BackgroundIntravenous (IV) drug treatment of preterm neonates is affected by: clinical status (i.e. sepsis/infections, immature physiology, pharmacokinetic/pharmacodynamic variation), shortage of ready-to-use formulations, small doses of drug required and the dangers of the IV route.PurposeTo identify the most prescribed IV antibiotics so that ready-to-use formulations can be prepared with standard concentrations (SCs) of drug avoiding handling (reconstitution/dilution) in the ward.Material and methodsThe Hospital Pharmacy, Neonatology and Hygiene Department of “Azienda Ospedali Riuniti-Ancona” conducted this multiphase study. Phase I: a review of IV antibiotics prescribed to preterm (24+0–31+6weeks) Neonatology inpatients from 2004–2013. Phase II: study of pharmaceutical quality and stability of SC (2 mg/ml) gentamicin sulphate (the gold standard in sepsis/infections). Aqueous solutions were prepared by pharmacists in two different ways: with and without filtration. Both batches were stored in polyethylene syringes for 90 days at 2–8°C and 25°C and were examined for: endotoxin absence with the LAL test (Limulus amoebocyte lysate, Endosafe Portable Test System) in accordance with the Italian Pharmacopoeia 12th edition (kinetic-chromogenic technique); sterility test (BacT/ALERT FA, six days of incubation at 36°C) for aerobic bacteria/fungi; quantification with HPLC-MS/MS technique of gentamicin components (C1, C2, C1a) at 0–3–7–14–21–28–60–90 days. Limits of detection (LOD) and quantitation (LOQ) were 0.25 ng. The SC was derived from the usual dose (2.5 mg/kg/12 h) for a 1,000 g patient.ResultsPhase I studies found: 1,011 preterm inpatients (521 males, 420 females), 222 cases of sepsis (52 early, 170 late) and 102 infections. Gentamicin was the most used antibiotic with 1,126 doses for 88 patients per year. Phase II studies certified: sterility (no microbiological growth), absence of endotoxins and stability of GS 2 mg/ml stored 90 days at 2–8°C and 25°C. No significant changes in concentration of gentamicin components: P not significant, t-test >0.05.ConclusionAfter this “pilot study” the next target could be to provide standard concentration unit dose treatments direct from the pharmacy to paediatric patients.References and/or AcknowledgementsNo conflict of interest.

Background There are almost 8,000 rare diseases (RD) (80% are genetically based) and 50% of them affect children. They are often highly complex metabolic diseases (MD): factors include heterogeneity (age of occurrence, aetiopathogenesis and symptomatology), low numbers affected, late diagnosis, lack of curative treatments and multisystem involvement. Decree 279/2001 of Italian Minister of Health instituted the ‘Rare Disease National Web’ and assigns to the Regions the task of finding hospitals and organisations to supply health services. Since 2002 our hospital ‘G. Salesi’ has been the reference centre for Marche Region. Purpose To strengthen cooperation between doctors, pharmacists and health workers, which was spontaneously born of individual needs and emergencies. This is needed to improve the level of treatment, respond to therapeutic/welfare necessities, and treat patients’ extremely complex emergencies. Materials and methods We checked medical records: patients with MD who enter our centre (for diagnosis, treatment and follow-up) and their prescriptions (basic treatment/emergency support). Hospital and regional doctors and pharmacists met in order to lay out shared protocols. Results Our Centre follows 850 RD patients; 27 (13 males and 14 females) with MD: Fabry’s (4), Sandhoff’s (2), Gaucher’s (1), mucopolysaccharidosis (6), organic acidemia (6), glycogenosis (3), leucinosis (1), Niemann-Pick type C (3) and pyruvate dehydrogenase deficiency (1). 59% are children (10 patients <10 years old). 30% need a particular diet, 18% need galenical preparations. 5 Patients have enzyme treatment in day hospital: 2 laronidase, 2 agalsidase alfa, 1 idursulfase. 26% of diagnoses comes from other centres. We wrote up a protocol to manage all the dietetic and therapeutic emergencies and sent it to all operators, especially for emergencies for metabolic acidosis, hyperammonaemia, and methylmalonic aciduria. Conclusions The ‘doctor-pharmacist’ team was born to improve the quality of life of MD patients. The pharmacist’s role consists of: responding to lack of resources/drugs (i.e. galenical preparations suitable for young children), helping doctors in therapeutic decisions, supporting patients and families with their healthcare needs. No conflict of interest.

Background Clopidogrel is a thienopyridine drug that acts by binding selectively and irreversibly to the adenosine diphosphate P2Y12 receptor on platelets. Platelet aggregation is consequently inhibited. Clopidogrel is used to prevent ischemic events in patients at risk, when other drugs fail or are not tolerated. Paediatric use is not authorised because of limited information about efficacy and safety. Purpose To illustrate our experience in the three-month use of clopidogrel in children with a systemic-to-pulmonary arterial shunt, prior to definitive surgical intervention. Materials and Methods On February 2012 a temporary systemic-to-pulmonary arterial shunt was placed in a four-month-old patient, affected by Tetralogy of Fallot with hypoplasia of the infundibulum and pulmonary valve. We administered two antiaggregant drugs, ASA 18 mg and clopidogrel 0.2 mg/Kg once a day, because of the high risk of thrombotic closure of the shunt. We chose an extemporaneous preparation of type 5 capsules with lactose as a diluent. After that, four other children (from 2 months to 4 years old) were treated with clopidogrel, mostly in association with ASA or together with enoxaparin. ResultsWe prepared capsules from 0.75 to 3.5 mg. For all patients we obtained authorization by the Ethics Committee and the parent’s informed consent. After surgery, the children were observed for 7–8 days depending on clinical follow up and complications. We checked the blood count and shunt patency with clinical observation, analysis and echocardiogram. After discharge, patients were first recalled 10–15 days later, then after 1–2 months to see the doctor, have an ECG, blood tests and echocardiogram. Pt was not necessary. No serious side effects were observed. Conclusions Paediatric clopidogrel treatment is rapidly increasing. A wider number of cases, a comparison with other professional experience, and, most of all, controlled clinical trials, would be desirable. No conflict of interest.

BackgroundBiologic molecules for rheumatological, gastroenterological and dermatological diseases are expensive treatments. Marche Region Resolution 974/2014 aims to estimate healthcare use of these drugs by introducing (since August 2014) a treatment plan for molecules not enlisted in the national (ie, AIFA-Italian Drug Agency) monitoring registry.PurposeTo optimise biologic drug use through adherence evaluation of patients who visited the Pharmacy of Macerata General Hospital (136 750 inhabitants/catchment area).Material and methodsWe drafted a review of certolizumab, etanercept, adalimumab, abatacept, infliximab, tocilizumab, golimumab and ustekinumab prescriptions received by the hospital pharmacy from September 2014 to August 2015. Diseases treated were: rheumatoid arthritis, ankylosing spondylitis, spondyloarthritis, psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, ulcerative colitis and Crohn’s disease. Data collection produced a database with patient information, prescriber, diagnosis, doses provided by the pharmacy and therapy adherence. Dosage, dosing schedule and administrations frequency (first or second year of treatment) were compared with data in the Summary of Product Characteristics (SPC). Body weight and year of treatment (first or following) were unknown.ResultsDuring 1 year of treatment, 2 207 239.03€ was spent on treating 229 patients (0.17% of inhabitants). Adalimumab, infliximab and etanercept had the highest costs (27.7%, 24% and 21.4%, respectively). The database displayed that: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis were the main diseases 53 (23.1%), 25 (10.9%) and 24 (10.5%) cases, respectively; 4354 doses had been provided (2625 packages). Leaving out treatment failures (interruptions and switches), the number of administrations was consistent with SPC data. A total of 28.8% patients (66/229) were non-adherent: 45 interruptions (68.2%) with 33.3% due to rheumatoid arthritis; and 21 switches (31.8%) with 33.3% for rheumatoid arthritis and 23.8% for psoriatic arthritis. Adalimumab had the most number of switches (9 vs 21) in the treatment of psoriatic arthritis (33.3%) and ankylosing spondylitis (22.2%).ConclusionTreatment plans allowed monitoring biologic prescriptions over a 1 year period and promoted clinician-pharmacist collaboration. Monitoring leads to a multidisciplinary approach and analysis of switching reasons (ie, inefficacy or adverse drug reactions) will be the next step to enhance the  quality of care in rheumatological, gastroenterological and dermatological patients.References and/or AcknowledgementsMarche Region Resolution 974/2014No conflict of interest.

BackgroundRelapsing remitting multiple sclerosis (RRMS) has an increasing incidence in young adults and a high social-economic impact. Treatment delays progression and does not cure the disease, but new oral drugs’ innovative pharmacodynamics profiles can improve the therapeutic approach. Therapy review could prompt a better understanding of RRMS care’s effectiveness.PurposeTo investigate the economic impact of RRMS therapy on the pharmacy of Macerata’s General Hospital from January 2011 to December 2014. To analyse patient demographics and clinical characteristics (ie, failures and adherence).Material and methodsThis review was conducted in collaboration with RecordData srl (prescription data regional provider) and neurologists and nurses for analysis of failure reasons. Teamwork produced a database of patients’ therapeutic histories. We analysed prescriptions of: first generation disease modifying therapies (DMT) (interferon β-1a and β-1b, glatiramer); second generation DMT (fingolimod, natalizumab); and relapsing therapy (methylprednisolone). Dosage and administration frequency were compared with data from the Summary of Product Characteristics (SPC).ResultsDuring the studied period, in a population of 118 patients treated (73 females; 45 males) with an average age of 39.8 years (range 16 to 63) and a mode of 32 years for both genders, 49 450 doses were prescribed (4086 packages: 21.9% in 2011; 24.72% in 2012; 25.48% in 2013; 27.9% in 2014) and 5 109 761.97€ spent (21.62% in 2011; 23.21% in 2012; 26.88% in 2013; 28.29% in 2014). Natalizumab, although only 1.62% of the provided doses (806/49 450), was the most expensive drug: 2 160 963.38€ (42.29%). Interferons represented 32.86% of costs with 38 154 doses (77.16%; -1.543 from 2011 to 2014) for 308 patients. From 2012, fingolimod was prescribed to 37 patients (10 304 doses; 20.84%) consisting of 12.48% of expenditure. Relapsing therapy concerned 83.1% of patients with 186 doses (0.37%) of methylprednisolone. Number of administrations was consistent with SPC data. Failures included 51 patients (43.22%): 17.65% interruptions (2 cases of adverse drug reactions); 42 (82.35%) switches (40.48% interferon-glatiramer; 28.57% interferon-fingolimod; 14.28% interferon-natalizumab).ConclusionThe review showed DMT high costs and complexity for RRMS management (interruptions/switches/relapsing). Teamwork is a priceless resource for patient healthcare. Monitoring is being extended through 2015, including teriflunomide, dimethyl-fumarate and alemtuzumab prescriptions.References and/or AcknowledgementsSummary of Product Characteristics.No conflict of interest.