IMPLEMENTATION OF A PHARMACEUTICAL PROTOCOL FOR THE RECEPTION, STORAGE AND DISPENSING OF SARS-COV-2 VACCINES
European Statement
Selection, Procurement and Distribution
Author(s)
Pablo Ciudad Gutiérrez, Marta Mejías Trueba, Héctor Luis Acosta García, Maria Victoria Gil Navarro, Sandra Flores Moreno
Why was it done?
To establish a protocol for the reception, storage and dispensing of SARS-COV-2 vaccines.
What was done?
A standardised work protocol was prepared detailing the role of hospital pharmacists in the reception, storage and dispensing of vaccines, which was approved by the Head of the Pharmacy Service. A certificate of receipt was also prepared with a view to keeping a record of the number of vials received, expiry date, batch, thawing date and temperature, as well as details of each person involved in the circuit.
How was it done?
Phase 1: Preparation, approval and diffusion of the protocol in the Pharmacy Service, anticipating the imminent arrival of SARS-COV-2 vaccines.
Phase 2: Implementation of the protocol, which consists of the following protocol:
1. The vaccine distributor will contact the Pharmacy Service within 30 minutes before the delivery.
2. Upon arrival of the delivery person, the pharmacist will receive the vaccines and both parties will sign a certificate of receipt including: their full name and ID card number, the date and time of receipt, the batch number and expiry date of vials, the date of thawing, as well as the vial temperature upon delivery. This certificate will be kept by the administration staff along with the delivery note.
3. The pharmacist responsible for the reception will store the vials received in the fridge and monitor their temperature.
4. The vaccines will be handed over to the Preventive Medicine Service, the service responsible for administering them, after filling out a certificate of receipt including: date, full name and ID card number of the persons delivering and receiving the vials, number of vials delivered and expiry date. This certificate, duly completed and signed, will be filed by the Pharmacy Service administration staff.
What has been achieved?
An efficient and scheduled protocol was implemented, registering all the certificates of reception, delivery notes, as well as the temperature of the fridges containing the vials.This allowed to identify and correct errors, achieving proper use and traceability of all the vials received, resulting in increased safety for patients.
What next?
This protocol is applicable to Hospital Pharmacy Services responsible for the reception, storage and dispensing of SARS-COV-2 vaccines.
Integration of a hospital pharmacy preparer within a new interventional technical platform
European Statement
Selection, Procurement and Distribution
Author(s)
Morgane HOUIX, Valérie VIAUD, Cécilia HURLUPE, Yannick POIRIER
Why was it done?
The pooling of stock for the 5 rooms required a referent for stock management. In order to free up caregivers from the administrative and logistical tasks related to pharmaceutical products, pharmacy has been directly integrated into the project of ITP.
What was done?
In May 2021, interventional cardiology, rhythmology and coronary angiography have been gathered in an interventional technical platform (ITP) of 5 operating rooms. A full-time hospital pharmacy preparer (HPP) position has been set up within the ITP.
How was it done?
For the success of the project, the 2 chosen PPH had to easily becoming part of ITP’s teams and must learn specifics of medical devices of each speciality. For this purpose an immersion in each sector was carried out during the installation of the ITP and continues today by participating in interventions. They shared in the process of installing the PTI’s arsenal of pharmaceuticals with careteams by grouping the initials allocations of products of each speciality. The products common to each endowment were gathered and harmonized after discussion with caregivers. Each sector has kept a stock of specific devices, called “out-of-stock”.
What has been achieved?
The installation took about 632 hours of HPP time. The allocations for each sector were respectively 68, 69 and 83 references, not including out-of-stock. The HPP’s work allowed reducing the common endowment from 220 to 134 products references. A satisfaction survey of PTI teams (doctors, nurses,…) after 4 months of practice showed a level of 78% of satisfaction. 1.3% of the responses concerned activities related the management of devices affected by production delay or stoppage and information on product changes to be unsatisfactory or moderately satisfactory. Every ITP teams now considers their presence essential, believes that it has improved relations with the pharmacy and management of stocks. A saving in nursing time was also noted.
What next?
The creation of this HPP position seems to satisfy all the ITP teams. A quantitative analysis of the benefits measuring the impact on care time, the amount of over-storage and the compliance indicators of the implantable medical device circuit will be carried out during 1 year, in order to assess the impact of the creation of HPP positions within the PTI.
Oxygen therapy in COVID-19 pandemic: how to keep breathing at home
European Statement
Selection, Procurement and Distribution
Author(s)
Elena Bazzoni, Roberto Pane, Claudia Montanari, Giulia Rocca, Camilla Ercoli, Maurice Oriente De Ponzio, Thérèse Gregori, Simonetta Radici
Why was it done?
Piacenza is one of the most hardly hit cities in Italy during the first wave of COVID-19. Due to the severe impact that this pandemic had in the area, hospitals were saturated with patients with respiratory failure. We thus needed to rapidly set strategies that allowed a fast dismissal of patients from the hospital without interrupting their oxygen therapies or avoid their hospitalization in case of mild respiratory failure.
What was done?
Starting from COVID-19 pandemic, our pharmaceutical unit cooperated with medical doctors of the area to allow home-delivery of oxygen therapies and grant continuity between hospital and territory. We thus developed a structured system that allowed fast activation, efficient tracking, prompt variations, and dismissal of patients from oxygen therapies at their house.
How was it done?
Since February 2020, all the oxygen therapy prescriptions from the hospital and the territory converged to the pharmaceutical service. In collaboration with the pneumology unit, we set up a database collecting patient generalities who needed oxygen therapy to grant the proper follow-up during the pandemic. In April 2020 the database was shared also with medical doctors belonging to the newly formed Special Unit for Assistential Continuity (USCA). This team was in charge of visiting patients at their houses. In collaboration with USCA and the IT service, we developed a web-based system that allowed real-time communication between Pharmacy, USCA teams, and some hospital units granting the continuity between hospital and territory.
What has been achieved?
From the beginning of the pandemic, the pharmaceutical unit has handled more than 960 requests of oxygen therapies regarding more than 900 patients. Our database is updated with all of the patients granting the tracking of each one of them as well as the therapies assigned. Our system also allowed USCA to follow patients on the territory reducing the pressure on hospitals. In 2020, indeed, more than 75% of oxygen prescriptions were requested by hospital units while in 2021, 81% of them came from USCA and territorial units.
What next?
Our currents efforts aim to reduce procedural complexity to grant access to pharmacological therapies. This new web-based system represents, indeed, an versatile and key tool to reach our goal. We are currently extending its use to the whole hospital for oxygen therapies independently of the underlying pathologies. This will allow an easy and complete transfer of these therapies on the territory. Moreover, we are implementing the possibility to prescribe drug-based pharmacological therapies in an in-home context.
Implementation of a telepharmacy service in outpatient’s pharmaceutical consultation
European Statement
Clinical Pharmacy Services
Author(s)
QUERALT LOPEZ NOGUERA, ÀNGELA CASTELLÓ NÒRIA, CRISTINA DIEZ VALLEJO, LAURA VIÑAS SAGUÉ, MARTA COMA PUNSET, SILVIA CABARROCAS DURAN, MIREIA VILA CURRIUS, ANNA DORDÀ BENITO, EDUARDO TEJEDOR TEJADA, CRISTINA TORO BLANCH, ROSA NURIA ALEIXANDRE CERAROLS, ROSA SACREST GÜELL
Why was it done?
The declaration of the state of emergency by SARS-CoV-2 pandemic on March of 2020 had an impact on hospital PC.
During that period, it was advised by Healthcare Authorisations to minimize the risk of infection or spread of SARS-CoV-2 in order to protect vulnerable groups. For that reason, it was not recommended to assist in the hospital if it was not necessary. This fact caused some organizational changes in OPC to adapt to the current situation.
What was done?
Our hospital Pharmacy Department created a telepharmacy service in outpatient’s pharmaceutical consultation (OPC) after state of emergency declaration by SARS-CoV-2. We created a standard operating procedure working together with communitarian pharmacists and the Region Pharmacist’s College. The main aim was to ensure pharmaceutical care (PC) quality in vulnerable patients and the correct medication distribution and conservation. Pharmaceutical care was developed by telephone call and medication was send to communitarian pharmacy.
A comprehensive analysis was made to concern the impact on drugs delivery selecting certified distribution company which ensured drug traceability, custody and conservation.
How was it done?
In 2020, approximately 60 patients per day used to attend in OPC. According to the large number of patients, we defined which patients could take advantage of this programme. The selection criteria were adherent patients with pulmonary pathologies (cystic fibrosis, asthma, bronchiectasis, etc.), multiple sclerosis, amyotrophic lateral sclerosis, reduced mobility or patients over 65 years old who lived in more than 30km closed to the hospital or without any family member that could come.
In order to ensure the process traceability, an informatics tool has been created by Region Pharmacist’s College. Pharmacy Department, community pharmacy and the distribution company assumed all expenses.
What has been achieved?
369 of 2.346 patients were included in our telepharmacy service during the state of emergency. There was high level of acceptance by all patients. Only low-risk patients or patients who had an on-site doctor visit were attends in OPC. Nowadays, 196 patients still benefit from the initiative.
What next?
Telepharmacy program avoids patient’s displacements that are particularly susceptible to COVID-19 negatives effects. Moreover, it guarantees PC quality, patient’s adherence, process traceability and correct medication conservation from hospital to patient’s home.
Medication reconciliation : a pharmaceutical teleconsultation for patients followed in hematology in a French Comprehensive Cancer Center
Pdf
European Statement
Clinical Pharmacy Services
Why was it done?
Oncology patients are often elderly and multi-medicated, with many physicians involved in their management. Their treatments can therefore often be changed while chemotherapy have a high risk of drug’s interactions. However, in our center, the length of patient stays and pharmaceutical resources are incompatible with the systematic achievement of reconciliation during hospitalization. In addition, more and more patients are benefiting from oral chemotherapy, outside any hospitalization. Besides, hematologists already offered teleconsultations to some patients, for their comfort and because of the COVID-19 pandemic.
What was done?
A pharmaceutical teleconsultation is now offered to our hematology patients in order to make the comprehensive list of medications taken, including self-medication, herbal medicines and food supplements. The comparison with the usual treatment in the medical record allows to update the patient file and prepares a proactive reconciliation.
How was it done?
A comparison and tests of the different reconciliation tools were carried out. The Hospiville® platform was chosen, also allowing remote and secure communication with retail pharmacies. Moreover, communication devices have been installed, such as webcams, headphones and microphones. This equipment was financed by our Regional Health Agency.
What has been achieved?
An appointment is offered to the patients listed on the weekly hematology teleconsultation schedule. Their usual pharmacy’s contact details are then requested.
Information collected from the medical file and from the pharmacy are provided on Hospiville®, then completed during the interview by Teams®. The pharmacist lists the prescribed medications, assesses the patient’s compliance and analyzes the interactions between drugs or complementary medicines. If necessary, the referring hematologist is contacted to adjust the drug’s management. Afterwards, the report of the teleconsultation is added to the medical file (Elios®).
What next?
By carrying out the consultation from home, patients report being more exhaustive in the information they provide. They also appreciate the short time needed and the easiness of speaking in familiar surroundings.
Thanks to scheduled teleconsultation, pharmacists further secure the patient’s medication path without disrupting the pharmacy’s activity. This experience will be used for the experiment “ORAL THERAPIES – home monitoring of patients on oral cancer drugs” in the French context of Article 51.
Securing the care pathway of patients in the new experimentation of medical cannabis through pharmaceutical interviews
European Statement
Clinical Pharmacy Services
Author(s)
Marie Guedon, Maëliss Laurent, Thibault Vallecillo, Catherine Mennesson, Mélanie Jennesson Lyver, Dominique Hettler, Céline Mongaret
Why was it done?
In March 2021, the “Agence Nationale de Sécurité du Médicament” initiated an experiment to evaluate the relevance and feasibility of the availability of MC as a narcotic drug, in France. In our hospital, we included children to treat drug-resistant epilepsy, and performed a dispensing process to secure the patient care pathway and strengthen collaboration between hospital pharmacists and primary care professional.
What was done?
The aim of this study is to secure the care pathway of patients included in a national experimentation of medical cannabis (MC) by developing pharmaceutical interviews. Thus, to optimize the continuity of patient care, a pharmaceutical report was developed, and addressed to the community pharmacists of the patient.
How was it done?
A working group was created including clinical pharmacists, a neuropediatrician and a coordination nurse. During medical consultations, pharmaceutical interviews were conducted and led to pharmaceutic reports, sent to the community pharmacies of the patients. In order to evaluate this report, a satisfaction survey was carried out.
What has been achieved?
During the first six months of the experimentation, three children were included. The clinical pharmacist team (two senior pharmacists and two pharmacy residents) performed ten dispensing processes. During the eight pharmaceutical interviews, four pharmaceutical interventions were performed. Firstly, the interaction between clobazam and MC (noticed in one patient) required a dosage adjustment. Then, the association between MC and hepatotoxic drugs (found in two patients) requires hepatic monitoring. A pharmacovigilance statement was also drafted to report side effects (digestive disorders). The satisfaction survey of community pharmacists showed that the transmitted information, mostly related to the medication review, was considered as useful for the community pharmacies of the patients. This data helped to guide the pharmaceutical interviews during their dispensing process.
What next?
Pharmaceutical interviews and their reports lead to secure the patient care pathway and improve the communication amongst health care professionals. Those measures provide an optimal case management and avoid therapeutic breakdown. Nevertheless, difficulties have been reported, mostly due to delay in the supply chain of the community pharmacies. Therefore, this system requires some adjustments before it can be applied on a larger scale. One of the suggestions is a provisional calendar of consultations and dispensations.
Added value of centralised compounding of vaccines against SARS-CoV-2 in Hospital Pharmaceutical Services – a quantitative analysis
European Statement
Production and Compounding
Author(s)
Rui Relvas, Rui Pedro Marques, Ana Castro, Sérgio Nobre, João Paulo Lopes da Cruz
Why was it done?
Medicines compounding by the HPS-staff is a primordial activity, and its centralisation allows several benefits in levels such as patient safety, quality, efficiency, and pharmacoeconomics. Despite this recognised importance, it is not always possible to quantify its added value. The fact that vaccines against SARS-CoV-2 are supplied in multi-dose vials and the need to prepare and assure enough doses to vaccinate a broad population presented itself as an excellent opportunity to analyse such indicators.
What was done?
A quantitative analysis of the importance and added value of centralised preparation and compounding of vaccines against SARS-CoV-2 at the Hospital Pharmaceutical Services’ (HPS) Compounding Unit from a Central Hospital in Portugal.
How was it done?
Between 27th December 2020 and 2nd August 2021, 13.030 doses were prepared (96.9% Pfizer/BioNTech; 3.1% AstraZeneca). At the first 3 vaccination sessions, multi-dose vials were diluted at the HPS, and each syringe measured by the nursing-staff previously to the administration.
After these initial sessions, each dose started to be individualised by the HPS-staff on pre-filled, ready-to-use syringes. Each vaccine dose was individualised on a horizontal laminar flow cabinet according to a previously approved operational procedure.
Reception, preparation, and dispensation records were retrospectively analysed. Key performance indicators were quantified.
What has been achieved?
During the first 3 sessions of vaccination, when nursing-staff measured each vaccine volume, a total of 1640 doses were administered. However, it would be possible to measure a total of 1932 doses (84,9%). The daily maximum of people vaccinated was 770.
In the following sessions was possible to prepare 11.390 doses, with a theoretical maximum of 10.892 (104,6%) and a daily maximum of 1.113.
This yield, over 100%, allowed an excess of 498 doses, which translated into the vaccination of 249 extra individuals fully vaccinated with the 2 doses. Factors like needle and syringe selection and preparation beyond an aseptic and validated environment contributed for the yield increase.
What next?
Series-production of compounded medicines in a sterile, validated, and controlled environment allows important benefits and this analysis shows the potentiation of every key performance indicator considered. These data should be considered for the future planning of population-wide activities involving the massive preparation of sterile medicines.
Critical points in the management of intratumoral treatments in oncology clinical trials
European Statement
Clinical Pharmacy Services
Author(s)
Lorena Garcia Basas, Pablo Latorre Garcia, Eugenia Serramontmany Morante, Patricia Garcia Ortega, Pilar Rovira Torres, Laura Maños Pujol, Isabel Cidoncha Muñoz, Maria Queralt Gorgas Torner
Why was it done?
Increasing number of CT with IT, in different pathologies, with different tumor locations, contributes an increase in the complexity of drug compounding and procedures. Their preparation, administration and handling requirements differ from current therapies.
What was done?
Identification of critical points concerning intratumoral treatments (IT) preparation in patients with cancer included in clinical trials (CT).
How was it done?
Ongoing CT with IT in our unit were reviewed to identify critical points regarding prescription and preparation process. 14 trials with IT, 8 (57%) of which have ongoing patients were identified. Two of these trials are “first in human”. The critical points were:
- Nature of the IT: virus (4, 29%), nanoparticles (3, 21%), ribonucleic acid (2, 14%), cyclic dinucleotides (2, 14%), monosaccharides (1, 7%), phospholipids (1, 7%) and proteins (1,7%).Particularly, virus have special safety measures and transport conditions
- Dosing units: mcg (4, 29%), plaque-forming unit/mL (PFU/mL)(3, 21%), mL (3, 21%), mg (2 14%), ng (1, 7%), 50% Tissue Culture Infectious Dose (TCID50)(1, 7%).
- Prior dilution before filling the syringe: 8 (57%) of our preparations require at least one prior dilution.
- Drug volume to prepare according to the tumor size: 8 (57%) IT preparations depend on the tumor size.
- Depending on the depth of the target tumor lesion (visceral or superficial), different size of needle is required. This is important because different priming volumes of the needles are necessary.
What has been achieved?
The whole information necessary for a complete prescription, validation and correct preparation goes further than information usually needed for current therapies such as chemotherapy. The results of the study of the critical points allow us to elaborate the standardized operational procedures (SOP) for each CT and IT. These SOPs include the necessary information for a correct preparation for each IT, reducing risk of mistakes and achieving uniformity in the process.
What next?
These types of therapies represent a challenge, and pharmacists have an important role in developing new procedures. Communication between radiology, oncology and pharmacy departments in a multidisciplinary teamwork is essential. This information may be useful to other centers due to the lack of experience and SOPs to work with this type of therapy.
Evaluation of pharmaceutical interventions documented by a pharmacy technician: where do pharmacy technicians have the biggest impact to avoid drug-related problems?
European Statement
Clinical Pharmacy Services
Author(s)
Ruth Borchers, Linda Krampe, Andreas Fischer, Christian Thomas, Holger Knoth
Why was it done?
The aim of this study was to identify the clinical pharmacy services where the integrating of pharmacy technicians have the biggest impact to avoid drug-related problems.
What was done?
In the field of clinical pharmacy services there are activities that are suitable for pharmacy technicians under the supervision of a pharmacist. At the university hospital in Dresden one full-time pharmacist and one half-time pharmacy technician (4h/d) are looking after 80 beds in the department of urology. The main tasks of the pharmacy technician are medication reconciliation as well as clinical prioritisation by using guidelines to identify patients who are at high risk of drug-related problems.
How was it done?
Since 2019 the pharmacy technician is recording the interventions in a categorical excel sheet, there are two documentation weeks per quarter. The categories are drug name, short description of the drug related problem, intervention, classification (dose-related problems, consultation of general practitioner, consultation of patient, electronic prescription, other drug-related problems after discussion with the pharmacist, drug substitution).
What has been achieved?
During 22 documentation weeks from 01/2019 till 09/2020 the pharmacy technician documented 468 interventions. The main interventions are drug substitution on admission considering local guidelines (n=181; 39%), consultation of the general practitioner because of identified discrepancies on the medicine lists (n=138; 29%) and consultation of patients because of identified discrepancies (n=78; 17%). Dose-related interventions and other drug-related problems are detected by the pharmacy technician and discussed with doctors under the supervision of the pharmacist (n=49; 10%).
What next?
Especially in the field of medication reconciliation trained pharmacy technicians can be suitable to prevent drug-related problems. The consultation of general practitioners and patients because of identified discrepancies on the medication lists are time-intensive and probably would not happen in the same way without integration of the pharmacy technician. The drug substitution in consideration of local guidelines and the preparation of the electronic prescription lead to fewer queries from nurses or doctors.
Further research should focus on the quality of pharmaceutical interventions conducted by pharmacy technicians under the supervision of pharmacists.
TELEPHARMACY ANALYTICS AND DATA VISUALIZATION THROUGH BUSINESS INTELLIGENCE
European Statement
Clinical Pharmacy Services
Author(s)
Cristina González Pérez, Laura Llorente Sanz, Ángel Liras Medina, Ana Andrea García Sacristán, María Molinero Muñoz, Lidia Ybañez García, José Alberto Peña Pedrosa, Henar González Luengo, María Luaces Méndez, José Manuel Martínez Sesmero
Why was it done?
Telepharmacy implementation in the context of SARS-CoV-2 pandemic conducted us through the management of a high volume of complex, real-time both clinical and economic data. A multidisciplinary working group (biomedical engineers from the Innovation Unit, clinicians, managers and hospital pharmacists) developed a software tool in April-May 2021.
What was done?
The design of an agile, customizable and dynamic dashboard for the visualization and analysis of Telepharmacy key performance indicators (KPI) through Business Intelligence (BI).
How was it done?
Phases:
1. Situation analysis. KPI definition. Ethics committee approval submission.
2. Extraction and processing of raw databases (Telepharmacy database, outpatient dispensing program, hospital admission database, drug catalog) through data mining.
3. Co-creation of the comprehensive dashboard in PowerBI®, by integrating database sources. Different panels have been designed where filters such as age, time frame, medical service, pathology, etc. can be applied.
• Description of general variables: patients, demography, shipments, time frame, medical department.
• Geolocation of the destinations of the patients’ home delivery.
• Pharmacological profile: top 10 drugs, distribution by active ingredient and drug classification group.
• Relative analysis of the beneficiary patients of Telepharmacy vs global outpatients
4. Pilot project by different types of users (administrative staff, clinicians and managers)
5. Structure design for automatic updating of the panels from the successive updates of the source databases
The quality of the raw databases can be a limitation. It has been necessary to define how to handle missing and duplicate data. Pre-processing, normalization and transformation data processes have been applied too.
Working within the hospital network ensures that there are no security gaps in terms of patient data protection.
For the external use of the dashboard, the granularity of the data is modulated to ensure enough clustering to avoid the identification of individual patients.
What has been achieved?
Processing the huge dataset (more than 2.4 million records) was possible by BI tools that synthesizes data, provides dynamic and engaging visualization (charts and graphs), allows the interactive reports customization for more effective communication of results and apply analysis based on Artificial Intelligence.
What next?
Applying new technologies will help us improve strategic decisions: interactions, behaviors and trends perceiving, weak points identifying, uncertainty reducing and over time monitoring.