Author(s)

Francesca Venturini, Olivia Basadonna, Roberta Rampazzo, Girolama Iadicicco, Giovanna Scroccaro

Why was it done?

Remdesivir is the first authorized medicine by the European Medicine Agency (EMA) for SARS-COV2 treatment. In the first place, remdesivir was supplied exclusively in the context of the Emergency Support Instrument by the European Committee. A limited number of treatments were available to each member state, before Veklury marketing. Also after the national procurement process, through the joint procurement agreement by the EU, the number of vials was limited.

What was done?

A controlled regional distribution of remdesivir (Veklury) was implemented by the Veneto Region, Italy, through the hospital pharmacies network, using a regional distribution center located at the hospital pharmacy of the Padova University hospital.

How was it done?

In the first shortage phase, the Italian Medicine Agency (AIFA) defined the selection criteria for the use of remdesivir, based on clinical trials evidence. A centralized authorization procedure was implemented: each hospital was requested to send daily individual prescriptions through the local hospital pharmacy, to a dedicated AIFA email address
After AIFA authorization, the Ministry of Health forwarded the authorizations to the regional distribution center, for drug distribution.
A map of hospital pharmacies references (e.g., pharmacist name, hospital postal address, mobile phone, presence of the pharmacist on duty, etc) was created, in order to quickly contact them for the distribution of the authorized therapies.
The regional distribution center took charge of the authorized therapies and provided a personalized distribution to all the hospitals in the region. Each day the Ministry of Health warehouse replaced the stock of the regional distribution center.

What has been achieved?

in a 3-week period, the regional distribution center dispensed therapies for 87 patients to 17 hospitals in the region. In two cases a zero stock ck of vials was managed with the reallocation of experimental drugs left by closed clinical trials and compassionate use programs, both authorized by AIFA and the manufacturer.

What next?

in the second phase of the shortage, single patient prescriptions will be validated by local hospital pharmacists in a national electronic registry. On a by-weekly basis, the infectious disease regional network will audit treated cases, to verify inclusion criteria and discuss future approaches. A centralized distribution will be maintained, allowing a small stock in each hospital for emergency use.

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Author(s)

Nikolaus Lindner, Doris Haider

Why was it done?

In Austria, Covid-19 infection rates began to increase in March. At Clinic Favoriten, over 700 patients were treated during the first wave. This resulted in an increasing demand of specimen collection sets. Even though various wholesalers and contractors were contacted, the orders could not be served in a quantitative or timely manner. These circumstances forced the pharmacy to look for alternative solutions.

What was done?

During the first wave of SARS-CoV-2 infections the hospital pharmacy of Clinic Favoriten, Vienna’s specialised Covid-19 center, assembled specimen collection sets manually to meet rising demands, compensate for shortages and secure vital diagnostics supply.

How was it done?

In collaboration with the laboratory department and other clinics of the Vienna health care group appropriate materials with CE-certification were sought to assemble a set that is easy to handle concerning production, distribution and application.
Sterile plastic tubes were filled aseptically with physiologic saline and labelled. Tubes and sterile swabs were then packed in a plastic bag that was sealed with a label providing general instructions for use. Manufacturing protocols as well as batch documentation ensured quality assurance and traceability.
Major obstacles included availability and suitability of the needed materials. Manufacturers of tubes and swabs had to be changed over time, which required close communication with medical wards and the laboratory department.

What has been achieved?

Over a period of seven weeks 2.033 specimen collection sets were assembled. In detail, a total of 20.330 swabs were packed and 10.165 tubes were filled. Through this measure a continuous supply of specimen collection sets, essential for further Covid-19 testing, was secured.
Moreover, the importance of a pharmacy in-house production with the aim of maintaining supply security was acknowledged throughout the entire hospital.

What next?

The initiative has demonstrated that pharmacists play a vital role in handling product shortages and maintaining supply security. In the future, the pharmacy will reinforce to monitor trends even more and will thus be able to balance changing demands and non-availabilities. Like this, the existence of an in-house pharmacy department securing appropriate supply will gain more and more significance. In times of increasing shortages, the initiative serves as a model for other healthcare systems confronted with similar difficulties.

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Author(s)

Lotte Deschepper, Kenny Noerens, Nilgün Kizilmese

Why was it done?

The COVID-19 pandemic caused limited availability of critical drugs and rapidly evolving treatment guidelines. Patient safety must be guaranteed at all times. However, the pandemic took the follow-up of drug shortages to an unprecedented level, increasing the risk of errors. Fulfilling this task was therefore difficult and new strategies needed to be implemented.

What was done?

In our hospital one pharmacist was dedicated fulltime to the COVID-19 drug management. Another pharmacist was committed to ensure the safe and efficacious use of drugs by conducting medication reviews and giving relevant drug and laboratory recommendations.

How was it done?

Microsoft Power BI ©, a tool to analyze data, was used to monitor the specific drug needs on the COVID-wards. Higher drug consumption was more rapidly detected and more specific actions could be executed. The available stocks in the hospital were also registered in a database and this information was updated and reported daily to the medical staff. In this way treatment guidelines could be proactively adjusted if necessary. Medication alerts were sent regularly by mail to ensure that all health care providers were informed about (temporary) changes in order to reduce the risk of medication errors.
Additionally, pharmacists collected evidence‐based drug information concerning indications, dosing, possible side effects, drug‐drug interactions and other precautions based on (inter)national guidelines. This information was used to develop a back-office validation tool that supported pharmacists to conduct medication reviews in a uniform manner. Daily updated reports from Microsoft Power BI © were used to analyze relevant interactions and contra-indications. Pharmaceutical recommendations were promptly documented and reported in the medical record of the patient and the physician was contacted immediately if urgent.

What has been achieved?

Due to the multi-disciplinary approach and guided medication use, therapy continuation could be guaranteed for all patients. Our validation tool resulted in the early detection and interception of medication errors ensuring patient safety.

What next?

A retrospective risk assessment will be done to evaluate our approach and a disaster plan concerning medication will be established based on our experience. The development of a computer-based analytical tool will be encouraged to maximize patient safety while minimizing risk of medication errors.

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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.

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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)

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.

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)

EDURNE FERNANDEZ DE GAMARRA MARTINEZ, NÚRIA PI SALA, RAQUEL AGUILAR SALMERON, ANTONI BROTO SUMALLA, MILAGROS GARCÍA-PELÁEZ, LIDIA MARTINEZ SÁNCHEZ, SANTIAGO NOGUÉ XARAU

Why was it done?

Antidotes are drugs used in emergency situations. Some of them often present availability issues due to shortages, high cost, complex acquisition (foreign drugs’ importation) or short validity periods. This tool was implemented in July 2015 to improve the availability of antidotes.

What was done?

A virtual network was designed in order to have a tool that allows pharmacy departments to locate antidotes: to know in which centres they are stocked, how much there is of each drug and when it would expire. It also facilitates communication between centres and loan movements in case they are required.

How was it done?

A web-based application was developed (www.redantidotos.org). It includes a public site with general information, an updated antidotes guide and a section where non-urgent toxicological consultations could be submitted. In addition, there is a private site (accessed through username and password) where each pharmacy department might introduce the stock they have of 18 selected antidotes (anti-digoxin antibodies, anti-vipera serum, botulism antitoxin, dantrolene, deferoxamine, defibrotide, dimercaprol, calcium disodium edetate, ethanol, fomepizole, glucagon, glucarpidase, hydroxocobalamin, idarucizumab, pralidoxime, physostigmine, silibinin and uridine triacetate). Each Hospital has two key users: a ‘farmatox’ (pharmacy department) and an ‘urgetox’ (emergency department). Their participation has been crucial for the success of the project.

What has been achieved?

Currently there are 63 Spanish hospitals included in the Antidotes Network. It has been used 49 times to locate an antidote that was needed and to request a loan between centres. Thirteen antidotes were involved in these movements. The most requested drugs have been anti-vipera serum (10/49), glucagon (6/49), anti-digoxin antibodies (5/49), botulism antitoxin (5/49) and fomepizol (5/49). Additionally, recommendations were published about stock availability and use of antidotes according to hospital complexity (Emergencias 2016;28:45-54).

What next?

The network was first implemented in Catalonia and now the project is being extended to other Spanish regions (currently it has been implemented in three out of 17 regions). We aim to continue improving communication between professionals involved in intoxication management, sharing knowledge and improving the care we offer to our patients.

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Author(s)

Kim Florian Green, Torsten Hoppe-Tichy

Why was it done?

Drug shortages are an increasing problem for hospitals in Germany. The management is time consuming and might endanger safety of drug therapy. Therefore, it is essential to take precautions to deal with upcoming shortages in advance.

What was done?

Development of an algorithm to create an essential drug list in consideration of logistic and clinical aspects.

How was it done?

The first step was classification of the hospital formulary. We used 4 types for classification (oral medication, parenteral medication, medicinal products, and dietetics). Following a priorisation for parenteral and oral drugs cause of the fact we discovered in an internal benchmark that durgshortages with parenteral drugs lead to a larger workload. After that we assessed drug consumption for each drug by year, quarter and month and conducted an extending selective inventory control (ABC-XYZ-Analysis).
Next step was to create a step-by-step decision-tree considering local clinical pathways and logistics define essential drugs. The algorithm displays typical procurement processes and infrastructure in German hospitals pharmacies and the common search for alternative drug therapies.

What has been achieved?

The combination of the algorithm and the ABC-XYZ-Analysis lead to an individual list of essential drugs and allows to define logistic measures for each of them.

What next?

The list allows us to define an adequate stock for upcoming drugshortages. Internal benchmarking for process robustness. External validation of our algorithm is necessary.