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Flashpharma: a training tool to ensure quality medication management

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European Statement

Patient Safety and Quality Assurance

Author(s)

Samantha HUYNH, Catarina GONCALVES BARROSO, Sophie PATERNOTTE, Sofia DA SILVA MENDES, Claire JUDEL, Elvire MARTIN-LEMAIRE, Georges NICOLAOS, Chloé DUPONT, Nicolas CORNILLET

Why was it done?

Raising awareness and ongoing training of healthcare professionals is a crucial criterion for High Authority for Health certification. Flashpharma provides reliable information, particularly for night-shift nurses. This becomes critical in a context of reduced physician presence and absence of pharmacists, and the increasing presence of temporary nurses due to staffing shortages.

What was done?

The pharmacy department developed FlashPharma, an innovative training tool to enhance medication management within healthcare units. For instance, it contributes by promoting the proper use of high-risk medications (HRM) and risky medications (RM) by providing information to care teams as close to the patient as possible.

How was it done?

A working group created eleven sheets based on literature and adapted to the practices of adult hospitalization departments. Validated by medical experts and institutional committees, they include points to watch and key figures. They link up with our institutional protocols, our prescribing software and the points addressed by the visiting experts during the mock certification. Accessible by flashing QR codes strategically positioned or on our web platform, they serve as a basis for discussion with caregivers. Trainers included pharmacists, a pharmacy intern, and a hospital quality manager. Anonymous written questionnaires were used to gather feedback.

What has been achieved?

Two QR codes are placed on automated dispensing cabinets and mobile medical carts, linking to sheets on MHR, RM, and guidelines for proper drug crushing and administration via an enteral feeding tube. Another QR code on refrigerators provides information on drug storage and temperature alerts management. A label provides information on drugs prescribed outside the booklet, with six therapeutic equivalence tables validated by doctors.
Three sessions were attended by nurses, healthcare managers, orderlies, and doctors (n=18). Fifteen (83%) participants strongly agreed, and 3 (17%) agreed that they acquired new knowledge. All participants would recommend these sheets; 16 (89%) strongly expressed their willingness to participate in a second session.

What next?

Positive feedback highlighted the need for further education in various hospital units. Feedback on the use of QR codes by day and night teams will be sought during subsequent sessions and quantified using analytical dashboards. Appropriate continuing education initiatives will be implemented in paediatrics, intensive care and operating room departments.

Implementation in a pharmacy service of a big data analysis programme for successful treatment

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European Statement

Patient Safety and Quality Assurance

Author(s)

LUCIA SOPENA, ALBERTO FRUTOS, VICENTE GIMENO, OLGA PEREIRA, RAQUEL FRESQUET, ARITZ MERCHAN, REYES GARCIA, PAULA GOMEZ, ALBERTO APESTEGUIA, MARIA ANGELES ALLENDE, TRANSITO SALVADOR

Why was it done?

The growing technological development of pharmacy services involves the coexistence of traditional warehouses with automated medicine dispensing systems controlled by different computer programs. The information is split into different systems and databases giving rise to possible errors due to the greater complexity. This is a threat but also an opportunity for the hospital pharmacist to lead the development, review, and improvement of medicine use processes and the use of health technologies to improve quality of care, patients’ safety and reduce costs. KNIME data analysis covered the need of our Pharmacy Service to blend data from any source in a single file simplifying the process.

What was done?

The Pharmacy Service of a university hospital has implemented Konstanz Information Miner (KNIME) data analysis and develop successful treatment project to optimise the stock management of several medicines.

How was it done?

An initial algorithm was designed by the union of seven files and can be executed at any time to obtain the updated data.

What has been achieved?

This file provides up-to-date information about the stocks, stock-outs, consumptions, orders and purchasing data of all medicines (average price, laboratory, date and number of orders, units to be received).
In addition, KNIME calculated the coverage time in days and months from weekly and monthly consumption, and the current stock in the warehouses, obtaining a global vision of highest turnaround pharmaceuticals drugs.
The program also allows to link and merge data of the list for shortages of medicines, supply disruptions and restocking time, and to improve the storing, delivering and administering of COVID-19 vaccines.
KNIME program has been especially important in our Pharmacy Service to get better care outcomes and more precise medication ordering, which allows significantly higher patient safety.

What next?

KNIME is a tool that could be successfully implemented and appropriately generalised as recommended to all Pharmacy Services that use different data sources and want to have a generalised view of the information. KNIME represents an advance in the stock and purchase management of medicines specialties to work more efficiently, which improve patient care and safety. Digital medication management also contributes to greener pharmacies by preventing unnecessary overstocking and thus excessive disposal arising from expired medications.

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.

COVID-19: Guidelines for Infection Prevention and Control in a Hospital Pharmacy According to ISO 9001:2015

European Statement

Patient Safety and Quality Assurance

Author(s)

SUSANA SANCHEZ SUAREZ, JOSE ANTONIO VINAGRE ROMERO, MARIA ISABEL BARCIA MARTIN, CAROLINA AGUILAR GUISADO, MERCEDES GARCIA GIMENO

Why was it done?

To keep occupational health and safety during a crisis in which healthcare settings were overloaded and facing a critical shortage of skilled professionals, due to sick leaves (2,75% of total cases), and for the need to maintain high quality of care processes. These were a big challenge that required to adapt operating procedures. In addition, and due to the effect of COVID-19 on the general population (overall incidence rate of 10.596 per 100,000 people) and in healthcare systems, the Spanish Ministry of Health (SMH) issued a technical document establishing a series of recommendations for COVID-19 infection prevention and control in patients medical assistance. This practice was designed to bring together national guidelines from the SMH that aimed to reduce COVID-19 impact, both in healthcare workers and general population, and meet ISO 9001:2015 requirements in SOP of a HP within a general hospital

What was done?

In order to ensure safe systems of work (SSoW) in the hospital pharmacy (HP) during the COVID-19 pandemic, specific operating procedures (SOP) were adopted in order to prevent the risk of contagion in daily operations for both patients and staff, according to the norm ISO 9001:2015

How was it done?

Four critical areas were identified according to risk management: High-risk areas: Preparation Area (PA) and Outpatient Dispensing Area (ODA); medium-risk area: Pharmacy Administration Area (PAA) and Inpatient Dispensing Area (IDA). Some SOPs were developed within these areas: Autologous serum eye drops preparation in the PA, pharmaceutical care and medication dispensing in the ODA, pharmacy receiving in the PAA and medicines return from COVID-19 areas. Different circuits were implemented for users and professionals, as well as general information and procedures directed at patients and personnel, to prevent infection. The individual protection equipment required in each SOP/area was also established

What has been achieved?

No COVID-19 case has been reported due to patient-professional interactions or working location and tasks. All operating procedures have been revised to fully comply with SMH guidelines and ISO 9001: 2015 requirements mitigating risks and maximizing performance in such critical circumstances

What next?

Adapting SOP to any infectious disease outbreak that may occur in the future and establishing early-detection mechanisms

How to become a resilient chemotherapy preparation unit?

European Statement

Patient Safety and Quality Assurance

Author(s)

Victorine MOUCHEL, Romy LINOSSIER, Chloé FERCOCQ, Jean-Luc PONS, Lucie BAILLET

Why was it done?

Injectable anti-cancer drugs are critical drugs and production disruption would result in discontinuity of care. Moreover, 60% of the production is dedicated to external clients as part of outsourcing contracts. To strengthen client’s confidence, we achieved the ISO 9001 certification in 2019. Implementing a BCMS is part of the overall quality and resilience process.

What was done?

In our hospital centre, production of injectable anti-cancer drugs is centralised in a chemotherapy preparation unit. Within the unit, we decided to implement a business continuity management system (BCMS). Therefore, we established and validated a business continuity plan (BCP) to face a production disruption and continue the delivery of products.

How was it done?

We followed the ISO 22301:2019 standard methodology. First, we performed the risk assessment as described by the ISO 22300: 2018 standard. A multidisciplinary working group (pharmacists, pharmacy technician, quality engineer) identified and analysed the risks likely to threaten the unit’s business continuity (BC). Risks were rated in term of criticality (Cr) from 1 to 4 and risks with Cr ≥ 3 were considered as priority risks. Then, a business impact analysis was led by the pharmacists and validated by the department chief. Strategies were set to face priority risks in accordance with the BC objectives. Finally, we documented the BCP and validated it thanks to tests followed by debriefing.

What has been achieved?

The risk assessment highlighted 23 risks and 13 of them (57%) were rated as priority risks. Most of the risks revolve around unavailability of production equipment or premises (fire, flood, natural disaster). The treatment of 7 of these risks was included in the action plan for 2021. Three strategies were documented to treat these risks: extended opening hours of the unit, closed system transfer device used in a contaminated isolator and production relocation in two other centres. Five tests were conducted to check necessary procedures and devices to use these strategies (closed system transfer device, remote access, transportation). Tests will be repeated yearly to maintain the BCP.

What next?

In conclusion, implementing a BCMS represents a continual improvement approach that will improve the unit’s ability to cope with a crisis in an appropriate way.

Implementation of a dashboard within a quality management system in the pharmacy department

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European Statement

Patient Safety and Quality Assurance

Author(s)

Hana Sakly

Why was it done?

The pharmacy must assess its own activity in order to better manage, to structure, respond to needs. This assessment is necessary in order to measure the productivity.

What was done?

The purpose of our work is to identify the key performance indicators for management and piloting a hospital pharmacy. The aim is to develop dashboards, a real management tool, for the management and monitoring of pharmaceutical activities in order to optimize performance and ensure continuous improvement.

How was it done?

The methodological basis of our study is based on a process-based management of hospital pharmaceutical activities. Our target is to achieve the same approach to these processes, within the various functional and concerned units, in order to harmonize and simplify the quantitative and qualitative monitoring of pharmaceutical activities.

What has been achieved?

Macroscopic cartography of pharmacy processes was established and the most critical processes were selected on the basis of a matrix. In total, eight key processes have been identified. The identity cards for these processes have been drawn up. Quality indicators have been identified. These indicators are intended to assess and monitor the processes. A first design of dashboards with the elements collected was proposed. This dashboard could evolve during the implementation of this project within the Pharmacy department.

What next?

These dashboards have to be finalized, validated and officially put into practice within the Pharmacy department. This methodology must be applied to the discipline of Clinical Pharmacy. Quantitative and qualitative assessment of the activities carried out within the pharmacy should be a subject for priority debate at the national level to finally find agreement on a relevant measurement tool.

LEARNING FROM SARS-CoV-2 EXPERIENCE TO FACE FUTURE EMERGENCIES: ELABORATION OF A HOSPITAL PHARMACY EMERGENCY PREPAREDNESS PLAN

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European Statement

Introductory Statements and Governance

Author(s)

Edoardo Calzavara, Elena Galfrascoli, Stefania Vimercati, Lorenzo Gambitta

Why was it done?

The discovering of Coronavirus disease in 2019 and the subsequent outbreak in many countries and regions constituted in the first 5 months of 2020 a prominent issue worldwide: hospital pharmacists as well as other health care personnel were hit by pandemic emergency and faced a great challenge. We as hospital pharmacists had to cope with shortage of drugs, disinfectants, test and reagents, Intensive Care Unit medical devices, personal protective equipment. For this reason, we needed to start interventions to meet the needs of the front-line medical and nurse staff.

What was done?

We decided to start a self-auditing process, we aimed to realize an emergency preparedness plan and a procedure, created from our experience, which will be helpful to face future emergencies.

How was it done?

The starting point was our Hospital Pharmacy process map, which identifies all pharmacy activities. For each one, actions taken during the emergency were described. Regulations at local and national level were analysed together with literature and international statements about hospital pharmacist role during health emergency.

What has been achieved?

We developed a process map in which we split up pharmacy activities into five big areas:

1. DIRECTION AND COORDINATION: team communication, role and responsibilities definition (“role mapping”); multidisciplinary external communication with hospital management facilities;

2. LOGISTICS AND ADMINISTRATION (Purchase, management and distribution of medical products): an inventory of drugs, medical devices and diagnostics was created, especially for the ones essential to challenge SARS-CoV-2 health emergency;

3. RESEARCH, GALENIC, “PATIENT CARE”: therapeutic protocols, galenic preparation, studies, home-therapies distribution and communication with patients;

4. PHARMACOVIGILANCE: close monitoring of potential Adverse Drug Reactions (ADRs);

5. REGULATIONS AND LEGISLATION: Updating and intra-hospital divulgation.

From this emergency process we created an emergency preparedness plan and an internal procedure, in which, for every activity area, we assigned specific roles and responsibilities and set operating instructions.

What next?

The emergency preparedness plan developed from our experience during SARS-CoV-2 emergency, will allow hospital pharmacists to anticipate, plan, and prepare strategies in case of future health emergencies, due to biologic infective agents. Our and other Hospital Pharmacies will be able to overcome priority drugs shortages, to set a drug home delivery service, to offer extemporary solutions, communicate and inform patients.

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