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Intrahospital circuit of autologous eye drops

European Statement

Patient Safety and Quality Assurance

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.

Implementation of a sequential antibiotic therapy programme in a third-level hospital

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European Statement

Clinical Pharmacy Services

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.

Evaluation and optimisation of the medication in patients with ileostomy

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European Statement

Clinical Pharmacy Services

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.

Evaluation of microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices

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European Statement

Production and Compounding

Author(s)

Timea Botházi, Lone Madsen

Why was it done?

The purpose was to find data for an increased microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf-life from 24 hours to 7 days. Existing data were studied to find evidence to support the prolonged shelf-life.

What was done?

The purpose was to find data for an increased microbiological shelf life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf life from 24 hours to 7 days. Existing data was studied to find evidence to support the prolonged shelf life.

How was it done?

A team from the production and quality assurance departments worked together on writing a report that could provide the rationale for the change of shelf-life.
We collected data from
– supplier qualification of the medical devices
– aseptic process simulations (APS)
– process validations
Data were evaluated and risk assessment was performed.
Six medical devices were included.
All suppliers were qualified as low risk.
APS for the specific production process showed no growth.
Process validation data for two types of medical devices showed no concern regarding sterility of preparations.

What has been achieved?

The increase of shelf life was accepted. First product was Blincyto® in infusion bag with Take Set Swan-Lock ® with shelf life increased to 4 days. Patients now visit the oncology clinic only twice a week instead of daily thus saving time and transportation.

What next?

The result means that new product implementation is quick because the only things to evaluate are the stability of the substance and the compatibility of this with materials in contact with it.

Supply difficulties in oxygen humidifiers: an opportunity to promote good practice

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European Statement

Selection, Procurement and Distribution

Author(s)

Margaux DUFOSSE, Claire ANDREJAK, Abir PETIT

Why was it done?

By May 2022, we learned about the sale discontinuation of oxygen humidifiers from one of the two manufacturers in our country, due to the constraints of MDR 2017/745. The second manufacturer restricts its products to hospitals with marketing partnerships. In our hospital, oxygen humidifiers are used regardless of the oxygenation medical device (nasal cannulas, masks, tubes or tracheotomy tube) or oxygen flow rate. We had to define indications and prescriptions to control consumption in our hospital.

What was done?

To promote good use of oxygen humidifiers and control our consumption in a context of shortage we have drawn up a scientific explanatory document, a procedure and a prescription support.

How was it done?

We suppressed services’ allocations for humidifiers, to encourage prescription via the Electronic Patient Record. We set up a working group, including pharmacists, resuscitators, pulmonologists and nurses, to write a good use sheet, underlining high-priority medical indications taking account of scientific literature and respiratory medicine learned societies’ recommendations. To assess its effectiveness, we compared humidifiers’ consumption before and after we set it up and evaluate prescriptions’ number and conformity for the first 4 months, from May to September 2022.

What has been achieved?

The group restricted indications to paediatric patients, patients with tracheotomy and patients with oxygen flow rates above 5L/min and upper respiratory tract lesions such as nose bleeding, nasal discharge congestion, or nasal mucosa’s irritation or lesions. We wrote the good use sheet, mentioning the circuit’s montage and conditions for dispensing humidifiers. Before the new procedure, the mean consumption was 1,415 units per month, versus 39 per month from June. Regarding prescriptions’ conformity, 12 (8.7%) out of 138 were denied: six patients on ambient air, four with nasal cannula, one without any severity criteria, a not nominative prescription.

What next?

This collaborative and multidisciplinary work enabled a change in practices. Supply difficulties, initially seen as challenging, are a great opportunity to promote good use, and secure patient care. Although they have now been resolved, with a new supplier, we maintain our measures to ensure patients’ security and well-being.

Implementation of automated alert system in high-alert medications in a network of hospitals

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European Statement

Patient Safety and Quality Assurance

Author(s)

ROSALIA FERNANDEZ CABALLERO, ALMUDENA GARCÍA GARCÍA, MARTA HERNÁNDEZ SEGURADO, MARTA GÓMEZ PÉREZ, CARMEN MAYO LÓPEZ, ARACELI HENARES LÓPEZ, VIRGINIA COLLADOS ARROYO

Why was it done?

Our aim was to improve the safety of HAM appointed by ISMP Spain (Institute for Safe Medication Practices) specially restricting the prescription, creating automated alerts and advising in administration.

What was done?

The main objective was to identify and standardise in prescription and administration the high-alert medications (HAM), included in pharmacotherapeutic guide (PG) in a network of Spanish hospitals with about 1.330 beds.

How was it done?

Literature about HAM and recommended strategies was reviewed. We divided these drugs into two groups: HAM (heightened risk of causing significant patient harm when they are used in error) and very HAM (an error could cause death of patient). We identified both groups in electronic prescription system as follows:
– HAM: all prescribers are able to prescribe these drugs and they find yellow warning sign in left side of the drug in prescription screen and nursing electronic work plan for administration.
– Very HAM: these drugs need tracheal intubation or monitoring measures when they are administered to patients. Only prescribers in intensive care (ICU) and surgery units (SU) are able to prescribe them. For certain drugs, needed in medical hospitalisation units, all prescribers are able to prescribe them and they must confirm the prescription with confirmation message: “You are prescribing a HAM, an error could cause significant patient harm. Are you sure to continue?”. They find red warning sign in prescription screen and nursing electronic work plan.
Alerts were configured by systems team in our electronic prescription system.

What has been achieved?

We have identified 379 drugs as HAM. 324 drugs were configured with yellow warning sign.
Sixty-five drugs were identified as very HAM. Fifty-eight drugs were disabled to prescribe by all prescribers (only in ICU and SU).
Seven drugs were configured with red warning alert and confirmation message: dobutamine, isoprenaline, ketamine, labetalol, levosimendan, carboprost and methylergometrine.

What next?

As next phase of our project, we must develop a procedure to identify and create alerts in new drugs added to our PG as systematic risk assessment process. Moreover, we must evaluate the real impact of our alert system in prescribers and nurse team, to reduce alert fatigue. We will work in automatic reports with ignored alerts.

Implementation of therapeutic drug monitoring active proposal in the hospitalised patient

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European Statement

Clinical Pharmacy Services

Author(s)

Alba María Fernández Varela, María Isaura Pedreira Vázquez, Sandra Koprivnik, Ana María Montero Hernández, Isaura Rodríguez Penín

Why was it done?

Therapeutic drug monitoring (TDM) allows an optimised pharmacological treatment and increases safety. Lately, we detected low interest in TDM which was confirmed from our annual activity report. An observational prospective study was carried out in a second- level hospital attending an area of 175 930 patients. The study included all inpatients prescribed a drug eligible for TDM from November 2020 to January 2021. The aim was to improve treatment individualisation of hospitalised patients through an active proposal for drug level determination of drugs susceptible for TDM at our institution: digoxin, vancomycin, antiepileptic drugs (carbamazepine, phenytoin, phenobarbital and valproic acid).

What was done?

The pharmacist encouraged therapeutic drug monitoring of susceptible treatments by an active proposal for drug level determination in the prescriptions programme.

How was it done?

Daily, a list of eligible patients was obtained. To this end, a filtering software was used. Taking into account patient’s demographics, clinical and analytical variables (creatinine clearance, the last TDM result, diagnosis) and active prescriptions (treatment initiation, interactions), the pharmacist makes a recommendation for plasma drug level determination.
Data sources: electronic prescription program, pharmacokinetic validation program and electronic medical record.

What has been achieved?

119 proposals of TDM were made in 107 patients: 79 digoxin, 31 vancomycin, 4 valproic acid, 3 carbamazepine and 2 phenytoin. 45,8% women.
74 drugs were discontinued before possible sample extraction and 5 monitorisations could not be performed due to patient death. Of the 40 remaining proposals, the physician requested monitoring of 35 drugs, which meant 87,5% acceptance rate.
It was observed that 17 levels were low or at a lower limit (a dose increase with subsequent verification of levels was proposed in 8 cases and accepted in all of them), 13 levels were in range, 4 were high or at an upper limit (in 3 of them the dose was decreased). One sample was extracted after the drug administration (vancomycin) therefore without value.

What next?

Pharmacists can contribute to treatment optimisation by being proactive. Many resources are not needed unless the burden of care was a limiting factor. The education and promotion of TDM would be interesting to improve the use of this service.

Optimising the process for incoming requests for new extemporaneous products

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European Statement

Production and Compounding

Author(s)

Mette Lethan, Tove Hansen, Louise Rasmussen Duckert, Trine Schnor

Why was it done?

In the clinic, a need for a NEP, as either a change in an existing product or a new formulation, may arise. Requests are risk assessed by the Hospital Pharmacy Drug Information Centre (DIC) before production is initiated. However, there was no clear process for handling requests, resulting in prolonged process times. NEP may require searching for new raw materials, new packaging or developing of a new formulation, which are time consuming tasks. Therefore, the wish to optimise the process arose.

What was done?

A procedure for handling requests for new extemporaneous products (NEP) in a Good Manufacturing Practice (GMP) regulated production was developed to improve success rate and aligning the process.

How was it done?

A small unit was formed with the purpose of handling requests for NEP. The unit consists of academics employed in the production department with expert knowledge about both sterile and non-sterile production.
A standard operating procedure was formed, in collaboration with DIC, which included a form, to be filled out with information needed for handling the request. This includes drug formulation, strength and dosage, along with any specific requirements.
The unit evaluates the request – is it possible for us to manufacture, sterile or non-sterile, are raw materials available in appropriate quality, analysis requirements, and stability of the product. The evaluation is made in communication with departments like Purchasing, Quality Control/Assurance, Stability as well as the relevant production department.
If a positive outcome, the request is given to the production department, to finalise production. If the outcome is negative a rejection is sent to the requester with a reason.

What has been achieved?

Based on data from the last three years, we now know how many requests we receive, which type of products are requested, processing times, and which products were made and why/why not.
There is a clear path of communication into the pharmacy and between relevant departments, ensuring that essential pharmaceuticals will be developed in a timely manner or a justified rejection is sent enabling the clinic to look for alternatives.

What next?

Some products are difficult to handle, such as cytostatics, antibodies and hormones. Next step is to investigate these product types.

Safe medicine practices: a multidisciplinary approach

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European Statement

Patient Safety and Quality Assurance

Author(s)

Betânia Abreu Faria, Sara Barroso, Antonieta Silva, Olga Martins

Why was it done?

Portuguese legislation “The Basic Health Law (No. 95/2019) and the National Plan for Patient Safety 2021-2026 (NPPS 2021-2026) and the goals of the World Health Organization (WHO) are fundamental pillars of healthcare safety. The NPPS has promoted patient safety in the Portuguese National Health Service, focusing on specific issues such as safety culture, unambiguous identification of patients, safe surgery, pressure ulcer prevention, prevention of falls, infections associated with healthcare and incident reporting and drug safety. Thus, it is essential to ensure the training of health professionals (HP) in the field of patient safety and the safe and rational use of medicines. The objectives of the training actions focused on the safe use of medication, promoting patient safety and sharing experiences between the various HP, in order to optimise the circuits and procedures already implemented.

What was done?

Multidisciplinary training actions were carried out within the scope of safe medicine practices.

How was it done?

A team of four pharmacists and one nurse carried out training actions in the context of Safe Medicines Practices. The following topics were addressed: medicine circuit; good practices in drug preparation; identification of medicines: Look-Alike Sound-Alike (LASA) and High-Alert Drugs; physicochemical incompatibilities; factors that modify stability after reconstitution/dilution; fractionation and crushing of Solid Oral Pharmaceutical Forms (SOPF); drug information sources; reporting adverse drug reactions and other incidents; good practices in medication administration. 

What has been achieved?

Training actions were carried out with a total of 29 hours of training and 357 participants. Suggestions for improvement were presented: optimisation of drug signage, compliance with established circuits, logistical aspects, on time drug information, improvement of communication channels, increase in the frequency of training actions. The trainees expressed receptiveness and interest in this initiative, which provided content that was little discussed and very relevant to their daily practice. 

What next?

The correct preparation and administration of medicines is essential to safeguard their effectiveness and patient safety, which is the ultimate goal of every health professional’s daily activity. The Pharmacist, as part of the multidisciplinary team, must promote strategies that safeguard Safe Practices throughout the drug circuit. Hence it is important to ensure the continuity of these trainings.

Creation of an ‘Agrippal’ programme to fight against nosocomial flu

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European Statement

Introductory Statements and Governance

Author(s)

Alexandre Benaiche, Mickael Tachon, Nathalie Arnouts, Amandine Gradelle, Kadidja Gribi, Remi Parsy

Why was it done?

The ‘Agrippal’ programme was created to strengthen the anti-influenza herd immunity in our hospital and reduce the risk of nosocomial influenza. It was then necessary to improve both the vaccination rate of the staff and the inhabitants of the institution’s living area who were potential users. The vaccines were previously distributed in departments and injections made by the nursing staff without any traceability. The purpose was also to improve knowledge about anti-influenza vaccination among staff and users.

What was done?

Our Healthcare-Associated Infectious Risk Prevention Unit (made up of hygienist pharmacists and nurses) launched a programme to fight against nosocomial influenza in our institution in winter 2018 to promote vaccination among staff and users and inform them about vaccination inside and outside the hospital.

How was it done?

Information conferences were held inside and outside the walls of the hospital for staff and residents of the city thanks to a partnership with the municipality to finance these events and communicate about their occurrence. Information materials (flyers) have also been made available to departments and some key departments (Emergency, Consultations, Obstetrics) were encouraged to inform patients at risk and their families about the positive impact of vaccination with provision of Health Insurance reimbursement forms. Our Healthcare-Associated Infectious Risk Prevention Unit created a Mobile Vaccination Team to vaccinate staff directly in the departments and encourage those who have not been vaccinated to do so.

What has been achieved?

The staff flu vaccination rate increased sharply, from 19% and 17% respectively in 2016 and 2017 to 34% in 2018 and 39% in 2019. Among vaccinated staff, 25% in 2018 and 17% in 2019 were primary vaccinated. Although the impact of actions aimed at users is difficult to measure, the number of nosocomial flu has been reduced in our hospital from 3.14 per 10,000 days of hospitalisation in 2017 to 0.58 and 0.61 respectively in 2018 and 2019.

What next?

This initiative has made it possible to double the rate of vaccinated staff in our institution and strengthen patient protection by reducing the risk of nosocomial flu. It only required a period of consultation between different actors without creating additional financial and human resources.

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