Calidad en la conservación de los medicamentos termolábiles en el ámbito domiciliario

Cuellar, Mendieta; Marco, José Luis Alejandre; Pérez-Castelló, I.; Escrivá, Ángeles

doi:10.1016/j.cali.2009.09.001

“…Refrigerators older than 5 years appeared as the only signi cant risk factor for inadequate storage. Both studies included a limited sample size and used mean temperature as the main variable 3 . Even though mean temperature was con rmed to correlate with consecutive time out of range in their second work, we believe mean temperature limits the results by reducing the amount of data.…”

Section: Discussionmentioning

confidence: 99%

“…There are few data on the temperature conditions in which TD are stored once dispensed to patients. Two studies conducted in Spain showed that at least half of patients did not maintain an acceptable mean temperature during transport and home storage 2,3 . Using a stricter de nition of adequate conditions of storage, a publication on biologic disease-modifying antirheumatic drugs found that only 6.7% of patients had stored their medications within the recommended range 4 ; while a similar study on golimumab showed that only 11.6% of injectors had been correctly stored 5 .…”

Section: Introductionmentioning

confidence: 99%

Thermolabile Drug Storage in an Ambulatory Setting

Pazo-Oubiña

¹

,

Alorda

²

,

Gómez-Lobón

³

et al. 2020

Preprint

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BackgroundMore and thermolabile drugs are becoming available, and in most cases, these medications are dispensed to ambulatory patients. However, there is no regulation once medications are dispensed to patients and little is known with regard to what happens during transport and home storage. Previous studies suggest that these drugs are improperly stored. The present study was designed to determine the storage conditions of thermolabile drugs once they are dispensed to the patient in the Hospital Pharmacy Department.MethodsThis is a prospective observational study to assess the temperature profile of 7 thermolabile drugs once they are dispensed to ambulatory patients at a tertiary care hospital. A data logger was added to the medication packaging. Temperature was considered inappropriate if one of the following circumstances were met: any temperature record less than or equal to 0ºC or over 25ºC; temperatures between 0-2ºC or 8ºC-25ºC for a continuous period over 30 minutes. The time series of temperature measurements obtained from each data logger were analyzed as statistically independent variables. The data shown did not undergo any statistical treatment and must be considered directly related to thermal measurements.ResultsOne hundred and fourteen patients were included and 107 patients were available for the analysis. On the whole, a mean of 50.6 days (SD 18.3) were measured and the mean temperature was 6.88ºC (SD 2.93). Three data loggers (2.8%) maintained all the measurements between 2ºC and 8ºC with less than 3 continuous data (< 30 minutes) out of this range but no data over 25ºC or below or equal to 0ºC. 28 (26.2%) data loggers had at least one measurement below zero, 1 data logger had a measurement greater than 25ºC and 75 (70.1%) were between 0ºC and 2ºC and/or between 8º and 25ºC for more than 30 minutes.ConclusionsOnce dispensed to patients, most thermolabile drugs are improperly stored. Future studies should focus on clinical consequences and possible solutions.

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“…In addition, an observational, prospective study published in Spain in 2010 assessed conservation conditions of two BTs in the homes of 60 patients. The study revealed that 58.3% kept the medication within incorrect temperature ranges (15). Deviations were higher when the fridge was older: fridges older than 5 years were considered a risk factor for inadequate storage (Relative Risk, 1.68; 95% confidence interval 1.04–2.71; p=0.02).…”

Section: Discussionmentioning

confidence: 99%

Survey on transportation and storage of biological therapies by patients

Saavedra¹,

Aimo²,

Andrade³

et al. 2019

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Objective To assess key aspects of transportation and storage of biological therapies (BTs) on the part of the patients, from the time they collect them from the pharmacy up until the moment of administration. Methods This was a cross-sectional study in the form of a survey completed by outpatients older than 18 years who were administered BTs. The survey was carried out by the authors between August 2016 and January 2017. Results A total of 83 outpatients were interviewed (mean age, 53; standard deviation, 15; 76% female). Sixty percent had rheumatoid arthritis, 24% had psoriatic arthritis, and 16% sustained other rheumatic and inflammatory diseases. Twenty percent had not been informed of the importance of proper refrigeration when they were first prescribed BTs; 77% had acquired the medication at least 7 days before administration; 28% had misplaced the drug in the fridge (65% of them in the freezer); 90% was unaware of the temperature range at which the BT should be kept in the fridge, and only one (1%) of them had once used a thermometer to find out the fridge temperature. Fifty-three percent had suffered frequent power outages the previous summer, 22% had experienced blackouts longer than 48 hours; 37% had taken the BT to another house to avoid wasting it, and four (5%) patients had disposed of the drug due to a prolonged power outage. Conclusion Upon prescribing BTs, it is imperative that physicians brief patients on the relevance of suitable transportation and storage methods, and a treatment failure should prompt a thorough assessment of transportation and storage conditions.

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“…There are few data on the temperature conditions in which TD are stored once dispensed to patients. Two studies conducted in Spain showed that at least half of patients did not maintain an acceptable mean temperature during transport and home storage (2,3). Using a stricter de nition of adequate conditions of storage, a publication on biologic disease-modifying antirheumatic drugs found that only 6.7% of patients had stored their medications within the recommended range (4); while a similar study on golimumab showed that only 11.6% of injectors had been correctly stored (5).…”

Section: Introductionmentioning

confidence: 99%

Thermolabile Drug Storage in an Ambulatory Setting

Pazo-Oubiña

¹

,

Alorda

²

,

Lobon

³

et al. 2020

Preprint

0

View full text Add to dashboard Cite

BackgroundMore and thermolabile drugs are becoming available, and in most cases, these medications are dispensed to ambulatory patients. However, there is no regulation once medications are dispensed to patients and little is known with regard to what happens during transport and home storage. Previous studies suggest that these drugs are improperly stored. The present study was designed to determine the storage conditions of thermolabile drugs once they are dispensed to the patient in the Hospital Pharmacy Department.MethodsThis is a prospective observational study to assess the temperature profile of 7 thermolabile drugs once they are dispensed to ambulatory patients at a tertiary care hospital. A data logger was added to the medication packaging. Temperature was considered inappropriate if one of the following circumstances were met: any temperature record less than or equal to 0ºC or over 25ºC; temperatures between 0-2ºC or 8ºC-25ºC for a continuous period over 30 minutes. The time series of temperature measurements obtained from each data logger were analyzed as statistically independent variables. The data shown did not undergo any statistical treatment and must be considered directly related to thermal measurements.ResultsOne hundred and fourteen patients were included and 107 patients were available for the analysis. On the whole, a mean of 50.6 days (SD 18.3) were measured and the mean temperature was 6.88ºC (SD 2.93). Three data loggers (2.8%) maintained all the measurements between 2ºC and 8ºC with less than 3 continuous data (< 30 minutes) out of this range but no data over 25ºC or below or equal to 0ºC. 28 (26.2%) data loggers had at least one measurement below zero, 1 data logger had a measurement greater than 25ºC and 75 (70.1%) were between 0ºC and 2ºC and/or between 8º and 25ºC for more than 30 minutes.ConclusionsOnce dispensed to patients, most thermolabile drugs are improperly stored. Future studies should focus on clinical consequences and possible solutions.

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Calidad en la conservación de los medicamentos termolábiles en el ámbito domiciliario

Cited by 17 publications

References 10 publications

Thermolabile Drug Storage in an Ambulatory Setting

Thermolabile Drug Storage in an Ambulatory Setting

Survey on transportation and storage of biological therapies by patients

Thermolabile Drug Storage in an Ambulatory Setting

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