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Active Pharmacovigilance of COVID-19 vaccines

European Statement

Patient Safety and Quality Assurance

Author(s)

Manuela de Sousa, Ana Catarina Felismino, Ana Rita Pereira, Ivone Máximo, Liliana Pedro, Natacha Santos, Paula Campos

Why was it done?

Vaccines against COVID-19 are classified as “Medicines subject to additional monitoring” by the European Medicines Agency, making it essential to implement active pharmacovigilance systems that allow for the rapid identification of new safety information.

What was done?

Active surveillance of the COVID-19 vaccination process of health-care professionals and immunoallergy patients of our hospital.

How was it done?

By proposal of the Pharmacy Service, a multidisciplinary Pharmacovigilance Committee composed of two Pharmacists, two Physicians and two Nurses was created. The vaccinated professionals and patients were periodically identified, with the support of the Occupational Health and Immunoallergy Departments. Questionnaires to identify Adverse Drug Reactions (ADR) were created in Google Forms® for each COVID-19 vaccine brand and sent to health-care professionals´ institutional email address, or to the email patients provided in the signed informed consent. The responses were exported to an EXCEL® database, analyzed by the Pharmacovigilance Committee, the ADRs identified and communicated to the regional Pharmacovigilance Centre.

What has been achieved?

From 29 December 2020 to 31 August 2021 a total of 2141 questionnaires were sent, 578 responses were obtained and 542 ADRs were communicated to the regional Pharmacovigilance Centre. No anaphylactic reactions were reported. Nº doses administered Nº responses Nº ADR identified Nº clinically significant ADR Most frequent ADR First dose Vaxzevria® 450 130 97 67 myalgia, headache, injection site pain Second dose Vaxzevria® 360 29 8 1 injection site pain, headache, fatigue First dose Comirnaty® 1176 404 172 19 injection site pain, injection site swelling, headache Second dose Comirnaty® 1176 404 254 97 injection site pain, myalgia, fatigue Single dose Comirnaty® 157 15 10 4 injection site pain, headache, fatigue COVID-19 Vaccine Janssen® 9 3 1 0

 

GPI Active Pharmacovigilance of COVID-19 vaccines Table

What next?

Increase awareness of the importance of Pharmacovigilance amongst hospital health-care professionals to combat sub-notification of ADRs. We also plan to extend this active Pharmacovigilance program to other medicines in use at our hospital.

Implementation of an artificial intelligence tool for the detection of drug safety problems

European Statement

Patient Safety and Quality Assurance

Author(s)

Noe Garin, Laia Lopez-Vinardell, Pau Riera, Adrian Plaza, Ivan Castellvi-Barranco, Jose Mateo-Arranz, M. Antonia Mangues

Why was it done?

APS is a rare disease with a high risk of thromboembolism. Recently, some data suggested an increased risk of thrombotic events with direct-acting anticoagulants (DOAC) compared with vitamin K antagonists in APS. Some agencies advise against the use of DOACs in these patients.

This methodology can be extrapolated to other risk situations, so this was a first step with AI to further detection of safety issues.

What was done?

We implemented an Artificial intelligence (AI) tool based on natural language processing (SAVANA®) to identify patients at risk of thromboembolism, defined as Antiphospholipid Syndrome (APS) diagnosis treated with direct-acting anticoagulants (DOAC). SAVANA® is an AI tool able to extract information contained in free-text from electronic clinical records.

A prior operation work was conducted, involving: direction, pharmacy, documentation, IT, SAVANA®, data protection. The work and previous meetings evaluated: feasibility, previous requirements, privacy issues, IT involvement and contract signings.

How was it done?

The implementation consisted of:
– Transference of medical record information to the SAVANA® cloud.
– Identification of the health problem (APS) and initial search.
– Search algorithm optimization in a multidisciplinary team.
– Evaluation of the search by SAVANA® by peer review in a sample of randomly selected cases (n=200).
– Precision and sensitivity analysis. Algorithm improvement.
– Obtaining the Gold Standard and validation.
– Definitive search for the detection of patients with APS in treatment with DOACs and performance of interventions.

What has been achieved?

The project implementation is at a very advanced stage. The algorithm has currently been evaluated and is being refined after precision and sensitivity analysis. Final validation and definitive identification of patients at risk is expected at the end of 2021. Patients detected during the implementation method have been evaluated with the haematology team.

What next?

This methodology can be implemented in any centre with computerized medical records. The use of AI is the only tool available for the identification of certain groups of patients when health problems are not coded. In other cases, its use regarding the extraction of lists allows a great capacity for analysis, absence of biases derived from human error, guarantee of reproducibility and complementary data obtention, mainly in samples of high size.

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.

IMPLEMENTATION OF ASSISTED ELECTRONIC PRESCRIPTION IN THE OUTPATIENT AREA

European Statement

Patient Safety and Quality Assurance

Author(s)

JUDIT PERALES PASCUAL, HERMINIA NAVARRO AZNAREZ, ANA LOPEZ PEREZ, LUCIA CAZORLA PODEROSO, IRENE AGUILO LAFARGA, ANA PEÑAS FERNANDEZ, Mª REYES ABAD SAZATORNIL

Why was it done?

Despite the volume of patients seen at UPEX, the complexity of care and the cost of the treatments, in 2019 the prescription was transcribed by pharmacists with the consequent risk/investment of time that this entails. The aim was to incorporate organizational/technological changes that would improve the safety and quality of pharmaceutical care.

What was done?

An outpatient is a patient who goes to the outpatient unit of their Hospital Pharmacy Service (UPEX) to collect a drug for hospital use/diagnosis or foreign drug (it will be administered without health personnel intervention).
We collaborated in the design and validation of the PresSalud®(Dominion®) program, developing the implementation of assisted electronic prescribing (AEP) as an objective in the SAMPA project (Registration and Promotion Service for Adherence to Medications for Elderly Patients).

How was it done?

Access from the electronic medical record to the prescription, the integration of the latter with the dispensing program and the latter with the pharmacy item program guarantees an increase in the safety of medication use by incorporating clinical decision aids.
Different prescription assistance protocols were developed. Presentations and sessions were given to hospital doctors explaining how to prescribe through PresSalud® adapting them to the different services implemented with AEP.

What has been achieved?

In 2018, the AEP was implemented in the infectious, digestive, dermatology, rheumatology, neurology and hematology service (only in hemophilia consultations). Between May-September 2020, it was expanded. It is currently 92.3% implemented and 100% is expected by the end of 2021 (with the rest hematology consultations).

Currently, the percentage of prescriptions to outpatients using AEP with respect to the total prescriptions in this area is 83%; this increase contributes to avoid errors in transcription and to reduce the time spent in checking the prescription, providing greater safety in the use of the medication and better patient care which translates into higher quality of care.

What next?

The implementation of the AEP guarantees safe and efficient prescription; in short, the organizational/technological changes that this entails contribute to improving the quality of pharmaceutical care received by the patient. The proposed solution can be easily extended to other hospitals implementing AEP.

IMPLEMENTATION OF AN APPOINTMENT MANAGEMENT MODULE APPLIED TO THE OUTSIDE PATIENT AREA

European Statement

Patient Safety and Quality Assurance

Author(s)

JUDIT PERALES PASCUAL, ANA PÉREZ LÓPEZ, HERMINIA NAVARRO AZNAREZ, ELENA HERRANZ BAYO, MARIA PEREZ MORENO, CARLOS-IGNACIO DIAZ CALDERON HORCADA, Mª REYES ABAD SAZATORNIL

Why was it done?

In 2019 the UPEX attended a large volume of patients without a scheduled appointment, long waits were generated and the pharmacotherapeutic follow-up was complicated. The purpose was to implement an appointment management module to avoid crowds, excessive waiting times, allowing better organizational management of care and knowledge of patients in each type of consultation.

What was done?

An outpatient is a patient who goes to the outpatient unit of their Hospital Pharmacy Service to collect a drug for hospital use/diagnosis or foreign drug (it will be administered without health personnel intervention).

An appointment management system was implemented in accordance with the objectives of the SAMPA project (Service for Registration and Promotion of Adherence to Medicines for Elderly Patients), included in the European STOPandGo project.

How was it done?

Creating a cross-cutting system for the entire clinical circuit from prescription to dispensing involved a great deal computer involvement. Although it began to be used in November 2018, it was not used by the mostly part of prescribing doctors until the end of 2020.
Now, when the patient leaves medical consultation, he/she will go to the pharmacy and will be seen by a pharmacist. Besides, the program will propose a return appointment when it calculates that the patient has a week’s worth of medication, thus preventing the patient from running out of medication. The pharmacist will decide if the patient needs pharmacotherapeutic follow-up.

What has been achieved?

In 2019, 5 services cited patients while in 2020 it was 14; the percentage of patients attending pharmacy cited increased from 73.2%(2019) to 79.4%(2020).
Currently, the pharmacist knows in advance which scheduled patients he has and can establish a better organizational care management and determine in advance if the patient needs a close pharmacotherapeutic follow-up. Additionally, with this system an average waiting time of 03:55min was achieved (in 2019 appointments with waits >30min were recorded).

What next?

The implementation of the appointment management system has made possible to achieve better organizational management of care,avoid crowds,excessive waiting times, and provide better patient care and pharmacotherapeutic follow-up. The proposed solution can be extended to other hospitals.

Applying novel technologies to advance hospital pharmacy practice

European Statement

Patient Safety and Quality Assurance

Author(s)

Ghalib Abbasi

Why was it done?

As we venture into the 2020s, health-system pharmacies need to consider these novel approaches to deliver pharmaceutical care to their patients given the changing population needs, lifestyles, and available home technologies accessible to most patients. The ultimate goals are to enhance patient safety, increase hospital pharmacy operational efficiency, and maximize revenue.

What was done?

Novel technologies were implemented at Houston Methodist to enhance patient safety and experience. These include voice-activated devices in patient rooms, smart glasses for pharmacists, smart phones for hospital pharmacy service provision, artificial intelligence, and tele-health

How was it done?

Careful infrastructure considerations/build took place along with pharmacist-driven algorithm write-up. During this GPI, we’d like to discuss specific steps to make this happen along with sensible benefits we realized from implementing each technology.

What has been achieved?

Our hospital pharmacists got significantly more involved in direct patient care where notable efficiencies were realized on the operational side. In addition, medication education was significantly enhanced with improved patient access to their in-house hospital pharmacist.

What next?

Next steps include deploying these these technologies to further service lines and patient care areas, as well as investing into further meaningful technologies. We’ll review what’s in the pipeline as well.

Surveillance system for adverse events after COVID-19 vaccination

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European Statement

Patient Safety and Quality Assurance

Author(s)

Kornelia Chrapkova, Stanislav Gregor, Michal Hojny

Why was it done?

A passive surveillance system exists in our country, giving limited options for the reporting of adverse drug reactions (ADR) to our National Drug Agency (NDA). The current system does not consider different patient´s criteria such as, age, variety of disabilities and preferences and does not enable healthcare professionals to report ADR in an easily accessible and comprehensive way.
In addition, our aim was to provide support to patients during the pandemic lockdown when accessing their general practitioner was difficult.

What was done?

A surveillance system was created to encourage and facilitate the reporting of potential vaccine adverse events (VAE) after healthcare professionals and patients received a COVID -19 vaccine that was administered in our vaccination centre (VC).

How was it done?

Following patients receiving a COVID-19 vaccination they were sent a text message with an information that in case of VAE they could contact us via text message, email, fill an electronic questionnaire or call us.
We assembled a team of 10 pharmacists providing a non-stop service for reporting VAE. To ensure consistency in advice given to patients a manual was created for a management of the most common and likely VAE.
By liaising with the Information Technology Department, we created an electronic tool integrated into the hospital information system (HIS) for recording VAE. This enabled us to make a comprehensive report and sent it directly to the NDA. Consequently, an alert on each reported VAE after the first dose of vaccine was available for every clinician to maximise patient´s safety.

What has been achieved?

Between 4th January 2021 and 8th June 2021:
6 109 732 vaccines were administered throughout our country.
5402 (0,09%) VAE were reported to NDA.
43 409 vaccines were administered in our VC.
3 456 (7,96%) VAE were reported to our VC out of which 816 were rated as unexpected and 28 as serious.

What next?

Presenting of the results of the project will be used as a part of the education of healthcare professionals in our hospital. By this sharing of knowledge our aim is to enable and maximise patient’s safety and treatment. The integrated electronic tool for recording and reporting ADR will be also applied for all other medications

COVID-19: Guidelines for Infection Prevention and Control in a Hospital Pharmacy According to ISO 9001:2015

European Statement

Patient Safety and Quality Assurance

Author(s)

SUSANA SANCHEZ SUAREZ, JOSE ANTONIO VINAGRE ROMERO, MARIA ISABEL BARCIA MARTIN, CAROLINA AGUILAR GUISADO, MERCEDES GARCIA GIMENO

Why was it done?

To keep occupational health and safety during a crisis in which healthcare settings were overloaded and facing a critical shortage of skilled professionals, due to sick leaves (2,75% of total cases), and for the need to maintain high quality of care processes. These were a big challenge that required to adapt operating procedures. In addition, and due to the effect of COVID-19 on the general population (overall incidence rate of 10.596 per 100,000 people) and in healthcare systems, the Spanish Ministry of Health (SMH) issued a technical document establishing a series of recommendations for COVID-19 infection prevention and control in patients medical assistance. This practice was designed to bring together national guidelines from the SMH that aimed to reduce COVID-19 impact, both in healthcare workers and general population, and meet ISO 9001:2015 requirements in SOP of a HP within a general hospital

What was done?

In order to ensure safe systems of work (SSoW) in the hospital pharmacy (HP) during the COVID-19 pandemic, specific operating procedures (SOP) were adopted in order to prevent the risk of contagion in daily operations for both patients and staff, according to the norm ISO 9001:2015

How was it done?

Four critical areas were identified according to risk management: High-risk areas: Preparation Area (PA) and Outpatient Dispensing Area (ODA); medium-risk area: Pharmacy Administration Area (PAA) and Inpatient Dispensing Area (IDA). Some SOPs were developed within these areas: Autologous serum eye drops preparation in the PA, pharmaceutical care and medication dispensing in the ODA, pharmacy receiving in the PAA and medicines return from COVID-19 areas. Different circuits were implemented for users and professionals, as well as general information and procedures directed at patients and personnel, to prevent infection. The individual protection equipment required in each SOP/area was also established

What has been achieved?

No COVID-19 case has been reported due to patient-professional interactions or working location and tasks. All operating procedures have been revised to fully comply with SMH guidelines and ISO 9001: 2015 requirements mitigating risks and maximizing performance in such critical circumstances

What next?

Adapting SOP to any infectious disease outbreak that may occur in the future and establishing early-detection mechanisms

A novel method to decline the number of inappropriate penicillin allergy alerts in electronic prescription systems

European Statement

Patient Safety and Quality Assurance

Author(s)

Saskia Coenradie, Hans Groot, de, Amy Rieborn, Erna Groot, de, Martti Visbeek, Denise Abswoude, Christian Alderweireld, Annegien Kenter

Why was it done?

Allergies for drugs and especially allergies for antibiotics of the penicillin group are common questions in electronic patient data systems (EPDS) in hospitals. In many cases the verification of an allergy is seldom a thorough process and so many inappropriate penicillin allergies are recorded in EPDS. Literature reports that only 10% of recorded allegies are appropiate. This has a detrimental effect when infections occur and patients have to be treated with antibiotics. When a penicillin allergy is recorded in the EPDS a warning not to prescribe any antibiotic from the penicillin group is given. In most cases the physician has to choose another antibiotic that is normally not first choice. This can have worse patient outcomes. We conducted a feasibility study to investigate if a reported penicillin allergy in a patient’s record was appropriate or not using a standard allergy algorithm consisting of 10 questions with YES or NO as answers.

What was done?

A novel method is tested to decline the number of inappropriate alerts for penicillin allergy in our electronic patient data system

How was it done?

When the reported allergy in a patients record popped up in our EPDS, a pharmacy technician was asked to have a medication – and allergy verification conversation with the patient. Only patients that were admitted to the emergency ward or the acute admittance ward of our hospital were included to test this method on feasibility. The feasibility study started in March 2021 after permission from our board of directors and after a declaration of our medical ethics committee stated that no judgement of this committee was neccessary. We started on the emergency ward in March 2021. Because of slow inclusions we decided in september 2021 that another ward needed to be included in this feasibility study to achieve the number needed to prove this method feasible (80 patients). Statistical analysis was done using IBM SPSS statistics,(vs 25) and the primary outcome was the total number and percentage of inappropriate penicilline allergies.

What has been achieved?

Up till October 2021 29 patients were included in this feasibility study. Most of them had an inappropriate record of penicllin allergy after a pharmacy technician had a medication- and allergy-verfication conversation using the standard algorithm. We will continue with this feasibility study until 80 patients have been included and our statistical analysis can be done appropriately.

What next?

Continue with inclusions until the number needed to statistical analysis has been reached (80 patients). We will then perform our statistical analysis and hope to report back to you at the 27th EAHP congress in 2023 that this method is effective and reproducible. And most importantly, decreases the number of inappropriate penicillin allergy records in hospitals. We are confident that with this method we create a tool to decrease the number of inappropriate allergy records in our electronic prescription system in our hospital.

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.

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