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Disposable Closed System for Sterile Drug Preparation and administration

European Statement

Patient Safety and Quality Assurance

Why was it done?

Our proposed system comes from the idea of a large clean room with pressure regimes, and airlock, hoods and other ancillary equipment, Which we made from it a very small clean room that is our box, when there will be no need for us as operators to get into it, or very simply take only those parts that are supposed to be sterile, and only those parts that are the two ends of the infusion bag and the end of the medicine vial

What was done?

“Closed” and airtight system for preparation (reconstitution, measurement, dilution) and injection of IV drugs at the patient’s bedside, in the various clinics and further home treatment, Disposable system, All its parts come in one piece without the need for threading, or assembly and disassembly
Estimated dimensions: 10 cm length, 5 cm width and 3.5 cm depth or similar, its shape can be rectangular or any shape convenient for use operation storage and destruction at the end of the process
Intended for a wide range of types of drugs – such as intravenous antibiotics, cytotoxic drugs, biological drugs, etc.
Designed according to its different variations for different types of vials and different amounts of drugs that come as a dry powder for dissolution, and are also suitable for drugs that come in the dissolved liquid form.
It is also intended for use with glass ampoules and there is a wide range of drugs that still come in glass ampoules
Intended for administration of drugs that do not need to be diluted in an infusion bag given in IV PUSH

How was it done?

We designed the device with 3D software (solid wark). It consists of a number of functional parts,
The sterile closed system comprises an airtight enclosure, which is shaped so as to define an enclosure interior; and an infusion-bag receptacle. An infusion-bag seal is configured, when in a sealing state, to make an airtight seal with respective external surfaces of a medication port and an IV tubing port of a bottom region of the infusion bag, when the medication port and an IV tubing port are inserted into the infusion-bag receptacle.

What has been achieved?

The proposed solution and its advantage
– A single-use system built in one piece, without the need for assemblies, disassembles, etc.
It will be possible to perform the entire process in one place, such as at the patient’s bedside or in the clinic, starting with the powdered drug dissolving process, mixing a measured dose, mixing it in an infusion bag and injecting it into the patient’s vein safely and accurately.
Maintains the perfect process under sterile conditions without fear of contamination of the injected drug
– Preparation in a system that is safe for the immediate environment and safe for the caregiver himself from contamination of drugs such as cytotoxic drugs, antibiotics and more
Savings in building very expensive infrastructure of clean rooms
Saving on very expensive disposables, such as closed system transfered deviced, robes and more
Save valuable work time dedicated team of pharmacists, nurses work time, work time transportation, storage places and more
Minimize the chance of errors in administering medications and confusion between different medications
Working with non-exposed needles reduces the chance of needle prick injury

What next?

Applied research will be carried out by pharmacists and nurses, in order to test the efficacy and safety of the device (by using a basic prototype), these experiments will use different IV administration drugs, we will test the method of dilution from a drug vials and glass ampoules, measure the exact dose and transfer to the infusion bag, and remove through the IV line, the accuracy of the preparation, the sterility of the preparation, the quality in terms of leakage or drip, comfort, safety and more are measured.

Assessing the Application of Essential Medication Errors Prevention Strategies in Healthcare Institutes: STOP Medication Error Project

European Statement

Patient Safety and Quality Assurance

Author(s)

Monira Alwhaibi

Why was it done?

This study is the first project of the STOP ME projects which aims to develop a tool that can assess the application of the essential strategies that can stop or minimize MEs in healthcare institutes in Saudi Arabia. Consequently, stakeholders in the healthcare system can identify current gaps that need feature improvement to enhance patient safety

What was done?

Medication Errors (ME) are defined as unintentional drug-induced harm that led to morbidity and mortality. The STOP (ME) project is a comprehensive series of research studies that aim to explore MEs in Saudi Arabia and how to stop such harmful events.

How was it done?

Extensive search of the literature review for the essential strategies to stop or minimize MEs was carried by the research team to develop a draft of the aimed tool. The survey tool was sent in round 1 to the Delphi experts’ panel for review. Based on received recommendations, the tool was updated and sent for round 2 review and consensus. The developed tool was then piloted to test the practicability of the tool before running the survey on large sample size (second project). The study was approved by the King Saud University Medical Centre IRB ethics committee [20/0153/IRB].

What has been achieved?

After using the Delphi technique two major changes happened to the survey. 1) Section A was removed (high alert medications). 2) A new section was added (ISMP publications) with some minor changes. Launching a pilot survey on thirty healthcare practitioners (physicians n=11, pharmacists n=10, nurses n=9) resulted in further minor changes by adding two new columns. The final tool was a survey consists of six sections including Demographics, Prescription, Dispensing, Administration, Monitoring and Quality, and Targeted Medication Safety Best Practices for Hospitals. All combined 86 questions with the determined time to answer the survey is in the range of 25-30 minutes. Overall feedback of the pilot survey was good.

What next?

This initiative “STOP ME” will have a significant impact in the field of medication safety research and will build awareness among institutes in Saudi Arabia that are lacking important strategies that prevent MEs

IMPROVING HIGH-RISK DRUG PRACTICES IN THE EMERGENCY DEPARTMENT – A MULTIDISCIPLINARY APPROACH

European Statement

Patient Safety and Quality Assurance

Author(s)

Mariosa Kieran

Why was it done?

Review of the 2019 Health Information and Quality Authority (HIQA) Medication Safety Monitoring Programme, and in-house Emergency Department (ED) medication variances review identified that risk reduction strategies for specific high-risk drugs and high-risk situations were required.

What was done?

A multidisciplinary team reviewed and implemented initiatives to improve medication safety practices for procedural sedation, emergency tray drugs and ketamine use in emergency settings was undertaken.

How was it done?

• Multidisciplinary teams (MDT) of key stakeholders were formed to review each high-risk drug / practice requiring improvement.
• The MDT developed the required procedures and policies that were further reviewed and approved by the relevant hospital committees.
• The MDT supported roll out of the improvement initiatives through communication, staff education and process review.

What has been achieved?

• A hospital wide procedural sedation policy and patient information leaflet was developed. Competencies for staff that perform procedural sedation have been identified. A specific procedural sedation incident report form has been piloted. A poster detailing the process for sedation reversal is in development.
• Emergency tray drug preparation, storage and use has been standardised across all hospital settings, including the introduction of dedicated emergency drug bags. The bags enable prompt drug retrieval during emergencies and supports safe storage, documentation and disposal of used /unused emergency drugs.
• A protocol for ED use of ketamine was developed. The protocol supports safe use of ketamine for specific emergency indications for which there is little published information, e.g. procedural sedation, analgesia and agitation.
• The initiatives were implemented and included in ED simulation training.

What next?

The described medication safety initiatives have considered the practice challenges for high risk drug access and use in emergency settings. The initiatives have standardised processes for specific high-risk drugs, supporting safer use. MDT collaboration ensured early and ongoing staff engagement from applicable disciplines, facilitating implementation and practice changes. Evaluation of the initiatives in practice is currently under review. The initiatives and learnings are transferrable to other emergency clinical settings.

Elaboration of a Good Practice Guide for the administration of parenteral antibiotics at children’s hospital

European Statement

Patient Safety and Quality Assurance

Author(s)

MOHAMMED ADNANE EL WARTITI, WAFAA ENNEFFAH, BOUCHRA MEDDAH, MUSTAPHA BOUATIA

Why was it done?

The GPG was developed in a concern of practices standardization to guarantee the safety and efficacy of parenteral antibiotics, especially those stored in vials which reuse in possible only if conditions of administration and stability are respected.

What was done?

We developed a Good Practice Guide (GPG) for the usage of major available parenteral antibiotics.

How was it done?

After we listed all parenteral antibiotics available at the hospital pharmacy, we selected the most used ones and we synthesized all manufacturers’ data to establish a GPG for their administration. We also used literature data to complete missing information in “Summaries of Product Characteristics” related to pediatric use of these drugs. Finally we determined the most antibiotics consuming units according to their defined daily doses, where GPG recommendations will be implemented, before their extension to all other units.

What has been achieved?

The GPG concerned the most used antibiotics, which mainly belong to the following classes: Beta-lactam, Glycopeptide and Imidazole antibiotics, Aminoglycosides and Quinolones. It specifies the galenical presentation, used solvents, volume and duration of administration, stability after reconstitution as well as incompatibilities and special measures relating to the use of these drugs. The most antibiotics consuming units are pediatric intensive care units, “IIB” pediatric unit and pediatric surgical emergency department.

What next?

The approach used in this work can be adopted in other similar structures in order to establish GPGs within the framework of a quality control policy aiming to raise the standard of care.

Drone delivery of prescription medicines: contact-free, direct-to-consumer shipment reduces risk of Covid-19 infection for vulnerable populations

European Statement

Patient Safety and Quality Assurance

Author(s)

Jon Michaeli, Bryan Li

Why was it done?

The novel delivery method provides an on-demand option for senior citizens at higher risk of serious Covid-19 infections to receive health essentials while maintaining social distancing. The program launched before Covid-19 vaccines were publicly available, and was sustained during a period of especially intense Covid-19 spread in the US from Nov 2020 – Jan 2021.

What was done?

In early May 2020, Matternet, CVS, and UPS launched direct-to-consumer drone delivery of prescription medicines and other health goods to The Villages, the United States’s largest retirement community with more than 135,000 residents. The operations have expanded in scope since and are ongoing

How was it done?

The drone flights were conducted by Matternet’s M2V9 UAV platform and drew upon the companies’ experience operating other US healthcare drone networks. Deliveries are dispatched from CVS store 8381 and flown to New Covenant United Methodist Church, with final delivery to front porches via golf cart. This is an important milestone on the journey to drone delivery to individual homes at scale.

What has been achieved?

Matternet and UPS have completed 2,500+ deliveries to date. The partnership has expanded operations to Elan Buena Vista, another retirement community nearby. The program’s success helped pave the way for other healthcare drone programs, including a new route at Wake Forest Baptist where Matternet and UPS are transporting Pfizer-BioNTech Covid-19 vaccines (first ever in the US).

What next?

Full automation achieved via Matternet’s proprietary drone port, the “Station,” will permit pharmaceutical drone delivery at scale and accelerate the roll-out of city-wide networks that give pharmacists more flexibility around where and how patients receive medicines. These networks will support and accelerate the shift to tele-health and “hospital at home” as well as just-in-time inventory management, with significant potential to reduce medical waste through stock centralization. First commercial deployment of the Station occurred in Lugano, Switzerland in September 2021. The same month, Matternet announced a partnership with the Abu Dhabi Department of Health and the UAE’s General Civil Aviation Authority to launch a city-wide medical network serving 40+ locations by 2023. Similar systems are planned for Europe, in cities such as Zurich, Berlin and Athens.

MEDICATION ERRORS RELATING TO ISOAPPEARANCES AT THE EMERGENCY ROOM

European Statement

Patient Safety and Quality Assurance

Why was it done?

To achive the international Organization for Standardization (ISO)´s objectives related to medication errors.

What was done?

A multidisciplinary isoappearances group formed by a clinical pharmacist, a nurse, and two physicians has been set up on site at the ER.

How was it done?

Observational study.

What has been achieved?

In the future, hopefully medication errors at the emergency setting would be reduced.

What next?

Because the Isoappearance group will promote patient safety.

ANTICHOLINERGIC MEDICATION IN HOSPITALIZED PATIENTS

European Statement

Patient Safety and Quality Assurance

Author(s)

SILVIA CORNEJO-UIXEDA, M JOSE MARTINEZ-PASCUAL

Why was it done?

The anticholinergic burden is the cumulative effect of concomitantly taking multiple drugs with anticholinergic properties. It estimates the risk of suffering anticholinergic adverse effects. Anticholinergic scales are lists that rank the anticholinergic potential of drugs into categories.

What was done?

Our aim is to know the use of drugs with anticholinergic effect (ACD) in a regional hospital.

How was it done?

Observational study in patients older than 70 years admitted to a regional hospital from January to September 2021. We reviewed the medication of the patients looking for ACD. Then, we calculated anticholinergic burden with the “Drug Burden Index” available in: http://www.anticholinergicscales.es/calculate. The variables collected were: age, gender, number of drugs with anticholinergic effect, if ACD were prescribed before hospitalization, readmission, anticholinergic burden, risk of suffering anticholinergic effect and anticholinergic symptoms.

What has been achieved?

average 81 years (70-100), 102 (56% woman), 46 (25%) did not have any ACD. 58 patients had 1 ACD, 56 patients 2 ACD, 12 patients 3 ACD, 8 patients 4 ACD, 2 patients 5 ACD. Of patients with ACD, anticholinergic burden average was 0.98 in surgical patients (medium risk) and 1 in medical patients (elevated risk). 68 patients had medium risk and 68 patients elevated risk. We found constipation in 17 patients, somnolence in 6 patients, and disorientation in 2 patients. ACD used were the following (surgical vs. medical patients): Antidepressants: 3 vs.10, benzodiazepines: 28 vs. 33, opioids: 17 vs. 27, antiemetics: 13 3 vs. 38, Antipsychotics: 4 3 vs. 49, antihistamines: 2 vs. 2, antiepileptic: 0 vs 9, other: 0 vs. 3.
56 patients (31%) were prescribed the same ACD that they took before hospitalization. Only 17 patients were readmitted in hospital in less than a month.
We just made 2 interventions. We proposed to lower the dose in one case. In another, we proposed give metoclopramide just if necessary.

What next?

Most of hospitalized patients have ACD prescribed. Half of them had a high risk. However, just a few had anticholinergic reactions. This could be explained because we only had the information of electronic history and maybe some of them were not collected.

Optimizing information on the fecal microbiota transplantation circuit

European Statement

Patient Safety and Quality Assurance

Author(s)

Julia Santucci, Céline Vaesken, Guillaume Saint-Lorant

Why was it done?

FMT is a therapy introduced in 2016 at the hospital. It is indicated for the management of recurrent and refractory Clostridioides difficile (CD) infections. In November 2020, with the resumption of the activity, we note a lack of knowledge of the different actors on this circuit: physician, nurses, fellows, patients himself.
The objective of the study is to reinforce the understanding and safety of the FMT circuit in a university hospital after the evaluation of the knowledge of the different actors.

What was done?

Implementation of a document to represent the circuit of fecal microbiota transplantation (FMT) in a French university hospital.

How was it done?

In this context, two questionnaires containing less than five questions on the functioning of the circuit were carried out with the nurse coordinators (NC) and the interns of the hepato-gastrology department. Subsequently, a document was drafted in consultation with the referring physician, the head of department and the pharmaceutical team to represent the FMT circuit.

What has been achieved?

With regard to the questionnaires, we obtained six answers from the NC, with 42% correct answers, 25% partial answers and 33% incorrect answers, and then six answers from the residents, with 20% correct answers, 7% partial answers and 77% incorrect answers.
These questions made it possible to draw up a diagram adapted to A4 format intended for all the actors in the circuit. It defines the different missions of all the actors with the corresponding deadlines and associated procedures.
In order to improve information, two interventions were carried out by the pharmacy: a staff meeting dedicated to the management of CD infections with the interns, co-hosted with the referring physician, and a presentation of the circuit to the NC.

What next?

Finally, this study made it possible to reinforce the safety of the FMT activity for the patient and to improve the management of the circuit for the various health professionals involved in this specialized therapy.

Impact of introducing a Unit Dose blister service in an Austrian hospital

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European Statement

Patient Safety and Quality Assurance

Author(s)

Theodora Steindl-Schönhuber, Gittler G.

Why was it done?

Medication dispensing is a time-consuming, labour-intensive, error-prone process in the daily routine on the wards. The project was triggered by the tight personnel situation during the Coronavirus pandemic: In November 2020 three wards with COVID-19 patients (91 beds) were integrated into our Unit Dose blister service to assist the nursing staff. A multidisciplinary effort (management, IT-department, doctors, nursing staff, pharmacy holding a GMP-manufacturer´s certificate) and long-established electronic patient records including medication data enabled fast realisation.
After transformation back to a chirurgical, an internal and a geriatric ward the service was continued and extended to the neurological unit (49 beds) due to positive feed-back. We wanted to study the observed positive effects of Unit Dose supply in more detail.

What was done?

In our hospital medication distribution has been switched from manual dispensing by ward staff to automated Unit Dose blister packaging by the pharmacy. Our study investigates the impacts of this change on medication safety, staff satisfaction, time and drug resources.

How was it done?

The percentage of pharmacy-blistered drugs, time gain for nursing staff, employee satisfaction, medication consumption and erroneous blister fillings were investigated.

What has been achieved?

Unit Dose in hospitals is not standard for many countries and is so far unique in Austria. Therefore, we would like to share our experiences and findings with our colleagues: Solid, oral dosage forms could be supplied by 99% via Unit Dose. Time for manual drug dispensing was reduced by 75%. A survey showed high employee satisfaction with the supply process as well as the quality and correctness of the blisters. Consumption of blisterable drugs and stocks on the ward were reduced by 44% and 78%, respectively. Errors in blister fillings in our setting amount to 0,006%. When compared to literature references on error rates for manual medication dispensing (up to low double-digit rates), patients benefit from increased drug therapy safety. On the basis of these results our initiative was granted the Austrian Patient Safety Award 2021 in the field of medication safety.

What next?

We plan to extend Unit Dose to the remaining wards and to investigate patient satisfaction with the blisters, cost-efficiency and distribution of high-cost medications.

Improving Patient Safety: A step forward in reducing missed medication in the Emergency Department (ED)

European Statement

Patient Safety and Quality Assurance

Why was it done?

Long waiting times and delays in patients leaving ED increase the risk for missed doses. Medication reviews and analysing incident reports identified missed doses as a patient safety issue where the strategies implemented aimed to improve this.

What was done?

Reducing missed doses and improving patient safety was addressed as follows:
 Integrated pharmacy service was established
 Audit completed
 Education model developed
 Stock list reviewed

How was it done?

Integrated pharmacy service:
-Outlined the role of the pharmacy team in ED.
-Pharmacist medication review service established which identified medication incidents particularly missed doses.
-Pharmacy technician role expanded: Reviewed patient charts, identified issues, collaborated with the ED team, and dispensed medication in medication
transfer bags.
-Implemented medication transfer service: Individual patient medication transfer bags were sent from ED to the transfer ward ensuring timely availability
of medication during transitions of care.

Data collection and analysis:
-Quantified missed doses and reviewed the percentage of these which were time-critical. Time-critical medications are medications where timely
administration is crucial to prevent patient harm.

Education model:
-Developed and implemented a pharmacy technician training programme: This ensured an optimal medication management service.
-A local list of time-critical medication was agreed upon. A poster was developed and erected in ED to highlight time-critical medication.
-Structured and targeted multi-disciplinary education was provided on time-critical medication and the impact of missed doses.

Stock list modified so medication was immediately available in ED. Capacity in the automated dispensing unit (ADU) was an obstacle so the ADU was reconfigured to overcome this.

What has been achieved?

 A clinical pharmacy service was established which reduced medication errors.
 Missed doses decreased by 75%.
 Time-critical medications are readily available.
 Medication transfer bags ensured timely availability of medication during transitions of care.
 Education model implemented which improved patient safety.

What next?

 Continue the integrated pharmacy service in ED.
 Missed doses will be assessed through point prevalence surveys, medication reviews, and incident reports.
 Extend the education model to other areas of the hospital and apply learning.
 This initiative can be adapted to other hospital settings.