Environmental criteria in medicine procurement
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Outi Lapatto-Reiniluoto, Suvi Sivula, Elina Ahomäki
Why was it done?
Price has been the most prominent criteria in procurement quality being the second. Environmental aspects haven’t been assessed earlier. Differences between the pharmaceuticals’ environmental burden can be considerable and by choosing wisely we would be more sustainable.
What was done?
Environmental criteria have not been used in Finland in hospital procurements earlier. We created the criteria which would be acceptable to all parties (hospitals, suppliers), would be reliably assessed, and easily copied to other hospitals.
How was it done?
Our tender had six questions for everyone and two more questions for antibiotics or hormones. The common questions were answered by yes / no / we do not know. Points given were 0, 1, 2. An example of the common question is: Does the company have a plan how to reduce CO2 emissions caused by itself?
Questions for antibiotics and estrogen hormones were: Company has told in which country and in which plant the API is produced and the formulation happens.
What has been achieved?
132 providers answered so far. Quality of answers varied considerably, from 0 to 12 points, mean 7 points. Questions for antibiotics created the most discrepancies: 41 providers; 15 were not able to answer these questions acceptably. The answers showed that the questions were not too difficult, these questions could be answered, and the answers can be analysed.
What next?
The criteria were very simple and assessing the answers was not difficult. Only one question was widely misunderstood. Questions were universal and can be used in other hospitals, too, which is the wish from the industry (same questions everywhere). Wide range of results showed differences between the companies. During this round we did not give any credit for the best products but in the future more responsible products should be rewarded. Antimicrobial resistance e.g., is a global problem but if the company does not know where its products are manufactured how can they look after wastewater treatment of their products.
Supply difficulties in oxygen humidifiers: an opportunity to promote good practice
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Margaux DUFOSSE, Claire ANDREJAK, Abir PETIT
Why was it done?
By May 2022, we learned about the sale discontinuation of oxygen humidifiers from one of the two manufacturers in our country, due to the constraints of MDR 2017/745. The second manufacturer restricts its products to hospitals with marketing partnerships. In our hospital, oxygen humidifiers are used regardless of the oxygenation medical device (nasal cannulas, masks, tubes or tracheotomy tube) or oxygen flow rate. We had to define indications and prescriptions to control consumption in our hospital.
What was done?
To promote good use of oxygen humidifiers and control our consumption in a context of shortage we have drawn up a scientific explanatory document, a procedure and a prescription support.
How was it done?
We suppressed services’ allocations for humidifiers, to encourage prescription via the Electronic Patient Record. We set up a working group, including pharmacists, resuscitators, pulmonologists and nurses, to write a good use sheet, underlining high-priority medical indications taking account of scientific literature and respiratory medicine learned societies’ recommendations. To assess its effectiveness, we compared humidifiers’ consumption before and after we set it up and evaluate prescriptions’ number and conformity for the first 4 months, from May to September 2022.
What has been achieved?
The group restricted indications to paediatric patients, patients with tracheotomy and patients with oxygen flow rates above 5L/min and upper respiratory tract lesions such as nose bleeding, nasal discharge congestion, or nasal mucosa’s irritation or lesions. We wrote the good use sheet, mentioning the circuit’s montage and conditions for dispensing humidifiers. Before the new procedure, the mean consumption was 1,415 units per month, versus 39 per month from June. Regarding prescriptions’ conformity, 12 (8.7%) out of 138 were denied: six patients on ambient air, four with nasal cannula, one without any severity criteria, a not nominative prescription.
What next?
This collaborative and multidisciplinary work enabled a change in practices. Supply difficulties, initially seen as challenging, are a great opportunity to promote good use, and secure patient care. Although they have now been resolved, with a new supplier, we maintain our measures to ensure patients’ security and well-being.
First Danish pharmaceutical tender with environmental criteria
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Lone Møller Deleuran, Bitten Abildtrup, Sofie Pedersen, Ulrik Wøldike, Nina Winther Müller
Why was it done?
Amgros is committed to make its mark on the sustainability agenda regarding medicine – both nationally and internationally. Thereby improving access to medicines for patients in a more sustainable way – this project serves as a first step in this direction.
What was done?
In 2021, the Danish procurement organisation Amgros I/S issued the first national pilot tender for hospital medicines in which environment was an important award criterion along with price. Amgros procures 99% of the pharmaceuticals used at public hospitals. The pilot project was conducted to gain knowledge and experience about planning and executing future tenders with environmental criteria. The pilot tender was limited to the hormonal therapeutic area.
How was it done?
The chosen environmental criteria were environmental management, packaging (plastics and paper/cardboard), transportation and social responsibility.
It was a long process, including external help from consultants (The Technical University of Denmark), legal consultation, market dialogue with feedback, developing and adjusting the criteria to comply with national procurement legislation. Hence assuring the evaluation of the offers could be conducted in a meaningful, simple, and structured manner during the subsequent evaluation phase.
As a part of the final tender, a questionnaire was attached consisting of multiple choice questions concerning the environmental criteria. In the evaluation, the price weighed 80%, whereas the environmental criteria weighed 20%.
What has been achieved?
Amgros received 85 offers from 19 suppliers of which 76 offers contained the questionnaire about environment. Sixteen (84%) of the bidding suppliers completed the questionnaire. Three suppliers won the tender solely due to their environmental capability.
The tender with environmental criteria did not seem to discourage suppliers from bidding nor resulted in increasing price levels.
The pilot tender has created a great deal of awareness among the suppliers about the importance of environment and sustainability in production, distribution, and sales of medicine.
What next?
The experience obtained from this pilot tender is paving the way for the future broader implementation of more sustainable medicines in all tenders. Furthermore, the results will be shared nationally and internationally. Hopefully, the results will encourage other countries to incorporate environmental criteria in future medicinal tendering processes.
Development of a pharmacy-led technical assessment pathway for personal protective equipment
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Rachel Huey, Catherine Goudy, Michael Scott
Why was it done?
The assessment process was developed in partnership with the Business Services Organisation Procurement and Logistics Service (BSOPaLS) and regional Infection Prevention and Control (IPC) colleagues in response to the outbreak of COVID-19 and escalating demand for PPE. In March 2020, early World Health Organization (WHO) guidance formed the basis of COVID-19 PPE ensemble recommendations. Prior to the COVID-19 pandemic, BSOPaLS procured such items from reputable market leaders. However, during this time of unprecedented demand on supply chains, there were many new manufacturers and suppliers with no previous experience of appropriate supply to healthcare. There were also many counterfeit goods being placed on the healthcare market.
What was done?
During the COVID-19 pandemic, the Medicines Optimisation Innovation Centre (MOIC) utilised pharmacist skills to undertake technical assessment of all Personal Protective Equipment (PPE) items procured for use across Health and Social Care Northern Ireland (HSCNI).
How was it done?
MOIC reviewed and validated all technical documentation associated with each PPE product to ensure that items procured were genuine, fit for purpose and met the relevant standards and regulations. Benchtop assessments were carried out by IPC colleagues and BSOPaLS carried out all procurement due diligence checks on potential suppliers. Early data from 1 April 2020 to 15 May 2020 showed that only 98 (16.5%) PPE offers reviewed met the required standard for approval, while 264 (44.6%) were rejected and a further 230 (38.9%) remained open. Some reasons for rejection included documentation deficiencies and misleading labelling.
What has been achieved?
This process resulted in procurement of only safe and effective products, putting safety of HSCNI staff and patients at the forefront. In addition, BSOPaLS worked closely with local manufacturers with no previous PPE experience, to establish more resilient supply chains for the future. Products manufactured locally were also assessed via this process, to ensure suitability for use within healthcare.
What next?
This efficient assessment process has now been implemented into the PPE procurement pathway for all future HSCNI purchases, enabling the application of due diligence in a transparent, robust and evidence-based manner. Provided there is opportunity to develop an appropriate knowledge base of the relevant regulations and standards, this process is transferable across many healthcare organisations.
FOLLOW-UP OF OFF-LABEL TOCILIZUMAB PRESCRIPTIONS IN COVID-19 IN A FRENCH UNIVERSITY HOSPITAL
European Statement
Education and Research
Author(s)
Caroline TRAN VAN HO, Marie-Anne ESTEVE, Pierre BERTAULT-PERES, Marjorie ROUDOT
Why was it done?
SARS-CoV-2 infection leads to pro-inflammatory molecules production (in particular IL-6). If the immune system is overwhelmed and cytokine production spikes, a hyper-inflammatory phenomenon occurs: the cytokinic storm, which can bring lead to the admission in an intensive care unit. Due to the absence of authorized treatment, several clinical trials (CTs) and off-label use of drugs have been set up.
What was done?
The aim of this study is to analyse the off-label use of tocilizumab in a French university hospital in comparison with different CTs.
How was it done?
A retrospective study of tocilizumab prescriptions in Covid-19 was conducted between 01/03/2020 and 30/04/2021 by extracting data from Computerised Physician Order Entry and Pharmacy Management software (Pharma®). History of patients was recovered by electronic medical records (Axigate®).
Results were compared to (1) RECOVERY Collaborative Group. Lancet. 2021, (2) Hermine O. JAMA. 2021, (3) Rosas IO. N Engl J Med. 2021, (4) Salama C. N Engl J Med. 2021.
What has been achieved?
Between 01/03/2020 and 30/04/2021, 68 patients received tocilizumab.
Seventy-seven percent of patients were in the intensive care unit and 42.6% died, whereas 31.0%, 19.7%, 11.1% and 10.4% died according to (1), (3), (2) and (4), respectively. Mechanical or invasive ventilation at the time of tocilizumab prescription was widely used (84%) compared to CTs (54.0%, 27.9%, 24.0%, 12.2% for (1), (3), (2), (4)). According to (1), there is a synergistic action between tocilizumab and dexamethasone. Eighty-four percent of patients received at least one dose of corticosteroids in agreement with (1) and (4).
What next?
The increase in off-label use of tocilizumab is related to the results of CTs. Because of the low number of patients, the differences in COVID-19 stages at tocilizumab initiation, and the absence of a control group, it is difficult to explain our data. Given the weak iatrogenic effects revealed in CTs and in-label use, the benefit/risk seems in favor of tocilizumab use against COVID-19. Further studies are needed to confirm the first hopes. Since Casirivimab / imdevimab, and amlanivimab / etesevimab have been granted early access in France, the therapeutic strategy will be updated.
Croatian hospital pharmacists managing earthquake(s) medical consequences during lockdown(s)
European Statement
Clinical Pharmacy Services
Author(s)
Mirna Momcilovic, Anita Simic, Petra Turcic
Why was it done?
Croatia was hit by 2 big earthquakes in 2020, both happened just right after 1st and 2nd lockdown due to high number of COVID-19 cases. Since most of the hospitals were strategically built on the hills, it was more destructive for them. It also hit a number of community pharmacies responsible for drugs supply to specific areas in the country. There was no electricity, no heating, no drugs supply, no fridge to store drugs, for days, so quick back-up plan was needed to provide minimal healthcare.
What was done?
Croatian hospital pharmacists organised a temporary pharmacy in a tent, filled it with drugs and medical products donated from community pharmacies, hospitals and wholesalers from Croatia and other European countries and started supplying patients with it.
How was it done?
It was modified way of dispensing, without prescription because there was no doctors and no place to prescribe it, based on patient’s medical documentation, if available, and patient’s medication history according to what patient said only. Pharmacists needed to use their knowledge about dosing, duration of action – difference between immediate release or modified release formulations, possibility of splitting tablets into equal parts to get the needed dose and, most important, substituting drugs from the same pharmacologic class (ex. switching from one inhaler for treatment of asthma containing ICS + LABA to another one that was available at the moment), taking into consideration patient’s needs and avoiding drug to drug interactions. Pharmacists provided patients with OTC drugs, free of charge, followed by an advice of how to use it. Non having prescription problem was solved afterwards by Croatian Health Insurance Fund. Also, all the supply of vaccine against COVID-19 available in Croatia at that point, was sent to an area hit by the earthquake. Vaccination was done by doctors, and pharmacists assisted by supplying them with all the equipment needed (needles, alcohol, cotton wool, etc.).
What has been achieved?
Patients were supplied by all the drugs/medical products needed in the first, critical week after an earthquake.
What next?
Following the Croatian example of handling an earthquake situation, there is an idea of organising a medical crisis team, would include pharmacist, in each European country.
Create the complete Product Overview for tendering and price negotiations
European Statement
Selection, Procurement and Distribution
Author(s)
Liselotte Kamper
Why was it done?
To ensure optimal price negotiations and tenders based on an up-to-date product overview including both pharmaceutical, therapeutic, and commercial knowledge.
What was done?
Team Horizon Scanning (HS) in Amgros has developed a comprehensive report covering all important information for a new medicine about to be marketed within the EU – an Extended Product Overview (EPO).
How was it done?
Following every meeting in the Committee for Medicines for Human Use (CHMP) at the European Medicines Agency (EMA), information on applications for marketing authorisation on new medicines is identified in the agenda and minutes. The following information is compiled:
• Name of the active substance
• (Commercial) name of medicine
• EMA procedure number
• Date of application
• Type of application (Orphan/Accelerated review/PRIME)
• Name of the marketing-authorisation applicant
• Therapeutic indication
The information is supplemented with:
• ATC-code
• Mechanism of action
• Incidence/Prevalence
• Potential impact for the patients and the health care system
• Already approved medicines to treat the same disease
The information is presented and discussed at an internal meeting in Amgros between the HS team and representatives from health economics, tendering and negotiations. At the meeting it is decided for which medicines it is relevant to produce an EPO. The EPO contains the above-mentioned information as well as the following information:
• A description of the disease
• A status of the current standard treatment of the disease
• Information from the clinical studies supporting the indication/application
• Other medicines in pipeline for the same indication, with a status on the timeline for applying for marketing authorization
• Analysis of the market into which the medicine will be launched
The final document is confidential.
What has been achieved?
The EPO-document ensures that Amgros is prepared in the best way in negotiations to agree on a price level that gives a reasonable match between the effect of the medicine and its costs compared with the current standard treatment. Thereby more cost-effective health solutions and possibility to achieve more health for money in the Danish hospital setting can be secured.
What next?
The HS team wish to expand the EPOs to also cover specific therapeutic areas of interest e.g., multiple myeloma and other complexed therapeutic indications.
Horizon Scanning in Denmark: Providing the health care system with an overview and impact estimation of new medicines
Pdf
European Statement
Selection, Procurement and Distribution
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.
DEVELOPMENT OF A DYNAMIC STOCK MANAGEMENT TOOL: “ILIKECOMMANDS” (submitted in 2019)
European Statement
Selection, Procurement and Distribution
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.
JOINT PROCUREMENT: LEARNING FROM A PILOT OF JOINT PROCUREMENT OF OLDER PRODUCTS (submitted in 2019)
Pdf
European Statement
Selection, Procurement and Distribution
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.