ADAPTING CLINICAL PHARMACY SERVICE PROVISION TO THE EMERGENCY DEPARTMENT DURING THE COVID19 PANDEMIC
European Statement
Clinical Pharmacy Services
Author(s)
Dearbhla Murphy, Mariosa Kieran, Jennifer Brown
Why was it done?
The Emergency Department (ED) at our institution is one of the busiest in Ireland. In 2019, there over 84,000 attendances. The ED CPS is multifaceted and involves clinical review of prescribed drugs, consultation with medical and nursing colleagues to ensure safe, effective and rational prescribing, drug supply and Medicines Reconciliation (MR). In order to meet patient requirements during the COVID19 pandemic, the ED was re-configured. The departmental changes necessitated realignment of the CPS to ensure evolving institutional requirements were being met while maintaining service provision.
What was done?
• ED Stock lists were reviewed and modified to ensure prompt availability of COVID19 treatments.
• Drug lists were devised for new ED zones to ensure availability of emergency and antidote medicines on a 24/7 basis.
• ED requirements for COVID critical medicines e.g. neuromuscular blockers, propofol, midazolam and antivirals were implemented in response to emerging evidence.
• Appropriate drug and fluid storage locations were reviewed in line with legislative requirements.
• Pharmacy technician top-ups were modified and standing orders introduced.
• Technician staff received Personal Protective Equipment (PPE) training to facilitate topping-up of drug presses in high-risk patient-facing areas.
• Access to critical care and COVID19 Respiratory Infection treatment protocols was expanded to ensure point of care access
• All associated SOPs were updated
• CPS provision was reviewed, changes introduced include:
1. fixed zone staffing allocations to reduce cross-contamination of staff
2. guidance on Infection Prevention and Control measures for completing MR patient interviews
3. electronic transfer of Clinical Pharmacist handover to ward based pharmacists
How was it done?
• A multidisciplinary team (MDT) of stakeholders was formed of Nursing Management, ED Consultants and the Pharmacy Department.
• The ED pharmacist coordinated the Pharmacy review.
• The procedures and policies governing CPS provision and ED drug stock holdings, storage and availability were reviewed and adapted.
• The MDT supported roll out of the changes in practice through communication and staff training.
What has been achieved?
Continuity of the CPS provision to the ED during COVID19 pandemic was ensured.
What next?
Through this review, the multidisciplinary ED team collaborated to successfully review CPS provision to adapt for the unique and evolving clinical needs of patients during the COVID19 pandemic. This ensured the safe delivery of a high quality CPS and continuity of drug supply.
PLAN FOR IMPROVING THERAPEUTIC EQUIVALENCE IN A HOSPITAL GPI
European Statement
Clinical Pharmacy Services
Author(s)
LUCIA JIMENEZ-PICHARDO, INMACULADA LOMARES-MANZANO, LEONOR GOMEZ-SAYAGO
Why was it done?
Hospital with 118 beds in which all medication prescribed by the doctor that was not included in the pharmacotherapeutic guide was purchased through an external pharmacy. The proposed objective was to elaborate an improvement plan in therapeutic equivalence, with the development of a TEG
What was done?
Therapeutic Exchange Guidelines (TEG) are an intervention on the prescription according to a previously agreed protoco, in which the prescribed drug is subtituted for the one available in the hospital (because it is considered equivalent or because it is a better therapeutic option).
In this way, the most appropriate drug included in the Pharmacotherapeutic Guide (PG) of the hospital would be selected.
How was it done?
A work schedule was established distinguishing five phases: a) Elaboration Phase, which consists of consulting and review of the medical specialties included in the hospital, b) Presentation / approval phase by the Pharmacy Commission, c) Modifications Phase, d) Disclosure Phase, through a clinical session to the hospital’s internists and other hospital medicians and e) Implementation Phase. For its preparation, a manual was consulted for the writing of TEG, guides from other reference hospitals and different bibliography obtained from Pubmed, as well as the technical data sheet of each drug.
What has been achieved?
The TEG is prepared over a period of 3 months and was structured with the following sections:
Therapeutic group according to the ATC classification of drugs (351), Reference drug included in the PG (443 drugs), Medicines not included
(620) y Recommended therapeutic attitude: substitute the one available at the hospital (469) (specifying dose and regimen), continue (82) or suspend treatment (69).
Subsequently, it was presented to the Pharmacy Commission, the appropriate modifications were made and the final version was released through a clinical session before its publication through the hospital’s intranet.
What next?
The therapeutic equivalence improvement plans are considered efficient management strategies, applicable in all hospitals and health centers. It is a multidisciplinary and continuous process that will require periodic reviews.
Hospital pharmacists contribute to a safe and efficient use of chimeric antigen receptor T cell drugs.
European Statement
Selection, Procurement and Distribution
Author(s)
José Luis Revuelta Herrero, Vicente Escudero, Roberto Collado, Belén Marzal, Ana Herranz, María Sanjurjo
Why was it done?
CAR-T cell-based therapies are advanced therapy medicinal products (ATMP) that are considered as drugs by the European regulatory authorities. ATMPs are usually associated with strong logistic and traceability requirements, serious adverse events and a high budget impact. Hospital pharmacists can help ensure a safe and efficient use of these drugs.
What was done?
A chimeric antigen receptor (CAR) T cell Therapy Committee was created in 2019 and it included members from the hematology, oncology, pediatric onco-hematology, hospital pharmacy, neurology, critical care medicine and immunology departments. An operating procedure defined the specific functions of the pharmacy department in the management of these drugs in the CAR-T cell program.
How was it done?
As some responsibilities might be shared with other professionals, it was key to define everyone’s contributions. In our case, an operating procedure with the responsibilities of the pharmacy department was developed based on the national and regional action plans for ATMPs in the national health system and the risk management plans for each drug. This operating procedure was reviewed and approved by the Committee.
What has been achieved?
The operating procedure was fully implemented and included the participation of hospital pharmacists in the following steps:
• Procurement: the inclusion of a patient in the program is agreed upon the Committee. The pharmacists provide a purchase order when all the requirements are met.
• Leukapheresis and shipment to the manufacturer: the apheresis is included in the computerized physician order entry (CPOE) and it is verified to confirm wash-out periods. Before the shipment, the pharmacists record the apheresis unique identifier and patient data.
• Product receipt: the pharmacists verify at receipt that the patient identity chain and the integrity of the product have been preserved.
• Bridge and lymphodepleting chemotherapy, CAR-T administration: specific protocols have been included in the CPOE. Prescriptions are verified by the pharmacists with special attention to the drug-free periods. After transporting the drug to the clinical unit and preparation, a pharmacy label for dispensing and administration is generated. This label includes a barcode for patient identity verification at bedside.
• Outcomes monitoring and pharmacovigilance: kits are provided to the clinical units for the management of CAR-T associated toxicities. Pharmacists are responsible for the adverse reactions reporting in coordination with clinicians.
What next?
We developed verification lists for each of the previous steps that have already been published (DOI: 10.3389/fonc.2021.636068). More ATMPs are expected to come and their management will require the participation of hospital pharmacists from different areas of expertise (procurement, clinical pharmacy, compounding etc).
Illustrating the role of the Diabetes Specialist Pharmacist in an acute hospital
European Statement
Clinical Pharmacy Services
Author(s)
Laura O’Donnell, Barry Keenan, Laura Loughran, Edel Davidson, Rosemary Donnelly, Sarah McGinnity
Why was it done?
In 2020, it was identified that diabetes specialist pharmacists working within diabetes inpatient teams were able to provide safe, effective and patient-centred care. However, it was equally identified that there was a lack of awareness of these new roles and their potential impact on care improvement. This is a major barrier to ensuring that specialist pharmacists become an integral part of diabetes inpatient teams.
What was done?
Diabetes specialist pharmacists from across Northern Ireland collaborated to define their role, and communicated their scope of practice in improving patient care as an infographic.
How was it done?
Acute hospital trusts in Northern Ireland were allocated temporary funding to demonstrate the benefits of a diabetes specialist pharmacist. There were localised differences in services provided according to the experience, and competence of the individual pharmacist, however as a team, pharmacists across Northern Ireland collaborated to help establish, develop and define the role. Work was mapped to the four guiding principles for medicines optimisation from the Royal Pharmaceutical Society Good Practice Guidance (2013). The comprehensive worklist was then transformed into an infographic to give a quick, visual and easy to understand illustration of the role.
What has been achieved?
The infographic is a unique tool to share the vision of what can be achieved by diabetes specialist inpatient pharmacists, and promotes clinical pharmacy services. The work was used to develop a business case for permanent funding, and is being used to inform a wider diabetes workforce planning strategy within Northern Ireland.
What next?
It is hoped that sharing this work will help inform and inspire teams who would like to incorporate a diabetes specialist pharmacist into their diabetes inpatient team, and provide a roadmap for those who are developing and establishing the role in their own hospital.
Next steps involve expanding the remit to include the other roles in which a diabetes specialist pharmacist can enhance care, for example outpatient clinics, and links with primary and intermediate care, to fully illustrate the role.
Partnership of Specialist Nurse and Specialist Pharmacist roles improves quality of care of IBD patients
European Statement
Clinical Pharmacy Services
Author(s)
Fernando Fuertes
Why was it done?
Monitoring of patients on immunomodulators increases the workload of consultants in gastroenterology outpatient clinics. Pharmacist-led monitoring clinics reduces the number of patients who had to discontinue treatment due to myelosuppression, optimises dosage by therapeutic drug monitoring (TDM), and increases adherence to blood monitoring.
What was done?
A creation of a outpatient pharmacist-led Inflammatory Bowel Diseases (IBD) clinic to monitor and optimised immunomodulators and biologic therapy. The role of the specialist pharmacist has added value and clinical oversight to the care of IBD patients as treatment with biologic therapy has become more prevalent. In addition, the pharmacist routinely participate in IBD multidisciplinary team meetings to help with decision-making and treatment optimisation.
How was it done?
The Department of Gastroenterology at Barnsley Hospital, developed the twin roles of a Specialist Gastroenterology Pharmacist and an IBD Specialist Nurse/Non-medical endoscopist in 2012 to augment IBD care. Both roles require accreditation for independent prescribing. The pharmacist has responsibility for therapeutic drug monitoring, the prescription of biologic treatment following induction and immunosuppressants, participate at MDT, patient support and patient education. The nurse oversees the clinical and endoscopic surveillance of patients including the running of the IBD telephone helpline service
What has been achieved?
Robust clinical, biochemical and endoscopic surveillance is crucial for the delivery of effective treatments and quality of care in IBD. Telemedicine and virtual clinics have become part of our mainstream clinical practice to allow our IBD patients rapid access to healthcare services, pathway-driven treatment decision-making processes and endoscopy. IBD specialist Nurse and pharmacist clinics allow efficient management of the Gastroenterology workload and show extremely high levels of patient acceptability and satisfaction.
What next?
IBD is a life-long condition associated with considerable ongoing morbidity. Patient’s social and psychological wellbeing can be affected if the disease is poorly controlled. It is proven the specialist role of the pharmacist adds value to the gastroenterology teams and improves patient’s care. However, there is a need to standardise the specialist IBD pharmacist like in others specialities such as haemato-oncologist pharmacist or anticoagulation pharmacist. A Continuous Professional Development (CPD) course has been launched in partnership with the School of Pharmacy at the University of Bradford (United Kingdom) to initiate this goal. Further recognition and awareness of the role is required with our profession to achieve the goal and improve patients’ quality of care.
TELEPHARMACY PROGRAMME IN CHRONIC NEUROLOGICAL PATIENTS DURING THE COVID PANDEMIC
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
ROSARIO MORA-SANTIAGO, JOSE-LUIS ORTIZ-LATORRE, ELENA SANCHEZ-YANEZ, ANGEL JURADO-ROMERO, ISABEL MOYA-CARMONA
Why was it done?
During the health alert caused by Covid-19, home delivery was quickly implemented in our country to reduce attendance at the Hospital Pharmacy Service (HPS) to obtain their medications.
In our HPS we transform home delivery into telepharmacy program (TP) with chronic neurological patients, who suffering pathologies that decrease their autonomy, with the purpose to optimize clinical outcomes and reduce the risk of contagion.
What was done?
The main purpose was to design a telepharmacy program (TP) undertstood as the provision of pharmaceutical care by pharmacists through the use of telecommunications to patients located at a distance. Telepharmacy services include patient follow-up and clinical service delivery. In our case, home delivery is also included.
How was it done?
We design the TP stratifying stable chronic patients (more than 6 months of treatment) by level of autonomy, physical distance to our Hospital and high risk (due to immunosuppressive treatment). Inclusion in the TP was proposed to patients with multiple sclerosis (MS) and aminotrophic lateral sclerosis (ALS).
Telepharmacy appointments were recorded and scheduled within the outpatient care activity, they were recorded in the patient’s medical history, as a pharmaceutical clinical follow-up, reviewing adherence, interactions and possible adverse events. Later, home delivery was made, through an external logistics company. Patients gave their consent to transfer personal data for home delivery.
Data collected were: sex and age, first or second line treatment in MS patients, pharmaceutical form (pill or syrup ) in ALS patients and number of total deliveries made.
What has been achieved?
We started on April 2020 with the program, six months later 56 patients were included, 48 with MS (total of MS patients attended by our HPS: 296) and 8 with ALS ( total of ALS patient attended by our HPS: 58). Median age: 45 years in MS group and 65 in ALS group. In MS group 37 patients received 1st line treatment and 10 second line. In ALS patients 6 received tablets and 2 syrup.
420 deliveries took place (average: 3,1 for patient).
What next?
The implementation of the TP was well accepted, avoiding longed displacement in patients with neurological pathologies. Our future target is to reach a greater number of patients that can be included in the program.
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.
IMPLEMENTATION OF A SAFE EXTERNAL DISPENSING SYSTEM DURING THE COVID-19 PANDEMIC IN A REFERRAL HOSPITAL
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARINA CORRALES PAZ, CLAUDIA RODRIGUEZ MORETA, INMACULADA LOMARES MANZANO, ANA GANFORNINA ANDRADES
Why was it done?
Due to the health crisis caused by the SARS-COV-2 virus, many hospitals have seen
the necessity to implement a safe dispensing system (telepharmacy) to provide medication to
high risk patients and those infected with Covid-19 in order to prevent interrupting their
treatments.
What was done?
To implement a system that guarantees a sure and effective supply of medical treatments to those vulnerable patients, those at increased risk or with difficult access to the hospital during the coronavirus pandemic.
How was it done?
A database was created with those patients attending our hospital’s outpatient service(OS)to pick up their medication within the next 7 days, verifying through pharmaceutical software and the patient’s medical history records (MHR)their next dispensing date. After checking if the patient had a medical appointmentthat could coincide with the dispensing date, a phone interview was conducted with the patient to schedule the pick-up of the medication through theOS or by telepharmacy(patients’ consent was requiredto use their personal information and we asked how the treatment was going). In our case the patients could pick-up their medication in the referral hospital (RH), a newly created OS in an affiliate hospital or by telepharmacy toprevent the collapse of the hospitals. We registered: number of patients attended in RH, new OS or by telepharmacy and number of dispensations. Patients were grouped in areas based on their city and delivery date for telepharmacy and in the case of patients picking up their own medication they were made an appointment.
What has been achieved?
During the months the state of emergency was in place in Spain (March 14th– June 21st)3385 patients were attended in total and 9316 medicationswere dispensed. 2245(66.3%) patients were attended in the RH (5794 dispensations), 583(17.2%) patients were attended through the new OS (1436 dispensations) and the rest 557(16.5%) had their medication sent to their address (2086 dispensations).
What next?
A safe and effective dispensing system was achieved to outpatients during the Covid-19 pandemic through the implementation of a new telepharmacymethod and the establishment of a new OSthat allows convenient dispensation of medication while minimising the risk of virus spread.
A multi-disciplinary teams’ collaborative approach to transition benralizumab dependent severe eosinophilic asthmatic patients to self-administration in response to the COVID-19 pandemic
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Grainne D’Ancona, Niall Stewart-Kelcher, Schaya Bains, Andrew Hearn, Joanne Kavangh, Cris Roxas, Linda Green, Linda Thomson, Marianna Fernandes, Brian Kent, Alexandra NanzerKelly, David Jackson, Jaideep Dhariwal
Why was it done?
The COVID-19 pandemic necessitated the rapid transition of benralizumab dependent SEA patients onto home administration to facilitate on-going therapy in a cohort of patients who were “shielding” under UK government guidance.
What was done?
246 severe eosinophilic asthmatic (SEA) patients treated with benralizumab; a biologic agent targeting the human interleukin-5 receptor (IL-5Rα), at a specialist NHS asthma clinic, were transferred to self-administration at home in response to the COVID-19 pandemic. Alongside this, patients continued to need to be newly initiated on benralizumab therapy in spite of the pandemic and innovative pathways were created to ensure rapid initiation of therapy and home administration.
How was it done?
A varied multi-disciplinary team including pharmacists, pharmacy technicians, specialist nurses, doctors, physios and phycologist conducted a variety of in-person and virtual (telephone and video) consultations to consent and train patients on self-administration in their own homes in a rapid transfer to home administration.
What has been achieved?
We have investigated this patient cohort for any unwarranted effects by comparing the last Asthma Control Questionnaire-6 (ACQ6) measured in clinic with that collected by telephone consultation 8-12 weeks after transition to home administration. 246 benralizumab patients were included in the analysis, of whom 49 (20%) were new. There was no significant difference in pre-biologic ACQ6, pre-homecare (baseline) ACQ6 or post-homecare ACQ6 between the new and established patient groups. Both cohorts exhibited a similar magnitude of improvement in their ACQ6 following the transition to home administration (-0.73 in the established group vs -0.73 in the new group, both P<0.0001). We have demonstrated that early transition to home administration in patients treated with benralizumab is not associated with worse clinical outcomes as assessed by ACQ6.
What next?
Evaluation of patient experience on the switch to self-administration is currently being carried out via patient surveys with this data due to be completed in early 2021. Further research is required to understand the potential influence of lockdown and/or telephone vs face-to-face ACQ reporting.
A multi-disciplinary teams’ collaborative approach to transition mepolizumab dependent severe eosinophilic asthmatic patients to self-administration in response to the COVID-19 pandemic
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Grainne D’Ancona, Niall Stewart-Kelcher, Schaya Bains, Andrew Hearn, Joanne Kavanagh, Cris Roxas, Linda Green, Louise Thomason, Marianna Fernandes, Brian Kent, Alexandra NanzerKelly, David Jackson, Jaideep Dhariwal
Why was it done?
The COVID-19 pandemic necessitated the rapid transition of the remaining 41 mepolizumab dependent SEA patients onto home administration to facilitate on-going therapy in a cohort of patients who were “shielding” under UK government guidance.
What was done?
87 severe eosinophilic asthmatic (SEA) patients treated with mepolizumab; a biologic agent targeting interleukin-5 (IL-5), at a specialist NHS asthma clinic, were transferred to self-administration at home compared to usual practice of administration in a hospital setting. 40 patient were transferred in late 2019 as a planned ‘pilot’ transition and 47 patients were transferred unplanned due to the COVID-19 pandemic. We investigated whether there was a change in asthma control following the transition to home administration and whether a differential response to treatment exists following transition to homecare before and after the onset of the COVID-19 pandemic.
How was it done?
A varied multi-disciplinary team including pharmacists, pharmacy technicians, specialist nurses, doctors, physios and phycologist conducted a variety of in-person and virtual (telephone and video) consultations to consent and train patients on self-administration in their own homes in a rapid transfer to home administration
What has been achieved?
Patients receiving mepolizumab at home were stratified according to those who had a planned transition prior to 1st Feb 2020 versus those who had an unplanned transition after this date necessitated by the COVID-19 pandemic. The last Asthma Control Questionnaire-6 (ACQ6) measured in clinic (“baseline”) was compared with that collected by telephone consultation 6-8 weeks after transition. Immediately prior to transition to homecare (baseline), the planned group had a lower mean ACQ6 than those in the unplanned group (1.19 vs 1.90, P=0.004). The ACQ6 on home administration decreased significantly in both groups (-0.47 in the planned group vs -0.56 in the unplanned group, both P<0.001). The ACQ6 for the planned cohort during homecare was significantly lower than that for the unplanned group (0.72 vs 1.34, P=0.012).
What next?
Evaluation of patient experience on the switch to home administration is currently being carried out via patient surveys with this to be completed in early 2021. Further research is required to understand the potential influence of lockdown and/or telephone vs face-to-face ACQ reporting.