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A risk-based choice of syringes and associated equipment for compounding and intravitreal administration of drugs for wet age-related macular degeneration

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European Statement

Production and Compounding

Author(s)

Espen Gleditsch, Dag Fossum

Why was it done?

There are no available syringes with CE approval for intravitreal administration. The CE approval for sterile single use syringes covers dosage and sterility, but not the special needs associated with intravitreal administration. The choice of syringe and associated equipment therefore have to be based on a risk assessment. The intravitreal administration includes increased patient risk regarding sterility (infection), particles (inflammation), injection volume (ocular pressure), silicone oil (floaters in the vision) and technical performance (leakage and compatibility with needle). The aim of this work was to find the syringes, associated equipment and compounding process that present least risk to the patients.

What was done?

Oslo hospital pharmacy delivers ready to use syringes for intravitreal administration of drugs for wet age-related macular degeneration. The pharmacy has in cooperation with the eye department at Oslo university hospital done a risk assessment in 2023 to decide syringes and associated equipment for compounding and administration.

How was it done?

The syringes historically used for intravitreal administration in Norway are Insulin syringes with prefixed needles (BD), Inject F syringes (BBraun) and Zero Residual syringes (SJJ Solutions). The needles used are TSK Low Dead Space needles and Zero Residual needles. The compounding methods are filling of the ready to use syringe from a bulk syringe by a needle or use of a Zero Residual bubble adaptor. All ready to use syringes are compounded in isolators with grade A in the working chamber, delivered with needle or cap, and packed in sterile bags. The risks associated with each syringe, needle and compounding process were assessed with a Failure Mode Effects Analysis Method.

What has been achieved?

The risk assessment shows that the risk to the patients are lowest when administering drugs for wet age-related macular degeneration with Zero Residual syringes and needles, filling the syringes with bubble adaptor and deliver with cap. This will give the lowest risk score regarding sterility, particles, injection volume, silicone oil and technical performance.

What next?

This work is relevant for other pharmacists and prescribing practitioners when assuring that syringes and associated equipment are of appropriate quality and suitable for intended use.

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.

Clinically digital program support for personalised dosing of vancomycin

European Statement

Clinical Pharmacy Services

Author(s)

Wei Wang, Hao Bai

Why was it done?

It depend on the pharmacokinetic (PK)/pharmacodynamic (PD) of vancomycin. Vancomycin can be described as a kinetic model with one compartment connected by a series of first-order kinetic rate processes. The mini programme uses two drug levels during the same dosing interval by the TDM to calculate the area under the curve (AUC) of vancomycin and integrated into patients’ condition and minimal inhibitory concentration of pathogen to provide an optimal dosing regimen of vancomycin.

What was done?

We designed and developed a mini programme support for personalised therapeutic drug monitoring (TDM) of vancomycin. This programme can be easily used in the WeChat by the mobile device.

How was it done?

The traditional vancomycin TDM strategy, which is guided by trough concentrations, has several limitations:
The recommended trough concentration range of 10-15mg/L assumes that the bacteria’s minimum inhibitory concentration (MIC) for vancomycin is ≤1mg/L. However, with the drifting of vancomycin’s MIC values over recent years, this trough concentration has not been able to effectively guide patient prognosis, as has been confirmed by many clinical studies.
There are practical difficulties: for example, the 2009 IDSA guidelines clearly specify that the trough concentration of vancomycin should be sampled half an hour before the fifth dose. However, in reality, due to misunderstandings by nursing staff or excessive workload, sampling times often deviate from this guideline.
After the trough concentration has been determined, there are no explicit measures for dose adjustment. The 2009 IDSA guidelines do not provide recommendations on how to adjust subsequent doses based on trough concentrations.
A decade later, in 2020, the IDSA released new vancomycin TDM guidelines. These guidelines suggest moving away from the trough concentration TDM strategy for vancomycin, and instead recommend using an AUC-guided strategy, determined by two-point blood concentration monitoring of vancomycin.

What has been achieved?

Vancomycin follows first-order pharmacokinetics. To monitor the AUC of vancomycin, it is necessary to measure the serum vancomycin concentration at two steady-state points, then use Monte Carlo simulations and Bayesian software to calculate the AUC and adjust the dosage. This process requires a large number of calculations. Therefore, there is an urgent need for an auxiliary decision making system in clinical practice that can facilitate personalised dosing of vancomycin.

What next?

This mini programme has run above 1 year, providing personalised medicine service of vancomycin to hundreds of patients in China, guiding the precise and rational use of antimicrobial drugs , enhancing the effectiveness of vancomycin and reducing drug toxicity in clinical practice.

Healthcare impact of a digital health programme for patients with chronic or high-frequency episodic migraine

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European Statement

Patient Safety and Quality Assurance

Author(s)

Anna de Dios-López, Neus Pagès-Puigdemont, Montserrat Masip-Torné, Pau Riera-Armengol, Rebeca Pelegrín-Cruz, Cristina Martínez-Molina, Noemí Morollón, Robert Belvís-Nieto, Maria Antònia Mangues-Bafalluy, Mar Gomis-Pastor

Why was it done?

Migraine is a neurological disorder characterised by frequent headache. Patients with an episodic migraine pattern have <15 monthly migraine days (MMD), whereas patients with a chronic pattern have ≥15 MMD. Migraine has a high prevalence (15-20% of female and 5-8% of male) and a great impact on their quality of life. Many migraine patients can benefit from preventive treatment. The use of a digital health programme in these patients can allow a real-time monitoring of treatment effectiveness (through the register of migraine attacks frequency) and adverse events. Additionally, it can improve the communication between patients and HCP.

What was done?

We tested a patients’ mobile phone (mHealth) application in chronic and high-frequency episodic migraine patients. This application was synchronically linked with a website for healthcare professionals (HCP) and hospital clinical records.

How was it done?

MyPlan is a mHealth application adapted from another one developed in our hospital for heart transplant patients. Firstly, we conducted a focus group with patients to understand their needs and preferences. This platform fulfils the quality and Data Protection Regulation.

What has been achieved?

13 patients and carers participated in two different focus groups. Another focus group was conducted with the Neurology Department of our institution. The results permitted to adapt the mHealth application with the following functionalities and registers:
• Synchronous (videocall) and asynchronous (direct message) communication between patients and HCP
• Medication adherence
• Treatment adverse events
• MMD and monthly headache days (MHD)
• Monitoring through the register of biomeasures (blood pressure, weight), lifestyle habits (diet, exercise) and questionnaires (MIDAS, HIT-6, EQ-5D, MSQ)
• Information
Data registered by the patient was used to guide clinical management and improve patients’ healthcare route.

What next?

The introduction of mHealth in the healthcare route of patients with migraine could benefit both patients and HCP. This strategy could be incorporated in other health facilities that attend migraine patients in an outpatient setting. Nowadays, a clinical trial is being conducted to demonstrate its clinical benefit.

Application of a supplier qualification program for primary packaging materials regulated as medical devices

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European Statement

Patient Safety and Quality Assurance

Author(s)

Andersen Lilli Moeller, Hansen Tove Solveig, Schnor Trine

Why was it done?

The QMS for the hospital pharmacy did not previously include primary packaging systems regulated by MDR. These packaging systems are a prerequisite for supply to patients of vital medicines like Total Parental Nutrition (TPN) and ready-to-use products such as antibiotics, cytostatics and pain reliefs.

What was done?

Several actions to combine Good Manufacturing Practice (GMP) and Medical Device Regulations (MDR1) were implemented.  Among others, comprehensive training programmes were conducted, and quality standards as well as supply chain mappings were included in Quality Management Systems (QMS).

How was it done?

A national strategic initiative was launched with actions decided in open dialogue with the Competent Authority and suppliers.

Priority was given to the most GMP-critical devices as TPN-bags and elastomeric pumps. Specifications were established and supply chains mapped.

To fast roll out competences across hospital pharmacies similar workshops with participation of a consultant with special competences within MDR were given.

What has been achieved?

Due to knowledge of the Supply Chain and extended cooperation with suppliers, a quick and effective reaction in relation to for example recalls is obtained.

Easier to explain suppliers how they can support our need for documentation to fulfill GMP related demands New clinical or political demands to ad-hoc compounding can be met fast and effective.

GMP related issues are part of a current national tender for elastomeric pumps.

What next?

More medical devices like transfer-sets, syringes used as utensils and gloves to be included in the supplier qualification program.
GMP related requirements to be a part of tenders on medical devices used as packaging systems.
Continued cooperation with suppliers to develop solutions in the interface between MDR and GMP.

Integration of a hospital pharmacy preparer within a new interventional technical platform

European Statement

Selection, Procurement and Distribution

Author(s)

Morgane HOUIX, Valérie VIAUD, Cécilia HURLUPE, Yannick POIRIER

Why was it done?

The pooling of stock for the 5 rooms required a referent for stock management. In order to free up caregivers from the administrative and logistical tasks related to pharmaceutical products, pharmacy has been directly integrated into the project of ITP.

What was done?

In May 2021, interventional cardiology, rhythmology and coronary angiography have been gathered in an interventional technical platform (ITP) of 5 operating rooms. A full-time hospital pharmacy preparer (HPP) position has been set up within the ITP.

How was it done?

For the success of the project, the 2 chosen PPH had to easily becoming part of ITP’s teams and must learn specifics of medical devices of each speciality. For this purpose an immersion in each sector was carried out during the installation of the ITP and continues today by participating in interventions. They shared in the process of installing the PTI’s arsenal of pharmaceuticals with careteams by grouping the initials allocations of products of each speciality. The products common to each endowment were gathered and harmonized after discussion with caregivers. Each sector has kept a stock of specific devices, called “out-of-stock”.

What has been achieved?

The installation took about 632 hours of HPP time. The allocations for each sector were respectively 68, 69 and 83 references, not including out-of-stock. The HPP’s work allowed reducing the common endowment from 220 to 134 products references. A satisfaction survey of PTI teams (doctors, nurses,…) after 4 months of practice showed a level of 78% of satisfaction. 1.3% of the responses concerned activities related the management of devices affected by production delay or stoppage and information on product changes to be unsatisfactory or moderately satisfactory. Every ITP teams now considers their presence essential, believes that it has improved relations with the pharmacy and management of stocks. A saving in nursing time was also noted.

What next?

The creation of this HPP position seems to satisfy all the ITP teams. A quantitative analysis of the benefits measuring the impact on care time, the amount of over-storage and the compliance indicators of the implantable medical device circuit will be carried out during 1 year, in order to assess the impact of the creation of HPP positions within the PTI.

Homemade personalized 3D printed guides for mandibular reconstruction – A pharmacist feedback

European Statement

Production and Compounding

Author(s)

Quentin Misandeau, Romain Bosc, Muriel Paul, Valérie Archer, Lionel Tortolano

Why was it done?

The plastic surgery department bought two 3D printers in order to design and create custom-made medical devices. The main objective was to decrease the delay between mandibular cancer diagnosis and the surgery. The delays of production in the medical device manufacturers may exceed 2 weeks. Those delays are considered as a lost of chance for the patients.

What was done?

We helped our surgeons to secured the production procedure and reduce the risks for patients. We create a management quality system for supply, production, sterilization and using of our homemade personalized 3D printed guides.

How was it done?

First, we created a task force of pharmacist and surgeons.
The main work was a risk analysis with the FMECA method for all the steps in the procedure (software, tools, actors and materials).

What has been achieved?

Some correctives actions were taken. The riskier points were the plastic materials toxicity risk, the sterilization procedure that has been validated and the production traceability. A biocompatibility evaluation was performed. A clinical evaluation has been initiated in the same period.

What next?

Since the new medical device regulatory (2017 /745 CE) was published in 2017, the article five, that regulate the 3D printing in hospital, changes the possibilities. In fact, as personalized 3D printed guides are available on the EU market, homemade personalized 3D printed guides for mandibular reconstruction could be not authorized anymore. The only way would be for the hospital to obtain the regulatory statut of manufacturer and comply with the essential requirements.

Patient education after Arthroplasty: what about the implants?

European Statement

Education and Research

Author(s)

Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer

Why was it done?

The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.

What was done?

In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.

How was it done?

First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.

What has been achieved?

The results show significant impact of this education session on all items especially those regarding the implants and medicines.

What next?

Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.

A PROTOCOL FOR PLACEMENT AND REMOVAL OF PERSONAL PROTECTIVE EQUIPMENT IN A POSSIBLE CASE OF CORONAVIRUS SARS-CoV-2

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European Statement

Selection, Procurement and Distribution

Author(s)

Rebeca Iglesias-Barreira, Emilio Rubén Pego-Pérez, Carlos Sandoval-Aquino, Cristina López-Pardo y Pardo, Maria Jesús Rodríguez-Gay

Why was it done?

To guarantee workers safety as well as optimize the use of PPE in the hospital.

What was done?

To develop a protocol for placement and removal of personal protective equipment (PPE), established for contact with possible or confirmed coronavirus SARS-CoV-2 infected patients, taking into account the medical devices (MD) available during the pandemic. Alternatives and strategies were also proposed for resources optimization. Final protocol resulted from a multidisciplinary team work (Hospital Pharmacy Service team and Emergency Service workers). It was finally revised and approved by the Medical and Quality Direction.

How was it done?

1)A systematic bibliographic review was made, for articles selection on the placement / removal of PPE. Technical specifications of the available MD and the sanitary recommendations of the competent organitations were reviewed.
2)Establishment of PPE components, and the order of placement and removal:
a. PPE placement:1-Wash hands (WH).2-Place shims.3-WH.4-Put on the first pair of gloves.5-Put on FFP2 mask.6-Wear waterproof protective overalls from the feet.7-Place garbage bags on feet and adjust them on legs.8-Wash gloves with a hydroalcoholic solution (HS).9-Put on second pair of gloves.10-Put on a standard/reinforced surgical gown.11-Wash HS.12-Put on surgical mask.13-Put on disposable gown.14-Put on third pair of gloves.15-Put on face protection screen. 16-Put on surgical cap and fit it over a face shield.
b. PPE removal: a) Before leaving the isolation room: 1-Remove and discard bags from both feet.2-Remove and discard disposable gown.3-Remove and discard the outermost gloves. b) Outside the isolation room: 1-Wash HS.2-Remove surgical cap and screen (reserve screen).3-Remove and discard surgical mask.4-Wash HS.5-Remove the standard/reinforced surgical gown and reserve it.6-Remove second pair of gloves.7-Wash HS.c) Before entering the clean area:1-Remove shoes.2-Remove third pair of gloves.d)Go to the clean area:1-Disinfect footwear.2-Wash HS.3-Remove monkey and if necessary reserve it. 4-Wash HS.5-Remove FFP2 mask and reserve it if necessary.6-WH.
c. A team member read and check all steps carried out during the all steps procedure.

What has been achieved?

The protocol was followed by 54 (100%) workers. Since its implantation, on March 16 th, only the 3,7% (n=2) of workers were infected by SARS-CoV-2.

What next?

The protocol is under constant revision and modification to adapt it to the available MD in every moment.

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Help us provide an overview of the scale of the problem, as well as insights into the impact on overall patient care.

Our aim is to investigate the causes of medicine and medical device shortages in the hospital setting,  while also gathering effective solutions and best practices implemented at local, regional, and national levels.

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Secure your spot in the Movement for Shortage-Free World

BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.