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Impact of an Integrated Medicines Optimisation Pharmacist (IMOP) on Biosimilar Uptake in the Mater Misericordiae University Hospital

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European Statement

Clinical Pharmacy Services

Author(s)

Grainne Johnston, Jennifer Brown

Why was it done?

The High Tech Scheme (HTS) in Ireland facilitates access to high cost drugs with proven cost benefit for patients. Combined national expenditure on adalimumab (Humira®) and etanercept (Enbrel®) exceeded €190 million in 2017. Biosimilar versions of both drugs are available, however largely not utilised. The most cost effective options for each drug were designated as the Best Value Biologic (BVB). Prescribing a BVB option offers the opportunity to save a considerable amount of money for the state.

What was done?

The Mater Misericordiae University (MMUH) Integrated Medicines Optimisation Pharmacist (IMOP) provided education and removed barriers to initiate biosimilar prescribing of adalimumab and Enbrel in the MMUH.

How was it done?

The MMUH IMOP was delegated to assist with implementation of BVBs prescribing.
The MMUH IMOP generated Patient Information Leaflets in relation to BVB switching.
The IMOP reviewed out-patients currently prescribed Humira® or Enbrel®, and provided education and information on switching from the originator to the BVB

What has been achieved?

Prior to the IMOP intervention, no patients in the MMUH had been prescribed a BVB.
Following IMOP intervention, between June 26 and September 27, 2019:
• 291 Humira® or Enbrel® patients were scheduled to attend MMUH rheumatology, gastroenterology and dermatology clinics.
• Of these, 64% (n=185) were switched to a BVB. An additional 19 patients were newly commenced on a BVB.
• The IMOP educated and counselled 91% (n=92), 93% (n=53) and 48% (n=13) of patients switched to a BVB in rheumatology, gastroenterology and dermatology respectively.
The largest contributing factor identified for patients not being prescribed a BVB was, no review by the IMOP prior to medical review; 65% (n=35), 59% (n=10) and 86% (n=12) for rheumatology gastroenterology, and dermatology respectively.

What next?

BVB prescribing can save vital health funds for the state while maintaining patient care. The MMUH IMOP is now progressing to adopt BVB prescribing for a number of other biological medicines at significant savings for the MMUH and state.

BIOSIMILARS: LET’S START RUNNING (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Beatriz Zurita Alonso, Marta Martí Navarro, Monica Estelrich, Alejandro Ballestero Corominas, Anna Badell Giralt, Diana Patricia Vera Rodríguez, Milagros Ricse Salcedo, Roxana Rubio Vargas

Why was it done?

The use of biosimilar drugs has been a breakthrough to improve the sustainability of the health system. Although since 2015 position papers have been published by some scientific societies, there is no clear consensus about the recommendation for a switch from the original drug to its biosimilar. The rate of biosimilar use in our country is one of the lowest in Europe.

What was done?

The pharmacy service led the creation of a working group formed by rheumatologists, gastroenterologists, dermatologists and pharmacists to promote the use of biosimilar drugs in our hospital.

How was it done?

The working group wrote a consensus document in which it was jointly decided to start all new biological treatments with biosimilars. In addition, it was decided that the prescribers would determine which patients were candidates for switch to a biosimilar based on clinical criteria. If the drug is administered subcutaneously, the pharmacist is responsible to explain the reason for the change and the management of the new device to the patient. In case of disagreement, the original is kept and communicated to the prescribing physician. If the drug is administered intravenously, it is the physician who informs the patient about the change.

What has been achieved?

From May 2019 to September 2019, 17 switches were made: 4 infliximab (66.7%), 9 adalimumab (10.1%) and 4 rituximab (80.0%). This measure led to an economic saving of €111,106.96 per year. Twenty new treatments with biosimilars were started: 1 with etanercept, 2 with infliximab, and 17 with adalimumab. This supposed an economic saving of €141,826.36/year if we compare with the cost of the original drug. The rate of antiTNF biosimilars increased from 33% to 48% in 5 months. None of the patients refused the use of a biosimilar. By now, all treatments maintain their effectiveness without safety issues. This optimisation of treatments will allow the hospital to treat a greater number of patients and invest in innovative treatments.

What next?

These results indicate a great opportunity to offer biological treatment to a higher number of patients every year. Therefore, our objective is to achieve the switch of remaining patients as it could generate an additional saving of €630,072.28 per year.

IMPROVING ANTIBIOTIC STEWARDSHIP AT A HOME HOSPITAL UNIT BY IMPLEMENTING THE PRODUCTION OF ELASTOMERIC PUMPS CONTAINING BENZYLPENICILLIN (submitted in 2019)

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European Statement

Production and Compounding

Author(s)

Maria Rautamo, Niina Laihanen , Laura Lehtola

Why was it done?

Erysipelas was the most commonly treated infectious disease at the home hospital unit in 2015. Previously the standard treatment was broad-spectrum antibiotic cefuroxime three times daily. The infectious disease specialist wanted to improve the antibiotic stewardship by shifting from cefuroxime to a continuous infusion of narrow spectrum benzylpenicillin. The aim of the initiative was also to improve patient care and reduce the number of treatment visits and thus overall treatment costs.

What was done?

The production unit at the hospital pharmacy began preparing elastomeric pumps containing benzylpenicillin for Helsinki city home hospital unit for the treatment of outpatients suffering from erysipelas. A pilot study was conducted in November 2018 before further implementation of the elastomeric pumps.

How was it done?

A benzylpenicillin 10 million IU infusion solution was prepared and transferred to elastomeric pumps (Folfusor LV10, Baxter) in the production unit at the hospital pharmacy. The production method was developed by pharmacists at the hospital pharmacy in cooperation with Baxter and the formulation as well as stability information was received from Baxter. The pilot study was planned and executed in cooperation with Helsinki city home hospital unit. The batch size of prepared elastomeric pumps was 7 pumps a week and the overall pilot period consisted of 5 weeks. A total of 8 patients were treated during this period. The opinions of nurses and patients about the use of elastomeric pumps were investigated through a questionnaire. The impact on treatment costs were also evaluated.

What has been achieved?

Elastomeric pumps containing benzylpenicillin have been implemented as a standard treatment for erysipelas at the home hospital unit. Cost savings from the pilot period of 5 weeks were 125 nurse visits corresponding to approximately 100 hours of work as well as 200 km of driving for nurses to patients’ homes. The patients were very pleased with the elastomeric pumps and the fact that the pump had to be changed only once daily.

What next?

Production and delivery of elastomeric pumps containing benzylpenicillin has expanded to other home hospital units. The implementation of elastomeric pumps containing other active ingredients is under investigation.

THE PHARMACIST IN THE LUNG CANCER MULTIDISCIPLINARY TEAM

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European Statement

Clinical Pharmacy Services

Author(s)

Ana Soares, Armando Alcobia

Why was it done?

Several clinical practice guidelines for LC recommend that multidisciplinary teams should be used to plan patients’ treatment. The evolution of thoracic oncology, namely the increasing knowledge of the diverse histologic and molecular phenotypes in non-small cell LC, has been driven to more complex treatment algorithms in recent years. This complexity increases the need for a multidisciplinary approach in therapeutic decision-making, which must be individualised and based on the best information available. The pharmacist’s inclusion in the multidisciplinary team is essential and was formerly proposed by the Pneumology Director to the Hospital Administration Board.

What was done?

A hospital pharmacist is a permanent member of the lung cancer (LC) multidisciplinary team, which has met weekly since January 2016, to plan the management and treatment of LC patients in our hospital. The pharmacist brings updated information about the efficacy and safety of drug treatments, its cost-effectiveness and its availability. The pharmacist improves communication with the Pharmacy and Therapeutic Committee.

How was it done?

The multidisciplinary team meets weekly to discuss the diagnosis and treatment options of LC patients, and includes a dedicated group of professionals: pulmonary oncologists, a thoracic surgeon, a radiation oncologist, a radiologist, a pathologist, a nuclear medicine specialist, a hospital pharmacist, a palliative care physician and an oncology nurse.

What has been achieved?

About 240 cases, corresponding to 200 patients were discussed per year. An average of 110 solicitations to the Pharmacy and Therapeutic Committee were made. The multidisciplinary team grants a systematic approach to diagnosis and therapeutics, in compliance with evidence-based guidelines, improves communication and coordination between professionals and short waiting times for the patient.

What next?

The next step is to systematise real-world data collecting, from the patients treated, to better understanding the effectiveness of treatment options and the real impact of the multidisciplinary team in patient outcome, ideally, extending it onto a national level.

PROGRAMME OF PHARMACOTHERAPEUTIC BENEFIT TO THE SOCIO-SANITARY CENTRES OF A SPECIFIC HEALTH AREA THROUGH THE HOSPITAL PHARMACY SERVICE

European Statement

Clinical Pharmacy Services

Author(s)

Gregorio Romero Candel, Maria Jesus Sanchez Cuenca , Nieves Cano Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera

Why was it done?

The healthcare provided in the SSC is not fully integrated into the structures of the National Health System. These patients present a higher risk of adverse events related to pharmacotherapy, due to patient factors, with the treatment, the health system and the institutionalisation. The integral approach of the pharmaceutical benefit was necessary for improving the efficiency, safety, health and economic results due to the process using drugs and other health products in the SSC.

What was done?

A pharmacotherapeutic benefit model has been started through the hospital pharmacy to the Socio-Sanitary Centres (SSC) of our health area. A pharmacotherapeutic management system based on the evaluation and selection of drugs and diet therapy items has been established.

How was it done?

An adherence protocol was made to the hospital pharmacy service, with the benefits that were to be provided to them. A guide was prepared with drugs and nutritional supplements that were available to them according to the Pharmacotherapeutic Guide of the Hospital Pharmacy Service, thus guaranteeing the most efficient products. A request model of both drugs and dietotherapics was developed for the SSC, assigning each centre one day per month to request the order and another day of dispensation. Finally, a calendar of distribution routes for each SSC was prepared.

What has been achieved?

For 12 months, eight SSC have been assigned to this programme, with 538 patients. Twelve shipments have been made to each centre, which have been provided with a total of 682,484 units of 223 active ingredients. The dispensation in diet therapy contained 28,045 units of 13 specialties. It has been possible to improve the pharmacotherapeutic coverage of these patients and reduce the expenditure on drugs in the area through centralised supply.

What next?

Development of follow-up programmes for patients with high health or economic impact drugs. Also, the adherence of new SSC, as well as increasing the dispensing portfolio, and achieving the integration of information systems, to have a total traceability from the patient to the different assistance levels.

A SET OF QUALITY IMPROVEMENT INTERVENTIONS TO INCREASE THE PERCENTAGE OF STAT IV MEDICINES, MEETING THE GOAL OF BEING READY WITHIN 30 MINUTES

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European Statement

Patient Safety and Quality Assurance

Author(s)

MELINDA LITAO, HANY ELATROUSH , KHATHLEEN ESER, ARWA AFANA, AHMED BAIBRAHIM, JAYSON DE JUZMAN, BAYAN RAMBO, DERI PASCUAL, MA ENCARNACION DELOS ANGELES, MANAL SALLAM, MALIK KHUWAJA

Why was it done?

STAT orders have always been a priority, however there are some areas which require some modification in the workflow to attain higher efficiency and to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

What was done?

A set of quality improvement interventions to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

How was it done?

This was a pre-post study in a government hospital between January and September 2018. LEAN and FOCUS-PDCA models were implemented to design the process of improvement. A medication-tracking system (MedBoard) was used to collect the data to measure the number of STAT IV medicines ready within 30 minutes. Data was also collected from the number of phone calls and faxes received from the day procedure unit (DPU) and home health care unit (HHC).

What has been achieved?

The cumulative data showed an increase in the percentage of STAT IV medicines being ready by 7%, equivalent to 707 orders per month (90% vs 97%), a reduction in the number of phone calls by 87.5% (48 vs six calls per day) and fax by 100% from the DPU and HHC units, which means that implementing the set of interventions were associated with an increase in percentage of STAT IV medicines being ready within 30 minutes. Additionally, there was a significant decrease in the number of phone calls and faxes, which allowed pharmacists to focus more on STAT IV orders.

What next?

Since the hospital pharmacy receives numerous orders on a day-to-day basis, this will facilitate prioritisation during the entire process. This aligns with the hospital goal of attaining ‘zero harm’, and is therefore a good example of good practice in a hospital setting. The use of Medboard in tracking medications and monitoring performance can be applied to allow any healthcare setting to ensure that goals are reached, and performance is maintained at the highest level. Designing a list of eligible medications that can be ordered as STAT can be used as a guide to avoid the abuse of STAT orders and can help in prioritising order preparation in the STAT IV room.

IMPLEMENTING A NATIONAL PORTFOLIO OF EXTEMPORANEOUS PHARMACEUTICAL PREPARATIONS USED IN DANISH HOSPITALS

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European Statement

Introductory Statements and Governance

Author(s)

Janne Jensen, Solvej Wandy Pedersen, Susanne Nørregaard, Karin Herkell, Anne Thestrup Nielsen, Anita Gorm Pedersen

Why was it done?

A group of hospital pharmacists representing all hospital pharmacies in Denmark have in a previous study identified and slimmed a national portfolio of extemporaneous pharmaceutical preparations used by Danish hospitals from a total of 2,754 preparations down to approximately 750 preparations being considered of clinical importance. Without a common overview of the national portfolio there will be initiated production of duplicates and almost identical products resulting in a large and inconsistent portfolio.
The purpose of this GPI was to make the national portfolio of extemporaneous pharmaceutical preparations accessible to all hospital pharmacists in Denmark and to implement a common procedure to evaluate preparations before adding them to the national portfolio to avoid duplets and obsolete products.

What was done?

A common national procedure for adding new preparations to the national portfolio was developed and implemented to avoid duplets and to ensure a uniform quality and appropriate risk assessment of the preparations.

How was it done?

A national database was developed and tested. Each hospital pharmacy entered their own extemporaneous pharmaceutical preparations in the database. Also, the extemporaneous pharmaceutical preparations manufactured by community pharmacies and used in the hospitals were entered in the database.
One hospital pharmacist in each of the five regions in Denmark was appointed as gatekeeper for the national portfolio. A template for an application form for new preparations was developed. When a physician requests a new preparation the application form will be completed by the clinical pharmacist. It is forwarded to the gatekeeper who will evaluate the preparation before approving it as a candidate for the national portfolio.

What has been achieved?

430 extemporaneous pharmaceutical preparations from the hospital pharmacies are entered and quality approved in the database. 255 extemporaneous pharmaceutical preparations manufactured by community pharmacies were entered in the database.
A national group of five gatekeepers was formed, and the workflow for both the group and the individual gatekeeper was described and implemented at all Danish hospital pharmacies.

What next?

The GPI provides an easy-accessible overview of the national portfolio of extemporaneous pharmaceutical preparations, releasing production time and resources at the manufacturing pharmacies.

TASK FORCE TO FACILITATE THE INTRODUCTION OF BIOSIMILAR MEDICINES NATIONALLY: THE CASES OF INFLIXIMAB AND ETANERCEPT

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European Statement

Selection, Procurement and Distribution

Author(s)

Karina Bentzen

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.