A PROTOCOL FOR PLACEMENT AND REMOVAL OF PERSONAL PROTECTIVE EQUIPMENT IN A POSSIBLE CASE OF CORONAVIRUS SARS-CoV-2
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Rebeca Iglesias-Barreira, Emilio Rubén Pego-Pérez, Carlos Sandoval-Aquino, Cristina López-Pardo y Pardo, Maria Jesús Rodríguez-Gay
Why was it done?
To guarantee workers safety as well as optimize the use of PPE in the hospital.
What was done?
To develop a protocol for placement and removal of personal protective equipment (PPE), established for contact with possible or confirmed coronavirus SARS-CoV-2 infected patients, taking into account the medical devices (MD) available during the pandemic. Alternatives and strategies were also proposed for resources optimization. Final protocol resulted from a multidisciplinary team work (Hospital Pharmacy Service team and Emergency Service workers). It was finally revised and approved by the Medical and Quality Direction.
How was it done?
1)A systematic bibliographic review was made, for articles selection on the placement / removal of PPE. Technical specifications of the available MD and the sanitary recommendations of the competent organitations were reviewed.
2)Establishment of PPE components, and the order of placement and removal:
a. PPE placement:1-Wash hands (WH).2-Place shims.3-WH.4-Put on the first pair of gloves.5-Put on FFP2 mask.6-Wear waterproof protective overalls from the feet.7-Place garbage bags on feet and adjust them on legs.8-Wash gloves with a hydroalcoholic solution (HS).9-Put on second pair of gloves.10-Put on a standard/reinforced surgical gown.11-Wash HS.12-Put on surgical mask.13-Put on disposable gown.14-Put on third pair of gloves.15-Put on face protection screen. 16-Put on surgical cap and fit it over a face shield.
b. PPE removal: a) Before leaving the isolation room: 1-Remove and discard bags from both feet.2-Remove and discard disposable gown.3-Remove and discard the outermost gloves. b) Outside the isolation room: 1-Wash HS.2-Remove surgical cap and screen (reserve screen).3-Remove and discard surgical mask.4-Wash HS.5-Remove the standard/reinforced surgical gown and reserve it.6-Remove second pair of gloves.7-Wash HS.c) Before entering the clean area:1-Remove shoes.2-Remove third pair of gloves.d)Go to the clean area:1-Disinfect footwear.2-Wash HS.3-Remove monkey and if necessary reserve it. 4-Wash HS.5-Remove FFP2 mask and reserve it if necessary.6-WH.
c. A team member read and check all steps carried out during the all steps procedure.
What has been achieved?
The protocol was followed by 54 (100%) workers. Since its implantation, on March 16 th, only the 3,7% (n=2) of workers were infected by SARS-CoV-2.
What next?
The protocol is under constant revision and modification to adapt it to the available MD in every moment.
THE APPLICATION OF AN EHEALTH MODEL IN THE HEALTH CARE SYSTEM
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MAR GOMIS-PASTOR, ANNA DE DIOS LÓPEZ, MARIA ANTONIA MANGUES, MIRIAM ORS, MERITXELL CUCALA, CATERINA SANPOL, VICTOR ROBERT, XAVIER BORRAS, GEMMA CRAYWINCKEL
Why was it done?
HTP are therapeutically complex patients who may benefit from an intensive telematic follow-up. Moreover, human relations among patients and health providers may be enhanced to improve patients’ empowerment with their health care. Additionally, interdisciplinary eHealth projects lead to increased interaction among health providers, expanding advanced patient-centered care in healthcare systems.
What was done?
An eHealth program directed to heart transplant patients (HTP) was implemented. The software developed was called mHeart and consists on a mobile phone application complemented by a website(https://n9.cl/ajut). A pilot study to validate the software and a clinical trial were conducted. This tool is now extended into clinical practice.
How was it done?
This project and its potential scalability has achieved the creation of a well-established framework involving among relevant others the Legal Department, the Information Systems Department, the patient data protection supervisor, and the Innovation Research Institute.
The success and the scalability of these innovative projects in our centre depended on health providers’ engagement with eHealth, new interoperability solutions, adequate institutional support, and government reimbursement models.
What has been achieved?
The clinical trial conducted in 134HTP has demonstrated to improve recipients’ adherence to immunosuppressants (85% mHeart follow-up vs 46% conventional follow-up)[OR=6.7 (2.9;15.8),P-value=.000], to improve patients’ experience of therapeutic regimens and to reduce in-clinic facilities because the mHeart follow-up. (65% mHeart follow-up vs 35% conventional follow-up)[OR=3.4 (1.7;6.9),P-value=.001].
What next?
This eHealth experience has allowed continuing creating evidence on the use of the eHealth in other populations: an onco-hematological platform, EMMA(Ehealth Medical self-Management Aid), has been designed including diverse profiles depending on the clinical specifications (e.g. multiple myeloma or bone marrow transplant conditions); MyPlan has been adapted to perform an interdisciplinary follow-up of any multimorbid population with polypharmacy. Thus, the system can be used in any multimorbid patients by activating or omitting certain modules that define the target patients’ specific comorbidities (e.g. glycemia module or blood pressure module).
The new EMMA and MyPlan will be clinically tested in diverse trials in 2020 including several health care interdisciplinary teams, including the emergency setting, onco-hematology, migraine, dyslipidemia and cardiovascular risk, among relevant others. In addition, other Spanish centers are implementing the eHealth model and the software in their Institutions assisted by the experience gathered.
Implementation of pharmacological consultation as part of geriatric trauma treatment
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Tanja Schicksnus
Why was it done?
The team of the geriatric trauma center consists of an orthopedic surgeon, geriatrician, nurse, physiotherapist, occupational therapist and a discharge management and diabetic nutrition expert according to the German society for orthopedic surgery (DGU) and now also a pharmacist who performs risk screening for drug-related problems such as fall, dizziness, cognitive impairment, conspicuous laboratory values, lack of appetite, etc. immediately after admission, in order to optimize drug therapy.
What was done?
The geriatric trauma center aims to provide geriatric patients with the best possible peri- and post-operative care after a fall with a fracture so that they resume their usual life and environment after the hospital stay. The pharmacist joined the interdisciplinary team with the aim of a medication review for the often multi-morbid and multi-prescription patients.
How was it done?
After the patient has been assigned to geriatric complex therapy according to the DGU criteria, the doctor requests a pharmacological consultation for this patient via the digital patient record. The pharmacist carries out a medication analysis with information from the record as well as bed side visits focusing on possible medication based problems.
Results are stored in the consultation report, serving as documentation and as basis for later evaluation. Important information for immediate implementation is highlighted in the digital file and transmitted to the attending physician by telephone.
Once a week, the entire team meets, with the scope for each patient being: What are the remaining problems? How can these be solved (interdisciplinary)?
What has been achieved?
During four months, medication reviews were carried out for about 100 patients. In the areas of bleeding risk, anticholinergic adverse events, antibiotics, malnutrition, dose adjustments and medicines inappropriate for geriatric patients, for one third of patients corrections led to an improvement in patients. For nearly 10% of patients also a prescription cascade was resolved and some medical device training has increased drug therapy safety.
What next?
Future benefit evaluation will be carried out based on resumption of patients due to a fall, in the categories: Time until next hospital admission, reason for next admission, adoption of optimized medication plan.
DELIVERY OF SPECIALISED MEDICINES IN MEDICINE POST BOXES – A PILOT STUDY
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Maja Kirstine Brøns, Gitte Borup
Why was it done?
The purpose was to move medicine collection from the outpatient clinics to a MPB in order to reduce CO2-emission, due to less kilometers traveled by patients, to increase equal access to healthcare services, and to reduce physical patient contact during a global pandemic.
What was done?
This was a pilot study that investigated a method for, and patient satisfaction with, delivery of specialized cost-free hospital medicines via Medicine Post Boxes (MPB) in rural areas.
How was it done?
The project was initiated by clinical pharmacists, who acted as interdisciplinary liaisons, who understood the clinical aspect of the medical treatment, the importance of good distribution practice and the logistic capacity at the hospital pharmacy. Having completed clinical controls via telephone, the clinic forwarded the information needed to the hospital pharmacy. Initially, all requisition forms were checked by clinical pharmacists to ensure complete information was given, and that documentation was performed properly. Once fully implemented, a task shifting onto pharmaconomist was done concerning the control of the requisitions, however initiation of cooperation and problem solving with the clinic was maintained as a pharmacist task.
What has been achieved?
Focus group interviews with doctors and nurses from the clinics expressed satisfaction with the flexibility of conducting clinical controls over the phone, and not having to handle the practical part of ordering, documenting and handing out medicines. No concerns of patient safety were expressed, and a wish for full coverage for medicine delivery via MPB was stated. A survey among the patients using the MPB was conducted: A total of 148 respondent participated of whom 98 % stated being ’very pleased’ or ’pleased’ with the service. Also, 98 % felt safe to ’a very high degree’ or ’high degree’ with using the MPB and 99 % wished to use the MPB again. Estimates of CO2 reduction have not yet been calculated.
What next?
MPB’s should be available in urban areas also, as it increases flexibility for the patients and healthcare professionals. The goal is to include all suitable clinics and patients who receive long term treatment with hospital medicines
PANDEMIC CRISIS COVID 19: THE DRUGS HOME DELIVERY AS A TOOL FOR ADHERENCE AND COMPLIANCE
European Statement
Clinical Pharmacy Services
Author(s)
BARBARA RE, MARTA DEL VECCHIO, CLAUDIA LAURIA PANTANO, ELIROSA MINNITI , VITO LADISA
Why was it done?
The covid-19 pandemic and the lockdown made it difficult and very often not possible to access hospital pharmacies for dispensing of drugs for cancer treatment
What was done?
Drugs homedelivery has been implemented for fragile patients and at risk both oncological and hemato-oncological, all over the italian territory
How was it done?
Through the telemedicine program, in agreement with the oncologist, patients unable to reach the pathology doctor’s office are contacted and the project explained to them. If the patient accepts the delivery at home, paths with specialized couriers have been activated, in compliance with the GDPR, which ensure the delivery of medicines within 48 hours. Upon delivery The Pharmacist contacts the patient to ensure that they have been received the medicines and reinforces how you take the drug and the potential side effects that need to be reported to doctor and / or pharmacist
What has been achieved?
In the period from March to September 2020, 501 deliveries were made, of which 301 in the regional territory and 200 in the national territory. 423 patients were contacted, A Customer Satisfaction was activated to which 90% of patients with a high degree of acceptance of the service responded
What next?
The Homedelivery service has shown that integrating telemedicine, with the collaboration oncologist and pharmacist, allows, when possible, to avoid fragile patients having to go to the hospital every month to collect the drug needed for their treatment. Furthermore, the role of the pharmacist will be increasingly central in the home clinical management of this patient population to assure Adherence and Compliance even in at Home setting.
DEFINING DOSAGE REGIMENS OF ERLOTINIB AND GEFITINIB IN NON-SMALL CELL LUNG CANCER PATIENTS USING MODELLING AND SIMULATION (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
SOFIA KONSTANTINIDOU, VANGELIS KARALIS
Why was it done?
Tyrosine kinase inhibitors (TKIs), like erlotinib and gefitinib, are widely used in anticancer therapy. However, after long term administration of TKIs, resistance is observed in the majority of patients. Thus, it is necessary to be able to define individualised dosage regimens for TKIs in cancer patients. Nowadays, modelling and simulation approaches represent the most powerful tool in the hands of clinical pharmacists towards precision medicine.
What was done?
Population pharmacokinetic (PK) – pharmacodynamic (PD) modelling was utilised to simulate erlotinib and gefitinib dosage regimens for non-small cell lung cancer. In silico clinical trials with virtual patients, of several resistance levels, were simulated in order to optimise pharmacotherapy and get better therapeutic outcomes.
How was it done?
The utilised PK/PD model and average parameter values were obtained from the study of Eigenmann and colleagues. This model was fully validated using statistical criteria and goodness of fit plots. In order to simulate many possible conditions that may occur in clinical practice, several different values of erlotinib and gefitinib clearance, absorption rate, pharmacodynamic characteristics (like tumor volume), and resistance were assessed. In addition, several dosage schemes were simulated. The entire modelling work was performed in Monolix® 2019R1.
What has been achieved?
Concentration vs. time and effect vs. time plots for the virtual patients were simulated for a variety of conditions and tumour resistance levels. For both TKIs, decrease of body clearance led to higher plasma concentrations, as well as more intense and longer duration of the effect (i.e. tumour volume shrinkage). Enhanced drug effect on resistant cells resulted in a decrease in tumour volume. In addition, a variety of concentration-time profiles were simulated, making it possible to choose the best regimen for each patient.
What next?
In this study, the use of modelling techniques led to the simulation of many conditions of patients and adjustment of dosage regimens according to their needs. Wider application of in silico methods using virtual patients will allow the design of the most appropriate individualised dosage schemes tailored to the patients’ requirements.
IMPACT OF PLANTS ON ANTICANCER DRUGS METABOLISM: DEVELOPMENT OF A DATABASE TO FACILITATE THE PHARMACIST’S EXPERTISE (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
ANAIS AMAR, SIMON CLAUTRIER, MORGANE GIOVANELLI, REGINE CHEVRIER
Why was it done?
The phytotherapy market has continued to grow for several years. However, in oncology, concomitant use of plants with oral or injectable chemotherapies can be harmful. Plants can interact with many cytochromes (CYP), impacting on the biotransformation and kinetics of drugs. While grapefruit or St John’s wort are already recognised as interfering with many therapies, the impact of many plants remains unknown for healthcare professionals. Tools exist to evaluate their effects on drug metabolism, but the multiplication of sources delays and complicates the advice of pharmacists.
What was done?
Centralise information on plant metabolism on a single support by creating a database. Facilitate pharmacist’s expertise about interactions between plants and anticancer drugs.
How was it done?
To create the database, it was necessary to establish an exhaustive list of plants. Three sources of information have been used:
– Inventory of phytotherapy products marketed in 4 drugstores
– Census of plants consumed by patients seen in pharmaceutical consultation (PC)
– Consultation of websites specialized in phytotherapy
Then, an Excel table has been developed:
– each line corresponds to a plant
– each column corresponds respectively to 17 CYP, a transport protein (Pgp), estrogen-like (EL) and antioxidant (AO) properties of the plant.
A colour code has been defined according to the inhibitory (yellow), inductive (blue), EL (purple) and AO (red) action of the plant. If there is no interaction, the box remains blank.
Plant effects data were collected from Hedrine®, Oncolien®, MSKCC, RX list and Drugs.com websites.
What has been achieved?
Finally, 174 plants have been accounted in drugstores, 82 were identified during PC and 129 found on websites. If 10% of plants have an EL action and 16% an AO effect, approximately 30% have inductive and/or inhibitory action of at least one CYP and/or PgP. Since the tool’s creation: 91% of answers could be given immediately to patients compared to only 9% delayed (plants still unreferenced).
What next?
This database is an essential tool for answering questions from patients with anticancer drugs. It saves precious time and responsiveness during PC, but also during patient phone calls. However, critical work with divergent information between sources is to be expected. Currently, as a precaution, we don’t recommend the use of plants subject to such a contradiction.
DYSPHARMA: AN ITALIAN WEB-APPLICATION FOR DRUG THERAPY MANAGEMENT IN DYSPHAGIC PATIENTS (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Serena Logrippo, Giulia Bonacucina, Matteo Sestili, Alessandro Caraffa, Marco Cespi, Roberta Ganzetti
Why was it done?
Dysphagia is a well-known community issue that affects primarily aged people [1]. The availability of appropriate dosage forms for dysphagic patients is essential to guarantee therapy adherence. Extemporaneous compounding of SODSs (e.g. crushing tablet or opening capsules and dispersing the obtained powder in an appropriate base or vehicle) is a common practice due to the unavailability of different dosage forms to satisfy the current needs of patient. However, compounding practice is neither risk-free nor error-free [2]. The aim of the work was to realise a web application to support HCPs in drug therapy management of dysphagic patients.
What was done?
To properly manage oral therapy in dysphagic patients, a multidisciplinary team developed an algorithm and applied it to over 8000 medicinal products available as solid oral dosage forms (SODSs). A web-based, decision-making tool was launched to support healthcare providers (HCPs) during the prescription, compounding and administration of SODFs to dysphagic patients.
How was it done?
An extensive review of the Italian pharmaceutical market database, product characteristic summaries and scientific literature were used for data collection. For each prescription drug formulated as SODF, an information sheet was elaborated and continuously updated.
What has been achieved?
DysPharma (www.dyspharma.it) is an on-line support currently available and under restyling. By registering and logging-in, it is possible to access technical content that comprises medicinal product details, drug-food interactions, extemporaneous compounding methods, and risk symbols. Medicinal products can be searched by active ingredient name, medicinal product name, and marketing authorisation.
Customised symbols are reported for: do not crush tablets or open capsules, do not split tablets, to wear personal protection devices in case of manipulation of hazardous drugs, and drug associated with dry mouth.
What next?
This decision support tool may be integrated with computerised medical records to reduce medication-prescribing and administering errors and to improve clinical outcomes of dysphagic patients.
References:
[1] Clavé, Pere, and Reza Shaker. “Dysphagia: current reality and scope of the problem.” Nature Reviews Gastroenterology & Hepatology 12.5 (2015): 259. [2] Logrippo, Serena, et al. “Oral drug therapy in elderly with dysphagia: between a rock and a hard place!” Clinical interventions in aging 12 (2017): 241.
IDENTIFICATION OF HAZARDOUS DRUGS IN EMERGENCY DEPARTMENT: DRUGS CABINET INSPECTION (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Mª Antonia Meroño-Saura, María López-Morte, Taida Rodríguez-Martínez, Pilar Pacheco-López, Consuelo García-Motos
Why was it done?
The publication of the NIOSH list and its application by INSHT in Spain has changed the concept of “Hazardous drug” in terms of its handling and administration, as well as personnel training involved in its management.
What was done?
The main objective is to label every drug considered “Hazardous” and to review the medication included in the Emergency Department kit in a tertiary hospital.
How was it done?
Literature about Hazardous drugs was reviewed. All the drugs included in the Emergency Department kit belonging were identified and classified according to their level published in the NIOSH list. A kit’s review was carried out on site, as well as a Hazardous drugs’ categorisation by adequate labels.
What has been achieved?
6 out of 239 drugs included in the emergency kit were labelled as Hazardous drugs, and could be found in 9 different presentations. Regarding its risk level according to the NIOSH list; chloramphenicol, risperidone and all different presentations of phenytoin were classified as level 2. Acenocoumarol, colchicine/dicycloverine and all different presentations of valproic acid were classified as level 3.
The following incidents were detected;
– Lack of identification: 8 out of the total number of drugs presented identification errors.
– Location error: 4 out of the total number of drugs were not well located.
– Photosensitive: 56 out of the total drugs were photosensitive, of which 11 were not correctly identified or stored.
– Expired drugs: 12 drugs, whose total stock was 399 units. 51 out of the total amount were expired.
After this review, the following measures were carried out:
– Orange labelling for Hazardous drugs’ identification, regardless of their risk level.
– Misidentified drugs were re-labelled, and those that were misplaced were placed in their assigned spot.
– Photosensitive drugs were correctly identified by blue labels and properly preserved.
– Expired drugs were withdrawn.
What next?
Simplifying Hazardous drugs’ identification by a categorisation following a colour code could lead to a safer manipulation by the professionals. During the review of the kit, several incidents were detected and sorted out, which avoided possible medication-related errors. Therefore, it is necessary to establish several control measures in emergency kits in order to avoid errors and improve the safety in the use of drugs.
ONCOLOGY PHARMACISTS: EXPANDING OUTPATIENT SERVICE MODELS TO INCREASE PATIENT IMPACT AND SAFETY (submitted in 2019)
European Statement
Clinical Pharmacy Services
Author(s)
Paul Firman, Karen Whitfield, Therese Hayes
Why was it done?
The provision of outpatient oncology services by pharmacists is still limited, but this role is an emerging one. There is limited literature to date that suggests that pharmacists can add value while satisfying the needs of patients with cancer, addressing medication use and symptoms, and potentially generating revenue for the practice. The value that clinical pharmacists can bring to outpatient clinics other than oncology clinics has been highlighted extensively, providing added weight to the argument for incorporating these professionals into the cancer care model.
What was done?
The oncology pharmacy team in a tertiary referral hospital with the assistance of activity-based funding commenced an outpatient clinic allowing patients an opportunity for medication reviews, appropriate counselling of oral chemotherapy and discussion of medication side effects which was a gap within the current service.
How was it done?
In consultation with pharmacy, medical, nursing and administrative staff a working party was formed to establish the outpatient pharmacy clinic. Factors including patient cohort, appointment scheduling, clinic room availability, referral methods, and key performance indicators were discussed. The group met monthly to discuss the progression of the clinic and any barriers.
What has been achieved?
Over the first 3 months (January – March 2019) 215 patients on an average of 7.5 medications were reviewed. Within the cohort 57% of the patients were taking high risk medications (known as PINCHA medications) and 37% received counselling on new medications. There were 37 medication interventions mostly involving drug−drug interactions and medication optimisation. For succession planning, pharmacist training has also occurred.
What next?
Outpatient oncology practice is a growing area of opportunity for pharmacists to provide clinical services as part of a multidisciplinary team. This is of benefit both to the multidisciplinary team and the patient, ensuring the best possible outcomes. With the growing complexity of oncology treatments, the pharmacist’s role is vital to ensure quality use of medicines, safety and patient centred care. Training is currently being undertaken to expand the role and to ensure continuity of the service.