Determination of the carbon footprint of morphine tablets and morphine solution for injection – a collaboration between Amgros and the Capital Region Pharmacy
European Statement
Selection, Procurement and Distribution
Author(s)
Bitten Abildtrup, Lone Deleuran, Mira Dysgård, Nina Müller, Sofie Pedersen, Trine Schnor, Ulrik Wøldike
Why was it done?
It is estimated that medicine contribute 20% of the Danish regions total CO2e emissions. Amgros and the Hospital Pharmacies of Denmark are committed to develop carbon reduction initiatives to assist the regions CO2e reduction strategy. It is essential to identify the main contributors of CO2e emissions in the lifecycle of a drug to support CO2e reduction.
What was done?
The Danish procurement organization Amgros I/S is responsible for buying medicine for Danish public hospitals. As part of the ambition for sustainability, The Capital Region Pharmacy (RAP) in collaboration with Amgros has made a bottom-up hotspot life cycle analysis (hLCA) of the carbon-footprint of morphine in tablets and solution for injection. The hLCA identified the main CO2e emission factors from API/excipient production to administration of the drug.
How was it done?
The energy consumption of the production processes was mapped at RAP. Five reference flows were modulated (tablets in three types of primary packaging and solution for injection in two types) and reported. The hLCA data for the API was extracted from literature while data for the excipients and packaging material were calculated using Ecoinvent. Ecoinvent is a life cycle inventory database used to support environmental assessments of products and processes.
What has been achieved?
The preliminary conclusion of the analysis shows the largest CO2e emissions per DDD originates from administering the drug due to the use of single-use materials.
Leaving out administration of the drug, the main CO2e emissions from tablets are API production and packaging materials. Packaging materials are the main CO2e contributor for the solution for injection.
The end report of the LCA was available, end of autumn 2023.
What next?
The hLCA’s are being used internally in Amgros to develop criteria for tenders. The hospital pharmacies can use the hLCA calculations to identify key subprocesses where reduction of the CO2e footprint is greatest.
The results contribute to:
• Danish hospital pharmacies better understand the CO2e emissions when prescribing and administering medicines
• Dialogue with the pharmaceutical industry about their CO2e emissions hotspots
Finally, the results will hopefully encourage other countries to incorporate environmental criteria in future medicinal tendering process for medicines.
Value-based procurement model for the purchase of hyaluronic acid for intra-articular use
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
ERMINIA CACCESE
Why was it done?
The aim is to hold a value-based tender by incorporating the clinical benefit into the competition score for the procurement of Hyaluronic Acid (AI) for intra-articular use.
The main purpose of this tender is to purchase the product with the best cost-effectiveness profile according to the Net Monetary Benefit (NMB) and putting drugs and medical devices in competition.
What was done?
In Italy as well as in Europe medical devices (MDs) procurement is based on construction features and on price. The price of MDs is not negotiated by regulatory authorities, but it’s defined by industry. Today, in a limited resources scenario, it is necessary to implement value-based procurement.
How was it done?
We used the NMB method (1) as an award criterion, a parameter that evaluates the cost-effectiveness of the therapeutic intervention.
A bibliographic search was carried out to support the chosen endpoints and the tender lots. The utility and cost values linked to therapeutic failure were sought and the minimum accepted quality was defined. The starting price was calculated per therapy cycle/patient.
Finally, a software was designed to calculate the value-based competition score.
What has been achieved?
The tender consisting of 3 lots was announced with resolution n.209/2023 (2). The technical evaluation focuses on the enhancement of the clinical benefit based on the following scores: price (30)/clinical benefit (70). The endpoints chosen for the evaluation of clinical benefit are deltaVAS and deltaEQ-5D. Both drugs and MDs can be offered for each therapeutic indication.
What next?
This tender is an example of value-based procurement that uses the evaluation of clinical effectiveness as a quality evaluation criterion.
The aim is to quantitatively link the purchase price of a therapeutic intervention to the extent of the benefit observed in clinical studies, rewarding the interventions that produce the greatest benefits. The innovative nature of our tender lies in putting drugs and MDs in competition in the same tender lot and for the same therapeutic indication, thus purchasing the product with the best cost-effectiveness profile based on scientific evidence. We are awaiting the award of the tender, the results of which we will publish shortly.
Pallet box implementation: a combination of improved working conditions, storage and waste optimisation?
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Elisabeth CESAR, Ludivine LECHEVRETEL, Adrien NIERENBERGER, Laurent DIETRICH, Anne FEGER-FALK
Why was it done?
We decided to experiment this new solution on coronarography-packs, which presents the biggest rotation among surgery-packs (5,392 units estimated for 2,023), in order to improve working conditions of logistic workers, decrease musculoskeletal disorders (MSD) and optimise storage.
What was done?
Pallet box have been implemented as a new logistic solution for surgery-packs in our hospital pharmacy on a proposal from one of our biggest suppliers. The aim of this comparative study between 52-pack pallet boxes and the previous storage solution by 4-pack boxes was to assess the potential benefit on handling work, storage, waste and its economic impact.
How was it done?
In order to compare these two solutions, we clocked the time and evaluated the cost of transport from delivery gate to storage room and healthcare-unit order-picking step (from picking up the first pack to cardboard flattening). We also estimated the amount of waste associated.
What has been achieved?
Pallet-boxes enable a 24% room saving (52 pallet-spots yearly (2 pallet-boxes piled on one spot) instead of 68) and a 31% global time saving (22 hours yearly (13h transport + 9h order picking) instead of 32 hours (17h transport + 15h order picking)). Time saving on order picking was 40%: picking step of one pack from a pallet box requires on average 6 seconds whereas 10 seconds were needed from 4-packs-boxes. Yearly 104 pallet-boxes (603 kg of empty cardboards) will be manipulated whereas 1,348 4-pack-boxes (1,213 kg) used to be handled resulting in a 2-fold decrease. Even though pallet-boxes halve cardboard-waste, they represent 1.5 times more wooden-pallets’ waste (104 versus 68). Furthermore the price of coronarography-packs are impacted by a 2% increase representing around 4,100€ yearly which is not balanced by savings on transport or order picking (10h ≈ 150€).
What next?
Logistic workers are unanimously satisfied in implementing pallet-boxes as it facilitates their work on many aspects: pallet transport, order picking, waste disposal. Despite being costlier, a decision has been made to implement pallet-boxes in the long-term in order to improve waste management and working conditions of logistic workers. Our hospital pharmacy is already thinking about extending pallet-boxes to other references in order to assess more precisely their impact on MSD in logistic workers.
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.