Author(s)

Hamza TAJRI, Abdelhafid BENOMAR, Houda ATTJIOUI, Majda BENABBES, Madiha ALAMI CHENTOUFI

Why was it done?

The sterilization of reusable medical devices is important for ensuring patient safety in hospital environments. However, the complexity of this process poses significant risks. The Failure Modes, Effects, and Criticality Analysis (FMECA) method offers a systematic approach to identify and mitigate these risks, thus enhancing the overall safety of sterilization practices.

What was done?

This work aimed to optimize the sterilization process at our hospital by applying the FMECA method. The focus was on evaluating each stage of the sterilization process, from pre-disinfection to storage and distribution.

How was it done?

A comprehensive FMECA was conducted on the eight main stages of the sterilization process: pre-disinfection, washing, rinsing, drying, packaging, sterilization, batch control and release, and storage and distribution. Each potential failure mode was evaluated in terms of severity (G), occurrence (O), and detectability (D) on a scale from 1 to 5, enabling the calculation of the Risk Priority Index (RPI).

What has been achieved?

The analysis revealed that contamination during drying and ineffective sterilization had the highest Risk Priority Numbers (RPNs), indicating the most critical risks in the process. As a result, these stages require special attention and priority corrective actions. The study also highlighted significant risks in other sterilization steps, underlining the importance of a comprehensive approach to risk management.

What next?

The application of FMECA has enabled us to identify critical areas within the sterilization circuit. Moving forward, we will implement targeted improvement strategies focusing on increased monitoring, preventive maintenance of instruments, and enhanced staff training, particularly regarding drying and sterilization processes.

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Author(s)

Tea Stiplošek, Alenka Kovačič

Why was it done?

The growing misuse of antimicrobials, resulting in resistant microorganisms and more adverse reactions, has been identified as a significant concern. To tackle this issue, a system was put in place to systematically monitor the hospital’s dispensing and use of reserve antimicrobials.

What was done?

We established a system where each reserve antimicrobial prescription in the hospital is reviewed by a pharmacist, who decides whether to dispense the drug or suggest therapy adjustments. The dispensation of antimicrobial drug to the patient is then recorded in the patient’s medical documentation.

How was it done?

A special prescription form has been prepared, used exclusively for ordering reserve antimicrobials from the pharmacy in our hospital, separate from other medications. The form is reviewed by a pharmacist, who calculates the patient’s creatinine clearance, examines inflammatory markers, checks the alignment of treatment with the antibiogram, and reviews potential interactions with other therapies before deciding whether to dispense the drug. If necessary, the pharmacist suggests modifications to the antimicrobial treatment. Each time the antimicrobial is dispensed, it is recorded in the patient’s medical documentation for easier treatment tracking.

What has been achieved?

This approach has established systematic control over the prescription of reserve antimicrobial drugs, with a clinical pharmacist introducing an additional prescription checkpoint. Analysis of data from our work between 2020 and 2023 shows that during this period, we dispensed 16,464 courses of reserve antimicrobials, with pharmacists recommending therapy adjustments in 2,211 cases (13.6%). On average, we recommended dose reductions in 43.5% of cases due to impaired kidney function and dose increases in 23.5% due to improved kidney function or the need for appropriate dosing for specific indications. Pharmacokinetic monitoring (TDM) interventions, including those for vancomycin, amikacin, and gentamicin, accounted for 29.75% of the interventions, while 3.35% of our recommendations involved therapy changes due to inappropriate treatment based on antibiograms or the patient’s impaired kidney function.

What next?

We are digitizing the ordering system, allowing departments to request antimicrobial drugs directly through the hospital information system. We are also developing an application to calculate kidney function and verify the correct antibiotic dosage for each patient, all in one place.

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Author(s)

A. HERREROS FERNÁNDEZ, P. FERNÁNDEZ-VILLACAÑAS FERNÁNDEZ, R. AÑEZ CASTAÑO, P. ORTIZ FERNÁNDEZ, M.A. MEROÑO SAURA, I. GARCÍA MASEGOSA, R. GUZMÁN LAIZ, P. SELVI SABATER, C. CABALLERO REQUEJO, L. RENTERO REDONDO, E. URBIETA SANZ.

Why was it done?

The preparation of sterile magistral formulas involves significant risks due to complex processes, material handling, and sterility requirements. A systematic risk assessment was essential to identify vulnerabilities, classify risk levels, and implement preventive measures to improve safety and compliance with regulatory standards.

What was done?

Sterile magistral formulas are personalized medications prepared in hospital pharmacy services to meet individual patient needs. In 2023, a risk matrix was implemented to systematically evaluate the risks associated with their preparation. This initiative aimed to enhance patient safety and ensure compliance with the “Guide to Good Practices for the Preparation of Medications in Hospital Pharmacy Services” (GGP).

How was it done?

Sterile magistral formulas prepared in the pharmacotechnics area of a hospital during 2023 were identified from a Microsoft Access® database. A Microsoft Excel® database was specifically designed to apply the GGP-based risk matrix, categorizing formulas into low, medium, or high risk. Each formula was evaluated across six key criteria: preparation process, route of administration, drug safety profile, number of units prepared, preparation vulnerabilities, and distribution process. Risk levels were assigned using a combination of letters (A-D) based on the matrix. Challenges included standardizing data collection and ensuring multidisciplinary collaboration to refine the matrix and ensure its applicability.

What has been achieved?

A total of 80 sterile magistral formulas were assessed. Of these, 38.75% were classified as medium risk, 36.25% as high risk, and 25% as low risk. Among medium-risk formulas, 67.7% included a “C” in the matrix, while 96.6% of high-risk formulas contained at least one “D.” The most frequent risk combinations were “BBAAAA” (11.25%) and “BBBAAA” (10%). The preparation process and administration route were the primary contributors to overall risk. Medium- and high-risk formulas, primarily intravenous mixtures of antibiotics and biological drugs, required preparation in a cleanroom environment, as recommended by the GGP.

What next?

This initiative demonstrated the value of a risk matrix in identifying and managing risks in the preparation of sterile magistral formulas. It represents a best practice model with significant potential for adaptation in other healthcare settings, enhancing patient safety and standardizing risk management in hospital pharmacy operations.

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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)

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

Why was it done?

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

What was done?

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

How was it done?

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

What has been achieved?

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

What next?

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

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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.