Skip to content

Development of standard kits with utensils for outpatient parenteral antibiotic therapy

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Louise Rasmussen Duckert, Marianne Kjettrup Jensen, Mette Lethan, Trine Schnor

Why was it done?

The hospital pharmacy wishes to support the implementation of OPAT and during the process the need for standardised kits with utensils was identified. The availability of kits with necessary utensils for aseptic handling of parenteral infusion would simplify and standardise the work for hospital and home nurses. Considerations regarding patient safety and sustainability were also in favour of the kits, as choice of utensils could secure compliance to regional guidelines considering use of closed systems and rinse of the line after infusion. Kits containing the exact needed utensils for an administration also reduces the possible waste.

What was done?

The hospital pharmacy has composed standard kits with utensils for outpatient parenteral antibiotic therapy (OPAT).

How was it done?

The kit is composed in collaboration between the pharmacy, hospital nurses and home nurses. The best suited infusion set was chosen – a closed system with two spikes for antibiotic mixing and infusion. Hereby nurses avoid direct contact with antibiotics and avoid antibiotic aerosols in the citizen’s home. The infusion set contains no PVC, phthalates or latex. When fully emptied the infusion set can be discarded as regular waste.
The kit also contains a sterile cover for the workstation, sterile ethanol swabs, gloves, pre-filled saline syringes for rinse of the line after infusion and a written manual. All is packed and labelled by the hospital pharmacy and lot numbers are registered for traceability.

What has been achieved?

The kits have been tested in selected municipalities and the content of the kit has been adjusted. As a result of the feedback a film has been recorded showing the handling of the infusion set. The video is used for training and a QR code on the written manual guides the home nurse to the video if needed. The kit is now used widely in the region and response is positive. With the set-up being identical in all municipalities in the region, handling antibiotics and utensils is simpler for the hospital nurse at discharge.

What next?

As the number of patients in home-based OPAT rises, experiences with the kits will probably result in wishes for adjustments. A new kit with utensils for changing PVK is under development.

Development of method for mobile aseptic preparation of advanced therapy medical products

European Statement

Production and Compounding

Why was it done?

The pharmacy received a request for reconstitution of an ATMP Luxturna. The pharmacy or hospital did not have a suitable aseptic facility that could perform the reconstitution in a way that allowed the ATMP to be administered to patients before the expiry after reconstitution (max. 4 hours).

What was done?

Development of a single use isolator for advanced therapy medical products (ATMP) or gene therapy drug preparation was undertaken. The single use isolator had to be mobile to enable pharmacy staff to preform reconstitution directly on ward or in OP-theatre. It had to comply with Health and Safety regulations and at the same time make it possible for pharmacy staff to use aseptic technique to be able to reconstitute ATMP.

How was it done?

A review of isolator technology was performed, and a suitable solution identified. The set-up was further developed in a team with representatives from pharmacy, the eye department at Rigshospitalet-Glostrup. A manufacturer of the equipment was selected, and development performed. The set-up for ATMP preparation was presented to The Danish Health and Safety (DHS) department responsible for handling this type of treatment. The approval was granted after a standard 90-day period. Pharmacy staff were trained in working with the set-up and a dry run made in the eye theatre with the full surgical team.

What has been achieved?

10 patients (19 eyes) have been treated, 4 male and 6 female patients with age span 12-39 years. After having performed the procedure twice there was enough routine to treat 2 patients per theatre day hence reducing the cost of preparation and increasing efficiency of the team.
The pharmacy and surgical team have established a great working relationship and now consider the set-up as routine.
In spring 2021 the set-up was approved by (DHS) for reconstitution of Zolgensma. On July 1 a pediatric patient was treated with Zolgensma using the method.

What next?

Plan to develop the method further and make it available for coming preparations of ATMPs and share knowledge of the method with other hospital pharmacy organizations.

DEVELOPMENT OF A STANDARDISED PAEDIATRIC PARENTERAL NUTRITION FOR THE FIRST DAYS OF LIFE OF A TERM OR PRETERM NEWBORN

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Isabelle Sommer, David Palmero, Céline Julie Fischer-Fumeaux, Lydie Beauport, Vincent Adamo, Hervé Schwebel, Pascal Bonnabry, Lucie Bouchoud, Farshid Sadeghipour

Why was it done?

PN can be composed of about 50 different ingredients, whereof the majority are amino acids (AA). Therefore, PN represents a complex and high-risk fabrication. ME are often related to PN and may include prescription, transcription, preparation, and administration errors. As the treatment with PN is indispensable for a good cerebral and neurologic development as well as a postnatal weight gain, ME can result in growth retardation, developmental disturbances, and infections.
This project was performed with the aim to reduce ME having an impact on vulnerable newborns and to improve the security and quality of their nutritional treatment.

What was done?

A standardized pediatric parenteral nutrition (PN) solution for the first days of life of newborn infants has been developed. An industrial partner manufactures the ready-to-use double-chamber bag which is available 24/7 and of high-quality allowing a secured administration as well as a reduction of medication errors (ME).

How was it done?

A working group composed of pharmacists, clinicians, neonatologists, and industrials developed a PN solution for the first days of life of newborn infants conforming to the needs of two different neonatal services. An applied standardized PN and the ESPGHAN guidelines haven been used as references. The feasibility of an industrial production of double-chamber bags has been evaluated and implemented.

What has been achieved?

The developed PN solution has been formulated for a peripheral venous administration with an osmolarity under 900 mOsm/L to allow a wider range of application. The production of double-chamber bags has been chosen to increase the stability and shelf-life. The first compartment contains an AA admixture and the second compartment contains glucose and electrolytes (sodium, calcium, organic phosphate). This solution is initially produced by the service of pharmacy and afterwards by the industrial partner. The standardized PN bag has been implemented successfully on the neonatal ward in March 2019. Since then, almost 1800 standardized bags have been used (appr. 90 bags/month), resulting in a reduction of individual on-ward PN preparations of nearly 80%.

What next?

Further standardized PN for newborn infants need to be developed to allow a safe nutritional treatment. On-ward PN preparations must be prohibited to prevent undetectable preparation errors.

DESIGN OF AN ANTI-HAEMORRHAGIC AGENTS PROTOCOL FOR AN INTENSIVE CARE UNIT (submitted in 2019)

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Mercedes Gómez-Delgado, Marta Valera-Rubio, Margarita Carballo-Ruiz, José Luis Ortiz-Latorre, Isabel Moya-Carmona

Why was it done?

Blood coagulation factors and their adequate use can be of particular importance in the treatment of massive haemorrhage, especially in the ICU. This initiative was taken in order to improve uptake and to avoid errors in the administration, which can be difficult in emergency situations.

What was done?

To define an emergency procedure that ensures correct management in cases of massive bleeding in an intensive care unit (ICU).

How was it done?

The development of drug use protocols for emergency situations is a simple task that facilitates health workers to manage them. Prioritising the drugs to be included in a protocol by a previous survey in a multidisciplinary setting is important to consider the different points of view. We carried out a review of the pharmacy service to the ICU needs of antihaemorrhagic drugs. ICU staff (doctors and nurses) were informed to reach an agreement about eligible drugs for being included in the protocol. ICU staff requested the inclusion of four drugs in the protocol according to the prevalence of use and the difficulty of administration: human fibrinogen, tranexamic acid, eptacog alfa and human prothrombin complex. We created a protocol with four information sheets, one of each drug, made of schematic information about: 1. Physical location (fridge or room temperature, number of shelf) and minimum safety stock (3 units of human fibrinogen, 4 units of tranexamic acid and 3 units of human prothrombin complex). 2. Indications and dosage according to the clinical situation and the patient characteristics (dosage adjustment according to renal or hepatic impairment, weight or age when applicable). 3. Recommendations for intravenous administration (flow rate, bolus, loading dose, dilution, mixture stability).

What has been achieved?

Mapping the information and dividing it into sections is essential for its rapid understanding in a high-stress work environment. The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient health care circuit for the ICU staff. It also optimises the consumption of this type of more monitored drugs.

What next?

We will monitor the compliance with this protocol, as well as possible updates that may be beneficial for a better understanding of the forms of administration.

STANDARDISATION OF DILUTED POTASSIUM INTRAVENOUS SOLUTIONS IN NEONATAL CARE UNITS (submitted in 2019)

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

Luis Pérez de Amezaga Tomás, María Magdalena Parera Pascual, Mónica Sanz Muñoz, Catalina March Frontera, Gonzalo González Morcillo, Alejandra Mandilego Garcia, Álvaro Medina Guerrero, Ana Filgueira Posse, Montserrat Vilanova Boltó

Why was it done?

Administration of intravenous KCl produces hyperkalaemia and this can result in cardiac arrest and death. The Institute for Safe Medication Practices (ISMP) as well as other security agencies have recommended the withdrawal of KCl 2M from ward stock. This project was born as a response to these recommendations. We focused on a group of patients where these practices have not been extensively implemented. The aim of the protocol was to standardise the prescription, preparation, dispensation and administration of KCl to neonates in our hospital.

What was done?

Development of a protocol that standardises diluted potassium intravenous solutions for neonates (including those preterm over 28 weeks of gestation). This allowed us to remove concentrated potassium chloride (KCl) 2M from neonatal care units in our hospital. For this purpose, the hospital pharmacy centralised the preparation and distribution of KCl ready-to-use infusions.

How was it done?

The elaboration of the protocol took place as follows: • A multidisciplinary team designed KCl ready-to-use solutions that met the requirements of the newborn: – Glucose 10% 250mL with 5 mEq KCl (20mEq/L solution) – Glucose 10% 250mL with 10 mEq KCl (40mEq/L solution). • The hospital pharmacy centralised the preparation of these solutions. A risk assessment was performed and determined an expiration date of 7 days. • These solutions were stocked at all neonatal care units: Intensive Care Unit, Hospitalized Paediatric Unit and Paediatric Emergency Unit. • Weekly, the hospital pharmacy distributes these solutions and disposes of the expired ones. • Only ready-to-use KCl solutions were able to prescribe at the electronic prescription programme. • A formation plan was implemented to train all the professionals involved in neonatal care.

What has been achieved?

The protocol was implemented in November 2016. Since then, 65 patients have been treated with 20mEq/L solution and only 1 patient with 40mEq/L solution. No remarkable imbalances in electrolytes have been detected resulting from the standardisation of the fluid therapy with KCl. Only 3 incidents have been registered. All of them were prescription errors (solution selection); they reached the patient but without damage.

What next?

Nowadays, we are developing a stability study of the KCl solutions in order to assess the appropriateness of the expiration date.

PROMOTING THE USE OF SAFER INJECTABLE MEDICINES USING A NOVEL METRIC

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

Gillian Cavell

Why was it done?

Despite the availability of RTU and RTA formulations of high-risk injectable medicines they were not always used. We developed the metric, to compare the use of RTU and RTA injectable medicines with the use of concentrates requiring further dilution or manipulation prior to administration e.g. dilution of morphine 10 mg/ml to 10 mg/10 ml prior to intravenous administration, e.g. withdrawal of 5 x 10 ml fentanyl 500 mcg/10 ml into a 50 ml syringe for continuous infusion, and identify areas for improvement.

What was done?

We have developed a series of metrics to measure compliance with national guidance for the safe use of injectable medicines. The guidance recommends use of ready-to-use (RTU) or ready-to-administer (RTA) injectable products, where these are available, to reduce the risk of patient harm from errors in the preparation of injections and infusions on hospital wards.

How was it done?

The metric utilises pharmacy-issue data to compare the number of units of RTU or RTA formulations issued to wards and clinical areas with the numbers of units of alternative products of the same drug entity. Expressed as a percentage the metric informs the organisation of the extent to which safer injectable medicines are being used, providing a baseline against which to review practice and reinforce the need to use alternative, safer formulations. A high percentage indicates good compliance.

What has been achieved?

The metrics have been used to successfully maximise the use of a range of safer formulations including RTA potassium chloride, RTU fentanyl 2500 mcg/50 ml vials for critical care infusion, 100 mg/10 ml paracetamol in neonatal units and RTU magnesium sulphate 20% (50 ml vials) for obstetric emergencies. Since the introduction of the metrics in 2016 a monthly scorecard of performance is reviewed by the Hospital Medication Safety Committee to identify and account for deviations.

What next?

The metrics are being shared with other organisations to benchmark performance. Ideas to promote implementation and business cases can be shared between organisations who may find implementing RTA and RTU injectable medicines challenging, especially where these are more expensive than formulations in established use.

A SET OF QUALITY IMPROVEMENT INTERVENTIONS TO INCREASE THE PERCENTAGE OF STAT IV MEDICINES, MEETING THE GOAL OF BEING READY WITHIN 30 MINUTES

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

MELINDA LITAO, HANY ELATROUSH , KHATHLEEN ESER, ARWA AFANA, AHMED BAIBRAHIM, JAYSON DE JUZMAN, BAYAN RAMBO, DERI PASCUAL, MA ENCARNACION DELOS ANGELES, MANAL SALLAM, MALIK KHUWAJA

Why was it done?

STAT orders have always been a priority, however there are some areas which require some modification in the workflow to attain higher efficiency and to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

What was done?

A set of quality improvement interventions to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

How was it done?

This was a pre-post study in a government hospital between January and September 2018. LEAN and FOCUS-PDCA models were implemented to design the process of improvement. A medication-tracking system (MedBoard) was used to collect the data to measure the number of STAT IV medicines ready within 30 minutes. Data was also collected from the number of phone calls and faxes received from the day procedure unit (DPU) and home health care unit (HHC).

What has been achieved?

The cumulative data showed an increase in the percentage of STAT IV medicines being ready by 7%, equivalent to 707 orders per month (90% vs 97%), a reduction in the number of phone calls by 87.5% (48 vs six calls per day) and fax by 100% from the DPU and HHC units, which means that implementing the set of interventions were associated with an increase in percentage of STAT IV medicines being ready within 30 minutes. Additionally, there was a significant decrease in the number of phone calls and faxes, which allowed pharmacists to focus more on STAT IV orders.

What next?

Since the hospital pharmacy receives numerous orders on a day-to-day basis, this will facilitate prioritisation during the entire process. This aligns with the hospital goal of attaining ‘zero harm’, and is therefore a good example of good practice in a hospital setting. The use of Medboard in tracking medications and monitoring performance can be applied to allow any healthcare setting to ensure that goals are reached, and performance is maintained at the highest level. Designing a list of eligible medications that can be ordered as STAT can be used as a guide to avoid the abuse of STAT orders and can help in prioritising order preparation in the STAT IV room.

×

EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.