Background

Limited information is known about the storage conditions of medicinal products post-dispensing in Saudi Arabia (SA). The particularly hot and humid climate in the region may lead to the loss of essential performance specifications.

Objective

To investigate the conditions in which medications are held after being dispensed, and up until administration by households in SA. In addition, storage practices adopted by households in the region, as well as their knowledge and awareness are explored. This study also discusses the opportunity of utilising Time-Temperature Indicators (TTIs) in the pharmaceutical industry in SA as a quality-assurance enhancement solution.

Methods

A cross-sectional questionnaire targeted at households in SA was designed to explore storage practices, background knowledge and awareness of factors that can influence drug stability. Additionally, temperature and relative humidity mapping of 35 different rooms in various homes and cities in SA, as well as car interiors, was performed.

Results

More than 1000 households have participated in this study from all regions of SA. Approximately, 95% have claimed to take part in storing medications at home. First-aid and supplemental purposes were two of the reasons 80.9% have claimed, while 43.2% claimed treatment for chronic conditions. Just over 35% claimed that not knowing how to dispose of medications, is the reason behind their storage. More than 35% of participants could not identify most suitable storage conditions, and >10% were unaware of the effect storage conditions may have on shelf-life. Many were found to store medication in inappropriate areas, liquid dosage forms for example were stored in freezers by more than 3%. Upon monitoring temperatures of all room types, 25ºC was exceeded throughout a 24-hour duration in bathrooms, kitchens and limited use rooms. Temperatures in parked car interiors exceeded 70ºC.

Conclusions

A significant percentage of households in SA lacked knowledge and awareness of good storage practices. However, due to high temperatures observed in the region, increasing knowledge and awareness is not enough, as medicinal cabinets with basic temperature control (e.g. designated secure fridge) are needed. Additionally, the use of TTIs to provide consumers with accumulated thermal history may enhance quality-assurance of thermally sensitive products.

中文翻译：

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沙特阿拉伯的药品家庭储存；呼吁利用智能包装解决方案

 背景

关于沙特阿拉伯 (SA) 药品配药后储存条件的信息有限。该地区特别炎热和潮湿的气候可能会导致基本性能规格的丧失。

 客观的

调查药物从配发后直至由南澳家庭管理的保存条件。此外，还探讨了该地区家庭采用的存储做法以及他们的知识和意识。本研究还讨论了在南澳制药行业中利用时间温度指示器 (TTI) 作为质量保证增强解决方案的机会。

 方法

针对南澳家庭的横断面调查问卷旨在探讨储存实践、背景知识和对影响药物稳定性因素的认识。此外，还对南澳各家庭和城市的 35 个不同房间以及汽车内饰进行了温度和相对湿度测绘。

 结果

来自南澳各地区的 1000 多个家庭参与了这项研究。大约 95% 的人声称参与在家储存药物。 80.9% 的受访者声称原因之一是急救和补充目的，而 43.2% 的受访者声称治疗慢性病。超过 35% 的人声称不知道如何处置药物是储存药物的原因。超过 35% 的参与者无法确定最合适的储存条件，>10% 不知道储存条件可能对保质期产生的影响。许多人被发现将药物储存在不适当的地方，例如液体剂型储存在冰箱中的比例超过 3%。在监测所有房间类型的温度后，浴室、厨房和有限使用房间的温度在 24 小时内超过了 25°C。停放的汽车内部温度超过 70°C。

 结论

南澳很大一部分家庭缺乏良好存储实践的知识和意识。然而，由于该地区出现高温，仅增加知识和意识是不够的，因为需要具有基本温度控制功能的药柜（例如指定的安全冰箱）。此外，使用 TTI 为消费者提供累积的热历史可以增强热敏感产品的质量保证。