March 2020 2020 March 27 Volume 1 Supplement 25th EAHP Congress 2020 25th–27th March Sweden Gothenburg, ABSTRACT BOOK
Volume 27 Supplement 1 Pages A1–A232 EUROPEAN JOURNAL OF HOSPITAL PHARMACY
S1 March 2020 27 CALL FOR ABSTRACTS - 2021
26th Congress of the EAHP, 24-26 March 2021, Vienna, Austria Abstract submission opens 1st August, 2020!
Original contributions from all fields of hospital pharmacy are encouraged and welcomed for poster presentation.
Deadline for submission: 15th October 2020
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Section 1: Introductory Statements and Governance Section 2: Selection, Procurement and Distribution Section 3: Production and Compounding Section 4: Clinical Pharmacy Services Section 5: Patient Safety and Quality Assurance Section 6: Education and Research Contents Volume 27 Supplement 1 | EJHP March 2020
Abstracts from the EAHP 2020 Congress A1 Section 1: Introductory Statements and A150 Section 5: Patient Safety and Quality Governance Assurance A9 Section 2: Selection, Procurement and A205 Section 6: Education and Research Distribution A215 National Poster Prize Winners A22 Section 3: Production and Compounding A222 Author Index A47 Section 4: Clinical Pharmacy Services
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SYNERGY SATELLITE EVENT
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Hospital pharmacists making the difference
Biologics in cancer care have enhanced the therapeutic options With the patents set to expire for a number of medications, for clinicians in the management of oncologic therapy. Monoclonal biosimilars therapeutic proteins offer the potential to increase antibodies (mAbs) are employed as targeted treatment and also access to therapies and reEuDe cancer costs for patients to resolve therapy-related hematologic defi ciencies. and healthcare systems.
Sponsored by an educational grant from Amgen Wednesday, 25 March 2020 25th Congress of the EAHP 25-27 March 2020 Gothenburg, Sweden
12:00 to 13:30, Hall C
Facilitator Despoina Makridaki
Presenters Oncology Biosimilars - ongoing challenges for hospital pharmacists Antonio Melo Gouveia
Budget impact and cost-effectiveness of oncology biosimilars Steven Simoens*
Biosimilars in Oncology: Healthcare and clinical considerations Ioannis Boukovinas* CONTACT US | [email protected]
ACPE UAN: 0475-0000-20-005-L04-P. A knowledge based activity. th The European Association of Hospital Pharmacists (EAHP) is accredited by the EAHP CONGRESS Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education SYNERGY SATELLITE EVENT
THE EAHP INVITES YOU TO ATTEND THE 2020 SYNERGY SATELLITE SESSION:
25th Congress of the EAHP 25-27 March 2020 Gothenburg, Sweden The Hospital Pharmacist can balance the antithrombotic benefit of the DOAC with its bleeding risk by recommending the appropriate dose of DOACs to physicians according to the patients’ characteristics. The Hospital Pharmacist as part of an antithrombotic stewardship programme needs to ensure adherence to anticoagulant guidelines to maximize the benefit of anticoagulation and minimize the complications. The Hospital Pharmacist’s role in antithrombotic stewardship SPONSORED BY AN EDUCATIONAL GRANT FROM BAYER
Facilitator Virgina Silvari Wednesday, 25th March 2020 14.45 to 16.15 room H1 Thursday, 26th March 2020 Presenters Minimising bleeding Antithrombotic stewardship: the proof of risk associated with 08.45 to 10.15 room H1 the pudding... anticoagulation use Paul Wright Patricia Van Den Bemt CONTACT US | [email protected]
ACPE UAN: 0475-0000-20-006-L04-P. A knowledge based activity. th
The European Association of Hospital Pharmacists (EAHP) is accredited by the EAHP CONGRESS Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Abstracts
Section 1: Introductory Statements and 1ISG-002 BIOLOGICAL DRUGS FOR THE TREATMENT OF MODERATE AND SEVERE PLAQUE PSORIASIS: A COST Governance ANALYSIS AND AN APPLICATION OF A CORRELATION ANALYSIS TO INVESTIGATE COST EFFECTIVENESS 1ISG-001 CAN RIVAROXABAN BECOME COST SAVING 1N Sagaria*, 2D Mengato, 1I Corbucci, 1G Felluga, 2G Morandell, 2ATavella.1School of COMPARED WITH VITAMIN K ANTAGONISTS IN THE Hospital Pharmacy, Department of Pharmaceutical Sciences University of Padova, Padova, TREATMENT OF PATIENTS WITH NON-VALVULAR Italy; 2Bolzano General Hospital, Hospital Pharmacy Department, Bolzano, Italy ATRIAL FIBRILLATION IN FRANCE? 10.1136/ejhpharm-2020-eahpconf.2 1SRobert*,2F Vincent, 3S Vengadessane. 1Chru Nancy, Pharmacy, Vandoeuvre Les Nancy, 2 3 France; Hospices Civils De Lyon, Pharmacie, Lyon, France; Université Paris Descartes, Background and importance The introduction of the first bio- Faculté De Pharmacie De Paris, Paris, France logical drugs has led to a new era for patients. Moreover, the recent arrival of biosimilars has guaranteed effectiveness 10.1136/ejhpharm-2020-eahpconf.1 at a more sustainable cost. We compared the recently Background and importance Non-valvular atrial fibrillation approved biological drugs with biosimilars and older biologi- (NVAF) affects 750 000 people in France and is associated cal molecules, using a new cost effectiveness analysis with significant morbidity, use of healthcare resources and approach. costs. The randomised controlled trial ROCKET-AF demon- Aim and objectives To compare the long term therapy cost strated that rivaroxaban is an efficacious alternative to war- and cost effectiveness of biological systemic therapies for treat- farin in patients with NVAF. The new oral anticoagulants ing patients with moderate to severe plaque psoriasis. (NOAC) appear to have an acceptable cost effectiveness Material and methods We collected therapy costs from our ratio in France. But is it possible that rivaroxaban could internal hospital database. We reported the purchase price, remain cost effective with the introduction of generic including any discounts. Efficacy data, measured with the PASI drugs? index, for 12/16 weeks, was obtained from a recent meta- Aim and objectives To determine the price threshold for rivar- analysis by Sawyer et al. We calculated the long term costs by oxaban to become cost effective compared with vitamin K multiplying the monthly cost for a single patient, including antagonists (VKAs) in the treatment of NVAF, using real the induction phase. Our cost effectiveness analysis was per- world evidence and from a French payer perspective. formed by a correlation analysis between efficacy and the cost Material and methods The annual cost differences associated of therapy for the 12/16 weeks of treatment. We calculated, with rivaroxaban use compared with VKAs among NVAF for each molecule at a different PASI, a correlation index (R) patients were estimated. Clinical events reflecting the efficacy to investigate if a correlation between cost and efficacy could and safety of the drugs were converted into costs. Drugs costs be established. and VKA monitoring were added to obtain a total cost. Cost Results Cost analysis of the first year and the first 3 years of differences were then calculated with a price of rivaroxaban therapy showed how the introduction of biosimilar drugs reduced by: 20% (reduction in the price of the brand name greatly lowered global expenditure. The cost/PASI ratio drug when the first generic is marketed)); 32.5% (total showed that adalimumab and infliximab biosimilars were the decrease in the price of the brand name drug 18–24 months most convenient drugs in relation to their cost and clinical after the first generic is marketed); 60% (price of a generic effectiveness (57C¼ /PASI90; 112C¼ /PASI90, respectively). compared with the brand name drug). Event rates were In terms of efficacy alone, a greater therapeutic result was obtained from the pragmatic study BROTHER. The annual observed for the most recently approved molecules, especially costs for each clinical event and for VKA monitoring were for PASI90/100. The cost/PASI ratio of these newer therapies obtained from the literature (studies in French setting). The was convenient only for PASI90 and 100 (guselkumab 41C¼ / cost of medicines in 2018 came from the French National PASI100). Therefore, there seems to be a positive, albeit Health Insurance database. weak, correlation between the effectiveness and cost of inno- Results The total cost difference associated with the use of vative drugs, especially for PASI90/100 where R increased rivaroxaban instead of VKAs were estimated at +303C¼ per with increasing PASI (PASI75, R=0.22; PASI100, R=0.32). patient per year. The total cost differences were +124C¼ , Conclusion and relevance The introduction of biosimilar drugs +12C¼ and 234C¼ with price decreases of 20%, 32.5% in the treatment of moderate to severe psoriasis has signifi- and 60%, respectively. The threshold for a cost saving cantly lowered costs. From the correlation analysis, we with rivaroxaban was a 34% decrease in the price of the observed some linearity between cost and efficacy; a higher drug. cost correlated with greater efficacy, especially for PASI90/100. Conclusion and relevance Rivaroxaban can become cost saving However, it should be noted that there is still a lack of longer with a 34% price reduction. The commercialisation of NOAC term studies (over 16 weeks) comparing more consistently generics should allow them to play an even more important long term therapies with drugs of different classes. role in the treatment of NVAF. REFERENCES AND/OR ACKNOWLEDGEMENTS REFERENCES AND/OR ACKNOWLEDGEMENTS https://doi.org/10.1371/journal.pone.0220868 No conflict of interest. No conflict of interest.
EJHP 2020;27(Suppl 1):A1–A232 A1 Abstracts
1ISG-003 STUDY OF THE USE OF INTRAVENOUS Material and methods A bibliographic research was conducted IMMUNOGLOBULINS DURING THE FOURTH QUARTER in MEDLINE and EMBASE databases to identify treatment OF 2018 AND ANALYSIS OF ITS OFF-LABEL USE schemes with daratumumab, lenalidomide, bortezomib and tha- lidomide, or their combinations, in NDMM. Only authorised S Izquierdo Muñoz, A Pariente Junquera*, A De Frutos Soto. Hospital Clínico Universitario De Valladolid, Farmacia Hospitalaria, Valladolid, Spain treatments used in clinical practice were selected. Efficacy was assessed as progression free survival. Randomised clinical phase 10.1136/ejhpharm-2020-eahpconf.3 II–III trials, which compared selected therapeutic alternatives in patients with NDMM-NoT, were included. Articles in Span- Background and importance The use of intravenous immuno- ish or English language were selected. Costs of the first year globulins (IVIg) has increased as a result of their therapeutic of treatment were calculated from a National Health System usefulness in a great number of diseases. Despite this, IVIg perspective, using notified laboratory sale prices and including label indications remain limited, so it is interesting to study taxes (4% VAT) and a 7.5% rebate (in accordance with the their off-label use. national Royal Decree Law 8/2010). Associated direct costs in Aim and objectives To describe the use of IVIg in our hospital the first year were added. Incremental costs of each therapeu- for 3 months and to determine if they have been used for tic alternative with respect to the reference was quantified. labelled indications. DVMP-D was taken as the reference in the cost incremental Material and methods This was a retrospective study (Octo- study. ber–December 2018) and a descriptive analysis of the use of Results Results of the systematic review included 593 studies. IVIg per patient and clinical indication. Information was col- Nine trials were selected which analysed seven drug combina- lected from the hospital’s information systems and the com- tions: DVMP-D; bortezomib+melphalan+prednisone (VMP); puter records of the Farmatools software. melphalan+prednisone+thalidomide with thalidomide for Results Eighty-nine patients received IVIG during the study maintenance (MPT-T); lenalidomide+dexamethasone for main- period, with an average age of 61 years at the end of the tenance (RD); lenalidomide+dexamethasone for 18 cycles study (3 months–86.7 years); there were 40 (45%) men and (RD18); melphalan+thalidomide+prednisone (MTP); and bor- 49 (55%) women. When IVIg were used as replacement ther- tezomib+lenalidomide+dexamethasone with lenalidomide+dex- apy, the dosage used was 200–400 mg/kg every 3–5 weeks. In xamethasone for maintenance (VRD-RD). Daratumumab the remaining indications, the dose used per treatment cycle +lenalidomide+dexamethasone with daratumumab for mainte- was 1–2 g/kg divided over 2–5 days. IVIG were used for nance was excluded for non-use by the National Health Sys- labelled indications in 80% of patients (71/89) compared with tem (combination not funded). A visit to outpatients was 20% for off-label indications (18/89). Among the latter, the estimated at 167C¼ , according to the bibliography. Treatment indications were: demyelinating neuropathies (6/18), myasthe- costs for the first year were: DVMP-D 184 214C¼ ; VMP 44 nia gravis (2/18), myopathies (2/18), encephalitis/encephalo- 435C¼ ; MPT-T 44 435C¼ ; RD 81 520C¼ ; RD18 81 520C¼ ; myelitis (2/18), Morvan syndrome (1/18), syndrome MTP 77 209C¼ ; and VRD-RD 104 850C¼ . Regarding incre- paraneoplastic (1/18), refractory atopic dermatitis (1/18), para- mental costs, the most expensive scheme was the reference neoplastic dermatomyositis (1/18), scleroderma (1/28) and anti- treatment (DVMP-D), followed by VRD-RD ( 79 364C¼ ). The synthetase syndrome (1/18). cheapest combination was MPT-T ( 164 094C¼ ), followed by Conclusion and relevance The use of IVIG in unauthorised VMP ( 139 779C¼ ). indications was frequent (20%), mainly in the field of neurol- Conclusion and relevance There are seven treatments, including ogy. This justifies the development of a protocol for the use daratumumab, lenalidomide, bortezomib and thalidomide for of IVIG in this field for those indications with more scientific NDMM-NoT. The most expensive schemes for the first year evidence and more common use: demyelinating neuropathies, of treatment are DVMP-D and VRD-RD; and the cheapest myasthenia gravis and myopathies. combinations are MPT-T and VMP.
REFERENCES AND/OR ACKNOWLEDGEMENTS REFERENCES AND/OR ACKNOWLEDGEMENTS No conflict of interest. None. No conflict of interest.
1ISG-004 ECONOMIC COMPARISON OF THERAPEUTIC ALTERNATIVES FOR FIRSTLINE TREATMENT OF 1ISG-005 ABC-VEN CROSSTAB ANALYSIS: A DECISION MAKING MULTIPLE MYELOMA SYSTEM FOR ANTICANCER MEDICINES MD Gil-Sierra*, S Fenix-Caballero, MDP Briceño-Casado, M Dominguez-Cantero, EJ Alegre- M Fragiadaki*, E Rinaki, M Petrongonas, L Tzimis. Chania General Hospital, Pharmacy, Del Rey. Hospital Universitario De Puerto Real, Pharmacy, Puerto Real, Spain 73300-Chania, Greece
10.1136/ejhpharm-2020-eahpconf.4 10.1136/ejhpharm-2020-eahpconf.5
Background and importance A combination of daratumumab, Background and importance Health systems have limited bortezomib, melphalan and prednisone with daratumumab for resources, and these should be used responsibly to optimise maintenance (DVMP-D) has been authorised as a firstline outcomes for patients. The ABC (pareto analysis for expendi- treatment for patients with newly diagnosed multiple myeloma ture) and VEN (health impact) methodology was developed by who are ineligible for stem cell transplantation (NDMM- the WHO to help hospitals evaluate current spending. NoT). An economic comparison of different alternatives avail- Aim and objectives A decision making system was developed able was performed, according to their economic impact. for inventory management of chemotherapy agents and medi- Aim and objectives To develop an economic comparison cines to treat their adverse reactions (CA-MtADR). As these among the therapeutic alternatives in NDMM. medicines are expensive, we formulated an ABC-VEN matrix
A2 EJHP 2020;27(Suppl 1):A1–A232 SYNERGY SATELLITE EVENT
THE EAHP INVITES YOU TO ATTEND THE 2020 SYNERGY SATELLITE SESSION:
25th Congress of the EAHP 25-27 March 2020, Gothenburg, Sweden BIOSIMILARS IN COLORECTAL CANCER What’s your gut feeling? SPONSORED BY AN EDUCATIONAL GRANT FROM PFIZER WEDNESDAY 25 MARCH 2020 17.15 TO 18.45 ROOM H1 THURSDAY 26 MARCH 2020 13.30 TO 15.00 ROOM H1
In the area of colorectal cancer, patent expirations are now occurring. Biosimilars of bevacizumab and cetuximab, will be coming to the market in the near future. The opportunity for savings is huge, as these drugs are a major part of the cost of treating colorectal cancer. To make the best of this new frontier, Hospital Pharmacists must understand the concepts and facts, to be able to provide a VFLHQWLÞFXQELDVHGDSSURDFKWRWKLVLVVXHZLWK a focus on patient care in a world of limited resources and a growing need of cost effective approaches to take in innovative drugs to treat cancer, which always come with a very high cost.
FACILITATOR: Juraj Sykora
FACILITATOR: Juraj Sykora| PRESENTERS: name surname, name surname, name surname PRESENTERS The importance of Policies of Biosimilars uptake in Best value biologics adoption a : Gastrointestinal Cancers Central and Eastern European National approach – in Europe - and countries: How to ensure a How clinical specialties have CONTACT US | [email protected] why biosimilars matter. sustainable biosimilar market? responded in England. Paul Cornes Tomáš Tesař Andrew Davies ACPE UAN: 0475-0000-20-004-L04-P. A knowledge based activity. th
The European Association of Hospital Pharmacists (EAHP) is accredited by the EAHP CONGRESS Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education AMGEN INVESTS IN A BROAD BIOSIMILAR PORTFOLIO TO ENABLE HEALTHCARE INNOVATION
©2020 Amgen Inc. All rights reserved. Amgen (Europe) GmbH, 6343 Rotkreuz, Switzerland January 2020. EUHQ-P-BIO-0819-077291 Abstracts as a combination of two analytical tools, to produce a budget Cooperative Oncology Group) performance status (PS) and optimising management system. type of cancer treatment (targeted therapy, immunotherapy or Material and methods Dispensing data for the first 6 months the historical standard of care, pemetrexed). We assessed pro- of 2019 from the haematology, oncology and chemotherapy gression free survival (PFS) and overall survival (OS) with the departments were collected. ABC analysis was performed: class Kaplan–Meier method. We assessed compliance with Italian A accounted for 72% of total expenditure, class B for 23% clinical practice guidelines and we analysed drug costs. and class C for 5%. The VEN tool was further extended to a Results We found 92 cases of NSCLC; 70% were men and score index (summarising the characteristics of the health mean age was 65 years. We found that 50% were treated impact of the medicines) grouped into three classes: class V with pemetrexed, 30% with immunotherapy and 20% with for vital, class E for essential and class N for non-essential targeted therapy; 61% were firstline treatments. Median PFS medicines. Crosstab ABC-VEN analysis resulted in three major was 4.3 months and median OS was 8.6 months. Targeted categories: I (AV, BV, CV, AE), II (BE, CE) and III (AN, BN, therapy was most likely to improve PFS (5.9 months), fol- CN). lowed by pemetrexed (4.3 months) and immunotherapy (2,9 Result Fifty-seven CA-MtADR were analysed. Expenditure for months). Targeted therapy was similarly best for OS outcome CA-MtADR was 40% of the total expenditure for medicines (15.3 months), followed by immunotherapy (11 months) and in the hospital. According to the ABC analysis, 7 medicines pemetrexed (8.6 months). After patient stratification, there (12%) were class A, 12 medicines (21%) class B, and 38 was no statistically significant difference between age, gender (67%) class C. According to the VEN analysis, 9 medicines or therapy groups. PS was an indicator of better prognosis: (16%) were characterised as V, 43 (75%) as E and 5 (9%) as cases with a baseline PS score of 0 (75%) were associated N. According to the ABC-VEN crosstab analysis, category I with longer PFS (5.5 months) and OS (11 months). Compli- (eg, daratumumab (ATC L01XC24)) included 16 medicines ance with clinical practice guidelines was high. Afatinib and (28%), category II (eg, trastuzumab emtansine (ATC gefitinib were the least expensive TKIs. Nivolumab was less L01XC14)) 36 medicines (63%) and category III (eg, panto- expensive than pembrolizumab. prazole (ATC A02BC02)) 5 medicines (9%). Conclusion and relevance TKIs for the management of NSCLC Conclusion and relevance ABC-VEN crosstab analysis revealed are cost effective. Afatinib is an important firstline option for three categories of corresponding priority: CA-MtADR cate- EGFR mutation positive NSCLC. Gefitinib can be an effective gory I, including expensive and/or vital medicines which need secondline therapy. Pemetrexed can still be recommended for patient oriented personalised stock management; CA-MtADR EGFR and ALK wild-type non-squamous advanced NSCLC. category II, medicines which should be monitored with special However, our analysis suggests a limited effectiveness of consideration to ensure availability (because they are essential); immunotherapy. and CA-MtADR category III, medicines where stock is accord- ing to demand (due to low price). ABC, VEN and ABC-VEN REFERENCES AND/OR ACKNOWLEDGEMENTS analysis can assist in developing a robust approach to improve No conflict of interest. budgetary planning in hospitals.
REFERENCES AND/OR ACKNOWLEDGEMENTS 1ISG-007 NEW CANCER DRUG APPROVALS IN PORTUGAL No conflict of interest. A Alcobia*, A Soares. Hospital Garcia De Orta, Pharmacy Department, Almada, Portugal
10.1136/ejhpharm-2020-eahpconf.7 1ISG-006 EFFECTIVENESS EVALUATION OF HIGH COST DRUGS FOR ADVANCED NON-SMALL-CELL LUNG CANCER: Background and importance In Portugal, all new drugs, after REAL WORLD EVIDENCE, COMPLIANCE WITH EMA approval, undergo a national health technology assess- CLINICAL PRACTICE GUIDELINES AND ECONOMIC ment process to decide their reimbursement status, by the EVALUATION SNS (Portuguese National Health System). Aim and objectives The objective of this study was character- A Isoardo*, E Grande, MM Ferrero, C Fruttero. Ao S Croce E Carle, SC Farmacia isation of the drug approval processes for cancer drugs by the Ospedaliera, Cuneo, Italy INFARMED (Portuguese Regulatory Agency). 10.1136/ejhpharm-2020-eahpconf.6 Material and methods The 10 latest drugs approved for differ- ent types of cancer were analysed, considering their therapeu- Background and importance Lung cancer has a poor prognosis tic indication, type of economic analysis performed and and is the most common cause of cancer death. In Italy, lung efficacy outcome. cancer is the third most common cancer. Treatment decisions Results This analysis was performed in October 2019. The 10 are based on the histology and molecular characteristics of the latest cancer drugs approved (midostaurin, olaparib, brentuxi- tumour. Treatment options for non-small-cell lung cancer mab vedotin, pomalidomide, durvalumab, venetoclax, ixazo- (NSCLC) are targeted therapies (tyrosine kinase inhibitors mib, alectinib, atezolizumab and cabozantinib) are for use in (TKIs)), immunotherapy or chemotherapy. refractory disease (60%), firstline treatment of metastatic dis- Aim and objectives To analyse drug effectiveness for advanced ease (20%) and maintenance therapy in patients who have not NSCLC in our hospital, to assess compliance with clinical progressed after firstline therapy (20%). A cost utility analysis practice guidelines and to perform an economic evaluation. was made for seven drugs, cost efficacy for two drugs and a Material and methods We identified all patients with advanced cost minimisation analysis for two drugs (one of the drugs NSCLC treated with high cost drugs (pemetrexed, erlotinib, had two types of analysis as there were two different groups gefitinib, afatinib, osimertinib, crizotinib, pembrolizumab and of patients). The efficacy outcome considered was overall sur- nivolumab) from 1 May 2016 to 30 April 2018. Patients vival in 60% and progression free survival in 30%. One eval- were stratified by age, gender, therapy, ECOG (Eastern uation considered overall response. The average HR for the
EJHP 2020;27(Suppl 1):A1–A232 A3 Abstracts efficacy outcome versus comparators was 0.74 for firstline or Background and importance Natalizumab is a monoclonal anti- refractory disease therapies and 0.42 for drugs used in mainte- body that blocks the immune reaction evoked during multiple nance therapy when patients had not progressed after firstline sclerosis (MS) attacks but it could also weaken immunosurveil- therapy. lance, leading to an increased risk of developing progressive Conclusion and relevance The health technology assessment multifocal leucoencephalopathy (PML). processes analysed were heterogeneous. Drug approvals must Many studies have demonstrated that extended interval dos- be balanced between clinical trials and real world evidence. ing (EID) of natalizaumab 300 mg every 6 weeks has the For innovative drugs, clinical trial extensions must be pub- same efficacy as standard interval dosing (SID) every 4 weeks, lished promptly after efficacy outcome modifications, leading but with a lower risk of PML. to review of the reimbursement evaluations. Aim and objectives To compare the costs of SID and EID administration of natalizumab and to estimate the savings asso- REFERENCES AND/OR ACKNOWLEDGEMENTS ciated with EID. No conflict of interest. Material and methods The analysis was carried out adopting a 3 year time horizon, the hospital perspective (corresponding to the National Health Service) and considering only the direct costs of the drug’s purchase price. The population was 1ISG-008 COST EFFICACY ANALYSIS OF ABIRATERONE IN patients diagnosed with MS and already being treated with NEWLY DIAGNOSED HIGH RISK METASTATIC the SID regimen at our hospital. The model used was based CASTRATION SENSITIVE PROSTATE CANCER on real clinical data: patients were selected from September A Soares, A Alcobia*. Hospital Garcia De Orta, Pharmacy Department, Almada, Portugal 2016 to September 2019. The annual cost considered 12 infusions for SID and 8 for 10.1136/ejhpharm-2020-eahpconf.8 EID of natalizumab, according to the actual regional public tender, which is mandatory (no possibility of further paybacks Background and importance Abiraterone was recently proved or discounts, or planned changes to the purchase agreement by the EMA for addition to androgen deprivation therapy in the next 3 years). (ADT), associated with prednisone (P), in metastatic castration Three different scenarios were considered: 75%, 85% and sensitive prostate cancer. The economic impact could be 95% of patients on the EID regimen and the remaining on important. the SID regimen, based on the clinical judgment that almost Aim and objectives The aim of this study was to evaluate the all patients could benefit from an EID regimen, but the possi- cost efficacy of abiraterone in newly diagnosed high risk meta- bility should also be foreseen that a patient could not wait static castration sensitive prostate cancer. more than 4 weeks between infusions. Material and methods Abiraterone efficacy outcomes are based Results In the first scenario, there were 512 patients receiving on the LATITUDE12trial. Treatment costs were calculated EID and 171 SID, corresponding to a total cost of¼ C 10 490 based on the direct costs of the drugs in 2019. This study 101, or¼ C 13 986 802 if all patients were receiving SID. was conducted from an institutional perspective—the hospital Treating 75% of patients with EID could reach a saving of perspective. ¼C 3 496 700. Results Based on the LATITUDE trial,12the overall survival The second scenario (581 vs 102) generated a cost of¼ C 10 for the abiraterone+P+ADT group was 53.3 versus 36.5 023 875 and a saving of¼ C 3 962 927, and the third scenario months in the ADT group. Median treatment duration was 24 (649 vs 34) a total cost of¼ C 9 557 648 with a saving of¼ C 4 months for the abiraterone+P+ADT group and 14 months 429 154. for the ADT group. Adding abiraterone+P to ADT resulted in Conclusion and relevance The analysis underlines the large sav- a marginal efficacy of 1,4 years compared with ADT alone. ings in direct costs if most patients are infused every 6 weeks. The marginal costs associated were 70.163C¼ . The incremental This also corresponds to lower administration related costs cost efficacy ratio calculated for abiraterone+P was 50.116C¼ . (indirect costs) that could be calculated in a future analysis. Conclusion and relevance Based on this analysis, the incremen- tal cost efficacy ratio calculated for abiraterone in metastatic REFERENCES AND/OR ACKNOWLEDGEMENTS castration sensitive prostate cancer setting was increased, con- No conflict of interest. sidering the potential number of patients. With limited budg- ets, cost efficacy analyses are useful tools for the pharmacy and for decisions by therapeutics committees on drug selection. 1ISG-010 INTRODUCTION OF RITUXIMAB BIOSIMILAR: AN OPPORTUNITY TO IMPROVE HEALTH SYSTEM REFERENCES AND/OR ACKNOWLEDGEMENTS EFFICIENCY? – 1. Fizazi K, et al. N Engl J Med 2017;377:352 60. ’ 2. Fizazi K, et al. Lancet Oncol 2019;20:686–700. C Panciroli*, L Cervi, D Mazza, G Mangoni, M Dall aglio, F Ruggiero, ML Medaglia. Asst Grande Ospedale Metropolitano Niguarda, SC Farmacia, Milan, Italy No conflict of interest. 10.1136/ejhpharm-2020-eahpconf.10
Background and importance The introduction of a biosimilar 1ISG-009 BUDGET IMPACT ANALYSIS OF A NATALIZUMAB drug represents similar efficacy at a lower cost, providing sav- EXTENDED INTERVAL DOSING REGIMEN ings without compromising patient treatment. Moreover, their E Pierobon, A Mastrogiacomo, F Capano*, D Ielo. AOU San Luigi Gonzaga, Pharmacy, quality is certified by regulatory agencies and high quality Turin, Italy clinical trials. In 2017, rituximab biosimilar (RB) was approved in Italy. At the end of 2017, our hospital imple- 10.1136/ejhpharm-2020-eahpconf.9 mented a new policy for using biologics, and decided to
A4 EJHP 2020;27(Suppl 1):A1–A232 Abstracts invest in RB with the aim of obtaining price reductions, and (codes: 89.37, 89.38)–(level 2 patients (L2)); inhaled cortico- to promote the switch not only in naïve patients but also in steroids (ICS) in combination with long acting beta adenore- those already being treated with an originator. ceptor agonists (LABA) and/or theophylline (ATC: R03DA04), Aim and objectives The purpose of the study was to evaluate and/or antileucotriene (ATC: R03DC), and/or anticholinergics prescription adherence, safety profile and economic impact of (ATC: R03BB)–(level 3 patients (L3)); high dose ICS therapy RB. (ATC: R03BA, R03AK)–(level 4 patients (L4)); adherence to Material and methods A retrospective analysis was conducted each medication–(level 5 patients (L5)); asthma hospitalisation over two periods: 2017 (period 1: pre-switch) versus 2018 (ICD9: 493) or treatment with systemic corticosteroids (ATC: (period 2: post-switch). Clinical data were collected from the H02)–(level 6 patients (L6)). For each patient level, the mean hospital prescription database, Farmasafe, to identify the num- annual healthcare costs per patient, based on total resource ber of patients receiving rituximab treatment, and the hospital consumption, were assessed. pharmacovigilance’s database to evaluate the safety profile. Results For a total of 4.6 million beneficiaries, aged 6 years, Costs considered were hospital prices, after price 103 138 (2.2%) patients were screened (L1). Spirometry tests renegotiation. were prescribed in 28 611 patients (27.7%) (L2), of whom Results In period 1, 202 patients were treated, 196 with ritixi- 13 432 (46.9%) had a prescription for ICS with LABA or mab originator (RO) and 6 with RB. In period 2, 193 other agents (L3). In 5782 (43%) patients treated with pre- patients were treated, 52 with RO and 141 with RB. The bio- vious combinations, high dose ICS therapy was prescribed similar proportion increased by 63% of the total amount of (L4), and of them, 3307 (57.2%) were treatment adherent rituximab used. During period 2, the switch was performed in (L5) and 1136 (35.2%) had a hospital admission for asthma 47 patients, 94 were naïve and there were no switch rever- or treatment with systemic corticosteroids (L6). For this last sions. The switch to RB was not performed in all patients as level of patients, centres specialising in Mabs prescription eval- some were randomised on clinical trials and others were com- uated eligibility. Total costs of the illness according to disease pleting RO treatment. Analysis of adverse drug reactions progression were¼ C 1279.6 for L1,¼ C 1567.7 for L2,¼ C 2045.3 showed no significant safety problems. In period 1, the total for L3,¼ C 2524.2 for L4,¼ C 3233.2 for L5 and¼ C 4326.2 for cost of RB+RO was¼ C 1 456 647, and during period 2, L6; overall asthma related treatment and hospitalisation costs ¼C 721 370. RB introduction translated to a 50% cost reduc- were¼ C 274.2 for L1,¼ C 400.1 for L2,¼ C 598.5 for L3, tion of¼ C 735 370. ¼C 784.3 for L4,¼ C 1118.4 for L5 and¼ C 1449.9 for L5. Conclusion and relevance The hospital’s biosimilars policy was Conclusion and relevance This analysis allowed estimation of associated with substantial and rapid incorporation and use of the number of asthma patients eligible for Mabs therapy in biosimilars. Moreover, introduction of RB resulted in signifi- the Veneto region. Our findings on healthcare costs high- cant cost savings with no major changes in safety profile. The lighted that the average cost per patient increased by severity use of rituximab will release funds that can be invested else- level. Post marketing, it will be possible to assess the appro- where within the healthcare setting. This is relevant for all priateness of Mabs prescriptions through indicators such as pharmacists involved in hospital pharmacy, particularly those over- and under-use. working in therapeutic areas where biologics are used. REFERENCES AND/OR ACKNOWLEDGEMENTS REFERENCES AND/OR ACKNOWLEDGEMENTS No conflict of interest. No conflict of interest.
1ISG-011 ASSESSMENT OF ASTHMA DIAGNOSED POPULATION 1ISG-012 NATIONAL REPORTING SYSTEM FOR DRUG ELIGIBLE FOR NEW MONOCLONAL ANTIBODY SHORTAGES: CLASSIFICATION AND TRENDS IN THERAPY AND RELATED COST IN THE VENETO REPORTED CAUSES FROM 2015 TO 2018 REGION 1,2A Benhabib*, 1,3P Maison. 1French National Agency for Medicines and Health Products Safety, Health Products Survey, Saint-Denis, France; 2Strasbourg Faculty of Pharmacy, 1L Degli Esposti*, 1V Perrone, 1D Sangiorgi, 2AM Menti, 2M Andretta. 1Clicon SRL-Health- Hospital Pharmacy, Strasbourg, France; 3Ea 7379- Paris Est Creteil University Upec and Chic Economics and Outcomes Research, Clicon SRL-Health-Economics and Outcomes Research, Hospital, Epidemiology Department, Créteil, France Ravenna, Italy; 2Uoc Hta-Azienda Zero-Regione Veneto, Uoc Hta-Azienda Zero-Regione Veneto, Padova, Italy 10.1136/ejhpharm-2020-eahpconf.12 10.1136/ejhpharm-2020-eahpconf.11 Background and importance Drug shortages are a major public Background and importance Novel treatment approaches for health threat worldwide, occurring across all therapeutic the management of severe refractory asthma include monoclo- classes. We focussed our study on the trends in reported nal antibodies (Mabs). causes of drug shortages in our country. Aim and objectives The study aimed to estimate the number Aim and objectives The aim of the study was to propose a of the most suitable patients with severe uncontrolled asthma classification and trends in reported causes of drug shortages. who are eligible for new Mabs therapy and related costs in Material and methods Data from the national reporting system the Veneto region (Italy). from a health product agency were analysed. This database Material and methods The regional administrative database was contains information regarding the causes of shortages of retrospectively analysed to identify specific eligibility and major therapeutics of interest (MTI) (ie, drugs where a short- assessment criteria. All patients aged 6 years with an exemp- age represents loss of a treatment opportunity for patients tion code for asthma (007) (level 1 patients (L1)) between 1 with a severe disease) which are mandatory reported by mar- January 2011 and 31 December 2016 were screened. The fol- keting authorisation holders to the agency. Data are presented lowing parameters were considered in succession: spirometry as numbers or percentages of pharmaceutical products (ie, the
EJHP 2020;27(Suppl 1):A1–A232 A5 Abstracts product name and its formulation) reported as shortages Results Forty-six apps were downloaded (31 Android, 6 iOS, between 2015 and 2018. 9 both platforms); 89.1% were free and 60.9% were updated Results The classification work identified two major categories in the last year. The most frequent cancers in the apps were of causes of drug shortages: causes related to the manufactur- prostate (30.4%), cervical (17.4%), testicular (13.0%) and ing process and those related to the drug distribution system. ovarian (13.0%). The main purpose was informative (63.1%), Causes related to manufacturing dysfunction were divided into preventive (23.9%) and diagnostic (13.0%). Seven apps five subclasses: 83 types of causes allowed the building of a (15.2%) were developed by healthcare organisations. systematic classification related to the manufacturing circuit. The average MARS score was 2.98 (SD=0.77), with a Material issues use ranked first (31%), followed by manufac- maximum of 4.63 and a minimum of 1.95. Functionality turing issues, pharmaceutical market and regulatory issues, and scores were similar among all the apps. The greatest differen- inventory and stockage practice (30.4%, 23.5% and 9.89%, ces were found in engagement and aesthetics criteria which respectively). The number of reported pharmaceutical market showed acceptable scores only in a third of the apps. Multi- causes of shortages showed a 3.5-fold increase between 2015 variate analysis showed statistically significant differences and 2018. In 78% of reported shortages, only one dysfunc- according to the platform and participation of health profes- tion caused the shortage. The number of multiple causes of sionals in the development (p<0.001 and p=0.01, shortages increased by 2.4 during the study period. respectively). Conclusion and relevance To our knowledge, there are no Conclusion and relevance Very few apps for patients with geni- studies with the same results. Drug shortages are increasingly tourinary cancers were focused on how to handle the disease reported in this country. Precise knowledge of the causes of after diagnosis, correct administration of treatment or the shortages can identify short term solutions to reduce their adequate monitoring of symptoms. The participation of health severity and long term solutions to reduce their numbers. professionals in the development was low but was correlated with quality. MARS is a helpful methodology to analyse app REFERENCES AND/OR ACKNOWLEDGEMENTS quality and make better recommendations to patients. The authors thank the drug shortages team and the phar- macosurveillance division. They also thank the professor team REFERENCES AND/OR ACKNOWLEDGEMENTS of Strasbourg Faculty of Pharmacy. No conflict of interest. No conflict of interest.
1ISG-014 COST EFFECTIVENESS ANALYSIS OF PATIENT SMARTPHONE APPLICATIONS FOR PATIENTS 1ISG-013 SELF-ADMINISTRATION OF MEDICATION DURING DIAGNOSED WITH GENITOURINARY TUMOURS: HOSPITALISATION IN A CARDIOLOGY UNIT ANALYSIS OF THE QUALITY USING THE MOBILE 1,2,3 3,4 3,5 6 2 7 APPLICATION RATING SCALE CA Sørensen*, A De Thurah, M Lisby, COlesen, SB Sørensen, U Enemark. 1Hospital Pharmacy Central Denmark Region, Clinical Pharmacy-Randers Regional Hospital, MÁ Amor*, R Collado-Borrell, V Escudero-Vilaplana, A Ribed-Sánchez, A Melgarejo-Ortuño, Randers Nø, Denmark; 2Randers Regional Hospital, Medical Department-Cardiology Unit, FJ García-Moreno, S García-Sánchez, Á Narrillos-Moraza, P Ruiz-Briones, A Herranz-Alonso, Randers Nø, Denmark; 3Aarhus University, Clinical Medicine, Aarhus, Denmark; 4Aarhus M Sanjurjo-Sáez. Servicio De Farmacia, Hospital General Universitario Gregorio Marañón, University Hospital, Rheumatology, Aarhus, Denmark; 5Aarhus University Hospital, Research Madrid, Spain Centre of Emergency Medicine, Aarhus, Denmark; 6Hospital Pharmacy Central Denmark Region, Clinical Pharmacy-Aarhus University Hospital, Aarhus, Denmark; 7Aarhus University, 10.1136/ejhpharm-2020-eahpconf.13 Public Health, Aarhus, Denmark
Background and importance The large number of health apps 10.1136/ejhpharm-2020-eahpconf.14 for genitourinary cancers means a transparent and objective evaluation by app experts and healthcare professionals is Background and importance Patient involvement is increasingly needed. becoming part of clinical practice, including self-administration Aim and objectives To analyse the quality of apps for patients of medication (SAM) during hospitalisation. Previously, we diagnosed with genitourinary cancers, using the mobile appli- have investigated the effectiveness of SAM in a randomised cation rating scale (MARS) methodology. controlled trial (RCT). The proportion of ward level dispens- Material and methods This was an observational, cross sec- ing errors was considered the best way to explore safety dif- tional descriptive study. Inclusion criteria were apps available ference between workflows. We saw that SAM was effective, in the ‘App Store’ and the ‘Play Store’ for genitourinary can- and also user friendly. However, due to the scarcity of health- cers intended for patients and/or careers. Inclusion period was care resources, a health economic evaluation is important February 2019. when choosing the best, safest and most economically advanta- Platform (Android/iOS), cost, date of the last update, type geous way to manage medication in hospital. of cancer, purpose and participation of health professionals on Aim and objectives To evaluate the cost effectiveness of SAM their development were recorded. A multivariate analysis was during hospitalisation compared with nurse-led medication dis- conducted. pensing and administration. The quality of the apps was assessed using MARS. This Material and methods A cost analysis (microcosting level) was evaluation includes 23 evaluation criteria clustered in five performed from a hospital perspective with a short term domains (engagement, functionality, aesthetics, information and incremental costing approach, including the costs of medica- subjective quality). Each evaluation criterion is rated from 1 tion, materials and nursing time spent on dispensing, adminis- to 5 according to its conformity (1=inadequate, 2=poor, tration, SAM start and discharge preparation. 3=acceptable, 4=good, 5=excellent). The total mean score of The RCT was performed in a cardiology unit and included MARS, which describes the overall quality of the app, was patients 18 years that were capable of SAM. In the interven- obtained by the mean score of every domain. tion group, patients were instructed about the medication and
A6 EJHP 2020;27(Suppl 1):A1–A232 Abstracts self-administered their own medication. In the control group, effectiveness. BIS reduced the risk of intraoperative awareness medication was dispensed by nurses in the ward. in high risk patients by 80% (OR=0.24, 95% CI 0.12, 0.48). The proportion of ward level dispensing errors was col- Furthermore, BIS reduced discharge time from postanaesthesia lected through disguised observation of patients in the patient care units by about 23 mins (95% CI 31.01, 13.69; room and nurses in the medicine room. I²=20%), postoperative nausea and vomiting by 12%, risk of A dispensing error was defined as a deviation between the postoperative cognitive disorders at 3 months after extubation prescription and the dispensed medication (eg, incorrect dose). by 3% (95% CI 0.05, 0.00; I²=52%) and risk of postop- Opportunity for errors (OEs) was defined as any medication erative delirium by 6% (95% CI 0.10, 0.03; I²=11%). dispensed and any medication prescribed but not dispensed. Conclusion and relevance BIS guided monitoring reduced the Dispensing error proportion=(dispensing errors/OEs)×100%. risk of intraoperative awareness in high risk patients under Results A total of 250 patients were recruited; 11 were with- intravenous general anaesthesia. Furthermore, BIS was effective drawn as they were discharged prior to observation. The pro- in reducing consumption of anaesthetic agents, time to dis- portion of men was 66% and mean age was 64.2 years (SD charge from postanaesthesia care units and postoperative 12.2). Total cost per patient in the intervention group was adverse events. It remains to be clarified whether BIS technol- 49.9C¼ (95% CI 46.7; 53.1C¼ ) compared with 52.6C¼ (95% ogy is cost effective, considering the low prevalence of intrao- CI 47.1; 58.1C¼ ) in the control group (p=0.09). Sensitivity perative awareness, and whether it represents a real benefit in analysis consistently showed total costs favouring the interven- perioperative and postoperative preventable adverse events. tion. The dispensing error proportion was 9.7% (95% CI 7.9 The costs of preventable adverse events should be evaluated at to 11.6%) (100 errors/1033 OEs) in the intervention group a single healthcare facility, considering the long term benefits. compared with 12.8% (95% CI 10.9 to 15.6) (132 errors/ 1028 OEs) in the control group (p=0.02). REFERENCES AND/OR ACKNOWLEDGEMENTS Conclusion and relevance SAM seem to cost less but the 1. https://www.ncbi.nlm.nih.gov/pubmed/24937564 2. https://www.eahp.eu/sites/default/files/abstract_book_-_bar19_-_updated.pdf results were not statistically significant. As SAM patients made 3. https://www.ncbi.nlm.nih.gov/pubmed/23962378 fewer dispensing errors compared with nurse-led medication No conflict of interest. dispensing, the results are suggested to be cost effective.
REFERENCES AND/OR ACKNOWLEDGEMENTS No conflict of interest. 1ISG-016 ENVISIONING SUSTAINABILITY IN PERSONALISED MEDICINE: FONDO AIFA 5% AND THE ITALIAN EXAMPLE 1ISG-015 EVALUATION OF BISPECTRAL INDEX MONITORING IN 1F Bocchio*, 1M Tizzoni, 1M Calvi, 2A Di Benedetto. 1Fondazione Irccs Policlinico San GENERAL ANAESTHESIA THROUGH A HEALTH Matteo Pavia, Uoc Farmacia, Pavia, Italy; 2Universita’ Degli Studi Di Milano, Scuola Di TECHNOLOGY ASSESSMENT METHOD: A POSSIBLE Specializzazione in Farmacia Ospedaliera, Pavia, Italy INTRODUCTION IN CLINICAL PRACTICE IN AN ITALIAN HOSPITAL? 10.1136/ejhpharm-2020-eahpconf.16 1EGuido*,2ME Borghesi, 2ASaccardi.1University of Milan, Specialisation School in Hospital Background and importance Sustainability in the era of person- Pharmacy, Milan, Italy; 2Asst Carlo Poma-Mantova, Hospital Pharmacy, Mantova, Italy alised medicine represents one the major problems because of 10.1136/ejhpharm-2020-eahpconf.15 the possible limited access to innovative therapies. Since 2003, the Agenzia Italiana del Farmaco (AIFA), along with pharma Background and importance International guidelines suggest industries, has established an innovative and unique pro- evaluation of clinical signs to guide the dosages of anaesthetic gramme, ‘Fondo 5%’,1 to deliver innovative and highly expen- agents in order to achieve the basic goals of anaesthetic man- sive therapies to patients with rare diseases after their agement. The use of the bispectral index (BIS) as standard approval by the EMA but before AIFA authorisation and reim- practice might be useful for anaesthesia management by reduc- bursement for the specific indication. A joint evaluation by ing the risk of intraoperative awareness (0.1–0.2% of the sur- physicians and clinical pharmacists, based on the scientific lit- gical population), consumption of anaesthetic agents, recovery erature, clinical reports, treatment plan and cost estimate anal- time and total cost of anaesthesia. ysis, produces a patient specific request for a peculiar drug Aim and objectives The objective of the study was to assess not otherwise available through conventional channels. AIFA is the efficacy of BIS guided anaesthesia monitoring for its responsible for the scientific evaluation, and final authorisation potential introduction as standard practice. or rejection. Once the treatment plan has received AIFA offi- Material and methods The study was conducted from January cial approval, the clinician is authorised to administer the 2008 to July 2019, using the following databases: PubMed, therapy whose cost will be subsequently refunded by the Cochrane Library, ECRI and NICE. The articles included AIFA.2 meta-analyses, randomised control trials, health technology Aim and objectives To describe the Italian method in order to assessment (HTA) reports and guidelines for BIS guided moni- improve the availability of the best innovative therapies, con- toring versus clinical signs as standard practice during general sidering sustainability of the national health system. anaesthesia in adult patients. The evaluation was conducted Material and methods Collection and processing of drug according to the scheme reported in the sub annex G of requests for Fondo 5% and analysis of the clinical and eco- Lombardy region Resolution XI/1046 which describes methods nomic impact. for the systematic research and critical analysis of the litera- Results From August 2018 to September 2019, 24 treatments ture sources and the drawing up of an HTA report. were authorised by AIFA: 20 (83%) in the adult and paediat- Results We reviewed 18 articles to analyse the benefits in ric haematological area (venetoclax for acute myeloid leukae- terms of more reliable statistical evidence and cost mia/mantle cell lymphoma, eltrombopag for pure red cell
EJHP 2020;27(Suppl 1):A1–A232 A7 Abstracts aplasia, pembrolizumab for Hodgkin lymphoma/non-Hodgkin (3%), P (1%) and R (1%); in 29% there was a stock short- lymphoma, ruxolitinib for myeloproliferative neoplasm BCR/ age, 60% of SI had an alternative and 47% of SI were not JAK2-rearranged, blinatumomab for acute lymphoblastic leu- registered on AEMPS. kaemia, ruxolitinib for graft versus host disease); 3 requests The total additional cost of supply problems was 52.054,04 (12%) came from the oncological/gynaecological area (trabecte- ¼C and 38% of SI were inconvenient for the pharmacy dina for tube ovarian carcinoma and serous ovarian adenocar- service. cinoma) and 1 (5%) from the ophthalmology area Conclusion and relevance Considering that most of the supply (cenegermin for neurotrophic keratitis). Eight of 24 authorised problems involved essential drugs, these problems can compro- patients (33%) are still receiving treatment and 16 (67%) have mise the quality of healthcare and patient safety. The J group completed their treatment programme. Of note, 16/23 (70%) was the most affected group which could result in an increase oncologic patients had a disease response; moreover, 4/9 in antibiotic resistance if it increased the consumption of (44%) high risk acute leukaemia patients have undergone broad spectrum antibiotics. AEMPS must improve SI informa- bone marrow transplant. The total cost of the authorised tion. Shortages usually increase treatment costs. treatments was about¼ C 700 000, of which¼ C 142 000 was already credited back to the hospital. REFERENCES AND/OR ACKNOWLEDGEMENTS Conclusion and relevance These results demonstrate that Fondo No conflict of interest. 5% represents a scientific based method guaranteeing access to highly expensive therapeutic programmes, impacting on patient survival, without affecting the cost effectiveness balance and 1ISG-018 APPLICATION OF A TIME SLOT MODEL IN ONCOLOGY: sustainability of the national health system. DELIVERY PLANNING AND PROCESS OPTIMISATION REFERENCES AND/OR ACKNOWLEDGEMENTS 1CBertino*,1MDiGerardo,1A Pirrone, 1EDallaFontana,2G Caravella, 2A Spagnuolo, 1. L.326/2003 2R Cursano. 1Università Degli Studi Di Milano, Scienze Farmaceutiche-Scuola Di 2. www.aifa.gov.it/fondo-nazionale-aifa Specializzazione Farmacia Ospedaliera, Milano, Italy; 2Asst Melegnano Martesana, No conflict of interest. Farmacia, Vizzolo Predabissi, Italy
10.1136/ejhpharm-2020-eahpconf.18
1ISG-017 IMPACT OF SUPPLY PROBLEMS IN A HOSPITAL Background and importance Initially, the aim of centralisation PHARMACY SERVICE of the management of antiblastic drugs was for the quality of preparations, workers’ protection, patient safety and reduction B Zarate, Á Pieras López, R Menárguez Blanc*, A Iglesias Carbajo, C Álvarez Asteinza, of the risks associated with environmental contamination. In A Lozano Blazquez, Á Arias-Martinez, I Maray Mateos, MD Macía Rivas, CL Fernández recent years, optimisation of hospital processes has become Laguna. Hospital Universitario Central De Asturias, Pharmacy, Oviedo, Spain more relevant. In 2017, a new time slot model for the deliv- 10.1136/ejhpharm-2020-eahpconf.17 ery of cancer therapies was introduced in the galenic prepara- tion laboratory. This type of model consists of time slots Background and importance Hospital management of drugs is defined on the basis of fixed criteria. a complicated task and it is necessary to take into account dif- Aim and objectives The aim was to optimise the management ferent factors, such as average consumption, seasonal varia- of anticancer drugs. tions, cost, physical space available for storage and therapeutic Material and methods A pharmacoeconomic analysis was car- innovations. Currently, this task is hampered by the numerous ried out on anticancer therapies administered in two oncology supply issues (SI) that in many cases affect regularly used departments, one of which was located 20 km from the prep- drugs. These problems can lead to shortages and produce lack aration site. Various parameters were taken into consideration: of effectiveness of treatments, compromise patient safety and costs and chemical–physical stability of the drugs, average increase treatment costs. number of daily dosing and duration of dosing. According to Aim and objectives To analyse non-oncohaematologic SI and these parameters, five time slots were identified for the oncol- their impact on the management of drugs in the pharmacy ogy on site (8.00, 9.30, 10.00, 12.00 and 14.00) and three service of a hospital. time slots for the off-site (14.00 on the previous day, 10.00 Material and methods This was a prospective study to evalu- and 11.00). High cost therapies can only be set up on the ate SI between June and November 2018 The variables col- same day for reasons of economic sustainability and to avoid lected were: start and end dates of SI, ATC code and if the waste. drugs were considered essential according to the WHO, if Results For the time slot 8.00 on site and 14.00 off-site the they produced shortages, if SI had alternatives (same dose following were chosen: low cost drugs, with good chemical– and same route of administration) and if the SI was regis- physical stability, long term administration, with a maximum tered on the official website of the Spanish Government of six therapies on site and four off-site. These therapies are (AEMPS) when detected. An economic analysis of SI was set up the day before administration. made with all the data registered in an Excel sheet. SI were Time slot 9.30 on site and 10.00 off site: preferably evaluated if they caused any inconvenience to the pharmacy medium and high cost drugs, long term, with a maximum of service (drug restriction, management and preparation three therapies on site and eight off site. difficulties). Time slot 10 on site: medium and high cost drugs, medium Results There were 76 SI affecting 74 drugs. The average or long term, with a maximum of six therapies. duration was 64 days (range 2–224) and 53% of the affected Time slot 12.00 on site and 11.00 off site: medium and drugs were considered essential according to the WHO. Most high cost drugs, medium or short term, for patients who affected ATC groups were: J (22%), C (16%), B (12%), N cannot undergo tests and medical examination the previous (12%), H (8%), V (7%), A (5%), G (5%), D (4%), S (4%) L day.
A8 EJHP 2020;27(Suppl 1):A1–A232 Abstracts
Time slot 14.00 on site: medium and high cost drugs, associated with dissatisfaction in HPs and therefore efforts short term, for patients who cannot undergo tests and medical should be made to programme the need for HPs in the examination the previous day. national healthcare system. Conclusion and relevance The introduction of a time slot model has led to advantages such as optimisation of time REFERENCES AND/OR ACKNOWLEDGEMENTS delivery, reduction of waiting times for patients, better com- No conflict of interest. munication and improvement in the occupancy rate of chairs in the day hospital.
REFERENCES AND/OR ACKNOWLEDGEMENTS Section 2: Selection, Procurement and No conflict of interest. Distribution
2SPD-001 IMPLEMENTATION OF HOME DELIVERY AND 1ISG-019 HOSPITAL PHARMACISTS AGED <45 YEARS: AN TELEPHARMACY SYSTEMS IN A THIRD LEVEL EMPLOYMENT STATUS AND JOB SATISFACTION HOSPITAL SURVEY IN ITALY 1J Cordero-Ramos, 1Ú Baños-Roldán, 1JA Fernandez-González-Caballos, 1C Castillo- 2 1 1SE Campbell Davies*, 2G Bagaglini, 3FBrera.1Italian Society of Hospital Pharmacy Sifo, Martin*, EM Delgado-Cuesta. Hospital Universitario Virgen Macarena, Hospital Pharmacy, 2 Young Pharmacists, Milano, Italy; 2Italian Society of Hospital Pharmacy Sifo, Young Seville, Spain; Hospital Universitario Virgen Macarena, Primary Care Pharmacy Department, Pharmacists, Roma, Italy; 3Italian Society of Hospital Pharmacy Sifo, Young Pharmacists, San Seville, Spain Donà Di Piave, Italy 10.1136/ejhpharm-2020-eahpconf.20 10.1136/ejhpharm-2020-eahpconf.19 Background and importance Our hospital catchment area is Background and importance The 4 year postgraduate Hospital mainly formed of several villages. For patients suffering path- Pharmacy Specialisation Course (HPSC) is a mandatory ologies that decrease their autonomy, such as multiple sclero- requirement to become a hospital pharmacist in the national sis, going to their hospital pharmacy can be a stressful activity. healthcare system in Italy. Despite different laws that have Given the increasing number of patients, we decided to design been enforced to create homogeneous national training, a a new delivery system but keeping all of the benefits of phar- diversified situation still occurs and no Ministry of Health maceutical care. contracts exist for hospital pharmacy interns. After complet- Aim and objectives Our main purpose was to design a home ing the HPSC, subjects with a hospital pharmacy diploma delivery system (HDS) and a telepharmacy system (TS). Our have to pass single hospital public examinations in order to secondary objective was to establish what happened to obtain a contract with the national healthcare system. There- patients, evaluating patient acceptance, time saved and kilo- fore, securing a permanent contract (PC) as a hospital phar- metres avoided. macist (HP) in Italy is a long process which is not always Material and methods We designed the new pathway, HDS straightforward. and TS, and also a 9 months observational retrospective study Aim and objectives The objective of the study was to describe (December 2018 to September 2019). A monthly–bimonthly the current situation of HPs aged <45 years in Italy after the HDS and TS was proposed to patients attending the outpa- HPSC. tient service, prioritising patients with low autonomy. One of Material and methods A cross sectional, descriptive survey of the requirements for patients to access the HDS was to pro- HPs aged <45 years was conducted in Italy (August to Sep- vide their consent to code personal data, such as their address tember 2019); data were collected through a 31 point Survey- and telephone number. Monkey based questionnaire sent to national society members To ensure HDS, patients were advised by telephone 3–5 via email. days before the next delivery. During the call, a pharmacist Results A 44% response rate was achieved (298/682): 56% also interviewed the patient, to asses adherence, asking how aged 35–45 years, 61% with HPSC >3 years ago. During the treatment was going and looking for any adverse reac- HPSC: 42% had no retribution; 56% obtained a scholarship tions. Electronic medical records were consulted to obtain var- from the university or hospital; and 2% worked in community iables. For evaluation of the time and distance saved by the pharmacies. Fifty-eight per cent had a PC, 38% a temporary pathway, we estimated the distance between the patients´ contract (TC) and 4% did not work in a hospital pharmacy. homes and the hospital in minutes and kilometres using Goo- Only 19% of HPs with a PC obtained their specialisation <3 gle Maps. years ago while 34% of HPs with a TC obtained their special- Results The new pathway commenced in December 2018 isation >3 years ago; 54% declared that TCs influenced nega- and 9 months later 135 patients were included in the HDS tively on job satisfaction. HPs with a PC were more satisfied and TS, 73 women (54%), with a median age of 56±15 with their professional expectations compared with HPs with years. A total of 420 deliveries took place (on average 3.1 TCs (56% vs 40%) while the former agreed more that their deliveries/patient). No patient rejected the programme once responsibilities were proportionate to their role compared with included. HDS and TS saved 67.8 min (41–97.6) and 69.3 the latter (56% vs 42%). However, HPs with a PC were km (47.5–88,2) for each patient per dispensation on more stressed compared with HPs with a TC (74% vs 66%), average. and 30% of HPs with a TC were dissatisfied compared with Conclusion and relevance The implementation of the new HPs with a PC (13%). pathway was well accepted by patients and saved a lot of Conclusion and relevance The results of this survey showed time and kilometres per dispensation. For people who find it that PCs for HPs should not be taken for granted. The sam- difficult to move due to their illness, HDS and TS can have a ple demonstrated that TCs and lower retribution were huge impact on their quality of life.
EJHP 2020;27(Suppl 1):A1–A232 A9 Abstracts
REFERENCES AND/OR ACKNOWLEDGEMENTS No conflict of interest. No conflict of interest.
2SPD-002 IMPROVEMENT IN AN ANTIMICROBIAL STEWARDSHIP 2SPD-003 ECONOMIC IMPACT OF THE INTRODUCTION OF PROGRAMME AFTER IMPLEMENTING A SCREENING LAMIVUDINE PLUS DOLUTEGRAVIR BITHERAPY IN HIV ALERT SYSTEM NAIVE PATIENTS 1ETevar*,2MJ Castillo Méndez, 1AFerrerMachín,3ML Padilla Salazar, 3LAbellaVázquez, L Cantarelli*, J Gonzalez Garcia, B Del Rosario Garcia, J Ramos Rodriguez, F Gutierrez 4J Ode Febles, 1KÁlvarezTosco,3M Hayek Peraza, 1MÁ Ocaña Gómez, 1JMerinoAlonso. Nicolas, J Garcia Cairos, S Garcia Gil, GJ Nazco Casariego. Complejo Hospitalario 1Hospital Nuestra Señora De La Candelaria, Pharmacy Service, Santa Cruz De Tenerife, Universitario De Canarias, Pharmacy, Santa Cruz De Tenerife, Spain Spain; 2Hospital Nuestra Señora De La Candelaria, Computer Department, Santa Cruz De 3 10.1136/ejhpharm-2020-eahpconf.22 Tenerife, Spain; Hospital Nuestra Señora De La Candelaria, Internal Medicine, Santa Cruz De Tenerife, Spain; 4Hospital Nuestra Señora De La Candelaria, Microbiology Service, Santa Cruz De Tenerife, Spain Background and importance Recently, the GEMINIS I and II studies have demonstrated how lamivudine (3TC) with dolute- 10.1136/ejhpharm-2020-eahpconf.21 gravir (DTG) bitherapy in naive patients is as effective as con- ventional triple therapy after 48 weeks of follow-up.1 Background and importance The implementation of an antimi- Aim and objectives To analyse the 5 year economic impact of crobial stewardship programme (AMSP) is very important but bitherapy treatment of HIV naive patients from the perspec- it has to be accompanied by personnel resources. It is there- tive of hospital management in a third level hospital fore necessary to effectively use the time spent in the AMSP Material and methods A mathematical model in Excel format reviewing only those treatments that can be improved. was designed to estimate the difference in costs between Aim and objectives To implement a screening alert system DTG/3TC bitherapy and the conventional regimens described (SAS) that shows only those antibiotic treatments that could in the GESIDA guide2 for naive patients, with a 5 year be improved by meeting predefined conditions and to evaluate perspective: the SAS. . Material and methods This was a quasi-experimental study. Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) . Using the information available in the electronic health record Dolutegravir+emtricitabine/tenofovir alafenamide (DTG (EHR) and in the pharmacy and microbiology applications, we +FTC/TAF) . developed a computer tool that analysed hundreds of situa- Raltegravir+emtricitabine/tenfovir alafenamide (RAL+FTC/ tions under pre-established conditions. For one month, before TAF) each AMSP team meeting, we recorded the total number of The model was applied using an incidence of the disease patients and prescribed antibiotics in the hospital compared of 8.6 new cases per 100 000 inhabitants (epidemiological with the number of treatments and patients that our system surveillance information system of the government of Spain). proposed to review. The budgetary impact on a reference hospital serving a refer- The main variable of our study was number of patients to ence population of 350 000 was estimated. The unit cost of check before and after the tool. Secondary variables included the drugs was obtained from the BOTplus database. number of antibiotics to review. Results The cost per month of treatment for the different rec- For the statistical analysis, the paired t test was used to ommended regimens was: 1007.43C¼ for DTG+FTC/TAF, determine if there were differences in the mean number of 1122.73C¼ for RAL+FTC/TAF, 863.00C¼ for DTG/ABC/3TC patients reviewed before and after using the SAS. and 637.74C¼ for 3TC+DTG bitherapy. The analyses were performed using SPSS/PC statistical pro- The introduction of bitherapy meant a saving compared gramme (V.24.0 for Windows, SPSS Inc, Chicago, Illinois, with other alternatives: USA). . ¼ Results Seven services were included in the study: vascular 485C patient/year compared with RAL+FTC/TAF and 634 ¼ surgery, cardiology, general surgery, geriatrics, internal medi- 366.92C (43.2%) after 5 years of treatment. . ¼ cine, neurology and traumatology. The number of antibiotics 370C patient/year compared with DTG+FTC/TAF and 483 ¼ to review without the SAS in each AMSP team meeting was 946.92C (36.7%) after 5 years of treatment. . ¼ 21 (7–22) compared with 7 (3–9) when we used the SAS. 225.26C patient/year compared with DTG+ABC/3TC ¼ Mean differences were found for patients to theoretically therapy and 294 640.08C (26.1%) after 5 years of check before using the SAS (14±7 patients) compared with treatment. those who were actually checked after using the tool (5±3 Conclusion and relevance HIV treatment continues to have a patients) (mean difference 9 (95% CI 5 to 12 patients); high budgetary impact. The introduction of bitherapy (3TC/ p=0.000124). DTG) in naive patients would mean a reduction in the direct Conclusion and relevance This software allows the collection costs of treating this pathology, with a saving of up to 40% of information contained in different systems and displays compared with conventional therapies. only the relevant one in an organised view for the user. Lim- ited personnel resources make the development of screening REFERENCES AND/OR ACKNOWLEDGEMENTS systems essential to optimise time and to prioritise which 1. Cahn P, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir diso- treatments need to be reviewed. proxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet 2019;393(10167):143–155. REFERENCES AND/OR ACKNOWLEDGEMENTS 2. Gesida-seimc. 2018. available at: http://gesida-seimc.org/wp-content/uploads/ 1. Rodríguez-Baños J, et al. Programs for optimizing the use of antibiotics (PROA) in 2019/02/Guia_Tar_Gesida_Ene_2019.pdf Spanish hospitals: GEIH-SEIMC, SEFH and SEMPSPH consensus document. Farm Hosp 2012;36(1). No conflict of interest.
A10 EJHP 2020;27(Suppl 1):A1–A232 Abstracts
2SPD-004 EFFICIENCY OF PRECISION DOSING WITH 2SPD-005 ECONOMIC ANALYSIS OF OSIMERTINIB IN INTRAVENOUS IMMUNOGLOBULINS IN PATIENTS PREVIOUSLY UNTREATED EGFR MUTANT ADVANCED WITH HAEMATOLOGICAL MALIGNANCIES NON-SMALL CELL LUNG CANCER M Dominguez Cantero*, FJ Salmeron-Navas, EM Barreiro-Fernandez, C Moreno-Ramos, A Ferrer Machín*, LG José Arístides, JA Martín Conde, T Betancor García, M Vera Cabrera, MP Briceño-Casado. Hospital Universitario Puerto Real, Servicio De Farmacia, Cadiz, Spain S Hernández Rojas, I González García, K Álvarez Tosco, J Merino Alonso. Hospital Pharmacist, Pharmacy Service, Santa Cruz De Tenerife, Spain 10.1136/ejhpharm-2020-eahpconf.23 10.1136/ejhpharm-2020-eahpconf.24 Background and importance Intravenous immunoglobulin (IVIG) therapy is relatively expensive and requires careful use. Background and importance Osimertinib improves progression IVIG dosing is based on actual body weight (ABW) but it is free survival (PFS) in previously untreated patients with EGFR mainly distributed in the extracellular and intravascular space mutated non-small cell lung cancer (NSCLC). However, its and minimally in body fat. This would allow adjusting the profitability has not been established in a third level hospital. dose by ideal body weight (IBW) or adjusted body weight Aim and objectives The aim of the study was to evaluate the (AdjBW), reducing the dose per patient. cost effectiveness of osimertinib in patients with mutated Aim and objectives The objective of this study was to describe EFGR NSCLC compared with other tyrosine kinase inhibitors the efficiency of precision dosing (PD) compared with ABW (TKIs). dosing in the initial dose of IVIG in patients with haematolog- Material and methods This was a cost effectiveness study of ical malignancies. osimertinib in patients with EFGR mutated NSCLC in a third Material and methods This was a retrospective descriptive level hospital over a period of 1 year of treatment (1 January study from May 2008 to September 2019. Patients with hae- 2018 to 12 January 2019). The protocol of the hospital was matological malignancies who had received at least one dose reviewed to include all therapeutic alternatives: afatinib, gefiti- of IVIG were included. Exclusion criteria were: <18 years of nib and erlotinib. age and absence of anthropometric and/or clinical data. PD The main variable of the study was the incremental cost was defined as the use of IBW (Devine formula in men and effectiveness ratio (ICER) of osimertinib compared with other Robinson formula in women) for dose calculation except: (1) TKIs. Secondary variables included: cost of treatment per ABW