WHEN CRISIS BECOMES COLLABORATION: A NATIONAL RESPONSE TO COMPOUNDED MEDICINES SHORTAGES
European Statement
Introductory Statements and Governance
Author(s)
F.H. Nielsen
A.G Pedersen
L. Jensen
M. Kristoffersen
P. Stoffersen
T. P Dahl
Why was it done?
The shutdown significantly increased the risk of shortages for 271 compounded medicines, many vital for specialised treatments. To secure patient safety and equal access, a coordinated national approach was required to mobilise production capacity and set priorities. Due to the short shelf life of compounded medicines, it was crucial to establish a rapid national response to prevent critical shortages.
What was done?
Following the sudden shutdown of a compounding pharmacy, a national response was initiated. A joint online platform was established between the National Group for Compounded Medicines and the National Task Force for Medicine Shortages, both composed of representatives from hospital pharmacies. This platform consolidated data and decisions, ensuring planning through a national perspective. Based on the merged data, production was coordinated between remaining compounding pharmacies, both public and private, to ensure supply.
How was it done?
An online platform was established to track stock levels across hospital pharmacies, and clinical criticality was assessed on a 1–3 scale visualised with a colour code showing national coverage in days or weeks. Oral solutions with short shelf life were identified as top priority due to imminent stock depletion. Each product was reviewed for possible substitution, therapeutic alternatives, or justification for compounding. Short-term measures included extemporaneous preparation, while long-term strategies involved outsourcing, substitution, and redistribution of stock. Regular national meetings ensured the remaining two compounding pharmacies developed joint production plans, distributing workload and adjusting capacity.
What has been achieved?
This initiative demonstrates how hospital pharmacies, through national collaboration, can ensure resilience in crises. Within two months, nearly all medicines were reintroduced, substituted, or outsourced, and supply maintained without major safety incidents. The national approach included both public and private pharmacies, and their collaboration was strengthened.
What next?
The model provides a transferable framework for future shortages, proving that collaboration, shared data, and prioritisation tools can ensure patient safety and equity of access. The same model has since been applied to other critical shortages, confirming its broader value.
ARTIFICIAL INTELLIGENCE AND AUTOMATION: TRANSFORMING HOW WE MANAGE DRUG RECALLS AND MEDICINE SUPPLY NOTIFICATIONS
European Statement
Patient Safety and Quality Assurance
Author(s)
Anna Lydon & Jonathan Day
Why was it done?
National drug recalls and Government issued Medicines Supply Notifications (MSNs) must be responded to promptly to minimise risk to patients and ensure stock safety. Within our Trust, comprising four hospital sites at different locations, an incident occurred where a recall email received over a bank holiday weekend which went unnoticed. The existing system relied solely on staff checking their emails, which posed a risk of delayed action—particularly during weekends, leave periods, and across multiple sites. This highlighted the need for a more robust and transparent process to ensure that all recalls and MSNs are received, actioned, and tracked in real time.
What was done?
A digital process was developed using Microsoft Power Automate and Artificial Intelligence (AI) to automate the handling of drug recalls and MSN emails. The flow triggers when a drug recall or MSN email is received. It extracts key information using AI and automatically distributes the information across the relevant pharmacy and clinical teams across all Trust sites.
How was it done?
When a drug recall or MSN email is received, the attached PDF is analysed with an AI model trained with specific prompts to extract key fields including the drug name, MSN number, date, impact level and required actions. The extracted data automatically populates the MSN or drug recall Excel log – replacing what was a manual data entry process. Power Automate then initiates an approval process and posts a summarised Teams notification into a Teams channel for all relevant members. Each member receives the alert and one person from each site must acknowledge receipt. Following acknowledgement from a member of each site, Power Automate posts a confirmation in the Teams channel, enhancing transparency and providing assurance that the recall has been actioned. AI determines the appropriate clinical speciality for the drug and automatically directs a summary email to the corresponding pharmacists and clinicians working in that area.
What has been achieved?
The process ensures consistent and timely handling of recalls and MSNs, reducing reliance on individual inbox monitoring. It has improved visibility across all sites, eliminated missed notifications, and significantly reduced manual data entry time. Staff feedback has been positive, with greater confidence that all recalls and MSNs are captured and actioned promptly.
What next?
Future plans include integrating automatic escalation plans for unacknowledged alerts. The same model could also be expanded to other time-critical communications, such as National Patient Safety Alerts to further strengthen medicines governance across the organisation.
OPTIMIZATION OF PEGASYS® DOSING THROUGH SYRINGES IN THE HOSPITAL PHARMACY: ENSURING SUPPLY DURING A GLOBAL SHORTAGE
European Statement
Selection, Procurement and Distribution
Author(s)
Torres-Pérez, Andrés
Iglesias-Valín, Ana Rut
Mateos-Salvador, María
Fernandez-Gabriel, Elena
Feal-Cortizas, María Begoña
Fernandez-Diz, Clara
Gómez-Costa, Eva
Caeiro-Martinez, Laura
Margusino-Framiñán, Luis
Why was it done?
An individualized dosing procedure for Pegasys® (peginterferon alfa-2a) was implemented, using syringes adjusted to the prescribed dose. The primary aim was to guarantee continuous and safe patient treatment during the global shortage, while also optimizing the use of 90 µg vials.
What was done?
In 2024, a worldwide supply disruption of Pegasys® occurred, creating a risk of treatment interruption for hematology patients. Since many prescriptions were below 90 µg, direct vial use caused significant drug waste and aggravated the shortage. A fractionation system was developed, combining coordinated workflow and a risk-based stability assignment, to ensure continuity of care for all patients with the additional benefit of reducing economic impact. The project started on 21 October 2024 and remains ongoing.
How was it done?
A structured workflow between hematology and the hospital pharmacy was established. After each medical visit, the hematologist contacted the pharmacist responsible for the hematology outpatient clinic, who reviewed the prescription and informed the compounding pharmacists of the preparation schedule and updated doses. Syringes were filled under aseptic conditions, stored at 2–8°C protected from light, and delivered to the hematology pharmacy clinic the day before dispensing.
The 30-day stability was assigned according to the hospital’s risk assessment matrix, supported by published stability data from similar products. The process was internally validated in line with hospital compounding standards.
What has been achieved?
To date, the strategy has allowed treatment of 18 patients, with 332 syringes obtained from 90 µg vials, the majority of which corresponded to 45 µg or lower doses. This approach achieved a 51% reduction in the number of vials used, representing savings of €20,791.
Most importantly, no patient experienced treatment delays or interruptions, ensuring therapeutic continuity and safe handling during the global shortage. No stability issues or administration-related problems were reported.
What next?
The protocol will be maintained in our hospital and could be adapted by other centers facing similar shortages. This experience highlights the key role of hospital pharmacists not only in cost management, but above all in the guarantee of safe and continuous access to essential medicines.
INTEGRATED STRATEGY FOR THE MANAGEMENT OF MEDICINE SHORTAGES: INFORMATION, COORDINATION AND PATIENT SAFETY
European Statement
Selection, Procurement and Distribution
Author(s)
N. El Hilali Masó
B. García Javier
R. Merino Mendez
M. Sancho Riba
A. González Bote
J. Fabregas Cortes
R. Diez Hernandez
F. Sala Piñol
Why was it done?
Medicine shortages are increasingly frequent and represent a critical challenge for hospital pharmacy services. These shortages can impact both the procurement and use of medication, potentially compromising patient safety. The introduction of alternative presentations or therapeutic options may lead to errors, particularly dosing errors or issues related to look-alike/sound-alike medicines.
Furthermore, the growing number of outpatient referred from community pharmacies due to shortages increases the pressure on hospital pharmacies and may delay treatment access for patients.
What was done?
Define a system that unifies and updates information on shortages and ensure accurate and timely communication of therapeutic alternatives and associated risks to healthcare professionals and reduce the risk of medication errors associated with alternative drugs. Likewise, a communication channel has been established to strengthen coordination with community pharmacies for the dispensing of medicines to outpatients.
How was it done?
An internal file was created to monitor active shortages and available alternatives for both inpatients and outpatients. When a substitution posed a risk related to prescribing or administration (e.g. dosage errors or look-alike/sound-alike) informative sheets were developed as a preventive measure to reduce medication errors.
What has been achieved?
Unify and update available information. 55 medicine shortages were actively managed through the implemented system. Three information sheets have been prepared to prevent administration errors (nitroglycerin, amiodarone, cotrimoxazole). Pharmacist staff have rapid access to validated information that allows healthcare professionals to take faster and safer clinical decisions. This has also improved collaboration with community pharmacies to enhance the outpatient access to needed medicines, reducing delays and patient burden.
What next?
Integration with the new hospital IT system will enable automated alerts and direct access to therapeutic alternatives through Pharmacy program.
Plans are in place to expand the network of collaborating community pharmacies, allowing patients to collect medicines locally during shortages, reducing unnecessary hospital visits and improving continuity of care. Monitoring and evaluation processes will be established to track the impact of this strategy on patient safety and healthcare efficiency.
COORDINATION OF MEDICATION SHORTAGE MANAGEMENT WITHIN THE PHARMACY SERVICE AND ACROSS HEALTHCARE LEVELS
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Palacio-Lacambra, ME
Cabañas-Poy, MJ
Lalueza-Broto, MP
Florensa-Royo, E
Fernández-Polo, Aurora
Marrero-Álvarez, P
Juárez-Giménez, JC
Gabarro-Portella, G
Gorgas-Torner, MQ
Why was it done?
The problems caused by medication shortages are significant, pose a risk to patient care, and require good coordination between different levels of the healthcare system (primary care and hospital pharmacy services (PS)). Drug shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in medication errors.
The objectives of the working group are to define the internal processes of the PS regarding the management of and communication between professionals about medication supply shortages and to coordinate the referral of primary care community patients for dispensing at the hospital.
What was done?
A multidisciplinary working group was established, including representatives from various pharmacy areas (management, outpatient dispensing, drug information center, pediatrics) and representatives from the Primary Care Medication Management Area in our Health Region, where our center serves as the reference hospital.
The “Supplier Shortage Working Instruction” has been updated, and a pathway has been established for referring patients from primary care to the outpatient pharmacies (adult and pediatric) of our hospital.
How was it done?
Internal meetings of the PS were held to update the “Supplier Shortage Working Instruction,” considering the different situations of medications in shortage (exclusive and/or non-substitutable, substitutable, and community pharmacy medications in shortage).
A meeting with Primary Care representatives was conducted to define the pathway for referring community patients with medications in shortage imported from abroad through the Spanish Agency of Medicines and Medical Devices.
What has been achieved?
The internal working instruction has been redefined, and a shared resource for the entire PS has been created to centralize relevant information for the management of medications in shortage, which is kept up-to-date.
A referral pathway has been established for Primary Care patients to the outpatient pharmacies of our hospital. Two pharmacists from the PS coordinate shortage information with Primary Care. Primary Care reports the number of patients with active prescriptions requiring medication, which ensures adequate stock levels and enables patient scheduling to enhance their experience.
What next?
Having an internal pathway has improved the management of medication shortages in the PS, as well as enabled the coordinated referral of community patients.
It is applicable to all PS involved in dispensing foreign medications due to shortages.
THE OCCURRENCE OF SHORTAGES AMONG COMMONLY USED MEDICATIONS AT COPENHAGEN UNIVERSITY HOSPITAL, AMAGER AND HVIDOVRE (AHH)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Ina Vierø Rinder, IVR
Why was it done?
Handling medication shortages in the hospital pharmacy are time-consuming, and a lot of resources are used to find alternatives. Though shortages are a national focus in Denmark, shortages are not a priority focus in the local hospital pharmacy. Shortages are often handled “on-the-go” locally and therefore not prioritized. The hospital pharmacy uses “Medication News”, posted on internal website, to broadcast information about long-term shortages to the hospitals. The aim was to determine the occurrence of shortages among commonly used medications at Copenhagen University Hospital, Amager and Hvidovre (AHH).
What was done?
A top 100-list of most bought packages of individual chemical substances (ATC5-level) was generated. The purchase data were obtained from the hospital pharmacy at AHH for the period from October 2023 to September 2024.
How was it done?
The list was analyzed to determine how many medications had experienced shortage during the specified period. The analysis was conducted by reviewing past “Medication News”, historical e-mails regarding shortages, and the hospital pharmacy’s own record of shortages.
What has been achieved?
The top 100-list of most bought packages of individual chemical substances (ATC5-level) revealed a total of 1149 item numbers. The 500 item numbers in ATC-level V07AZ** (Chemicals and reagents for analysis) were excluded due to their use. Of the remaining 649 item numbers, 43 item numbers had experienced shortage during the specified period. Of the 43 item number shortages, 22 (51 %) had resulted in a “Medication News” on the internal website. The shortages were distributed in the ATC-levels A (16 %), B (9 %), C (5 %), D (2 %), H (9 %), J (12 %), L (5 %), M (7 %), N (30 %), R (2 %) and S (2 %).
What next?
The generated data of the top 100-list of used chemical substances has given rise to more attention on shortages in the hospital pharmacy. In the future it is assumed that the number of shortages will rise, and it should be possible to increase the attention of short-term shortages by using the obtained data e.g., integrate the data in a daily status meeting. Thereby the shortages can be handled as a priority and not “on-the-go”.
PharmaSwap: a pioneering healthcare initiative reducing medication waste and promoting sustainability
European Statement
Selection, Procurement and Distribution
Author(s)
Piter Oosterhof, Jelmer Hein Faber, Lieke van Kerkhoven, Rob Haenen
Why was it done?
PharmaSwap is a response to the significant issue of medication waste in the healthcare sector. The problem of medication waste was well-documented, with scientific research indicating that annually, a minimum of €100 million worth of prescribed medications was being discarded in the Netherlands. These medications were being wasted when they reached their expiration dates, resulting in both financial losses and environmental pollution. PharmaSwap was introduced to tackle the problem of medication waste by creating an online platform that enables pharmacists and pharmaceutical wholesalers to list and sell medications with approaching expiration dates at discounted rates. Our initiative sought to improve the situation by not only reducing the financial losses associated with medication waste but also by addressing the environmental concerns linked to the disposal of medications. By promoting the reuse of medications and encouraging a shift toward sustainability in the pharmaceutical sector, PharmaSwap aimed to make a positive impact on healthcare and the environment.
What was done?
The initiative that has been developed and implemented is https://www.PharmaSwap.com. PharmaSwap is an online marketplace established in 2018 by pharmacists Piter Oosterhof and Jelmer Faber. This platform facilitates the exchange and sale of medications among (hospital) pharmacies and pharmaceutical wholesalers that are nearing their expiration dates at discounted rates.
How was it done?
The introduction of PharmaSwap faced several obstacles:
1) Regulatory barriers: initially, regulations didn’t allow medication redistribution. We collaborated with regulatory bodies to find a legal solution.
2) Legal adjustments: we worked with authorities to amend regulations, creating a legal framework for PharmaSwap.
3) Building trust: gaining trust from pharmacists and wholesalers required transparent communication and showcasing benefits.
4) Technical development: developing the platform required the right tech partners and resources.
5) Awareness and adoption: we conducted awareness campaigns and partnered with (inter)national associations to promote PharmaSwap.
Through these efforts, we successfully overcame obstacles and implemented PharmaSwap, reducing medication waste and promoting sustainability.
What has been achieved?
1) Medication waste reduction: PharmaSwap has significantly reduced medication waste, preventing the disposal of medications, while pioneering a unique and innovative approach.
2) Environmental impact: PharmaSwap has saved 9,719 packaging units, leading to a substantial reduction in environmental pollution from medication disposal.
3) Cost Savings: healthcare systems have saved €1,165,115 by recovering the value of otherwise discarded medications.
4) Network growth: PharmaSwap connects 836 out of 2,000 Dutch pharmacies and collaborates with 8 pharmaceutical wholesalers, including one partner compliant with Good Distribution Practice (GDP).
These outcomes highlight PharmaSwap’s impactful contributions to waste reduction, cost savings, and sustainability in healthcare, supported by its expanding network of participants.
What next?
PharmaSwap’s success in reducing medication waste, saving costs, and promoting sustainability makes it a compelling example of good practice in healthcare. Its transferability to other healthcare settings involves replication, regulatory adaptation, education, partnerships, technology integration, data management, and a commitment to continuous improvement. Moreover, we are currently in advanced meetings with several other European countries, exploring the potential for international expansion and collaboration to further extend the positive impact of PharmaSwap.
Designing a specific critical must-have medicine for our hospital
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
María Isabel Sáez Rodríguez, Marta Eguiluz Solana, Marta Miranda Magaña
Why was it done?
Shortages are common in our setting. Having a list of critical and must-have drugs (CMHD) specifically designed for our centre allows us to reduce risk of complications due to delays in drugs administration.
What was done?
Monitoring and mitigating potential shortages of critical medicinal products and medical devices by redacting a list of critical pharmacy and health products to have in our centre.
How was it done?
First, we conducted bibliographic research, finding official list of CMHD by FDA, EAHP, and AEMPS.
Afterwards, we crossed those lists with the pharmacotherapeutic guide (PTG) in our centre, identifying those drugs that are considered CMHP, and checking their stock.
Discrepancies between the list provided by official agencies and our PRG were evaluated by the clinical pharmacist, taking into account our centre complexity and surroundings, nearby hospitals and type of patients attended.
With our findings, we redacted a list of CMHP specifically designed for our centre.
What has been achieved?
During our revision, we found discrepancies between our PTG and the official lists of CMHD:
• Some medicines, like certain antidotes, were not considered CMHD. These drugs were included in our list, according to intoxications incidence in our area.
• Lack of stock of must-have products in the official list. Some of them, like coagulation factors, were not considered a CMHD in our centre due to their availability in nearby hospitals. Others, like albendazole, were not included due to low incidence of disease they treated.
Evaluating each drug necessity helped us identify certain health emergencies we may come across in our centre, and prepare for them accordingly. Also, stock revision showed us which medicines have suffered from shortages in the past.
Finally, we achieved our main goal of having a specifically designed list CMHD for our centre.
What next?
Doing a revision of must-have products and adapt it to the centre’s situation enables us to have a better stock control, and serves as a back-up in case of shortages. Our CMHD list must be periodically revised, making sure it adapts to any potential changes in our centre’s situation.
Measures taken in hospital management following the impact of the coronavirus pandemic.
European Statement
Selection, Procurement and Distribution
Why was it done?
The aim of the study is to assess the crisis impact on the consumption of pharmaceutical products in the intensive care unit in order to estimate, rationalize the need and prevent supply problems.
What was done?
Due to Covid-19 pandemic and its major economic impact, we carried out a comparative study of the consumption of pharmaceutical products in the intensive care unit before and during the crisis.
How was it done?
A list of pharmaceutical products to be evaluated has been established beforehand. The choice was made for the products most used in intensive care units in accordance with the recommendations of COVID management. The list includes drugs and medical devices.
In order to compare the consumption of these products in terms of quantity and cost, data collection was carried out over two periods, each of 6 months, before and during the crisis in Tunisia. The first from January 1st, 2019 to June 30th, 2019, the second from January 1st, 2021 to June 30th, 2021.
What has been achieved?
As a result of this assessment, it was possible to quantify the increase in several drugs and medical devices. It led us to:
-modulate our supply of these products
-take rationalization measures in cooperation with doctors
-develop management protocols according to the recommendations and available products
– close monitoring of prescriptions and compliance with protocols in order to optimize consumption, avoid any abuse and limit breaks as much as possible.
Tab. Variation of consumption and cost
Product Consumption2019 Consumption2021 Variation factor of the consumption Variation factor of the cost
Hypnotic curares 25 170 6.8 8.1
Antithrombotics 647 2286 3.5 8.1
Antibiotics 932 4060 4.4 11.2
Fluconazole 240 378 1.6 1.9
Dexamethasone 845 1268 1.5 2.0
Isolation gown 740 6925 9.4 7.8
Masks 6100 13300 2.2 2.2
hydroalcoholic products 123 217 1.8 1.8
What next?
A generalization of the drafting and updating of the protocols concerning the management and the dispensing is programmed for all the other departments which will be validated by the therapeutic committee and the antibiotics committee.
IMPLEMENTATION OF A BIGDATA ANALYSIS PROGRAM FOR STOCK MANAGEMENT IN A PHARMACY SERVICE
European Statement
Clinical Pharmacy Services
Author(s)
LUCÍA SOPENA, VICENTE GIMENO, OLGA PEREIRA, Mª ANGELES ALLENDE, RAQUEL FRESQUET, RAQUEL GRACIA, BEATRIZ BONAGA, MERCEDES ARENERE, TRÁNSITO SALVADOR, ALBERTO FRUTOS
Why was it done?
The growing technological development of pharmacy services involves the coexistence of traditional warehouses with automated medicine dispensing systems controlled by different computer programs. The information was splitted into different systems and databases giving rise to possible errors due to the greater complexity.
This is a threat but also an opportunity for the hospital pharmacist to lead the development, review, and improvement of medicine use processes and the use of health technologies.
KNIME data analysis covered the need of our Pharmacy Service to blend data from any source in a single file simplifying the process.
What was done?
The Pharmacy Service of a tertiary-level hospital has implemented Konstanz Information Miner (KNIME) data analysis and treatment program to optimize the stock management of several medicines.
How was it done?
An initial algorithm was designed by the union of 7 files and can be executed at any time to obtain the updated data.
What has been achieved?
This file provides up-to-date information about the stocks, stock-outs, consumptions, orders and purchasing data of all medicines (average price, laboratory, date and number of orders, units to be received).
In addition, KNIME calculated the coverage time from consumption, and the current stock in the warehouses, obtaining a global vision of highest turnaround pharmaceuticals drugs.
The program also allows linking and merging data of the list for shortages of medicines, supply disruptions and restocking time provided by the Spanish Agency of Medicines and Medical Devices (AEMPS).
KNIME program has been especially important in our Pharmacy Service during the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Big data analysis has allowed the hospital pharmacist to anticipate missing specialties and to make a rapid response in ensuring the availability of Essential Medicines List (EML) composed by 75 proposed by AEMPS and 138 by our hospital (e.g. antiinfectives, analgesics, muscle relaxants, anesthetics).
What next?
KNIME is a tool that could be successfully implemented and appropriately generalized as recommended to all Pharmacy Services that use different data sources, and want to have a generalized view of the information.
KNIME represents an advance in the stock and stockpiling management of medicines specialties to work more efficiently, which improve patient care and safety.