DEVELOPMENT OF RECOGNITION PATHWAY FOR ADVANCED SPECIALIST PHARMACISTS IN THE HEALTH SERVICE EXECUTIVE THROUGH TRIPARTITE WORKING BETWEEN EMPLOYER, UNION AND PROFESSIONAL ASSOCIATION.
European Statement
Clinical Pharmacy Services
Author(s)
Richard Sykes – Pharmacist Executive Manager, Portiuncula University Hospital/ Hospital Pharmacists Association Of Ireland
Muriel Pate – Chief II Pharmacist, Health Service Executive
Prof. Judith Strawbridge – School of Pharmacy and Biomolecular Sciences (PBS), Royal College of Surgeons in Ireland
Why was it done?
The development of hospital clinical pharmacy in Ireland has steadily progressed over recent decades. Historically, pharmacists working in the Health Service Executive (HSE) lacked a career structure that recognised specialist-level practice.
What was done?
Following extensive stakeholder negotiations, a validation model was introduced to assess pharmacists’ practice against internationally recognised standards. Pharmacists submitted evaluation forms to a validation panel, which reviewed their evidence. Those meeting the criteria were regraded as Advanced Specialist Pharmacists.
How was it done?
The validation criteria were aligned with the International Pharmaceutical Federation (FIP) Advanced Stage 2 framework, covering six domains: Expert Professional Practice, Working with Others, Leadership, Management, Education, Training and Development, and Research and Evaluation. A panel of pharmacists assessed electronic applications and scored them accordingly. Over 300 Acute Hospital Pharmacists submitted evidence, and those meeting the threshold were deemed to demonstrate advanced practice. These individuals were regraded to the newly created Advanced Specialist Pharmacist grade.
What has been achieved?
The HSE has now formally recognised that pharmacists in acute hospital settings are working at an advanced level. This recognition allows for the direct creation of advanced roles within the health system. A job specification outlining responsibilities and educational requirements has been published, ensuring transparency. Over 200 pharmacists successfully demonstrated specialist practice across a range of specialties and were regraded.
What next?
The creation and appointment of Pharmacists to the grade of Advanced Specialist has now prompted the need for further development. 1. The utilisation of existing Hospital Pharmacists Association Specialist Interest Groups to facilitate peer support for Pharmacists in their specialist roles.
2. A plan to establish a pipeline of Pharmacists to fill new and replacement Advanced Specialist Pharmacist vacancies.
3. Further negotiation to apply the same structures within the service in non acute hospital roles
References
1 .Advanced Specialist Pharmacist resources, Health Service Executive, July 2024, (online) https://www.hse.ie/eng/staff/resources/hr-circulars/hr-circular-016-2024-phase-2-implementation-of-the-mc-loughlin-report-in-hospital-pharmacies.html
MANAGEMENT AND TRACEABILITY OF IMPLANTABLE MEDICAL DEVICES: THE BREAST IMPLANT CONSIGNMENT STOCK
European Statement
Selection, Procurement and Distribution
Author(s)
M Rivano, N Tatti, V Mureddu, G Bertolino, M Atzeni, R Deidda, A Cadeddu
Why was it done?
Breast implants are invasive medical devices classified as Class III — the highest risk category. The European Medical Device Regulation (EU MDR 2017/745), fully applicable since 26 May 2021, requires implantable devices to be tracked using a Unique Device Identification (UDI) code, serial number, batch number, and expiration date.
In addition, a National Breast Implant Registry was established in Italy in 2023 (DM 207/2022), which must be completed after each implantation. The Registry’s objectives are to ensure clinical follow-up for individuals who have undergone implantation, enabled timely patient traceability when needed, and support epidemiological surveillance. This initiative aimed to ensure compliance with both European and national requirements while improving device availability and minimizing waste.
What was done?
The hospital pharmacy implemented a new management system for breast implants used in plastic surgery, based on a consignment stock model and computerized traceability of each device.
How was it done?
To comply with regulatory requirements and optimize surgeons’ workflow, the hospital pharmacy in collaboration with plastic surgery department, set up a consignment stock for breast implants. Devices are recorded upon arrival at the pharmacy and stored within the surgical department. A predefined selection of implants of various sizes is made available in the operating room, allowing surgeons to choose the most suitable option for each procedure.
After implantation, the surgeon completes the implant form and registers the device in the National Registry, while the pharmacy issues the corresponding billing order.
What has been achieved?
The consignment stock ensures the availability of different sizes according to patient needs and provides cost savings, as devices are billed only after implantation, thereby reducing product expiry.
Computerized registration guarantees accurate tracking of serial numbers and UDIs in compliance with MDR regulations and the National Breast Implant Registry.
In 2024, a total of 106 breast implants were made and registered, with a stock expiry rate of 0%. Currently, 47 devices, including sizers and implants, are available in the consignment stock.
What next?
This management model has already been extended to other class III devices, such as aortic endoprostheses used in vascular surgery, and is increasingly being applied in interventional cardiology. Future implementation is planned for cochlear implants and pacemakers.
Integration of a hospital pharmacy preparer within a new interventional technical platform
European Statement
Selection, Procurement and Distribution
Author(s)
Morgane HOUIX, Valérie VIAUD, Cécilia HURLUPE, Yannick POIRIER
Why was it done?
The pooling of stock for the 5 rooms required a referent for stock management. In order to free up caregivers from the administrative and logistical tasks related to pharmaceutical products, pharmacy has been directly integrated into the project of ITP.
What was done?
In May 2021, interventional cardiology, rhythmology and coronary angiography have been gathered in an interventional technical platform (ITP) of 5 operating rooms. A full-time hospital pharmacy preparer (HPP) position has been set up within the ITP.
How was it done?
For the success of the project, the 2 chosen PPH had to easily becoming part of ITP’s teams and must learn specifics of medical devices of each speciality. For this purpose an immersion in each sector was carried out during the installation of the ITP and continues today by participating in interventions. They shared in the process of installing the PTI’s arsenal of pharmaceuticals with careteams by grouping the initials allocations of products of each speciality. The products common to each endowment were gathered and harmonized after discussion with caregivers. Each sector has kept a stock of specific devices, called “out-of-stock”.
What has been achieved?
The installation took about 632 hours of HPP time. The allocations for each sector were respectively 68, 69 and 83 references, not including out-of-stock. The HPP’s work allowed reducing the common endowment from 220 to 134 products references. A satisfaction survey of PTI teams (doctors, nurses,…) after 4 months of practice showed a level of 78% of satisfaction. 1.3% of the responses concerned activities related the management of devices affected by production delay or stoppage and information on product changes to be unsatisfactory or moderately satisfactory. Every ITP teams now considers their presence essential, believes that it has improved relations with the pharmacy and management of stocks. A saving in nursing time was also noted.
What next?
The creation of this HPP position seems to satisfy all the ITP teams. A quantitative analysis of the benefits measuring the impact on care time, the amount of over-storage and the compliance indicators of the implantable medical device circuit will be carried out during 1 year, in order to assess the impact of the creation of HPP positions within the PTI.
OPTIMISATION OF CANCER CARE PATHWAY OF SCHEDULED PATIENTS WHEN OUTSOURCING CHEMO SUPPLY (submitted in 2019)
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Charlotte Chatain, Orane Gleizes, Séverine Barbault-Foucher, Sophie Barthier, André Rieutord, Niccolo Curatolo
Why was it done?
The production of chemotherapy of our hospital will be outsourced by September 2019. This is going to lead to new constraints including anticipated production before patients are admitted to the clinical ward.
What was done?
The clinical pathway of scheduled patients receiving chemotherapy in the main full hospitalization unit of the hospital was optimised.
How was it done?
The clinical pathway of scheduled patients was mapped to describe each step and validated by all the concerned health professionals. Data were collected between October and December 2017 to monitor the percentage of anticipated orders by physicians for chemotherapy production (also called “OK production”). Critical steps and/or bottlenecks were identified. Brainstorming workshops were set to identify areas of improvement with pharmacists, physicians, nurses and secretaries. Finally, the proposals made were implemented.
What has been achieved?
Two critical steps have been identified in this pathway: the receipt of the biological test results by the secretary and the “OK production” given by the physician. It has been decided for the secretary to call patients 72 hours (instead of 24 hours) before to remind them to do their biological test in the medical laboratory. An electronic and standardised prescription with the specific date for the biological test has also been created. In addition, a follow-up form was completed by pharmacists to secure all the critical steps and remind secretaries when they had to call patients and remind physicians when they had to give the “OK production”. Over a two months period, “OK production” given 24−48 hours before the admission increased from 18% to 40% (n= 15 patients).
What next?
These clinical pathway improvements allowed a better anticipation. The process-oriented approach used to identify solutions was very fruitful and led to collaborative solutions likely to be applied and accepted by both clinical ward and pharmacy. This method could be applied to improve other types of processes in our hospital.
EXCESSIVE REORDERS: A CONTEST REDUCES WORKLOAD
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Krista Mikula, Silvia Hetz
Why was it done?
In the 1,200-bed teaching hospital of Wels-Grieskirchen, Upper Austria, wards place routine orders of formulary medicines online. These orders are then processed by the logistics team of the hospital pharmacy in predefined order between 6:45 and 9:00 am. Any later reorders have to be placed by telephone, leading to considerable extra time needed for processing. It is known that the interruption of an ongoing task leads to an additional 20 minutes needed to return back fully concentrated to the initial task (Besser fix als fertig: Hirngerecht arbeiten in der Welt des Multitasking, Bernd Hufnagl ISBN: 978-3-85485-331-2). The goal was to reduce time-consuming reorders by telephone to free up time for other value-adding tasks.
What was done?
At the beginning of each observation period (i.e. 3 months), the intervention wards received detailed information regarding their leading ranking position (TOP 3) and how they compared with other wards, their reorder frequency, the time-consuming impact reordering had on hospital pharmacy processes and logistical advice how to best reduce and avoid reordering. After each of the observation periods, wards with a need for intervention changed (i.e. reorders were reduced) in the TOP 3 ranking.
How was it done?
Starting in January 2014 reorders were systematically analysed across all wards by using consumption and ordering data from the hospital logistics IT system. Those three wards with the highest number of reorders received special attention as intervention wards.
What has been achieved?
The transparent information and display of those wards leading in terms of reorder frequency and quantity triggered the ambition to no longer stay among those TOP 3 wards. Starting with a total number of yearly reorders of 8,390 (2014), the intervention reduced reorders to 4,781 in 2017 (minus 43%). The most successful ward reduced the number of annual reorders from 472 in 2014 to 230 in 2015 (minus 51.48%). Two-hundred and twenty-nine reorders were placed in 2017 (minus 51.48%). The intervention was repeated for five observation periods and 15 wards were involved. After 1.25 years, these wards were ranked again, not because they had bad results, but because all wards had improved. This information initiative has become self-limiting, as overall reorder compliance stabilised at a low level. Considering the overall time needed for reorder processing (i.e. an average of 32 minutes per reorder, including a relevant process steps) a total of 1,950 hours per year (equivalent to 1 FTE) was freed for more value-adding tasks.
What next?
Constant re-evaluation of reorders take place to occasionally identify new needs for action.
IMPROVING INVESTIGATIONAL DRUG MANAGEMENT: AN INNOVATIVE PROCESS
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Francesca Vecchione, Melania Rivano, Patrizia Tadini
Why was it done?
The new process was developed in order to face the significant increase of ID management assigned to the Pharmacy, along with the logistic problems due to the several areas of storage, dispensing and administration. Additionally, it allowed to assure the effective use of ID reducing the risk of failure and improving the patient safety.
What was done?
The Good Clinical Practice guidelines establish that the principal investigator (PI) can delegate the investigational drug management to a pharmacist. In our university teaching hospital with a large amount of clinical trials (CT), pharmacy service proposed an optimisation of ID (investigational drug) management through the elaboration of a form to request the ID. Along with this, we assigned each protocol to a specific type of management and we created an intranet site from where healthcare professionals can download the form.
How was it done?
The pharmacy service created for each CT a specific form organized into 5 sections. Section A, B and C were filled up with protocol information (name, centre code, PI) patient data (initials, patient code) and the treatment schedule. Section C, completed by data manager, showed the quantity of drug to be dispensed and the expected day of administration. Section D was completed with batch and expiry date. The form had to be signed by the pharmacist at the moment of the dispensation and signed back by the committed person who took it. Section E reminded the type of management assigned to the protocol. Five different types of management had been identified, based on the characteristics of storage, the activities required by the protocol (IWRS, unblinded pharmacist, drug preparation) and the dispensing method.
What has been achieved?
Data from January to June 2017 attested 60 ongoing protocols, 722 dispensations for patient, 237 drugs prepared by pharmacists and 986 in Chemotherapy preparation unit. The development of the new procedure ensured the ID tracking, the overcoming of logistical difficulties and an increase of the safety.
What next?
We are going to keep on improving the pharmacist role in CT by ensuring ID are handled, stored and correctly managed. The objective is to enhance the collaboration of clinical research professionals in the management of CT.
LET’S DIVERSIFY TO GUARANTEE ACCESS TO THE HOSPITAL PHARMACIST’S EXPERTISE: ALL GOOD THINGS COME IN FOURS!
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Maria Kundracikova, Petra Pölzleitner, Katharina Ocko, Bernadette Aretin, Barbara Datterl, Klara Jadrna, Eva-Luise Hobl, Martin Holbik, Sonja Steininger-Salmer, Helga Fend, Gerda Laml-Wallner, Martina Anditsch, Gunar Stemer
Why was it done?
Due to limited human ressources (8 FTE) in the medicines information and clinical pharmacy department only selected wards could be provided with daily clinical pharmacists’ presence offering medication review, patient discharge counselling and ward round participation. To expand the reach of our clinical services, two further service pillars were introduced complementing the already existing services.
What was done?
The Vienna General Hospital is a 1900 bed university hospital in which patients and health care professionals have access to hospital pharmacists’ expertise via various channels. In addition to already existing services (i.e. provision of hospital-wide medicines information and clinical pharmacy services on particularly selected wards) two new services (i.e. e-pharmacy consult and a dedicated drug interactions and pharmacotherapy clinic) have recently been implemented.
How was it done?
As ward services are staff-intensive, alternatives to expand the access of patients and health care professionals to the hospital pharmacists’ expertise were examined. An e-pharmacy consult was designed, implemented, and promoted in collaboration with the hospital IT department. E-consults can electronically be requested by all wards (e.g. for medication review, patient counselling), but mainly aim at those areas which are not regularly covered by a clinical pharmacist. E-consults are executed by the medicines information pharmacist on duty. Recently, a special clinic was implemented as a collaborative project with the clinical pharmacology department addressing the specific medicines-related needs of patients with complex medication regimens.
What has been achieved?
The scope of services provided by the department currently comprises four pillars: (1) provision of medicines information (2016: 1.200 requests), (2) clinical pharmacy services (2016: 9.000 medication-related problems prevented), (3) pharmacy e-consults, and (4) the drug interactions and pharmacotherapy clinic. While the scope and reach of services was expanded by diversification, the two new services are operated with existing ressources after reassignment of tasks.
What next?
After the implementation of new services (i.e. e-consult, clinic) constant promotion is needed to increase the awareness level among health care professionals in the hospital. Quality assurance and continuity of service provision is crucial for acceptance.
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.