REVIEW OF THE HOSPITAL HIGH-ALERT MEDICATIONS LIST USING HOSPITAL AND INTERNATIONAL DATA (submitted in 2019)
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European Statement
Patient Safety and Quality Assurance
Why was it done?
In University Medical Centre Ljubljana (UMCL) a HAM list was created in 2008 and has not been significantly changed since then. Our aim was to develop a systematic strategy to review the list by including local data.
What was done?
We comprehensively updated the hospital list of high-alert medications (HAM) and identified hospital specific medications not yet present on HAM lists. We joined international HAM data supported by medication error (ME) reports and expert opinion with data from the hospital ME reporting system.
How was it done?
We analysed 390 MEs submitted to the UMCL ME reporting system from 2016 to 2018. We compared the HAM list from Institute for Safe Medication Practices (ISMP) and the UMCL HAM list. The criteria such as frequency of the reported ME, severity of harm for the patient, affected population, novelty, etc, were used to identify potential HAM. Furthermore, we calculated the probability of the ME report for the individual medications from the reported MEs and the hospital medication consumption data. The calculation was done for the medications involved in 3 or more reported MEs (Tyynismaa et al, 2017) and for the medications involved in MEs which caused harm to the patient.
What has been achieved?
The joined results from the comparison of HAM lists and reported MEs showed that several other medications could be added to the UMCL HAM list, e.g. individualised parenteral nutrition for the paediatric population, oral sedation agents for children, dialysis solutions, lidocaine IV, methadone, bupivacaine, and nusinersen. The probability-based HAM identifying method supported our previous suggestions to extend the UMCL HAM list. Additionally, the method unexpectedly revealed medications with a high probability of ME and/or harm for the patients, that are not included in any HAM list (ISMP, UMCL), such as romiplostim, parenteral iron preparations, ampicillin with sulbactam, and others.
What next?
In future we plan to develop a paediatric specific HAM list based on the same strategy; i.e. considering international suggestions and analysing paediatric ME reports in UMCL.
PHARMACEUTICAL INTERVENTIONS IN PARENTERAL NUTRITION: METHODOLOGY AND RESULTS (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Teresa Cabeças, Sara Franco, Rita Oliveira, Maria Pereira
Why was it done?
PN is an alternative or complement in patients whose oral and/or enteral nutritional intake is inadequate/unsafe or whenever the digestive tract is not functioning or this route is contraindicated. Success in choosing the most appropriate PN depends on a specialised multidisciplinary team that can provide nutritional support that results in improved clinical outcomes and patient safety. With the decision flowchart (designed in January 2019), the hospital clinical pharmacist intervenes in the calculation of the patient’s nutritional needs and, consequently, in the counselling of the most appropriate PN bag and clinical and biochemical monitoring of the patient.
What was done?
Definition and implementation of action methodology, in a form of flow chart, for patients in need of parenteral nutrition (PN).
How was it done?
Implementation of the following therapeutic decision methodology: 1. Validation of parenteral support nutritional option according to decision flowchart; 2. Filling out a patient’s nutritional needs spreadsheet −anthropometric assessment; biochemical data; calculation of protein requirements; calculation of non-protein energy needs; calculation of total energy requirements; choosing the appropriate volume; validation of the route of administration; 3. Selection of the most suitable PN bag from the Hospital Formulary (preferably after ionic corrections); 4. PN bag suggestion to the prescribing physician; 5. Acceptance and alteration (or not) by the prescribing physician; 6. Clinical and biochemical monitoring of the patient; 7. Optimisation of nutritional therapy when applicable.
What has been achieved?
From January to August 2019 the Pharmaceutical Services intervened in all 21 PN prescriptions. In this universe, 15 were in the context of gastroenterology surgery, 5 due to infection and 1 due to non-gastrointestinal cancer disease. The intervention was not accepted in only 5 cases.
What next?
Clinical pharmacists play a key role in supporting the prescription of PN. The future is challenging, particularly in assessing patients’ outcomes and quality of life, as well as the economic and financial dimension. It will also be essential to create a Clinical Nutrition Commission that covers PN, enteral and oral feeding.
THE ACTIVITIES AND IMPACT OF A HOSPITAL-WIDE MEDICATION INITIATIVE (submitted in 2019)
European Statement
Patient Safety and Quality Assurance
Author(s)
Alice Oborne, Mark Kinirons, Virginia Aguado, Steve Wanklyn, Laura Watson, Jaymi Mistry, Duncan McRobbie, Abhiti Gulati, Emma Ritchie, David Wood, Niall Stewart-Kelcher, Adrian Hopper, Patricia Snell, Tony West
Why was it done?
Medicines are common interventions but have inherent dangers: 9% inpatient prescriptions contain errors, and medication errors occur at an estimated rate of one per patient per day [1-3]. Medication incident reporting was low, with high proportions of harmful incidents.
What was done?
Senior and junior staff collaborated to systematically improve safe medication processes and outcomes in a 1200-bedded multi-site hospital. The work aimed to reduce harm from medicines and improve medication safety culture.
How was it done?
Pharmacists, doctors, nurses and governance staff set up a Medication Safety Forum which met monthly to focus on high risk drugs, processes and patients. Published literature and international guidance were reviewed [1-3]. Twelve subgroups worked on safer opioid, insulin, anticoagulant, allergy and injectable medicine use and paediatric, elderly, critical care and peri-operative care. Subgroups published guidelines on the hospital intranet. External aviation and patient safety experts reviewed processes. Medication incident data were reported to staff monthly from June 2008. A monthly medication safety newsletter (total 68), screensaver messages, podcasts, mouse-mats, ‘safety days’, audit, training and senior staff promoted best practice. Electronic prescribing and medication administration (EPMA) with decision support was introduced in 2015.
What has been achieved?
The Medication Safety Forum met monthly 2009−2019. Medication incident reporting increased from 60 to over 400 per month (total 31330 over 11 years), whilst harmful incidents all reduced (Figure). Incidents with harm reduced from 51 to 24 in the first to last 20 months. Dose omissions reduced by 10% despite an increase in patient acuity, anticoagulant use and insulin use. The most common incident type was wrong dose, agreeing with national incident data. New guidelines included 30 for insulin, 28 anticoagulation and 19 opioid use. Medication incident reporting increased from 10th to highest in similar hospitals [3].
What next?
Multidisciplinary leadership, multimedia guidance, technology, audit and feedback in medication safety can be applied in any healthcare setting to enhance patient safety. Further system enhancements are planned.
References:
[1]National Patient Safety Agency 2004. Seven steps to patient safety
[2]Prescribing report, 2010. www.rcpLondon.ac.uk
[3]NHS Improvement organisational data reports
ALGORITHM OF SAFE AND CORRECT PREPARATION OF CHEMOTHERAPY (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Marijana Fortuna, Petra Tavčar, Jure Dolenc, Monika Sonc
Why was it done?
To support us in understanding our role in the preparation of chemotherapy products. To prevent the risk of harm to patients. Recognise prescribed error in pre-documented chemotherapy protocols
What was done?
Cytostatics are carcinogenic, mutagenic and teratogenic drugs. Handling requires a number of organisational and technical systems. All products should be safely and accurately prepared with special care to ensure the highest possible product quality, correct dose, the right patient, the right medicine, the right carrier solutions and right administration, without microbiological and particle contamination. The prescription and preparation of cytostatic drugs must be closely monitored. The most important factor in achieving this is the constant training of pharmacists in pharmaceutical techniques.
How was it done?
This year started with monthly reviews and training in the following subjects by using a written algorithm. Risk to product: Drugs reconstitution negative pressure isolators, leakage/damage or defects of vials, particles, transport and storage. Risk to patient: Incorrect calculations, microbiological contamination, incorrect administration, extravasation, incorrect administration route, incorrect labelling. Risk to operators: Contamination, toxicity, equipment, gloves, cleaning, occupational exposure. All checks have been made throughout the whole of preparation process, adhering to standard operating procedures (SOP-s).
What has been achieved?
We concluded that continuing education by using a writhen algorithm is useful practice. It helps prevent automatic work, remind us to check each step in process and know how to recognise errors in chemotherapy prescriptions and preparation. In 25 cases of prescribed chemotherapy, intervention of a pharmacist was required. In 5 cases of chemotherapy preparation, pharmaceutical techniques have detected a discrepancy in the prescribed therapy.
What next?
Regardless of experience at work, it is necessary to constantly repeat how to work properly, and awareness why we are doing this.
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.
BUILDING THE FOUNDATIONS OF A MEDICATION SAFETY PROGRAMME IN AN ACUTE HOSPITAL (submitted in 2019)
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European Statement
Patient Safety and Quality Assurance
Author(s)
Bernie Love, Tracy McFadden, Patrick Martin, Val Connolly, Deirdre Brennan, Michelle Griffin, Danielle Bracken, Siobhan Maguire, James Carr
Why was it done?
Avoidable harm caused by medication is one of the most commonly reported adverse events in healthcare settings.
What was done?
Connolly Hospital Blanchardstown launched a formal Medication Safety Programme in November 2017 by appointing a Medication Safety Facilitator and establishing a multidisciplinary Medication Safety Committee to promote and support the safe use of medications. The Medication Safety Committee undertook a number of activities to establish the programme in the hospital.
How was it done?
-An evidence-based literature review to define and guide the scope, breadth and direction of the programme. -A baseline in-depth analysis of locally reported medication incidents (2016/2017) on the National Incident Management System (NIMS) was conducted to identify initial targets for improvement. Analysis was undertaken using NCC-MERP, a recognised and validated tool used specifically for medication incidents. -An annual work-plan, incorporating necessary elements of a medication safety programme, was devised by the committee defining goals for the year.
What has been achieved?
Safety Culture: • Prominent commitment from hospital management to medication safety. • Investigations into medication errors aligned to a just and fair systems approach. • Promotion and encouragement of medication safety reporting and learning with a Medication Safety Awareness Day. • Implementation of the ‘Know, Check, Ask’ campaign to enhance medication safety by empowering patients. Governance: • Organogram updated to reflect reporting relationship of new committee. • Medication Safety made standing item at Quality & Safety Executive meetings. • Annual report submitted to Hospital Executive Committee Measurement & Monitoring of medication incidents: • Quarterly report produced and disseminated to front-line staff tracking and trending medication incidents including narratives. • Performance indicators established for: -No. of incidents reported (2018 reporting increased by 32% over 2017); -Reporter of incidents; -Category of harm; -Stage of medication use process where incidents have occurred. Education & Training: • Regular face-to-face education sessions arranged with front-line staff. • Quarterly medication safety bulletin devised and disseminated, informed by audit findings and incident reports. • The successful Medication Safety Minute initiative from St James’s Hospital was adopted and implemented, with content informed by local incidents. Development, Updating and Dissemination of PPPGs. • New IV drug administration guides (n=53) developed and updated. • Introduction of one-page ‘Medicines Information Sheet’ as quick reference guides for key topics. • DOAC prescription and administration guide developed and circulated. Audit: • Audit programme established informed by incident analysis, complaints and best-practice including introduction of an ‘audit window’ to gather hospital-wide data. Quality Improvement: • Informed by incident analysis, best-practice and audit findings, a number of moderate-high leverage quality improvement projects were initiated including removal of concentrated potassium from general clinical areas, introduction of an insulin & glucose monitoring record and introduction of an automated dispensing cabinet for out-of-hours access to medication.
What next?
The structural aspects established for the Medication Safety Programme have been successful in establishing a programme in the hospital and are reproducible by other centres.
Work continues in Connolly Hospital to identify themes of incidents, audit of practice and implementation of quality improvement initiatives.
AN AUDIT OF DISCHARGE PRESCRIPTIONS FOR SURGICAL AND MEDICAL PATIENTS WITH A QUALITY IMPROVEMENT INITIATIVE (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Eva Heffernan, Deirdre Smith , Avril Tierney, Louise McDonnell
Why was it done?
Transitions of care such as hospital discharge present an opportunity for medication error. Lapses in communication at this interface are common. For the next healthcare provider (HCP) to issue the correct medication safely and in a timely manner, the discharge prescription needs to bridge this communication gap. Prescribing errors are the most frequent subtype of medication errors and can be repeated systematically for prolonged periods. Detection of medication error using tools such as audit, learning from these errors and planning corrective action is essential to building safer healthcare systems.
This study adapted the Health Information and Quality Authority (HIQA) national standard for patient discharge summaries to create a benchmark for discharge prescriptions in SVPH. A QI initiative targeting prescribers was developed. This was designed as a bundle intervention and was called the Discharge Prescription Education Bundle (DPEB).
What was done?
The aim of this project was to evaluate the current level of discrepancies on discharge prescriptions for surgical and medical patients and to ascertain if a quality improvement (QI) initiative can impact on the severity of medication error at the point of discharge.
How was it done?
Uncontrolled consecutive baseline and re-audit of discharge prescriptions on a 26-bed mixed medical and surgical ward. The baseline audit assessed 70 patients’ discharge prescriptions. Deviations from the standard were termed discrepancies. Discrepancies were divided based on capacity to cause error (NCC-MERP Category A) and error occurred (NCC-MERP Category B-I). Discrepancies where an error occurred (NCC-MERP Category B-I) were reported using the in-house medication incident reporting (MIR) system and dually assessed by an independent panel and the project lead for potential to cause harm. The QI initiative was implemented and its impact assessed with a re-audit of 70 patients’ discharge prescriptions.
What has been achieved?
The overall number of discrepancies reduced from 156 in the baseline to 59 in the re-audit (p<0.05). Overall compliance with the audit standards improved from 17.1% to 54.3% (p <0.05). In the baseline audit 22.8% (n=16) of patients had a discrepancy where an error occurred; this reduced to 2.65% (n=2) in the re-audit (p<0.05). The severity of errors reduced in the re-audit.
What next?
The QI initiative used was proactive not reactive. Use of the discharge education bundle was not restricted to pharmacy opening hours.
This initiative was very low cost to implement. Following on from the successful results of this project one component of DPEB called the discharge prescription visual prompt is now preprinted on all SVPH discharge prescriptions as a reminder to prescribers.
AN OBSERVATIONAL MULTICENTRE STUDY TO PROMOTE INDEPENDENT CLINICAL RESEARCH AND EDUCATION TO YOUNG HOSPITAL PHARMACISTS: THE QOSMOS PROJECT (submitted in 2019)
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European Statement
Education and Research
Author(s)
Daniele Mengato, Federica Milani, Laura Agnoletto, Nicoletta Freddi, Roberta Rampazzo, Vera Damuzzo, Nicola Realdon
Why was it done?
Recently, the national monitoring of Hospital Pharmacy Students (SHP) highlighted a lack of education in clinical research and in designing of independent studies among students. To fill this gap, we established a collaboration between Scientific Associations and Student Organisations.
What was done?
In 2017 the Italian Society for Clinical Pharmacy and Therapeutics (SIFaCT) and the National Association of Hospital Pharmacy Students (ReNaSFO) established a join action to improve students’ research competencies. To this end, we designed the QOSMOS study: “Quality Of life (QoL) in Multiple Sclerosis (MS): a Multicentre Observational Study”.
How was it done?
The study has both educational and scientific objectives. Scientific objectives were to update data on QoL in MS and to correlate QoL to drug therapy. Regarding the educational challenge, every SHP participant received, by a panel of expert colleagues, the methodologic basis on observational studies and how to arrange teamwork activities. SHP could participate either as co-investigators or as members of teams which managed ethical approval, case report form (CRF), study monitor and data analysis. Investigators enrolled patients, collected clinical data and administrated a CRF, consisting of a questionnaire on QoL (MSQoL54).
What has been achieved?
22 SHP from 16 Italian centres, equally distributed from Southern to Northern Italy, joined the project. 20 SHP participated as co-investigators, one was included in the Scientific Committee of the study and 1 participated in the team dedicated to the Ethical Committee. We enrolled 341 patients with relapsing/remitting MS from May 2018 to June 2019 (median=20 per centre). The study achieved primary and secondary endpoints and pointed out a significant decrease in QoL related to physical health in patients treated with teriflunomide compared to other oral drugs (p=0.002).
What next?
Results will be presented in a scientific paper for submission to a peer-reviewed journal. This final aspect of the project has an educational goal once again, namely to bring young colleagues closer to writing and disseminating science. As QOSMOS gained good results, a new study investigating the role of clinical pharmacist in the Infectious Disease Department is starting with the goal to investigate optimisation strategies for treatment of HIV-positive patients.
DEVELOPMENT OF GUIDELINES FOR SAFE HANDLING OF ONCOLYTIC VIRUSES (submitted in 2019)
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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.
DESIGN OF AN ANTI-HAEMORRHAGIC AGENTS PROTOCOL FOR AN INTENSIVE CARE UNIT (submitted in 2019)
Pdf
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.