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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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Author(s)

DESPOINA MAKRIDAKI, KALLIOPI ALLAGIANNI, NIKOLAOS SKORDAS

Why was it done?

In our hospital is located the main CF Unit for Adults in the country. Ensuring that as many as possible young patients benefit from accessing the new and crucial treatment, even during COVID-19 period, reflects our commitment to improve patients’ outcomes and overall survival,

What was done?

A Phase 3, open-label clinical trial (CT) with 3 enrolled patients runs since April 2019 and two early access (EA) programs with 23 enrolled patients run since the end of July 2020 to permit the access of cystic fibrosis (CF) patients with the F508del mutation in the innovative combination therapy of ivacaftor, tezacaftor and elexacaftor (IVA/TEZA/ELEXA) in our hospital.

How was it done?

3 outpatients enrolled in the CT and procedures regarding the protocol have been followed strictly. Medication dispensing is conducted every 12 weeks.
In the EA procedure, 2 parallel programs have been approved by authorities, one for the homozygous including 19 patients and one for the heterozygous including 4 patients. Dispensing is programmed every 4 weeks, although an initial stock for 3 months was shipped to pharmacy.
The role of HPs was decisive for the quick start of the EA programs during COVID-19 period. Roadmap was designed at the beginning by HPs in collaboration with the physicians to accelerate approval and shipment procedures and also regarding licensing for each patient, drug receipt, storage, dispensing, accountability, electronic registry in designated EA platform and additional electronic recording and follow up in the electronic Pharmacy platform for both the IVA/TEZA/ELEXA and supporting therapies (e.g. inhaled antibiotics, a-dornase)
For 17 EA patients with chronic obstructive pulmonary disease in exacerbation, hospitalization before starting the IVA/TEZA/ELEXA therapy was necessary. HPs monitored closely their cartexes to avoid adverse reactions and delays in therapy.
HPs served all outpatients on personal afternoon appointments, to avoid overcrowding in the hospital during the pandemic.

What has been achieved?

Critically ill patients have been able to receive in priority the IVA/TEZA/ELEXA treatment, without cost, and valuable scientific experience has been gained.

What next?

EA programs have received 3 months extension until reimbursement negotiations are completed by authorities. In the meantime, we design a cost affordable procedure to ensure continuity of access for our patients.

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Author(s)

FRANCESCA VAGNONI, ANDREA MARINOZZI, SABRINA GUGLIELMI, CHIARA CAPONE, FRANCESCA MURA, ADRIANA POMPILIO, SIMONE LEONI

Why was it done?

The management of CT requires thorough documentary evidence and well-organized reporting system in compliance with the Good Clinical Practice. Since 2009, the entire onco-haematology workflow is fully-controlled by information technology devices and robotic systems to prevent medication errors and guarantee data integrity. The implementation of APOTECAtrial was aimed to extend the same level of control to CTs.

What was done?

In 2018, a clinical trial (CT) managing system (APOTECAtrial) was integrated into the existing fully-automated workflow of the chemotherapy production unit. APOTECAtrial was developed to enable real-time visualization of CT-related data and trace the processing of investigational (IMP) and non-investigational (NIMP) medical products, such as delivery, assignment, preparation, return, and disposal.

How was it done?

A team of hospital pharmacists, physicians, clinical data managers, and IT specialists analysed the CT workflow and defined the system specifications. Data related to IMP/NIMPs (both for parenteral and oral administration), patients enrolled, and investigator/sponsor affiliations were entered into APOTECAtrial and sorted by CT. The onco-haematology unit’s electronic prescribing system was bidirectionally interfaced with APOTECAtrial. Aseptic preparation of patient-specific injectable therapies was implemented in the supporting device for manual preparation that checks dosage accuracy and identity by photographic and barcode recognition.

What has been achieved?

Since 2018, the overall number of CTs managed was 95. In total, 81 IMPs/NIMPs and 135 patients were entered into the system, while 2740 injectable therapies were prepared, 690 oral medications and 60 pre-filled syringes delivered. The following major objectives were achieved: automated inventory accounting and stock management, reduced manual time-consuming activities (i.e. documentation, transcription), standardized reports in digital not-editable format, and full traceability. In addition, audit trail tool tracks all user edits and changes performed at any stages of the CT management by electronically recording user’s name, date, and time. APOTECAtrial was evaluated by clinical research associates (CRA), clinical research organizations (CRO) and CT sponsors and approved for use in the daily clinical practice.

What next?

The project represents a good example of multidisciplinary collaboration focused on improving the quality of the processes in healthcare settings. The implementation of information technology and automation ensures improved data integrity, safety, and working efficiency, which are key determinants for managing CTs in hospital pharmacies.

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Author(s)

MARINA RODRÍGUEZ MARÍN, HILARIO MARTÍNEZ BARROS, MARÍA DEL ROSARIO PINTOR RECUENCO, BEATRIZ MONTERO LLORENTE, ANA MARÍA ÁLVAREZ DÍAZ

Why was it done?

It was done in order to optimize opioids stock to meet the needs of COVID-19 patients and protocolize the correct quarantine without modifying the computerized registration in the 39 ADS.

What was done?

A procedure was implemented to optimize the stock and manage the quarantine of opioids in Automatic Dispensing Systems (ADS) during and after their use in hospital units hosting COVID patients.

How was it done?

As hospitalization units were being adapted to host COVID-19 patients, opioids stock had to be modified to meet their new demands. Reversely, when hospitalization units were recovered to host their usual type of patient, the opioids had to be replaced and quarantined for ten days, according to our Preventive Medicine Unit. All these movements were recorded.
We followed this process:
1. Physical and computerized unloading of opioids without dispensing in recent months and emptying of the returned drawer (storage space for opioids withdrawn from the ADS which were not used).
2. Relocation to hospitalization units hosting COVID-19 patients,
3. Replacement of all (minidrawers) where opioids were kept with clean ones
4. Quarantine in the Pharmacy Service, for the drugs unloaded which were unable to be immediately relocated.
5. Cleaning and sanitizing of the removed minidrawers from COVID-19 hospitalization units’ ADS to be used in the next conversion.

What has been achieved?

29 ADS of the 39 available in the hospital were optimized.
Given the decreased in COVID-19 admissions during May, the hospital made a schedule to return to normality which allowed to leave 5 ADS in quarantine without the need to unload or replace any drug,. The other 24 ADS had to be cleaned and disinfected,. It led to the physical unloading of 182 specialties (a total of 1,519 units), the physical and computerized unloading of 124 specialties (850 units) and the emptying of the returned drawers (18 specialties and 20 units). 504 minidrawers were replaced by other cleaned and disinfected ones and 298 specialties (2,080 units) were replaced.

What next?

Enhancing our protocol to allow us to spend more time with the patients in Covid’s further waives.

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Author(s)

Elodie Delavoipière, Laura Fazilleau, Carine Lehoussel, Isabelle Goyer, François-Xavier Roth, Julien Mourdie, Agnès Bobay-Madic, Simon Rodier, Bernard Guillois, Albane Cherel

Why was it done?

360° virtual room of errors is an innovative educational tool which can be included in strategies of ME risk management. NICUs are high-risk areas and consequently, a priority target. Therefore, we developed and evaluated a virtual reality-training program based on medication error management in the NICU of a university hospital centre.

What was done?

A virtual reality-training course was developed and evaluated, regarding prevention and management of medication errors (ME) in NICUs.

How was it done?

A multidisciplinary working group was set up (2 pharmacists, 2 neonatologists, 1 pharmacy resident and 3 NICU nurses) to define: the target audience, the training model, the assessment methods (pre-training and post-training evaluations), training days and educational materials.

What has been achieved?

The program was intended for professionals involved in the medication circuit in the NICU: physicians, residents, and nurses. Weekly sessions have been scheduled in order to train 99 professionals. Every session was run by 3 professionals (physician, nurse and pharmacist) and lasted two hours and a half. The session was divided into 5 stages: 1/pre-training evaluation, 2/briefing, 3/360° digital simulation allowing ME detection, 4/debriefing, 5/ post-training evaluation. Although, it was a digital-training, a pedagogical formula with “classroom” training sessions has been chosen in order to promote interactivity between learners and trainers particularly during the debriefing. This virtual reality-training course was assessed by Kirkpatrick’s four levels of training evaluation model: satisfaction questionnaires, knowledge evaluation and skills self-assessment, audits of practices, monitoring of indicators (adverse event reports). Assessments were done before each session, immediately after and within 3 months of the session, to both evaluate and enhance educational impact.

What next?

This concept promotes the link between clinicians from the NICU and the multi-disciplinary approach concerning the risk management of ME. By directly involving all the healthcare professionals, this innovative training provides a patient-safety culture development and the implementation of safety measures. The implementation of this training concept in a multi-centric assessment of professional practices should enable to confirm pedagogical interest of such innovative sessions and his deployment in other health facilities.

Author(s)

Cyril Magnan, Elise Betmont, Guillaume Saint Lorant, Hubert Benoist

Why was it done?

Evaluate the economic impact of improvement actions taken since 2017 on TSPs management.

What was done?

Cold chain is a major issue in the pharmaceutical industry as a growing number of its products are temperature-sensitive and also in hospitals. In 2017, 27 cold chain breaks were declared by care units (CU) within a French teaching hospital, resulting in a risk for patient care and a potential loss of 40,363 euros, of which 18,505 euros (45%) could be avoided. Following this first study, a set of measures have been implemented in our establishment in order to secure the cold chain.

How was it done?

Potential losses and avoided losses of TSPs have been analyzed continuously since 2017 according to the same methods in a teaching hospital with 1,600 beds. In case of a thermal excursion (ET), the pharmacy is, according to the institutional procedure, immediately warned by an electronic alarm day and night or by a call from the care service, making it possible to define the action required from the service concerning the methods of keeping TSPs.

What has been achieved?

Since 2017, a mobile isothermal enclosure has been implemented for the transport of TSPs during the day in the CU. Connected temperature-monitoring sensors have been installed on so-called “at-risk” refrigerators. The alarm reports to the pharmacy was instituted in order to intervene as quickly as possible. Part of the refrigerators has been renewed and awareness has been raised among all CUs for the good traceability of temperature readings, allowing a drop from 24% in 2018 to 65% of compliant traceability in 2019. Following these improvement actions, 53 ETs with a potential loss of 53,769 euros were declared in 2019, of which 39,753 euros of losses could be avoided. Currently, 74% of ET losses can be avoided compared to 43% in 2017.

What next?

This economic assessment of the potential losses and the avoided losses of PTs shows the positive impact of the various improvement measures taken since 2017 as well as education of the UDS to secure TSPs. A regional awareness was implemented thanks to a collaboration with the regional health agency in order to promote TSPs management in the hospitals.

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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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Author(s)

Elodie Delavoipière, Marianne Pavard, Anne-Laure Richard, Julien Montreuil, Albane Cherel, Céline Bouglé

Why was it done?

Every year in our country, 10,000 preventable deaths and more than 130,000 preventable hospitalizations are related to drug misuse. This issue is a priority of the national health strategy. Therefore, we developed a CPD training program on the issues and methods of managing the risk of ME.

What was done?

A regional multi-disciplinary Continuing Professional Development (CPD) program was developed, dealing with the risk management of medication errors (ME).

How was it done?

This program was submitted to the National CPD Agency and accepted as a continuing education measure, corresponding to the national orientation: “control of risks associated with healthcare acts and pathways”. The program and the training materials were developed by a 13-member regional working group, including hospital pharmacists and quality managers, the drug observatory and the regional health quality network.

What has been achieved?

The training is intended for any health professional involved in the medication circuit in a health or medico-social institution: physicians, pharmacists, residents, nurses, pharmacy technicians… The first part is an e-learning slide presentation with voice commentary, on the theoretical aspects of ME and on the principles of a priori and a posteriori risk management. Concrete examples of ME are integrated throughout the slide presentation. This e-learning is divided into 4 parts and is accessible for 1 month. It must be validated by the learner before participating in the second part of the training: a face-to-face simulation session with 15 learners and 2 hospital trainers (pharmacist and health quality professional). During half a day, the learners apply a posteriori risk management by analysing a fictional adverse event (ME). The case addresses several themes: never events, drug reconciliation, city-hospital link, lack of communication, human factors. Questionnaires completed before, during and after the training allow for the evaluation of learners’ satisfaction as well as the impact of the training on their knowledge and skills.

What next?

This regional training will promote the link between actors from different institutions and the multi-disciplinary approach around the management of the risks of ME. In addition, we provide an awareness kit on ME reporting, including a customizable slide show and a quiz, which allows short sessions to be conducted in any health facility.

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Author(s)

Božena Bürmen

Why was it done?

In University Medical Centre Ljubljana (UMCL) a HAM list was created in 2008 and has not been significantly changed since then. Our aim was to develop a systematic strategy to review the list by including local data.

What was done?

We comprehensively updated the hospital list of high-alert medications (HAM) and identified hospital specific medications not yet present on HAM lists. We joined international HAM data supported by medication error (ME) reports and expert opinion with data from the hospital ME reporting system.

How was it done?

We analysed 390 MEs submitted to the UMCL ME reporting system from 2016 to 2018. We compared the HAM list from Institute for Safe Medication Practices (ISMP) and the UMCL HAM list. The criteria such as frequency of the reported ME, severity of harm for the patient, affected population, novelty, etc, were used to identify potential HAM. Furthermore, we calculated the probability of the ME report for the individual medications from the reported MEs and the hospital medication consumption data. The calculation was done for the medications involved in 3 or more reported MEs (Tyynismaa et al, 2017) and for the medications involved in MEs which caused harm to the patient.

What has been achieved?

The joined results from the comparison of HAM lists and reported MEs showed that several other medications could be added to the UMCL HAM list, e.g. individualised parenteral nutrition for the paediatric population, oral sedation agents for children, dialysis solutions, lidocaine IV, methadone, bupivacaine, and nusinersen. The probability-based HAM identifying method supported our previous suggestions to extend the UMCL HAM list. Additionally, the method unexpectedly revealed medications with a high probability of ME and/or harm for the patients, that are not included in any HAM list (ISMP, UMCL), such as romiplostim, parenteral iron preparations, ampicillin with sulbactam, and others.

What next?

In future we plan to develop a paediatric specific HAM list based on the same strategy; i.e. considering international suggestions and analysing paediatric ME reports in UMCL.

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Author(s)

Bernie Love, Tracy McFadden, Patrick Martin, Val Connolly, Deirdre Brennan, Michelle Griffin, Danielle Bracken, Siobhan Maguire, James Carr

Why was it done?

Avoidable harm caused by medication is one of the most commonly reported adverse events in healthcare settings.

What was done?

Connolly Hospital Blanchardstown launched a formal Medication Safety Programme in November 2017 by appointing a Medication Safety Facilitator and establishing a multidisciplinary Medication Safety Committee to promote and support the safe use of medications. The Medication Safety Committee undertook a number of activities to establish the programme in the hospital.

How was it done?

-An evidence-based literature review to define and guide the scope, breadth and direction of the programme. -A baseline in-depth analysis of locally reported medication incidents (2016/2017) on the National Incident Management System (NIMS) was conducted to identify initial targets for improvement. Analysis was undertaken using NCC-MERP, a recognised and validated tool used specifically for medication incidents. -An annual work-plan, incorporating necessary elements of a medication safety programme, was devised by the committee defining goals for the year.

What has been achieved?

Safety Culture: • Prominent commitment from hospital management to medication safety. • Investigations into medication errors aligned to a just and fair systems approach. • Promotion and encouragement of medication safety reporting and learning with a Medication Safety Awareness Day. • Implementation of the ‘Know, Check, Ask’ campaign to enhance medication safety by empowering patients. Governance: • Organogram updated to reflect reporting relationship of new committee. • Medication Safety made standing item at Quality & Safety Executive meetings. • Annual report submitted to Hospital Executive Committee Measurement & Monitoring of medication incidents: • Quarterly report produced and disseminated to front-line staff tracking and trending medication incidents including narratives. • Performance indicators established for: -No. of incidents reported (2018 reporting increased by 32% over 2017); -Reporter of incidents; -Category of harm; -Stage of medication use process where incidents have occurred. Education & Training: • Regular face-to-face education sessions arranged with front-line staff. • Quarterly medication safety bulletin devised and disseminated, informed by audit findings and incident reports. • The successful Medication Safety Minute initiative from St James’s Hospital was adopted and implemented, with content informed by local incidents. Development, Updating and Dissemination of PPPGs. • New IV drug administration guides (n=53) developed and updated. • Introduction of one-page ‘Medicines Information Sheet’ as quick reference guides for key topics. • DOAC prescription and administration guide developed and circulated. Audit: • Audit programme established informed by incident analysis, complaints and best-practice including introduction of an ‘audit window’ to gather hospital-wide data. Quality Improvement: • Informed by incident analysis, best-practice and audit findings, a number of moderate-high leverage quality improvement projects were initiated including removal of concentrated potassium from general clinical areas, introduction of an insulin & glucose monitoring record and introduction of an automated dispensing cabinet for out-of-hours access to medication.

What next?

The structural aspects established for the Medication Safety Programme have been successful in establishing a programme in the hospital and are reproducible by other centres.
Work continues in Connolly Hospital to identify themes of incidents, audit of practice and implementation of quality improvement initiatives.