD were removed (26% of unused MD returned and analysed) and the amount of nine MD was reduced (8%).For MD removed from kits, a storage space was provided in the operating room cabinet.We replaced two MD and added one MD.In addition, new kits will be created for specialised surgery.Conclusion?Analysis of unused MD returned is useful for identification of critical issues and for standardisation-optimisation (the most difficult requirement), significantly reducing MD amount returned to the pharmacy, which negatively affects working time.We cleared human resources’ activity that can be used to implement the Surgical Block Pharmacy activity and increase kthe production of kits.In this way operating rooms’ needs can be met, confirming the efficiency of our system.No conflict of interest
BackgroundOncology drugs feature multiple adverse effects, however, physicians often consider toxicity acceptable and focus on the outcome, providing tools to deal with unavoidable side effects. The threshold of evaluation of adverse drug reactions (ADR) is different from other areas and many adverse effects are so predictable that are not even considered.PurposeTo record the toxicity reported in our hospital for patients receiving cancer treatment, to perform a quantitative evaluation, and to estimate the culture of pharmacovigilance in this field.Material and methodsWe analysed ADR reports included in the National Network of Pharmacovigilance in 2014, and then sorted the ADR reports by category: antineoplastic agents and immunomodulators. We identified: the type of drug, active ingredients most reported, seriousness of the symptoms experienced and their resolution.ResultsDuring the reporting period, there were 67 ADRs. 74% involved injectable drugs and more than half (61%) related to generics/biosimilars. Major toxicity was reported for: oxaliplatin (10), paclitaxel (9), filgrastim (7, 5 non-response to treatment), carboplatin (6), Afinitor and docetaxel (5). 81% were non-serious reactions. All were known and reported in drug leaflets. Most adverse reactions occurred during drug administration or the following days. Regarding outcome, 48% completely resolved (reversible toxicity in a short period), 27% improved and only 3% had a resolution with sequelae. There were no drug related deaths. 1 ADR was caused by a medication error and 1 involved an off-label use.ConclusionData collected showed ADR reporting related to injectable drugs and generics/biosimilars. ADRs were mostly not serious, did not become chronic and were known; we can therefore suspect an important phenomenon of under reporting. In onco-haematology there have been many new drugs launched on the market (many oral), and for many of them the safety profile needs to be further evaluated: pharmacovigilance is an important resource. The pharmacist has a key role in raising awareness of the problem, but also in encouraging appropriate reporting.No conflict of interest.
BackgroundVinorelbine is an antineoplastic drug belonging to the family of vinca alkaloids. Initially it was marketed for intravenous use and then it was made available as an oral formulation, to improve access and adherence to treatment, and to reduce procedures and costs of hospitalisation. Metronomic chemotherapy, compared with traditional schedules, is based on more frequent administration of low dose drugs, with the aim of preventing tumour angiogenesis.PurposeTo investigate the use of metronomic chemotherapy with oral vinorelbine in our hospital; an epidemiological analysis and an economic evaluation were performed.Material and methodsWe examined prescriptions of vinorelbine and discharge sheets of oncology outpatient visits in 2015. We analysed the costs of the treatment schedules.Results31 patients were treated with oral vinorelbine, 18 (58%) with the metronomic schedule (off-label) for metastatic breast cancer (15) and metastatic non-small cell lung cancer (3). Mean age was 69 years (range 43–85); almost all patients were women (30/31) and with a good performance status at the beginning of treatment (12 PS 0, 5 PS 1, 1 missing). 15 patients had progressive disease and 3 were partially responding. Mean length of this type of chemotherapy was 3 months, with good compliance and tolerance. In 2015, consumption of oral vinorelbine increased (+380% vs 2014), while consumption of the injectable formulation decreased (−44%). Direct costs of the oral formulation of vinorelbine (both metronomic and traditional schedule) were higher than the direct costs of the intravenous formulation; for the latter, we must however add the costs of hospitalisation and hospital staff for preparation and administration of the drug.ConclusionWe can explain the rise in consumption of the oral formulation with the use of metronomic therapy and with an increase in the number of patients. The metronomic schedule was used as maintenance therapy and the preferred candidate is the elderly patient, a unique setting where the risk/benefit ratio of any antineoplastic treatment should be carefully evaluated. Metronomic chemotherapy with oral vinorelbine is an appealing option for patients who express their preference for oral chemotherapy.No conflict of interest
Background Immunostimulating and immunosuppressive agents for multiple sclerosis (MS) are long-term treatments, often hardly bearable by the patients. In western countries, adherence to the treatment for chronic illnesses comes only to 50%; this is among the main causes of sub-optimal clinical results, as well as inappropriate spending. Purpose To try to use a financial compensation tool (called File F) as an epidemiological database to verify treatment adherence of MS patients followed at our centre. Materials and methods File F is a tool for tracking non-reimbursed drug compensation through the hospitalisation and outpatient rates, used in some regions as a means of compensation between different Local Health Authorities belonging to the same region or between hospitals and Local Health Authorities. We analysed the adherence to treatment of patients with MS using the indicator “proportion of days covered” (PDC) which identifies a threshold value of 80% beyond which the patient can be defined as adhering to the therapy. The analysis was performed on data extrapolated from the administration database. Results We analysed all the dispensed prescriptions data of 5 years (2008–2012) for a total of 203 patients (136 women with average age 47 years, 67 men with average age 46 years). The average incidence per year of new cases of disease was 0.107 with a trend to reduce over the 5-year period. 66% did not make changes to the treatment during the period, 26% used 2 drugs, 6% tried 3 drugs and 1.5% had used 4 medicines. There was no correlation between the time of the observation of treatment and the number of switches (R2 = 0.035). The PDC indicator shows that only 6.4% of the patients had a percentage adherence less than 80%. Analysing by the individual drugs showed that the mean adherence was greater for fingolimod, worse for patients who use interferon beta-1a by 44 mcg. In this subgroup there was no statistically significant difference (P = 0.6) between those who used the pen rather than the syringe (91.5% vs. 90%). Conclusions The administration database turned out to be as a rich tool of information and easy to use. The adherence to treatment was in reality very high. The few patients who have shown a figure less than 80% are primarily in treatment with injected forms of the drug, and this showed that there was less compliance for this route of administration than for the oral route. The pen does not seem to particularly facilitate administering the treatment. For people with low grip ability we will compare with the neurologists in order to explore the causes and effects adding to the analysis with data from the region. No conflict of interest.
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