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Initiative for sequential antibiotic therapy: enhancing antimicrobial stewardship in hospitalised patients

European Statement

Patient Safety and Quality Assurance

Author(s)

Ignacio Javier Tamboleo Sánchez, Julia Fernández Vela, Fernando Lago Ballester, Mª CARMEN MIRA SIRVENT, Elena Conesa Nicolas

Why was it done?

The initiative started in October 2022, it was a response to the challenges associated with prolonged intravenous antibiotic use. The overarching goals were to enhance patient care, mitigate unnecessary intravenous antibiotic prescriptions, and foster a culture of responsible antimicrobial stewardship. Recognizing the need for a systematic and collaborative approach, the Antimicrobial Stewardship Program (ASP) pharmacist played a central role in implementing interventions across various medical specialties, with a clear focus on improving patient outcomes.

What was done?

The initiative promoted the adoption of sequential antibiotic therapy among hospitalised patients undergoing intravenous treatment for more than three days. Leveraging the Wise Antimicrobial Stewardship Support System® (WASPSS®) and detailed analysis of medical records, the programme identified eligible patients based on criteria such as clinical stability, oral bioavailability, infection specifics, and antibiotic suitability.

How was it done?

The ASP pharmacist’s central role proved instrumental, with 74% of alerts resulting in actionable recommendations. WASPSS® detects every patient with intravenous antibiotic more than 3 days and the ASP pharmacist decides which patients will benefit from sequential therapy. Choosing the recommendation criteria is essential to have a good response from medical specialties ensuring a more efficient and tailored approach to intervention implementation. The main obstacles to the introduction of this initiative were the establishment of refined communication routes and the targeted training to the different specialties which are not yet fully implemented.

What has been achieved?

Results revealed that 74% of alerts met the criteria for transitioning from intravenous to oral administration. Among the 573 alerts reviewed, 45.1% witnessed a successful switch to oral antibiotics, 21.2% showed no change, and 16.7% of patients were discharged. Notably, higher acceptance rates were observed in specific specialties, such as pneumology (61.3%) and general medicine (54.4%). Nevertheless, oncology (35,3%) general and digestive surgery (25,8%) had the lowest acceptance rate. In conclusion, the global acceptance rate was lowest than expected (43,8%) but there are many improvements measures that are being carried out.

What next?

This initiative serves as a beacon for responsible antibiotic management, making noteworthy contributions to patient safety, cost-effectiveness, and the overall quality of healthcare delivery. Recommending ongoing collaboration, continuous training, and regular analysis of recommendation criteria will enhance its impact.

Assesing cold chain compliance for biotherapy drugs in a university hospital’s medical departments

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European Statement

Patient Safety and Quality Assurance

Author(s)

AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI

Why was it done?

It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.

What was done?

Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.

How was it done?

Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.

What has been achieved?

A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.

What next?

The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.

Intrahospital circuit of autologous eye drops

European Statement

Patient Safety and Quality Assurance

Why was it done?

The number of patients treated with autologous eye drops has increased significantly in recent years, which has led to the need to create an intra-hospital circuit to ensure the traceability of samples throughout the extraction, processing and dispensing process.

What was done?

Create a circuit to ensure traceability of the patient’s plasma at all times, thus avoiding any confusion.

How was it done?

In order to avoid the transport of samples by patients and consequently the loss of samples or possible errors, the following circuit was developed:
– The extraction and centrifugation of the patient’s blood is agreed with the Biochemistry Service, the orderly is in charge of taking it to the pharmacotechnics laboratory, in the Pharmacy Service, where the time of delivery will be noted.
– If the plasma arrives before 12:00 noon, the patient will be called late in the morning for dispensing. If the delivery is later, it will be scheduled for the following day.
– The eye drops are then prepared.
– Finally, they are dispensed directly from the laboratory by the pharmacists or by the technicians trained for this purpose, always under the supervision of the pharmacist responsible for the area. Traceability is maintained throughout the entire process.
To make everything possible, several training meetings had to be held with Bioquimica.

What has been achieved?

Since the implementation of this circuit at the beginning of 2023, 166 batches of autologous eye drops have been produced for 72 patients, with only one error recorded, where a plasma that was not correctly identified was delivered and discarded.
In addition, the waiting time for dispensing the preparation was reduced by 33%, from 30 minutes to less than 10 minutes, thus achieving greater patient satisfaction.

What next?

The application of this circuit prevents samples from being transported by the patient, avoiding any type of accident, as well as ensuring the correct traceability of the samples. On the other hand, patient waiting times are reduced by dispensing samples directly from the laboratory area, thus avoiding waiting times for consultations.

Securing the management of experimental product in investigator services in case of non-nominative dispensing: a risk based approach

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European Statement

Patient Safety and Quality Assurance

Author(s)

Mélanie Hinterlang, Mona Assefi, Pauline Glasman, Delphine Brugier, Meriem Charfi, Fanny Charbonnier-Beaupel, Marie Antignac, Carole Metz

Why was it done?

Clinical trials in critical care sometimes demand swift inclusion and administration, often occurring at any hour of the day or night. To enhance patient care, the experimental drug may be provided in a non-nominative manner directly from the pharmacy unit to the care unit for storage before any inclusion as a stock. This dispensing pathway is considered less secure than the conventional named dispensing but can be necessary. The objective of this risk analysis for this dispensing process was to identify the risks, determine the number of them with unacceptable criticality, and propose actions to reduce criticality of these risks.

What was done?

A risk analysis of non nominative dispensation of experimental drugs process was conducted to streamline, secure, optimize, and standardize this dispensing process.

How was it done?

Following a preliminary investigation, three pilot services were chosen: surgical intensive care, post-interventional recovery room (SSPI), and cardiology. The Failure Mode, Effects, and Criticality Analysis (FMECA) method was applied to the non-nominal dispensing circuit of experimental drugs from reception at the pharmacy unit to the administration of the drug to patient. Investigators, clinical research associates, nurse, and pharmacists participated.

What has been achieved?

Following the FMECA, 281 risks were identified. The majority were either acceptable (123 or 44%, 110 or 39%, 147 or 52%) or tolerable (139 or 49%, 148 or 53%, and 130 or 46%) for the intensive care, SSPI, and cardiology services, respectively. Unacceptable risks numbered 19 (7%), 23 (8%), and 4 (1%) for intensive care, SSPI, and cardiology services, respectively. The process identified as most critical for all three services was communication. After risk prioritization, a plan comprising 17 actions was implemented.

What next?

This risk analysis demonstrated that control over the non-nominal dispensing circuit is achievable. Once the actions are in place, a reduction in criticality is anticipated due to a decrease in the frequency. Theoretically unacceptable risks are now at 0%. In the long term, this project has the potential to participate to improve the care of patients enrolled in emergency clinical trials and boost research in the concerned units.

Development of a new method for risk assessment related to management of clinical trials in hospital pharmacy: classification of protocols by risk index (ρ) and development of strategies for errors’ minimization

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European Statement

Patient Safety and Quality Assurance

Author(s)

Giulia CANCELLIERI, Piera POLIDORI

Why was it done?

Hospital pharmacist provides all management of investigational medical product(IMP), i.e. its conservation, distribution, return and destruction. However, each clinical trial involves different methods of managing the drug: this can mislead the pharmacist who has to manage multiple trials at the same time. With the aim of minimizing errors that may arise from the simultaneous management of different clinical trials, we have developed a method to classify clinical protocols by “risk index”.

What was done?

With the aim of minimizing errors resulting from management of clinical trials in hospital pharmacy, we have developed a method to classify experimental protocols into low-moderate-high risk(risk index). For each of these categories, standard procedures were then outlined in order to minimize the occurrence of any errors.

How was it done?

In order to determine risk index(ρ) we have identified all risks related to IMP’s management: pharmacological risk(φ), dependent on pharmacological characteristics of IMP; technological risk(α), if drug should be compounding; risk related to number of patients enrolled(np); risk inherent to the protocol(π), i.e. whether protocol involves placebo, or randomization, etc. These risks were then related through the formula created by us, ρ=φ+(α*np)+π: protocols are defined low-risk if ρ<50, moderate-risk if 51<ρ151. For each risk index, standard procedures were outlined in order to minimize risks, i.e.(for high-risk) inclusion of at least four pharmacists in “Delegation of Responsibilities Log”; scheduling monthly meetings with trial’s Monitor; dispensing of IMP with supervision by at least two pharmacists; etc.

What has been achieved?

We applied this method to 45 active trials in our hospital. For 3/45(6,7%) protocols, φ>75 because IMPs are carcinogenic; instead, 26/45(57,8%) protocols, involve IMP’s compounding; finally 29/45(64,4%) protocols are randomized and 14/29(48,3%) of these involve use of placebo. By applying aforementioned formula, we found that 3/45(6,7%) protocols are low-risk, 32/45(71,1%) moderate-risk, 10/45(22,2%) high-risk. For these 10, standard procedures were applied, to improve the safety of patients enrolled in a clinical trial.

What next?

We promote use of this method in other clinical centers, because we believe it can be a valid tool for risk minimization. Finally, we hope that we will receive numerous feedback from these centers to further improve the proposed method.

Analysis of quality indicators in the compounding area through a mobile application

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European Statement

Patient Safety and Quality Assurance

Why was it done?

To identify improvement opportunities in the Pharmacy Compounding Area through the analysis of indicators obtained from a traceability App.

What was done?

In 2022, a mobile application (App) was designed and implemented to facilitate the traceability of preparations compounded in the Pharmacy (parenteral nutrition, chemotherapy and other individualized sterile preparations). In addition, the analysis of data registered in the App has provided valuable information about the compounding unit performance.

How was it done?

Monthly reports from May to December 2022 were analysed, focusing only on chemotherapy preparations. The indicators selected were: the average number of monthly preparations, weekly workload distribution, daytime distribution of compounded preparations, preparations returned to the Pharmacy, percentage of treatments prepared on the same day of administration, and percentage of preparations compounded after the scheduled administration time.

What has been achieved?

An average of 139 chemotherapy preparations per day was recorded. The daily distribution highlights that Thursdays and Fridays are the busiest days with the 45% of the total weekly preparations. Furthermore, the morning shift carries out most of the compounding work, with 79% of the preparations being compounded before 3 PM. This information might be useful to the management team to better distribute tasks and resources. Data analysis indicates that 62% of the preparations are compounded in advance, while the remaining 38% are prepared on the same day of administration, which is also valuable information to organize the compounding workflow. On average, 59 preparations were returned per month. Finally, we found that 8.1% of the chemotherapy drugs were prepared with a median delay of 47 minutes from the expected time of administration. All these items are currently being monitored as quality indicators in order to find the way to minimize them.

What next?

The analysis of data recorded in the App provides us valuable management indicators for organizing work in the preparation area.
Tracking these indicators serves as a quality tool for the area and helps us identify opportunities for improvement.

Design, implementation and impact on patient safety of a mobile application for patients on antiretroviral therapy

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European Statement

Patient Safety and Quality Assurance

Author(s)

Esther Chamorro de Vega, Carmen Rodriguez Gonzalez, Belen Mayo Canaleja, María Pilar Montero Anton, Sergio Herrera Bermejo, Rosa Romero Jimenez, Vicente Escudero Vilaplana, Roberto Collado Borrell, Ana Herranz Alonso, María Sanjurjo Sáez

Why was it done?

The profile of patients receiving antiretroviral therapy (ART) has changed. Patients are more active, autonomous and have greater information and communication needs.
Mobile health, especially apps, can help to healthcare professionals to optimize pharmacotherapeutic follow-up and provide patients greater autonomy facilitating communication with healthcare professionals and contributing to the humanization of their care.
Through this application we seek to achieve the following objectives:
– Allow patients to participate in their illness and/or treatment, promoting their compliance and safety and communication with the healthcare professional.
– Strengthen pharmacotherapeutic monitoring of patients receiving ART, avoiding visits to the emergency room and hospital consultations.
– Generate pioneering evidence on the impact of mobile applications on the pharmacotherapeutic monitoring of patients on ART.

What was done?

FarMCuida® is a mobile application designed for a closer and better pharmacotherapeutic monitorization of patients on antiretroviral therapy (ART). Through this app the patient can actively participate in his or her disease and treatment.

How was it done?

A multidisciplinary group was created to design and develop an app called FarMCuida® for patients on ART in a tertiary hospital. Once the app was designed and developed, we offered the app to patients starting or undergoing ART. Identification and inclusion of candidate patients was performed in the Pharmaceutical Care Consultation of the Pharmacy Service. The pharmacists responsible for the Infectious Diseases area performed real-time pharmacotherapeutic follow-up of the patients.
Records of adverse effect (AE) and Safety-related messages received (Adverse effects, interactions, drug administration) can be analyzed. All data can be exported from FarmCuida®. Informed consent is requested from all the patients included.

What has been achieved?

FarMCuida® was designed as a digital health mobile application that allows our patients to participate in their disease and/or treatment, promoting treatment safety, as well as making available a source of information and bidirectional communication, in real-time, between patients and healthcare professionals.
During a period of 13 months, a total of 152 patients were included in FarMCuida®. Seventy-two percent of the patients were diagnosed with HIV infection while 27.6% of them were included in the HIV pre-exposure prophylaxis programme.
In AE module, 58 adverse events (AEs) were registered. Twenty-two percent of the patients registered at least one AE.
Thirty-two percent of patients used the Messages module to communicate with healthcare professionals.
One hundred and twenty-six telematic consultations were carried out. Two hundred and five messages were exchanged between the patient and the pharmacist.
Forty-three percent of the consultations corresponded to doubts about interactions: 66.7% interactions with other drugs, 28.5% with herbal products and 4.8% with vitamin supplements. Three type D interactions and one type X interaction were identified.
In addition, 11% of the consultations corresponded to doubts about the administration of ART while 5.2% were related to adverse effects experienced by the patient.
At least three visits to the emergency department were avoided, resulting in health care and economic savings for the health system.

What next?

Based on the limited studies on the impact of mobile applications on the pharmacotherapeutic follow-up of patients, the results obtained will allow us to generate evidence in this regard. It is worth highlighting the flexibility of FarMCuida® design, being easily adaptable to different pathologies and hospital centres.

Development of a hospital pharmacist led re-evaluation of medication errors

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European Statement

Patient Safety and Quality Assurance

Why was it done?

All errors, whether involving medication or not, are required to be reported and classified in the hospital reporting system. However, the system is poorly adapted for medication management and lacks the relevant terms. This results in the same type of error being classified in various ways, making systematic quality improvement difficult. A pilot study confirmed the system’s shortcomings, after which a new medication management process was developed and evaluated.

What was done?

The existing process for classifying medication errors was supplemented with a new process in which hospital pharmacists reclassified medication errors detected in the reporting system. The reclassification was based on a predefined medication management process.

How was it done?

A medication management process was developed in collaboration with specialist nurses and in accordance with applicable regulations and policies. The process consisted of the following activities: 1) Prescription, 2) Ordering/Delivery, 3) Storage/Narcotics Control, 4) Preparation, 5) Handover/Administration, 6) Medicines information in transitions of care, 7) Follow-up of treatment, and 8) Miscellaneous. The process was validated by having four hospital pharmacists independently classify 176 medication errors. Consistency in the assessment was evaluated, and the process was corrected as needed. All medication errors classified as medication-related in 2022 or containing the word “medication” in free text were thereafter exported from the reporting tool to Microsoft Excel and then into a data processing and performance monitoring tool for further analysis.

What has been achieved?

A total of 756 medication errors were identified in the reporting tool, distributed across 65 different activities. Hospital pharmacists identified an additional 305 errors through free-text searches that had not been reported as medication-related. A total of 1,061 medication errors (756+305) were reclassified and grouped into eight activities. The highest risk of errors was associated with the preparation (19%), followed by storage/narcotics control (18%), and prescription (17%). The new process, involving hospital pharmacists in classification, creates conditions for a more systematic approach to medication errors. The pilot project was presented at the hospital’s themed day for World Patient Safety Day 2022.

What next?

Discussions have been initiated with system developers to improve the reporting tool. Discussions with hospital management will be initiated with the goal of creating a structure in which hospital pharmacists have an active role in the hospital’s work on patient safety related to medication.

Flashpharma: a training tool to ensure quality medication management

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European Statement

Patient Safety and Quality Assurance

Author(s)

Samantha HUYNH, Catarina GONCALVES BARROSO, Sophie PATERNOTTE, Sofia DA SILVA MENDES, Claire JUDEL, Elvire MARTIN-LEMAIRE, Georges NICOLAOS, Chloé DUPONT, Nicolas CORNILLET

Why was it done?

Raising awareness and ongoing training of healthcare professionals is a crucial criterion for High Authority for Health certification. Flashpharma provides reliable information, particularly for night-shift nurses. This becomes critical in a context of reduced physician presence and absence of pharmacists, and the increasing presence of temporary nurses due to staffing shortages.

What was done?

The pharmacy department developed FlashPharma, an innovative training tool to enhance medication management within healthcare units. For instance, it contributes by promoting the proper use of high-risk medications (HRM) and risky medications (RM) by providing information to care teams as close to the patient as possible.

How was it done?

A working group created eleven sheets based on literature and adapted to the practices of adult hospitalization departments. Validated by medical experts and institutional committees, they include points to watch and key figures. They link up with our institutional protocols, our prescribing software and the points addressed by the visiting experts during the mock certification. Accessible by flashing QR codes strategically positioned or on our web platform, they serve as a basis for discussion with caregivers. Trainers included pharmacists, a pharmacy intern, and a hospital quality manager. Anonymous written questionnaires were used to gather feedback.

What has been achieved?

Two QR codes are placed on automated dispensing cabinets and mobile medical carts, linking to sheets on MHR, RM, and guidelines for proper drug crushing and administration via an enteral feeding tube. Another QR code on refrigerators provides information on drug storage and temperature alerts management. A label provides information on drugs prescribed outside the booklet, with six therapeutic equivalence tables validated by doctors.
Three sessions were attended by nurses, healthcare managers, orderlies, and doctors (n=18). Fifteen (83%) participants strongly agreed, and 3 (17%) agreed that they acquired new knowledge. All participants would recommend these sheets; 16 (89%) strongly expressed their willingness to participate in a second session.

What next?

Positive feedback highlighted the need for further education in various hospital units. Feedback on the use of QR codes by day and night teams will be sought during subsequent sessions and quantified using analytical dashboards. Appropriate continuing education initiatives will be implemented in paediatrics, intensive care and operating room departments.

Sustainable practice in parenteral medication administration: gloves at your disposal?

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European Statement

Patient Safety and Quality Assurance

Author(s)

Carine Schuurmans

Why was it done?

• The use of gloves in medication administration can vary depending on several factors, including the specific healthcare hygienic policies, local guidelines, and the type of medication being administered. There is no uniform practice across all of Europe.
• According to the Dutch guideline on administration of parenteral medication disposable gloves are traditionally used during parenteral medication administration.
• Most parenteral medications do not pose a significant hazardous risk and the administration of ready to use preparations does not pose a significant infection risk.

What was done?

• Re-evaluation of the Dutch guideline on administration of parenteral medication from a sustainability point of view.
• Reducing unnecessary glove usage in medication administration.

How was it done?

• Re-evaluating the need for disposable gloves from both an infection prevention and medication hazard point of view.
• Discussion with experts and users.
• Implementation of findings both in the inpatient and outpatient departments.

What has been achieved?

• Overall growing attention to correct glove usage.
• Reduction of use of disposable gloves during parenteral medication administration and other medical procedures
• CO2-, land occupation and water reduction by respectively 6000 CO2 eq, 600m2, 300m3 and 3500 €/month

What next?

• Revision of the Dutch guidelines on administration of parenteral medication

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