Parenteral Nutrition Waste Reduction Initiative
European Statement
Selection, Procurement and Distribution
Author(s)
Marie O Halloran, Siobhán Nestor
Why was it done?
This project was undertaken in reaction to an evolving healthcare environment. It was important to identify patterns to improve the efficiency of the purchasing and dispensing process, and to ensure that PN levels held in the Pharmacy Department respond to requested use within the hospital. The aim was to reduce the amount of PN bags expiring with associated cost savings and waste avoidance.
What was done?
The Pharmacy Department is responsible for dispensing Parenteral Nutrition (PN) in the Mater Misericordiae University Hospital (MMUH). PN is purchased from a third party manufacturer. On receipt by the hospital, the standard PN bag has an expiry date of approximately 60 days. Given the need for rapid turnover of PN to avoid expiration and wastage, coupled with the rapidly changing healthcare landscape, the pharmacy instigated a review of the factors contributing to PN waste and opportunities to improve and optimise the associated processes.
How was it done?
• PN Stock Holding Review
Due to surgery volumes and the complexity of the patient cohort in MMUH, the Pharmacy Department are required to hold a stock of PN bags for patients to access in a timely manner. The agreed levels of stock held was identified as a key target to reduce waste. The quantity of each stock bag held was reviewed between Pharmacy and Clinical Dietetics utilising recent usage pattern reports. This resulted in removing certain bags from MMUH stock entirely and reducing the stock quantity of slow-moving bags.
• Improved communication to dietitians
A standard email template was devised to send to all stakeholders, by a Dispensary Pharmacist, detailing the stock of each bag on hand and highlighting bags which would expire in the following two weeks. The Dietitians endeavour to utilise this short-dated stock for suitable patients to avoid waste.
What has been achieved?
Through the improvement initiatives outlined above, PN waste reduced by 74% (117 bags versus 31 bags) in Q1-Q3 2021, compared to the same period in 2020. This resulted in a considerable associated cost saving.
What next?
We will continue our collaborative work with Clinical Dietetics to further reduce PN waste. We now have a dynamic stock management process, which responds to the changing patient cohort in MMUH.
IMPLEMENTATION AND ADEQUACY OF HOME DELIVERY AND TELEPHARMACY DURING THE FIRST YEAR OF THE COVID-19 PANDEMIC
European Statement
Selection, Procurement and Distribution
Author(s)
Mª Ángeles Parro Martín, Beatriz Montero Llorente, Teresa Gramage Caro, Manuel Vélez Díaz-Pallarés, Miguel Ángel Rodríguez Sagrado, Hilario Martínez Barros, Ana María Álvarez Díaz
Why was it done?
To ensure continuity of treatment and pharmacotherapeutic follow-up in patients vulnerable to SARS-CoV-2 infection included in a home delivery and telepharmacy program.
What was done?
Implementation and adaptation of home delivery and telepharmacy during the first year of the COVID-19 pandemic.
How was it done?
A work procedure was designed to detail the new functions to be performed by administrative assistants (AA), pharmacy technicians (PT) and pharmacists (PH). A first procedure was designed, which was adapted and improved after 6 months of experience, giving rise to procedure 2.
Procedure 1
– AA phone call to patients scheduled to obtain consent for home delivery and confirm delivery data.
– The PH grouped patients who had confirmed home delivery in the appointment manager.
– The PH reviewed the electronic prescription of all patients and performed telepharmacy to those who were due and/or had incidents.
– The PT prepared the packages.
Procedure 2
Phase 1
– The AA called all patients scheduled until the end of the year to offer them the option of remaining in the home delivery and telepharmacy program permanently. If they accepted, their consent and delivery data were recorded. From this point on, the call to offer home delivery and telepharmacy was discontinued; it was only offered to patients when they attended in person.
– A specific diary for home delivery patients was created.
– The telepharmacytelepharmacy was added to the PH diary.
Phase 2
– Trained PT in home delivery incident resolution (address changes, absent patients, package rejection) to reduce FAR’s working hours.
Phase 3
– Development of a computer application: computerization of manual processes (labels, identification of refrigerated shipments, SMS delivery confirmation sent to patients, and request for appointment changes).
What has been achieved?
31,066 home delivery have been performed on 7,170 different patients. 7,443 telepharmacy consultations have been performed.
PT training and computer development has reduced the PH dedication from 7 hours to 3 hours.
What next?
Establish criteria for prioritization of patients who are candidates for home delivery and telepharmacy.
Implementation of video call instead of telepharmacy
Create the complete Product Overview for tendering and price negotiations
European Statement
Selection, Procurement and Distribution
Author(s)
Liselotte Kamper
Why was it done?
To ensure optimal price negotiations and tenders based on an up-to-date product overview including both pharmaceutical, therapeutic, and commercial knowledge.
What was done?
Team Horizon Scanning (HS) in Amgros has developed a comprehensive report covering all important information for a new medicine about to be marketed within the EU – an Extended Product Overview (EPO).
How was it done?
Following every meeting in the Committee for Medicines for Human Use (CHMP) at the European Medicines Agency (EMA), information on applications for marketing authorisation on new medicines is identified in the agenda and minutes. The following information is compiled:
• Name of the active substance
• (Commercial) name of medicine
• EMA procedure number
• Date of application
• Type of application (Orphan/Accelerated review/PRIME)
• Name of the marketing-authorisation applicant
• Therapeutic indication
The information is supplemented with:
• ATC-code
• Mechanism of action
• Incidence/Prevalence
• Potential impact for the patients and the health care system
• Already approved medicines to treat the same disease
The information is presented and discussed at an internal meeting in Amgros between the HS team and representatives from health economics, tendering and negotiations. At the meeting it is decided for which medicines it is relevant to produce an EPO. The EPO contains the above-mentioned information as well as the following information:
• A description of the disease
• A status of the current standard treatment of the disease
• Information from the clinical studies supporting the indication/application
• Other medicines in pipeline for the same indication, with a status on the timeline for applying for marketing authorization
• Analysis of the market into which the medicine will be launched
The final document is confidential.
What has been achieved?
The EPO-document ensures that Amgros is prepared in the best way in negotiations to agree on a price level that gives a reasonable match between the effect of the medicine and its costs compared with the current standard treatment. Thereby more cost-effective health solutions and possibility to achieve more health for money in the Danish hospital setting can be secured.
What next?
The HS team wish to expand the EPOs to also cover specific therapeutic areas of interest e.g., multiple myeloma and other complexed therapeutic indications.
Hospital pharmacists contribute to a safe and efficient use of chimeric antigen receptor T cell drugs.
European Statement
Selection, Procurement and Distribution
Author(s)
José Luis Revuelta Herrero, Vicente Escudero, Roberto Collado, Belén Marzal, Ana Herranz, María Sanjurjo
Why was it done?
CAR-T cell-based therapies are advanced therapy medicinal products (ATMP) that are considered as drugs by the European regulatory authorities. ATMPs are usually associated with strong logistic and traceability requirements, serious adverse events and a high budget impact. Hospital pharmacists can help ensure a safe and efficient use of these drugs.
What was done?
A chimeric antigen receptor (CAR) T cell Therapy Committee was created in 2019 and it included members from the hematology, oncology, pediatric onco-hematology, hospital pharmacy, neurology, critical care medicine and immunology departments. An operating procedure defined the specific functions of the pharmacy department in the management of these drugs in the CAR-T cell program.
How was it done?
As some responsibilities might be shared with other professionals, it was key to define everyone’s contributions. In our case, an operating procedure with the responsibilities of the pharmacy department was developed based on the national and regional action plans for ATMPs in the national health system and the risk management plans for each drug. This operating procedure was reviewed and approved by the Committee.
What has been achieved?
The operating procedure was fully implemented and included the participation of hospital pharmacists in the following steps:
• Procurement: the inclusion of a patient in the program is agreed upon the Committee. The pharmacists provide a purchase order when all the requirements are met.
• Leukapheresis and shipment to the manufacturer: the apheresis is included in the computerized physician order entry (CPOE) and it is verified to confirm wash-out periods. Before the shipment, the pharmacists record the apheresis unique identifier and patient data.
• Product receipt: the pharmacists verify at receipt that the patient identity chain and the integrity of the product have been preserved.
• Bridge and lymphodepleting chemotherapy, CAR-T administration: specific protocols have been included in the CPOE. Prescriptions are verified by the pharmacists with special attention to the drug-free periods. After transporting the drug to the clinical unit and preparation, a pharmacy label for dispensing and administration is generated. This label includes a barcode for patient identity verification at bedside.
• Outcomes monitoring and pharmacovigilance: kits are provided to the clinical units for the management of CAR-T associated toxicities. Pharmacists are responsible for the adverse reactions reporting in coordination with clinicians.
What next?
We developed verification lists for each of the previous steps that have already been published (DOI: 10.3389/fonc.2021.636068). More ATMPs are expected to come and their management will require the participation of hospital pharmacists from different areas of expertise (procurement, clinical pharmacy, compounding etc).
HOSPITAL PHARMACY MEDICATION DELIVERY DURING COVID-19 PANDEMIC
European Statement
Selection, Procurement and Distribution
Author(s)
Andreia Fernandes, Mafalda Brito, Tatiana Mendes, Armando Alcobia
Why was it done?
Many patients had their health care needs compromised due to accessibility issues. They could not come to the PS because of the mandatory confinement, prophylactic isolation and medical indication.
What was done?
In the context of the Covid 19 pandemic, between April and June 2020, pharmaceutical Services (PS) instituted several alternatives delivery processes that guaranteed patients’ access to the medication, usually provided on the PS.
How was it done?
Pre-existing accessibility projects to deliver medication in community and hospital pharmacies have been adopted. In order to respond to all requests, new ways and protocols of medication distribution/delivery, like city hall transport, courier services and humanitarian aid (for example, motards), were created. For all deliveries outside PS, pharmaceutical telephone follow-up (teleconsultation) was realized.
What has been achieved?
7448 medication dispensations were registered, of which 80.7% were realized in person in the hospital PS (n = 6679). In the homolog period, 10621 dispensations were registered, of which 95.9% were in person (n = 10183).
438 deliveries were sent to community pharmacies, a total of 219 patients (54.3% female, maximum age 100, minimum 9 years). 41% increase compared to 2019. 198 shipments were realized to different hospitals and others healthcare units, corresponding to 120 patients (56 female, maximum age 85, minimum 8 years). 25% increase over the previous year.
New alternatives: City Hall 66 deliveries for 62 patients (58.0% female, minimum age 18, maximum 97 years), other deliveries 35 users (50.7% male, maximum age 94 and minimum age 10 years).
What next?
The Covid-19 pandemic triggered a need for adaptive evolution of pre-existing accessibility projects, but also the creation of new protocols and alternative means to respond to all patients who may have their healthcare compromised due to accessibility issues. The positive points were the implementation speed, maintenance of adherence to therapy (teleconsultation), traceability, reduced costs, synergy between patients/associations/pharmacists/healthcare professionals and a high degree of satisfaction. In spite of some limitations (dependent on volunteering; need for human resources; structured communication) we aspire to improve the new approaches of medication delivery on a nation level.
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.
RESOURCES OPTIMISATION OF LOPINAVIR/RITONAVIR IN THE SANITARY EMERGENCY DUE TO SARS-CoV-2 IN A THIRD-LEVEL HOSPITAL IN THE ULTRA-PERIPHERY
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Lierni Goitia Barrenetxea, Natalia Toledo Noda, Moisés Pérez León, Victoria Morales León
Why was it done?
Lopinavir/ritonavir is a HIV-1 and HIV-2 proteases inhibitor indicated for HIV. It was used in patients with a positive SARS-CoV-2 test after being recommended by the Chinese health authorities. The hospital protocol guideline was: 400/100mg every 12 hours orally. It was presented in both tablets and oral solution, which was reserved for patients intubated in the ICU and those who were not able to take tablets.
What was done?
Optimizing the use of lopinavir/ritonavir solution during the state of sanitary emergency.
How was it done?
Descriptive study of resources optimization for lopinavir/ritonavir and actions carried out to ensure the availability of the antiviral in intubated SARS-CoV-2 positive patients. Preparation and stability data were obtained from official sources (Spanish Agency for Medicines and Health Products) and from the Spanish Society of Hospital Pharmacy.
What has been achieved?
The Pharmacy Service designed a protocol to repackage lopinavir/ritonavir 80/20mg/mL solution in syringes containing the exact amount for a single dose (400/100mg in 5ml), for single use. The solution is formulated on an alcoholic basis and there is an interaction with the polyurethane nasogastric tube because the polyurethane absorbs alcohol causing the catheter to swell and deteriorate, which is why, other services were notified to use polyvinyl chloride catheters or silicone. Likewise, the syringes used to repackage the solution were exclusive for oral administration used in pediatrics, with the aim of reducing medication administration errors, since it is not possible to connect parenteral injection needles with them. These measures were intended to make the dispensing system as efficient as possible, as once the drug entered a unit with patients with a positive test, it was contaminated, therefore it could not be reused. Additionally, the fact that the hospital is located on an island made it even more difficult to acquire the medicine, given the supply problems nationwide, the great restriction of air and maritime traffic and loan limitations from other hospitals.
What next?
The measures adopted managed to ensure the availability of lopinavir/ritonavir solution in all admitted patients, optimizing the scarce availability of a solution medication whose presentation is formulated in multidose containers. By adding the use of syringes for exclusive oral use, administration errors were prevented.
IMPLEMENTATION OF A TELEPHARMACY PROGRAMME TO HOSPITAL OUTPATIENTS DURING THE COVID-19 PANDEMIC
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Rosalia Fernández-Caballero, Virginia Collados Arroyo, Clara Herranz Muñoz, Araceli Henares López
Why was it done?
Every month, an average of 700 patients receive pharmaceutical care in the outpatient consultation (OC) of our first-level hospital. Given the mobility restriction measures applied by the spanish government during the pandemic, access to this consultation was difficult for some patients. The aim of this program is to ensure the access to medication for all patients and prevent them and professionals to virus exposure. Telepharmacy program consists of providing pharmaceutical care based on available means of communication and access to medication through home drug delivery.
What was done?
During the COVID-19 pandemic, we designed and implemented a telepharmacy programm to ensure access to medication for all patients.
How was it done?
Once weekly, the pharmacist contacted the listed patients during the following week in OC by telephone or via the hospital’s electronic platform, to offer the possibility of participating in the program. During teleconsultation, pharmacist provided the same attention as in face-to face consultation: administrative situation of the patient, adequate medical follow-up, assessment of adherence, review of interactions and adverse events and treatment changes. Moreover, we e-mailed the patient’s consent for home drug delivery by and external company. In case the patient didn’t have a web mail, we requested verbal consent. Once a week, one pharmacy technician prepared the medication and the selected company performed the home delivery in guaranteed storage conditions. To minimize the burden of work, the medication was sent for two months per patient. Oncohematological patients, who came to their doctor’s appointment every month, were excluded from this program.
What has been achieved?
Between March 20 and October 9, we have included 595 patients in this program and conducted 1190 teleconsultations and 872 home drug deliveries with a great satisfaction of outpatients.
What next?
Our next step is to improve the web system for sending alerts through our electronic platform to automate the home delivery process and thereby to reduce the logistic burden of the pharmacist and to increase the pharmaceutical care given to patients.
OPIOIDS STOCK OPTIMISATION UTILISING AUTOMATIC DISPENSING SYSTEMS DURING AND AFTER COVID-19 PANDEMIC
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
MARINA RODRÍGUEZ MARÍN, HILARIO MARTÍNEZ BARROS, MARÍA DEL ROSARIO PINTOR RECUENCO, BEATRIZ MONTERO LLORENTE, ANA MARÍA ÁLVAREZ DÍAZ
Why was it done?
It was done in order to optimize opioids stock to meet the needs of COVID-19 patients and protocolize the correct quarantine without modifying the computerized registration in the 39 ADS.
What was done?
A procedure was implemented to optimize the stock and manage the quarantine of opioids in Automatic Dispensing Systems (ADS) during and after their use in hospital units hosting COVID patients.
How was it done?
As hospitalization units were being adapted to host COVID-19 patients, opioids stock had to be modified to meet their new demands. Reversely, when hospitalization units were recovered to host their usual type of patient, the opioids had to be replaced and quarantined for ten days, according to our Preventive Medicine Unit. All these movements were recorded.
We followed this process:
1. Physical and computerized unloading of opioids without dispensing in recent months and emptying of the returned drawer (storage space for opioids withdrawn from the ADS which were not used).
2. Relocation to hospitalization units hosting COVID-19 patients,
3. Replacement of all (minidrawers) where opioids were kept with clean ones
4. Quarantine in the Pharmacy Service, for the drugs unloaded which were unable to be immediately relocated.
5. Cleaning and sanitizing of the removed minidrawers from COVID-19 hospitalization units’ ADS to be used in the next conversion.
What has been achieved?
29 ADS of the 39 available in the hospital were optimized.
Given the decreased in COVID-19 admissions during May, the hospital made a schedule to return to normality which allowed to leave 5 ADS in quarantine without the need to unload or replace any drug,. The other 24 ADS had to be cleaned and disinfected,. It led to the physical unloading of 182 specialties (a total of 1,519 units), the physical and computerized unloading of 124 specialties (850 units) and the emptying of the returned drawers (18 specialties and 20 units). 504 minidrawers were replaced by other cleaned and disinfected ones and 298 specialties (2,080 units) were replaced.
What next?
Enhancing our protocol to allow us to spend more time with the patients in Covid’s further waives.
DEVELOPMENT OF AN IT TOOL TO ESTIMATE THE THERAPEUTIC NEEDS OFHOSPITALISED PATIENTS WITH COVID19 INFECTION BASED ON SIR EPIDEMIOLOGICALMODEL
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Daniele Leonardi Vinci, Adriano Meccio , Alessio Provenzani, Piera Polidori
Why was it done?
The COVID 19 pandemic unprecedently challenged National Health Services to assure adequate patient care, despite a constantly escalating drugs demand. This complex situation requires appropriate planning to avoid misleading estimations, which would have consequences on patients and overall resources available.
What was done?
We created a tool to perform a timely estimation of the drug needs to treat the COVID-patients based on epidemiological forecasting.
How was it done?
The tool’s epidemiological forecasting was based on a compartmental model in which the population is divided into three compartments (Susceptible-Infectious-Removed, SIR), and transmission parameters are specified to define the rate at which persons move between stages. The appropriate data entry was guaranteed by the creation of a form in which users can enter information regarding: The population considered, the R0 calculation, the number of already known infected cases, the application of Non-Pharmaceutical Interventions and the number of hospital beds. The drugs need for the forecasted patients was calculated according to a list of critical care drugs compiled consulting previous published scientific works, national and international guidelines. The list includes 51 drugs belonging to different therapeutic group, such as: antiarrhythmics, antibiotics, antipyretics, antivirals, heparins, IV-fluids, local anesthetics, neuromuscular blockade agents, sedative agents and vasopressors. For each drug it was estimated the percentage average ICU uptake for therapeutic group and active principle.
What has been achieved?
A tool consisting of an excel template, that, based on the information inserted, automatically calculate the number of patients classified by the intensity of care (hospitalized not-ICU, Hospitalized ICU, ventilated, intubated or with shock) and creates a table that includes, for each drug to be used, the following information: therapeutic group, active principle, dosage considered, pharmaceutical form, total dosage for patients considered and total quantity of unit doses for patients considered. The tool is also made adaptable to different clinical situations, through the possibility of editing the assumptions adopted regarding the epidemiological and therapeutical parameters or the inclusion of new items in the drugs list.
What next?
Our tool represents an opportunity for the immediate and efficient estimation of the drugs necessary to assist the COVID19 patients during emergency scenarios. It will be periodically updated as new evidences will be available.