BIOSIMILARS: LET’S START RUNNING (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Beatriz Zurita Alonso, Marta Martí Navarro, Monica Estelrich, Alejandro Ballestero Corominas, Anna Badell Giralt, Diana Patricia Vera Rodríguez, Milagros Ricse Salcedo, Roxana Rubio Vargas
Why was it done?
The use of biosimilar drugs has been a breakthrough to improve the sustainability of the health system. Although since 2015 position papers have been published by some scientific societies, there is no clear consensus about the recommendation for a switch from the original drug to its biosimilar. The rate of biosimilar use in our country is one of the lowest in Europe.
What was done?
The pharmacy service led the creation of a working group formed by rheumatologists, gastroenterologists, dermatologists and pharmacists to promote the use of biosimilar drugs in our hospital.
How was it done?
The working group wrote a consensus document in which it was jointly decided to start all new biological treatments with biosimilars. In addition, it was decided that the prescribers would determine which patients were candidates for switch to a biosimilar based on clinical criteria. If the drug is administered subcutaneously, the pharmacist is responsible to explain the reason for the change and the management of the new device to the patient. In case of disagreement, the original is kept and communicated to the prescribing physician. If the drug is administered intravenously, it is the physician who informs the patient about the change.
What has been achieved?
From May 2019 to September 2019, 17 switches were made: 4 infliximab (66.7%), 9 adalimumab (10.1%) and 4 rituximab (80.0%). This measure led to an economic saving of €111,106.96 per year. Twenty new treatments with biosimilars were started: 1 with etanercept, 2 with infliximab, and 17 with adalimumab. This supposed an economic saving of €141,826.36/year if we compare with the cost of the original drug. The rate of antiTNF biosimilars increased from 33% to 48% in 5 months. None of the patients refused the use of a biosimilar. By now, all treatments maintain their effectiveness without safety issues. This optimisation of treatments will allow the hospital to treat a greater number of patients and invest in innovative treatments.
What next?
These results indicate a great opportunity to offer biological treatment to a higher number of patients every year. Therefore, our objective is to achieve the switch of remaining patients as it could generate an additional saving of €630,072.28 per year.
VANCOMYCIN CONTINUOUS INFUSION FOR PATIENTS ON ICU (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Why was it done?
In the ICU there was a lot of misunderstanding around the administration of vancomycin by intermittent dosing, particularly around the timing of pre-dose vancomycin levels and appropriate dose adjustment. It could take several days for a patient to reach the therapeutic range of vancomycin.
What was done?
A protocol for the administration of vancomycin by continuous infusion was developed for patients on ICU, replacing the previous method of giving vancomycin by intermittent dosing; this was developed in consultation with the Anaesthetics and Microbiology Departments.
How was it done?
To develop a vancomycin continuous infusion dosing schedule for patients admitted to ICU, through a review of the available literature and with reference to vancomcyin continuous infusion protocols already established on ICUs in other hospitals. A proposal for administration of vancomycin continuous infusion needs to be included on the electronic clinical information system currently in use in the ICU. An IV drug monograph for vancomcyin by continuous infusion will be included in the ‘ Intravenous Medication Infusion Guidelines’; this will provide information on compatibility with other infusions if required. To recommend vancomycin continuous infusion in patients as agreed with the Anaesthetics and Microbiology Consultants at the daily ward review, this would require the patient to have a dedicated IV line.
What has been achieved?
A finalised version of the Vancomycin Continuous Infusion protocol has been developed in consultation with Anaesthetic and Microbiology Consultants. We have included additional information for patients on CRRT (continuous renal replacement therapy) that has been used in some patients on continuous vancomycin infusion. A standardised prescription for infusion of vancomycin is available on the electronic prescribing system. Vancomycin continuous infusion is now recommended for any patients requiring vancomycin therapy on the ICU.
What next?
We would propose to audit the number of patients on Vancomycin Continuous Infusion in the ICU, including time taken to reach therapeutic range, frequency of sampling and any other cost-saving initiatives perceived.
SIMULATION CURVES MAY HELP TO ASSESS ANTIBIOTICS ORALISATION PROCEDURES (submitted in 2019)
European Statement
Clinical Pharmacy Services
Author(s)
Andreas von Ameln-Mayerhofer, Martin Breuling, Ina Geist
Why was it done?
In the context of antibiotic stewardship, rapid oralisation of a parenteral antibiotic is recommended in many antibiotic stewardship guidelines. Such a sequence therapy is easy to implement if both application pathways lead to comparable efficacy levels at the site of infection. However, this does not apply to all anti-infectives, in particular some beta-lactam antibiotics represent a challenge in therapy. Additionally, the information about this topic is very sparse in the literature.
What was done?
In order to achieve an improvement in antimicrobial prescriptions, we have addressed possible problems regarding oralisation of antibiotics. For this purpose, we graphically compared the simulated efficacy levels of parenteral and oral forms of beta-lactams.
How was it done?
We programmed a computer based procedure that allows a simulation of plasma levels of antibiotics upon intravenous versus oral administration. Based on the obtained data and EUCAST-based MIC-distributions for a set of bacteria, we assessed the respective putative clinical actions.
What has been achieved?
Our simulations show that some oral beta-lactams do not reach the PK/PD condition of a sufficient therapy (fT>MHK) in the approved dosage. The simulations have been used for education seminars with physicians and partly led to an improvement in oralisation procedures. Additionally, an oralisation standard has been established.
What next?
Our next step is to develop a special prescription form for oral antibiotics which will enable us to control prescription behaviour even more effectively. We plan to monitor the prescription habits for anti-infectives more closely before and after establishing the prescription form.
IMPROVING ANTIBIOTIC STEWARDSHIP AT A HOME HOSPITAL UNIT BY IMPLEMENTING THE PRODUCTION OF ELASTOMERIC PUMPS CONTAINING BENZYLPENICILLIN (submitted in 2019)
Pdf
European Statement
Production and Compounding
Author(s)
Maria Rautamo, Niina Laihanen , Laura Lehtola
Why was it done?
Erysipelas was the most commonly treated infectious disease at the home hospital unit in 2015. Previously the standard treatment was broad-spectrum antibiotic cefuroxime three times daily. The infectious disease specialist wanted to improve the antibiotic stewardship by shifting from cefuroxime to a continuous infusion of narrow spectrum benzylpenicillin. The aim of the initiative was also to improve patient care and reduce the number of treatment visits and thus overall treatment costs.
What was done?
The production unit at the hospital pharmacy began preparing elastomeric pumps containing benzylpenicillin for Helsinki city home hospital unit for the treatment of outpatients suffering from erysipelas. A pilot study was conducted in November 2018 before further implementation of the elastomeric pumps.
How was it done?
A benzylpenicillin 10 million IU infusion solution was prepared and transferred to elastomeric pumps (Folfusor LV10, Baxter) in the production unit at the hospital pharmacy. The production method was developed by pharmacists at the hospital pharmacy in cooperation with Baxter and the formulation as well as stability information was received from Baxter. The pilot study was planned and executed in cooperation with Helsinki city home hospital unit. The batch size of prepared elastomeric pumps was 7 pumps a week and the overall pilot period consisted of 5 weeks. A total of 8 patients were treated during this period. The opinions of nurses and patients about the use of elastomeric pumps were investigated through a questionnaire. The impact on treatment costs were also evaluated.
What has been achieved?
Elastomeric pumps containing benzylpenicillin have been implemented as a standard treatment for erysipelas at the home hospital unit. Cost savings from the pilot period of 5 weeks were 125 nurse visits corresponding to approximately 100 hours of work as well as 200 km of driving for nurses to patients’ homes. The patients were very pleased with the elastomeric pumps and the fact that the pump had to be changed only once daily.
What next?
Production and delivery of elastomeric pumps containing benzylpenicillin has expanded to other home hospital units. The implementation of elastomeric pumps containing other active ingredients is under investigation.
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.
ANTIMICROBIAL STEWARDSHIP: WHAT IF EVERYTHING IS ON YOUR SCREEN? (submitted in 2019)
Pdf
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.
THE IMPACT OF AN ELECTRONIC ALERT IN PREVENTING DUPLICATE ANTICOAGULANT PRESCRIBING (submitted in 2019)
European Statement
Patient Safety and Quality Assurance
Author(s)
Alison Brown, Gillian Cavell, Nikita Dogra, Cate Whittlesea
Why was it done?
Anticoagulants are high-risk drugs. An NHS England Patient Safety Alert was published in 2015 highlighting harm from inappropriate co-prescription of anticoagulants1.
What was done?
A ‘duplicate anticoagulant alert’ (Anticoagulant MLM) was implemented within our electronic prescribing system (EPMA) to alert prescribers if co-prescription of two or more anticoagulants was attempted, with the intention of preventing the completion of a potentially harmful prescription. We conducted a retrospective review of the impact of the Anticoagulant MLM on preventing co-prescription of low-molecular weight heparin (LMWH) and direct oral anticoagulants (DOACS)
How was it done?
The study took place in a 950 bed UK acute teaching hospital. A report of all Anticoagulant MLM alerts generated for adult inpatients between 26th June 2017 and 8th October 2018 was extracted from EPMA. Data on drugs prescribed, alert acceptance or override and duplicate anticoagulant administration were collected. Where alerts were overridden, appropriateness of the override was assessed by an anticoagulation specialist pharmacist. Ethics approval was not needed.
What has been achieved?
The Anticoagulant MLM triggered on 894 occasions; 113 in response to attempted prescription of a LMWH for a patient already prescribed a DOAC. 65 of 113 alerts were overridden (duplicate prescription completed). 48 alerts were accepted (duplicate prescription avoided). Of the 65 overridden alerts, consecutive doses of both anticoagulants were scheduled appropriately. No duplicate doses were administered in 44 cases (44/65, 67.7%). 15 duplicate prescriptions were either cancelled before administration or not administered concurrently (15/65, 23.1%). Duplicate doses were administered against 6 prescriptions (6/65, 9.2%), on 3 occasions. No patient harm was identified. The alert prevented inappropriate co-prescription of anticoagulants to 48 patients. Overrides were justified in 44 cases. Anticoagulants were correctly prescribed for 92/113 (81.4%) patients. It was outside the scope of this project to investigate why alerts were overridden. ‘Alert fatigue’2 and alert frequency3 are recognised factors limiting the effectiveness of electronic alerts in changing a planned course of action.
What next?
The alert remains in place as a barrier to error. Further work is needed to identify reasons for anticoagulant alert overrides.
THE PHARMACIST IN THE LUNG CANCER MULTIDISCIPLINARY TEAM
Pdf
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.
PROTOCOL IMPLEMENTATION FOR PRESCRIBING AND DISPENSING POSTEXPOSURE PROPHYLAXIS KITS FOR HUMAN IMMUNODEFICIENCY VIRUS IN A THIRD-LEVEL HOSPITAL
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Clara Estaún-Martínez, Isabel Moya-Carmona, Laila Dani-Ben Abdel-lah, Jose Manuel Fernández-Ovies
Why was it done?
This initiative was taken in order to improve uptake and completion rates of PEP, and to homogenise the healthcare circuit for these patients and the prescribed drugs.
What was done?
A protocol was implemented in order to standardise the prescription and dispensation of postexposure prophylaxis (PEP) after occupational or nonoccupational exposure to human immunodeficiency virus (HIV).
How was it done?
A multidisciplinary team including Infectious Diseases and Preventive Medicine (PM) doctors, pharmacists and Emergency Room (ER) staff developed the following protocol for PEP according to World Health Organisation and national guidelines: – standard three-drug regimen for PEP: Tenofovir disoproxil fumarate/Emtricitabine + Raltegravir for 28 days. The pharmacy service (PS) repackages kits for five, 23 or 28 days that include antiretroviral drugs (AD) and written information about the treatment (use, length of the treatment, main interactions and side effects, contact number). Only 5-day PEP kits will be located in the ER. – Twenty-four-hour access granted to PEP kits as it is strongly recommended to initiate PEP as early as possible (ideally within 72h). –
Established healthcare circuit for patients in the ER:
• Monday–Fridays (8h00–15h00): patients will be immediately referred to PM, then they will go the PS in order to receive a 28-day PEP kit and pharmaceutical care.
• Out of this schedule and bank holidays: ER doctors will give patients a 5-day PEP kit and they will be referred to PM the next working day. After visiting PM, the patient will go to the PS in order to receive the rest of PEP (23-day kit) and pharmaceutical care. –
Several meetings took place in order to explain this new circuit to the health professionals involved and written copies were available on the ER as well as on the intranet.
What has been achieved?
The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient healthcare circuit for the patients. It also optimises the evaluation and monitoring of these patients by PM and the pharmacist, and grants prompt PEP initiation and 24h access to the AD. The 28 days (or 5+23 days) kits help to accomplish the proper length of treatment, without using the regular packages which include 30 days of treatment (saving €43.17 per treatment).
What next?
We will monitor the compliance with this protocol and the drugs prescribed for PEP.
HOSPITAL PHARMACY UNIFIES ELECTRONIC STANDARD PRESCRIPTION THROUGHOUT THE REGION
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
The primary aim was to increase patient safety by quality-assuring ESPs and guiding clinicians to rational and safe prescribing. The Central Denmark Region (1.3 million citizens) has five hospitals, each with their own hospital and ward management. ESPs were previously set up and maintained locally, often by clinicians at ward level, resulting in several thousand, and a huge variety of ESPs for the same indication/treatment. Often only small differences separated these, but larger differences were also observed. Both patients and clinicians move around hospitals within the region. Varying ESPs from hospital to hospital confused clinicians and compromised patient safety.
What was done?
The regional Drug and Therapeutics Committee (DTC) commissioned the Hospital Pharmacy, Central Denmark Region to take over management of electronic standard prescriptions (ESP) in the shared Electronic Prescribing System (EPS). The pharmacy was also commissioned to lead the unification of local to regional ESPs, in collaboration with clinical specialists. ESPs are electronic ‘packages’ of one or more prescriptions, set up for treatment of defined conditions/procedures e.g. knee-replacement. When the clinician prescribes an ESP, the predefined prescriptions appear automatically in the patient’s medicines list.
How was it done?
The Hospital Pharmacy highlighted clinical areas/treatments with several variations of the same ESP. The DTC appointed relevant clinicians to work with a pharmacist on unifying these, to one (or more) standardised ESPs, to be used in the whole region. The pharmacist was coordinator for the ad-hoc working groups. After approval by the DTC, these ESPs replaced the existing. If a department wanted an ESP that differed from the regional ESP, this had to be approved by the DTC.
What has been achieved?
Regional ESPs have been approved for:
• Abortion (reduced from 17 to six).
• Helicobacter pylori eradication (reduced from 28 to two).
• Treatment of paracetamol-overdosage.
Many new ESPs have been approved, promoting:
• Safe prescribing of complicated regimes e.g. fosphenytoin loading/maintenance.
• Use of regional formulary drugs e.g. antibiotics for pneumonia/urosepsis.
What next?
We continue to work on other regimes that can be unified e.g. treatment of Wernickes prophylaxis/syndrome and parenteral nutrition. We recently met with pharmacists from two other regions that use the same EPS as us – maybe we can share ESPs nationwide in future.