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SECURING THE COLD CHAIN: PORTUGUESE HOSPITAL PHARMACY RESPONSE TO THE 2025 NATIONAL BLACKOUT

European Statement

Patient Safety and Quality Assurance

Author(s)

Inês Carmo, Ana Parola, Inês Oliveira, Margarida Carvalho, Marta Carvalho, Ana Mirco.

Why was it done?

On April 28, 2025, a nationwide blackout affected Portugal, disrupting the national power grid and severely compromising the cold chain of vaccines in primary health care facilities, along with all forms of mobile communication. Given this event, the response by the Pharmaceutical Department (PD) of a Local Health Unit responsible for delivering vaccines to 38 Primary Health Care Facilities (PHCF) required evaluation due to major clinical, financial, and operational risks.

What was done?

Vaccines exposed to any temperature excursion during storage were identified and placed under quarantine, preferably using an alternative cold storage unit with an independent power source, when available, and distinctly labeled. Through a standardized notification form, each incident was promptly reported within 48 to 72 hours to the cold chain supervisor and PS. During the first week after the blackout, PS reviewed each report to determine the vaccine’s stability and possible return to the supply chain.

How was it done?

Hospital pharmacists collected key data such as temperature variations, time outside safe range, and affected vaccine batches. They consulted reliable sources (databases and Summary of Product Characteristics) and sought information from the supplier laboratory. Upon analyzing all data, PHCF received precise recommendations on suitability for ongoing use.

What has been achieved?

On April 28, 2025, 40 cold chain incidents were notified, affecting 12,442 vaccines units. After thorough analysis, 12,202 units were authorizes for use, reducing clinical and economic impact. Only 240 units were discarded, resulting in a loss of 6,018.50 € out of a total stock valued at 284 544, 60 €. Joint action by Pharmacist and PHCF assured continuity of patient care and vaccine safety, preventing disruptions to the National Vaccination Program.

What next?

The nationwide blackout exposed vulnerabilities in the PHCF cold chain, highlighting the need for more refrigerators, continuous electronic monitoring, backup generators, refrigerated vehicles, and standardized protocols between PS and PHCF.

A RISK-BASED APPROACH – INTRODUCING NEW COLD STORAGE FACILITIES

European Statement

Selection, Procurement and Distribution

Author(s)

Anne Flou Kristensen
Alice Østergaard Deleuran

Why was it done?

When introducing new storage facilities, a risk-based approach according to EU GMP/EudraLex – Volume 4, must be applied during implementation and qualification, to ensure supply continuity, product quality and patient safety.

What was done?

The existing cold storage facility was worn out and difficult to keep in compliance. The aim of the project was thus to implement a new compliant cold facility to ensure redundance and robustness and to accommodate current work processes related to cold storage.

How was it done?

The implementation was divided into different phases; design and dimensioning, and construction and qualification, where a risk-based approach was applied in each phase, securing the correct measures were considered at the right time. Further, qualification principles presented in EU GMP, Annex 15 were adapted, and a full qualification cycle including SAT, DQ, IQ, OQ and PQ was conducted.

What has been achieved?

The design and dimensioning of the facilities resulted in two separate cold storage rooms, supplied from two separate redundant refrigerating units. This secures robustness in case of system failure from one of the units, and in case of facility maintenance.
The risk-based qualification plan included the current workflows regarding cooling of large-volume products. A comprehensive DQ and IQ was conducted to secure correct design and installation, and OQ and PQ included different testcases encompassing extensive temperature mapping, hot and cold spot detection, max load-test, crash and recovery testing and daily operations to test if the storage facilities were compliant with correct storage conditions and current workflows.

What next?

The cold storage facilities were implemented according to the plan after a successful execution of the qualification. Qualification results identified check points to use in temperature monitoring and defining work-process parameters, e.g. door-opening time related to loading, to mitigate the risks of exceeding correct storing conditions. Further, in case of a deviation related to temperature or established workflows, the extensive results can be applied to evaluate and ensure the quality of stored items. The project demonstrates the importance of adapting quality by design approach, to enhance robustness and consistence when implementing new cold storage facilities.

OPTIMIZING HOSPITAL PHARMACY STOCKS WITH CC-MPC (CHANCE-CONSTRAINED MODEL PREDICTIVE CONTROL) APPROACH

European Statement

Selection, Procurement and Distribution

Author(s)

S.Hajjaj,I.Bennani, S.Alaoui, A.cherif Chefchaouni ,S.El Deeb,S. Boufaress, Y.Hafidi, S.ElMerrakchi,F. Bandadi, B.Moukafih,A.El Kartouti

Why was it done?

Hospital pharmacies frequently face drug shortages due to unpredictable demand, long lead times, and budget constraints. Traditional reorder point policies are insufficient for handling stochastic consumption, and shortages can impact patient care. Applying predictive and probabilistic control methods allows for optimized decision-making, reduces unnecessary orders, and ensures higher service levels.

What was done?

A predictive inventory management framework based on CC-MPC is being developed and assessed through simulation to optimize hospital pharmacy stock levels under uncertainty .

How was it done?

The approach combines:
1. Data collection: Weekly consumption data of strategic drugs over a defined period, including average delivery times and historical stockout events.
2. Probabilistic modeling: A normal distribution is used to characterize demand uncertainty, with mean (μ) and standard deviation (σ) based on historical consumption data.
3. CC-MPC model parameterization: includes Safety stock thresholds, probabilistic stockout risk levels, constraints (storage,order, operational and economical) adapted to the hospital’s context.
4. Prospective simulation: generates optimized ordering plans over 6–12 month horizons, using rolling-horizon updates.
5. Practical integration: daily recalculation of optimal orders based on updated consumption data.

What has been achieved?

Based on previous simulation studies, the CC-MPC approach has the potential to reduce the number of orders by 40% and average stock levels by approximately 10%, while preventing stockouts over extended periods. Estimated annual budget savings ranged from 1 000 € to over 27 000 €, highlighting the possible benefits of implementing this predictive framework in hospital pharmacies.

What next?

Once the method tested and data collected,the next step is to transform the method into a software application, which can be integrated into pharmacy operations. This program is designed for practical hospital use. It aims to optimize stock management under real-world conditions.

Can my medicine be returned to the refrigerator? Minimisation of wastage in case of storage incidents of cold-chain homecare medications

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European Statement

Clinical Pharmacy Services

Author(s)

Hilde Omestad, Maria Grønkjær Abrahamsen, Fatima Afif Mouaanaki, Charlotte Mosbæk Dybdahl, Anne Wulff Petersen, Emil Dalsgaard Züricho, Philip Hojrizi, Charlotte Arp Sørensen

Why was it done?

The sustainability strategy of the Central Denmark Region include less consumption and less waste. Our Pharmacy delivers an increasing amount of high-cost homecare medications, requiring refrigerator storage. In case of an accidental temperature exposure, patients may ask whether their medicine can be used or not. There may be a delay during transport or a breakdown of their refrigerator at home. During these medicines’ shelf-lives, most products can be kept at room temperature for days, weeks or months. When SmPC and the insert package leaflet says that the product should not be returned to the refrigerator, high-cost medicines sometimes are wasted, only because of this warning, instead of giving them a shorter shelf-life. When we hesitate to return packages to the refrigerator, time can elapse while waiting for the manufacturer’s or pharmacist’s answers to the patient’s questions after storage incidents.

What was done?

The Hospital Pharmacy categorized 47 Blood Coagulation Factors and Monoclonal Antibody Products requiring storage at 2-8 °C if Summary of Product Characteristics (SmPC) had any warning of returning a product to the refrigerator or not, after an unwanted time at room temperature

How was it done?

We asked manufacturers if a return of their product to the refrigerator would cause any harm. Should their product be disposed of because it has been put back into a refrigerator after being left out? Our findings were documented in a local guideline and in the Danish national information database (SAID).
Drug Information Pharmacists discussed several cases of real-world handling situations to be more confident to reduce medicine wastage.

What has been achieved?

Being aware of the reasons for these warnings, reduced medicine wastage in certain cases of incidental storage. The pharmacists have been given tools for pharmaceutical professional assessments in cases of temperature challenges.

What next?

Spread the good news. Improve communication between manufacturer and pharmacy, because manufacturer can’t be responsible for storage different from their SmPC. Inspire manufacturers to improve their storage warnings in SmPC

OPTIMIZATION OF RISK MANAGEMENT OF DRUGS COLD CHAIN IN HOSPITAL BY FAILURE MODES, EFFECTS AND CRITICALITY ANALYSIS “FMECA” METHOD

European Statement

Selection, Procurement and Distribution

Author(s)

Ismail Bennani, Amine Cheikh, Hafid Mefetah, Mustapha Bouatia

Why was it done?

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

What was done?

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

How was it done?

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

What has been achieved?

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

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

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

What next?

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

LEARNING FROM RETURN: HOW RETURNS CAN HELP TO IMPROVE THE PROCESS OF DISTRIBUTION

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European Statement

Selection, Procurement and Distribution

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.