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Impact of drug-drug interaction alerts on prescribing patterns in a teaching hospital

European Statement

Patient Safety and Quality Assurance

Author(s)

Joana Pinto, José Feio, Sebastião Silva, Francisco Machado, Ana Dinis, Margarida Abreu, João Peres, Mariana Guia

Why was it done?

Clinical decision support systems comprising information on DDI improve DDI risk detection, avoiding preventable patient harm. The resulting DDI alerts can change prescribers’ behaviour to benefit patient care. However, an excessive number of alerts can lead to alerts’ desensitisation by prescribers.

What was done?

We monitored the drug-drug interactions (DDI) alerts displayed in the prescription system through three subsequent homologous periods, occurring after the integration of a DDI database in the prescribing software system of a teaching hospital to assess its impact on the prescribing pattern.

How was it done?

We developed a DDI database – MedH® – to be integrated into the prescribing software system to support hard stop DDI alerts. only the higher clinical risk DDIs were included in this database in order to restrain the burden of alerts and warrant acceptance by health professionals.
Data of all inpatient hospital prescriptions over a 12-month period prior to MedH® implementation were extracted and intersected with MedH® DDI BD to identify the top 10 co-prescribed binomials at risk of severe DDI. The number of alerts for the same binomials was then monitored through three subsequent, post-implementation, homologous periods.

What has been achieved?

Considered the TOP10 observed in the pre-implementation period, the number of alerts for all binomials has consistently reduced over the three post-implementation periods analysed.
The integration of MedH® DDI BD into the prescribing system, resulted in changes in the prescribing pattern, translated by a decrease, between 67% and 100%, in the number of alerts for a sample of control risk binomials coinciding with the top 10 co-prescribed risk binomials observed in the pre-implementation period. These results reflect the good acceptance by the professionals and the didactic effect achieved by the exposure to alerts.
More importantly, these results are indicative of the effectiveness of the implementation of MedH® Alerts in reducing patient exposure to high-risk combinations of medicines, thus promoting patient safety.

What next?

It will be important to ensure that data from IDD alerts are rigorously analysed to recognise clinical situations in which the co-administration of risk binomials is justified, to ensure consistent application of recommended risk minimisation measures, and the availability of safer therapeutic alternatives whenever possible.

Pharmaceutical care for human immunodeficiency virus pre-exposure prophylaxis users

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European Statement

Clinical Pharmacy Services

Author(s)

NURIA FERNANDEZ PIÑEIRO, CRISTINA GONZALEZ PEREZ, LIDIA YBAÑEZ GARCIA, NATALIA SANCHEZ-OCAÑA MARTÍN, JOSE MANUEL MARTINEZ SESMERO

Why was it done?

In our area all care for PrEP users was centralised in a specialised centre. Here, a multidisciplinary team made up of doctors, nurses and pharmacists integrated in a patient-centred care model. PrEP users are a potentially vulnerable population. Health education and motivation are provided in the PhC consultations to raise awareness about the use of medication and adherence to treatment, which are key to avoiding HIV infection. The use of sex-related drugs is a growing health problem in this population and has been associated with increased HIV transmission risk.

What was done?

Development and implementation of a monographic pharmaceutical care (PhC) consultation for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) users.

How was it done?

On 20 January 2020, the PhC consultation was launched in a monographic STI care centre linked to a tertiary hospital.
– On the same day as the first medical appointment, the user attends a PhC appointment. In this unit the user receives the necessary information to properly take the medication. Possible interactions are reviewed, not only with medications, but also with natural medicine, sports supplements and drugs. All doubts are resolved and the medication is dispensed.
– Every 3 months medical follow-up is carried out and, in the PhC consultation, where not only possible adverse effects are reviewed, but also adherence and related problems are specially monitored. To increase the quality of care, active communication between all health personnel was ensured.

What has been achieved?

Until 30 September 2022, 3,460 initial visits and 13,349 follow-up visits have been made (411 of them through telepharmacy during the lockdown as a result of the global pandemic by SARS-CoV-2). From the users, 98.98% were men who have sex with men (MSM), 0.80% transgender women, 0.04% transgender men and 0.18% were women. 70.3% used sex-related drugs (Chemsex), with the most used substances being Popper (37.1%), mephedrone (28.2%) and gamma hydroxybutyrate (GHB) (24.6%).

What next?

In our experience, the role of hospital pharmacists as a reference health personnel for HIV-PrEP users has become clear, not only as an expert in medication. Given the prevalence of drug use in this population makes the health education that we hospital pharmacists can provide especially important.

Pharmacological reconciliation as an improvement chance: a hospital ward experience

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European Statement

Patient Safety and Quality Assurance

Author(s)

Annamaria Tesse, Cataldo Procacci, Domenica Ancona, Salvatore Lenti

Why was it done?

Often the elderly patient suffers from several pathologies at once and commonly he is in polytherapy. According to the Italian Ministerial Recommendation No. 17, errors in drug therapy can cause serious harm to the patient. By increasing the patient’s awareness and reducing the number of potentially inappropriate prescriptions, it will be possible to improve the effectiveness of therapies and to reduce side effects.

What was done?

In an Internal Medicine department, the concurrence between doctors and pharmacists has led to a project that aims to reduce duplications of therapy and to improve the health status of the patients. This through pharmacological recognition and subsequent therapeutic reconciliation carried out on patients in discharge.

How was it done?

In Internal Medicine ward, from June to August 2022, we gather the terapies for 48 hospitalised patients aged over 65 years and suffering from two or more chronic diseases. Reconciliation boards were then developed using Intercheck Web a “Mario Negri” Institute of Pharmacological Research’s software. Sequentially the physician, according to the chemist, proceeded to remodulate the therapies especially in those cases where there were serious interactions.

What has been achieved?

140 drug interactions were detected, on average 2.91 interactions per patient. Especially, 16 class D (very serious), 22 class C (major), 83 class B (moderate), 19 class A (minor) reactions were archived. The modified or partially modified therapies at discharge were 71%. This restriction bought to a curtailment of drugs taken and a removal of unnecessary drugs.

What next?

The team are doing a patient follow-up to six months and a year so earlier results will be soon available. Reducing drug intake is possible, and it involves a downsizing in side effects and in an increase in patient compliance. Information to the patient is essential and, by using this procedure on a large scale, it will be possible to optimise the management of the chronic patient at home and inpatient care.

Low-risk pregnancy: how to help the doctor prescribe?

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European Statement

Clinical Pharmacy Services

Author(s)

Ana Rita Silva, Cláudia Santos

Why was it done?

Low-risk pregnant women are also prone to suffer from minor pathological conditions, such as migraines, low back pain, gastrointestinal disorders. In view of this particularity, collaboration was requested from the pharmaceutical services to prepare a therapeutic guide to make available to all doctors in the hospital, in particular general and family medicine.

What was done?

Develop a pocket guide with OTC medicines classification in pregnant women for the following symptoms: pain control; colds; gastrointestinal changes and skin changes, according to Food and Drug Association (FDA) classification, for general and family practice physicians in the hospital.

How was it done?

It was necessary to define which pathologies/symptoms we would focus on, this choice was made in collaboration with the person responsible for the obstetrics service. Then, focusing our work on low-risk pregnant women, we selected some drugs that are prescribed to non-pregnant women for chosen pathologies/symptomatologies. These drugs were thus analysed in view of their safe use in low-risk pregnant women using tools such as the summary of drug characteristics, the FDA website, the UpToDate online platform. The guide was made available to general and family physicians.

What has been achieved?

The drug classification was compiled in a table organised by INN, divided by pathology/symptomatology, with the FDA classification and also a column with a pictogram indicating the safety of the drug for use during pregnancy. The acceptance by clinicians was very positive, reinforcing that it is important to pay special attention when prescribing in the 1st and 3rd trimester of pregnancy, use the lowest effective dose and for the shortest possible period, avoid using “new” drugs unless there are safety studies.

What next?

The next step to support clinicians will be to develop other tools to help prescribe other classes of drugs as well as another population group, such as safe drugs in breastfeeding.

Software tool development for reconstitution and administration of parenteral antibiotics in hospitals: an international project

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European Statement

Patient Safety and Quality Assurance

Author(s)

Zora Ćetković, Dragana Rajinac, Ivana Baralić , Jelena Marković, Darija Kuruc Poje, Miroslav Kota, Špela Urh, Irina Tegelj, Vesna Bizjak, Dragana Mitrić, Tijana Kovačević, Andrej Pečet, Irena Radivojša, Sanja Filkova, Vesna Bašić-Milošević

Why was it done?

Medication errors regarding reconstitution and administration of parenteral antibiotics are frequent in hospitals. In our study conducted in 12 Southeastern European hospitals in 2021, we demonstrated the need of parenteral antibiotic reconstitution/dilution database in hospital pharmacy practice. Moreover, according to European Statements of Hospital Pharmacy (statement 5.5.), implementation of electronic decision support system by HPs should help to decrease the risk of medication errors. The purpose of software tools is to gather all relevant information regarding parenteral antibiotic reconstitution/dilution and make them easily accessible.

What was done?

A group of hospital pharmacists (HPs) from 6 Southeastern European countries created new software tools (a mobile-responsive website and mobile applications for Android and iOS) for providing information on reconstitution and administration of parenteral antibiotics in collaboration with software developer. These tools contain parenteral antibiotic reconstitution/dilution database in seven different languages (English, Serbian, Croatian, Slovenian, Bosnian, Macedonian and Montenegrin).

How was it done?

Technical requirements for website and mobile applications were designed by HPs. The development of these software tools was carried out by a software developer and funded by European Association of Hospital Pharmacists (EAHP). The final version of the software went through a rigorous evaluation, conducted by HPs during development and all technical problems were resolved consequently.

What has been achieved?

· Designing and developing these software tools helps HPs to provide evidence-based information about parenteral antibiotic reconstitution/dilution at the point of care, thus improving decision-making process and patient safety. · Reconstitution of parenteral antibiotics in wards is efficient and smooth. · Oral and written instructions for parenteral antibiotic reconstitution/dilution are replaced by electronic decision support tools, designed to prevent medication errors. · HP’s interventions are required to support the use of these software tools.

What next?

Our next challenge is wider use of these software tools in order to ensure the appropriate reconstitution/dilution of parenteral antibiotics in wards by nurses and physicians. These software tools are applicable in hospital setting and can be used by all regional hospitals. Additionally, they can be easily incorporated in hospital information system. We also plan to update periodically antibiotic reconstitution/dilution database, as new information becomes available.

Do we provide patients with sufficient information for the safe use of thermolabile medicines?

European Statement

Clinical Pharmacy Services

Author(s)

Miguel Angel Carvajal-Sanchez, Josefa Leon-Villar, Pilar Pacheco-Lopez, Javier Ibañez-Caturla, Paula Torrano-Belmonte, Lydia Fructuoso-Gonzalez, Juan Antonio Gutierrez-Sanchez, Maria Hernandez-Sanchez

Why was it done?

In recent years, we have witnessed a significant increase in the number of thermolabile pharmaceutical specialities, which makes it necessary to keep strict control of the storage temperature from manufacture to administration.

In this context, patient education is a fundamental step in ensuring that these medicines are administered effectively and safely.

What was done?

A study was carried out to determine the quality of the information provided by Hospital Pharmacy Service (HPS) professionals to patients regarding the storage of thermolabile medicines (TM) at home.

After analysing the variability of the results, we established in a protocolised manner the necessary and sufficient information items to be included in the pharmaceutical advice to patients regarding the storage of this type of medicines.

How was it done?

A random selection of 28 HPS professionals (13 nurses, 10 specialist pharmacists and 5 resident pharmacists) was made. Each participant, in isolation and individually, made a selection of criteria to be contained in the patient information regarding the transport and storage of TM.

The results obtained were:

General information:

o Informing that it is a TM: 89.28%.

o Telephone number for incidents: 10.71%.

o Keep out of the reach of children: 3.57%.

o Return if discontinuation of treatment: 3.57%.

Storage:

o Specify location in refrigerator: door/indoor distinction 28.57%; Avoid contact with walls: 28.57%; specific place in refrigerator 3.57%.

o Do not store next to food: 17.85%.

o Refrigerator/freezer distinction: 10.71%.

Transport:

o Recommendations for correct transport: 50%.

o Time elapsed from dispensing to refrigerator storage: 39.29%.

Administration:

o Tempering prior to administration (when necessary): 39.28%.

o Visual inspection: 7.14%.

o Check expiry date: 7.14%.

o Frecuency of administration: 3.57%.

What has been achieved?

Completion, standardisation and systematisation of the provision of information to patients on TM.

What next?

Training sessions will be given to all HPS professionals involved, including new recruits and pharmacy assistants. This is an initiative applicable to all HPS.

PERFORMING A COMMITTEE OF EVALUATION OF TREATMENTS IN SPECIAL SITUATIONS

European Statement

Clinical Pharmacy Services

Author(s)

Susana Redondo-Capafons, Laura Soriano, Irene López-Rico, Jorge Del Estal, Rocío Cebrián, Marcela Manriquez, Maria Reventós, Sandra Fernández-Molina, Mònica Gómez-Valent

Why was it done?

Before CTSS was performed, TSS were requested to Pharmacy Department for evaluation and decision. Because of complexity of these treatments, it was decided that it was necessary to evaluate them with other professionals to make a consensual decision.
In May 2019, CTSS was born. It is a multidisciplinary committee with 10 different health professionals: head of pharmacy, head of healthcare management, head of strategy and operations management, a clinical pharmacologist, five pharmacists and a secretary. Requesting doctors and heads of involved services are invited to explain TSS in the meeting.

What was done?

Committee (C) of Treatments in Special Situations (TSS) (CTSS) have been established. Requests are received by a specific email for the committee and a standard template was performed to be completed by requesting doctor (patient clinical information and evidence supporting request) and by Pharmacy Service (regulatory status of the drug, pharmacology and cost of treatment).

How was it done?

Some limitations as lack of human resources with exclusive dedication for making reports and lack of training in evaluation of this kind of treatments are the most important obstacles. Currently, each member is self-taught and under excessive work- pressure.

What has been achieved?

From May 2019 to August 2021, 273 treatments in 59 meetings sessions (average 4.63 evaluations/meeting) were evaluated.
The 91,6% of treatments were approved. In 95,9% of requests, one drug was evaluated.
There were 18 services involved, being oncology and hematology the most active departments.
Evaluated TSS were classified in six categories: 66,7% of requests were drugs without approved indication, 19,8% drugs approved indication pending price by government, 2,5% approved indication but denied funding by government, 1,8% foreign medicines, 4% compassionate use and 5.2% others according to criteria of each autonomous communities in Spain.

What next?

CTSS allows make a consensual decision between different professionals and establishes a flow to manage TSS requests. This multidisciplinary scenario generates knowledge and evidence in the use of these kind drugs reducing uncertainty in TSS use in relation to its efficacy and safety and, in cases of high budgetary impact-drugs, to minimize inequities of access by standardizing decision-making. Applicable to all hospitals.

TELEPHARMACY ANALYTICS AND DATA VISUALIZATION THROUGH BUSINESS INTELLIGENCE

European Statement

Clinical Pharmacy Services

Author(s)

Cristina González Pérez, Laura Llorente Sanz, Ángel Liras Medina, Ana Andrea García Sacristán, María Molinero Muñoz, Lidia Ybañez García, José Alberto Peña Pedrosa, Henar González Luengo, María Luaces Méndez, José Manuel Martínez Sesmero

Why was it done?

Telepharmacy implementation in the context of SARS-CoV-2 pandemic conducted us through the management of a high volume of complex, real-time both clinical and economic data. A multidisciplinary working group (biomedical engineers from the Innovation Unit, clinicians, managers and hospital pharmacists) developed a software tool in April-May 2021.

What was done?

The design of an agile, customizable and dynamic dashboard for the visualization and analysis of Telepharmacy key performance indicators (KPI) through Business Intelligence (BI).

How was it done?

Phases:
1. Situation analysis. KPI definition. Ethics committee approval submission.
2. Extraction and processing of raw databases (Telepharmacy database, outpatient dispensing program, hospital admission database, drug catalog) through data mining.
3. Co-creation of the comprehensive dashboard in PowerBI®, by integrating database sources. Different panels have been designed where filters such as age, time frame, medical service, pathology, etc. can be applied.
• Description of general variables: patients, demography, shipments, time frame, medical department.
• Geolocation of the destinations of the patients’ home delivery.
• Pharmacological profile: top 10 drugs, distribution by active ingredient and drug classification group.
• Relative analysis of the beneficiary patients of Telepharmacy vs global outpatients
4. Pilot project by different types of users (administrative staff, clinicians and managers)
5. Structure design for automatic updating of the panels from the successive updates of the source databases
The quality of the raw databases can be a limitation. It has been necessary to define how to handle missing and duplicate data. Pre-processing, normalization and transformation data processes have been applied too.
Working within the hospital network ensures that there are no security gaps in terms of patient data protection.
For the external use of the dashboard, the granularity of the data is modulated to ensure enough clustering to avoid the identification of individual patients.

What has been achieved?

Processing the huge dataset (more than 2.4 million records) was possible by BI tools that synthesizes data, provides dynamic and engaging visualization (charts and graphs), allows the interactive reports customization for more effective communication of results and apply analysis based on Artificial Intelligence.

What next?

Applying new technologies will help us improve strategic decisions: interactions, behaviors and trends perceiving, weak points identifying, uncertainty reducing and over time monitoring.

ANTIMICROBIAL DOSING IN OBESE PATIENTS: ADJUSTMENT GUIDE TO HELP IN PRESCRIPTION AND VALIDATION

European Statement

Clinical Pharmacy Services

Author(s)

ANA CASTRO BALADO, MARÍA TERESA RODRÍGUEZ JATO, IRIA VARELA REY, MANUEL BUSTO IGLESIAS, FRANCISCO CAJADE PASCUAL, MARIA PUENTE IGLESIAS, IRENE ZARRA FERRO

Why was it done?

The prevalence of obesity has increased considerably in last decades. Pathophysiological changes in obese patients (body mass index >30kg/m2) produce pharmacokinetic and pharmacodynamic alterations that can condition the correct exposure to drugs if standard dosages are used. Incorrect dosing in obese patients can lead to toxicity or therapeutic failure. Usually, it is difficult to find information on drug dosing in this population, being sometimes contradictory.

What was done?

To develop an antimicrobial dosage infographic guide for obese patients to facilitate the correct prescription and validation in our hospital.

How was it done?

Initially, the pharmacy service established the antimicrobial groups to be included in the infographic guide, and within each of them, the most used in hospitalized patients were identified. A bibliographic search was carried out using the keywords “obese”, “dosing”, “antimicrobial” and “patient”. Technical data sheets, PubMed, Google Scholar, UpToDate, Micromedex and other hospital guidelines were consulted. A peer review was carried out and a table with antimicrobial groups and subgroups was designed, stablishing the body weight recommended for the adjustment if needed (total weight (TBW), ideal weight (IBW) and adjusted weight (ABW)), doses, and observations (monitoring of plasma levels, administration in extended/continuous infusion and/or special considerations). The table consisted of a total of 38 antibiotics, 10 antifungals, 6 antivirals and 4 antituberculous drugs. Of the total antimicrobials reviewed, 40% were dosed in obese patients by maximum dose, 38% were dosed based on weight (21% by ABW, 10% by IBW, and 7% by TBW) and 22% by standard doses. Equations for body weight descriptors were added in the infographic.

What has been achieved?

The protocol was validated by the hospital’s infectious diseases commission. Dosing information was then entered into the hospital’s electronic prescribing program facilitating the correct antimicrobial prescription and validation in obese patients. Training was provided in the intensive care unit, and the final document was disseminated through the hospital intranet and via email to all prescribing physicians in the center, being well embraced.

What next?

We will continue making formative sessions, as well as possible updates that may be beneficial for a better antimicrobial dosing in obese patients to avoid toxicities and/or therapeutic failure.

Elaboration of a Good Practice Guide for the administration of parenteral antibiotics at children’s hospital

European Statement

Patient Safety and Quality Assurance

Author(s)

MOHAMMED ADNANE EL WARTITI, WAFAA ENNEFFAH, BOUCHRA MEDDAH, MUSTAPHA BOUATIA

Why was it done?

The GPG was developed in a concern of practices standardization to guarantee the safety and efficacy of parenteral antibiotics, especially those stored in vials which reuse in possible only if conditions of administration and stability are respected.

What was done?

We developed a Good Practice Guide (GPG) for the usage of major available parenteral antibiotics.

How was it done?

After we listed all parenteral antibiotics available at the hospital pharmacy, we selected the most used ones and we synthesized all manufacturers’ data to establish a GPG for their administration. We also used literature data to complete missing information in “Summaries of Product Characteristics” related to pediatric use of these drugs. Finally we determined the most antibiotics consuming units according to their defined daily doses, where GPG recommendations will be implemented, before their extension to all other units.

What has been achieved?

The GPG concerned the most used antibiotics, which mainly belong to the following classes: Beta-lactam, Glycopeptide and Imidazole antibiotics, Aminoglycosides and Quinolones. It specifies the galenical presentation, used solvents, volume and duration of administration, stability after reconstitution as well as incompatibilities and special measures relating to the use of these drugs. The most antibiotics consuming units are pediatric intensive care units, “IIB” pediatric unit and pediatric surgical emergency department.

What next?

The approach used in this work can be adopted in other similar structures in order to establish GPGs within the framework of a quality control policy aiming to raise the standard of care.