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.
MEDICATION MANAGEMENT OF COMBINATION THERAPY IVACAFTOR , TEZACAFTOR AND ELEXACAFTOR FOR CYSTIC FIBROSIS PATIENTS WITH THE F508del MUTATION BY THE HOSPITAL PHARMACY IN A CENTRAL GENERAL HOSPITAL
European Statement
Clinical Pharmacy Services
Author(s)
DESPOINA MAKRIDAKI, KALLIOPI ALLAGIANNI, NIKOLAOS SKORDAS
Why was it done?
In our hospital is located the main CF Unit for Adults in the country. Ensuring that as many as possible young patients benefit from accessing the new and crucial treatment, even during COVID-19 period, reflects our commitment to improve patients’ outcomes and overall survival,
What was done?
A Phase 3, open-label clinical trial (CT) with 3 enrolled patients runs since April 2019 and two early access (EA) programs with 23 enrolled patients run since the end of July 2020 to permit the access of cystic fibrosis (CF) patients with the F508del mutation in the innovative combination therapy of ivacaftor, tezacaftor and elexacaftor (IVA/TEZA/ELEXA) in our hospital.
How was it done?
3 outpatients enrolled in the CT and procedures regarding the protocol have been followed strictly. Medication dispensing is conducted every 12 weeks.
In the EA procedure, 2 parallel programs have been approved by authorities, one for the homozygous including 19 patients and one for the heterozygous including 4 patients. Dispensing is programmed every 4 weeks, although an initial stock for 3 months was shipped to pharmacy.
The role of HPs was decisive for the quick start of the EA programs during COVID-19 period. Roadmap was designed at the beginning by HPs in collaboration with the physicians to accelerate approval and shipment procedures and also regarding licensing for each patient, drug receipt, storage, dispensing, accountability, electronic registry in designated EA platform and additional electronic recording and follow up in the electronic Pharmacy platform for both the IVA/TEZA/ELEXA and supporting therapies (e.g. inhaled antibiotics, a-dornase)
For 17 EA patients with chronic obstructive pulmonary disease in exacerbation, hospitalization before starting the IVA/TEZA/ELEXA therapy was necessary. HPs monitored closely their cartexes to avoid adverse reactions and delays in therapy.
HPs served all outpatients on personal afternoon appointments, to avoid overcrowding in the hospital during the pandemic.
What has been achieved?
Critically ill patients have been able to receive in priority the IVA/TEZA/ELEXA treatment, without cost, and valuable scientific experience has been gained.
What next?
EA programs have received 3 months extension until reimbursement negotiations are completed by authorities. In the meantime, we design a cost affordable procedure to ensure continuity of access for our patients.
HOW TO HANDLE ACTIVE AND PLACEBO DRUGS FOR A CLINICAL TRIAL IN THE PRODUCTION SYSTEM CATO IN ORDER TO SECURE THE BLIND AND TO ENSURE THE EXACT SAME PREPARATION OF ACTIVE AND PLACEBO PRODUCTS
European Statement
Production and Compounding
Author(s)
Kirsten Lykke Vorbeck
Why was it done?
When preparing treatments for blinded clinical trials it is very important to make sure that it is not possible to distinguish between the active and the placebo dose, as this may lead to unblinding of the treatment and thus jeopardise the results of the trial.
What was done?
The purpose was to find solutions for how to handle active and placebo drugs in the production system CATO to ensure they would end up being identical when prepared.
How was it done?
Before preparing a drug using CATO the drug must be registered in the system with all of its data. It is not possible to have two different sets of data for one drug. CATO records detailed documentation of what is being done during preparation and it is not possible to pretend to pick one drug and then grab another instead. Also, the label is printed automatically so it will show exactly what was prepared. We decide on a common name for the active/placebo and register both of these in the system under that name so that they will be prepared in exactly the same way and appear identical on the label but are still distinguishable in the batch documentation. We name the drug ‘Protocol name Active substance/placebo’ and register the stock of both active drug and the sodium chloride solution that is used as placebo under that name. We will also stock vials of NaCl for this purpose next to the drug it is being placebo for, and NaCl can be prepared pretending it has the density of the drug. CATO will think they are the same drug but they have been registered with their very different batch numbers, maybe with a NaCl after the number of that, so it is always possible to see what was actually being prepared.
What has been achieved?
Our doses of active and placebo are indistinguishable. Labels are the same and, for example, withdrawal into a syringe and insertion of a needle into the port of the infusion bag will be done in the same way.
What next?
These very simple routines can be used anywhere for the preparation with CATO and possibly also with other systems.
IMPROVING INVESTIGATIONAL DRUG MANAGEMENT: AN INNOVATIVE PROCESS
European Statement
Clinical Pharmacy Services
Author(s)
Francesca Vecchione, Melania Rivano, Patrizia Tadini
Why was it done?
The new process was developed in order to face the significant increase of ID management assigned to the Pharmacy, along with the logistic problems due to the several areas of storage, dispensing and administration. Additionally, it allowed to assure the effective use of ID reducing the risk of failure and improving the patient safety.
What was done?
The Good Clinical Practice guidelines establish that the principal investigator (PI) can delegate the investigational drug management to a pharmacist. In our university teaching hospital with a large amount of clinical trials (CT), pharmacy service proposed an optimisation of ID (investigational drug) management through the elaboration of a form to request the ID. Along with this, we assigned each protocol to a specific type of management and we created an intranet site from where healthcare professionals can download the form.
How was it done?
The pharmacy service created for each CT a specific form organized into 5 sections. Section A, B and C were filled up with protocol information (name, centre code, PI) patient data (initials, patient code) and the treatment schedule. Section C, completed by data manager, showed the quantity of drug to be dispensed and the expected day of administration. Section D was completed with batch and expiry date. The form had to be signed by the pharmacist at the moment of the dispensation and signed back by the committed person who took it. Section E reminded the type of management assigned to the protocol. Five different types of management had been identified, based on the characteristics of storage, the activities required by the protocol (IWRS, unblinded pharmacist, drug preparation) and the dispensing method.
What has been achieved?
Data from January to June 2017 attested 60 ongoing protocols, 722 dispensations for patient, 237 drugs prepared by pharmacists and 986 in Chemotherapy preparation unit. The development of the new procedure ensured the ID tracking, the overcoming of logistical difficulties and an increase of the safety.
What next?
We are going to keep on improving the pharmacist role in CT by ensuring ID are handled, stored and correctly managed. The objective is to enhance the collaboration of clinical research professionals in the management of CT.