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Author(s)

Simone Leoni, Sabrina Guglielmi, Vincenzo Nicola Menditto, Adriana Pompilio, Francesca Vagnoni

Why was it done?

During the pandemic, almost all hospital departments were converted in COVID-19 wards and clinicians of several specializations were asked to work in. In a situation characterized by a great number of patients, mainly old and with several comorbidities, health professionals had to employ quickly drugs never used before and supported by limited scientific evidences. In this context the percentage of possible DDI rises out of proportion exposing patients to potential devastating consequences.

What was done?

During COVID-19 emergency we develop a quick reference tool for clinicians involved in first line assistance to patients. A table summarizing drug-drug interactions (DDI) of the most used therapies was created to allow professionals making the best pharmacological decision.

How was it done?

After a literature review using Micromedex and TERAP (Mario Negri Institute), we have created two table summarizing DDI of lopinavir/ritonavir (LR) and hydroxychloroquine (HC). Those drugs have been grouped according to pharmacological group and clinical relevance. The tables were provided to Infectious Disease, Intensive Care Unit and Emergency Medicine departments.

What has been achieved?

The tables showed 359 DDI for LR (67% contraindicated/severe, 12% major and 21% moderate) and 176 for HC (96% contraindicated/severe, 1% major and 3% moderate). Almost all contraindicated/severe interactions of HC were the same of LR and regarded: protein kinase inhibitors, beta2 agonists, macrolides and fluoroquinolones antibiotics, some antidepressants, phenothiazines, protease inhibitors and antiarrhythmics. Other LR severe interaction were: factor Xa inhibitors, statins and benzodiazepine derivates. Both LR and HC present moderate interactions with acid pump inhibitors, while LP interacts with Ca and vitamin K antagonists and antiepileptics.
Interactions mentioned have a great impact, since they concern drugs commonly used and hypertension, diabetes, respiratory system disease, cardiovascular disease are the most frequent comorbidities linked to COVID-19. Tables provided had a positive impact in avoiding DDI. Pharmacist was consulted for drug dosing and frequency adjustments. The intervention was fully accepted and extended to the rest of COVID-19 wards.

What next?

The project represents a good example of multidisciplinary collaboration able to improve safety and efficacy in pharmacological treatments. The added value of the Pharmacist and the simplicity of the tool make it useful and easy to extend to other healthcare settings.

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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)

Robert Baghdarsarian, Karin Hellström, Mattias Paulsson

Why was it done?

The health care providers at the Paediatric Emergency Ward discovered that when opening glass ampoules of morphine by snapping the top off, this did not result in the normal straight cut by the score. A close examination also revealed residual glue and the glass at the ampoule neck not being fully transparent. The sealed outer packaging also seemed manipulated for most of the morphine ampoules stored in the ward medication room. Simultaneously, staff discovered that one of the paediatric patients had not received the anticipated analgesic effect of the ordered morphine infusion.

What was done?

This case report describes how the compounding unit of Uppsala University Hospital (CU) was able to assist in analysing the contents of morphine glass ampoules and infusion solutions, in a case with suspected tampered containers

How was it done?

CU has invested in an easy-to-use spectrophotometer to check the concentration and identity of chemotherapy prepared in the clean rooms. The primary focus is to have an independent system to check preparations done by the chemotherapy robot e.g. in connection with software upgrades. This equipment was within hours adapted to be used for morphine analyses. The results clearly show that the infusion labelled 10 mg/mL was tampered with, containing only 0,4 mg/mL morphine. Samples were also sent to the Microbiological laboratory to check for risks for microbial exposure during infusion of tampered morphine.

What has been achieved?

CU was able to provide results of the contents of all ampoules, and the infusion solution administered to the patient, within a couple of hours and without any cost. The results showed that all ampoules had been emptied from its labelled contents and likely refilled with Sodium Chloride 9 mg/mL. The infusion solution given to patient was also likely prepared from a tampered ampoule. These results were crucial information in the conversation with parents about the incident, and the subsequent report to the police regarding the probable violence offence.

What next?

We recommend that all healthcare settings evaluate the possibility to collaborate closer with the hospital pharmacy, and in new ways.
Thanks to our CU being an integral part of the hospital with close interaction with wards, this rapid handling was possible to stage.

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Author(s)

Carlos Aparicio Carreño, Arantxa Gándara Ande, Beatriz Fernández González, Andrea Forneas Sangil, Belén Rodríguez de Castro, Rubén Pampín Sánchez, Cristina Martínez-Múgica Barbosa, Paloma NIeves Terroba Alonso

Why was it done?

To improve safety during preparation and administration of IAD.

What was done?

A new computerized system was established to improve quality control and traceability in preparation and administration of intravenous antineoplastic drug (IAD).

How was it done?

The software currently in use was updated, checking densities of IAD, weights of diluents and consumables. Protocols in pharmacology were adapted and maximum permissible error rates during elaboration were established. The Aseptics Pharmacy Department was equipped with a barcode label printer (BLP), a barcode scanner (BS), a precision scale and an All In One computer for the biological safety cabinet (BSC). The Haematology and Oncology Day Treatment Unit (DTU) was equipped with a BLP (for hospital bracelets) and portable computers with BS.
Regarding elaboration, a qualitative control was performed in the BSC by scanning data matrix or barcodes, recording batches and expiration dates, both of the diluent and antineoplastic agents. A quantitative gravimetric test was also performed using weight measurement of the diluent and devices before and after adding the drug. When the mixture was correctly prepared a label was printed with an identifying barcode.
Administration of the right bag to the right patient was also ensured by scanning barcodes in DTU: A hospital bracelet with a barcode was printed to identify each patient at their arrival to DTU. Prior to administration, double scan confirmation was made, checking patient´s bracelet and treatment (label), by using BS, ensuring that each patient received the drug, at the right dose, on time and by the correct route of administration.

What has been achieved?

All intravenous cancer therapies have been administered with double scan confirmation in DTU since the new system was established (November 2019).
This new way of processing IAD has been completely installed, but not all the antineoplastic treatments have been prepared with quality control.
The whole process has also left a complete computer record of the staff, task performed, time, duration and potential incidents.

What next?

We will gradually implement quality control while processing all intravenous antineoplastic treatments.

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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)

Xando Díaz-Villamarín, Ana Pozo-Agundo, Paloma García-Navas, Alba Antúnez-Rodríguez, Celia Castaño-Amores, Cristina Lucía Dávila-Fajardo

Why was it done?

Nowadays, it is known that at least 33% of patients show variable response to drugs. Of those, genetic polymorphisms explain around 15-30% of these cases, single nucleotide polymorphisms (SNP) being the genetic markers most clinically relevant. In 2013, 40 million SNPs were identified in humans and some have been observed to determine drug response. These observations lead to the incorporation of genotyping some of these SNPs as a recommendation in many drug labels before treatment initiation.
Since patient´s drug response may be determined by certain SNPs in different genes it is necessary to develop CDSS based on pharmacogenetic (PGx) information that makes feasible its application in clinical routine, translating genotypes into phenotypes and dosing recommendations.

What was done?

We have developed a local Clinical Decision Support Systems (CDSS) that informs the physician on the availability of a PGx test in our hospital for certain prescribing drugs. This system will also be able to translate the genetic information into dosing recommendations.

How was it done?

We selected all the SNPs affecting drug response for which there is already a PGx test available in our hospital. All of them have been previously validated, and, only genes/SNPs related to drug response with the highest level of evidence, available in the Dutch Pharmacogenomics Working Group (DPWG) and Clinical Pharmacogenetics Implementation Consortium (CPIC) dosing guidelines with a minor allele frequency higher than 0,1% in our population have been included. We have considered all the different genotypes according to the SNPs included and linked them to a phenotype and dossing recommendation according to CPIC/DPWG guidelines.

What has been achieved?

Our CDSS connects different drugs with available PGx test in our unit, showing which gene should be genotyped before prescription. It translates genotypes into phenotypes and also provides dosing recommendations once PGx results are received, according to the CPIC and/or DPWG guidelines. Nowadays, this system facilitates the workflow for the implementation of pharmacogenetic tests in our hospital.

What next?

We have developed a CDSS that manages PGx information facilitating the implementation of pharmacogenetics in daily clinical routine. It will also allow us to expand our services to other medical departments within our hospital.