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ANALYSIS OF DISCREPANCIES BETWEEN DATABASES OF DRUG-PLANT INTERACTIONS: A NEW TOOL THAT FACILITATES DAILY DECISION MAKING

European Statement

Clinical Pharmacy Services

Author(s)

Belén Serna Serrano, Victoria Lerma Gaude, Ana Valladolid Walsh, Cristina Del Pozo Carlavilla, Juan Manuel Collado Sanz, Héctor Alabort Ayllón, Eduardo Tébar Martínez, Andrea Drozdz Vergara

Why was it done?

In the pharmacist-patient clinical interview (CI), DP-I revision is frequent due to consumption increase of phytotherapy in recent years. The aim of the initiative was to study the degree of discrepancy (DD) based on the severity criteria (SC) found about the recommendations on the management of DP-I. Nowadays there are multiple databases with lack of unification. Patients diagnosed of Multiple Sclerosis (MS) are frequently interviewed by the pharmacist and they often take herbal medicines (HM).

What was done?

We unified the information collected from the commonly consulted databases of drug-plant interactions (DP-I) whose information could be scarce or contradictory, by creating a tool based on the most consulted plants in our clinical practice (CP).

How was it done?

To create our own DP-I tool, the sources consulted were:
– Our own plant database based on CP. A total of 56 plants.
– Six official databases of DP-I: (A)-Phytotherapy official monographs, (B)-MedInteract®, (C)-Micromedex®, (D)-UpToDate-Lexicomp® (E)-Medscape®.

In order to unify the DP-I information consulted and to be able to identify the DD (0 to 2), the SC for all databases were unified in 3 levels: if the database had 5 levels (1=1-2; 2=3-4; 3=5) or 4 levels (1=1-2; 2=3; 3=4). In first place we decided to test this tool with a small sample size of drugs (6 drugs commonly used for the treatment of MS) to check whether the discrepancy between the databases usually consulted was significant or not.

What has been achieved?

Finally, 6 DP-I were detected with Hypericum perforatum (HP) and Echinacea angustifolia (EA):

The DD seems to be similar between A-B databases and greater respect to the rest of them. Depending on the database consulted the pharmacist’s performance could change and consequently, pharmaceutical care may be affected. Since this tool was implemented in our CP, none of our MS patients have taken HP or EA, therefore, it has not been necessary to modify their treatment because of DP-I.

What next?

This tool could speed up the pharmacological review of possible DP-I and improve decision-making for the care of MS patients. Our next step is to increase the sample of analysed drugs commonly used in other pathologies, such as antiretroviral drugs.

Implementation of a tool for annual quality assessment of drug information provided by hospital pharmacies

European Statement

Clinical Pharmacy Services

Author(s)

Dorothea Strobach, Ute Chiriac, Sigrun Klausner, Claudia Langebrake, Christiane Querbach, Carolin Schuhmacher

Why was it done?

Although guidelines for DI demand regular quality assurance procedures, no method of evaluation is internationally agreed on. The tool should be feasible, reproducible and reflect real-life quality of DI. It should allow to identify areas for quality improvement in general and for every participant.

What was done?

We developed a tool for annual quality assessment of drug information (DI) provided by hospital pharmacies on behalf of the German Association of Hospital Pharmacists ADKA e.V.. The tool has been successfully implemented for four years.

How was it done?

We developed a new tool for quality assessment of DI using a fictitious test enquiry and simulated real-life conditions and proved it representative for real-life quality [1]. The answers for the test enquiry are evaluated by blinded experts for content and formal requirements. For four years, 2017-2020, annual assessment of DI was offered to German language hospital pharmacies with changing topics and enquiry levels. Participants receive their own result in comparison to average of all regarding content-related and formal requirements. A proposal for an answer is published afterwards for educational purposes.

What has been achieved?

The annual DI quality assessment tool was successfully implemented as shown by increasing numbers of participating hospital pharmacies (45/71/79/118). Areas for improvement have been identified in general and can be identified by each participant as well. As an example, presentation of references has improved over the years [2]. Since 2018, a certificate of participation is offered as document for quality assurance audits thereby underlining the importance of this hospital pharmacy service.

What next?

Annual quality assessment for DI by hospital pharmacies will be further offered. Results over years will be evaluated for overall effect of the annual test tool on quality improvement regarding content-related and formal requirements. This method for annual quality assessment of DI provided by hospital pharmacies could be implemented by other countries.

References
1. Strobach D et al. EJHP 2020 online ahead of print. doi: 10.1136/ejhpharm-2020-002409
2. Strobach D et al. Krankenhauspharmazie 2020;41:187-91

IMPLEMENTATION OF A SAFE EXTERNAL DISPENSING SYSTEM DURING THE COVID-19 PANDEMIC IN A REFERRAL HOSPITAL

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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.

THE LABOUR OF HOSPITAL PHARMACY SERVICES IN THE COVID-19 HEALTH CRISIS

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European Statement

Clinical Pharmacy Services

Author(s)

CLARA NOTARIO DONGIL, PATRICIA ARAQUE ARROYO, MARÍA MAR ALAÑÓN PARDO, ALEJANDRO MARCOS DE LA TORRE, MARÍA CARMEN GARCÍA CONDE, BEATRIZ PROY VEGA

Why was it done?

The circuit was designed during the pandemic period responding to the COVID-19 situation. The aim was providing the best service to hospitalized patients. The activity began on March 10, 2020.

What was done?

Due to the current pandemic caused by SARS-CoV-2, our Pharmacy Service (PS) has been reorganized and adapted its activity by areas according to the needs of a given situation.

How was it done?

1.- Priority areas were set up.
2.- Main activities to develop in each section were defined.
3.- There was a redeployment of the PS staff.

What has been achieved?

Pharmaceutical assistance: PS developed pharmacotherapeutic protocols, collaborated giving advice to medical staff selecting appropriated treatments and detecting the most important interactions between drugs. It also advised regarding to compatibility and stability of medication, providing in addition written information through tables and triptychs elaborated.

Pharmacotechnics: 1,320L of hydroalcoholic solution were elaborated and 1,161L that were donated to the hospital were repackaged; 5.3L of hydroxychloroquine 25 mg/mL oral suspension were prepared for patients in the Intensive Care Units (ICU).

Parenteral preparations: Perfusion elaboration was centralized in the PS; 495 infusions of midazolam 1.6 mg/mL and 1,570 of fentanyl 0.012 mg/mL were formulated to ICU. Individualized doses of intravenous tocilizumab belonged to 31 patients were elaborated.

Management and acquisition of medicines: Two new hospitalization areas and three new ICUs were set up, equipped with medication kits. We increased the frequency of medication replacement and the stock of medication in the hospitalization units was adapted. We made a continuous review of medication stocks due to high stocks turnover because an elevated demand. To guarantee the supply of medicines related to SARS-CoV-2, medication was requested through the application of “management of medicines in special situations” of the Ministry of Health. 45 applications were processed.

What next?

The project is applicable to whatever PS, a defining figure in SARS-CoV-2 health crisis´s management, giving priority to essential services.

A PHARMACOGENETIC CLINICAL DECISION SUPPORT SYSTEM (CDSS)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Xando Díaz-Villamarín, Ana Pozo-Agundo, Paloma García-Navas, Alba Antúnez-Rodríguez, Celia Castaño-Amores, Cristina Lucía Dávila-Fajardo

Why was it done?

Nowadays, it is known that at least 33% of patients show variable response to drugs. Of those, genetic polymorphisms explain around 15-30% of these cases, single nucleotide polymorphisms (SNP) being the genetic markers most clinically relevant. In 2013, 40 million SNPs were identified in humans and some have been observed to determine drug response. These observations lead to the incorporation of genotyping some of these SNPs as a recommendation in many drug labels before treatment initiation.
Since patient´s drug response may be determined by certain SNPs in different genes it is necessary to develop CDSS based on pharmacogenetic (PGx) information that makes feasible its application in clinical routine, translating genotypes into phenotypes and dosing recommendations.

What was done?

We have developed a local Clinical Decision Support Systems (CDSS) that informs the physician on the availability of a PGx test in our hospital for certain prescribing drugs. This system will also be able to translate the genetic information into dosing recommendations.

How was it done?

We selected all the SNPs affecting drug response for which there is already a PGx test available in our hospital. All of them have been previously validated, and, only genes/SNPs related to drug response with the highest level of evidence, available in the Dutch Pharmacogenomics Working Group (DPWG) and Clinical Pharmacogenetics Implementation Consortium (CPIC) dosing guidelines with a minor allele frequency higher than 0,1% in our population have been included. We have considered all the different genotypes according to the SNPs included and linked them to a phenotype and dossing recommendation according to CPIC/DPWG guidelines.

What has been achieved?

Our CDSS connects different drugs with available PGx test in our unit, showing which gene should be genotyped before prescription. It translates genotypes into phenotypes and also provides dosing recommendations once PGx results are received, according to the CPIC and/or DPWG guidelines. Nowadays, this system facilitates the workflow for the implementation of pharmacogenetic tests in our hospital.

What next?

We have developed a CDSS that manages PGx information facilitating the implementation of pharmacogenetics in daily clinical routine. It will also allow us to expand our services to other medical departments within our hospital.

Horizon Scanning in Denmark: Providing the health care system with an overview and impact estimation of new medicines

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European Statement

Selection, Procurement and Distribution

Author(s)

Helle Brauner

Why was it done?

There was a need for improved planning and preparing processes, as when it comes to price negotiations and estimates on financial burden and strategic procurement.

What was done?

Amgros, a part of the Danish health care system, has secured the supply of medicines and hearing aids to public hospitals and hearing clinics across Denmark for 30 years. This is done through efficient procurement and tendering procedures, creating economies of scale and savings.

In addition to this, in January 2017, Amgros launched its own Horizon Scanning unit. Now, the Danish Horizon Scanning system provides the health care system with an overview of medicines, indications and extensions e.g. pharmaceutical forms expected to be entering the Danish market within the next 2-3 years.

How was it done?

In 2016, it was decided to establish an Horizon Scanning system in Denmark. Then, input from internal and external stakerholders regarding their needs and expectations were gathered.

The outputs from the Horizon scanning unit consist of an overview of medicines about to reach the Danish market, as well as estimates of costs for new, expensive medicines and possible savings, for example if there are cheaper biosimilar drugs on the market. We also assess potential patient population and location of treatment. This is done in close cooperation with several Danish clinicians.

Sources for verifying and validating the data inputs are primarily EMA, complemented with commercial databases and a niche group of other sources. Data is gathered in a database.

What has been achieved?

The outputs enable our stakeholders to better plan the introduction of new medicines, to secure more cost-effective health solutions for everyone and to achieve more health for money in the Danish hospital setting.

Danish Regions, the interest organization for the health care regions, use the estimates in their annual negotiations with the Government on finances and the individual regions use them in their own budgets.

The predictability this system brings to Denmark is key in a future with more rare diseases, treatments and advanced pricing.

What next?

The Horizon scanning function is continuously being developed to meet the needs of our stakeholders, as we want to enable them in providing health care to the Danish citizens.

THE APPLICATION OF AN EHEALTH MODEL IN THE HEALTH CARE SYSTEM

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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.

IMPACT OF PLANTS ON ANTICANCER DRUGS METABOLISM: DEVELOPMENT OF A DATABASE TO FACILITATE THE PHARMACIST’S EXPERTISE (submitted in 2019)

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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.

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.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.