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Author(s)

Helle Brauner

Why was it done?

There was a need for improved planning and preparing processes, as when it comes to price negotiations and estimates on financial burden and strategic procurement.

What was done?

Amgros, a part of the Danish health care system, has secured the supply of medicines and hearing aids to public hospitals and hearing clinics across Denmark for 30 years. This is done through efficient procurement and tendering procedures, creating economies of scale and savings.

In addition to this, in January 2017, Amgros launched its own Horizon Scanning unit. Now, the Danish Horizon Scanning system provides the health care system with an overview of medicines, indications and extensions e.g. pharmaceutical forms expected to be entering the Danish market within the next 2-3 years.

How was it done?

In 2016, it was decided to establish an Horizon Scanning system in Denmark. Then, input from internal and external stakerholders regarding their needs and expectations were gathered.

The outputs from the Horizon scanning unit consist of an overview of medicines about to reach the Danish market, as well as estimates of costs for new, expensive medicines and possible savings, for example if there are cheaper biosimilar drugs on the market. We also assess potential patient population and location of treatment. This is done in close cooperation with several Danish clinicians.

Sources for verifying and validating the data inputs are primarily EMA, complemented with commercial databases and a niche group of other sources. Data is gathered in a database.

What has been achieved?

The outputs enable our stakeholders to better plan the introduction of new medicines, to secure more cost-effective health solutions for everyone and to achieve more health for money in the Danish hospital setting.

Danish Regions, the interest organization for the health care regions, use the estimates in their annual negotiations with the Government on finances and the individual regions use them in their own budgets.

The predictability this system brings to Denmark is key in a future with more rare diseases, treatments and advanced pricing.

What next?

The Horizon scanning function is continuously being developed to meet the needs of our stakeholders, as we want to enable them in providing health care to the Danish citizens.

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Author(s)

Rebeca Iglesias-Barreira, Emilio Rubén Pego-Pérez, Carlos Sandoval-Aquino, Cristina López-Pardo y Pardo, Maria Jesús Rodríguez-Gay

Why was it done?

To guarantee workers safety as well as optimize the use of PPE in the hospital.

What was done?

To develop a protocol for placement and removal of personal protective equipment (PPE), established for contact with possible or confirmed coronavirus SARS-CoV-2 infected patients, taking into account the medical devices (MD) available during the pandemic. Alternatives and strategies were also proposed for resources optimization. Final protocol resulted from a multidisciplinary team work (Hospital Pharmacy Service team and Emergency Service workers). It was finally revised and approved by the Medical and Quality Direction.

How was it done?

1)A systematic bibliographic review was made, for articles selection on the placement / removal of PPE. Technical specifications of the available MD and the sanitary recommendations of the competent organitations were reviewed.
2)Establishment of PPE components, and the order of placement and removal:
a. PPE placement:1-Wash hands (WH).2-Place shims.3-WH.4-Put on the first pair of gloves.5-Put on FFP2 mask.6-Wear waterproof protective overalls from the feet.7-Place garbage bags on feet and adjust them on legs.8-Wash gloves with a hydroalcoholic solution (HS).9-Put on second pair of gloves.10-Put on a standard/reinforced surgical gown.11-Wash HS.12-Put on surgical mask.13-Put on disposable gown.14-Put on third pair of gloves.15-Put on face protection screen. 16-Put on surgical cap and fit it over a face shield.
b. PPE removal: a) Before leaving the isolation room: 1-Remove and discard bags from both feet.2-Remove and discard disposable gown.3-Remove and discard the outermost gloves. b) Outside the isolation room: 1-Wash HS.2-Remove surgical cap and screen (reserve screen).3-Remove and discard surgical mask.4-Wash HS.5-Remove the standard/reinforced surgical gown and reserve it.6-Remove second pair of gloves.7-Wash HS.c) Before entering the clean area:1-Remove shoes.2-Remove third pair of gloves.d)Go to the clean area:1-Disinfect footwear.2-Wash HS.3-Remove monkey and if necessary reserve it. 4-Wash HS.5-Remove FFP2 mask and reserve it if necessary.6-WH.
c. A team member read and check all steps carried out during the all steps procedure.

What has been achieved?

The protocol was followed by 54 (100%) workers. Since its implantation, on March 16 th, only the 3,7% (n=2) of workers were infected by SARS-CoV-2.

What next?

The protocol is under constant revision and modification to adapt it to the available MD in every moment.

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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.

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)

Steffen Amann, Rudolf Bernard, Georg Berndt , Meike Bindemann, Myga Brakebusch, Jörg Brüggmann, Frank Dörje, Miriam Gyalrong-Steur, Anita Kellermann, Markus Müller, Elfriede Nusser-Rothermundt, Rainer Riedel, Eva Tydecks

Why was it done?

Given rising cost-pressure and increasing numbers of supply shortages, changes between generics have become daily practice in hospital pharmacies. To ensure constant treatment quality and patient safety, the equivalence of a potential new product with the current one must be guaranteed before changing brands. So far there has been no transparent, standardised tool for the comparison of generics workable in everyday clinical practice. Developing such a tool was our project’s aim.

What was done?

We developed an Excel-based tool for the qualitative and pharmacoeconomical evaluation of generics before changing brands (aut-idem substitution) in hospitals.

How was it done?

A working-group of pharmacists from seven hospitals developed the “HERA” tool (HTA-evaluation of geneReric phArmaceuticals). Starting from a base version, 22 generic products were assessed with the tool during five evaluation rounds. Based on these results the instrument was gradually refined. Within HERA‘s Excel matrix a potentially to-be-used generic is compared with the current one. The economic evaluation is based on unit prices and prescription volumes, but also includes process costs associated with the product change. The assessment of pharmaceutical quality is based on 34 criteria from six areas (licensed uses, drug substance, dosage form and excipients, handling, safe design, packaging and storage). The objective quality evaluation is complemented by the assessment of hospital-specific features. Complex substitutions – e.g. associated with a handling change – require involvement of the medical staff using the product. The purchasing decision is taken based on the synopsis of pharmaceutical quality and economic evaluation.

What has been achieved?

The standardised evaluation of product differences before substitutions allows for the early identification of potential problems of brand changes and helps avoiding them for the benefit of patient safety. HERA also guarantees reproducibility and transparent, QM-compliant documentation of product changes. The pharmacies of our purchasing group now routinely use HERA for the assessment of generics before intended brand substitutions. Each evaluation is conducted in one pharmacy and shared with the others via data-cloud.

What next?

We have published a paper on HERA and presented it at the German Hospital Pharmacists congress in 2018. Our aim is to create a network of colleagues with shared access to all colleagues’ HERA product evaluations to reduce the workload for the individual pharmacies.

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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.