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Aflibercept redosification impact in a second-level hospital.

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European Statement

Production and Compounding

Author(s)

Javier Alfonso Buendía Moreno, Andrea Portela Sotelo, Lidia Martínez Valdivieso, Jaime Fernandez-Bravo Rodrigo, Gema Marcos Pérez, Dolores Barreda Hernandez

Why was it done?

Aflibercept is an Agent against Vascular Endothelial Growth Factor A (VEGF-A) whose intravitreal indications such as Age-related Macular Degeneration (AMD), Macular Edema (ME), Retinal Vein Occlusion (RVO), have a high economic impact on a Pharmacy Service (PS) budget.

What was done?

A protocol for the redosification of aflibercept intravitreal therapy was implemented by the Commission of Pharmacy and Therapeutics and the Ophthalmology Service, which proposed the redosification of aflibercept vials into sterile syringes for intravitreal use.

How was it done?

Aflibercept 4 mg vials were recompounded by infirmary staff in a horizontal laminar air flow cabinet into syringes with the recommended dosage of 2 mg, hence one vial could approximately be fractionated for the production of 2,5 syringes.
The variables compiled to maintain the trazability of aflibercept through the programmes of computerized clinical history, MambrinoXXI® and electronic prescription, Farmatools®, were: sex, age, indications, number of spent vials and syringes prepared and average number of syringes dispensed per patient. In addition, it was compared the direct estimated cost of the syringes vs. vials to calculate the saving cost.

What has been achieved?

During the year 2019, 305 patients received aflibercept syringes, 172 (56’4%) were male, the average age was 76 years (41-95). Main diagnoses were 145 AMD, 71 ME, 43 diabetic ME and 33 RVO. The total numbers of vials spent were 341, the syringes dispensed were 1174 and the average number of syringes dispensed per patient was 3’85. The total price of one vial was 612’31€, so one redosificated syringe in the PS approximately costs 204’10€. Therefore the use of syringes instead of vials had a potential saving cost of 331.672€ (58’01%) if the vials would have been used. The cost reduction of the intravitreal therapy with aflibercept supposed a saving of 1’58 % of the total expenditure of the PS during 2019.

What next?

The optimization of aflibercept intravitreal therapy is a big cost-effective measure for reducing costs in a PS. It helps to reduce costs in a therapy that is increasing the number of patients each year contributing to the financial sustainability of Health Systems and improves the efficacy of the resources of PS.

IMPLEMENTATION OF A SAFE EXTERNAL DISPENSING SYSTEM DURING THE COVID-19 PANDEMIC IN A REFERRAL HOSPITAL

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European Statement

Clinical Pharmacy Services

Author(s)

MARINA CORRALES PAZ, CLAUDIA RODRIGUEZ MORETA, INMACULADA LOMARES MANZANO, ANA GANFORNINA ANDRADES

Why was it done?

Due to the health crisis caused by the SARS-COV-2 virus, many hospitals have seen
the necessity to implement a safe dispensing system (telepharmacy) to provide medication to
high risk patients and those infected with Covid-19 in order to prevent interrupting their
treatments.

What was done?

To implement a system that guarantees a sure and effective supply of medical treatments to those vulnerable patients, those at increased risk or with difficult access to the hospital during the coronavirus pandemic.

How was it done?

A database was created with those patients attending our hospital’s outpatient service(OS)to pick up their medication within the next 7 days, verifying through pharmaceutical software and the patient’s medical history records (MHR)their next dispensing date. After checking if the patient had a medical appointmentthat could coincide with the dispensing date, a phone interview was conducted with the patient to schedule the pick-up of the medication through theOS or by telepharmacy(patients’ consent was requiredto use their personal information and we asked how the treatment was going). In our case the patients could pick-up their medication in the referral hospital (RH), a newly created OS in an affiliate hospital or by telepharmacy toprevent the collapse of the hospitals. We registered: number of patients attended in RH, new OS or by telepharmacy and number of dispensations. Patients were grouped in areas based on their city and delivery date for telepharmacy and in the case of patients picking up their own medication they were made an appointment.

What has been achieved?

During the months the state of emergency was in place in Spain (March 14th– June 21st)3385 patients were attended in total and 9316 medicationswere dispensed. 2245(66.3%) patients were attended in the RH (5794 dispensations), 583(17.2%) patients were attended through the new OS (1436 dispensations) and the rest 557(16.5%) had their medication sent to their address (2086 dispensations).

What next?

A safe and effective dispensing system was achieved to outpatients during the Covid-19 pandemic through the implementation of a new telepharmacymethod and the establishment of a new OSthat allows convenient dispensation of medication while minimising the risk of virus spread.

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

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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.

THE LABOUR OF HOSPITAL PHARMACY SERVICES IN THE COVID-19 HEALTH CRISIS

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European Statement

Clinical Pharmacy Services

Author(s)

CLARA NOTARIO DONGIL, PATRICIA ARAQUE ARROYO, MARÍA MAR ALAÑÓN PARDO, ALEJANDRO MARCOS DE LA TORRE, MARÍA CARMEN GARCÍA CONDE, BEATRIZ PROY VEGA

Why was it done?

The circuit was designed during the pandemic period responding to the COVID-19 situation. The aim was providing the best service to hospitalized patients. The activity began on March 10, 2020.

What was done?

Due to the current pandemic caused by SARS-CoV-2, our Pharmacy Service (PS) has been reorganized and adapted its activity by areas according to the needs of a given situation.

How was it done?

1.- Priority areas were set up.
2.- Main activities to develop in each section were defined.
3.- There was a redeployment of the PS staff.

What has been achieved?

Pharmaceutical assistance: PS developed pharmacotherapeutic protocols, collaborated giving advice to medical staff selecting appropriated treatments and detecting the most important interactions between drugs. It also advised regarding to compatibility and stability of medication, providing in addition written information through tables and triptychs elaborated.

Pharmacotechnics: 1,320L of hydroalcoholic solution were elaborated and 1,161L that were donated to the hospital were repackaged; 5.3L of hydroxychloroquine 25 mg/mL oral suspension were prepared for patients in the Intensive Care Units (ICU).

Parenteral preparations: Perfusion elaboration was centralized in the PS; 495 infusions of midazolam 1.6 mg/mL and 1,570 of fentanyl 0.012 mg/mL were formulated to ICU. Individualized doses of intravenous tocilizumab belonged to 31 patients were elaborated.

Management and acquisition of medicines: Two new hospitalization areas and three new ICUs were set up, equipped with medication kits. We increased the frequency of medication replacement and the stock of medication in the hospitalization units was adapted. We made a continuous review of medication stocks due to high stocks turnover because an elevated demand. To guarantee the supply of medicines related to SARS-CoV-2, medication was requested through the application of “management of medicines in special situations” of the Ministry of Health. 45 applications were processed.

What next?

The project is applicable to whatever PS, a defining figure in SARS-CoV-2 health crisis´s management, giving priority to essential services.

SARS-CoV-2 specimen collection kits: maintaining supply through in-house production

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European Statement

Production and Compounding

Author(s)

Nikolaus Lindner, Doris Haider

Why was it done?

In Austria, Covid-19 infection rates began to increase in March. At Clinic Favoriten, over 700 patients were treated during the first wave. This resulted in an increasing demand of specimen collection sets. Even though various wholesalers and contractors were contacted, the orders could not be served in a quantitative or timely manner. These circumstances forced the pharmacy to look for alternative solutions.

What was done?

During the first wave of SARS-CoV-2 infections the hospital pharmacy of Clinic Favoriten, Vienna’s specialised Covid-19 center, assembled specimen collection sets manually to meet rising demands, compensate for shortages and secure vital diagnostics supply.

How was it done?

In collaboration with the laboratory department and other clinics of the Vienna health care group appropriate materials with CE-certification were sought to assemble a set that is easy to handle concerning production, distribution and application.
Sterile plastic tubes were filled aseptically with physiologic saline and labelled. Tubes and sterile swabs were then packed in a plastic bag that was sealed with a label providing general instructions for use. Manufacturing protocols as well as batch documentation ensured quality assurance and traceability.
Major obstacles included availability and suitability of the needed materials. Manufacturers of tubes and swabs had to be changed over time, which required close communication with medical wards and the laboratory department.

What has been achieved?

Over a period of seven weeks 2.033 specimen collection sets were assembled. In detail, a total of 20.330 swabs were packed and 10.165 tubes were filled. Through this measure a continuous supply of specimen collection sets, essential for further Covid-19 testing, was secured.
Moreover, the importance of a pharmacy in-house production with the aim of maintaining supply security was acknowledged throughout the entire hospital.

What next?

The initiative has demonstrated that pharmacists play a vital role in handling product shortages and maintaining supply security. In the future, the pharmacy will reinforce to monitor trends even more and will thus be able to balance changing demands and non-availabilities. Like this, the existence of an in-house pharmacy department securing appropriate supply will gain more and more significance. In times of increasing shortages, the initiative serves as a model for other healthcare systems confronted with similar difficulties.

IMPLEMENTATION OF A TELEPHARMACY PROGRAMME TO HOSPITAL OUTPATIENTS DURING THE COVID-19 PANDEMIC

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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

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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

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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.

Role of pharmacists during COVID-19 pandemic in a Belgian general hospital

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European Statement

Patient Safety and Quality Assurance

Author(s)

Lotte Deschepper, Kenny Noerens, Nilgün Kizilmese

Why was it done?

The COVID-19 pandemic caused limited availability of critical drugs and rapidly evolving treatment guidelines. Patient safety must be guaranteed at all times. However, the pandemic took the follow-up of drug shortages to an unprecedented level, increasing the risk of errors. Fulfilling this task was therefore difficult and new strategies needed to be implemented.

What was done?

In our hospital one pharmacist was dedicated fulltime to the COVID-19 drug management. Another pharmacist was committed to ensure the safe and efficacious use of drugs by conducting medication reviews and giving relevant drug and laboratory recommendations.

How was it done?

Microsoft Power BI ©, a tool to analyze data, was used to monitor the specific drug needs on the COVID-wards. Higher drug consumption was more rapidly detected and more specific actions could be executed. The available stocks in the hospital were also registered in a database and this information was updated and reported daily to the medical staff. In this way treatment guidelines could be proactively adjusted if necessary. Medication alerts were sent regularly by mail to ensure that all health care providers were informed about (temporary) changes in order to reduce the risk of medication errors.
Additionally, pharmacists collected evidence‐based drug information concerning indications, dosing, possible side effects, drug‐drug interactions and other precautions based on (inter)national guidelines. This information was used to develop a back-office validation tool that supported pharmacists to conduct medication reviews in a uniform manner. Daily updated reports from Microsoft Power BI © were used to analyze relevant interactions and contra-indications. Pharmaceutical recommendations were promptly documented and reported in the medical record of the patient and the physician was contacted immediately if urgent.

What has been achieved?

Due to the multi-disciplinary approach and guided medication use, therapy continuation could be guaranteed for all patients. Our validation tool resulted in the early detection and interception of medication errors ensuring patient safety.

What next?

A retrospective risk assessment will be done to evaluate our approach and a disaster plan concerning medication will be established based on our experience. The development of a computer-based analytical tool will be encouraged to maximize patient safety while minimizing risk of medication errors.

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Help us provide an overview of the scale of the problem, as well as insights into the impact on overall patient care.

Our aim is to investigate the causes of medicine and medical device shortages in the hospital setting,  while also gathering effective solutions and best practices implemented at local, regional, and national levels.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.