Abstract
One of the challenges in pharmaceutical logistics is to ensure that thermolabile drugs reach the patient with quality. This prospective cross-sectional study aimed to analyze the current cold chain scenario in Brazil. A semi-structured electronic questionnaire was applied for data collection. The total sample was 1793 pharmacists (CI: 99.998%; ME: 5%; p: 0.00002). 74.1% of the pharmacists reported that transportation is the most critical stage; 97.2% stated that the chosen mode influences the quality of the products; 52.5% reported only having partial parameters (tools) for the assessment of quality and that thermolabile medications possibly arrive altered to the final consumer due to the cold chain (59.8%); 66.9% do not have specific training on thermolabile medicines and 50.9% did not receive the technical data sheets of the products through the registration holders; 20.7% reported not being able to analyze or perform any activity related to qualification and validation. The absence of markings in the manual records (50.6%), the non-validation of the equipment used for conservation (30.6%) and the incorrect storage of medicines at domestic refrigerators (45.5%), near food (35.8%), were also noted. The non-measurement of the temperature of the products received was affirmed by 56.7%, as well as the use of thermometers to measure parameters (45.3%); 58.7% of the establishments do not have thermal mapping and 55.3% of the professionals are unaware of the thermal durability of the packaging. Due potentially inadequate situation, there is urgency to implement tools that guarantee the quality of thermolabile drugs in all its logistical stages.
Highlights
The literature reports that the failure of the cold chain has occurred due to the deficiency in the training of the employees involved, the application of an inadequate monitoring method, the incorrect use of tools, or the use of inappropriate equipment for measurement
Other factors are the absence of an assessment for the reintegration of thermolabile drugs exposed to a temperature excursion, as well as the absence of legislation with specific guidelines that impose continuous monitoring of products, ensuring the conservation of thermolabile products (Bogataj et al, 2015; Brown et al, 2016; Cardoso, 2015; Castro, 2019; Cattani, 2020; Cohen et al, 2007; Di Maio & da Silva, 2014; Ferraz, 2015; Fontelles, 2012; Freitas, 2013; Kartoglu & Milstien, 2014; Lavor et al, 2014; Lloyda et al, 2014; Luna et al, 2011; Lobera et al, 2014; Milstien, 2014; Ramírez et al, 2016; Ricote-Lobera et al, 2014.)
A systematic review was carried out on the main scientific databases such as the Virtual Health Library (VHL), Scielo, Pubmed and the CAPES Periodic Portal, seeking to respond directly and impartially to the objectives proposed between the years 1998 to 2020, due to the scarcity of published works related to the theme
Summary
The literature reports that the failure of the cold chain has occurred due to the deficiency in the training of the employees involved, the application of an inadequate monitoring method, the incorrect use of tools, or the use of inappropriate equipment for measurement. Other factors are the absence of an assessment for the reintegration of thermolabile drugs exposed to a temperature excursion, as well as the absence of legislation with specific guidelines that impose continuous monitoring of products, ensuring the conservation of thermolabile products (Bogataj et al, 2015; Brown et al, 2016; Cardoso, 2015; Castro, 2019; Cattani, 2020; Cohen et al, 2007; Di Maio & da Silva, 2014; Ferraz, 2015; Fontelles, 2012; Freitas, 2013; Kartoglu & Milstien, 2014; Lavor et al, 2014; Lloyda et al, 2014; Luna et al, 2011; Lobera et al, 2014; Milstien, 2014; Ramírez et al, 2016; Ricote-Lobera et al, 2014.) Tools such as standardization of processes, training and / or qualification of professionals through permanent education, monitoring and control of temperature in all logistical operations, the use of calibrated equipment for temperature measurement and the capacity of these equipments to record the thermal information, for example, is essential to guarantee the ideal conditions of medicines (Brazil, 2010a; Di Maio et al, 2014; Luna et al, 2007; Taylor, 2001). Critical issues related to product quality could be raised, such as access to technical information, training, current legislation, and the tools used to control and measure product conditions
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