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Author(s)

PAULA HERNANDO MARTÍNEZ, VIOLETA LAFARGA LAPIEZA, DAVID JAMES BOARDMAN GONZÁLEZ, GRACIA PICAZO SANCHÍZ, CARIDAD MARTÍ GIL, DOLORES BARREDA HERNÁNDEZ

Why was it done?

The administration of medications through NGT is a common practice in the hospital setting. However, it cannot be assumed that this route of administration shares same properties as the oral route. Proper administration requires considering the pharmacokinetic and pharmacodynamic proper1es and adapting recommendations to the medication’s pharmaceutical form(PF). Incorrect manipulation can lead to undesirable effects, such as a reduction or loss of therapeutic efficacy, as well as an increase in adverse effects, toxicity or mechanical, metabolic, and/or infectious complications.
Despite the wide bibliography on this topic, there is a lack of knowledge among patients, caregivers, and hospital staff when there is not adequate training on the use and care of the NGT.

What was done?

Development of a pharmaceutical care project for patients with nasogastric tubes(NGT) to ensure the proper administration of medications through the tube and their correct handling.

How was it done?

In May 2024, a working group of pharmacists was formed in the Hospital Pharmacy Department (HPD) with the aim of creating a protocol for the adjustment of medications for administered through a NGT in hospitalized patients. A document was developed with general recommendations on maintenance, interactions with drugs, food and enteral nutrition, aimed at patients, caregivers and healthcare professionals to ensure the correct use of the tube. Additionally, a literature review was conducted on the various available manipulation guidelines (Technical sheets, dysphagia Guide from La Paz Hospital 2021 and the Guide for Drug Administration through Tubes Reina Sofía Hospital 2023), as well as validated apps such as (Deglufarm®, Medisonda®) which provide handling and administra1on instructions for each PF.

What has been achieved?

A daily search was conducted for hospitalized patients with nasogastric tubes to identify the need of instructions on medication handling. A fillable document was designed with the necessary recommendations for the handling of each prescribed medication during the hospitalization. During the pharmaceutical validation, patients with NGT were reviewed, and personalized reports were created according to the prescribed treatments.

What next?

To evaluate the level of patient sa1sfaction and including new needs. In addition, the aim is to implement this protocol upon discharge, in order to offer a personalized report with recommendations for the prescribed medications.

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Author(s)

Diana Monteiro
Luísa Álvares
Sara Brandão Madureira
Patrocínia Rocha

Why was it done?

The confirmation of a clinical diagnosis of brain death requires the demonstration of the cessation of brainstem functions and their irreversibility. Therefore, when this evaluation is incomplete or unreliable, it is necessary to support this diagnosis using diagnostic tests such as brain perfusion SPECT. This is performed after the injection of the radiopharmaceutical technetium-99m hexamethylpropyleneamine oxime (99mTc-HMPAO) and by assessing the obtained images for the lack of cerebral perfusion to confirm the diagnosis.
Given the importance of reliable results, a high radiochemical purity of 99mTc-HMPAO is imperative in quality control to prevent false positives.

What was done?

Selection of a method to evaluate the radiochemical purity of 99mTc-HMPAO.

How was it done?

A literature review was conducted to select the most suitable method for the conditions existing in the institution. The research focused on the Summary of Product Characteristics (SmPC), the European Pharmacopoeia (Ph. Eur. 11.0), the United States Pharmacopeia (USP 42) and several published articles.
After selecting the method, three assays were performed to validate it.

What has been achieved?

For evaluating the radiochemical purity of 99mTc-HMPAO, both the SmPC and Ph.Eur. 11.0 recommend a combination of two thin-layer chromatography (TLC) methods with a high-dimension stationary phase, for which the institution does not have a chromatographic tank.
The USP 42 describes a combination of three TLC methods, using acetonitrile as the mobile phase, which is also unavailable at the institution.
In contrast, the miniaturized method by Fuente et al. uses two TLC methods, with a silica gel stationary phase and sodium chloride (0.9%) and methyl ethyl ketone as mobile phases. This method was selected given that the institution has the required phases, the stationary phase dimensions are suitable for the available chromatography tanks and the execution time for the assay is feasible.
For method validation, three assays were conducted, yielding values exceeding 80% (the reference value).
The selected method represents a rapid, reproducible and reliable alternative for evaluating the radiochemical purity of 99mTc-HMPAO. It was implemented in the institution in October 2022.

What next?

In the future, we aim to develop quality control methods for all radiopharmaceuticals in use at the institution, in order to guaranty the quality of all the exams performed.

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Author(s)

Luísa Álvares
Sara Brandão Madureira
Diana Monteiro
Patrocínia Rocha

Why was it done?

Lutetium (177Lu) oxodotreotide is indicated for treating subtype 2 somatostatin receptor-positive (SSTR2) gastroenteropancreatic neuroendocrine tumors, well-differentiated G1 and G2, progressive, inoperable or metastatic. This radiopharmaceutical targets cells with SSTR2 overexpression, emitting radiation that causes cell death.
Initially, the Summary of Product Characteristics (SmPC) included the gravity method for intravenous administration, using a system with two needles, one connected to a NaCl 0.9% solution, with or without a perfusion pump, using gravity to facilitate the flow of the radiopharmaceutical.
This method was adopted and optimized due to incidents during administration.

What was done?

Optimization of the administration method of lutetium (177Lu) oxodotreotide to maximize the administered radioactivity and enhance protection for healthcare professionals.

How was it done?

The first administration using the described method occurred in October 2022.
Subsequent treatments required transferring the radiopharmaceutical to a syringe and using a syringe pump due to incidents during administration.
A perfusion pump was later introduced to manage the flow of NaCl 0.9% solution.
In May 2024, a three-way stopcock was connected to the short needle.

What has been achieved?

Since October 2022, 23 administrations have been conducted. In the first, the percentage of remaining radioactivity in the vial was 2.19%.
The use of a syringe pump increased handling and exposure risks and was rejected due to the lack of protective barriers.
Adding a perfusion pump to the NaCl 0.9% line didn’t fully resolve perfusion issues. This was resolve by adding a three-way stopcock connected to the short needle. The additional third line allows for a syringe to be attached and force air into the system, promoting the radiopharmaceutical flow.
The average remaining radioactivity improved from 1.71% to 0.98% after final optimization.
No incidents, such as leaks or perfusion issues, occurred after optimization.
This optimization reduced the remaining radiopharmaceutical activity values, ensuring complete administration. It also minimizes professional exposure and contamination risks, as the radiopharmaceutical remains in the original vial, as indicated in the SmPC.

What next?

We aim to apply this optimized method in other treatments with the same radionuclide.

Author(s)

Gulseren Lafci
Magali Ferro
Valerie Chaminant

Why was it done?

In accordance with french legislation concerning the quality of drug management in healthcare establishments, an assessment of professional practices was carried out within our nursing home. The aim was to study the compliance of drug preparation and administration methods with good practice in our nursing home.

What was done?

A clinical audit has been set up in our nursing home. It was carried out by 2 hospital pharmacists over 3 half-days to consider the preparation of weekly doses, daily doses, and an administration.

How was it done?

One of the 4 sectors of the nursing home was randomly selected. The medication management of all its residents was evaluated. The evaluation criteria were divided into 2 main parts: “drug preparation” and “drug administration”. The part on drug preparation was divided into 4 sub-sections (person in charge of preparation, room and hygiene, preparation, conditioning). The part on drug administration was also divided into 4 subsections (concordance between prescription and administration, identitovigilance, administration, traceability).

A criterion was defined as compliant if all the responses to the items were in line with the procedure, and as non-conforming if only one of the responses was not.

A conformity rate was defined for the entire audit (overall conformity), for each part (partial conformity) and sub-part (average conformity).

What has been achieved?

The care of the 19 residents in the sector was assessed (23.4% of nursing home residents).

The overall conformity rate of our clinical audit was 38.6%. Partial conformity of the “drug preparation” part was 32.3% (the average conformities of sub sections were: 50% for “person in charge of preparation”, 25% for “premises and hygiene”, 22.5% for “preparation” and 56.25% for “packaging”). Partial conformity of the “drug administration” part was 47.8% (the average conformities of sub-sections were: 100% for “concordance prescription/administration” and “identitovigilance”, 27.3% for “administration” and 42.8% for “traceability”).

What next?

The majority of non-conformities were due to a lack of human and material resources. In addition, a lack of knowledge was observed for substitution equivalence and galenic. The results were presented and proposals for improvement, such as raising staff awareness and providing resources, were made to the hospital’s medical committee.

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.

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Author(s)

Ana Concepción Sánchez Cerviño, Jorge Coca Crespo, Maria Rivera Ruiz, Juan Ignacio Alcaraz López, Adrián López Fernández, Elena Pérez García, Bárbara Ubeda Ruiz, Amelia Sánchez Guerrero

Why was it done?

Sequential therapy, or switch therapy, consists of an early conversion from intravenous to oral (PO) treatment, without compromising the therapeutic effectiveness. In advantage, PO in selected cases, avoids intravenous associated risks, it is more comfortable to patients and represents an important economic saving.

The aim of the GPI was to implement a daily program that allows the pharmacist to identify the patients that would benefit from the AST.

What was done?

Implementation of a program of antibiotic sequential therapy (AST) and evaluate the outcome of the pharmaceutical recommendations carried out in a third-level hospital.

How was it done?

A database was created to select the active antibiotic prescriptions with more than 72 hours duration, susceptible to AST: metronidazole, clindamycin, levofloxacin, ciprofloxacin and linezolid.

Patients clinical criteria for initiating AST were established as:
• Temperature ≤ 37 ºC
• Systolic blood pressure ≥ 90 mmHg
• Heart rate < 100 bpm • Respiratory rate < 24 rpm • Oxygen saturation ≥ 90% • Capacity for oral intake Once the patients were identified, the pharmacist communicated the recommendation to the doctor in charge, and worked together to make a final decision. Due to the high burden of care, the follow-up of patients who could not be substituted to PO in the first 72 hours was lost.

What has been achieved?

From October 2022 to March 2023, 453 patients on intravenous antibiotic treatment were reviewed. The mean age was 65.7 ± 20.9, and 57.4% of the patients were men.
47 patients were selected as they met the established criteria.

All the antibiotics presented a similar percentage of recommendation with a mean of 19.2% ± 6.3. Of this percentage, 59.6% of the patients were switched to oral antibiotics. Stands out linezolid, with a 83.3% of acceptance.

Lower respiratory tract infections were the most prevalent, representing 51.6% of the total. However, only 11 patients (5.1%) were suggested for AST due to the frequent use of nasal spectacles or oxygen therapy, a criterion that excludes AST

What next?

The high number of accepted recommendations shows the importance of implementing an AST programme in order to optimize antimicrobial treatment, and this initiative could be easily implemented to all Pharmacy Services.

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Author(s)

STEFANIE HEHENBERGER, IRENE LAGOJA, SANDRA BIELITZ-HOLZER

Why was it done?

Creation of a stoma means change in secretion, intestinal motility and absorption. Depending on localisation, this has also consequences for the absorption of drugs or certain drug forms. Data on absorption of drugs in ostomy patients are rare, but as most drugs are absorbed in the small intestine, ileostomy patients may more likely experience difficulty in absorbing and, therefore, gaining maximum benefit from oral medications.

What was done?

As part of a project, it was evaluated whether and which drug-related problems (DRPs) occur in stoma patients and, if so, measures for optimising drug therapy were proposed.
Relevant drug data (tmax, site of absorption, etc.) were collected and systematised in tabular form and the need for further pharmaceutical interventions was surveyed.

How was it done?

Over a period of 21 weeks, medication of Ileostomy patients (new created and pre-existing) hospitalised in various wards was screened.
A Level 3 medication analysis was performed, and the medication was then analysed with regard to possible stoma-specific DRPs.
All DRPs and pharmaceutical interventions were categorised and documented, and the identified DRPs brought to the attention of the patient’s medical team for review/ discussion in written form and/or personally.

What has been achieved?

Seventy-nine DRPs were identified in 15 medication reviews, of which 49 (62%) were classified as stoma associated DRPs. The pharmaceutical interventions were categorised, most common recommendations were monitoring (18) and change of the medication form (15). Acceptance of the interventions was also recorded (82%). Since a HOS (High output stoma) occurred frequently, an escalation scheme for the therapy of liquid stool and/or stool volume ≥1500ml/day was established. Finally, an interdisciplinary cooperation taking into account the complex patient factors could successfully be established.

What next?

Due to these results it can be assumed that ileostomy patients benefit greatly from pharmaceutical interventions, and that clinical-pharmaceutical care of ileostomy patients contributes to the drug therapy safety of this patient group and is therefore now being continued and incorporated into everyday clinical practice. In addition, further projects such as the creation of a standard operating procedure (SOP) for the interdisciplinary care of ileostomy patients are in progress.

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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.

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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.

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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