The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
Redispensing of expensive oral anticancer medicines: a practical application
European Statement
Clinical Pharmacy Services
Why was it done?
OAM are widely used in the treatment of solid tumors and are administered orally in cycles that require self-administration at home. However, dose adjustments and discontinuations often lead to leftover medication which is discarded as waste. Therefore, the increasing use of expensive OAM comes with the downside of a financial and environmental burden. To reduce this waste, returned OAM to the pharmacy could be considered for redispensing to other patients providing guaranteed quality.
What was done?
We defined quality criteria for redispensing of oral anticancer medicines (OAM) in our hospital pharmacy. These criteria were laid down in a Standard Operating Procedure (SOP) to assess the eligibility for redispensing of returned OAM. This SOP was implemented in daily pharmacy practice.
How was it done?
A systematic risk analysis was conducted to determine eligibility of OAM for redispensing taking relevant guidelines and product information into account. The defined quality criteria were translated into a SOP and implemented in daily pharmacy practice. Over a year period, the number of returned OAM accepted for redispensing was quantified, and the reduction in financial waste and environmental burden calculated.
What has been achieved?
From the systematic risk analysis, four categories of quality aspects were identified: product presentation suitability (stability characteristics, storage requirements), physical condition (unopened or opened secondary or primary packaging, visual appearance), authentication (Falsified Medicines Directive, confirmation of initial dispense, recall), and additional aspects (remaining shelf life, period of storage under uncontrolled conditions). The first category identified that in principle, 75% of the licenced OAM (n=..products) dispensed at our institute is eligible for redispensing. From all combined quality aspects, a flow chart was created according to which each individual returned OAM is assessed . During the study period, 10,415 OAM dose units out of 13,210 returns (79%) were accepted for redispensing. The total value of OAM accepted for redispensing was €483,301, accounting for 0.9% of the total value dispensed during this period. Furthermore, the potential reduction in environmental burden was estimated at 1132.1 g of potent active pharmaceutical ingredient.
What next?
We established an easily implementable, comprehensive quality assessment of returned OAM for redispensing. Wide implementation of this approach would result in serious OAM cost and waste reduction.
Clinical and economic optimisation for the management of patient at risk of respiratory syncytial virus infection
European Statement
Clinical Pharmacy Services
Author(s)
Erica Cusumano, Giorgia Nairi, Cristina Baiamonte, Chiara Schimmenti, Lo Verso Clelia, Carolina Scaccianoce, Marcello Vitaliti, Sceila Affronti, Marco Benanti, Paolo Amari, Patrizia Marrone
Why was it done?
Until 2020, pavilizumab, refunded by National Health System for Respiratory Sincytial Virus (RSV) infection prophylaxis of paediatric patient at risk, was dispensed in 50 mg (FL 50) and/or 100 mg (FL 100) unit packs, regardless of the prescribed dose, with subsequent preparation on the ward and waste of any residual drug. Therefore, the project’s purpose, from November 2021, was to overcome the past distributive criticalities of pavilizumab.
What was done?
In our Hospital, Early Start 2.0 project (E.S-2.0) was implemented in collaboration with the neonatal intensive care unit. The E.S-2.0 purpose was to increase quality and safety of Pavilizumab galenic preparation to guarantee the patient’s health and generate an economic saving with an optimisation of hospital resources.
How was it done?
The E.S.-2.0 involved weekly drug days for the delivery to department staff of personalised galenic preparations of pavilizumab, prepared by hospital pharmacy service in a contamination-controlled environment. Through the hospital management system, prescriptions for the period November 2021 to April 2022 were extrapolated to verify the validity of the project. There were 85 patients. A palivizumab consumption database was created to evaluate the mg saved after E.S.-2.0 and the related economic savings.
What has been achieved?
Project implementation allowed us to obtain an economic saving of 9.33% related to 2339.01 mg that would have been dispensed and wasted without E.S-2.0. The results obtained considering the costs of pavilizumab (FL-50: 10.79 €/mg and FL-100: 8.96 €/mg) and our saving indicators: mg saved= mg that would have been delivered before E.S-2.0 – mg after E.S-2.0; € saved = (mg residues that would have been dispensed and wasted before E.S-2.0 from FL 100 x 8.96 €/mg) + (mg residues that would have been dispensed and wasted before E.S-2.0 from 50 x 10.79 €/mg). In addition, the personalised galenic preparations in controlled contamination pharmacy premises guaranteed a sterile pharmacological manipulation process.
What next?
E.S.-2.0 represents a cost saving policy safeguarding patient security. Practice described is worthy of implementation in hospitals not just for prophylaxis of RVS infection but also for the management of all patients undergoing treatment with therapies that can be prepared in galenical laboratory.
A human albumin (HA) prescription model as strategy to maximise the appropriate use in shortage conditions
European Statement
Introductory Statements and Governance
Author(s)
Giorgia Babaglioni, Lorenzo Silva, Elena Festa, Daniela Paganotti, Tullio Elia Testa
Why was it done?
In Italy, the rising PDMPs demand had to face the international shortage caused by the SARS-CoV-2 pandemic outbreak. The self-sufficiency level of albumin represents one of the National Blood Centre (NBC) main challenge, in view of the health system sustainability.
What was done?
The hospital pharmacy of a northern Italy centre, in accordance with the Good Use of Blood Committee, introduced a nominal form for human albumin (HA) requests to evaluate and rationalise the HA clinical-therapeutic demand. It represents a pharmacist led intervention approach shared by physicians, in favour of an economically sustainable healthcare contrasting the lack of plasma-derived medicinal products (PDMPs).
How was it done?
Prescription criteria were updated according to the most recent guidelines. The cut-off of blood albumin level above 2.5 g/dl has been introduced as eligibility threshold value and for the daily dose calculation, except for HA calculation based on volumes for plasmapheresis and large volume evacuative paracentesis in hepatic cirrhosis. The pharmacy provides a maximum of five days therapy, then a new revaluation and updating of blood albuminemia was required; 690 total requests were analyzed.
What has been achieved?
In March 2023, HA consumption was 61400 gr, collapsed by 75% in April and then settled at – 58% in May and June. The most important reductions in monthly requirements affected the surgical (- 75%), intensive (- 62%), internist (- 64%) and gastro-hepatological (- 52%) areas. 97,5% of requests were on-label: 20% for plasmapheresis or paracentesis, 21% for liver failure, 16% for cirrhosis of the liver with refractory ascites. 26% of requests (n = 180) reported in-range blood albumin value, while the 14% was unknown or ongoing because administered in emergency phase. 37% of requests has been evaded even if the blood albumin was > 2,5 g/dl due to mandatory clinical need. Thanks to the new prescription model it was possible to save € 91 752 in the second quarter.
What next?
The introduction of the reasoned request allowed to achieve albumin self-sufficiency with voluntary blood donations and reduce the market products purchase. Furthermore, it fostered the clinicians awareness on the HA use appropriateness, considering crystalloids and non-protein colloids as alternative therapeutic strategies as resuscitation fluids.
Using informatics to optimise a medicines saving programme in a large NHS trust
European Statement
Selection, Procurement and Distribution
Author(s)
Julie Featherstone, Alice Lo, Golnaz Douraghi-Zadeh
Why was it done?
The dashboard was initiated to provide accurate and timely expenditure data to the Medicines Value Team (MVT) which could then be appropriately interrogated and fed back to all relevant Trust and pharmacy staff. The aim was to quickly identify unexpected variance and progress on CIPs that allowed review with clinical and procurement teams.
What was done?
With the informatics team, a dashboard was developed to monitor medicines expenditure and Cost Improvement Plan (CIP) savings on a monthly basis. The dashboard incorporated varying tracking methods to provide timely data on biosimilar switching, contract price changes and individual medicine optimisation schemes at East Kent Hospitals University Foundation Trust (EKHUFT).
How was it done?
The dashboard required many hours working with the informatics team to ensure good understanding of the information required. Different CIPs had to be tracked and reported in different ways. A mixture of reporting and visual styles were needed to represent the data in a user-friendly way. It was recognised that data validation was required to ensure the accuracy of the dashboard, using a variety of recognised resources, e.g. RX Info.
What has been achieved?
A full, multi-tabular dashboard is available on the Trust Information Portal. Tracked expenditure data is reported monthly by the MVT at pharmacy and Trust meetings. This has enabled realistic and timely data to be included in overall financial forecasting and feedback to clinical teams on their CIPS. The dashboard has been designed to support the rapid addition of new schemes as they are identified to track potential savings and report at the earliest opportunity. The combined use of the dashboard with close MVT oversight has resulted in closer working with clinical and procurement teams. This has led to better identification, tracking and reporting of all medicines saving opportunities in the Trust, saving over £1 million in 2022/23.
What next?
The dashboard will continue to be developed further by the MVT to maximise the capture and reporting of CIPs at EKHUFT. It will also be used to support regular medicines value reviews with senior clinical pharmacists and their teams to help identify future medicines savings opportunities – essential in this challenging financial climate in the National Health Service (NHS).
Application of new indicators of antimicrobial agent use based on consumption in a tertiary hospital
European Statement
Patient Safety and Quality Assurance
Author(s)
Saúl Herrera Carranza, Carlos Sanz Sánchez, Sira Sanz Márquez, José Francisco Valverde Cánovas, Leonor Moreno Núñez, Ana Vegas Serrano, Rafael Hervás Gómez, Oriol Martín Segarra, Juan Emilio Losa García, Montserrat Pérez Encinas
Why was it done?
Spanish Society of Hospital Pharmacy(SEFH) proposed 13 indicators(bibliography:Gutiérrez-Urbón JM, Gil-Navarro MV, Moreno-Ramos F, Núñez-Núñez M, Paño-Pardo JR, Periáñez-Párraga L. Indicators of the hospital use of antimicrobial agents based on consumption. Farm Hosp. 2019;43(3):94-100) which could help to improve the quality of antimicrobial use.
Indicators are related directly(dir): higher value-better practices; indirectly(ind):lower value-better practices; or heterogeneity: homogeneous percentages(%)-better practices.
What was done?
The creation of a tool for calculating new indicators of antimicrobial agents based on consumption using Defined Daily Dose per 100 hospital stays(DDD/100s).
How was it done?
We built an Excel tool to input required data in order to calculate the indicators with the formulas defined for their automated estimation:
-Overall antibacterial consumption(ind)
-Overall consumption of antifungals(ind)
-Consumption of carbapenemics(ind)
-Consumption of fluoroquinolones(ind)
-Ratio macrolides-p/fluoroquinolones-p(dir)
-Ratio metronidazole-p/piperacillin-tazobactam+carbapenemics(dir)
-Fosfomycin consumption(dir)
-Sequential therapy(dir)
-Ratio anti-SRSA/anti-MRSA agents(dir)
-Ratio amoxicillin/amoxicillin-clavulanic acid(dir)
-Ratio amoxicillin-clavulanic acid/piperacillin-tazobactam(dir)
-Diversification of anti-pseudomonas beta-lactam(heterogeneity): %anti-pseudomonal carbapenemics, %piperacillin-tazobactam and %anti-pseudomonal cephalosporins+aztreonam.
— Ratio fluconazole/equinocandins (dir)
DDD/100s for the years 2018-2022 were calculated in order to see the annual evolution. Required data: antibiotic (ATC Group: J01) and antifungal (ATC Group: J02) consumption by drug and route of administration (oral (o), parenteral (p) and others). Calculation of DDD/100s according to grammes consumed (obtained with Hospital Pharmacy software) and ATC/DDD-Index (World Health Organization). To visually analyse results, graphs were included.
What has been achieved?
We realised that our hospital improved by decreasing consumption of antibacterial, antifungal, carbapenemics and fluoroquinolones; and so, an early parenteral-oral switch.
However, the other ratio-based indicators are stable or worsening yearly: macrolides-p/fluoroquinolones-p, metronidazole-p/piperacillin-tazobactam+carbapenemics, fosfomycin consumption, anti-SRSA/anti-MRSA agents, amoxicillin/amoxicillin-clavulanic acid, amoxicillin-clavulanic acid/piperacillin-tazobactam, fluconazole/equinocandins and diversification of anti-pseudomonas beta-lactam.
What next?
These indicators provide possible improvement actions to enhance the use of antimicrobial agents. Consumption of fosfomycin or amoxicillin/amoxicillin-clavulanic acid ratio should be cautiously analysed due to outpatient (or in emergencies) management of uncomplicated infections. As improvement actions in our hospital, increase the use of metronidazole-p in anaerobic infections or cloxacillin and cefazolin de-escalation can be promoted as soon as sensitivity is confirmed by antibiogram-test. Diversify antibiotic pressure on pseudomonas, trying to reduce piperacillin-tazobactam by prescribing ceftazidime or cefepime, and reserving aztreonam for beta-lactams allergics. Similarly, decrease piperacillin-tazobactam use by prescribing amoxicillin-clavulanic acid if anti-pseudomonal coverage is not necessary.
THE ROLE OF DNA SEQUENCING AND MOLECULAR TUMOR BOARD COUNSELLING IN THE SELECTION OF THE MOST APPROPRIATED THERAPY IN ONCOLOGY
European Statement
Clinical Pharmacy Services
Author(s)
Marta Anghilieri, Francesco Guidoni, Vito Ladisa
Why was it done?
The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow the parallel sequencing of many samples producing in short times a big amount of data. To enable comprehensive analysis of the data and develop new specific and clinically useful therapies, we have introduced the approach of evaluating the data by the MTB, which includes pharmacists as experts in drugs and their use.
What was done?
Hospital Pharmacists (HPs) are integrated into the Molecular Tumour Board (MTB), a multidisciplinary group, to select the most appropriated therapy for oncology patients, ensure and facilitate patient access, and demonstrate therapeutic appropriateness found by MTB analisys.
How was it done?
MTB members, including HPs, perform DNA sequencing on each patient using NGS to identify known/unknown alterations. These data are entered into a database available to all MTB members and are the basic tool for selecting potential target therapy. The MTB meets once a week to discuss and integrate the observed DNA alterations with the patient’s clinical history. In this way, the most appropriate target therapy for the patient can ultimately be selected. The HPs then provide the patient with access to medications.
What has been achieved?
In this study, 208 patients affected by Non-Small Cell Lung Cancer were evaluated. DNA sequencing of patients identify 117 altered genes. After an extensive literature search, 15 genes were highlighted as potential targets for available drugs. They marked 116 patients potentially tractable with target therapy, of which 47 patients were candidates to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, among candidates for drugs in clinical practice, treatment was started in 65% and continued in 53%; among those treated with drugs not in clinical practice, treatment was started in 23% and continued in 69%.
What next?
The inclusion of HPs in MTB allows for more deliberate use and better selection of drugs. HPs provide valid support to select drugs and facilitate access to them: HPs individualise the applicable therapy for a larger number of patients through MTB, they analyse the therapeutic outcome (MTB-selected therapy has a bigger chance to last longer) and the cost impact on the NHS.
Implementation of a new work circuit in monography consultation of immune-mediated diseases of the pharmacy service
European Statement
Patient Safety and Quality Assurance
Author(s)
ALBA MARIA MARTINEZ SOTO, MARIA ONTENIENTE CANDELA, CARLES INIESTA NAVALON, PATRICIA ORTIZ FERNANDEZ, PILAR FERNANDEZ-VILLACAÑAS FERNANDEZ, ANABEL HERREROS HERNANDEZ, GEMMA MARTINEZ SOTO, CARMEN CABALLERO REQUEJO, MAYTE GIL CANDEL, ELENA URBIETA SANZ
Why was it done?
– Guide the pharmacist in the development of an individualised follow-up strategy for patient evaluating the frequency with which appointments should be established in the consultation of Pharmaceutical Care.
– Use the information from the specific questionnaires to detect possible failures therapeutic.
– Use the results obtained in the PROs to direct the recommendations pharmacotherapeutic to perform, which will be assessed in a multidisciplinary committee of immune-mediated diseases.
– Promote higher quality pharmaceutical care.
What was done?
Implementation of a circuit to improve pharmaceutical care and follow-up pharmacotherapeutic, incorporating the stratification of
patients according to the “Model of Stratification and Pharmaceutical Care for Diseases Immune-mediated Inflammatory Diseases” (MAPEX) and the use of Patient Reported Outcomes (PROs).
How was it done?
1. Selection of patients to include.
2. Design a database in Access for the collection of stratification data and PROs.
3. Selection of specific and generic PROs.
4. Stratification of active patients according to the MAPEX methodology at the beginning of the implantation and in patients who start during the follow-up period will be stratified at the baseline visit.
5. Establish a strategy for carrying out questionnaires (PROs) in consultation.
What has been achieved?
An Access database has been created that incorporates the blocks established by the MAPEX model with each of its variables broken down, allowing us to obtain the patient global score.
3 pathology-specific PROs have been selected (RAPID3 in rheumatoid arthritis, PSAID12 in Psoriatic Arthritis and BASDAI in Ankylosing Spondylitis) and a generic one, EuroQol-5D-5L.
The follow-up strategy based on the stratification was selected as the one proposed by the MAPEX model.
To carry out the PROs, those patients with arthropathies that are were under treatment with biological drugs.
It was decided to pass a specific PRO according to his pathology and the generic having a baseline intake, another at 16 weeks and another a year.
What next?
Design a study to measure the results in terms of quality of care obtained with this new circuit.
Implementing machine learning techniques to estimate the impact of underdosed DOACs, and aim patients at high bleeding risk in an elderly frail population treated for atrial fibrillation
European Statement
Clinical Pharmacy Services
Author(s)
Dorian Protzenko, Vincent Hoang, Guillaume Hache
Why was it done?
We unveiled during an audit that, in the past 2 years, 19% of our hospital DAOCs prescriptions were underdosed: due to the population profile (old, frail), the conventional bleeding risk scores were consistently high and, as such, not informative. To avoid a hypothetical bleeding risk, physicians were randomly underdosing patients beyond guidelines, without any evidence regarding the efficacy.
What was done?
Using machine learning, we unveiled that underdosing direct oral anticoagulants [DAOCs] to prevent bleeding risk in an old and frail population had no significant impact on drug-related hospitalization [DRH] nor death, and cannot be supported. To help targeting patients for whom extra care would be more beneficial rather than underdosed DAOCs, we built a predictive model of bleeding events and provided risk factors among our population.
How was it done?
We performed a retrospective study, based on data collected during the audit, of patients treated between October 2020 and April 2022 with Apixaban or Rivaroxaban for atrial fibrillation [AF]. Demographic and clinical criterias (i.e., GFR, polypathology, co-medications, prescribed DAOC, respecting dosage and scheduling) were collected. The occurrence of specific outcomes (i.e., bleeding and thrombosis that led to medical care and drug seizure, DRH and death) were retrieved from the patients’ medical records. Machine learning explorations were performed using RStudio®.
What has been achieved?
119 patients were included. We modeled using logistic regression the impact on selected outcomes of underdosing DAOCs. We found out that underdosed DAOCs were associated with a lower bleeding risk (OR=0.30, CI95%[0.07;0.95]), a higher thrombosis risk (OR=6.67, CI95%[1.23;50.0]), but without any impact on DRH nor death. Unsupervised algorithms unveiled that DAOC choice (Rivaroxaban: OR=2.80, CI95%[1.15;7.13]), sex (Male: OR=0.44, IC95%[0.16;1.12]) and using dosages from guidelines (OR=3.32, CI95% [1.05;14.80]) were predominant explanatory variables regarding bleeding risk. The choice of DAOC was the only covariate that impacted DRH (Rivaroxaban: OR=2.78, CI95%[1.22;6.56]). Finally, using a gradient-boosting algorithm, bleeding risk was predicted with a 0.73 roc-auc, superior to conventional models.
What next?
Therapeutic education of patients and caregivers, telephone follow-up or pharmaceutical consultations will be implanted for patients at high bleeding risk. An audit will be performed next year to measure underdosed prescriptions rate, and improve the model with new data.
6 months after the implementation of a Good Practice Form (GPF): the example of Versatis
European Statement
Selection, Procurement and Distribution
Author(s)
Laetitia ALRIC, Isabelle PLOCCO-DESMONTS, Anne-Laure DUBOIS, Sophie TOUQUET-ARNAUD, Kim NGUYEN, Blandine ARMAND, Isabelle HERMELIN, Audrey LEFRANCOIS
Why was it done?
Versatis is a lidocaine patch used in case of post-zona neuralgia. In June 2021, after a note of concern raised by the OMEDIT (Observatoires du MEdicament, des Dispositifs médicaux et de l’Innovation Thérapeutique) regarding its overuse by staff members of the CHRO (Centre Hospitalier Régional d’Orléans).
What was done?
We analysed the change in prescriptions and consumption since the implementation of a Good Practice Form (GPF) in September 2021, concerning Versatis created in collaboration with the CLUD (Comité de LUtte contre la Douleur).
How was it done?
Analysis of nominative dispensations between 09/21 and 02/22.
Consultation of shared electronic patient records.
Medical evaluation of prescriptions by rheumatology and pain-management physicians.
Methodological strategy validated by the physician in charge of professional practices evaluation.
What has been achieved?
Before the implementation, 3839 patches would have been consumed over a 6-month period versus 1541 after, marking a 59.9% decrease.
The population under scrutiny was made up of 106 patients (male-to-female ratio = 1,3; average age = 64 years). The average number of patches delivered per patients was of 15 (min=5; max=160), with 1,1 patches per localisation, for an average length of treatment of 14,4 days. 97 GPF were archived, representing 91,5% of use.
In-label prescriptions (post zona neuralgia with localised allodynia) concerned 14 (13,2%) patients.
Regarding pertinent off-label prescriptions (neuropathic pain with localised allodynia, with a maximum of 1 patch/zone/day): 36% of patients exhibited neuropathic pain, including 9% with allodynia, with 4% 1 patch/zone/day. 9,4% benefited from rheumatological or pain management consultations.
48% of prescriptions respected the 12/24h rest-time, and 79% the limit of 1 patch/zone/day off-label.
After medical expertise, 3 prescriptions were found to be unjustified – 2 due to lack of information and 1 concerning post-gout crisis pain.
What next?
Despite the patch’s small price, the implementation was of significant impact over the hospital’s consumption (and by extension, over the hospital prescribing dispensed in the community), due to its adoption by over 90% of medical prescribers. This, despite a majority of off-label prescriptions, which were rated as pertinent over 90% of the time. The GPF will have been optimised since this evaluation took place, notably with a more precise definition of allodynia.
PERFORMING A COMMITTEE OF EVALUATION OF TREATMENTS IN SPECIAL SITUATIONS
European Statement
Clinical Pharmacy Services
Author(s)
Susana Redondo-Capafons, Laura Soriano, Irene López-Rico, Jorge Del Estal, Rocío Cebrián, Marcela Manriquez, Maria Reventós, Sandra Fernández-Molina, Mònica Gómez-Valent
Why was it done?
Before CTSS was performed, TSS were requested to Pharmacy Department for evaluation and decision. Because of complexity of these treatments, it was decided that it was necessary to evaluate them with other professionals to make a consensual decision.
In May 2019, CTSS was born. It is a multidisciplinary committee with 10 different health professionals: head of pharmacy, head of healthcare management, head of strategy and operations management, a clinical pharmacologist, five pharmacists and a secretary. Requesting doctors and heads of involved services are invited to explain TSS in the meeting.
What was done?
Committee (C) of Treatments in Special Situations (TSS) (CTSS) have been established. Requests are received by a specific email for the committee and a standard template was performed to be completed by requesting doctor (patient clinical information and evidence supporting request) and by Pharmacy Service (regulatory status of the drug, pharmacology and cost of treatment).
How was it done?
Some limitations as lack of human resources with exclusive dedication for making reports and lack of training in evaluation of this kind of treatments are the most important obstacles. Currently, each member is self-taught and under excessive work- pressure.
What has been achieved?
From May 2019 to August 2021, 273 treatments in 59 meetings sessions (average 4.63 evaluations/meeting) were evaluated.
The 91,6% of treatments were approved. In 95,9% of requests, one drug was evaluated.
There were 18 services involved, being oncology and hematology the most active departments.
Evaluated TSS were classified in six categories: 66,7% of requests were drugs without approved indication, 19,8% drugs approved indication pending price by government, 2,5% approved indication but denied funding by government, 1,8% foreign medicines, 4% compassionate use and 5.2% others according to criteria of each autonomous communities in Spain.
What next?
CTSS allows make a consensual decision between different professionals and establishes a flow to manage TSS requests. This multidisciplinary scenario generates knowledge and evidence in the use of these kind drugs reducing uncertainty in TSS use in relation to its efficacy and safety and, in cases of high budgetary impact-drugs, to minimize inequities of access by standardizing decision-making. Applicable to all hospitals.