Community pharmacists' perceptions of the POM to P reclassification of medicines for sexual and reproductive health – A survey study

Abstract

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