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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.

Reconciliation of weekly methotrexate for non-oncologic use: results from a prospective cohort

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European Statement

Clinical Pharmacy Services

Author(s)

Adrian Viudez-Martinez, Ana Ramirez-Lopez, Javier Lopez-Nieto, Geronima Riera, Eduardo Climent-Grana

Why was it done?

Medication errors harm at least 1.5 million people every year. According to the Institute for Safe Medication Practice (ISMP), ongoing errors with oral methotrexate (MTX) for non-oncologic use suggest that more needs to be done to reduce the risk of patient harm, especially considering its potentially severe side effects.

What was done?

Identification and prevention of MTX-related medication errors for non-oncologic use by medication reconciliation at hospital admission. Analysis of errors’ type prevalence were also performed.

How was it done?

Design: prospective cohort performed in a tertiary hospital from September 2021 to April 2023.
Inclusion criteria: Inpatients with weekly methotrexate for non-oncologic use.
Intervention applied: medication reconciliation comparing inpatient’s e-prescription, clinical record, outpatient medication history and pharmacist-driven interview.
Data analysed: demographic data (age, sex, admission cause) treatment-related data (indication, methotrexate and folic acid posology, administration route, day of the week).

What has been achieved?

Out of 79 admission episodes (53.1 % men, median age: 72 years (range: 18-96 years), 63 (80% )were urgent.
Most patients had been prescribed methotrexate for rheumatoid arthritis (n=56), but also for polyarthritis (n=9), psoriatic arthritis (n=8), pulmonary sarcoidosis (n=2), pemphigus (n=1), spondylarthritis (n=1) and Still syndrome (n=1).
Methotrexate doses’ frequency were: 15 mg (28.9%), 10 mg (27.6%), 20 mg (11.9%), 7.5 mg (9.2%), 25 mg (7.9%), 12.5 mg (6.6%), 17.5 mg (5.3%) and 5 mg (2.6%).
Medication errors were identified and prevented in 38 out of the 77 episodes recorded (49.4%). There were classified as follows: dose (38.5%), day (17.9%), dose and day (17.9%), dose and administration route (10.3%), omission (10.3%), administration route (2.6%) and lack of indication (2.6%).
Folic acid doses’ frequency was: 10 mg the day after MTX (47%), 5 mg the day after MTX (28%), 5 mg daily except the same day as MTX (17%), 15 mg the day after MTX (8%).

Medication errors were identified and prevented in 51 out of the 77 episodes recorded (66.2%). There were classified as follows: omission (38.8%), day (33.3%), day and dose (16.7%), dose (9.3%) and drug (1.9%).

What next?

Performing medication reconciliation in every admission, measuring its potential benefits using validated tools for clinical pharmacists’ intervention assessment, such as the CLEO tool, which can, ultimately, serve as preamble to objectively measure the pharmacists’ impact in healthcare efficiency and patients’ safety.

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.

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

Development of bags ready to use for parenteral nutrition in the preterm patient

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European Statement

Production and Compounding

Author(s)

Eleonora Castellana, Simonetta Felloni, Matilde Scaldaferri, Giuseppina Bonfante, Elena Maggiora, Francesco Cresi, Maria Francesca Campagnoli, Alessandra Coscia, Maria Rachele Chiappetta, Francesco Cattel

Why was it done?

The purpose was to provide the Neonatal-Intensive-Care-Unit (NICU) with ready-to-use bags that could improve patient safety by minimizing procedural incidents and maximize resource efficiency while providing clinically appropriate nutrition for the single PP.

What was done?

Seven standard bags (SSB), ready-to-use, have been formulated and developed for parenteral nutrition (PN) in preterm patients (PP). An assisted prescribing software was developed for selecting the most appropriate standard bags (SB).

How was it done?

The project was carried out in collaboration between pharmacists, nurses and neonatologist of NICU.
The composition of the SB was identified from the retrospective analysis of the types of individualized bags requested from the Pharmacy and from the analysis of the recommended ESPGHAN-Paediatric-Parenteral-Nutrition-2018 contributions.

What has been achieved?

SSB ready-to-use were identified:

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The bags have been produced by an industrial partner according to Good Manufacturing Practice-Annex 1. The shelf life is 90 days.

The SSB were implemented successfully on the PP. Starting from 2021, approximately 250 bags/month have been used, with a reduction in individual preparations by the Pharmacy of approximately 80%.

This approach showed results in terms of clinical results and economic outcomes. The computer program guided the physician to the most appropriate standardized solution.

Early and timely administration of ready-to-use PN showed reduced weight loss and a shorter duration of PN than individualized bags (21 vs 25 days).

What next?

The project described has shown benefits including improved nutrient supply, fewer prescribing and administration errors, lower risk of infection, cost sav-ings, ready availability of the bags 24/7 and safe and effective supply of SB. This project will be strengthened in our hospital.

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.

90% reduction of medication waste by reusing returned medication from medical wards

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European Statement

Selection, Procurement and Distribution

Author(s)

Douwe van der Meer, Peder Nygard

Why was it done?

In our hospital 30% of the daily distributed medication for individual patients was not administered. Reasons for not administering were for example lack of need because of patients clinical performance, discontinuation of prescriptions or early discharge. Because of safety concerns, like mix-ups, our standard procedure was to discard all returned medication. This resulted in a waste of about 220.000 pills annually.

What was done?

We reduced medicine waste by 90% by reusing returned medication from our medical wards. With this result we made an important step for our hospital to meet the national sustainability goals in the Dutch ‘Healthcare Green Deal (3.0)’.

How was it done?

Reusing returned medication brings multiple safety concerns. By performing a prospective risk analysis we identified three major risks: mix-ups, expired medication and accepting non-qualitative packages (like slightly opened blisters or incomplete labels). With these risks identified we redefined our distribution process on four key elements: 1) Every medication has a barcode on unit level and if not, is labelled by our team through duplicating the ‘Falsified Medicine Directive’-barcodes to small 2D barcode labels which includes expiration date. 2) All returned medication is checked by a pharmacy employee on major quality aspects. 3) Returned medication is placed in a separate ‘return-box’ in front of the original stock inside the distribution cabinet. 4) Expiration dates are checked more frequently and are checked upon distribution and administration through barcode scanning.

What has been achieved?

The new distribution process was implemented in all of our eight distribution cabinets and resulted in saving 90% of the returned medication; witch amount to 200.000 pills and 70.000 euro savings annually. On average we work with 6 employees daily, who need 15 minutes extra per person per day to process returned medication.

What next?

Our goal is to save all returned medication that meets our quality standards. 5% of the returns that are not reused are medicines not included in the assortments of the specific distribution cabinet, so extra logistic and administrative steps are needed to place them back in the pharmacy stock. We are exploring new ways to make this next step in reducing medication waste further.

Computerised registration of drug prescriptions in the operating room during cardiac surgery: simplicity and traceability

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European Statement

Patient Safety and Quality Assurance

Author(s)

Elisabetta Volpi, Giuseppa Lo Surdo, Mattia Lorenzini, Anna Carmignani, Debora Luccetti, Stefania Baratta, Mario Cossu, Maurizio Mangione, Pierantonio Furfori, Monica Baroni, Paolo Del Sarto, Stefania Biagini

Why was it done?

This implementation was designed to provide a safe tool for the particular context of the operating room, in which prescription and administration are actions usually urgent and concomitant. The program suggests a rapid list of prescriptions standardized for adult patients (i.e. dose, diluent, bolus/drip) and allows to register any other drug or modify default information, respecting the rules for a clear prescription before registration.
Our aim was to demonstrate the possibility to validate this program and prove its functionality.

What was done?

In 2019 a multidisciplinary group (doctors, nurses, pharmacists, computer scientists) created an electronic program dedicated to the Cardiac Operating Room of the Heart Hospital, Fondazione Monasterio (Italy), which allow the prompt registration of drug prescriptions and administrations. Furthermore this program guarantees traceability of the drugs administered by the nurses, in order to improve medication safety practice.

How was it done?

This program was created into the electronic prescribing system available in Fondazione Monasterio. The standardized prescriptions already in use in the operating room were reviewed by a pharmacist, consulting the information in the Summary of Product Characteristics (SmPC), in the literature or by contacting the company that holds the MA. For each discrepancies identified a solution was proposed and shared with the working group, in order to validate a definitive list.
The prescriptions extracted by the IT Systems unit 6 months before and after the implementation of the new program were therefore analyzed.

What has been achieved?

A list of 182 standardized prescriptions was validated and reported in the program.
Among the 10,320 prescriptions made before the new program none had traceability of the drugs administered, while the 8,730 of the following period were complete and 99.6% of them fell within the standardized prescriptions, demonstrating the functionality and correct selection by the working group.
The development of a program for the computerized registration of prescriptions made during the surgery, which respond to the requirements of drug safety and traceability, represents an example of good practice.

What next?

We have implemented this tool in the paediatric population, with particular precautions due to the weight variability (i.e. dose/kg). The next step could be integration with further assessments (e.g., kidney function evaluation) and the transfer to other settings

Medication reconciliation practice at transitions of care: a new challenge or opportunity for the clinical pharmacist?

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European Statement

Clinical Pharmacy Services

Author(s)

Elisabetta Volpi, Giuseppa Lo Surdo, Sara Tonazzini, Stefania Alduini, Maurizio Mangione, Umberto Paradossi, Monica Baroni, Sergio Berti, Stefania Biagini

Why was it done?

Several data suggest that pharmacists and physician collaboration, direct pharmacist interaction with patients or caregivers through medication reconciliation and discharge counselling decreases the number of adverse drug events (ADEs) and plays an overall positive role in transitional care. Our aim is to demonstrate the constant necessity of pharmacist led medication reconciliation in order to maintain a high standard of care and safe medication use.

What was done?

Medication reconciliation at hospital discharge is essential for the prevention of medication discrepancies and patient harm. Hospital pharmacists are recognised as one of main healthcare providers that can support the physicians in this activity.
Since 2016, the medication reconciliation process has been performed by physicians and clinical pharmacists before home discharge from the Heart Hospital, Fondazione Toscana G.Monsaterio in Italy.

How was it done?

We analysed the medication reconciliation activity performed in our hospital over time and we observed that the number of unintentional discrepancies was always around 20%.
A shared pre-discharge prescription review programme has been activated with all doctors, so when the final lists of drug prescriptions are ready, the pharmacist examines them and suggests improvements or corrections to the doctor before the discharge letter is delivered to patients. Among the unintentional discrepancy observed, the most frequent were omissions of chronic therapy, lack of information about suspension for low molecular weight heparin or antibiotics.

What has been achieved?

A strong collaboration between physicians and clinical pharmacists has been achieved as we shared the results of this improvement. The same activity has been required and extended to the paediatric ward where the demand of simple, clear and complete information is even more crucial given the particular inter-individual variability and fragility of this population.

What next?

We would like to improve the prescription review programme also at admission in order to minimise drug omissions and at transition between different wards or different hospitals with the aim of improving communication between health care settings.

Implementation of a protocol to ensure continuity of pharmaceutical care in hospitalised outpatients

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European Statement

Clinical Pharmacy Services

Author(s)

MARCELO DOMINGUEZ CANTERO, CARMEN MARIA DOMINGUEZ SANTANA, MARCELINO MORA CORTES, ESMERALDA RIOS SANCHEZ, JUAN MANUEL BORRERO RUBIO

Why was it done?

Patients who withdraw medication from outpatient pharmacies in Spanish hospitals are provided with pharmaceutical care and pharmaceutical care stratification tools in specific outpatient pharmacy consultations. These patients are usually multi-pathological with multiple drug interactions, contraindications, and important adverse effects. Therefore, during the hospital admission of these outpatients, it was appropriate to provide continuous care from the hospital pharmacy. Before the implementation of the protocol, there was no specific and systematic follow-up of hospitalized outpatients.

What was done?

Implementation of a protocol that provides pharmaceutical care to outpatients during hospitalization, ensuring continuity of care through the pharmacy service.

How was it done?

The main problem with the implementation was the real-time detection of hospitalized outpatients. The development of a software tool to facilitate the location of patients provided an impetus for the implementation of the project. The computer tool selected patients who met the inclusion criteria (hospitalized outpatients with medication withdrawal in the outpatient unit in the last two months). Patients treated with erythropoietin and colony stimulants were excluded.

What has been achieved?

Seventy-nine patients were included in the study between April and September 2023; 62.1% were male. Main pathologies included 41.9% oncohaematologic diseases, 18.9% human immunodeficiency virus, and 17.7% immune-mediated inflammatory diseases.
The reason for admission was related to the pathology for which outpatient medication was withdrawn in 27 patients (34.2%), and six patients (7.6 %) were admitted due to an AE of the medication withdrawn in outpatients. Pharmaceutical interventions (PI) were performed in 21.5% of the patients reviewed, and 76.5% were accepted. PI reasons included discontinuation of treatment (64.7 %), modification (17.7 %), initiation (11.8 %) and monitoring (5.9 %).

What next?

With our protocol, we want to show that outpatients within the pool of patients admitted to a hospital are a priority target group. For these patients, the hospital pharmacist can improve treatment during hospitalization with a high degree of pharmaceutical intervention.