Adequacy and effectiveness of thromboembolic prophylaxis in multiple myeloma patients treated with inmunomodulatory drugs.
European Statement
Clinical Pharmacy Services
Author(s)
Alba María Fernández Varela, Laura López Sandomingo, Nieves Valcarce Pardeiro, Isaura Rodríguez Penín
What has been achieved?
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A pharmacist-led pharmacovigilance initiative for the first Austrian Covid-19-vaccination campaign
European Statement
Patient Safety and Quality Assurance
Author(s)
Nikolaus Lindner, Katharina Heitzeneder, Nora Hummer, Elisenda Pichler, Doris Haider
Why was it done?
Due to the lack of long-term safety data, the principal goal was to assure a safe and effective use of the available vaccines by coordinating stringent logistical operating procedures as well as by facilitating early detection and evaluation of possible safety signals. A further objective of this initiative was to increase the awareness among healthcare workers regarding the possible health risks associated with a SARS-CoV-2 infection and Covid-19 vaccines as preventable countermeasures.
What was done?
A Covid-19 vaccination pharmacovigilance campaign was implemented in a clinical setting with the focus on patient safety and quality assurance as part of an employee vaccination rollout. The pharmacy department set up a pharmacovigilance service-point to assess vaccine safety as well as potential adverse events and assure patient care by close follow up.
How was it done?
Assessing and reacting to individual safety signals on time represented a critical challenge. Pharmacists designed questionnaires capturing possible adverse events. In order to lower the barriers for participation it was decided to take a paper-based approach instead of electronic distribution. A pharmacovigilance service-point was continuously managed by two pharmacists directly at the vaccination site to achieve a high response rate. Throughout the campaign the completed questionnaires were simultaneously evaluated, as rapid action was key to detect safety signals early and implement measures accordingly.
What has been achieved?
The results showed a high response rate to the questionnaire of 95% and 53% after the first and second dose, respectively. A significant increase of symptoms after the second dose compared to the first dose reflected the findings of the marketing authorisation study. Based on the analysis no further safety precautions were needed. However, appointments before night or weekend shifts had to be discouraged as well as the vaccination of the whole staff from one department on the same day. As a result, disruptions to patient care could be avoided successfully.
What next?
This initiative serves as a valuable model for upcoming vaccination campaigns and especially for pharmacovigilance projects aiming to assess adverse events of recently approved medicines. Moreover, the successfully implemented multi-disciplinary approach represents the basis for further hospital-wide pharmacy projects and may facilitate the implementation of pharmacist-provided vaccination services.
Quality Improvement Project of Clozapine Prescribing Process in a Mental Health Unit
European Statement
Clinical Pharmacy Services
Author(s)
Charlotte Stafford, Aoife Delaney, Virginia Silvari, Thomas Cronin, Deirdre Lynch
Why was it done?
The Pharmacy Department dispenses clozapine to 142 patients. A new prescription was issued each time a patient was dispensed clozapine (approximately 40 new prescriptions per week). From January 2019 to June 2020 there were 42 clozapine incidents (incidents/month= 2) reported by the Pharmacy Department to the MHU. A four week review also showed that prescription queries (dose changes and transcription errors) consumed 6 hours of pharmacy staff time. The new 6-monthly, electronically stored prescription and the dedicated email address should address these issues.
What was done?
A newly devised proforma clozapine prescription has been developed by the Pharmacy Department and has become valid for 6 months for patients on 4-weekly blood monitoring. A copy of each patient’s prescription is stored electronically in the Mental Health Unit (MHU) share drive. A new dedicated pharmacy clozapine email address has been generated for all clozapine dose changes to be communicated to.
How was it done?
Four new clozapine prescriptions were developed by the Pharmacy Department:
– a maintenance dose prescription
– standard titration days 1 to 8
– standard titration days 8 to 15
– blank titration prescription.
The new prescriptions for patients on 4-weekly blood monitoring, valid for 6 months, are now stored in the MHU share drive to reduce the risk of transcribing errors.
What has been achieved?
Once the new system had been established, a further 4 week review showed that only 10 minutes over 4 weeks was spent by pharmacy staff dealing with a prescription query. All dose changes were now communicated by email. Incident reporting has decreased, with 5 clozapine incidents being reported by the Pharmacy Department between January to June 2021 (incident/month <1).
What next?
A business case highlighting the importance of a dedicated Clozapine Pharmacist has been submitted to further develop the clinic and ensure safety of this vulnerable cohort of patients.
Deprescribing interventions performed by hospital pharmacists reduce potentially inappropriate medication at hospital discharge
European Statement
Patient Safety and Quality Assurance
Author(s)
Alba Martin Val, Adrià Vilariño Seijas, Arantxa Arias Martínez, Anna Terricabras Mas, Andrea Bocos Baela , Maite Bosch Peligero, Carles Quiñones Ribas
Why was it done?
In CCPs the efficacy and safety of many drugs are unknown or questionable, in fact, medication may be the cause for side effects. Deprescribing is aimed to reduce the use of potentially inappropriate medications (PIMs) and improve patient outcomes. Pharmacist deprescribing interventions may contribute to reassess prescriptions and withdraw those with a negative risk/benefit balance.
What was done?
To analyze the pharmacist deprescribing interventions in complex chronic patients (CCPs) performed in hospital and primary care.
How was it done?
This prospective study was carried out in a tertiary hospital between February and March 2021. CCPs whom medication was reconciliated at hospital discharge were included and the pharmacist interventions (PIs) performed were analyzed. After hospital discharge, the acceptance of the PIs was verified and were notified to the primary care physician in case of not being accepted in hospital setting. Drugs involved in PIs were classified according to the therapeutic group established by the Anatomical Therapeutic Chemical classification and high-risk medication was quantified using the Institute for Safe Medication Practices classification for chronic patients. Deprescribing interventions were classified according to the Less-Chron criteria and other medication-related problems were also quantified.
What has been achieved?
Among the 55 patients included, 55% were female, the mean age was 83 years and the mean of medication per patient was 13. A total of 111 PIs were performed, 44% (n = 49) were deprescribing interventions and 56% (n = 63) other problems related to medication. Fifty-five per cent of patients presented 1 or more PIMs, and a mean of approximately 1 PIMs per patient was reported. The most frequent therapeutic groups involved in PIs were cardiovascular system (34.2%), nervous system (29.7%) and alimentary tract and metabolism medication (13.5%). High-risk medication represented 41% of all PIs. The most frequent deprescribing interventions were associated to blood pressure treatment (30.6%), benzodiazepines (24.4%) and statins (12%). The 65% of deprescribing interventions were accepted among hospital and primary care settings.
What next?
Deprescribing interventions supported by hospital pharmacists reduce potentially inappropriate medications, however, deprescribing practice is still limited in hospital and primary care.
Role of Hospital Pharmacist in the compassionate use of Risdiplam since the submission to Ethics Committee to the therapy in patients affected by Spinal Muscular Atrophy: an example of close collaboration with the neuromuscular team.
European Statement
Introductory Statements and Governance
Author(s)
Anna Esposito, Claudia Panico , Loretta Cervi, Emilio Albamonte, Alice Zanolini, Valeria Sansone
Why was it done?
This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.
What was done?
The hospital pharmacist (HP) supports the neuromuscular team (NT) in submitting the request to access compassionate use with Risdiplam in patients affected by spinal muscular atrophy (SMA). Risdiplam is an orally administered, survival motor neuron 2-directed RNA splicing modifer for the treatment of SMA.1 The HP is involved in Ethics Committee (EC) approval, is responsible for reconstituting and storage of oral solution and is also responsible of re-supply and pharmacovigilance surveillance. This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.
How was it done?
HP is involved from the initial phases of the compassionate use of the drug. The NT that screens and enrolls the patients in the compassionate use program with Risdiplam by submitting a formal request to the EC. The teams of the EC, which includes the HP, evaluates the appropriateness and inclusion criteria for each patient. Once the patient is considered eligible, and treatment is approved, the HP receives the drug from Pharma, provides quality control and assigns the drug for each patient. HP prepares the oral solution and stores the products at 2-8°C until dispensing. After the initial dispensation it is the HP’s responsibility to work closely with the NT in order to maintain treatment over time, ensuring the right timing for re-supply of the drugs and medical devices.
What has been achieved?
There are currently 30 patients on therapy and they are monitored to ensure re-supply and reporting of any adverse events. Home delivery procedure was implemented in agreement with EC in cases where outpatient dispensing was difficult, especially due to logistical difficulties caused by the Covid-19 pandemic, if clinical conditions were stable. In addition, a strong collaboration between the HP and NT was implemented in order to provide access to an increasing number of patients.
What next?
Risdiplam has recently been approved and the HP is involved in the procurement and maintenance of ongoing therapies and ensures supply to new patients. The drug is under negotiation and HP will be involved in contracting procedures based on the expected number of patients and definitive inclusion criteria to access the drug
How robotics improved safety and working efficiency in a European premium cancer institute
Pdf
European Statement
Production and Compounding
Author(s)
Mathilde Roche, Annabelle Angapin, Vincent Blazy, Alexandre Hyvert, Loretta Moriconi, Matteo Federici, Bintou Diawara, Cindy Monnel, Lison Ferreol, Assia Mitha, Hail Aboudagga, Romain Desmaris
Why was it done?
Initially, robot’s operations required prescription re-transcription and chemotherapy relabelling by technicians, leading to manual data entry risks. Robots are known for high-standardised procedures, great repeatability and limited human intervention: adding bidirectional interface enabled improvement of patient safety. Moreover, it shows significant benefits during the compounding process, streamlining pharmacy workflows and ensuring full and paperless traceability.
What was done?
In 2018, our chemotherapy production unit implemented an automated anticancer drugs compounding platform, embedding two APOTECAchemo robots. This aims to meet the increasing patient-specific chemotherapy demands (78,000 preparations/year). In order to minimise human risk and optimise work efficiency, implementation of a bidirectional interface between the robots and the hospital’s Electronic Prescribing Software (EPS) was considered as mandatory, to allow exchange and clinical information retrieval.
How was it done?
In 2020, pharmacists and the IT team defined the interface specifications. Bidirectional information flow was implemented using Health Level Seven (HL7) standards. Interface between EPS and APOTECAmanager was developed and a comparative robot performance analysis was undertaken by evaluating processed drug products, compounded preparation numbers and actual average usage time per day. The staff (i.e. two technicians) remained identical. Data were retrieved from robot’s embedded statistical tool over three months, before (March-May 2020) and after interface implementation (July-September 2020).
What has been achieved?
During these six months, 13,746 preparations were compounded, with 95% infusion bags and 5% elastomeric pumps. Most of these preparations were produced in advance (administration on day+2 or day+3). After interface implementation, the average production raised by 40.5% (from 1,905 to 2,676/month). Interface implementation increased also the average robot operating hours from 3.6 hours/day/robot to 5.8 hours/day/robot (+61.1%). In total, 19 different molecules were compounded, including conventional anticancer drugs and monoclonal antibodies with the number of reconstituted drug vials increasing by 38.1% (from 625 to 863).
What next?
Interface between robots and the EPS was successfully implemented, thereby enabling improved safety and efficiency. Today, syringes and paediatric preparations are still made manually. They require visual and analytical controls to verify their conformity. Mid 2021, a third robot customized for syringes and paediatric preparations will be installed in the compounding unit, to secure these preparations in a more efficient way.
Aflibercept redosification impact in a second-level hospital.
Pdf
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.
DRUG-DELIVERY-SYSTEMS FOR OPAT SELF-ADMINISTRATION: A GRAPHIC GUIDE
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Tania Truelshoej
Why was it done?
Department of infectious diseases at Aarhus Universitetshospital, Denmark, has succesfully implemented OPAT as a standard modality for certain patients requiring long-term intravenous antibiotic therapy e.g. patients with cystic fibrosis. This also include a guideline to OPAT self-administration at home.
To implement the OPAT guidelines throughout the hospital there was a need for an overview of available ready-to-use antibiotics for OPAT. The graphic guide is a help for the physicians in choosing the right drug-delivery-system suitable for OPAT self-administration.
What was done?
A graphic guide showing the ready-to-use antibiotics for outpatient parenteral antimicrobial therapy (OPAT) with special emphasis on drug-delivery-systems suitable for self-administration was developed.
How was it done?
Most information about the available ready-to-use antibiotics were obtained at the hospital pharmacy. In addition, the requirements for the different drug-delivery-system were obtained by interviewing nurses from different wards
What has been achieved?
Available ready-to-use antibiotics was listed in a graphic form with the following information: type of antibiotics, drug-delivery-system, available doses recommendations to time of administration and storage time and temperature. The drug-delivery-system were all illustrated with a photo.
The graphic guide is now part of the implemented guideline for OPAT at the hospital and is also available as a printed poster to place e.g. in the medicine room.
The guide is a help for the physicians in choosing the right drug-delivery-system suitable for OPAT self-administration and helps to raise overall awareness of the possibility of OPAT as self-administration at the hospital.
What next?
Implementation of the OPAT guideline and the included graphic guide has increased awareness of the need for the hospital pharmacy to deliver ready-to-use antibiotics that can match the needs for safe and efficient treatment at home. This is an important strategic focus for the hospital pharmacy in the coming years.
SARS-CoV-2 specimen collection kits: maintaining supply through in-house production
Pdf
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.
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.