The role of pharmacists at a temporary COVID-19 hospital
European Statement
Selection, Procurement and Distribution
Author(s)
Francesco Falbo, Oscar Martinazzoli, Agnese Bruni, Rosanna Lettieri, Simona Polito, Luisa Zampogna, Valentina Marini, Michela Mazzucchelli, Marcello Sottocorno
Why was it done?
The involvement of the pharmacist featured:
– Drug supply and storage
– Medical devices (MD) and personal protective equipment supply
– The creation of a catalog of required drugs
– Medication supply chain management and dispensing
– Management of medical gases
– Evaluation of the effectiveness and safety of drug therapy.
What was done?
As the COVID-19 epidemic spread, temporary critical care hospitals have been opened in order to attend the incoming burden of infected patients. In April 2020, one of the largest ever temporary healthcare structure was created in only 10 days. The ark hospital was opened for nearly 10 months and hospital pharmacists supported the effort for the pharmacy management.
How was it done?
The development of a catalog of required drugs has been accomplished using the consumption analysis on drugs and MD in March 2020 of the permanent hospital Covid unit. Thus, we created a dynamic catalog – constantly updated – consisting of 530 drugs and 345 medical devices. The medical staff members of the temporary hospital filled a special form for extra-catalog material. Running a cost-effectiveness analysis, the pharmacist managed to evaluate the purchase, rather than recommend a valid alternative from the material on the catalog.
The pharmacy warehouse was planned by dividing the MDs categories. Likewise, the drugs were stored according to their pharmaceutical form and their alphabetical order.
What has been achieved?
The materials requirements planning was achieved in 15 days, including medical supply ordering and the pharmacy warehouse organization. Pharmacists ensured the optimization of resources, the availability, safety and optimal use of medicines and MDs, as well as the monitoring of the adverse drug reactions (ADR). Hence, all patients received the appropriate pharmacotherapy. The pharmacist played a key role in the good functioning of the ark hospital in collaboration with all the medical team.
What next?
In conclusion, a new protocol and standard of care for managing health emergency will be the following and challenging step.
ANTICHOLINERGIC MEDICATION IN HOSPITALIZED PATIENTS
European Statement
Patient Safety and Quality Assurance
Author(s)
SILVIA CORNEJO-UIXEDA, M JOSE MARTINEZ-PASCUAL
Why was it done?
The anticholinergic burden is the cumulative effect of concomitantly taking multiple drugs with anticholinergic properties. It estimates the risk of suffering anticholinergic adverse effects. Anticholinergic scales are lists that rank the anticholinergic potential of drugs into categories.
What was done?
Our aim is to know the use of drugs with anticholinergic effect (ACD) in a regional hospital.
How was it done?
Observational study in patients older than 70 years admitted to a regional hospital from January to September 2021. We reviewed the medication of the patients looking for ACD. Then, we calculated anticholinergic burden with the “Drug Burden Index” available in: http://www.anticholinergicscales.es/calculate. The variables collected were: age, gender, number of drugs with anticholinergic effect, if ACD were prescribed before hospitalization, readmission, anticholinergic burden, risk of suffering anticholinergic effect and anticholinergic symptoms.
What has been achieved?
average 81 years (70-100), 102 (56% woman), 46 (25%) did not have any ACD. 58 patients had 1 ACD, 56 patients 2 ACD, 12 patients 3 ACD, 8 patients 4 ACD, 2 patients 5 ACD. Of patients with ACD, anticholinergic burden average was 0.98 in surgical patients (medium risk) and 1 in medical patients (elevated risk). 68 patients had medium risk and 68 patients elevated risk. We found constipation in 17 patients, somnolence in 6 patients, and disorientation in 2 patients. ACD used were the following (surgical vs. medical patients): Antidepressants: 3 vs.10, benzodiazepines: 28 vs. 33, opioids: 17 vs. 27, antiemetics: 13 3 vs. 38, Antipsychotics: 4 3 vs. 49, antihistamines: 2 vs. 2, antiepileptic: 0 vs 9, other: 0 vs. 3.
56 patients (31%) were prescribed the same ACD that they took before hospitalization. Only 17 patients were readmitted in hospital in less than a month.
We just made 2 interventions. We proposed to lower the dose in one case. In another, we proposed give metoclopramide just if necessary.
What next?
Most of hospitalized patients have ACD prescribed. Half of them had a high risk. However, just a few had anticholinergic reactions. This could be explained because we only had the information of electronic history and maybe some of them were not collected.
HIGH DOSES OF TREPROSTINIL ENTAIL LOWER HOSPITALIZATION COSTS IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION IN NINE EUROPEAN COUNTRIES
European Statement
Introductory Statements and Governance
Author(s)
Irene Lizano, Ferran Montpart, Elisenda Pomares, Guillem Saborit-Canals, Míriam Fernández
Why was it done?
Treprostinil is a prostacyclin analogue indicated for the treatment of PAH. A recent retrospective study analyzed drug safety events observed in the clinical trials of oral and subcutaneous (SC) treprostinil. This analysis showed that higher treprostinil doses were associated with lower PAH-related hospitalization rates, compared to lower doses.
What was done?
To estimate annual pulmonary arterial hypertension (PAH)-related hospitalization costs in patients treated with different treprostinil doses in nine European countries (Belgium, France, Germany, Italy, Poland, Portugal, Spain, The Netherlands and the United Kingdom).
How was it done?
A cost estimation model was developed to calculate hospitalization costs in patients with PAH who were treated with treprostinil at different doses. Annual hospitalization rates were gathered from a retrospective analysis of an oral and SC treprostinil global safety database. Patients were categorized into three groups based on total daily dose: low, medium and high. Low dose was defined as <4.0 and <1.9 mg/day (9.0 and >7.6 mg/day (>30 ng/kg/min). PAH-related hospitalization costs were included and, when not available, heart failure-related costs were considered as it is the main cause of hospitalization in PAH patients. Mean annual hospitalization costs per dose were calculated using annual PAH-related hospitalization rates (0.9 for low dose, 0.4 for medium dose, and 0.3 for high dose) and unit costs per hospitalization in each country. All costs were obtained from national databases or published literature and were expressed in 2021 euros.
What has been achieved?
Mean annual PAH-related hospitalization costs ranged from €1,649 to €8,382 for low dose, from €733 to €3,726 for medium dose, and from €550 to €2,794 for high dose. Thus, hospitalization costs for high-dose patients were 3 times lower than for low-dose patients (mean difference €2,610) and 1.3 times lower than those for medium-dose patients (€435).
What next?
High doses of treprostinil result in lower hospitalization costs than low and medium doses in patients with PAH. Therefore, an appropriate drug titration might lead to potential cost savings in various European settings.
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.
HOW TO SECURE THE COLD CHAIN MANAGEMENT OF TEMPERATURE-SENSITIVE PRODUCTS IN THE HOSPITAL AND WHAT IS THE ECONOMIC IMPACT?
European Statement
Patient Safety and Quality Assurance
Author(s)
Cyril Magnan, Elise Betmont, Guillaume Saint Lorant, Hubert Benoist
Why was it done?
Evaluate the economic impact of improvement actions taken since 2017 on TSPs management.
What was done?
Cold chain is a major issue in the pharmaceutical industry as a growing number of its products are temperature-sensitive and also in hospitals. In 2017, 27 cold chain breaks were declared by care units (CU) within a French teaching hospital, resulting in a risk for patient care and a potential loss of 40,363 euros, of which 18,505 euros (45%) could be avoided. Following this first study, a set of measures have been implemented in our establishment in order to secure the cold chain.
How was it done?
Potential losses and avoided losses of TSPs have been analyzed continuously since 2017 according to the same methods in a teaching hospital with 1,600 beds. In case of a thermal excursion (ET), the pharmacy is, according to the institutional procedure, immediately warned by an electronic alarm day and night or by a call from the care service, making it possible to define the action required from the service concerning the methods of keeping TSPs.
What has been achieved?
Since 2017, a mobile isothermal enclosure has been implemented for the transport of TSPs during the day in the CU. Connected temperature-monitoring sensors have been installed on so-called “at-risk” refrigerators. The alarm reports to the pharmacy was instituted in order to intervene as quickly as possible. Part of the refrigerators has been renewed and awareness has been raised among all CUs for the good traceability of temperature readings, allowing a drop from 24% in 2018 to 65% of compliant traceability in 2019. Following these improvement actions, 53 ETs with a potential loss of 53,769 euros were declared in 2019, of which 39,753 euros of losses could be avoided. Currently, 74% of ET losses can be avoided compared to 43% in 2017.
What next?
This economic assessment of the potential losses and the avoided losses of PTs shows the positive impact of the various improvement measures taken since 2017 as well as education of the UDS to secure TSPs. A regional awareness was implemented thanks to a collaboration with the regional health agency in order to promote TSPs management in the hospitals.
THE ADDITION OF A COST ANALYSIS CHANGES THE OUTCOME OF A TENDER (submitted in 2019)
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Camilla Munk Mikkelsen
Why was it done?
Including a CA in the evaluation is time-consuming and I wanted to evaluate whether the obtained drug recommendation was different from the result we could have achieved without the inclusion of a CA. The CA process includes data collection from clinicians within resource consumption per drug, including the costs of time usage of physician, nurse and patient, transportation expenses, monitoring costs, blood tests, co-medicine, utensils, shipping and hospital facilities. When a CA is included it is possible to take the derived costs associated with treatment of different drug dispensing forms and specific costs of treatment with various analogue drugs into account to achieve a recommendation upon the lowest total price including the tender price and the derived costs associated with the treatment.
What was done?
Tenders are made on ATC-level 5, but clinically equivalent therapeutic areas are evaluated on ATC-level 4. The analogue competition is an important strategic tool when conducting tenders and elaborating national recommendations on therapeutic areas (TA). Since 2017 the evaluation of TA has been based on a clinical evaluation, an economic evaluation and a tender. Previously the call for tenders was based on clinical evidence only. To evaluate whether the addition of a cost analysis (CA) to a tender evaluation would alter the drug recommendation of TA, a re-evaluation of the processed TA, evaluated from October 2018 until October 2019, was made on multiple sclerosis, rheumatoid arthritis and severe asthma.
How was it done?
The drug recommendations on TA made in the period was re-evaluated. Results from the cases with multiple sclerosis, rheumatoid arthritis and severe asthma were evaluated on clinical evaluation, tender price and finally with or without the CA.
What has been achieved?
From October 2018 to October 2019 three TA have ended the evaluation process. The recommendation of severe asthma had a similar outcome regardless of the process used. For multiple sclerosis and rheumatoid arthritis, the CA altered the drug recommendations.
What next?
In order to balance resource consumption on performing CA and the economic impact on the outcome, the plan is to identify TA where it isn’t meaningful to conduct a cost analysis. In all other areas a CA will be included in the standard procedures.
CENTRALISED ONLINE REGISTRY FOR PATIENT WITH METASTATIC COLORECTAL CANCER TREATED WITH REGORAFENIB (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Vanesa Alonso Castro, Beatriz López Centeno, Daniele Alioto, Angela Gil Martin, Ignacio Martin Casasempere, Maria Segura Bedmar, Ainhoa Aranguren Oyarzábal, Maria Jose Calvo Alcántara
Why was it done?
The European Society for Medical Oncology (ESMO) has developed the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) to assess the magnitude of clinical benefit for cancer medicines. In the CORRECT trial, regorafenib has an ESMO-MCBS score of 1 (questionable benefit). It is necessary to assess the effectiveness and safety of regorafenib treatment in real clinical practice.
What was done?
To describe the implementation of a centralised registry (CR) for all patients with metastatic colorectal cancer (mCRC) being treated with regorafenib in a Regional Health Service (RHS).
How was it done?
A working team including oncologists, hospital pharmacists and RHS professionals developed the CR for patients with mCRC starting treatment with regorafenib in 2019. The variables selected were: age, sex, ECOG, primary tumour location, number of metastatic sites, presence of liver or brain metastases, RAS-mutation status, BRAF-mutation status, previous lines, follow-up variables (dose, type of response and adverse events), date and reason for withdrawal.
What has been achieved?
The CR is available for all professionals in the RHS in April 2019 and it is compulsory to include all patients starting treatment in 2019. Forty-nine patients were included (59.2% males). The median age was 68 years. The baseline characteristics of the patients were: − 36.7% and 63.3% of patients had ECOG 0 and 1 respectively; − 79.4% had the primary tumour in the left colon; − 36.7% had 3 or more metastatic sites; −71.4% and 2.0% had liver and brain metastases respectively; − RAS gene was mutated in 57.1% of patients and undetermined in 2.0%; − BRAF gene was mutated in 4.1% of the patients and undetermined in 34.7%; −in 65.3% of patients regorafenib was the fourth line or later therapy. With median treatment duration of 2.5 months, 42.9% of patients had discontinued treatment: 30.6% had progressive disease, 8.2% had adverse events and 4.1% had died.
What next?
The experience obtained with this registry has allowed us to know the use profile of this drug in all hospitals of RHS. A comprehensive assessment of the collected data and a longer follow-up period are necessary to assess the effectiveness and safety of regorafenib treatment in real clinical practice.
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.
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.
SHORT, TARGETED NEWSLETTERS IMPROVE ADHERENCE TO NATIONAL TREATMENT GUIDELINES
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Ane Hornbaek Mortensen
Why was it done?
Previously, a quarterly report showing adherence to national treatment guidelines was issued to all hospital administrations in our region. It was their responsibility to forward this to the appropriate specialists/consultants. This often failed and even when it was done, our experience showed that it wasn’t read by the consultants. Consequently, prescription patterns didn’t change despite the report highlighting the wards that weren’t complying with the national treatment guidelines.
What was done?
Short newsletters including graphs/tables showing the ward’s degree of adherence to national treatment guidelines were emailed to the chief consultant of the specific ward.
How was it done?
In our region a 6-person analytical team, which includes 3 hospital pharmacists, monitors adherence to national treatment guidelines issued by our national council for the use of expensive hospital medicines (RADS). Based on the results, the analytical team decides which newsletters to write. The hospital pharmacists in the analytical team are responsible for writing the newsletters and emailing them direct to the relevant specialist/consultant.
What has been achieved?
It seems as if the introduction of more targeted information has led to more rapidly changing prescription patterns. One example is oral iron chelating agents to hematological patients where a RADS guideline was issued recommending that all new patients should receive deferipron instead of deferasirox. This information was initially issued through the usual channels (via hospital administration) but no change in the use of deferipron/deferasirox was seen. This only happened after emailing a newsletter directly to the chief consultants of the three hematology wards in our region, showing the current use of deferipron/deferasirox and the potential cost reduction. Nine months and three newsletters later the percentage of deferipron use on the hematology wards increased from 2% to 27%, leading to a 22% cost reduction. Target was 25% deferipron (the guideline only covered new patients). The total increase in the percentage of deferipron use on hospitals in our region was 351% compared to an increase of between 0 and 19% in the other four national regions.
What next?
Continued and increased use of targeted communication in the health care system is required to ensure that specific information reaches the relevant players.