HANDLING OF HAZARDOUS DRUGS IN HEALTHCARE SETTINGS – HAZARD EVALUATION AND PROTECTIVE MEASURES RELATED TO EXPOSURE LEVELS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Falko Schüllner, Martina Jeske, Martin Munz, Sabine Bischinger, Anna Reich
Why was it done?
The right handling of hazardous drugs in healthcare settings is essential to ensure occupational safety and health as the use and number of these potent drugs increase. In the last decades, protection at the workplace has become more important and several organizations analyze substances for this very reason. Although the antineoplastic drugs remain the principal focus, other drugs may also be considered hazardous because they are potent or cause irreversible effects.
What was done?
In this study drugs used in the University Hospital considered hazardous and to describe potential exposure values were evaluated in connection with exposure limits. A health risk assessment was conducted regarding protective measures related to exposure levels.
How was it done?
The National Institute for Occupational Safety and Health (NIOSH) assumes five categorizations with hazardous potential. According to their ATC-Code, substances from this categorization were listed. Findings of the European Chemicals Agency (C&L inventory), European Directorate for the Quality of Medicines & HealthCare, manufacturer’s guidance, European public assessment report, and safety data sheets were compared with categorization from the International Agency for Research on Cancer, NIOSH, Food and Drug Administration pregnancy categories, and publications from the German Berufsgenossenschaft für Gesundheit und Wohlfahrtspflege. The topic of exposure was divided into a determination of exposure limits in safety data sheets or in the “Grenzwerteverordnung” and into published information regarding exposure in healthcare settings. Monoclonal antibodies were examined separately. For risk assessment purposes, Stoffenmanager and other relevant tools were used.
What has been achieved?
717 substances were analyzed. 461 of them showed at least one probable hazardous or hazardous characteristic. It was possible to establish 177 threshold values, 124 for hazardous substances. The range of threshold values for the criterion “hazardous” was 0,015 μg/m3 – 10 mg/m3. Further research yielded a few public health publications referring to exposure values.It is hardly possible to quickly obtain information on the hazard potential of drugs, but C&L inventory has shown good results . Beside, there is a lack of data on exposure limit values, which is due to the difficulty in providing safety data sheets from manufacturers. As a result, exposure tools are not readily available for use by healthcare workers.
What next?
In an ongoing process every new drug will be evaluated towards the hazardous properties respectively associated exposure limits and communicated to the health care workers in the institution.
IMPLEMENTATION DESIGN OF A SECURITY STRATEGY IN THE HANDLING OF HAZARDOUS DRUGS IN A SOCIAL HEALTH CENTRE
Pdf
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.
HOME DELIVERY SERVICE DURING COVID-19 PANDEMIC TO RHEUMATOLOGIC DISORDERS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Ana Pelaez Bejarano, Maria de las Aguas Robustillo Cortes, Pilar Villar Santos, Olalla Montero Pérez, Ignacio Garcia Gimenez
Why was it done?
Rheumatologic disorders carry increased risk of infection compared with the general population, so facilitate access to hospital medications is of vital importance.
What was done?
On 14 March 2020, the Spanish government declared a state of alarm to deal with the spread of COVID-19. Medication dispensing protocols were immediately established to deliver drugs to patients who could not come in person to the hospital pharmacy department. These measures were designed to benefit citizens who, due to age or physical fragility, were more vulnerable to contagion. We had the collaboration of community pharmacies actively practicing during the COVID-19 pandemic and a logistics service, with no extra cost to the public healthcare system.
How was it done?
Between 30 March and 1 September 2020, a circuit was designed as follows: First, patient request the delivery service in the community pharmacy of their choice, which sending the request of each patient to college of pharmacists. Later, this institution sending of applications received from all pharmacies to hospital pharmacy. Here, the hospital pharmacist reviewed the patient’s electronic medical record, checking that the medication requested was appropriate, modifying it if deemed necessary (change of drug, dose, and so on). A pharmaceutical cooperative sending antirheumatic drugs to the community pharmacies. Finally, the community pharmacist who received the package checked the medication and, with the patient, reviewed and reinforced the information on the treatment.
What has been achieved?
587 patients were included: 211 rheumatoid arthritis, 173 psoriatic arthritis, 121 psoriasis and 82 ankylosing spondylitis. The delivery service enabled us to provide antirheumatic drugs to patients in their immediate environment through a service that was free for both the patient and the hospital pharmacy service. This contributes to guaranteeing the achievement of the pharmacotherapeutic objectives established for these patients.
What next?
Further action is needed to identify which groups of patients require more intensive pharmaceutical care and, therefore, who could benefit most from telepharmacy, and not only the delivery service.
Implementation of a dashboard within a quality management system in the pharmacy department
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
The pharmacy must assess its own activity in order to better manage, to structure, respond to needs. This assessment is necessary in order to measure the productivity.
What was done?
The purpose of our work is to identify the key performance indicators for management and piloting a hospital pharmacy. The aim is to develop dashboards, a real management tool, for the management and monitoring of pharmaceutical activities in order to optimize performance and ensure continuous improvement.
How was it done?
The methodological basis of our study is based on a process-based management of hospital pharmaceutical activities. Our target is to achieve the same approach to these processes, within the various functional and concerned units, in order to harmonize and simplify the quantitative and qualitative monitoring of pharmaceutical activities.
What has been achieved?
Macroscopic cartography of pharmacy processes was established and the most critical processes were selected on the basis of a matrix. In total, eight key processes have been identified. The identity cards for these processes have been drawn up. Quality indicators have been identified. These indicators are intended to assess and monitor the processes. A first design of dashboards with the elements collected was proposed. This dashboard could evolve during the implementation of this project within the Pharmacy department.
What next?
These dashboards have to be finalized, validated and officially put into practice within the Pharmacy department. This methodology must be applied to the discipline of Clinical Pharmacy. Quantitative and qualitative assessment of the activities carried out within the pharmacy should be a subject for priority debate at the national level to finally find agreement on a relevant measurement tool.
INCOMPATIBILITIES OF PARENTERAL DRUGS IN INTENSIVE CARE – ANALYSIS AND OPTIMISATION OF ADMINISTRATION SCHEDULES OF CENTRAL VENOUS CATHETERS AND FREQUENTLY USED DRUG COMBINATIONS
Pdf
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
Pdf
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.
ISMP MEDICATION SAFETY SELF ASSESSMENT® FOR HIGH-ALERT MEDICATIONS – ASSESSMENT OF THE SAFETY OF SYSTEMS AND PRACTICES ASSOCIATED WITH SIX CATEGORIES OF HIGH-ALERT MEDICATIONS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
A. Sonnleitner-Heglmeier, M. Jeske, C. Petter, S. Grimm, S. Kerndler, U. Horvath
Why was it done?
The aim of this initiative was to assess, from December 14, 2018 to February 7, 2019, the practices associated with six high-risk drug classes – opioids, insulin, anticoagulants, methotrexate for non-oncological indications, muscle relaxants, chemotherapeutics – and high-risk drugs in general at the Unversity Hospital Innsbruck using the ISMP Medication Safety Self Assessment® for high-risk drugs. A further reason was to build up a strong and active cooperation amongst interdisciplinary teams with the focus on clinical pharmacy to raise awareness towards the competencies of clinical pharmacists.
What was done?
We translated, adjusted and introduced the Medication Safety Self Assessment® for High-Alert Medications from the Institute for Safe Medication Practice (ISMP) – U.S.A. to our university hospital. With a clinical pharmaceutical approach in multidisciplinary teams, we revealed challenges on different wards in the hospital and discussed and planed appropriate solutions.
How was it done?
The first step was to find an appropriate assessment accreditation programm which was found by the ISMP Medication Safety Self Assessment® for High-Alert Medications. This tool offers the opportunity to assess the safety of systems and practices associated with up to 11 categories of high-alert medications. As the assessment was written in english it had to be translated by us into german for a better basis for discussions. Further, as the ISMP assessment is implemented in the U.S.A., words and processes had to be adjusted to the work in an austrian university hospital. To optimize the outcome of the ISMP, the drug therapy pharmacy department, health care practitioners, and care management, jointly implemented a quality assurance project.
What has been achieved?
Different hazardous workflows and medication handling processes beginning from pharmacy despensing until receiving patients got identified and discussed. The urgent need of a patient data management system was emphasized to safely ensure a closed loop medication management. This would allow a clear and trackable communication in and between different wards and reduction in errors made by clincal staff.
What next?
The foundation was built for compulsory personal trainings done by clinical pharmacists on different wards. The awareness towards the importance of clinical pharmacy was strongly increased leading to more inclusion e.g. developing guidelines.
Using in-house rapid quality control equipment to reveal morphine ampoule tampering – A case report
Pdf
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.
NEW TECHNOLOGIES TO IMPROVE SAFETY IN PREPARATION AND ADMINISTRATION OF INTRAVENOUS ANTINEOPLASTIC DRUGS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Carlos Aparicio Carreño, Arantxa Gándara Ande, Beatriz Fernández González, Andrea Forneas Sangil, Belén Rodríguez de Castro, Rubén Pampín Sánchez, Cristina Martínez-Múgica Barbosa, Paloma NIeves Terroba Alonso
Why was it done?
To improve safety during preparation and administration of IAD.
What was done?
A new computerized system was established to improve quality control and traceability in preparation and administration of intravenous antineoplastic drug (IAD).
How was it done?
The software currently in use was updated, checking densities of IAD, weights of diluents and consumables. Protocols in pharmacology were adapted and maximum permissible error rates during elaboration were established. The Aseptics Pharmacy Department was equipped with a barcode label printer (BLP), a barcode scanner (BS), a precision scale and an All In One computer for the biological safety cabinet (BSC). The Haematology and Oncology Day Treatment Unit (DTU) was equipped with a BLP (for hospital bracelets) and portable computers with BS.
Regarding elaboration, a qualitative control was performed in the BSC by scanning data matrix or barcodes, recording batches and expiration dates, both of the diluent and antineoplastic agents. A quantitative gravimetric test was also performed using weight measurement of the diluent and devices before and after adding the drug. When the mixture was correctly prepared a label was printed with an identifying barcode.
Administration of the right bag to the right patient was also ensured by scanning barcodes in DTU: A hospital bracelet with a barcode was printed to identify each patient at their arrival to DTU. Prior to administration, double scan confirmation was made, checking patient´s bracelet and treatment (label), by using BS, ensuring that each patient received the drug, at the right dose, on time and by the correct route of administration.
What has been achieved?
All intravenous cancer therapies have been administered with double scan confirmation in DTU since the new system was established (November 2019).
This new way of processing IAD has been completely installed, but not all the antineoplastic treatments have been prepared with quality control.
The whole process has also left a complete computer record of the staff, task performed, time, duration and potential incidents.
What next?
We will gradually implement quality control while processing all intravenous antineoplastic treatments.
USE OF LINKED DATA SOURCES IN DYNAMIC DASHBOARDS TO VISUALISE HOSPITAL PRACTICE DIFFERENCES IN MEDICATION USE AND OUTCOMES
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Rawa Ismail, Jesper van Breeschoten, Michel Wouters, Anthonius de Boer, Alfonsus van den Eertwegh, Maaike van Dartel, Caspar van Loosen, Doranne Hilarius
Why was it done?
Most drugs obtain approval based on limited numbers of highly selected patients and mostly surrogate outcomes. Little is known on hospital variation on the use of new treatments in daily clinical practice. Benchmark information can be used to limit between hospital variation and provides real world evidence on the value of these treatments.
What was done?
In the Dutch Institute for Clinical Auditing (DICA) medicines project, administrative data on the use of expensive drugs from hospital pharmacies were linked to clinical data from national quality registries and hospital declaration data. Data were visualised in six dynamic dashboards (lung cancer, breast cancer, rheumatic disorders, colorectal cancers, gynaecological cancers and metastatic melanoma), leading to insight into expensive drugs use and clinical outcomes in real-world practice.
How was it done?
The three data sources were linked using patient-specific data and provide real-world insights in anti-cancer drug use and outcomes. After linkage, data were validated by individual sessions with hospital pharmacists and medical specialists.
What has been achieved?
Hospital pharmacists and medical specialists gained insight into expensive drugs use and treatment patterns in patient groups, compared to other hospitals. The dashboards also contain information on outcomes such as toxicity, emergency admissions, time-to-next treatment and users receive signals when their use of expensive medicines deviates from the benchmark. An example of the information provided by the dashboards was the number of stage IV non-small cell lung cancer patients treated with only one or two gifts of pembrolizumab. All hospitals received a report on this subpopulation to improve their treatment approach. Other findings were differences in the adjuvant treatment of stage III colon carcinoma patients and the treatment duration of trastuzumab/pertuzumab as adjuvant treatment in breast cancer patients.
What next?
The DICA medicines project is an example of good practice as it reuses available data sources without any additional registration burden. In the future, the dashboards will be extended with survival data and PROMs data. The focus of the program in the next year will be to include all hospitals in the Netherlands and to extend the dashboards with more features.