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REMDESIVIR SHORTAGE DURING SARS-COV2 PANDEMIC: A REGIONAL APPROACH
European Statement
Selection, Procurement and Distribution
Author(s)
Francesca Venturini, Olivia Basadonna, Roberta Rampazzo, Girolama Iadicicco, Giovanna Scroccaro
Why was it done?
Remdesivir is the first authorized medicine by the European Medicine Agency (EMA) for SARS-COV2 treatment. In the first place, remdesivir was supplied exclusively in the context of the Emergency Support Instrument by the European Committee. A limited number of treatments were available to each member state, before Veklury marketing. Also after the national procurement process, through the joint procurement agreement by the EU, the number of vials was limited.
What was done?
A controlled regional distribution of remdesivir (Veklury) was implemented by the Veneto Region, Italy, through the hospital pharmacies network, using a regional distribution center located at the hospital pharmacy of the Padova University hospital.
How was it done?
In the first shortage phase, the Italian Medicine Agency (AIFA) defined the selection criteria for the use of remdesivir, based on clinical trials evidence. A centralized authorization procedure was implemented: each hospital was requested to send daily individual prescriptions through the local hospital pharmacy, to a dedicated AIFA email address
After AIFA authorization, the Ministry of Health forwarded the authorizations to the regional distribution center, for drug distribution.
A map of hospital pharmacies references (e.g., pharmacist name, hospital postal address, mobile phone, presence of the pharmacist on duty, etc) was created, in order to quickly contact them for the distribution of the authorized therapies.
The regional distribution center took charge of the authorized therapies and provided a personalized distribution to all the hospitals in the region. Each day the Ministry of Health warehouse replaced the stock of the regional distribution center.
What has been achieved?
in a 3-week period, the regional distribution center dispensed therapies for 87 patients to 17 hospitals in the region. In two cases a zero stock ck of vials was managed with the reallocation of experimental drugs left by closed clinical trials and compassionate use programs, both authorized by AIFA and the manufacturer.
What next?
in the second phase of the shortage, single patient prescriptions will be validated by local hospital pharmacists in a national electronic registry. On a by-weekly basis, the infectious disease regional network will audit treated cases, to verify inclusion criteria and discuss future approaches. A centralized distribution will be maintained, allowing a small stock in each hospital for emergency use.