An international panel of experts and opinion leaders with experience in healthcare management discussed the future organisation of medical treatment and hospital pharmacy
The international community of APOTECA users was founded in 2012 and meets biannually in Ancona, Italy. The community consists of current users of the APOTECA technology, international experts and opinion leaders in oncology pharmacy, occupational exposure to hazardous drugs and aseptic processing. The aim of the APOTECA community is to share knowledge, experience and best practices regarding the optimal use of IV preparation robots, and furthermore to envision the future role of robotics and technologies in hospital pharmacy.1–5 Future trends of robot technology are discussed particularly with regard to the users’ needs and specific experiences. Collaborative applied research of the manufacturer and users of robot technology is initiated in order to develop evidence-based recommendations. A remarkable achievement of the international APOTECAcommunity has been the development of a set of 35 recommendations dedicated to automated IV compounding in (hospital) pharmacies, to be used worldwide as a reference document.6 The recommendations should contribute to a better understanding of the role of robotic compounding in hospital and health-system pharmacy and serves as a guide to approach this topic with the pharmacy community, regulatory bodies, and manufacturers of robotic equipment, medical devices and medicinal products employed.
In September 2016, members of this community met to look ahead and develop a vision of worthwhile changes in hospitals, especially hospital pharmacy practice and management.7 Participants were asked to work according to the concept of backcasting,8 in which they started by defining a desirable future and then worked backwards in order to identify steps that will connect the future to the present. By contrast, forecasting9 is a process of making predictions for the future based on past and present data and most commonly by analysis of trends. The target was set up for 2022, the tenth anniversary of the international APOTECAcommunity.
Prior to the meeting, a survey based on future trends was sent to the participants. This aim was to evaluate how much the group estimates that certain trends will affect hospital pharmacy practice in the future. The results of the survey represented the starting point for the identification of worthwhile scenarios and targets for 2022. The survey started with 25 statements,10,11 grouped in five categories: roles and responsibilities; drugs; health System; technology; and patient (Table 1). Participants were asked to rate the occurrence probability of the statements in 2022 ranking from ‘very likely’ to ‘very unlikely’ on a four-grade scale. The ratings were assigned to numerical values: from very likely = 10 points, to very unlikely = 1 point. For each statement the level of agreement was calculated by addition of the points assigned by the participants. Out of 41 surveys sent to participants from 14 countries, the response rate was 93%.
None of the statements gained unanimous consensus of the participants. Overall, eight statements were scored with a high consensus (score above 6), 11 statements with a medium consensus (score between 4 and 5), and 6 statements with a low consensus (score less than 4). Considering the results of the initial survey, participants joined in four working groups to discuss about a dedicated target and to identify the needs and risk and opportunities that might result. Each working group discussed one of the four categories, that is: (1) role and responsibility; (2) technology; (3) drugs; and (4) health system.
Role and responsibility
There was consensus among the experts that pharmacists will become stakeholders on the effectiveness, sustainability and alignment to best practice of drug usage, taking into consideration scientific evidence as well as ethical and financial issues concerning the pharmacological therapy. Today, these aspects are not fully integrated in daily clinical practice. The richness of information available from all around the world and the local areas will allow pharmacists to implement advanced strategies to optimise drug utilisation.
The responsibility of the pharmacist will encompass drug therapy management, monitoring of medication adherence and clinical outcome of the patients. Pharmacists will have to encourage the implementation of evidence-based medicine.12 Pharmaco-epidemiological studies and clinical trials will improve evidence, especially related to local and specific situations.
To achieve this aim, time is the critical factor and the appropriate selection of technologies will reduce the operational activities of pharmacists. By delegating of certain activities, pharmacies can achieve potential benefits in terms of quality control and productivity.
Strategies to achieve the defined objective:
- Automation will play an important role for aseptic preparation (hazardous, non-hazardous parenterals) and compounding of non-sterile dosage forms, either automation should improve the quality of products by standardisation and automated control of every production step in order to avoid potential human errors. Moreover, automated preparation of advanced therapeutic medicinal products (ATMPs), for example, oncolytic virus and cell therapies will be feasible.
- New training methods and skills based on technological education will facilitate specialization of technicians and the future role of the pharmacist. Change management tools can be used to overcome the hesitation of some staff members to apply the modern technologies. The skill-mix of a department with automation is different than before automation. Engineers and IT experts now play a role as trainers and corporation partners.
From the participants’ perspective, in 2022, a network of interconnected and interoperable software tools and equipment will allow a manifold of data coming from the hospital information system to be evaluated. Thereby, optimum treatment, improved quality of care, patient safety and cost–benefit relationship will be facilitated. New automated technologies will allow the optimisation of processes and workflow in the hospital and hospital pharmacy. Taking this into consideration, improvements related to clinical, medical and pharmaceutical activities will be facilitated by standardisation of practices. This last point is fundamental to facilitate independence of the technicians during the preparation process and freeing the pharmacists to focus on high value activities (compare: role and responsibilities). Concurrently, the technology should be flexible, based on modules for specifics needs to ensure the operations’ efficacy. Moreover, the standardization of different procedures will minimise possible human errors.
Strategies to achieve the defined target are:
- Electronic Medical Records containing the medical history of the patients and the outcome of the medical therapy is integral to automated clinical support. In addition, the outcome of the individual patient will be simulated by a software tool and the software will help to select the treatment protocol with the highest probability of reaching the desired outcome for a patient. This unique database should interoperate with the prescribing software in terms of a high-level decision support system for every physician. In any case, patients must consent the data management in a central database, as privacy laws are to be regarded. Sharing patients’ and health systems’ information between different countries could be limiting.
- Effective control systems and complete traceability of the preparation processes ensure a high level of safety and dosage accuracy of the preparations. The possibility to trace medications through barcode scanning, to record the compounding steps, to store the preparation data, to check the final weight of the preparations and to identify the active ingredient by IR/UV spectroscopy will increase the quality and safety of preparations.
- Identification and preparation advices will support dose calculation and automatic computing of drug and vehicle volumes, provide a complete list of all components needed for compounding (including the type of needle to be used on vials and final containers and type of filters to be added to infusion lines) and detailed preparations instruction via text messages, videos and pictures.
- Devices for coding and tracing of lot numbers and expiry dates, automatic reordering of drugs and consumables will facilitate the stock inventory and strategies to avoid errors or inattentions.
- New innovative technology solutions must come along with economic sustainability.
About the survey and the discussion rounds, the main goal to be reached in 2022 is the increased efficiency of medication therapy selection and preparation. The final decision on the optimum therapy should be based on outcomes related to the disease of the individual patient and the aim to avoid ineffective drugs for a specific situation. The development and introduction of new specific genetic tests will allow an increase of highly personalised treatments. The economical part must be taken in consideration and financial sustainability plays also an important role. Strategies to achieve the defined targets are:
- The development of biosimilars and generics is essential for the financial sustainability. Software tools to calculate the costs of drug therapy treatment for the individual patient will facilitate the access to innovative therapies and the cost management of pharmacies and hospitals.
- Increased knowledge on drug’s stability will shift the preparation from just-in-time to batch production. The objectives are reduction of waste and increased patient satisfaction resulting from reduced waiting times. The studies collected, considering the relative ranking, can be reorganised in an evidence pyramid to give pharmacy a tool to evaluate decisions related to the organisation of production. The increasing importance of research on drug’s stability could lead to legal obligation for pharmaceutical industry to provide detailed information on the physicochemical stability and the period to 5% decomposition of the active substance or formation of toxic degradation products which are limiting the in-use stability.
- Extension of microbiological stability due to the implementation of guidelines on environmental monitoring, media fills and sterility test for aseptic preparation as well as utilisation of robots for fully automated compounding.
The realisation of the above outlined scenarios will only be possible if in 2022 a reorganisation and centralisation of hospitals’ activities will take place in specialised centres of adequate size to guarantee best and qualitative services for 1–1.5 million inhabitants. To make this system possible, patients will be treated in the lowest cost of care settings such as hospital or home, in order to prevent long-term hospitalisations and avoid high-cost treatments. Necessarily a change of management and more flexibility of pharmacy resources is essential to move from ward to ambulatory care. Starting from this future prospect, the back-casting activity identified the main points necessary to connect the ‘centralised health model’ to the present:
- Standardisation of procedures, protocols, therapeutic pathways through the implementation of a technology platform is necessary to achieve centralisation of the services.Certified logistics and regulations are the bases for the centralisation of specific health activities and will assure the required service level through software and system’s traceability and facilities complying to the Good Preparation Practice and Good Manufacturing Practice rules
- Strict and stream-lined workflow to optimise the management of pharmacy’s activities such as procurement, preparation, distribution and clinical decisions
- Staff flexibility is a key issue for an efficient execution of the centralised model
The vision that emerged from the discussion was the continuous development and full exploitation of technological platforms. Advanced technology will facilitate high quality and efficient ‘Good Preparation Practice’ of high potent medications such as antineoplastic drugs, radiopharmaceuticals, and oncolytic virus products in centralised pharmacy-based compounding centres. The interconnection between advanced professional skills, software and robotic means will be more accurate. The whole process will be documented comprehensively and anytime retrievable. Prescribing, compounding and administration of the various therapies will be interconnected allowing a significant productivity gain, increased patients’ safety, a higher service level, and improved quality of care and patients’ quality of life.
An international panel of experts and opinion leaders with experience in healthcare management discussed the future organisation of medical treatment and hospital pharmacy. By the concept of back-casting, the main steps to bridge the present to the eligible future were identified, considering future developments of technology and platforms. The upcoming activity of the international community will be the identification of essential key performance indicators for the monitoring of activities and progress to reach the scenario outlined for 2022.
This article was made possible by the APOTECA International Community Meeting, which is organised every two years by Loccioni Humancare. Special thanks to the community members who participated in the meeting and worked on the results presented in this article.
Helle McNulty MScPharm Capital Region Pharmacy, Copenhagen, Denmark
Irene Krämer PharmD PhD Pharmacy Department, University Medical Center, Johannes Gutenberg-University, Mainz, Germany
Jacopo Raffaelli MPharm Loccioni, Deutschland GmbH, Calw, Germany
Mirjam Crul PharmD PhD Pharmacy Department, OLVG, Amsterdam, The Netherlands
Samuel Calabrese BSPharm MBA FASHP Cleveland Clinic, Cleveland, OH, USA
Adam Osborn PharmD MS Veldt Community, Winston-Salem, NC, USA
Ana Clopes PharmD Catalan Institute of Oncology, Barcelona, Spain
Anand Khandoobhai PharmD MS Johns Hopkins Hospital, Baltimore, MD, USA
Angela W Yaniv BS PharmD Cleveland Clinic, Cleveland, OH, USA
Antoine Cherfan PharmD BCPS FCCP CACP Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
Antonio Bosetto Dr Ing AB Consulting, Bologna, Italy
Carla Masini PharmD Scientific Institute of Romagna for the Investigation and treatment of Cancer (IRST), Meldola, Italy
Carlo Polidori PhD Department of Experimental Medicine and Public Health Unit, University of Camerino, Camerino, Italy
Celestino Bufarini PharmD University Hospital of Ancona, Ancona, Italy
Demis Paolucci PhD MS Chem Loccioni Humancare, Angeli di Rosora, Italy
Franca Goffredo PharmD Istituto di Candiolo IRCCS, Torino, Italy
François Lemare PhD PharmD Institute Gustave Roussy, Paris, France
Helle McNulty MScPharm Capital Region Pharmacy, Copenhagen, Denmark
Huei-Xin Lou PharmD MOH Holdings, Singapore, Republic of Singapore
Irene Krämer PhD PharmD Pharmacy Department, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany
Jennifer Tryon PharmD MS FASHP Wake Forest Baptist Medical Center, Winston-Salem, NC, USA
Joseph J Bonkowski PharmD MHA MS Wake Forest Baptist Medical Center, Winston-Salem, NC, USA
Junghyun Kim PharmD Samsung Medical Center, Seoul, South Korea
Karsten Bucher PhD PharmD Kantonsapotheke, Zurich, Switzerland
Kristoffer Olavesen BME Hospital Pharmacy Enterprise South Eastern Norway, Oslo, Norway
Li-Jiuan Shen PharmD National Taiwan University Hospital, Taipei, Taiwan
Lise Rødøy PharmD Hospital Pharmacy Enterprise South Eastern Norway, Oslo, Norway
Lita Chew BScPharm MMedSci National University of Singapore and National Cancer Centre, Singapore
Liv Hatlelid PharmD Hospital Pharmacy Enterprise South Eastern Norway, Oslo, Norway
Maria de la Paz Pacheco Ramos PharmD Hospital Clínico San Carlos, Madrid, Spain
Masahiro Okuda PhD PharmD Mie University Hospital, Mie, Japan
Melissa McDiarmid MD MPH University of Maryland School of Medicine, Maryland, MD
Mirjam Crul PhD PharmD OLVG Hospital, Amsterdam, Netherlands
Montse Rey PharmD Catalan Institut of Oncology, Barcelona, Spain
Nate J Peaty PharmD MS BS Wake Forest Baptist Medical Center,Winston-Salem, NC, USA
Norberto Patrignani PhD Polytechnic University of Turin, Turin, Italy
Osama Tabbara BSPharm EMBA BCNSP Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
Rudolf Schierl PhD MSChem Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig Maximilian University of Munich, München, Germany
Ru-Jiun Guan PharmD National Taiwan University Hospital, Taipeh, Taiwan
Samuel Calabrese MBA BSPharm FASHP Cleveland Clinic, Cleveland, OH, USA
Scott Knoer PharmD MS FASHP Cleveland Clinic, Cleveland, OH, USA
Seonyoung Chung PharmD Samsung Medical Center, Seoul, South Korea
Tom DiPiro PharmD MBS MS Wake Forest Baptist Medical Center, Winston-Salem, NC, USA
Vincenzo Moretti PharmD University Hospital of Ancona, Ancona, Italy
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