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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.

Author(s)

Alison Anastasi, Karl Farrugia

Why was it done?

This was done as a tender was being issued also for medicines that still had a patency and had no competition and the prices quoted for were higher than other international external reference prices. Thereby a new pricing reimbursement system was undertaken and items procured were studied intensively before choosing the right procurement model. The main point was thinking outside the box inducing interest in international companies who were willing to support and assist the innovative local systems by participating in the new systems leading to improved access and better value for money.

What was done?

In September 2016, a workshop and strategy meeting was organised at WHO Denmark to discuss global procurement strategy and share country practices. Malta was one of the facilitators and invited speakers. In the past years tendering was the main system for procurement. However, on having a thorough understanding of medicines and non-pharmaceuticals, market strategy, and patency other processes have been studied and adopted. The models involve negotiations, pay per use systems, and pay per performance models.

How was it done?

This was done by setting multidisciplinary teams within the hospitals and by having good research methodology skills. This led to smoothing the gaps between the actual horizon scanning, health technology assessments and final choice of procurement strategy. International liaison, partnership with the industry, and relevant focus groups with annual seminars made this possible as mixed experts met and gave their best shot at this new system. The fact that no one size fits all made procurement more interesting and from one cycle to the other there is a learned curve that brings successful results.

What has been achieved?

Malta achieved better competition, uninterrupted sourcing, investments and stable pricing with continuous yearly reductions. From negotiations of patented medicines Malta saved approximately 1.5-2 Million Euro per year since 2013. With respect pay per use systems such as the total knee replacements Malta gave a capped price and ended up paying half of what is used to pay and companies managed to bid for the set price. In renal dialysis the cycle involved payment per patient service thereby reducing wastage, storage, and ordering of consumables and this will render a cost saving of 5Million Euro throughout cycle. The new processes launched for multiple sclerosis will dictate that whoever reaches the cheapest price ranking will be used to start the patients clinically and the pay per cure cycle for Hepatitis C will lead to savings and complete eradication in five years time.

What next?

Malta is one of 6 small EU Member States so besides its size and geography there are other elements were it triggers the procurement department to think of innovative ways to treat our patients and as yet remaining sustainable. There are other projects in the pipeline however, Malta is sharing its good practice with the industry, with the WHO and other international fora so that certain elements are taken on board as standardised systems for equality of service and treatment in all countries.

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Author(s)

Hanne Fischer, Bente Dam, Bitten Abildtrup, Helle Pasgaard Rommelhoff, Lars Munck

Why was it done?

Challenges with drug supply is a global as well as a national problem. A decline in interest among the suppliers to submit tenders in our country, has been detected. This is more profound compared to other European countries due to a small market and a strict interpretation of EU public procurement rules.

What was done?

The aim of the study was to evaluate whether three selected contract types motivated suppliers to submit tenders, submit with a lower price and whether they affected national backorders.

How was it done?

In 2015 and 2016, the national purchasing authority for all drugs used in all the public hospitals, tested three new contract types on 18 drugs: a) Purchase obligation for the national purchasing authority b) Limit on reimbursement obligation for replacement drug and c) Two national suppliers of one drug. Contract type a and b aimed to reduce the suppliers’ economic risk and c was primarily tested to secure national drug supply.

Suppliers, who had the opportunity to submit tenders for the new contract types, were included in the study. For the 2015-tenders’ 7 of 8 semi structured interviews were carried out and for the 2016-tenders, 10 electronic questionnaires were provided (50 % respond rate). In total 2 parallel importers and 15 generic suppliers participated.

What has been achieved?

The respondents reported that contract type a motivates to submit tenders and submit with a lower price. It might reduce national backorders due to a predictable sale.

The generic respondents reported that contract type b reduces their economic risk, which motivates to submit tenders and due to that might reduce national backorders.

The respondents reported that contract type c did not have considerable effect on the national supply, since the forecast and amount of orders from both suppliers is fixed months in advance.

What next?

In order to address the challenges with drug supply, new types of contracts, which reduce the suppliers’ economic risk, will be further implemented in future national tenders.

Author(s)

Alison Anastasi, Karl Farrugia

Why was it done?

The amount of shortages was considerable leading to interruption of treatment, hoarding, wastage, hospital admissions incurring more expenses. Malta is one of the small EU Member states and its geographical position does not facilitate sourcing. Thereby on analysing the matter further, walking directly into the chaos creating order, inventing, creating, connecting and making things happen was the mainstay since then. The industry accepted the partnership invitation and sourcing increased both from the local and international scenario. Best in class operational efficiency, quality & functional excellence was achieved. According to the National Audit office in 2012, Malta had a recurring issue with shortages of medicines and now in 2016 we have had nil shortages for 30 weeks.

What was done?

1. Establishment of a dedicated team – Emergency Response Unit (ERU)
2. Enterprise Resource Planning inventory management
3. Customer demand forecast modelling
4. Partnership with the industry
5. Innovative procurement strategies e.g. negotiations, therapeutic time-based agreements, e-auctioning, framework agreements, managed entry access
6. Registration: Allowing bidders to register after they were awarded the tender; parallel importation

How was it done?

The challenges faced included influencing and providing leadership to partners in the delivery of on demand innovative solutions, strategic sourcing involving language translations, registering medicines by the department, demand supplier relationships, payment within 60 days, ageing population, procurement services revenue and profit growth. The winning strategy foundation was the interaction and integration of people (internal and external stakeholders) to business information and business intelligence.

What has been achieved?

The department has achieved good results measured by the number of shortages, better quality of life, by reduction of hospital admissions thereby reduction in costs. The average medicine shortages in 2013 was 56; in 2014 (40); in 2015 (5) and in 2016 (1) till October. The budget allocated per year has increased due to longevity however more patients are being treated and the cost savings lead to innovative technology access.

What next?

Having mitigation measures in place such as pre-planned need analysis; choosing the right process; reducing unnecessary care and focusing on sustainability is good practice. Locally this is being implemented for the procurement of non-medicines and in fact cost savings running into millions have resulted.

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Author(s)

Chloé HERLEDAN, Laura BEAUMIER, Laurence MINISCHETTI, Marie-Christine ALBERTO-GONDOUIN

Why was it done?

Existing floor stocks are limited to usual psychiatric drugs. On-call resident pharmacists dispense additional treatments during pharmacy closing hours. Hence, extending the floor stocks would facilitate continuity of care. SASC centralisation enables simple and secured access to medication while saving space in care units.

What was done?

A new drug and medical device floor stock was implemented in our psychiatric hospital. The floor stock is contained in a secured automated storage cabinet (SASC) located in a protected area inside the pharmacy and accessible during its closing hours. Utilisation training was offered to nurses through multiple formats.

How was it done?

Floor stock composition has been established from frequent requests made during on-call time and can be consulted on the pharmacy website. Prescriptions and patient informations can be checked before removal on a computer in the SASC area. The SASC requires badge identification, unit and patient name entry and provides traceability of removals. Moreover, cold storage requiring drugs are housed in a refrigerator unlocked through the SASC. Regarding utilisation training, all night nurses had to attend a demonstration of the SASC performed by the resident pharmacists. This demonstration was also offered to day nurses and head nurses during weekly pharmacy open days for three months. In addition, an instruction manual and a video tutorial were produced and uploaded on the website.

What has been achieved?

60/67 (89.5%) night nurses, 80/256 (31.2%) day nurses and 10/20 (50.0%) head nurses have attended the SASC demonstration. A satisfaction survey conducted among trained nurses or head nurses had an 18.7% response rate. 26/28 (92.9%) of respondents attended the demonstration and all were satisfied by its quality. 2/28 (7.1%) only used the instruction manual. All respondents declared being able to use the SASC, however 7/28 (25.0%) would need assistance from the instruction manual or video tutorial.

What next?

Further utilisation training or assistance will be provided by the video tutorial. Removals and prescriptions will be checked by pharmacists to uncover picking errors. Impact on resident pharmacists’ workload will be assessed within six months. Finally, SASC centralised floor stock is an interesting approach for hospital pharmacies with limited staff to improve continuity of care.

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Author(s)

Karina Bentzen

Why was it done?

Introducing biosimilar medicines in the clinical setting may significantly reduce hospital medicines expenditure – but only if the biosimilar medicines are used. Lack of knowledge and insecurities about biosimilar medicines among healthcare professionals and patients must to be addressed to ensure implementation in the clinical setting.

What was done?

To facilitate the introduction of biosimilar medicines in Denmark, a special Taskforce was appointed. The aim was to enhance knowledge of biosimilar medicines among healthcare professionals and prepare implementation of biosimilar medicines in the clinical setting.

How was it done?

A special “Taskforce for introduction of biosimilars” was appointed. The Taskforce consisted of physicians including clinical pharmacologists, pharmacists, drug tender specialists and staff from the “Council for the Use of Expensive Hospital Drugs”, who issue national treatment guidelines.
Planning the introduction of biosimilar infliximab in Denmark started more than a year prior to the granting of marketing authorization. During this time, the Taskforce arranged seminars and facilitated meetings with specialists from the clinical setting to provide knowledge of biosimilars, to discuss the introduction of biosimilar medicines and how to switch patients. Based on these discussions the “Council for the Use of Expensive Hospital Drugs” dictated the use of biosimilar medicines nationally.
The Taskforce also created educational materials for doctors, nurses and patients and a “Q & A” website.

What has been achieved?

Biosimilars were adopted into the Danish market after a very quick introduction. The market share of the biosimilars was 95% within 3-4 months.

The price reduction after introducing biosimilar medicines was approx. 60%, and the quick implementation of the drugs in the clinical setting has significantly reduced medical costs.
Total annual savings in Denmark: 22 mio € (infliximab) and 15 mio €* (etanercept. * Estimate based on the first 6 months).

What next?

More new biosimilar medicines are expected to be introduced into the Danish market in the near future. The Taskforce will continue their work to ensure similar successful implementations.

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Author(s)

Claudia Wunder, Szabolcs Tobi

Why was it done?

To introduce returns to supply chain is a critical process in distribution of medicinal products, as non-compliance with storage conditions or inappropriate handling can impair the quality and hence endangers patient safety. In terms of a continous improvement process we considered a standardization and a supervision of this field as mandatory.

What was done?

A standard form for handling of returns was developed. It was designed to ensure that important process steps are done and documented. Furthermore it should offer the opportunity to learn about the reasons why users return medicinal goods to the pharmacy. After one year of usage (2015) the forms were evaluated with the objective of validation and improving the process. According to PDCA-cycle measures were deduced based on the results.

How was it done?

The standard form guides the process and assures
– that medicinal products are stored under quarantine until approval by pharmacist,
– that storage conditions are proved for the time the goods were out of pharmacy,
– that the quality of each returned medicinal product is checked carefully and
– that the reason for return is documented.
The standard forms were collected and evaluated concerning
– number of returns,
– reasons for returns,
– value of returns.

What has been achieved?

The standard form proved to be a useful tool to gain information about gaps in the process of distribution. The evaluation demonstrated that users had problems with ordering due to article changes and unclear names in the warehouse management system. It showed the need for education of trainees and pointed out lacks of communication between pharmacy and wards. The analysis also presented the money-saving potential of re-utilization of returns. What was achieved is an improvement of distribution process by
– implementing an intensive and standardized education for trainees,
– optimizing main data in warehouse management system,
– sensitizing the responsible persons and
– getting in closer communication with nurses on wards.
Besides that the economic benefit of the process could be proved.

What next?

At the end of 2016 the impact of the measures shall be reviewed. Benchmarks shall be deduced to audit the functionality of the process in future.

Author(s)

A. Navarro Ruíz, A. Martínez Valero, R. Gutiérrez Vozmediano, A. Andújar Mateos, A. Martí Lorca, I. Jiménez Pulido

Why was it done?

The purpose was to increase the efficiency of this management process involving a high workload due in part to the absence of information.

What was done?

In Spain, the availability of drugs under special circumstances is regulated by the Spanish Royal Decree 1015/2009 of 20 June, which established three instances: (1) use of investigational medicinal product undergoing a clinical trial, (2) use of medical products for a medical purpose not in accordance with the authorised product information (off-label use) and (3) access to unauthorised medicines in our state but which are legally marketed in other states. Also, each region has its own regulatory system for medicines. In the pharmacy department, we have developed a software application for managing requests for medicinal products in the situations described above, and in accordance with our region’s regulations. It is organised in different sections that collect patients, prescribing physician details, medicinal products and diagnostic information. It has restricted access through user accounts and a menu for multiple search parameters.

How was it done?

In the pre-design phase, we held individual meetings with pharmaceutical and administrative staff involved in this process to identify their specific needs and priorities, and to assess these once the software application was created. The database management system used for the development of the computer application was Microsoft Access 2003. Once finished, it was tested for 2 months to help pinpoint specific errors and improvement opportunities.

What has been achieved?

Computerisation of this process has improved the efficiency in requests management, facilitating the use of information, increasing speed and reliability, allowing the possibility of analysing large volumes of data, providing greater confidentiality and increasing security through backups.

What next?

The next step will be to assess the usefulness of this software application using a satisfaction survey. To incorporate this initiative into other hospitals in our area requires only compatible software able to run the application.To extend its use to other regions would need adaptation of this software application to the existing regulations in each region.

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Author(s)

L. Munck

Why was it done?

Globally, we are facing an increasing amount of drug shortages, even though international regulatory authorities take initiatives to improve this.

We have national order data available through one national organisation that manages all tenders and backorders for drug supplies to all hospital pharmacies.

Access to order data enabled us to start this improvement initiative in May 2014, and hence fight the backorder challenge at the national level.

What was done?

We applied LEAN and Supplier Collaboration to turn around the trend of increasing amount of drug backorders to hospital pharmacies.

Our initiative consisted of tight follow-up and continuous improvements with ‘TOP6-suppliers’, (ie, the 6 suppliers with currently the most negative impact on our national drug supply).

‘TOP6-suppliers’ are selected each week at LEAN board meetings.
Tight supplier follow-up, by e-mail, weekly:
We informed the ‘TOP6-suppliers’ that they currently are among the suppliers with the most backorders, and asked them to:

• Confirm/update delivery dates for all open backorders
• Inform us of the underlying reason for each backorder

The suppliers continue to receive weekly emails, as long as they are selected as ‘TOP6-supplier’.

Continuous improvement meetings, face-to-face, quarterly:
We had meetings with the 3 suppliers with the highest level of backorders/poorest level of improvements.

Meeting agenda: Reasons behind current backorder situation and actions to improve.

How was it done?

Obstacles—>Our solutions:
Too busy managing actual backorders and no time to drive improvements—>Added one dedicated resource to drive this initiative.

How to manage our effort—>Develop leading key performance indicators (KPIs) that ensure focus on influence and improvements.

We were not always confident that our effort would provide the expected results—>Continue to focus on the agreed approach and KPIs, even if it takes approximately 12 months before we achieve improvements.

What has been achieved?

• Backorder amount decreased by 25%.
• 3rd quarter2014: On average, 99 item-numbers in backorder (range 87-117).
• 3rd quarter 2015: On average, 74 item-numbers in backorder (range 67-99).
• Closer dialogue and improved cooperation with our suppliers with most/critical backorders.

What next?

1. Share achievements.
2. Start an international network to share best practices.
3. Together achieve further improvements in drug supply.

Author(s)

H. Thoong

Why was it done?

PETC admits approximately 15 000 patients per year and is a high user of high cost drugs. Traditionally, a pharmacist provided a clinical and supply service with no technical support. Frequently, prescriptions were written late, dispensed items were lost and patients waited unnecessarily to receive treatment. Furthermore, patient non-attendance and medication re-supply due to misplacement of original dispensed items led to stockpiling of medicines.

What was done?

A pharmacy technician (PT) coordinated medication service was introduced onto the Paediatric Elective Treatment Centre (PETC) to decrease patient waiting time (PWT) and drug wastage.

How was it done?

Prior to admission, patients requiring medication were identified by a PT. If medication had been prescribed, this was transcribed onto a pharmacy order form. The prescription chart and order form were clinically checked by a pharmacist. If the drug had not been prescribed, prescribers were contacted. The medication was dispensed and delivered to the ward in advance. The PT ensured all required medication was readily available on the ward. Data on PWT, time to process medication orders, cost of unused drugs and number of items available prior to attendance were collected for a 6 month period.

What has been achieved?

Total cost savings achieved due to returned unused medication amounted to £82 074.

What next?

To extend the role of the PT in PETC. Therefore, the PT will undertake basic medication reconciliation, assessment of patients’ own drugs and notify the clinical pharmacist of patients requiring a full medication review.