DYSPHARMA: AN ITALIAN WEB-APPLICATION FOR DRUG THERAPY MANAGEMENT IN DYSPHAGIC PATIENTS (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Serena Logrippo, Giulia Bonacucina, Matteo Sestili, Alessandro Caraffa, Marco Cespi, Roberta Ganzetti
Why was it done?
Dysphagia is a well-known community issue that affects primarily aged people [1]. The availability of appropriate dosage forms for dysphagic patients is essential to guarantee therapy adherence. Extemporaneous compounding of SODSs (e.g. crushing tablet or opening capsules and dispersing the obtained powder in an appropriate base or vehicle) is a common practice due to the unavailability of different dosage forms to satisfy the current needs of patient. However, compounding practice is neither risk-free nor error-free [2]. The aim of the work was to realise a web application to support HCPs in drug therapy management of dysphagic patients.
What was done?
To properly manage oral therapy in dysphagic patients, a multidisciplinary team developed an algorithm and applied it to over 8000 medicinal products available as solid oral dosage forms (SODSs). A web-based, decision-making tool was launched to support healthcare providers (HCPs) during the prescription, compounding and administration of SODFs to dysphagic patients.
How was it done?
An extensive review of the Italian pharmaceutical market database, product characteristic summaries and scientific literature were used for data collection. For each prescription drug formulated as SODF, an information sheet was elaborated and continuously updated.
What has been achieved?
DysPharma (www.dyspharma.it) is an on-line support currently available and under restyling. By registering and logging-in, it is possible to access technical content that comprises medicinal product details, drug-food interactions, extemporaneous compounding methods, and risk symbols. Medicinal products can be searched by active ingredient name, medicinal product name, and marketing authorisation.
Customised symbols are reported for: do not crush tablets or open capsules, do not split tablets, to wear personal protection devices in case of manipulation of hazardous drugs, and drug associated with dry mouth.
What next?
This decision support tool may be integrated with computerised medical records to reduce medication-prescribing and administering errors and to improve clinical outcomes of dysphagic patients.
References:
[1] Clavé, Pere, and Reza Shaker. “Dysphagia: current reality and scope of the problem.” Nature Reviews Gastroenterology & Hepatology 12.5 (2015): 259. [2] Logrippo, Serena, et al. “Oral drug therapy in elderly with dysphagia: between a rock and a hard place!” Clinical interventions in aging 12 (2017): 241.
ONCOLOGY PHARMACISTS: EXPANDING OUTPATIENT SERVICE MODELS TO INCREASE PATIENT IMPACT AND SAFETY (submitted in 2019)
European Statement
Clinical Pharmacy Services
Author(s)
Paul Firman, Karen Whitfield, Therese Hayes
Why was it done?
The provision of outpatient oncology services by pharmacists is still limited, but this role is an emerging one. There is limited literature to date that suggests that pharmacists can add value while satisfying the needs of patients with cancer, addressing medication use and symptoms, and potentially generating revenue for the practice. The value that clinical pharmacists can bring to outpatient clinics other than oncology clinics has been highlighted extensively, providing added weight to the argument for incorporating these professionals into the cancer care model.
What was done?
The oncology pharmacy team in a tertiary referral hospital with the assistance of activity-based funding commenced an outpatient clinic allowing patients an opportunity for medication reviews, appropriate counselling of oral chemotherapy and discussion of medication side effects which was a gap within the current service.
How was it done?
In consultation with pharmacy, medical, nursing and administrative staff a working party was formed to establish the outpatient pharmacy clinic. Factors including patient cohort, appointment scheduling, clinic room availability, referral methods, and key performance indicators were discussed. The group met monthly to discuss the progression of the clinic and any barriers.
What has been achieved?
Over the first 3 months (January – March 2019) 215 patients on an average of 7.5 medications were reviewed. Within the cohort 57% of the patients were taking high risk medications (known as PINCHA medications) and 37% received counselling on new medications. There were 37 medication interventions mostly involving drug−drug interactions and medication optimisation. For succession planning, pharmacist training has also occurred.
What next?
Outpatient oncology practice is a growing area of opportunity for pharmacists to provide clinical services as part of a multidisciplinary team. This is of benefit both to the multidisciplinary team and the patient, ensuring the best possible outcomes. With the growing complexity of oncology treatments, the pharmacist’s role is vital to ensure quality use of medicines, safety and patient centred care. Training is currently being undertaken to expand the role and to ensure continuity of the service.
CAPTURE DATA AND CONQUER CLOTS (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
VTE is a collective term for blood clots usually in the legs or lungs. In Europe, there are 544,000 VTE-related deaths every year. VTE is responsible for more deaths than AIDS, breast cancer, prostate cancer and motor vehicle accidents combined. SVPH Pharmacy Department has been conducting annual Clinical Audits on VTE prophylaxis using a paper based system. However, the process was time consuming and limited the frequency of audit and the opportunities for identifying opportunities for improvement in compliance. SVPH has a high number of patients with high risk of VTE including Medical Oncology patients and Surgical patients. Compliance rates over preceding years were running at 75%; however, it is hoped to achieve a target of 90% compliance by 2020.
What was done?
An App was developed to collect data on venous thromboembolism (VTE) prophylaxis compliance across St Vincent’s Private Hospital (SVPH)
How was it done?
Different technologies were explored and an App developer was selected. Funding was sourced. Stakeholders were invited to get involved in the development team; this part was challenging and a lot of negotiations were had as to how the format of the App would be developed and carried forward. The next step when all the details had been finalised was launching the App.
What has been achieved?
Every month seven patients are randomly selected for audit and an auditor (in SVPH a pharmacist) inputs the data on the App which the lead auditor analysis. At SVPH compliance has increased from 75% prior to the app, to post implementation of the App where monthly VTE audits were conducted on all inpatient wards. The results are 92% compliance with VTE prophylaxis for 2018, and for 2019 up to Sept 2019 96% compliance.
What next?
It is hoped that this App will be a useful tool that will help SVPH and other hospitals to achieve a higher compliance with VTE prophylaxis guidelines and help prevent clots in patients. This App can be customised to individual hospital requirements. Technology has been shown to assist with clinical audit and will be used in various projects to make auditing easier and faster and therefore help healthcare workers to provide a better service to patients.
IMPLEMENTATION OF AN ASSISTED ELECTRONIC PRESCRIPTION SYSTEM IN A CRITICAL CARE UNIT (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARTA VALERA-RUBIO, ROSARIO MORA-SANTIAGO, MARIA ISABEL SIERRA-TORRES, JOSE LUIS ORTIZ-LATORRE, ISABEL MOYA-CARMONA
Why was it done?
The existence of different prescription systems could lead to validation errors when the pharmacist responsible for the ICU is not available. Furthermore, ICU physicians could not benefit from all the advantages that the official prescription system included. The presence of a common integrated prescription system among all units allow the exchange of prescription drug information between the ICU and the rest of the units, in accord with the health situation of the patient. Moreover, with this new system they can have access to allergies, renal adjustment doses, recommended posologies, therapeutic exchanges, and pharmacy validation, among other items.
Moreover, with this new system they can have access to allergies, renal adjustment doses, recommended posologies, therapeutic exchanges, and pharmacy validation, among other items.
What was done?
The intensive care unit (ICU) used a computerised physician order entry system different from all the hospital units. The pharmacy service, along with the ICU physicians and nurses, have tried to adapt the special features of this unit to integrate it with the clinical decision prescription system that is official in the hospital.
How was it done?
A multidisciplinary team formed by ICU staff (doctors and nurses) and pharmacists met to discuss the points that should be followed when implementing the new electronic prescription programme. In these working meetings, especially with physicians, we tried to agree on what and how the infusion protocols would be included in the new system, based on the infusion pumps guides made by both units. A pilot phase was established by the end of July 2019 to detect possible errors in the process of prescription, and mostly, when a patient changed from two units, from the ICU to another health care service and vice versa. All errors or discordances found were discussed between the pharmacist and the physician or the nurse, and in order to solve them we contacted the managers of the prescription system or we modified the parameters that are included in the system such as names of drugs, dosage guidelines, new nurses’ orders, etc.
What has been achieved?
The implementation of this new system has been well embraced by the staff, since it allowed a more efficient and secure health care circuit for the patients. All physicians are now able to use this system while the other one is no longer used.
What next?
We will continue making formative sessions with both physicians and nurses, in order to solve all the doubts that can appear during the training period. We will update periodically the available data and make improvements in the programme configuration.
DESIGN AND ELABORATION OF AN INTELLIGENT INTRAVENOUS INFUSION PUMPS GUIDE FOR THE INTENSIVE CARE UNIT (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARTA VALERA-RUBIO, MARIA ISABEL SIERRA-TORRES, ELENA SÁNCHEZ-YAÑEZ, JOSE LUIS ORTIZ-LATORRE, ISABEL MOYA-CARMONA
Why was it done?
Critically ill patients often require the administration of several intravenous drugs and that includes infusion pumps. New infusion pumps offer the ability to build a drug library within the infusion system itself. This allows intravenous infusion medication safety to be improved. Because of that, it is highly important to have an updated administration guide and an IV smarts pumps library for the everyday clinical practice. This guide was developed in order to help ICU staff to practice safe prescribing and managing of medicines and to reduce the incidence of adverse drug events and administration errors.
What was done?
We developed an updated guide on intravenous drug administration including infusion parameters for intelligent intravenous infusion pumps, so called “IV smarts pumps”, used in the intensive care unit (ICU).
How was it done?
A database with the most important intravenous drugs used was created by a multidisciplinary working team (pharmacists, physicians and nurses). The drugs included were divided into therapeutic groups and were distributed among the participating members for the drug information review process. The therapeutics groups included were: sedatives, analgesics, antihypertensives, vasopressors, anti-arrhythmics and others such as insulin, heparin, etc. For each drug, a bibliographic research was conducted, gathering information from manufacturers, intravenous drugs databases (Uptodate®, Micromedex®, Stabilis®) and other hospital guidelines. The data collected included: drug name, lower and upper hard limit, default dilution, flow rate, default rate, rate upper soft and hard limit, bolus default, flow rate and volume upper limit, loading dose, duration, dilution volume, default, and lower and upper hard limit.
What has been achieved?
This guideline promotes, mainly, the safe use of drugs usually administered in critically ill patients, and is available for all the staff in this unit. Its elaboration has made it possible to avoid medication errors and to establish a narrower bound between the pharmacy service and the critical care unit, developing new partnerships which could lead to new projects.
What next?
We are still working on improving this guide, making it easier to understand and with a unified vocabulary. We will update it periodically in order to include new evidence and new drugs if necessary.
DEVELOPMENT OF GUIDELINES FOR SAFE HANDLING OF ONCOLYTIC VIRUSES (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Faten Ahmad Díaz, Eugenia Serramontmany Morante, Carla Esteban Sánchez, Pablo Latorre García, Montserrat Carreres-Prieto, Javier Martínez Casanova
Why was it done?
Different critical points were detected: 1) some OV dose prescription depends on tumor size, 2) special storage conditions, 3) special safety measures related to preparation to prevent cross-contamination and technician exposure, 4) special transport conditions in a safety container, and 5) safe administration. The increasing number of clinical trials with OV combined with the identified critical points implies a better coordination between the different departments involved.
What was done?
Development of a standardised working procedure for the safe handling considerations, storage requirements, and modes of administration of oncolytic viruses (OV) in patients with cancer.
How was it done?
Different meetings were arranged with a multidisciplinary team to standardise procedures, in order to avoid errors: 1. The pharmacist validates the prescription volume reflected on the certified sheet according to the tumour size. Then, a pharmacy technician is authorised to remove the vials from the freezer to start the preparation. 2. Special −80ºC freezer is needed to preserve the OV. 3. According to the preventive medicine service, OV must be prepared in biological safety cabinet class II (BSC) with personal protective equipment. At the end of preparation, the BSC must be cleaned with the OV appropriate disinfectant and ventilated for 1 hour before restarting to work again. So, the OV preparation was established at 7 a.m. in order to avoid cross-contamination with the chemotherapy (first preparation in the day). 4. Safety transport must be considered, so OV is packaged in a special hermetic box. 5. The majority of the OV preparations are administered intralesionally at the radiology room so safe administration is needed to avoid the room contamination.
What has been achieved?
By using these procedures, it is possible to work with a single BSC, avoiding delays in the administration of other therapies while reducing the risk of mistakes.
What next?
These types of therapies represent a novel therapeutic modality: their preparation, administration and handling requirements differ from current therapies; pharmacists have an important role in developing new procedures to incorporate them into clinical practice. This protocol may be useful to other centres due to the lack of experience and standardised guidelines to work with this type of therapy.
OPTIMISING WORKFLOW AND MEDICATION IN THE ACUTE WARD − BETTER USE OF PHARMACISTS’ SKILLS (submitted in 2019)
European Statement
Clinical Pharmacy Services
Author(s)
Mia P von Hallas, Trine RH Andersen
Why was it done?
Physicians in acute wards have limited time to see all patients. Time for medication history, reconciliation and review is limited, due to great patient turnover. The physicians did not consider the pharmacist medication review alone as a contribution to the workflow or to relieve the high workload.
What was done?
Through user surveys among the physicians in the Acute Ward, pharmacist tasks were adjusted to benefit the physician’s high work flow. Before the survey, pharmacists performed medication reviews which were communicated to the physician. The adjusted pharmacist tasks on the ward includes medication history, reconciliation and transfer of the medication to the electronic medicine module (Epic), securing up-to-date medicine data during hospitalisation.
How was it done?
A questionnaire was developed regarding four areas (Pharmacist competencies, Pharmacist tasks, Pharmacist medication review, Multidisciplinary teamwork) and distributed among the physicians. Based on the anonymous responses, the pharmacists adjusted their tasks to include medication history, medication reconciliation and transfer of medication to Epic, complying with the suggestions in the questionnaire survey. Obstacles were low percentage of respondents (15/33 (45%) prior to the initiative and 12/39 (31 %) after), and the large replacement of junior physicians in the period between surveys.
What has been achieved?
Pharmacists feel more part of the multidisciplinary team and attitudes towards the pharmacist service among physicians has changed. A new survey after implementation of the new workflow showed that 73% found medication reconciliation was a pharmacist task, compared to 29% before. After implementation, 90% of physicians believed that pharmacists could do medication review (67% before intervention). The acknowledgement that pharmacists were able to transfer medication to Epic was increased from 20% to 90%. The attitude has changed from considering pharmacists as medication advisers to considering pharmacists as part of the multidisciplinary team in the ward.
What next?
The questionnaire survey will be repeated annually to continually improve the workflow and contribution of clinical pharmacist services to the heathcare professional team in the acute ward.
A NOVEL CLOSED SYSTEM DRUG-TRANSFER DEVICE FOR ORAL DOSAGE FORM HELPING PATIENTS WHO CANNOT SWALLOW SOLIDS (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
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.
FOUR YEARS OF A REGIONAL MEDICINES OPTIMISATION INNOVATION CENTRE – WHAT HAS BEEN ACHIEVED? (submitted in 2019)
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Michael Scott, Glenda Fleming, Catherine Harrison
Why was it done?
There is a wide recognition that there are significant issues with regard to the issue of medicines, such as the fact that 30−50% of medicines are not taken as required. Thus the DoH decided to set up MOIC as a vehicle to focus activities in order to address this issue and optimise medicines use.
What was done?
A Regional Medicines Optimisation Innovation Centre (MOIC) was set up in 2015 by the Department of Health (DoH) in Northern Ireland as a key enabler for the Government policy document namely the Medicines Optimisation Quality Framework.
How was it done?
The DoH requested the Northern Health and Social Care Trust to locate the centre within the Trust based on the fact that there had been a long standing academic practice centre with the School of Pharmacy at Queens University of Belfast. Barriers that had to be addressed were highlighting the regional nature of the centre, to get engagement with all sectors of the service and building relationships with other key organisations, including the private sector. Initial core funding was provided by the DoH.
What has been achieved?
MOIC has successfully evaluated improved systems with regard to hospital pharmacy such as doctor-light discharge (90 minutes faster), post-discharge telephone follow-up (30 day readmission rate reduced by 9.9%), and medicines optimisation in older people service in care home settings (reduced Emergency Department attendances and medicines costs). In addition MOIC has been successful in 3 EU funding bids relating to medicines optimisation and has published over 30 papers. It has also been accredited as a Statement Implementation Learning Collaborative Centre (SILCC) site and also a Centre of Excellence by the Spanish Hospital Pharmacists Association. MOIC has also successfully worked with the private sector including pharmaceutical, device and technology companies. It has also been accredited as a knowledge provided by Invest NI.
What next?
MOIC has delivered on its key initial objectives, related to medicines optimisation with good collaborative work across health, academia and commercial organisations, in the UK and Europe. It will have a key role in meeting the WHO Global Challenge of reducing medication-related harm by 50% by 2023 for the region and further optimising medicines systems.
This approach with government policy support could be relatively easily established in any other region.
MULTIDISCIPLINARY CAR-T TEAM (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARGHERITA GALASSI, CHIARA DELLA COSTANZA , CLAUDIA TIRONE, SARA BERTOLI, ERNESTO RUFFINO, ELEONORA FERRARI, ELENA ALIPRANDI , VITO LADISA
Why was it done?
CAR-T cell therapies are a new advanced type of personalised immunotherapy against cancer. In the EU the authorised therapies are tisagenlecleucel and axicabtagene ciloleucel, both used in our centre as third line for the registered indication of diffuse large B-cell lymphoma. CAR-T therapies production and administration process consists of multiple stages: patient’s leukapheresis, genetic engineering of lymphocytes, lymphodepleting chemotherapy (LC), CAR-T cell infusion, monitoring of the patient. Considering the complexity of the procedure and the observance of specific schedules, these therapies should be administered in highly specialised centres complying with specific organisational requirements, with disposal of an adequate multidisciplinary team.
What was done?
A multidisciplinary team (CAR-T team) was constituted for the management of CAR-T therapies (Chimeric Antigen Receptor T). The pharmacist was included in the team for the planning and organisational phase of the process.
How was it done?
The pharmacist is responsible for the approval of the physician’s prescription, the LC preparation according to Good Manufacturing Practice (GMP), the LC distribution on scheduled time, the making available of treatments for supporting the patient until CAR-T infusion, and treatments after infusion for management of adverse events. At the arrival of the CAR-T product, the pharmacist is responsible for the check and release of it in good condition. The LC protocols foresee the administration of cyclophosphamide and fludarabine on the 5th, 4th and 3rd day before the CAR-T infusion, and are defined on the basis of the summary-of-product characteristics. The medications are provided locally and refunded by the national health system.
What has been achieved?
In our center 8 patients were treated with compassionate use of axicabtagene ciloleucel. The pharmacist’s presence in the multidisciplinary team was advantageous because, through validation of the therapies and verification of dosages, they guarantee further security to the patients. The high-tech automated centralisation and computerisation of chemotherapies at our centre ensured quality and safety of the preparations.
What next?
The realisation of defined paths and codified proceedings, the respect of fundamental timings for the success of the process and the chemotherapy preparation centralisation could lead to increased investment, decisive for obtaining a high quality product and process level. The experience, now limited to haematology, could be used for future CAR-T applications.