TASK FORCE TO FACILITATE THE INTRODUCTION OF BIOSIMILAR MEDICINES NATIONALLY: THE CASES OF INFLIXIMAB AND ETANERCEPT
Pdf
European Statement
Selection, Procurement and Distribution
Why was it done?
Introducing biosimilar medicines in the clinical setting may significantly reduce hospital medicines expenditure – but only if the biosimilar medicines are used. Lack of knowledge and insecurities about biosimilar medicines among healthcare professionals and patients must to be addressed to ensure implementation in the clinical setting.
What was done?
To facilitate the introduction of biosimilar medicines in Denmark, a special Taskforce was appointed. The aim was to enhance knowledge of biosimilar medicines among healthcare professionals and prepare implementation of biosimilar medicines in the clinical setting.
How was it done?
A special “Taskforce for introduction of biosimilars” was appointed. The Taskforce consisted of physicians including clinical pharmacologists, pharmacists, drug tender specialists and staff from the “Council for the Use of Expensive Hospital Drugs”, who issue national treatment guidelines.
Planning the introduction of biosimilar infliximab in Denmark started more than a year prior to the granting of marketing authorization. During this time, the Taskforce arranged seminars and facilitated meetings with specialists from the clinical setting to provide knowledge of biosimilars, to discuss the introduction of biosimilar medicines and how to switch patients. Based on these discussions the “Council for the Use of Expensive Hospital Drugs” dictated the use of biosimilar medicines nationally.
The Taskforce also created educational materials for doctors, nurses and patients and a “Q & A” website.
What has been achieved?
Biosimilars were adopted into the Danish market after a very quick introduction. The market share of the biosimilars was 95% within 3-4 months.
The price reduction after introducing biosimilar medicines was approx. 60%, and the quick implementation of the drugs in the clinical setting has significantly reduced medical costs.
Total annual savings in Denmark: 22 mio € (infliximab) and 15 mio €* (etanercept. * Estimate based on the first 6 months).
What next?
More new biosimilar medicines are expected to be introduced into the Danish market in the near future. The Taskforce will continue their work to ensure similar successful implementations.
EASE OF ACCESS TO INTRAVENOUS DRUG COMPATIBILITY INFORMATION FOR CLINICAL PRACTITIONERS
Pdf
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.
DEVELOPMENT OF AN INTERACTIVE PLATFORM FOR PROVINCE CLINICAL PHARMACEUTICS WHO ARE IN CHARGE OF THE TREATMENT OF HEPATITIS C INFECTED PATIENTS
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
S. Jornet Montaña, M. Martín Marqués, P. Jolonch Santasusagna, M. Juan Aguilar, C. Gomez Blanco, P. Salvador Collado
Why was it done?
The constant development of new therapies against hepatitis C and the lack of experience in their management requires health professionals to work together.
What was done?
An online platform was created to make inquiries, resolve doubts and establish a shared database among clinical pharmaceutics within the province.
How was it done?
Meetings of the provincial pharmaceutical association were conducted to jointly identify shared necessities across professionals and to determine the best communication system to be used in terms of efficiency, speed and reliability.
What has been achieved?
The pharmaceutical association created an interactive platform, which was easily accessible from a virtual campus. The platform eases the tasks of sending inquiries and comments about side effects to all pharmaceutical professionals in the system, simultaneously and in a timely fashion. This platform also allows the creation of debate forums to answer questions, and promotes knowledge sharing among participants. As time goes by and based on experience of new drugs, a drug interactions database is created. The platform also allows knowledge of whether specific combinations of drugs have been used and the hospital’s own experience, even if no official studies exist. In addition, the platform allows updating the previously introduced interactions and shows who has done it, so this participant can be asked if necessary. This system also allows the sharing of written information, such as patient brochures, recommendations, bibliography and scientific society links and other websites of interest.
What next?
The created platform meets the pharmaceutical participants’ expectations and allows equal treatment of all patients independently of the hospital where they are located. This platform allows professionals to work together for the same cause and overcome individual knowledge and resources constraints. This platform will be used for other illnesses for which special pharmaceutical attention is required. Finally, the platform will be expanded by inviting other provinces to join our project.
COMPUTERISATION OF THE REQUEST MANAGEMENT OF MEDICAL PRODUCTS UNDER SPECIAL CIRCUMSTANCES
European Statement
Selection, Procurement and Distribution
Author(s)
A. Navarro Ruíz, A. Martínez Valero, R. Gutiérrez Vozmediano, A. Andújar Mateos, A. Martí Lorca, I. Jiménez Pulido
Why was it done?
The purpose was to increase the efficiency of this management process involving a high workload due in part to the absence of information.
What was done?
In Spain, the availability of drugs under special circumstances is regulated by the Spanish Royal Decree 1015/2009 of 20 June, which established three instances: (1) use of investigational medicinal product undergoing a clinical trial, (2) use of medical products for a medical purpose not in accordance with the authorised product information (off-label use) and (3) access to unauthorised medicines in our state but which are legally marketed in other states. Also, each region has its own regulatory system for medicines. In the pharmacy department, we have developed a software application for managing requests for medicinal products in the situations described above, and in accordance with our region’s regulations. It is organised in different sections that collect patients, prescribing physician details, medicinal products and diagnostic information. It has restricted access through user accounts and a menu for multiple search parameters.
How was it done?
In the pre-design phase, we held individual meetings with pharmaceutical and administrative staff involved in this process to identify their specific needs and priorities, and to assess these once the software application was created. The database management system used for the development of the computer application was Microsoft Access 2003. Once finished, it was tested for 2 months to help pinpoint specific errors and improvement opportunities.
What has been achieved?
Computerisation of this process has improved the efficiency in requests management, facilitating the use of information, increasing speed and reliability, allowing the possibility of analysing large volumes of data, providing greater confidentiality and increasing security through backups.
What next?
The next step will be to assess the usefulness of this software application using a satisfaction survey. To incorporate this initiative into other hospitals in our area requires only compatible software able to run the application.To extend its use to other regions would need adaptation of this software application to the existing regulations in each region.
IS IT POSSIBLE TO TURN AROUND THE TREND ON INCREASING AMOUNT OF BACKORDERS AT THE NATIONAL LEVEL
Pdf
European Statement
Selection, Procurement and Distribution
Why was it done?
Globally, we are facing an increasing amount of drug shortages, even though international regulatory authorities take initiatives to improve this.
We have national order data available through one national organisation that manages all tenders and backorders for drug supplies to all hospital pharmacies.
Access to order data enabled us to start this improvement initiative in May 2014, and hence fight the backorder challenge at the national level.
What was done?
We applied LEAN and Supplier Collaboration to turn around the trend of increasing amount of drug backorders to hospital pharmacies.
Our initiative consisted of tight follow-up and continuous improvements with ‘TOP6-suppliers’, (ie, the 6 suppliers with currently the most negative impact on our national drug supply).
‘TOP6-suppliers’ are selected each week at LEAN board meetings.
Tight supplier follow-up, by e-mail, weekly:
We informed the ‘TOP6-suppliers’ that they currently are among the suppliers with the most backorders, and asked them to:
• Confirm/update delivery dates for all open backorders
• Inform us of the underlying reason for each backorder
The suppliers continue to receive weekly emails, as long as they are selected as ‘TOP6-supplier’.
Continuous improvement meetings, face-to-face, quarterly:
We had meetings with the 3 suppliers with the highest level of backorders/poorest level of improvements.
Meeting agenda: Reasons behind current backorder situation and actions to improve.
How was it done?
Obstacles—>Our solutions:
Too busy managing actual backorders and no time to drive improvements—>Added one dedicated resource to drive this initiative.
How to manage our effort—>Develop leading key performance indicators (KPIs) that ensure focus on influence and improvements.
We were not always confident that our effort would provide the expected results—>Continue to focus on the agreed approach and KPIs, even if it takes approximately 12 months before we achieve improvements.
What has been achieved?
• Backorder amount decreased by 25%.
• 3rd quarter2014: On average, 99 item-numbers in backorder (range 87-117).
• 3rd quarter 2015: On average, 74 item-numbers in backorder (range 67-99).
• Closer dialogue and improved cooperation with our suppliers with most/critical backorders.
What next?
1. Share achievements.
2. Start an international network to share best practices.
3. Together achieve further improvements in drug supply.
IMPLEMENTATION OF A PHARMACY TECHNICIAN COORDINATED MEDICATION SUPPLY SERVICE IN A PAEDIATRIC ELECTIVE TREATMENT CENTRE
European Statement
Selection, Procurement and Distribution
Why was it done?
PETC admits approximately 15 000 patients per year and is a high user of high cost drugs. Traditionally, a pharmacist provided a clinical and supply service with no technical support. Frequently, prescriptions were written late, dispensed items were lost and patients waited unnecessarily to receive treatment. Furthermore, patient non-attendance and medication re-supply due to misplacement of original dispensed items led to stockpiling of medicines.
What was done?
A pharmacy technician (PT) coordinated medication service was introduced onto the Paediatric Elective Treatment Centre (PETC) to decrease patient waiting time (PWT) and drug wastage.
How was it done?
Prior to admission, patients requiring medication were identified by a PT. If medication had been prescribed, this was transcribed onto a pharmacy order form. The prescription chart and order form were clinically checked by a pharmacist. If the drug had not been prescribed, prescribers were contacted. The medication was dispensed and delivered to the ward in advance. The PT ensured all required medication was readily available on the ward. Data on PWT, time to process medication orders, cost of unused drugs and number of items available prior to attendance were collected for a 6 month period.
What has been achieved?
Total cost savings achieved due to returned unused medication amounted to £82 074.
What next?
To extend the role of the PT in PETC. Therefore, the PT will undertake basic medication reconciliation, assessment of patients’ own drugs and notify the clinical pharmacist of patients requiring a full medication review.
DEVELOPMENT OF A 7 DAY CLINICAL PHARMACY SERVICE
Pdf
European Statement
Introductory Statements and Governance
Author(s)
S. Antoniou, M. Sullivan, P. Wright, J. Quinn
Why was it done?
The cardiac centre receives over 1800 acute admissions per year, with 20% of patients admitted on weekends. National reports highlight increased mortality at weekends, which has led to a call for the NHS to provide a consistent service throughout the week1. In accordance with the European statements of hospital pharmacy2, there was a need to ensure all prescriptions be reviewed and validated promptly on admission.
What was done?
Implementation of a 7 day clinical pharmacy service to a newly merged cardiac centre.
How was it done?
A successful business case for additional resources allowed for expansion of existing service to be delivered. This facilitated change in working hours for frontline staff, including provision of a shift system ensuring the EU working time directive3 was not exceeded. Expansion of the ward based pharmacy technicians’ role to include ward based dispensing led to timely access to medicines. An increase in the visibility of pharmacy staff at the ward level facilitated a patient facing clinical pharmacy service over the 7 days.
What has been achieved?
All new admissions and discharges are reviewed at weekends with visits to coronary and intensive care. Medicines reconciliation within 24 h is above 95%. 98% of discharge medication is supplied at ward level and 93% prepared prior to discharge prescription written. Feedback from patients, nursing and medical staff has been extremely positive.
What next?
The service is currently provided for patients admitted within the cardiac services. A review is underway to consider staffing requirements to implement the service across the whole site and the trust.
High Performance Medicines Management – HPMMF
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Lars-Åke Söderlund, Marie Olsson Nerfeldt , Birgitta Elfsson
Medication Safety Audits developed and conducted by a hospital pharmacy in Finland
Pdf
Author(s)
E. Celikkayalar, E. Suvikas-Peltonen, J. Palmgren
IMPROVING STAFF TRAINING IN A CYTOTOXICS PREPARATION UNIT
Pdf
European Statement
Production and Compounding
Author(s)
S. Sernache, H. Goncalves, A. Gouveia
Why was it done?
Improved processes were required due to new CPU facilities, PIC & acute requirements and workplace safety legislation. The training program started in 2013. Our aim was to change from an informal training to a program where minimal qualification standards were achieved despite heavy workload and budget constraints.
What was done?
Implementation of a training program for the Cytotoxics Preparation Unit (CPU) focusing on product and staff safety. Key steps were hand washing with fluorescent gel, media fill and simulated preparations with fluorescent dye. Wipe sampling of cytotoxic contamination and microbiological control were performed.
How was it done?
Absence of national experience required literature review and support from other hospital in Europe. Lack of commercial products and budget constraints led to adoption of more affordable solutions like in-place compounding of fluorescein vials, and use of standard sodium chloride IV bags for media fill. Other resources were procured externally and adapted.
We enhanced motivation with involvement of staff in the goals and open discussion of results.
What has been achieved?
All relevant staff went through the training and reached the qualification thresholds. All technicians successfully performed media fill test (no microbial growth), and fluorescein test (no dye spots counted). Hand wash results had median of 5 spots of inadequate washing. Results were discussed with staff and new session implemented afterwards. Only 9% of staff (n=33) did not improve, median of results was 1 spot . Regular microbiological monitoring results meet GMP criteria for the laminar flow cabinets, and cytotoxic contamination (8 drugs tested in 5 locations) is in line with reference values except for 5-FU storage shelf.
What next?
Training program is to be repeated yearly, as well as the monitoring processes. Despite budgetary and staff constraints, a sustainable training program can be implemented with adaptation of published sources, resulting in adhesion to good practice.