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.
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.
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.
DEVELOPMENT OF AN INFORMATIC HAZARD VULNERABILITY ANALYSIS TOOL TO MINIMISE MEDICINES SHORTAGES (submitted in 2019)
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Daniele Leonardi Vinci, Enrica Di Martino, Rosario Giammona, Piera Polidori
Why was it done?
The 2018 Medicines Shortages Survey conducted by EAHP showed that 91% of responding pharmacists had experienced problems sourcing medicines, therefore it is important to use tools that identify early the shortage risk associated with each drug included in a hospital formulary in order to adopt appropriate countermeasures.
What was done?
We create an informatic HVA Tool (HVAT) to assess the risk associated with medicine shortage.
How was it done?
The HVAT created consists of an Excel spreadsheet subdivided into three macro areas: probability that the shortage will occur based on shortage in the last 2 years, magnitude factors which increase the risk of shortage, and mitigation factors which reduce it. A score was assigned to each item in each macro area. The score of the probability was: 1=no previous deficiency; 1.5=one deficiency; 2=two or more deficiencies. Magnitude was divided into: relevance of active substance (AS) (1= not life-saving and not High Risk Medicines (HRM); 2=not life-saving but HRM; 3=life-saving); budget impact (0=no alternative drug; 1=alternative drug costs equal to or less than the deficient one; 2=cost of the alternative drug higher than the deficient one but sustainable for all patients; 3=cost not sustainable for all patients); percentage of patients treated with the drug (1=less than 20%; 2=from 20% to 50%; 3=more than 50%). Mitigation factors were: therapeutic alternative (1=same AS and same route; 1.5=same AS and different route; 2=different AS and route not intravenous (IV); 2.5=different AS and route IV; 3=no alternative drug); stock available (1=for a month of autonomy; 2= autonomy between 1 week and one month; 3=autonomy less than 1 week); availability of the drug (1=drug available in EU; 2=drug available exclusively extra-EU; 3=drug not available).
What has been achieved?
The HVAT obtained allows us to calculate the value of the risk multiplying P by S, where P is the percentage of probability (value of probability obtained/2) and S is percentage of severity [(sum of values of magnitude obtained + sum of values of mitigation obtained)/18]. Based on the score obtained, drugs are classified as: low (60%) risk of shortage.
What next?
We will implement the HVAT in our hospital in order to reduce the impact of shortages.
PHARMACEUTICAL INTERVENTIONS IN PARENTERAL NUTRITION: METHODOLOGY AND RESULTS (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Teresa Cabeças, Sara Franco, Rita Oliveira, Maria Pereira
Why was it done?
PN is an alternative or complement in patients whose oral and/or enteral nutritional intake is inadequate/unsafe or whenever the digestive tract is not functioning or this route is contraindicated. Success in choosing the most appropriate PN depends on a specialised multidisciplinary team that can provide nutritional support that results in improved clinical outcomes and patient safety. With the decision flowchart (designed in January 2019), the hospital clinical pharmacist intervenes in the calculation of the patient’s nutritional needs and, consequently, in the counselling of the most appropriate PN bag and clinical and biochemical monitoring of the patient.
What was done?
Definition and implementation of action methodology, in a form of flow chart, for patients in need of parenteral nutrition (PN).
How was it done?
Implementation of the following therapeutic decision methodology: 1. Validation of parenteral support nutritional option according to decision flowchart; 2. Filling out a patient’s nutritional needs spreadsheet −anthropometric assessment; biochemical data; calculation of protein requirements; calculation of non-protein energy needs; calculation of total energy requirements; choosing the appropriate volume; validation of the route of administration; 3. Selection of the most suitable PN bag from the Hospital Formulary (preferably after ionic corrections); 4. PN bag suggestion to the prescribing physician; 5. Acceptance and alteration (or not) by the prescribing physician; 6. Clinical and biochemical monitoring of the patient; 7. Optimisation of nutritional therapy when applicable.
What has been achieved?
From January to August 2019 the Pharmaceutical Services intervened in all 21 PN prescriptions. In this universe, 15 were in the context of gastroenterology surgery, 5 due to infection and 1 due to non-gastrointestinal cancer disease. The intervention was not accepted in only 5 cases.
What next?
Clinical pharmacists play a key role in supporting the prescription of PN. The future is challenging, particularly in assessing patients’ outcomes and quality of life, as well as the economic and financial dimension. It will also be essential to create a Clinical Nutrition Commission that covers PN, enteral and oral feeding.
DEVELOPMENT OF GUIDELINES FOR SAFE HANDLING OF ONCOLYTIC VIRUSES (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Faten Ahmad Díaz, Eugenia Serramontmany Morante, Carla Esteban Sánchez, Pablo Latorre García, Montserrat Carreres-Prieto, Javier Martínez Casanova
Why was it done?
Different critical points were detected: 1) some OV dose prescription depends on tumor size, 2) special storage conditions, 3) special safety measures related to preparation to prevent cross-contamination and technician exposure, 4) special transport conditions in a safety container, and 5) safe administration. The increasing number of clinical trials with OV combined with the identified critical points implies a better coordination between the different departments involved.
What was done?
Development of a standardised working procedure for the safe handling considerations, storage requirements, and modes of administration of oncolytic viruses (OV) in patients with cancer.
How was it done?
Different meetings were arranged with a multidisciplinary team to standardise procedures, in order to avoid errors: 1. The pharmacist validates the prescription volume reflected on the certified sheet according to the tumour size. Then, a pharmacy technician is authorised to remove the vials from the freezer to start the preparation. 2. Special −80ºC freezer is needed to preserve the OV. 3. According to the preventive medicine service, OV must be prepared in biological safety cabinet class II (BSC) with personal protective equipment. At the end of preparation, the BSC must be cleaned with the OV appropriate disinfectant and ventilated for 1 hour before restarting to work again. So, the OV preparation was established at 7 a.m. in order to avoid cross-contamination with the chemotherapy (first preparation in the day). 4. Safety transport must be considered, so OV is packaged in a special hermetic box. 5. The majority of the OV preparations are administered intralesionally at the radiology room so safe administration is needed to avoid the room contamination.
What has been achieved?
By using these procedures, it is possible to work with a single BSC, avoiding delays in the administration of other therapies while reducing the risk of mistakes.
What next?
These types of therapies represent a novel therapeutic modality: their preparation, administration and handling requirements differ from current therapies; pharmacists have an important role in developing new procedures to incorporate them into clinical practice. This protocol may be useful to other centres due to the lack of experience and standardised guidelines to work with this type of therapy.
DESIGN OF AN ANTI-HAEMORRHAGIC AGENTS PROTOCOL FOR AN INTENSIVE CARE UNIT (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Mercedes Gómez-Delgado, Marta Valera-Rubio, Margarita Carballo-Ruiz, José Luis Ortiz-Latorre, Isabel Moya-Carmona
Why was it done?
Blood coagulation factors and their adequate use can be of particular importance in the treatment of massive haemorrhage, especially in the ICU. This initiative was taken in order to improve uptake and to avoid errors in the administration, which can be difficult in emergency situations.
What was done?
To define an emergency procedure that ensures correct management in cases of massive bleeding in an intensive care unit (ICU).
How was it done?
The development of drug use protocols for emergency situations is a simple task that facilitates health workers to manage them. Prioritising the drugs to be included in a protocol by a previous survey in a multidisciplinary setting is important to consider the different points of view. We carried out a review of the pharmacy service to the ICU needs of antihaemorrhagic drugs. ICU staff (doctors and nurses) were informed to reach an agreement about eligible drugs for being included in the protocol. ICU staff requested the inclusion of four drugs in the protocol according to the prevalence of use and the difficulty of administration: human fibrinogen, tranexamic acid, eptacog alfa and human prothrombin complex. We created a protocol with four information sheets, one of each drug, made of schematic information about: 1. Physical location (fridge or room temperature, number of shelf) and minimum safety stock (3 units of human fibrinogen, 4 units of tranexamic acid and 3 units of human prothrombin complex). 2. Indications and dosage according to the clinical situation and the patient characteristics (dosage adjustment according to renal or hepatic impairment, weight or age when applicable). 3. Recommendations for intravenous administration (flow rate, bolus, loading dose, dilution, mixture stability).
What has been achieved?
Mapping the information and dividing it into sections is essential for its rapid understanding in a high-stress work environment. The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient health care circuit for the ICU staff. It also optimises the consumption of this type of more monitored drugs.
What next?
We will monitor the compliance with this protocol, as well as possible updates that may be beneficial for a better understanding of the forms of administration.
ASSORTMENT COUNCIL SECURES THAT MEDICAL PRODUCT AND INFORMATION IS AVAILABLE TO NURSES, PHYSICIANS AND PHARMACISTS (submitted in 2019)
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Katja Heikkinen, Charlotta Vinterflod
Why was it done?
AC’s mission is to secure that the right product and product information is available as well as in case of shortages assist with alternative products and information. Correct information is fundamental to achieve an effective and secure supply chain of medical products. This reduces time spent on ordering, delivery time is shortened and finding information is more efficient.
What was done?
The hospital pharmacy in Region Västra Götaland, Sweden (VGR) established an assortment council (AC) that assists buyers of medical products within the region. By creating a defined assortment the goal was to direct healthcare professionals to order procured, recommended and cost-efficient medicines and enable structured availability monitoring.
How was it done?
A counsel of pharmacists was formed to administer a defined assortment consisting of 95% of the most commonly used medical products. The availability is monitored daily and every disruption of supply is handled in a structured way. Alternative marketed or unlicensed medical products are identified and information about these are communicated through VGR’s ordering system or by newsletters. If an equivalent product is available, it will be delivered automatically without the need for placing a new order. The AC also collaborates with the region’s medical specialists and drug and therapeutics committee (DTC) when searching for alternatives.
What has been achieved?
Defined assortment has been reduced from 6000 products to approximately 3000. In 2018 in addition to the daily updated availability information, 14,300 orders out of 410,000 were automatically replaced with an equivalent product and 41 newsletters about shortages were published. Nurses get more time for patient care when shortages information is readily available, and replacement of equivalent products can be delivered automatically
What next?
By implementing this way of working in other hospital regions or on a national level, caregivers would be able to free up resources and focus on patient care and at the same time be able to find quality assured information about shortages and alternatives in an efficient manner.
CAN THE CLINICAL PHARMACIST INCREASE HOSPITAL STAYS’ PRICING? (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Thibault Stala, Niels Martignene, Céline Monchy, Anne-Laure Lefebvre, Geoffrey Strobbe, Ali Hammoudi, Frédéric Feutry, Malgorzata Cucchi, Guillaume Marliot
Why was it done?
In France, hospitalisations’ reimbursement is linked to care severity. In this context, health care must be as comprehensive as possible on the comorbidities’ registration. As part of prescription validation, the clinical pharmacist can easily highlight comorbidities associated with specific treatments, in order to improve their codification and consequently to better valorise hospital stays.
What was done?
This work involves evaluating the ability of the clinical pharmacist to detect comorbidities related to certain treatments.
How was it done?
Six comorbidities, associated with the prescription of specific therapies, were chosen: – Dyskalaemia (potassium or polystyrene sulfonate prescriptions); – Neuropathic pain (NP) or anxio-depressive disorder (ADP) (amitriptyline, anafranil, pregabalin, gabapentin, duloxetine or capsaicin prescriptions); – Iron deficiency anaemia (IDA) (injectable iron prescriptions); – Hypovolaemia (HV) (ringer Lactate, serum albumin or gelatin prescriptions); – Hypercalcaemia (HC) (bisphosphonate and/or calcitonin prescriptions); – Severe infection (Inf) (linezolid, daptomycin, teicoplanin, aztreonam and carbapenem prescriptions). Retrospectively, all stays ending between 01/01/2019 and 31/03/2019, and containing at least one prescription of the previously mentioned therapies, were considered. Then, the medical records were analysed to verify the presence of the comorbidity corresponding to the prescribed drug(s). The coding was checked, otherwise, the comorbidity was added. Finally, the revaluation of the stays’ cost has been estimated.
What has been achieved?
The number of stays by suspected comorbidity, based on prescribed treatments, is : – 175 dyskalaemia; – 231 NP or ADP; – 155 IDA; – 124 hypovolaemia; – 41 hypercalcaemia; – 16 severe infection hypovolaemia and severe infection were quickly set apart because of the difficulty to confirm these comorbidities with the only retrospective medical record information. No stay with IDA or hypercalcaemia has been revalorised. The price of a single stay with dyskalaemia has been increased, by €530. However, NP or ADP has increased the cost of 6 to 13 stays, resulting in a total revaluation of €6000 to €11,000.
What next?
The stays’ remuneration is the hospitals’ main source of income. This work makes it possible to quickly determine if the clinical pharmacist can bring added value in the field of hospital stays’ pricing. The next step is the transition to forward looking. It would also be possible to assess other comorbidities.
A NOVEL CLOSED SYSTEM DRUG-TRANSFER DEVICE FOR ORAL DOSAGE FORM HELPING PATIENTS WHO CANNOT SWALLOW SOLIDS (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
It remains that new solutions to increasing the safety of handling Solid Dosage Form hazardous drugs have to be developed. Conceptually, through operating in a closed system, CSTDs should significantly reduce the risks to pharmacists and nurses There are two main drawbacks of the known solutions:
1. The crushing and dilution of the solid dosage form medicine is done with an open vessel to the environment, such as a porcelain crater, which may cause the work environment to be contaminated with carcinogenic or teratogenic substances, that could expose and endanger the medical staff to hazardous substances in the course of their duties as providers of medical care.
2. The tools available today are reusable, requiring a thorough cleaning process between different materials (drugs), which can lead to cross-contamination between different doses of drugs, which are crushed one after the other with the same instrument.
What was done?
CSTD – for oral dosage form new device of its kind, combines the act of crushing the various drugs, dissolve in liquid and give to a patient who cannot swallow for various reasons, that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.
How was it done?
We designed the device with 3D software (solid wark). It consists of a number of functional parts. The main ones are: a 20 ml barrel, a top part of which is a piston with a bottom basket loaded with the solid medicine; this part is sealed as a barrel from above. With the help of mechanical rotation, the drug breaks down into small particles that fall into the inner space of the barrel. Adding the liquid through a fluid port disposed on the bottom barrel which it is completely sealed. The removal of the liquid drug through a unique adapter which at its end is adapted to the gastric tube or oral administration to the patient,
What has been achieved?
1. The complete process of crushing and liquefying of the solid drugs is carried out under sealed conditions to the immediate environment and without fear of exposure to residues of toxic substances to the medical caregiver. 2. A one-time use system saves complex cleaning process. 3. There is no risk of cross-contamination between different drugs. 4. Saving personal protective equipment such as gloves, masks, lab coats clean rooms, etc. which is necessary for protection and for the safety of the caregiver team.
What next?
Applied research will be carried out by pharmacists and nurses to test the efficiency of the new device (as a basic prototype). These experiments will take various non-cytotoxic pills, will be dummy operations, in which the crushing and liquefying will be performed, and the solution or suspension will be transferred through the gastric tube, according to an approved research protocol.