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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.

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Author(s)

Krista Mikula, Silvia Hetz

Why was it done?

In the 1,200-bed teaching hospital of Wels-Grieskirchen, Upper Austria, wards place routine orders of formulary medicines online. These orders are then processed by the logistics team of the hospital pharmacy in predefined order between 6:45 and 9:00 am. Any later reorders have to be placed by telephone, leading to considerable extra time needed for processing. It is known that the interruption of an ongoing task leads to an additional 20 minutes needed to return back fully concentrated to the initial task (Besser fix als fertig: Hirngerecht arbeiten in der Welt des Multitasking, Bernd Hufnagl ISBN: 978-3-85485-331-2). The goal was to reduce time-consuming reorders by telephone to free up time for other value-adding tasks.

What was done?

At the beginning of each observation period (i.e. 3 months), the intervention wards received detailed information regarding their leading ranking position (TOP 3) and how they compared with other wards, their reorder frequency, the time-consuming impact reordering had on hospital pharmacy processes and logistical advice how to best reduce and avoid reordering. After each of the observation periods, wards with a need for intervention changed (i.e. reorders were reduced) in the TOP 3 ranking.

How was it done?

Starting in January 2014 reorders were systematically analysed across all wards by using consumption and ordering data from the hospital logistics IT system. Those three wards with the highest number of reorders received special attention as intervention wards.

What has been achieved?

The transparent information and display of those wards leading in terms of reorder frequency and quantity triggered the ambition to no longer stay among those TOP 3 wards. Starting with a total number of yearly reorders of 8,390 (2014), the intervention reduced reorders to 4,781 in 2017 (minus 43%). The most successful ward reduced the number of annual reorders from 472 in 2014 to 230 in 2015 (minus 51.48%). Two-hundred and twenty-nine reorders were placed in 2017 (minus 51.48%). The intervention was repeated for five observation periods and 15 wards were involved. After 1.25 years, these wards were ranked again, not because they had bad results, but because all wards had improved. This information initiative has become self-limiting, as overall reorder compliance stabilised at a low level. Considering the overall time needed for reorder processing (i.e. an average of 32 minutes per reorder, including a relevant process steps) a total of 1,950 hours per year (equivalent to 1 FTE) was freed for more value-adding tasks.

What next?

Constant re-evaluation of reorders take place to occasionally identify new needs for action.

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Why was it done?

The consumption of medicine for the treatment of wAMD, DME and RVO is increasing. The medicines used are in the top five of the most expensive drugs in Denmark. With the prospect of more patients, greater costs and the introduction of new drugs in the field, there was a need to develop a national treatment guideline.

What was done?

An expert committee prepared a national treatment guideline including a clinical medicine comparison report for the treatment of wet age-related macular degeneration (wAMD), diabetic macular oedema (DME) and retinal vein occlusion (RVO). The aim was to create uniform treatment across the country and to trigger competition between medicines in the hope of achieving lower prices.

How was it done?

An expert committee consisting of physicians, clinical pharmacist, clinical pharmacologist and medicine procurement pharmacist was appointed. The committee prepared a national treatment guideline including a clinical medicine comparison report based on existing clinical evidence and Danish practice. The committee reached the conclusion that the anti-vascular endothelial growth factor (VEGF) drugs ranibizumab and aflibercept are ranked equally in terms of effect and side effects. The choice of anti-VEGF should be determined solely by price and dosage. A tender was prepared in alignment with the guidelines. This result led to the development of a medicine recommendation, which was passed onto hospital pharmacies, clinical pharmacists and physicians to ensure implementation in the clinic. Feedback from the clinics concerning estimated consumption was forwarded to the drug suppliers and was continuously monitored by the procurement pharmacist to ensure compliance at the clinics.

What has been achieved?

The clinicians switched patients to the new first-line choice. The market share of first-line treatment was 89% compared to 25% before the guideline. Two tenders were published based on the guideline. The first resulted in a price reduction of 28%, the second a reduction of 54%. Total actual savings in the first tender (based on a 31-month contract period) was €38m. In the second tender (based on the first 12 months of the contract period) was €35m.

What next?

New medicines are expected to be approved in the near future. We will continue to use and develop national treatment guidelines in combination with tender procedures and proper implementation of guidelines to obtain better and cheaper treatment options for patients.

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Author(s)

Lars Munck

Why was it done?

After years with increasing numbers of backorders and unplanned drug changes implemented in the hospitals under time pressures, we decided in 2017 to replace firefighting with proactive action through better transparency between hospital pharmacies and drug suppliers.

What was done?

We established a national Sales & Operations planning (S&OP) unit able to develop and implement a national S&OP process for drugs on national tender:
• All hospital pharmacies estimate their expected purchase volume (number of packs) of each item-number.
• National estimates for each item-number are shared on a national supplier portal (web-page).
• Advise suppliers, when new estimates are shared on the portal, to confirm supply capability or report potential supply problems.
• Proactive solutions/decisions are made for potential supply problems.
• Suppliers share production lead-time to enable planning of tenders and drug-changes accordingly.
• Monthly review process in place: hospital pharmacies/clinical pharmacy update estimates for changed drug use, suppliers re-confirm their supply capability accordingly, and national solutions/decisions are made for new potential supply problems.

How was it done?

1. INVOLVING hospital pharmacies and suppliers in step-by-step development.
2. HELPING hospital pharmacies to estimate and identify estimates that require revision to improve estimate accuracy.
3. ACTIVE COMMUNICATION of estimates to suppliers.
4. Rebuild supplier’s TRUST in our estimates as accuracy improved.
5. Ask suppliers to confirm supply capability.
6. Open and CROSS-FUNCTIONAL DIALOGUE. Dialogue concerning possible solutions to potential supply problems.

What has been achieved?

Proactive solutions/decisions for potential supply problems have improved the overall supply situation/information, and have improved patient safety, as fewer unplanned drug changes are implemented under time pressures. The number of backorders have stabilised during 2017 to 2018. We have not experienced the explosions in backorders that some of our neighbouring countries have experienced. Transparency across the supply chain has generated trust and enabled more value-adding and cross-functional dialogue such as sharing causes of estimate changes and early sharing of potential supply problems. Positive feedback from hospital pharmacies and suppliers regarding resources/benefits from participating in the S&OP process.

What next?

Continue to improve the S&OP process/tools. Helping hospital pharmacies in predicting changes in drug estimates, based on the impact of national decisions about drug selection in therapeutic areas. Willing to help other countries.

Author(s)

Ismail Bennani, Amine Cheikh, Hafid Mefetah, Mustapha Bouatia

Why was it done?

The strict control of medicines cold chain is linked to a triple risk for a hospital: a risk for the patient through the efficiency and safety of the drug, a financial risk, and a regulatory risk.

What was done?

Our study aimed to map the process of management of medicines requiring a strict cold chain control at a referral pediatric hospital and to identify the critical points associated to this process in order to realize a risk analysis using the FMEA method

How was it done?

The method used is FMEA for a priori inductive risk analysis which aims to identify potential system failures. These failures are analyzed to determine their criticality by establishing an index for each failure that will be scored and calculated using the formula: Criticality index = frequency × severity × detectability.
The rating of each criterion is based on predetermined rating tables.

What has been achieved?

Process Mapping: The mapping of the process allowed identify 7 major actors: the supplier, the general store, the logistics platform for product reception, the transportation, the logistics department of hospital, the pharmacy and the patient.
Identification of the critical points: All failures modes that were ranked between 201 and 504 on criticality index are considered as main critical points:

Problem of breakdown of electricity and its management: 504
Respect of the cold chain at the level of the care services until administration: 448
Temperature indicators at the level of care services: 384
Conditions of transportation: 315
Temperature monitoring at pharmacy level: means and management: 245
Logistics agents transport time management: 210

Implementation of improvement actions: Corrective and preventive improvement measures have been defined and implemented, such as: setting up alternatives to power outages, periodic temperature assessments at all critical levels, and integration of remote control and monitoring computer devices.

What next?

The continuous improvement of the medicines’ cold chain remains an important topic for the institutions in view of the overall risks associated with the quality of these medicines, therefore to the medical treatment of the patient.