社区药剂师对性健康和生殖健康药物从 POM 到 P 重新分类的看法--一项调查研究

IF 1.5 Q3 PHARMACOLOGY & PHARMACY
P. Crilly, S. Abdallah, J. Davey, I. Al-Saery
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引用次数: 0

摘要

在英国,药品重新分类是改变药品法定分类的过程,例如从处方药 (POM) 变为药房药 (P) 或一般销售清单 (GSL) 药品。1 这项工作由药品和保健品监管局 (MHRA) 负责监督,在确保安全、负责任地使用药品的同时,还能提高患者获得某些药品的机会。 调查社区药剂师(CPs)对性保健和生殖保健药品从 POM 到 P 的重新分类的看法:枸橼酸西地那非(Viagra Connect,用于治疗勃起功能障碍)、去氧孕酮(Hana/Lovima,用于避孕)和半水合雌二醇(Gina,用于治疗阴道萎缩)。 研究对象为大伦敦地区的所有 CP。调查包括五个部分共 59 个问题。第一部分是对药品重新分类的总体看法,其他部分则针对所研究的药品。最后一部分是人口统计数据。问题类型包括多项选择、5 点李克特量表和自由文本。建议的样本量为 340 个(95% CI),因此共访问了 210 家药房中的 398 家 CP。研究获得了大学伦理委员会的伦理批准。在发放硬拷贝调查表一周前,向参与者张贴了参与者信息表 (PIS)。调查表也可在 Microsoft Forms 上下载。数据用 Microsoft Excel 和社会科学统计软件包 (SPSS) 进行分析。描述性统计以数字和百分比表示。 答复率为 37.7%(N=150/398)。大多数 CPs(88%)认为药物重新分类增加了他们的角色,并为公众提供了更多的药物。然而,只有不到一半的 CP(44%)对重新分类的过程有很好的了解。所有受访药店都有西地那非出售,但只有 50% 的药店出售去氧孕烯,只有 28% 的药店出售雌二醇。不出售去氧孕烯和/或雌二醇的原因包括公众对这些产品的供应缺乏了解,以及公众对购买这些产品缺乏兴趣。虽然西地那非作为 P 类药物的供应被视为改善安全获取的积极因素,但许多 CPs(86%)对其滥用的高风险表示担忧。在培训方面,与去氧孕烯或雌二醇的培训相比,西地那非的培训得到了更高的评价。大多数 CP(67%)表示,将案例研究纳入 POM 转 P 的培训有助于他们了解哪些患者可以安全地购买这些药物。 CPs 对非处方药的性健康和生殖健康药物的可获得性持肯定态度。不过,他们也对某些药物可能被滥用表示担忧,并认为需要提高人们对这些产品供应情况的认识。那些为重新分类药物编写培训材料的人应该将案例研究纳入其中,因为这些案例研究有助于做出处方药决策。本研究的局限性在于没有达到建议的样本量。 1.药品:重新分类您的产品[互联网]。2023 年 [2023 年 5 月 30 日引用]。见 https://www.gov.uk/guidance/medicines-reclassify-your-product#:~:text=The%20MHRA%20procedure%20is%20straightforward,%27me%2Dtoo%27%20reclassifications。 2.2. Blenkinsopp A, Bradley C. Over the Counter Drugs:2. Blenkinsopp A, Bradley C. Over Counter Drugs: Patients, Society, and the increase in self medication.BMJ [Internet].1996 Mar 9 [cited 2023 May 30];312(7031):629-32.可查阅: https://www.bmj.com/content/312/7031/629
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Community pharmacists' perceptions of the POM to P reclassification of medicines for sexual and reproductive health – A survey study
In the UK, medicines reclassification is the process of changing the legal classification of a medication, such as from a prescription-only medicine (POM) to a pharmacy (P) or general sales list (GSL) medicine.1 It is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). and improves patient access to certain medications while ensuring safeguards are in place for their safe and responsible use.2 A number of the most recent POM to P reclassifications have been for medications used in sexual and reproductive healthcare. To investigate community pharmacists' (CPs’) perceptions of POM to P medicine reclassifications for sexual and reproductive health: sildenafil citrate (Viagra Connect, for erectile dysfunction), desogestrel (Hana/Lovima, for contraception), and estradiol hemihydrate (Gina, for vaginal atrophy). The study population was all CPs in Greater London. The survey consisted of 59-questions in five sections. The first section was for general perceptions about the reclassification of medicines, while the other sections were specific to the medicines studied. The final section was demographics. Question types included multiple-choice, 5-point Likert scale, and free text. The recommended sample size was 340 (95% CI), therefore, 398 CPs, in 210 pharmacies, were approached. Ethical approval was obtained from the university ethics committee. Participants were posted a participant information sheet (PIS) one week before distribution of the survey as a hard copy. The survey was also available on Microsoft Forms. Data were analysed in Microsoft Excel and Statistical Package for Social Sciences (SPSS). Descriptive statistics were given in numbers and percentages. The response rate was 37.7% (N=150/398). Most CPs (88%) perceived that medication reclassification increased their role and provided greater access to medicines for the public. However, less than half (44%) had a good understanding of the reclassification process. Sildenafil was available to purchase in all of the visited pharmacies, however, desogestrel was only sold in 50% of them, and estradiol was sold in only 28%. Reasons cited for not selling desogestrel and/or estradiol included lack of public awareness about the availability of these products, and a lack of public interest in purchasing them. While the availability of sildenafil as a P medicine was seen as a positive for improving safe access, many CPs (86%) expressed concerns about the high risk of its misuse. In terms of training, the available training for sildenafil received higher ratings compared to that for desogestrel or estradiol. Most CPs (67%) indicated that having case studies incorporated into the training for POM to P switches helped them understand which patients could safely purchase these medications. CPs are positive about the availability of sexual and reproductive health medications over the counter. They do have concerns, however, about the potential of some of these medications to be misused, and also feel that more awareness of the availability of these products needs to be raised. Those producing training materials for reclassified medications should incorporate case studies as these support CP decision making. A limitation of this study was that the recommended sample size was not achieved. 1. Medicines: reclassify your product [Internet]. 2023 [cited 2023 May 30]. Available from: https://www.gov.uk/guidance/medicines-reclassify-your-product#:~:text=The%20MHRA%20procedure%20is%20straightforward,%27me%2Dtoo%27%20reclassifications. 2. Blenkinsopp A, Bradley C. Over the Counter Drugs: Patients, society, and the increase in self medication. BMJ [Internet]. 1996 Mar 9 [cited 2023 May 30];312(7031):629–32. Available from: https://www.bmj.com/content/312/7031/629
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来源期刊
CiteScore
2.90
自引率
5.60%
发文量
146
期刊介绍: The International Journal of Pharmacy Practice (IJPP) is a Medline-indexed, peer reviewed, international journal. It is one of the leading journals publishing health services research in the context of pharmacy, pharmaceutical care, medicines and medicines management. Regular sections in the journal include, editorials, literature reviews, original research, personal opinion and short communications. Topics covered include: medicines utilisation, medicine management, medicines distribution, supply and administration, pharmaceutical services, professional and patient/lay perspectives, public health (including, e.g. health promotion, needs assessment, health protection) evidence based practice, pharmacy education. Methods include both evaluative and exploratory work including, randomised controlled trials, surveys, epidemiological approaches, case studies, observational studies, and qualitative methods such as interviews and focus groups. Application of methods drawn from other disciplines e.g. psychology, health economics, morbidity are especially welcome as are developments of new methodologies.
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