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)

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)

Catarina Diogo, Rui Caceiro, Catarina Canário, Sónia Camões, Sofia Bastos, Cláudia Silva, Maria Helena Duarte, Armando Alcobia

Why was it done?

To improve the medication circuit in Ophthalmology at our hospital—which has grown exponentially and was largely paper-based, and prone to errors—a digital application called NOA-Digital was developed in 2023.

What was done?

Assess the impact of implementing the NOA-Digital application.

How was it done?

A retrospective comparative study was done. Data was collected through the application and Excel files between June and August 2024 and the corresponding period of the previous year.

What has been achieved?

The use of the application eliminated paper prescriptions and their transcription to Excel files, which previously generated a document with over 120,000 fields filled by the pharmacist annually. In a total sample of 701 patients, 1,384 prescriptions were entered into the application, and 1,800 injections were prepared. The implementation of the application reduced by 80% the time pharmacists spent on administrative tasks. This was achieved through the automation and centralization of processes and easy access to information. The optimization of the workflow facilitated the inclusion and monitoring of more patients, leading to increased production. Additionally, it improved the pharmacist’s organization and availability, allowing for the refinement of production techniques, which optimized vial usage and generated savings (€27,058.50 – about 13%). The application also eliminated common errors from the previous system – incomplete and duplicate prescriptions – and provided access to previously unrecorded information.

What next?

The implementation of the NOA-Digital application proved to be an effective solution for improving the ophthalmic medication circuit, promoting greater safety, efficiency, and quality while contributing to cost reduction. Continued monitoring and analysis of its use is recommended to identify additional improvement opportunities and assess its adaptability for implementation in other pharmaceutical services.

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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.

Author(s)

Ignacio Javier Tamboleo Sánchez, Julia Fernández Vela, Fernando Lago Ballester, Mª CARMEN MIRA SIRVENT, Elena Conesa Nicolas

Why was it done?

The initiative started in October 2022, it was a response to the challenges associated with prolonged intravenous antibiotic use. The overarching goals were to enhance patient care, mitigate unnecessary intravenous antibiotic prescriptions, and foster a culture of responsible antimicrobial stewardship. Recognizing the need for a systematic and collaborative approach, the Antimicrobial Stewardship Program (ASP) pharmacist played a central role in implementing interventions across various medical specialties, with a clear focus on improving patient outcomes.

What was done?

The initiative promoted the adoption of sequential antibiotic therapy among hospitalised patients undergoing intravenous treatment for more than three days. Leveraging the Wise Antimicrobial Stewardship Support System® (WASPSS®) and detailed analysis of medical records, the programme identified eligible patients based on criteria such as clinical stability, oral bioavailability, infection specifics, and antibiotic suitability.

How was it done?

The ASP pharmacist’s central role proved instrumental, with 74% of alerts resulting in actionable recommendations. WASPSS® detects every patient with intravenous antibiotic more than 3 days and the ASP pharmacist decides which patients will benefit from sequential therapy. Choosing the recommendation criteria is essential to have a good response from medical specialties ensuring a more efficient and tailored approach to intervention implementation. The main obstacles to the introduction of this initiative were the establishment of refined communication routes and the targeted training to the different specialties which are not yet fully implemented.

What has been achieved?

Results revealed that 74% of alerts met the criteria for transitioning from intravenous to oral administration. Among the 573 alerts reviewed, 45.1% witnessed a successful switch to oral antibiotics, 21.2% showed no change, and 16.7% of patients were discharged. Notably, higher acceptance rates were observed in specific specialties, such as pneumology (61.3%) and general medicine (54.4%). Nevertheless, oncology (35,3%) general and digestive surgery (25,8%) had the lowest acceptance rate. In conclusion, the global acceptance rate was lowest than expected (43,8%) but there are many improvements measures that are being carried out.

What next?

This initiative serves as a beacon for responsible antibiotic management, making noteworthy contributions to patient safety, cost-effectiveness, and the overall quality of healthcare delivery. Recommending ongoing collaboration, continuous training, and regular analysis of recommendation criteria will enhance its impact.

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Author(s)

AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI

Why was it done?

It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.

What was done?

Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.

How was it done?

Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.

What has been achieved?

A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.

What next?

The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.

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)

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.