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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

User satisfaction assessment in outpatient pharmaceutical consultations: results and future perspectives

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European Statement

Patient Safety and Quality Assurance

Author(s)

Eva Gomez-Costa, Purificacion Cid-Silva, Juan Luis Hurtado-Bouza, Laura Caeiro-Martinez , Pablo Feijoo-Vilanova, Andrea Luaces-Rodriguez, Sandra Rotea-Salvo, Alejandro Martinez-Pradeda , Maria Isabel Martin-Herranz

Why was it done?

The purpose is to identify deficiencies and improvement areas in the outpatient consultation area for evaluation and proposal of possible solutions.

What was done?

Implementation of an user satisfaction evaluation system for outpatient consultations at the Pharmacy Service of a tertiary-level hospital and initial results assessment.

How was it done?

The system was put into operation in January 2023 through a QR code placed in each consultation room and in the waiting areas accessible to all patients. The survey allows for differentiation between the different pharmacy service centers in the hospital, patient-caregiver patient category, age group, and whether it was the first consultation or an appointment for treatment continuation. Users can rate aspects related to information, waiting time from the appointment time to receiving attention, the professionalism of the staff, respect for privacy, pharmaceutical information about the treatment, and the facilities. This rating can be classified into: very good, good, bad, very bad, except for the waiting time: reasonable or excessive. Final question is an overall assessment of the service from 0 to 10. Survey allows for comments or suggestions.

What has been achieved?

A total of 86 surveys were conducted between January and September 2023. The majority were from users of the pharmacy service in the main building of the university hospital complex (82.6%). 10.6% were from first-time appointment and were mainly patients who answered (67.4%). Age groups: 65 years (12.8%). Regarding the evaluation, the results were: information about appointments, 51.8% very good; waiting time from the appointment time to receiving attention, 59.3% reasonable; professionalism of the staff, 59.3% very good; respect for privacy, 59.3% very good; pharmaceutical information about the treatment, 51.2% very good. The evaluation of facilities where pharmaceutical care is provided to the patient were: 33.7% bad and 9.3% very bad. The average score for the overall assessment was 6.7 points.

What next?

The evaluation of the information obtained from the surveys will serve as a basis for implementing corrective measures and possible improvements. The progressive increase in the number of survey will facilitate the detection of new issues and allow us to track changes in user satisfaction over time.

Nationwide German standardised concentration list for continuous infusions in intensive care patients

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European Statement

Patient Safety and Quality Assurance

Why was it done?

In intensive care patients, numerous drugs are continuously administered. Standardised concentrations and dose adjustment by infusion rate are recommended to minimise medication errors, e.g., by the EAHP Special Interest Group for investigating Medication Errors in Intensive Care Units. This principle is also followed more and more in German hospitals. However, there is a lack of a national standardised concentration list.

What was done?

The joint working group aimed to develop and implement a nationwide standardised concentration list for continuously administered infusions in intensive care patients in German hospitals.

How was it done?

A joint working group of the German Society of Hospital Pharmacists (ADKA e.V.) and the German Interdisciplinary Association of Intensive and Emergency Care (DIVI e. V.) compiled a nationwide continuous infusion standard for intensive care patients. Based on a national survey conducted in 2021, a list of plausible, commonly used drugs and concentrations was compiled. Drugs and concentrations to be listed were further evaluated in a multi-stage process based on predefined criteria (e.g. volume sparing concentration, one concentration per drug [where applicable], preferring ready-to-use medication, operational considerations).

What has been achieved?

A joint working group of the German Society of Hospital Pharmacists (ADKA e.V.) and the German Interdisciplinary Association of Intensive and Emergency Care (DIVI e. V.) compiled a nationwide continuous infusion standard for intensive care patients. The national continuous infusion standard encompasses 41 drugs and 49 standard concentrations, recommended vehicle solutions and data on the physicochemical stability of the infusions during administration. Thirty-seven active substances are listed with one concentration, heparin with two concentrations, epinephrine and sufentanil with three concentrations, and norepinephrine with four.

What next?

Healthcare professionals in German intensive care units are encouraged to adopt this standardised concentration list to improve medication safety. Flowcharts provided by the working group will facilitate the implementation of the defined standard concentrations.

Routine generation of real-world evidence: an integrated system for the systematic recording of clinical data on innovative outpatient hospital medicines

European Statement

Patient Safety and Quality Assurance

Author(s)

Manuel Mazarío-García, Amparo Molina Lázaro, Gemma Garrido Alejos, Ferran Sala-Piñol, Núria Juvanet Ribot, Lluís de Haro i Martin

Why was it done?

In 2011, the Catalan Health Service (CatSalut) introduced the Registry of Patients and Treatments of Outpatient Hospital Medicines (RPT-OHM) within their Standard Health Record Platform (SHRP) for the comprehensive evaluation, effectiveness and safety of OHM. CatSalut requires fulfilling RPT-OHM before medicines billing. However, SHRP lacked integration with ICS’ clinical and billing information systems.

What was done?

The Catalan Health Institute (ICS) is the largest healthcare provider in Catalonia and is made up of eight hospitals. The ICS developed and implemented a structured data collection tool named the Hospital-Information-System-integrated Registry of Patients and Treatments (RPT-HIS). This tool systematically collects a range of critical information, spanning from prescription inception to treatment cessation, such as:
• Administrative patient, prescriber, and treatment particulars.
• Active ingredients or combinations, initiation and termination dates, therapeutic indications, and ICD-10 diagnoses.
• Baseline clinical variables recorded upon treatment commencement.
• Dynamic clinical data captured or typed from medical records throughout follow-up according to predefined intervals.
• Cessation variables detailing reasons for treatment discontinuation.

How was it done?

At ICS’ headquarters, a dedicated team of internal business analysts and functional support officers, along with contracted developers, collaborated to design, implement, and maintain RPT-HIS. Monthly coordination meetings ensure efficient integration of new OHM and monitor the registry’s progress. Simultaneously, a network of local reference pharmacists emerged in all eight ICS hospitals, fostering continuous knowledge exchange and driving innovative enhancements.

What has been achieved?

In the first half of 2023, 52,907 initiation, follow-up, or discontinuation forms were completed. Among these, 93.7% met all preset treatment-specific validation rules, underscoring the initiative’s effectiveness. Subsequently, utilization and budgetary impact reports across ICS hospitals have been elaborated, covering general and special patient populations, indicating a positive impact on operational efficiency and patient care.

What next?

In the near future, the real-world data amassed and stored in RPT-HIS could help to underpin refined drug therapy, optimize health outcomes, and strategically position medicines for specific conditions, also aiding in selection and purchase. This initiative serves as a model of good practice, demonstrating the potential of integrated data collection systems, aligned with the routine process of OHM utilization, to improve patient care. The successful implementation of RPT-HIS suggests its viability for adoption in other healthcare settings.

A strategy to prevent weekly methotrexate medication mistakes in a regional health service

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European Statement

Patient Safety and Quality Assurance

Author(s)

Vanesa Alonso Castro, Pablo Jimenez Moreno, Marta Alcaraz Borrajo, Angel Luis Mataix Sanjuan, Beatriz Casamayor Lázaro, Maria Dolores García Cerezuela , Cristian Rosas Espinoza, Beatriz Santos Mena, Estrella Maroto García, Beatriz López Centeno, Daniele Alioto, María Jose Calvo Alcántara

Why was it done?

MTX is an immunosuppressor drug utilised in certain types of cancer and inflammatory diseases. Its dosage and frequency of administration varies depending on indication.
Throughout the years, medication errors (ME) have been reported at national and supranational levels where patients have received excessive doses (the most common being daily administration of the drug rather than weekly) with severe consequences for the patients, including death.
In our RHS, 222 ME related to MTX have been reported in the last 5 years,seven of them resulted in harm to the patient.

What was done?

An integral strategy to ensure the correct prescribing of weekly Methotrexate (MTX) was developed in a Regional Health Service (RHS).

How was it done?

1st PHASE (May 2021):
a. Monthly reporting to prescribers of their patients affected by duplicated prescriptions or incorrect dosing instructions for review and amending. These reports are available on the IT platform that collates prescribing indicators.
b. Development and dissemination of training materials to correctly prescribe medications with non-daily dosing instructions in the RHS electronic prescription tool.
2nd PHASE (After two years of follow-up):
a. Request to implement ME prevention plans (MEPP) to the hospitals of the RHS.
b. Creation and dissemination of informative material for patients and/or caregivers, where the weekly dosing instructions is emphasized.

What has been achieved?

Incidence of MTX prescribing mistakes: When this strategy was implemented, prescriptions for 2388 patients had been identified as potential mistakes. 1 year later, the incidence had diminished by 78.1% (2146 cases were resolved, 242 were still active and 310 were new). 2 years later, the incidence remained stable with a reduction of 78.5% thoroughout the whole period and 514 patients affected (150 new MTX prescribing mistakes in the last year).
• MEPP implantation (2nd PHASE): In two months, six hospitals (17.6% of all) implemented a MEPP. The key strategies that should be included in the MEPPs were disseminated to all hospitals by our team.

What next?

Thanks to this strategy, MTX prescribing mistakes have fallen by 78.5% in two years. However, prescribing mistakes continue to be made, which demonstrates the need for continuous training and awareness raising among prescribers to prevent ME related to MTX.

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