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Official websites use. Share sensitive information only on official, secure websites. In the hospital setting, the medication-use system for temperature-sensitive drugs is a high-risk process. To analyze the risks associated with the hospital-based medication-use process and to propose corrective and preventive actions for the most critical failure modes. A multidisciplinary team was trained to analyze the medication-use process for temperature-sensitive drugs and to identify potential failures using a risk analysis method known as failure mode, effects, and criticality analysis FMECA. The most critical failure modes were selected using the Pareto law, and relevant improvement actions were proposed. This analysis identified 41 failure modes for the 9 stages of the medication-use process, of which only 36 were deemed assessable by the participants. A total of 48 corrective actions were proposed. The proposed action plan prioritized 3 areas for improvement: the documentation system, staff training, and equipment acquisition. A second FMECA should be carried out to reassess the medication-use process after implementation of these improvement actions. The second FMECA, allowing detection of residual risks and identification of new risks, will be part of a continuous improvement process. Keywords: cold chain, temperature-sensitive drug, risk management, patient safety. Any improper operation in the process of cold chain logistics may have a significant effect on the quality of temperature-sensitive drugs and vaccines, endangering the safety of patients receiving them. For example, power outages, inadequate conditions during transport, or unsuitable storage conditions can lead to a break in the cold chain, causing the degradation of vaccines and other pharmaceuticals. Indeed, the hospital pharmacist represents an essential link in the cold chain, intervening in almost all stages of the system, from purchase and supply to administration to patients. Errors may occur at any stage of the process, with the pharmacist being responsible not only for identifying the failures but also for evaluating them and implementing the measures necessary to correct or prevent them. The objectives of this study were to analyze a priori the potential failure modes of the medication-use process for temperature-sensitive drugs and to propose corrective and preventive actions, by setting up a concrete action plan to minimize the risks and ensure the safety of the system and thus the safety of patients. This study was a failure mode, effects, and criticality analysis FMECA , carried out in the pharmacy department of a university hospital over a 3-month period October to December The FMECA involved 6 steps: training, functional analysis, qualitative study, quantitative study, determination of the hierarchy of criticality, and proposals for improvement. A multidisciplinary working group was trained to ensure consistency in the discussion and rating of failure modes. The group was made up of 8 members: 2 pharmacists H. For implementation of the study, 4 bimonthly meetings were scheduled. This method allowed us to analyze the various stages, to define the main actors at each stage, and to describe the medication-use process clearly and simply. The working group identified potential failure modes by brainstorming. For each failure mode, the possible effects on or consequences for both the patient and the temperature-sensitive drugs were defined, the causes of failure were identified, and various means of detecting the risk were found. For each stage of the medication-use process, a summary matrix of failure modes, as well as their causes and effects, was developed. The same matrix was used for rating the frequencies, detectability, and severity of failure modes according to proposed scales Table 1. Decisions were based on voting by the working group, with divergent ratings subject to discussion to ensure consensus. The criticality index of each failure mode was calculated as the product of frequency, detectability, and severity. This calculation made it possible to prioritize the various failure modes identified and to appropriately target actions to be taken. For this purpose, the working group used a Pareto diagram. After ranking the failure modes in descending order according to their respective criticality indexes, the cumulative criticality indexes and the percentages of cumulative criticality indexes were calculated for application of the Pareto law. Once the most critical failure modes were identified, corrective action plans were put into place. A total of 41 failure modes were identified and subjected to analysis. The working group deemed 5 failures to be non-evaluable, because they were not specific to the medication-use process for temperature-sensitive drugs. Three of these failure modes belonged to the first stage, relating to purchase and supply error in supply of the product, delay in supply of the product, insufficient amount ordered relative to need ; one occurred in the second stage, relating to delivery and transport delivery error ; and one occurred in the seventh stage, relating to dispensing to care units error in dispensing. In the end, 36 failure modes were selected for evaluation Table 2. Criticality indexes were calculated for the failure modes identified in the qualitative study. The calculated values were between 4 and 60, as shown in Table 2. According to the Pareto law, 18 of the 36 failure modes were critical, having criticality indexes between 12 and Figure 3 illustrates the Pareto chart. Pareto chart. The failure modes FMs are presented along the horizontal axis in descending order of their criticality index. The solid black curve depicts the cumulative percentage of the criticality index. According to the most critical failure modes selected by the Pareto law, the working group proposed several ameliorative, corrective, and preventive actions. Monitoring indicators were put in place to measure the impact of these improvement actions. The first indicator chosen by the working group was the number of temperature alerts, an indirect measure of the efficacy and safety of temperature-sensitive drugs. The second monitoring indicator was the state of operation of cold chain equipment, to identify maintenance needs, with the goal of preserving the quality of temperature-sensitive drugs. This indicator is used for operational purposes i. Controlling the cold chain remains a topical issue for hospitals. It is linked to a triple risk: a financial or economic risk, a regulatory risk, and above all a risk to patients if the quality of a drug is altered. In this study, the a priori analysis of risks associated with the medication-use process for temperature-sensitive drugs was carried out by the FMECA method because it is the most suitable method for the hospital setting, according to several previous studies. This method of combining ideas is 1 of the 7 basic tools of quality. Moreover, the FMECA helps in identifying the most important critical events, which is helpful for deciding upon and prioritizing improvement actions. In the AMELIORE study, the team opted for a criticality threshold beyond which recommendations were made 23 ; however, they did not explain their choice of threshold value. Arenas Villafranca and others 24 classified failure modes according to their relative importance. Again, however, the method of selecting priority risks was not specified. In the current study, the Pareto law was used to define critical failure modes. The criticality index can be rated according to a scale that allows visual assessment using a colour code: green for acceptable, yellow for tolerable, and red for unacceptable. It can be divided into 3 or more levels, for example, acceptable, tolerable, and unacceptable risk or, alternatively, low, high, and major criticality. Improvement actions are then prioritized according to these categories. The Pareto law allowed us to select 18 critical failure modes. The stage with the most failure modes was storage in patient care units. Conversely, the stages of delivery and transport and of receipt of the order at the storehouse had the least critical failure modes. These results cannot be directly compared with any study in the literature because we found no prior studies using FMECA to analyze the medication-use process for temperature-sensitive drugs. Instead, we compared our results with those of studies using the FMECA method and studies on improvement of the cold chain. One study of the latter type, conducted in a health care establishment, highlighted 14 critical points along the entire medication-use process for temperature-sensitive drugs, beginning with delivery by suppliers and ending with delivery to patients 11 ; by comparison, we found 18 points of critical failure. Some failure modes were common to the earlier cold chain study 11 and our analysis, namely, noncompliance with the cold chain during transport from the supplier, absence of temperature indicators in the medication packages, noncompliance of pharmacy refrigerators and cold rooms, noncompliance with the cold chain during transport to clinical departments, and storage conditions for products requiring temperature control in compliant refrigerators in clinical departments. Indeed, the delivery and transport stage in our study showed a single critical failure with a criticality index of 24, suggesting noncompliance with the cold chain during transport. This crucial stage must be appropriately controlled, given it is the first link in the entire cold chain. The study by Saint-Lorant and others 11 similarly showed that the transport stage is critical. The only efficient way to transport temperature-sensitive drugs is to use a refrigerated truck, to equip the packages with a USB temperature recorder, and to train logistics staff. To secure this stage, it is important to check the USB temperature recorder of the order upon receipt, to prioritize documentation of receipt of temperature-sensitive drugs, and to put them away promptly. Saint-Lorant and others 11 suggested limiting the number of people involved in accepting medication deliveries and to make the receptionist aware of the importance of this task. Eleven of the 18 critical failure modes identified in the current study involved storage: at the storehouse, in the various pharmacy units, and in patient care units. Three failure modes related to storage in the storehouse were deemed critical. The first was a difference between the temperature shown on the display and the actual temperature. To remedy this potential failure mode, the working group proposed qualifying the refrigerated cabinets, to verify that the device continued to operate well under actual conditions of use over time monitoring of continuous temperature recording, regular verification of proper functioning of the alarms, renewal of the characterizations of the refrigerated cabinet , calibrating the thermometers, and putting in place preventive maintenance procedures. The second critical failure mode was a power outage, for which the main action proposed was installation of an audible alarm system. A remedial procedure in case of a break in the cold chain and the establishment of a preventive maintenance schedule for electrical installations were also proposed. Saint-Lorant and others 11 planned to group temperature-sensitive drugs into categories according to their stability, to allow their retrieval in case of a break in the cold chain. To address this potential failure mode, staff were asked to unpack the drugs quickly before storing them. The stage of storage in the various pharmacy units had 3 critical failure modes according to the Pareto law: a difference between the temperature displayed by the thermometer and the actual temperature, power outage, and refrigerator door not closed properly. The proposed improvement actions were to train staff and ensure preventive maintenance of equipment. Storage in the patient care units represents the penultimate stage of the medication-use process; it is crucial because it is the last step before drug administration. This stage also had the greatest number of failure modes of any stage: there were 9 failures, 5 of which were critical according to the Pareto law: difference between the temperature displayed by the thermometer and actual temperature, required temperature not reached in refrigerator, medication left outside the refrigerator before storage, inadequate storage in the refrigerator e. The corrective actions were as follows: training of paramedical staff and sensitization to the challenges of the cold chain, monitoring the temperature of refrigerators 3 times daily, and returning to the pharmacy any temperature-sensitive drugs not administered to patients to avoid cluttering refrigerators on the care units. Regular pharmaceutical audits within the various clinical services have also been proposed. Saint-Lorant and others 11 have also provided for pharmaceutical audits in clinical services to remedy fault points and to put in place any corrective actions needed to improve the cold chain. Similar to other work using FMECA, 26 , 27 subjectivity in the rating of each risk was the main limitation of this study. In fact, the identification of failure modes and their rating are mainly based on the risk perceptions of various health care professionals, given that everyone participates and reacts according to their own experience. In this study, storage in patient care units was the stage of the medication-use process with the most critical failure modes and required the most interventions to ensure patient safety. Securing this high-risk process is a means of ensuring the efficiency of patient care within the framework of continuous quality improvement. Admittedly, implementation of quality improvement measures appears to be difficult, time-consuming, and expensive; however, such an approach makes it possible to prevent the deterioration of temperature-sensitive drugs and thus to reduce the financial losses due to breakdown of the cold chain. A second FMECA should be carried out to reassess the medication-use process after implementation of improvement actions. As a library, NLM provides access to scientific literature. Can J Hosp Pharm. Show available content in en fr. Find articles by Hana Sakly. Find articles by Ines Chakroun. Find articles by Khouloud Ben Jeddou. Collection date Summer. In submitting their manuscripts, the authors transfer, assign, and otherwise convey all copyright ownership to CSHP. Open in a new tab. Competing interests: None declared. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. No impact on the drug drug stable, packaging intact. Alteration of packaging, with no effect on the drug. Decrease in duration of stability of the active substance alteration of active substance. Degradation of active substance; drug not administered to patients. Degradation of active substance; safety or therapeutic effectiveness compromised in the event of administration to patients. Exceptional, no record of occurrence or virtually nonexistent. High: probability is high that failure mode will be detected before it reaches the patient. Possible: failure mode can be detected, but there is a risk of it being overlooked. Unlikely: detection of failure mode is difficult. Noncompliance with cold chain during transport. Medicines left outside refrigerated cabinet before storage. Door of refrigerated cabinet not closed properly. Prolonged or frequent opening of door to refrigerated cabinet. Required temperature not reached in refrigerated cabinet. Storage of boxes in unsuitable space in storehouse. Refrigerated cabinets cluttered with medication. Difference between temperature showing on refrigerated cabinet display and actual temperature. Distribution from storehouse to pharmacy units. Advance preparation of orders for temperature-sensitive drugs. Noncompliance with cold chain during transport to pharmacy units. No monitoring of compliance with cold chain in the reception area. Difference between temperature displayed on thermometer and actual temperature. Required temperature not reached in refrigerator. Prolonged or frequent opening of refrigerator door. Inadequate storage in refrigerator in vegetable drawer or in door or in contact with freezer compartment or frozen walls of refrigerator. Storage of boxes in an unsuitable space within pharmacy unit. Dispensing from pharmacy to the various care units. Noncompliance with cold chain during transport to care units. Medication left outside refrigerator before storage. Inadequate storage in refrigerator in vegetable drawer or in door or in contact with freezer compartment or frozen walls of the refrigerator. Storage of temperature-sensitive drugs outside refrigerator in the cabinet. Extended interval between taking medicine out of the refrigerator and administering it to patient. Error in preparation of temperature-sensitive injectable drugs: injection without prior warming. Set up a preventive maintenance procedure for refrigerators. Put in place suitable packaging and isothermal bags for transport. Place the USB temperature recorder inside the package from the time of order delivery to allow visualization of the temperature variation curve. Set up a procedure to organize the receipt of temperature-sensitive drugs. Set up a preventive maintenance procedure for refrigerated cabinets. Designate an agent responsible for collecting the order and putting it away. Raise awareness and train paramedical staff on the importance of respecting the cold chain. Develop a procedure for receipt of temperature-sensitive drugs in patient care units. Plan the departure time of the truck according to traffic conditions, and choose the shortest route possible. Assign the truck driver only one task to collect the order of the temperature-sensitive drugs. Acquire a refrigerated truck and a USB temperature recorder. Develop a procedure to organize the transport stage of temperature-sensitive drugs. Implement a procedure in case of a break in the cold chain. Install a preventive system for activation during natural disasters. Ensure regular maintenance of the electrical installation. No monitoring of compliance with cold chain in reception area. Distribution to pharmacy units from storehouse. Acquire coolers or isothermal packets for delivery to clinical services. Perform pharmaceutical audits in clinical departments. Extended interval between taking medicine out of refrigerator and administering it to patient. Inform and train paramedical staff on rules for using temperature-sensitive drugs. Distribute tasks within the service for better organization. Dispensing from the pharmacy to the various care units. Take temperature-sensitive drugs out of refrigerated storate at the last minute before they are dispensed. Empty boxes of temperature-sensitive drugs and transfer to refrigerated cabinet upon receipt. Organize the frequency of orders for temperature-sensitive drugs as needed.

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