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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.

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.

SAFETY IMPROVEMENT IN PAEDIATRICS: ASSISTED PRESCRIPTION OF INTRAVENOUS MIXTURES (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Iván Maray Mateos, Miguel Alaguero Calero, Adrián Rodriguez Ferreras, Cristina Calzón Blanco, Cristina Álvarez Asteinza, Lucía Velasco Roces, Ana Lozano Blazquez

Why was it done?

Intravenous drugs in the paediatric population bring up additional issues than the usual in adults. In their prescription, not only does the dose have to be adapted to the patient’s weight, the volume in which the drug is diluted must also be adapted to the reduced fluids requirement without jeopardising the stability of the mixture. In view of these facts, IV drug prescription in paediatrics implies a higher risk of medication errors. This new prescribing system simplifies prescription and reduces risks.

What was done?

Development of an assisted prescription system of intravenous mixtures adapted to paediatric patients in which both the drug dose and the diluent volume are automatically calculated according to the patient’s weight.

How was it done?

A literature review of drug dosing in paediatrics and their stability in different diluents was performed. For every drug the following parameters were considered: maximum dose in children (mg/kg), maximum concentration allowed (mg/ml), common doses and volumes in adults. Using these values, a system was built which calculated drug dose and diluent volume according to the patient’s weight and the maximum concentration allowed for stability reasons. For safety and to ease the preparation, the diluent volume in millilitres was rounded up to the next 10. In order to avoid overdosing overweight or older paediatric patients, maximum dose and diluent volume were narrowed down to the usual quantities in adults. Ultimately, this system was integrated in the electronic prescription system. A protocol was created, named “drug name” IV mixture PEDIATRICS. So, by selecting this protocol in a specific patient, the target dose and the diluent volume are automatically calculated.

What has been achieved?

This system was implemented for 38 drugs. From July 2018 to April 2019, 910 IV mixtures have been prescribed from the following Anatomical Therapeutic Chemical (ATC) groups: A02 Drugs for acid related disorders (39), J01 Antibacterials for systemic use (287), J02 Antimycotics for systemic use (3), J05 Antivirals for systemic use (8), A04 Antiemetics and antinauseants (175), N02 Analgesics (395), N03 Antiepileptics (3).

What next?

This method could be implemented in other electronic prescription programmes. The system must be updated by the Pharmacy Department, introducing new drugs and constantly reviewing stability databases, posology regimens, and information regarding dilution of parenteral drugs.

SUCCESSFUL DEVELOPMENT OF A SHARED INFORMATION DATABASE FOR HOSPITAL PHARMACIES IN DENMARK – BENEFITING FROM AGILE PROJECT MANAGEMENT (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Stine Ulsø, Hilde Omestad, Susanne Weng Rømer, Sisse Emilie Mejsner, Mads Nielsen, Jesper Heltoft-Christensen

Why was it done?

The existing solution, established in 2001, was running on an insecure platform, the system was expensive to maintain and changes difficult and slow to implement. The need for an update led to a change of supplier, hosting and platform.

What was done?

A new database was developed for documentation and quality assurance of drug related queries received by hospital pharmacies in Denmark. The information in the database is shared across all hospital pharmacies in Denmark and is an important tool for the Medicines Information Centers located there. Existing queries were transferred from the old to the new database.

How was it done?

A working group was established consisting of three pharmacists and superusers from three different hospital pharmacies, one project manager employed by the sponsor (Amgros) and two developers employed by the new supplier (Progressive). The project was structured using monthly physical meetings and ad hoc video conference meetings. The work tasks in the development process were divided and carried out in two-week sprints by the developers and subsequently tested and validated by the pharmacists. All participants agreed to a periodic heavy workload and showed great flexibility. The close and frequent collaboration between all members affected the teamwork in a positive way, hence the group was motivated and managed to agree on common solutions and compromises despite different database usage and different locations.

What has been achieved?

A new, stable and more intuitive database was developed in only 5 months due to the structured and flexible way of working and a close motivated teamwork. The database was taken into use from one day to another and quickly adapted. Since the development several hospital pharmacies have increased their use of the database. The amount of information shared nationally has improved.

What next?

The initiative resulted in a useful tool implemented within a short time. The way of working intensively and focused with physical meetings and video conferences made a good basis to succeed. Especially the sprint cycles can be used in different healthcare settings involving different projects.

SAFER DRUGS WITH AWARD WINNING DATABASE

European Statement

Patient Safety and Quality Assurance

Author(s)

Kaveh Teimori, Hannah Colldén, Reza Asasdian

Why was it done?

Hospitalized patients often need multiple intravenous drugs simultaneously which are commonly mixed in-line before entering the blood stream. Physicochemically incompatible drugs cause reduced efficacy, clogged catheters and drug precipitation, which can be harmful or even fatal. The risks add uncertainty to the stressful working environment for clinical practitioners. According to a local 2012 survey 68% (n=44) of Sahlgrenska University Hospital (SUH) intensive care unit (ICU) nurses had co-administered drugs uncertain of their compatibility. Hospital pharmacists are hence asked for guidance to optimize compatibility and patient safety.

What was done?

Nurses, doctors and pharmacists were provided with accessible and evidence based information on IV drug compatibility in order to improve drug therapy, working environment and patient safety.

How was it done?

Drug compatibility data was collected by hospital pharmacists who assessed its applicability to Swedish conditions. The results were documented in charts and procedure documents. A project for creating a database was initiated in collaboration with the IT organization in Västra Götaland Region (VGR). A survey was designed to evaluate how the SUH’s ICU nurses experienced the database. Collaboration with nurses, doctors and clinical pharmacists helped improving the quality of the database.

What has been achieved?

Drug compatibility lectures given to nurses, doctors, pharmacists on a continuous basis. Procedure documents implemented in eight clinics. A peer-reviewed work flow is established. The database contains over 2500 assessed drug combinations. Over 700 nurses, doctors and pharmacists from 11 counties plus Norway and Denmark have requested access to the database. Clinics avoid drug mixing by choosing multi-lumen catheters with greater capacity. The 2016 survey showed that 88% (n=86) of SUH’s ICU nurses had co-administered drugs uncertain of their compatibility. The database affected their decisions in 93% (n=45) of the cases, 85% (n=34) found information easier and 88% (n=34) felt more certain when making decisions. A new pharmacist role – IV Compatibility Manager – was introduced and implemented in VGR. In 2016, this work received the national annual award Guldpillret (“The Golden Pill”).

What next?

In the next years, the database will become nationally available and integrated into electronic journal systems. Compatibility issues may then be identified already when prescribing, further improving patient safety.

Development of a guide intravenous administration

European Statement

Clinical Pharmacy Services

Author(s)

Gregorio Romero Candel, Esther Domingo Chiva, Jose Marco del Rio, Marca Diaz Rangel, Wals Valladolid, Sergio Plata Paniagua, Nuria Maryinez Monteagudo

Why was it done?

Critically ill patients often require the administration of several intravenous drugs. Besides, we have many times limited intravenous accesses in which the administration of drugs and other intravenous compounds such as parenteral nutrition must be shared.
Because of that, it is very important to have drug administration guides standarizing every-day clinical practice.
This guide was developed in order to reduce the health care workers burden and promote patient’s safety.

What was done?

We developed an updated guide on direct intravenous administration of drugs for health care workers of both critical care and emergency departments.

How was it done?

A database with every intravenous drug that is included in the Pharmacotherapeutic Guide in our hospital was prepared, alphabetically organized by Active Pharmaceutical Ingredient (API). The following data were collected: API, tradename, available dosage forms and recommendations for direct intravenous administration.
For each API, a bibliographic research of information was conducted, among other hospital administration guides, manufacturer´s product information, drug databases (BOT plusR, Micromedex) and requests of information to the technical departments of the manufacturer.
In case of a discrepancy in the information, the guide with higher evidente or more recent was selected.
The antineoplastic drugs were not included in this guide because they are not used or prepared in critical care or emergency departments.

What has been achieved?

This guide promotes safe administration of drugs in critically ill patients, being a useful, accesible and easy-to-use tool for nurses.
Its elaboration allows us to standarize the direct intravenous drug administration, to inform every health care worker and make them aware about its importance. Besides, the Pharmacy Department actively participated in the process of safe drug administration in our hospital

What next?

We are still working on the same departments to improve safety in drug therapy in critically ill patients. Currently, improvement measures that are being developed are: new pharmacotherapeutic protocols specifically for this unit; drugs and drug-diluent compatibility guidelines and new training sessions.

EASE OF ACCESS TO INTRAVENOUS DRUG COMPATIBILITY INFORMATION FOR CLINICAL PRACTITIONERS

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European Statement

Patient Safety and Quality Assurance

Author(s)

K. Teimori, H. Colldén, R. Asadian Falahieh

Why was it done?

Therapy at an intensive care unit (ICU) involves co-infusion of multiple drugs into the same IV line. This may involve mixing of incompatible drugs resulting in particulates being infused, putting the patient at risk. In 2012, a local survey showed 65% (n=142) of participating nurses had co-administered drugs where they were unsure of their compatibility. Preventing incompatibilities by providing healthcare practitioners with point of care IV drug compatibility information fitted to local needs was deemed a necessity. Drug compatibility requires a thorough understanding of chemistry, and information from published studies must be evaluated and assessed to determine applicability to local clinical conditions. Clinics had requested the support of pharmacists for this work.

What was done?

An online intravenous (IV) compatibility database based on these data was created. A group of international clinical pharmacists interested in collaborating in improving the quality of the database was identified. Information material aimed at educating healthcare personal was developed.

How was it done?

Published drug compatibility data and information on physiochemical properties were collected and assessed by a team of hospital pharmacists for applicability to seven clinics. Support, guidance and expertise in the subject had been readily offered to clinical practitioners through telephone calls, email and meetings.

What has been achieved?

Six custom compatibility charts totaling 3600 drug pairs have been created, and procedure documents for IV compatibility have been implemented in each clinic. Over 30 educational lectures on IV compatibility have been held.

The database consisting of 2500 drug combinations presents accessible detailed information on compatibility. Its quality is continuously reviewed by international colleagues.

What next?

The database is fitted to national clinical traditions, providing accessible data to nurses and physicians to support decisions on which drugs to co-infuse. In the next few years, the database will become nationally available. If integrated into the electronic journal system, this could help doctors consider compatibility issues while prescribing, further improving patient safety.