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Author(s)

Maja Kirstine Brøns, Gitte Borup

Why was it done?

The purpose was to move medicine collection from the outpatient clinics to a MPB in order to reduce CO2-emission, due to less kilometers traveled by patients, to increase equal access to healthcare services, and to reduce physical patient contact during a global pandemic.

What was done?

This was a pilot study that investigated a method for, and patient satisfaction with, delivery of specialized cost-free hospital medicines via Medicine Post Boxes (MPB) in rural areas.

How was it done?

The project was initiated by clinical pharmacists, who acted as interdisciplinary liaisons, who understood the clinical aspect of the medical treatment, the importance of good distribution practice and the logistic capacity at the hospital pharmacy. Having completed clinical controls via telephone, the clinic forwarded the information needed to the hospital pharmacy. Initially, all requisition forms were checked by clinical pharmacists to ensure complete information was given, and that documentation was performed properly. Once fully implemented, a task shifting onto pharmaconomist was done concerning the control of the requisitions, however initiation of cooperation and problem solving with the clinic was maintained as a pharmacist task.

What has been achieved?

Focus group interviews with doctors and nurses from the clinics expressed satisfaction with the flexibility of conducting clinical controls over the phone, and not having to handle the practical part of ordering, documenting and handing out medicines. No concerns of patient safety were expressed, and a wish for full coverage for medicine delivery via MPB was stated. A survey among the patients using the MPB was conducted: A total of 148 respondent participated of whom 98 % stated being ’very pleased’ or ’pleased’ with the service. Also, 98 % felt safe to ’a very high degree’ or ’high degree’ with using the MPB and 99 % wished to use the MPB again. Estimates of CO2 reduction have not yet been calculated.

What next?

MPB’s should be available in urban areas also, as it increases flexibility for the patients and healthcare professionals. The goal is to include all suitable clinics and patients who receive long term treatment with hospital medicines

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Author(s)

Daniele Leonardi Vinci, Enrica Di Martino, Rosario Giammona, Piera Polidori

Why was it done?

The 2018 Medicines Shortages Survey conducted by EAHP showed that 91% of responding pharmacists had experienced problems sourcing medicines, therefore it is important to use tools that identify early the shortage risk associated with each drug included in a hospital formulary in order to adopt appropriate countermeasures.

What was done?

We create an informatic HVA Tool (HVAT) to assess the risk associated with medicine shortage.

How was it done?

The HVAT created consists of an Excel spreadsheet subdivided into three macro areas: probability that the shortage will occur based on shortage in the last 2 years, magnitude factors which increase the risk of shortage, and mitigation factors which reduce it. A score was assigned to each item in each macro area. The score of the probability was: 1=no previous deficiency; 1.5=one deficiency; 2=two or more deficiencies. Magnitude was divided into: relevance of active substance (AS) (1= not life-saving and not High Risk Medicines (HRM); 2=not life-saving but HRM; 3=life-saving); budget impact (0=no alternative drug; 1=alternative drug costs equal to or less than the deficient one; 2=cost of the alternative drug higher than the deficient one but sustainable for all patients; 3=cost not sustainable for all patients); percentage of patients treated with the drug (1=less than 20%; 2=from 20% to 50%; 3=more than 50%). Mitigation factors were: therapeutic alternative (1=same AS and same route; 1.5=same AS and different route; 2=different AS and route not intravenous (IV); 2.5=different AS and route IV; 3=no alternative drug); stock available (1=for a month of autonomy; 2= autonomy between 1 week and one month; 3=autonomy less than 1 week); availability of the drug (1=drug available in EU; 2=drug available exclusively extra-EU; 3=drug not available).

What has been achieved?

The HVAT obtained allows us to calculate the value of the risk multiplying P by S, where P is the percentage of probability (value of probability obtained/2) and S is percentage of severity [(sum of values of magnitude obtained + sum of values of mitigation obtained)/18]. Based on the score obtained, drugs are classified as: low (60%) risk of shortage.

What next?

We will implement the HVAT in our hospital in order to reduce the impact of shortages.

Author(s)

TRISTAN TERNEL, MELINDA PLACE, BERENICE GILLOTEAU, ELODIE DECHAMBENOIT, EMELINE DEVOS, FATEN ABOU-DAHER, ANAELLE DECOENE, THOMAS QUERUAU LAMERIE, FREDERIQUE DANICOURT

Why was it done?

The main purpose of developing this tool is the need to provide centralised product parameters through a unique summary screen that permits a regular monitoring of inventory, enabling us to identify the glitches before things get out of control, resolve issues the soonest to improve the stock control system (order threshold, market), maintaining compliance and documenting usage to prevent sudden shortages, in a harmonised way in order to reduce the time spent to order.

What was done?

Development of a dynamic stock management tool plugged into a computerised model (Excel©), to integrate all data needed for a stock forecast in terms of specialties, providers, therapeutic classes, last order date, supply disruptions, market, restocking time, turnover, stock, orders, security threshold, average daily consumption, average time of supply, and delivery estimated time for all pharmaceutical products in hospital.

How was it done?

It’s important to know how much you have from each product, and each dosage of the same product, through a dynamic database that’s collecting all data (product code and average daily consumption) and highlighting the order quantity threshold. This reliable inventory is updated on a daily basis with data extracted from our economic and financial management coupled with Business Object©. Using specific formulas and filters, and referring to the decision flowchart, such data allow adjusting and optimising our stock management in real time.

What has been achieved?

First, this tool has allowed us to gather all required data and, subsequently, reduced the need to another application (such as NEWAC© and MAGH2©). Second, it has allowed us to understand the mechanism of order suggestions by displaying characteristics of some sectors (such as expensive products and chemotherapy). Moreover, it improved the management of supply disruptions by showing the solution of each disrupted product in a summary table, which results in significant time saving along the drug supply chain.

What next?

An organised supply chain, a fast response to overcome and handle sudden supply shortages, as well as a huge time saving are the main reasons to rely on this efficient system, which lead to an optimised and secure patient care. Moreover, it fits any computer software, and its application is very friendly to be used in every hospital pharmacy.

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Author(s)

Katja Heikkinen, Charlotta Vinterflod

Why was it done?

AC’s mission is to secure that the right product and product information is available as well as in case of shortages assist with alternative products and information. Correct information is fundamental to achieve an effective and secure supply chain of medical products. This reduces time spent on ordering, delivery time is shortened and finding information is more efficient.

What was done?

The hospital pharmacy in Region Västra Götaland, Sweden (VGR) established an assortment council (AC) that assists buyers of medical products within the region. By creating a defined assortment the goal was to direct healthcare professionals to order procured, recommended and cost-efficient medicines and enable structured availability monitoring.

How was it done?

A counsel of pharmacists was formed to administer a defined assortment consisting of 95% of the most commonly used medical products. The availability is monitored daily and every disruption of supply is handled in a structured way. Alternative marketed or unlicensed medical products are identified and information about these are communicated through VGR’s ordering system or by newsletters. If an equivalent product is available, it will be delivered automatically without the need for placing a new order. The AC also collaborates with the region’s medical specialists and drug and therapeutics committee (DTC) when searching for alternatives.

What has been achieved?

Defined assortment has been reduced from 6000 products to approximately 3000. In 2018 in addition to the daily updated availability information, 14,300 orders out of 410,000 were automatically replaced with an equivalent product and 41 newsletters about shortages were published. Nurses get more time for patient care when shortages information is readily available, and replacement of equivalent products can be delivered automatically

What next?

By implementing this way of working in other hospital regions or on a national level, caregivers would be able to free up resources and focus on patient care and at the same time be able to find quality assured information about shortages and alternatives in an efficient manner.

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Author(s)

Helle Pasgaard Rommelhoff, Lise Grove, Dorthe Bartels, Trine Ann Behnk, Lars Ole Madsen

Why was it done?

To share learning from a pilot of procuring pharmaceuticals jointly across borders in three European countries as well as post-learning on planning and execution elements in order to have a successful joint procurement.

What was done?

Three European countries decided to implement a joint procurement pilot in order to seek solutions for some of the supply issues in the three markets. This was a consequence of being a small volume market with potentially limited attractivity for suppliers of older products. An initial evaluation of synergies and discrepancies among the involved countries supported the understanding of how to jointly procure medicines for the hospital sector.

How was it done?

The visualised model of a product lifecycle was applied to understand where a pilot of joint procurement would support the supply issues of the older products. This led to a shared understanding between the countries on where the supply issues may occur and potential solutions. An evaluation of building the joint procurement process, which took approximately 2 years, is now available as a best practice with “Do’s and Don’ts” for other countries with joint procurement interest. Criteria in the tenders announced were either price alone or in combination with. One of the tenders included a mandatory bid for all 3 markets, the rest of the tenders were mandatory for 2 of the markets with optional submission for the 3rd market. This was an outcome of hearings with suppliers. The feedback from the hearings was modifying the tender materials into a new proposal for suppliers. A political framework was signed between the countries to have a shared fundament to build on.

What has been achieved?

The final outcome of a joint procurement was evaluated. Evaluation of the submission and preparation part showed that the majority of joint tenders had an efficient competition on price with a representative amount of suppliers bidding. It also shown that it was vital to have collaboration and to listen to stakeholders in order to have a robust insight on what was possible for all involved parties. The thorough preparations supported the process and the final outcome. There was dual engagement between the stakeholders and transparency on the wish from countries to overcome barriers and conduct joint procurement to support supply issues.

What next?

Efficient and timely planning is crucial. Collaborations between the involved stakeholders are important. Mutual understanding of the interests and strategy is helpful in building a shared view on the problems and potential solutions. It is seen as essential, when planning joint procurement, to include logistic thinking already in the early tender planning phase.

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Author(s)

Quentin HIVER, Agathe ROGER, Marine EGOT, Ivan VELLA, Marie-Hélène TYWONIUK

Why was it done?

Community and hospital pharmacists are required to apply the European directive on falsified medicines. In France, we are currently undergoing a transition phase for the progressive generalisation of serialisation. French pharmacies are more or less ahead of schedule for the implementation of decommissioning. In our pharmacy, the decommissioning has been operational since February 2019. After 8 months of practice, we are able to provide data as a basis for work and thinking.

What was done?

Determining and evaluating, by feedback approach, the organisational and economical impacts of drug serialisation for a hospital pharmacy

How was it done?

• Step-by-step description of the supply chain after implementation of decommissioning. • Collection of the man-hours necessary for: decommissioning implementation, software training, routine decommissioning, problem solving. • Census of financial investments

What has been achieved?

After analysis of our supply chain, the reception stage appeared to be the most favorable for decommissioning, in terms of practicality, safety and traceability. Several steps have thus been added at reception: Identification of serialized boxes, manual scan, checking of the decommissioning report and the number of decommissioned boxes, printing of the report. The pharmaceutical time necessary for the decommissioning implementation has been estimated to up to 28 hours. The software training was made in small groups of 2−3 agents, requiring 9 minutes per agent on average. The decommissioning is currently requiring 17 minutes for 100 boxes. Over 8 months, the time necessary for the pharmacists to solve problems linked with serialisation (non-operational Hub, corrupted database, error message at decommissioning…) was estimated to up to 7 hours. The financial investment amounts to 17200 euros (software+ergonomic desk+man-hours at implementation).

What next?

The decommissioning itself doesn’t have a major impact on the pharmacy’s organization. But, ensuring a clear and safe supply chain, to identify which boxes must be decommissioned and which boxes can be dispensed, is time-consuming. It goes through a proper working environment with a forward supply chain and traceability tools. Moreover, the encountered problems were mainly due to computer failures, requiring a performing software with an efficient maintenance. We are currently working on improving the ergonomics of the workstation to avoid the risk of musculoskeletal disorders due to decommissioning.

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Author(s)

Eleni Rinaki, Marinos Petrongonas, Maria Fragiadaki, Leonidas Tzimis

Why was it done?

MSs are a frequent problem in our hospital. In a study carried out in 2018, we investigated reported shortages during one year and found that 56% of cases of unsatisfied wards’ requests were due to failure of pharmacy’s procedures to restore availability. In 70% of these cases, time to re-stock was more than 4 days and strong involvement of HPs in following up and taking measures was required. The purpose of this tool is to bring together all relevant information of shortages, aiming to improve hospital pharmacy’s response as well as following-up MSs for further investigation or research.

What was done?

A new software module in Hospital Information System (HIS) for monitoring medicines’ shortages (MSs) was conceived by hospital pharmacists (HPs), and it was designed, developed and integrated to the ICT system. This module helps HPs easily track which medicines were totally or partially substituted due to insufficient quantities and gives additional information (such as residual quantity of a medicine on prescription date, on inspection date, pending orders, known shortage) needed for managing MSs. In this tool, MSs and relevant information, such as causes, measures to re-stock and shortage’s impact, can be entered, centrally managed and regularly reported.

How was it done?

Implementation of the module in ICT system was made at zero cost by the ICT service provider, following technical specifications designed by HPs. The final product was multi-checked by HPs during development and all technical problems have been resolved accordingly.

What has been achieved?

• Quick intervention of HPs to restore medicines availability is feasible. • We can now have precise and easier follow up, with less human resources required. • MSs are collected, registered and easily utilised to draw conclusions. • HPs’ interventions to deal with MSs are easier to evaluate

What next?

ICT tools’ development is very important in facilitating hospital pharmacy’s practice, especially when human recourses are restricted. These software modules can be easily incorporated in every HIS. Pharmacists are competent and should have a central role in designing such tools. We are planning to evaluate our new MSs management procedure; in the long run, incorporating in this tool a risk assessment algorithm will be an asset.

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Author(s)

MARGHERITA GALASSI, CHIARA DELLA COSTANZA, CLAUDIA TIRONE, ELENA ALIPRANDI, ERNESTO RUFFINO, SARA BERTOLI, ELEONORA FERRARI, ELISABETTA MARTINELLI, VITO LADISA

Why was it done?

Intravitreal bevacizumab is refunded by National Health System for AMD and diabetic macular oedema but the splitting process must be carried out only by authorised pharmacies. Recently the established regional refund price was lowered to €55/dose that covers the costs of intravitreal bevacizumab but not the other authorised drugs ranibizumab and aflibercept. Our Centralized Pharmacy operated the repackaging of intravitreal bevacizumab for internal patients but we implemented a new process and a new procedure in order to provide doses to hospitals not equipped in performing sterile preparations.

What was done?

We implemented a production process to repackage a drug to be used in treatments not covered by marketing authorisation. Bevacizumab was split into fractional doses for off-label intravitreal injections; the doses obtained were given to our hospitalised patients as therapy for uveal melanoma and provided to hospitals in our region as therapy for patients with age-related macular degeneration (AMD) and diabetic macular oedema.

How was it done?

The procedure for preparing intravitreal injections was reviewed to optimise traceability aspects of processing batches, individual doses of finished products and particularly to choose the most suitable packaging for transport to hospitals that will administer the drug. Further quality control to regional law was established on processes and finished product: environmental, instrumental, maintenance controls. All processes were validated in accordance with applicable regulations. Agreements related to prescription, purchase, conservation and transport of bevacizumab doses were signed with the hospitals that administer the drug.

What has been achieved?

The price refunded for a single intravitreal dose of an anti-VEGF (vascular endothelial growth factor) drug from August 1 2019 is €55, previously the price for each single dose of ranibizumab was €600. Considering that AMD therapy requires a monthly injection for about a year we can assume a standard average cost saving of €6540/patient.

What next?

AMD is the leading cause of blindness among populations over 50 years old. To provide treatments to all those affected by degenerative eye diseases in the next years, we must operate cost savings policies safeguarding patient security. The practice described is worthy of implementation in hospital realities.

Author(s)

Christine Dinsen-Andersen, Hanne Fischer, Anita Gorm Pedersen, Dagmar Bertelsen, Marianne Hald Clemmensen

Why was it done?

Before the NTF was established, each hospital pharmacy made their own assessments and solutions to CMS. This led to a lack of coordination in the national supply and knowledge sharing. As the number of CMS increased, a need for a coordinated national initiative became evident. The aim of the NTF is to secure better communication to healthcare professionals and to establish clearly defined rolls and responsibility in the supply chain from wholesaler to hospital pharmacy. Patient safety aspects should be included in all relevant steps of the process.

What was done?

A National Task Force (NTF) for critical medicines shortages (CMS) have been established with the main objective to provide therapeutic and patient safety assessment of CMS on a national level. In addition to this the NTF takes considerations regarding the supply chain into account in the assessments.

How was it done?

To secure national engagement, members of the task force were appointed according to a consensus between the hospital pharmacies in Denmark. The NTF includes participants from 3 hospital pharmacies, the national wholesaler for hospital pharmacies and a patient safety organization. Based on challenges of geographical dispersion and different local practices, an effort was put into: • securing a systematic work flow, for the group; • creating a digital platform with access for members from different organizations; • agreeing on when a medicine shortage is critical.

What has been achieved?

• Early intervention – resulting in opportune solutions. • Agility in allocation of remaining stock between hospital pharmacies. • Optimisation of choice of alternative treatment during period of shortage. • Secure supply of alternative drugs on national level. • Initiate agreement between physicians on choice of alternative on a national level. • Attention to patient safety challenges – preventing adverse events.

What next?

Joined forces have resulted in coordinated and optimised solutions to managing CMS, enabling the hospital pharmacies to secure patient safety. Hence the NTF shall continue its work. Having a national unit as NTF provides the basis for coordinated initiatives and for corporation with health and medicines authorities and market authorization holders.

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Author(s)

María Lourdes Recio Blázquez, José Manuel Martínez Sesmero, Lidia Ybáñez García, Gonzalo Hernando Llorente, María Molinero Muñoz

Why was it done?

The purpose is to control two environmental conditions to guarantee the comfort of the workforce and the quality of the finished product quality. 519,321 SODFs have been repackaged in unit doses last year. The 8% of the SODFs come from multidose containers that have been exposed to environmental temperature and humidity during this process. Employees have been exposed to identical conditions.

What was done?

A temperature (t) and relative humidity (RH) control system has been established in the enclosure where the solid oral dosage forms (SODFs) are packaged in unit doses.

How was it done?

Among the diversity of hygrometric sensors commercialised, a device equipped with a condenser was chosen. The operation is based on modifying the capacity when varying the dielectric constant of the medium, in this case, due to varying the amount of water contained in the air between the plates. – C = ε A / D – C: capacity value. – ε: dielectric constant. – A: area of the condenser plates. – D: distance between the condenser plates. The device also incorporates a temperature sensor. The t (ºC) and RH of each moment are shown, for visual inspection, on the device screen. The data obtained with certain time frequency can be stored on a Secure Digital memory card and be downloaded on a computer that has that program installed (on spreadsheet format) helping to obtain graphics as well.

What has been achieved?

The range of t (ºC) has remained stable between 26 and 24ºC for 6 months, with minimal variations from maximum 28.5ºC to minimum 23.4ºC. The UNE 100713: 2005 is met. RH has been below 45% during 68% of the days worked, which has favored the repackaging of the units affected by humidity but not the worker. The range of RH has varied between 56.3% and 23.6%, not complying with the UNE 100713: 2005 standard.

What next?

Metabolic rate, clothing insulation, air temperature, radiant temperature, air speed and humidity shall be addressed when defining conditions for acceptable thermal comfort. It would be helpful to regulate the commercialisation of multidose pharmaceutical specialties susceptible to deterioration when opening the package.