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Benefits beyond the EU Falsified Medicines Directive – The hospital setting

European Statement

Patient Safety and Quality Assurance

Why was it done?

The purpose of the report was to investigate and share what benefit opportunities exist because of the introduction of the EU FMD barcode.

What was done?

EFPIA, the industry association, commissioned a report to investigate what benefits had occurred in the hospital setting, following the introduction of the EU Falsified Medicines Directive (EU FMD).

www.be4ward.com/benefits-beyond-eu-falsified-medicines-directive/

How was it done?

The author worked directly with Guy’s and St Thomas’ NHS Foundation Trust in the UK and AZ Sint-Maarten in Belgium. In addition, he reviewed various relevant case studies and publications.

What has been achieved?

The report demonstrates benefits exist at all points in the hospital supply chain, where packs are handled, stored and processed. Opportunities also exist to web enable the product to provide digital content and services to healthcare providers and patients.

The introduction of standardised barcodes and product identification enables hospitals to leverage benefits opportunities which were difficult to realise before this level of harmonisation and barcoding prevalence.

• The costs of operating the EU FMD can be minimised, integrating with normal operations and leveraging the use of conveyor systems and robotics are successfully reducing the workload impact by up to an expected 80%.

• Barcodes and product identification brings impressive financial benefits to those hospitals which leverage them. In one hospital they were able to save £4 million through the reduction of over ordering products. In another, the improved accuracy and speed in the recharging of procedures identified £840K in lost revenues in a single year.

Scanning barcodes, is being used to deliver value across all three of the benefit opportunity areas: Improved Patient Safety, Enhanced Clinical Effectiveness and Operational Efficiencies. It is possible to offset the costs of EU FMD implementation and operation through the additional benefits.

What next?

Share the report findings to enable hospitals to leverage the opportunities of the EU FMD barcode.

Impact of a specialist pharmacist on hepato-pancreatico-biliary (HpB) surgical ward rounds at a large tertiary liver centre.

European Statement

Clinical Pharmacy Services

Author(s)

Connor Thompson, Alison Orr

Why was it done?

Surgical patients are at risk of medication-related adverse events, with some of these patients having co-morbidities requiring long-term medications prior to surgery. Published data suggests pharmacist interventions can reduce adverse drug reactions (ADRs) and medication errors and reduce hospital length of stay.

What was done?

The effect of implementing a pharmacist into the HpB surgical ward round (WR) was unknown, this would also support ongoing service development projects in liver pharmacy on patient pathways.

This study aimed to establish the range and clinical impact of interventions made by the specialist pharmacist when attending HpB post-surgical WR as part of ongoing pharmacy engagement and service development.

How was it done?

A prospective study looking at interventions of a specialist pharmacist on WR over a one-month period, attending two WR per week. Review of all post-surgical HpB on an inpatient ward. All interventions collated and categorised based on commonality.

What has been achieved?

Over the course of data collection, the pharmacist reviewed 140 patients and made 477 interventions as part of the WR. This included 45 history medications being started, identification of 32 ADRs to current treatment, 16 instances of vancomycin dose adjustments, confirmation of anticoagulation for 17 patients and addition of 101 antibiotic stop dates contributing to better antimicrobial stewardship. There were also 70 instances of a nurse/doctor/patient requiring additional information on medication treatments.

What next?

This has highlighted the scale of interventions a pharmacist can make on a WR. Emphasising not only adjustment of medications but also the need for medication related information by healthcare professionals and patients alike.

Moving forward a pharmacist will attend at least two WR per week, with potential scope for support in pre-assessment and post-operative clinics to review weaning of analgesia and long-term management of pancreatic replacement for example.

With the recent announcement regarding new standards for the initial education and training of pharmacists in the UK, it would be valuable to assess the impact of a prescribing pharmacist on these WR.

Value of Integrated Inventory Management and Automation Solution for Medical Devices and Supplies: a case study

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European Statement

Patient Safety and Quality Assurance

Author(s)

Serdar Kaya, Ulker Sener

Why was it done?

Despite medical devices and supplies are often high-cost products, they are often sub-optimally managed by hospitals. The objectives of the installation were the optimization and the automation of the inventory, and the charge management workflows, to comply with JCI (Joint Commission International) standards and address current challenges as safety, labor, stock-outs, space, costs and charges accountancy, traceability.

What was done?

An integrated Inventory Management and automation solution was implemented at Amerikan Hospital Istanbul (BD Pyxis™ SupplyStation™ system). 83 automated dispensing cabinets, a central management system, and a data analytics solution, are serving the 278-beds hospital.

How was it done?

The workflows for medical devices/supply inventory, and for patients charge management were mapped pre-installation and major challenges identified. Based on these needs, the decision to automate the hospital supply management was made. The cabinets were installed in the whole hospital but in particular in operating rooms, emergency rooms and intensive care units.

What has been achieved?

The impact of automation was measured one-month pre and one-month post installation, and five major areas of improvements have been identified:
1) Significant decrease in workload: -8% for nurses; -30% for charge secretaries
2) Missing charge rate reduced from 2.5% to 0.1%
3) Improved use of space and material organization
4) Inventory optimization: 0% stock-out, -16% expired items; – 45% on-hand inventory
5) Improved materials and patients’ safety, ensuring that supply were managed in the right way by the right staff. Patients are now protected by the risk of being provided with the wrong device.
All the nurses (n>50) were interviewed, reporting great satisfaction and ease of use with the new system. Furthermore, a positive return on investment was achieved in 4 years.

What next?

Due to legal regulations (MDR Regulation/ UDI Tracking requirements) the hospital is planning to leverage the automated system to achieve a full compliance and traceability of critical medical devices throughout their hospital.
The decision of investing in automation demonstrated important benefits in terms of safety and efficiency, with a positive impact on the hospital’s economy as well.

IMPLEMENTATION DESIGN OF A SECURITY STRATEGY IN THE HANDLING OF HAZARDOUS DRUGS IN A SOCIAL HEALTH CENTRE

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European Statement

Patient Safety and Quality Assurance

Author(s)

CRISTINA MORA HERRERA, VICTORIA VAZQUEZ VELA

Why was it done?

Occupational exposure to HD can cause health damage to exposed healthcare professionals, so protective measures must be taken

What was done?

The hazardousness of drugs can cause damage due to exposure in healthcare workers from Social Health Centers (CSS). As an objective, the design of a security strategy in the handling of hazardous drugs (HD) was proposed with the elaboration of a safety working procedure (SWP) and preventive measures. In addition, the HDs were identified, with proposals for alternatives and recommendations for handling and administration were released.

How was it done?

Observational cross-sectional study to identify employment MPs in a public CSS. The demographic characteristics of the patients and their Pharmacotherapeutic prescription were recorded. A total of 107 residents were included, with a mean age of 78.9 years and 59.8% (64) men. The average stay in the center was 7.4 years (1-27). Regarding functional capacity, 53.3% were considered assisted, 89% of them with grade III -II assessment, that is, large dependents and severe dependents. Of the valid group (46.7%), 70% belonged to socially excluded. The most prevalent pathologies in the center are vascular, neurodegenerative, osteomuscular and respiratory. The mean number of medications per patient was 4.8. Only 6 patients did not receive Pharmacological treatment.
The design of the security strategy was structured in 3 phases; 1st)Elaboration of an SWP with assignment of functions/responsibilities, preventive measures to be adopted in the handling of HDs, description of the circuit and quality indicators of the strategic procedure; 2nd)Carrying out a descriptive observational cross-sectional study to identify the HDs used. The list of active principles (AP) included “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014” was compared with those included in the GFT of the center; 3rd)Releasing of recommendations through information sessions/ workshops for healthcare professionals.

What has been achieved?

An effective and safe employment system/circuit is established in the SWP, with relative preventive measures to control associated risks that may occur in handling and/or administration. 22 HDs were identified. A safer alternative was proposed for 9. Recommendations for the handling of HDs, associated risks and proper use of PPE were disseminated through 2 training sessions.

What next?

The identification of hazardous drugs and communication of improvement actions made it possible to implement a standard work procedure guaranteed safety in handling, and to provide an adequate means to avoid exposure due to healthcare workers.

INCOMPATIBILITIES OF PARENTERAL DRUGS IN INTENSIVE CARE – ANALYSIS AND OPTIMISATION OF ADMINISTRATION SCHEDULES OF CENTRAL VENOUS CATHETERS AND FREQUENTLY USED DRUG COMBINATIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Martina Jeske, Jasmin Stoll, Vanessa Funder, Sabine Bischinger

Why was it done?

Due to the limited number of ports, it is necessary to administer several drug solutions via the same access. Incompatibility reactions can occur and may lead to a reduction or loss of drug efficacy and severe damage to the patient’s health. The objective was to create standardized administration protocols for central venous catheters and verify parenterally administered drugs’ incompatibility reactions. A further purpose was to build multidisciplinary cooperation to improve the drug administration processes.

What was done?

To optimize the drug therapy at four intensive care units (ICUs) of the University Hospital, the pharmacy department, physicians, and care management, jointly implemented a quality assurance project. In multidisciplinary teams, we had to overcome various challenges in different wards to develop standards regarding administering drugs via multi-lumen catheters. We analyzed all frequently used drugs (n=72) for their compatibility and summarized findings in a crosstable.

How was it done?

The current situation was recorded using a questionnaire and collecting individual cases of protocols for central vein catheters. About 2000 drug-drug-combinations were analyzed using three databases, KiK 5.1, Micromedex, Stabilis 4.0, corresponding specialist information, and manufacturer data. Nevertheless, the compatibility check based on the databases is subject to some restrictions. In several cases, the databases give different or contradictory results, and compatibility data are rarely available for some combinations. The project revealed that although infusion therapy is standardized in intensive care units, there are fewer standards regarding administering drugs via multi-lumen catheters. There are significant differences between theory and practice in terms of handling infusion therapy.

What has been achieved?

Different hazardous practices got identified and eradicated. The incompatibility table allows a quick assessment. The advantages/disadvantages of varying software systems were broadly discussed. KiK 5.1 was implemented in the ICUs, Micromedex in the pharmacy department. The team agreed that existing uncertainties must be decided jointly. Different practices in different wards may pose a threat to patient safety. The results were presented in a clinic-wide interdisciplinary training.

What next?

The awareness towards the need for cooperation and hospital pharmacists’ competence concerning incompatibility reactions strongly increased, leading to more standardization in the infusion therapy and avoiding incompatible drug combinations. The aim is to initiate a continuous improvement process.

Possible interactions from COVID-19 drug employment: the Hospital Pharmacist’s intervention in a regional hospital

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European Statement

Patient Safety and Quality Assurance

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.

TELEMEDICINE AND HOMEDELIVERY: MANAGEMENT OF THERAPEUTIC CONTINUITY IN THE PANDEMIC ERA.

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European Statement

Clinical Pharmacy Services

Author(s)

Marta Del Vecchio, Federica Chinotti , Claudia Lauria Pantano, Elirosa Minniti, Erika Cataldo, Francesco Guidoni, Vito Ladisa

Why was it done?

The Severe Acute Respiratory Syndrome – Coronavirus – 2 (SARS-CoV-2 ) pandemic made it difficult to monitor the patient’s health condition because many of them were locked down at home, unable to attend routine hospital visits.

What was done?

The hospital pharmacist, focusing on therapeutic continuity, closely collaborated with the clinicians in monitoring patient’s condition using telemedicine and homedelivery services.

How was it done?

In the multidisciplinary team, the pharmacist and the clinician defined the criteria to choose the most suitable patients for the homedelivery service. One of the options was to dispense the drug in a neighboring hospital. Because of the sanitary system regionalization, some of those hospitals could have been located even more than 100 km away, resulting in a problem for the most critical patients. In order to help them, home delivery and telemedicine services has been considered. The clinician used to visit patients on digital platforms, making clinical evaluations based on the results of blood tests, diagnostic tests and imaging techniques. According to clinician’s indications, the pharmacist took contact with patients, in first to collect informations about any residual storage of the drugs, adverse reactions, therapeutic compliance and then to proceed with the delivery. Everything has been done in conformity with the General data protection regulation (GDPR).

What has been achieved?

From March to September 2020, the homedlivery service count 501 speditions all over the Nation, 480 patients has been contacted to recive therapy and 250 of them has been intensively monitored by calling to manage their follow up. Everything has been done in order to protect critical patients from pandemic, safeguarding the therapeutic continuity,in compliance with pharmacovigilance, risk managment and cost saving for the national health system, considering that the suspension of therapies could be considered an additional and not quantifiable cost, but certainly important.

What next?

The hospital pharmacist must collaborate ever more with the clinician even in the post-pandemic phase, remotely managing not only the most weak patients, but extending the telemedicine and homedelivery services to an increasing number of patients, in order to safeguard their health .

HOME DELIVERY OF DRUGS, A DISPENSING SYSTEM THAT HAS COME TO STAY

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European Statement

Clinical Pharmacy Services

Author(s)

Ignacio Salar Valverde, Maria García Coronel, Consolacion Pastor Mondéjar, Mayte Gil Candel, Iris Muñoz Garcia, Carles Iniesta Navalon, Elena Urbieta Sanz

Why was it done?

This project was carried out to avoid the possibility of contagion by SARS-CoV-2 when going to collect the medication. The circuit began at the end of March and the month of April 2020.

What was done?

Send the hospital dispensing medication to the patient’s home.

How was it done?

The first step was to specify the patient was considered at risk for SARS-CoV-2, in the end, patients over 65 years of age or immunosuppressed were considered at risk.
The second step was what order to follow to select and evaluate candidate patients for home delivery, for which the solution was simple, it was decided to follow the order of the pharmacy agenda for the collection of medication. The SELENE® electronic medical record program was used to evaluate the patient’s risk.
The third step was to contact him by phone, to check if there was a possibility of collecting the medication by a family member / caregiver, and if not, confirm a delivery address.
The last step was the preparation of the medication in the proper conditions of conservation and identified with the name and address of the patient. Shipments were organized from the pharmacy service. Patients were given an appointment in the pharmacy agenda for the next shipment.

What has been achieved?

There were 139 home deliveries of medication, 47 in March and 92 in April. Around 139 telephone calls were made, they are not counted, not all patients could be contacted in the first attempt, and up to three attempts were made per patient.
The majority, 124 shipments, were made through the service that the hospital made available to them, except for 13 that were made through the Red-Cross and 2 through Civil-Protection.

What next?

Although the delivery of medication at home and was already carried out in some pharmacy services, because of the pandemic it has spread to the rest of the hospitals in our country.
This service should be maintained, despite its cost, for patients who meet a series of criteria, which must be established and agreed upon. In addition, a telephone follow-up should be carried out on the patients that we send the medication to their home.

Early detection of prerenal acute kidney injury (AKI) inpatients through multidisciplinary action.

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European Statement

Clinical Pharmacy Services

Author(s)

MARGARITA BELTRAN GARCÍA, NATALIA MARTÍN FERNÁNDEZ, MERCEDES SALGUEIRO LAZO, SANTIAGO SANDOVAL FERNÁNDEZ DEL CASTILLO, MIGUEL ÁNGEL CALLEJA HERNÁNDEZ, ANTONIO LEÓN JUSTEL

Why was it done?

AKI is an underdiagnosed syndrome due to delay in detection and late referral to the nephrology unit. A real-time electronic alert system integrated into a multidisciplinary protocol could be useful for early identification and diagnosis.
Among the risk factors associated with AKI is the use of nephrotoxic drugs such as NSAIDs and COX-2, ACE inhibitors and ARA-II, Cyclosporine and Tacrolimus.

What was done?

A multidisciplinary protocol was established for the detection and early action of prerenal AKI inpatients with hospital and Primary Care monitoring.

How was it done?

An authomatic electronic tool, agreed between Biochemistry and Nefrology units, was designed for the selection of AKI patients. The pharmacist was contacted when a prerenal AKI was detected, who generated an alert in the electronic prescription system in order to recommend actions related to prescribed nephrotoxics drugs. An analysis was request to check renal function in these patients, after 48 hours in the hospital and after 1 month of discharge from the Primary Care.
There were many previous meetings and the leadership of each unit was maintained in the participation of strategies.

What has been achieved?

The aim was to improve the detection of prerenal AKI in inpatients and increase the quality of healthcare in these patients.
For this 3-month pilot phase, were selected 3 clinical unit and 9 prerenal AKI cases have been detected. The most frequent risk factors were: 9 cases due to volume deplection, 6 due to nephrotoxic drugs use and 3 due to chronic kidney damage (CKD). The measures adopted were: add fluid therapy in all cases, cancel nephrotoxic drugs and modify the diuretic drugs prescription in 6 of 7 cases. There was only 1 death.

What next?

This strategy will be extended to all hospital clinical units. Data will be obtained on incidence and morbidity and mortality in these patients, as well as on length of hospital stay.

Using in-house rapid quality control equipment to reveal morphine ampoule tampering – A case report

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European Statement

Patient Safety and Quality Assurance

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.