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DESIGN OF AN ANTI-HAEMORRHAGIC AGENTS PROTOCOL FOR AN INTENSIVE CARE UNIT (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Mercedes Gómez-Delgado, Marta Valera-Rubio, Margarita Carballo-Ruiz, José Luis Ortiz-Latorre, Isabel Moya-Carmona

Why was it done?

Blood coagulation factors and their adequate use can be of particular importance in the treatment of massive haemorrhage, especially in the ICU. This initiative was taken in order to improve uptake and to avoid errors in the administration, which can be difficult in emergency situations.

What was done?

To define an emergency procedure that ensures correct management in cases of massive bleeding in an intensive care unit (ICU).

How was it done?

The development of drug use protocols for emergency situations is a simple task that facilitates health workers to manage them. Prioritising the drugs to be included in a protocol by a previous survey in a multidisciplinary setting is important to consider the different points of view. We carried out a review of the pharmacy service to the ICU needs of antihaemorrhagic drugs. ICU staff (doctors and nurses) were informed to reach an agreement about eligible drugs for being included in the protocol. ICU staff requested the inclusion of four drugs in the protocol according to the prevalence of use and the difficulty of administration: human fibrinogen, tranexamic acid, eptacog alfa and human prothrombin complex. We created a protocol with four information sheets, one of each drug, made of schematic information about: 1. Physical location (fridge or room temperature, number of shelf) and minimum safety stock (3 units of human fibrinogen, 4 units of tranexamic acid and 3 units of human prothrombin complex). 2. Indications and dosage according to the clinical situation and the patient characteristics (dosage adjustment according to renal or hepatic impairment, weight or age when applicable). 3. Recommendations for intravenous administration (flow rate, bolus, loading dose, dilution, mixture stability).

What has been achieved?

Mapping the information and dividing it into sections is essential for its rapid understanding in a high-stress work environment. The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient health care circuit for the ICU staff. It also optimises the consumption of this type of more monitored drugs.

What next?

We will monitor the compliance with this protocol, as well as possible updates that may be beneficial for a better understanding of the forms of administration.

ASSORTMENT COUNCIL SECURES THAT MEDICAL PRODUCT AND INFORMATION IS AVAILABLE TO NURSES, PHYSICIANS AND PHARMACISTS (submitted in 2019)

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European Statement

Selection, Procurement and Distribution

Author(s)

Katja Heikkinen, Charlotta Vinterflod

Why was it done?

AC’s mission is to secure that the right product and product information is available as well as in case of shortages assist with alternative products and information. Correct information is fundamental to achieve an effective and secure supply chain of medical products. This reduces time spent on ordering, delivery time is shortened and finding information is more efficient.

What was done?

The hospital pharmacy in Region Västra Götaland, Sweden (VGR) established an assortment council (AC) that assists buyers of medical products within the region. By creating a defined assortment the goal was to direct healthcare professionals to order procured, recommended and cost-efficient medicines and enable structured availability monitoring.

How was it done?

A counsel of pharmacists was formed to administer a defined assortment consisting of 95% of the most commonly used medical products. The availability is monitored daily and every disruption of supply is handled in a structured way. Alternative marketed or unlicensed medical products are identified and information about these are communicated through VGR’s ordering system or by newsletters. If an equivalent product is available, it will be delivered automatically without the need for placing a new order. The AC also collaborates with the region’s medical specialists and drug and therapeutics committee (DTC) when searching for alternatives.

What has been achieved?

Defined assortment has been reduced from 6000 products to approximately 3000. In 2018 in addition to the daily updated availability information, 14,300 orders out of 410,000 were automatically replaced with an equivalent product and 41 newsletters about shortages were published. Nurses get more time for patient care when shortages information is readily available, and replacement of equivalent products can be delivered automatically

What next?

By implementing this way of working in other hospital regions or on a national level, caregivers would be able to free up resources and focus on patient care and at the same time be able to find quality assured information about shortages and alternatives in an efficient manner.

CAN THE CLINICAL PHARMACIST INCREASE HOSPITAL STAYS’ PRICING? (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Thibault Stala, Niels Martignene, Céline Monchy, Anne-Laure Lefebvre, Geoffrey Strobbe, Ali Hammoudi, Frédéric Feutry, Malgorzata Cucchi, Guillaume Marliot

Why was it done?

In France, hospitalisations’ reimbursement is linked to care severity. In this context, health care must be as comprehensive as possible on the comorbidities’ registration. As part of prescription validation, the clinical pharmacist can easily highlight comorbidities associated with specific treatments, in order to improve their codification and consequently to better valorise hospital stays.

What was done?

This work involves evaluating the ability of the clinical pharmacist to detect comorbidities related to certain treatments.

How was it done?

Six comorbidities, associated with the prescription of specific therapies, were chosen: – Dyskalaemia (potassium or polystyrene sulfonate prescriptions); – Neuropathic pain (NP) or anxio-depressive disorder (ADP) (amitriptyline, anafranil, pregabalin, gabapentin, duloxetine or capsaicin prescriptions); – Iron deficiency anaemia (IDA) (injectable iron prescriptions); – Hypovolaemia (HV) (ringer Lactate, serum albumin or gelatin prescriptions); – Hypercalcaemia (HC) (bisphosphonate and/or calcitonin prescriptions); – Severe infection (Inf) (linezolid, daptomycin, teicoplanin, aztreonam and carbapenem prescriptions). Retrospectively, all stays ending between 01/01/2019 and 31/03/2019, and containing at least one prescription of the previously mentioned therapies, were considered. Then, the medical records were analysed to verify the presence of the comorbidity corresponding to the prescribed drug(s). The coding was checked, otherwise, the comorbidity was added. Finally, the revaluation of the stays’ cost has been estimated.

What has been achieved?

The number of stays by suspected comorbidity, based on prescribed treatments, is : – 175 dyskalaemia; – 231 NP or ADP; – 155 IDA; – 124 hypovolaemia; – 41 hypercalcaemia; – 16 severe infection hypovolaemia and severe infection were quickly set apart because of the difficulty to confirm these comorbidities with the only retrospective medical record information. No stay with IDA or hypercalcaemia has been revalorised. The price of a single stay with dyskalaemia has been increased, by €530. However, NP or ADP has increased the cost of 6 to 13 stays, resulting in a total revaluation of €6000 to €11,000.

What next?

The stays’ remuneration is the hospitals’ main source of income. This work makes it possible to quickly determine if the clinical pharmacist can bring added value in the field of hospital stays’ pricing. The next step is the transition to forward looking. It would also be possible to assess other comorbidities.

A NOVEL CLOSED SYSTEM DRUG-TRANSFER DEVICE FOR ORAL DOSAGE FORM HELPING PATIENTS WHO CANNOT SWALLOW SOLIDS (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

SALIM HADAD

Why was it done?

It remains that new solutions to increasing the safety of handling Solid Dosage Form hazardous drugs have to be developed. Conceptually, through operating in a closed system, CSTDs should significantly reduce the risks to pharmacists and nurses There are two main drawbacks of the known solutions:
1. The crushing and dilution of the solid dosage form medicine is done with an open vessel to the environment, such as a porcelain crater, which may cause the work environment to be contaminated with carcinogenic or teratogenic substances, that could expose and endanger the medical staff to hazardous substances in the course of their duties as providers of medical care.
2. The tools available today are reusable, requiring a thorough cleaning process between different materials (drugs), which can lead to cross-contamination between different doses of drugs, which are crushed one after the other with the same instrument.

What was done?

CSTD – for oral dosage form new device of its kind, combines the act of crushing the various drugs, dissolve in liquid and give to a patient who cannot swallow for various reasons, that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.

How was it done?

We designed the device with 3D software (solid wark). It consists of a number of functional parts. The main ones are: a 20 ml barrel, a top part of which is a piston with a bottom basket loaded with the solid medicine; this part is sealed as a barrel from above. With the help of mechanical rotation, the drug breaks down into small particles that fall into the inner space of the barrel. Adding the liquid through a fluid port disposed on the bottom barrel which it is completely sealed. The removal of the liquid drug through a unique adapter which at its end is adapted to the gastric tube or oral administration to the patient,

What has been achieved?

1. The complete process of crushing and liquefying of the solid drugs is carried out under sealed conditions to the immediate environment and without fear of exposure to residues of toxic substances to the medical caregiver. 2. A one-time use system saves complex cleaning process. 3. There is no risk of cross-contamination between different drugs. 4. Saving personal protective equipment such as gloves, masks, lab coats clean rooms, etc. which is necessary for protection and for the safety of the caregiver team.

What next?

Applied research will be carried out by pharmacists and nurses to test the efficiency of the new device (as a basic prototype). These experiments will take various non-cytotoxic pills, will be dummy operations, in which the crushing and liquefying will be performed, and the solution or suspension will be transferred through the gastric tube, according to an approved research protocol.

THE OPIOID WORKING GROUP: AN INTERDISCIPLINARY WORKING GROUP TO IMPROVE THE CORRECT PRESCRIPTION AND APPLICATION OF OPIOIDS IN THE HOSPITAL SETTING (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Imke Willrodt, Delia Bornand, Jimena Ramos, Stojan Petkovic, Giulia Mohr, Anne Leuppi-Taegtmeyer

Why was it done?

Due to critical incidents involving opioids reported internally at the University Hospital Basel in 2018, there was an urgent need to evaluate underlying reasons for these events. The Opioid AG was established with the aim to mitigate risks for the correct prescription and application of opioids, and therefore to improve patient safety.

What was done?

The Opioid Working Group at the University Hospital Basel is an interdisciplinary working group including representatives from different professions (physicians, nurses, pharmacists) and departments (medical, surgery, gynaecology, emergency, pain therapy, palliative care, pharmacology and toxicology, patient safety and information technology).

How was it done?

The thorough analysis of root causes for the critical incidents revealed prescribing and application errors, such as non-observance of kidney failure, pharmacodynamic interactions of opioids with other prescribed drugs, inadvertent overdosing – in particular with liquid drug formulations, or patient mix-ups.

What has been achieved?

Consequently, the following steps are being taken to address these risks: 1. Optimisation of the prescribing software including opioid prescription templates, links to existing opioid unit conversion tables for liquid forms of diamorphine, morphine, hydrocodone and oxycodone (milligrams to millilitres) as well as clearer display of “as required” opioid prescriptions on the patients’ electronic drug charts. 2. Preparation of Standard Medication Preparation Schemes for nursing staff of the emergency department. 3. Development of an additional label (concentration, patient initials, date of reconstitution, date of expiry of reconstituted solution) for parenteral diamorphine. 4. Improvement in detailed written instructions for the correct preparation, labelling, application and disposal of intravenous and oral drugs (to include opioids). 5. Evaluation of a hospital opioid safety self-assessment tracking tool.

What next?

A comprehensive evaluation will take place, 6 months after the implementation of all measures. We will use the number of naloxone prescriptions on the wards as a key performance indicator to measure the success of this project. The reported critical incidents involving opioids will also be assessed before and after the implementation of all measures.

This evaluation will help to identify open questions, potential gaps and further needs for improvement to be addressed by the interdisciplinary team.

SOFTWARE TOOL DEVELOPMENT FOR THE ASSISTANCE OF HOSPITAL PHARMACISTS IN MEDICINES’ SHORTAGES MANAGEMENT (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Eleni Rinaki, Marinos Petrongonas, Maria Fragiadaki, Leonidas Tzimis

Why was it done?

MSs are a frequent problem in our hospital. In a study carried out in 2018, we investigated reported shortages during one year and found that 56% of cases of unsatisfied wards’ requests were due to failure of pharmacy’s procedures to restore availability. In 70% of these cases, time to re-stock was more than 4 days and strong involvement of HPs in following up and taking measures was required. The purpose of this tool is to bring together all relevant information of shortages, aiming to improve hospital pharmacy’s response as well as following-up MSs for further investigation or research.

What was done?

A new software module in Hospital Information System (HIS) for monitoring medicines’ shortages (MSs) was conceived by hospital pharmacists (HPs), and it was designed, developed and integrated to the ICT system. This module helps HPs easily track which medicines were totally or partially substituted due to insufficient quantities and gives additional information (such as residual quantity of a medicine on prescription date, on inspection date, pending orders, known shortage) needed for managing MSs. In this tool, MSs and relevant information, such as causes, measures to re-stock and shortage’s impact, can be entered, centrally managed and regularly reported.

How was it done?

Implementation of the module in ICT system was made at zero cost by the ICT service provider, following technical specifications designed by HPs. The final product was multi-checked by HPs during development and all technical problems have been resolved accordingly.

What has been achieved?

• Quick intervention of HPs to restore medicines availability is feasible. • We can now have precise and easier follow up, with less human resources required. • MSs are collected, registered and easily utilised to draw conclusions. • HPs’ interventions to deal with MSs are easier to evaluate

What next?

ICT tools’ development is very important in facilitating hospital pharmacy’s practice, especially when human recourses are restricted. These software modules can be easily incorporated in every HIS. Pharmacists are competent and should have a central role in designing such tools. We are planning to evaluate our new MSs management procedure; in the long run, incorporating in this tool a risk assessment algorithm will be an asset.

ANTIMICROBIAL STEWARDSHIP: WHAT IF EVERYTHING IS ON YOUR SCREEN? (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Marinos Petrongonas, Maria Fragiadaki, Eleni Rinaki, Leonidas Tzimis

Why was it done?

Implementation of antimicrobial stewardship programmes in hospitals is part of the national strategy to promote prudent use of antimicrobials. As HPs chair stewardship teams, they are responsible for assessing prescription and monitoring antimicrobial use. Designing and developing automated informative tools facilitates HPs in their role.

What was done?

Hospital pharmacists (HPs) designed and developed software tools to support the antibiotic stewardship team’s work. Particular developments were: a) Α PC application (GrAD_calc), in Microsoft Excel, to calculate antimicrobial consumption, instead of ABC_calc tool. GrAD_calc takes advantage of the unique codes for each branded product and transforms aggregated data, provided by the Hospital Information System (HIS), into antibiotic consumption in DDDs/100 occupied bed-days. Results are presented in charts and figures, in a format that enables ease of comparative monitoring over time. b) Necessary indexes of the above calculator and documentation needed as justification for restricted antimicrobials dispensing have been integrated into the HIS; in result, data for national surveillance programme for antimicrobial consumption are automatically exported. Useful information for pre- and post-prescription review, like demographics, indication(s), co-morbidities, current and previous treatments, microbiology tests’ results, susceptibility reports, is available and easily accessible to prescribers, HPs, and infection disease specialists.

How was it done?

HPs created GrAD_calc on their own resources, while changes in HIS were made by ICT service provider, following technical specifications described by HPs. A number of technical problems have been resolved with the contribution of HPs.

What has been achieved?

• Monitoring of antimicrobial use by pharmacy is quicker and effortless. • Handwritten documentation included in restricted antimicrobials’ prescriptions has been replaced by an electronic decision support system, as tool to improve antimicrobial prescribing and stewardship. • Useful information from patient’s medical record is directly available to HPs and physicians, and facilitates hospital’s policy for assessing antimicrobial prescriptions. • Data, like indication, medicine, dosage scheme, microbiology results and susceptibility reports, are recorded electronically and update patients’ pharmaceutical records, permitting further use for pharmaco-epidemiology studies. 

What next?

Next challenge is wide use of tools developed, to optimise pharmaceutical services provided and dispense restricted antibiotics only when accordingly justified. GrAD_calc is applicable in hospital setting and HIS’s tool is incorporated and can be used by all regional hospitals.

SUCCESSFUL DEVELOPMENT OF A SHARED INFORMATION DATABASE FOR HOSPITAL PHARMACIES IN DENMARK – BENEFITING FROM AGILE PROJECT MANAGEMENT (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Stine Ulsø, Hilde Omestad, Susanne Weng Rømer, Sisse Emilie Mejsner, Mads Nielsen, Jesper Heltoft-Christensen

Why was it done?

The existing solution, established in 2001, was running on an insecure platform, the system was expensive to maintain and changes difficult and slow to implement. The need for an update led to a change of supplier, hosting and platform.

What was done?

A new database was developed for documentation and quality assurance of drug related queries received by hospital pharmacies in Denmark. The information in the database is shared across all hospital pharmacies in Denmark and is an important tool for the Medicines Information Centers located there. Existing queries were transferred from the old to the new database.

How was it done?

A working group was established consisting of three pharmacists and superusers from three different hospital pharmacies, one project manager employed by the sponsor (Amgros) and two developers employed by the new supplier (Progressive). The project was structured using monthly physical meetings and ad hoc video conference meetings. The work tasks in the development process were divided and carried out in two-week sprints by the developers and subsequently tested and validated by the pharmacists. All participants agreed to a periodic heavy workload and showed great flexibility. The close and frequent collaboration between all members affected the teamwork in a positive way, hence the group was motivated and managed to agree on common solutions and compromises despite different database usage and different locations.

What has been achieved?

A new, stable and more intuitive database was developed in only 5 months due to the structured and flexible way of working and a close motivated teamwork. The database was taken into use from one day to another and quickly adapted. Since the development several hospital pharmacies have increased their use of the database. The amount of information shared nationally has improved.

What next?

The initiative resulted in a useful tool implemented within a short time. The way of working intensively and focused with physical meetings and video conferences made a good basis to succeed. Especially the sprint cycles can be used in different healthcare settings involving different projects.

OPTIMISATION OF CANCER CARE PATHWAY OF SCHEDULED PATIENTS WHEN OUTSOURCING CHEMO SUPPLY (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Charlotte Chatain, Orane Gleizes, Séverine Barbault-Foucher, Sophie Barthier, André Rieutord, Niccolo Curatolo

Why was it done?

The production of chemotherapy of our hospital will be outsourced by September 2019. This is going to lead to new constraints including anticipated production before patients are admitted to the clinical ward.

What was done?

The clinical pathway of scheduled patients receiving chemotherapy in the main full hospitalization unit of the hospital was optimised.

How was it done?

The clinical pathway of scheduled patients was mapped to describe each step and validated by all the concerned health professionals. Data were collected between October and December 2017 to monitor the percentage of anticipated orders by physicians for chemotherapy production (also called “OK production”). Critical steps and/or bottlenecks were identified. Brainstorming workshops were set to identify areas of improvement with pharmacists, physicians, nurses and secretaries. Finally, the proposals made were implemented.

What has been achieved?

Two critical steps have been identified in this pathway: the receipt of the biological test results by the secretary and the “OK production” given by the physician. It has been decided for the secretary to call patients 72 hours (instead of 24 hours) before to remind them to do their biological test in the medical laboratory. An electronic and standardised prescription with the specific date for the biological test has also been created. In addition, a follow-up form was completed by pharmacists to secure all the critical steps and remind secretaries when they had to call patients and remind physicians when they had to give the “OK production”. Over a two months period, “OK production” given 24−48 hours before the admission increased from 18% to 40% (n= 15 patients).

What next?

These clinical pathway improvements allowed a better anticipation. The process-oriented approach used to identify solutions was very fruitful and led to collaborative solutions likely to be applied and accepted by both clinical ward and pharmacy. This method could be applied to improve other types of processes in our hospital.

THE PHARMACIST IN THE LUNG CANCER MULTIDISCIPLINARY TEAM

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European Statement

Clinical Pharmacy Services

Author(s)

Ana Soares, Armando Alcobia

Why was it done?

Several clinical practice guidelines for LC recommend that multidisciplinary teams should be used to plan patients’ treatment. The evolution of thoracic oncology, namely the increasing knowledge of the diverse histologic and molecular phenotypes in non-small cell LC, has been driven to more complex treatment algorithms in recent years. This complexity increases the need for a multidisciplinary approach in therapeutic decision-making, which must be individualised and based on the best information available. The pharmacist’s inclusion in the multidisciplinary team is essential and was formerly proposed by the Pneumology Director to the Hospital Administration Board.

What was done?

A hospital pharmacist is a permanent member of the lung cancer (LC) multidisciplinary team, which has met weekly since January 2016, to plan the management and treatment of LC patients in our hospital. The pharmacist brings updated information about the efficacy and safety of drug treatments, its cost-effectiveness and its availability. The pharmacist improves communication with the Pharmacy and Therapeutic Committee.

How was it done?

The multidisciplinary team meets weekly to discuss the diagnosis and treatment options of LC patients, and includes a dedicated group of professionals: pulmonary oncologists, a thoracic surgeon, a radiation oncologist, a radiologist, a pathologist, a nuclear medicine specialist, a hospital pharmacist, a palliative care physician and an oncology nurse.

What has been achieved?

About 240 cases, corresponding to 200 patients were discussed per year. An average of 110 solicitations to the Pharmacy and Therapeutic Committee were made. The multidisciplinary team grants a systematic approach to diagnosis and therapeutics, in compliance with evidence-based guidelines, improves communication and coordination between professionals and short waiting times for the patient.

What next?

The next step is to systematise real-world data collecting, from the patients treated, to better understanding the effectiveness of treatment options and the real impact of the multidisciplinary team in patient outcome, ideally, extending it onto a national level.