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A cardiovascular risk assessment by a pharmacist in the community pharmacy is a prerequisite to pharmacy supply of sildenafil.9 Such risk assessment is undertaken using a series of questions asked to the patients before a supply can be made. Sildenafil is still available on NHS prescription along with tadalafil, vardenafil, and avanafil. There is a lack of research in relation to presentation and management of ED in primary care, particularly in the UK. To date, no longitudinal research has looked into the prescribing patterns and costs of PDE-5Is in English primary care settings. Given the association of ED with CVDs, including diabetes, vascular disorders, and mental health conditions,2,3,10 understanding any link that exists between deprivation and ED drugs prescribing trend will enable targeted interventions to manage comorbidities and reduce health inequality. The primary aim of this study was to investigate the trend in quantity and cost of prescribing of sildenafil and tadalafil in primary care settings in England between 2009 and 2019.

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The highest yearly increase occurred from 2014–2015, which showed a 42.1% increase. A 5.8% yearly increase in the rate of prescription was observed between 2017 and 2018. A 0.5% increase in the rate of prescribing between 2018 and 2019 was observed, suggesting modest impact of reclassification on the prescribing practices. The number of items prescribed per 1000 men were 124.2 and 125.8 in 2018 and 2019, respectively. The spending on primary care prescriptions for ED decreased by 71.0% from £77.4 million in 2009 to £22.4 million in 2019.

Regional issues

The spending on sildenafil decreased by 90% and tadalafil decreased by 75%. The biggest decreases were seen after 2014 for sildenafil and 2018 for tadalafil (Figure 1). The most deprived regions consistently showed higher rates of prescriptions for ED drugs. In 2019 there were 190.4 items prescribed per 1000 men of all ED drugs in the most deprived region. This figure was approximately 21.0% higher compared with the data from the least deprived regions, where a total of 150.5 items were prescribed per 1000 men. Specific objectives related to the investigation of: a) whether a prescribing trend of ED drugs is associated with deprivation and demography of various English geographical regions; and b) whether the legal reclassification of sildenafil to ‘pharmacy-only’ medicine has impacted on the trend in quantity and cost of prescribing of ED drugs in England.

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A secondary analysis of routinely collected data on the prescribing and dispensing of two ED drugs, sildenafil and tadalafil, within the NHS England primary care settings between January 2009 and November 2019, was conducted. This time period includes switches from patented medicines to generic drugs for both tadalafil and sildenafil, as well as the reclassification of sildenafil to ‘pharmacy-only’ medicine in March 2018. Prescribing datasets were extracted from NHS Digital sources including OpenPrescribing.net and Prescription Cost Analysis (PCA).11 These included data on the number of items prescribed, cost of prescribing, and prescribing patterns within specific clinical commissioning groups (CCGs) for both drugs. Data were adjusted for inflation using the Bank of England inflation calculator based on Office for National Statistics (ONS) composite price index.12 Data were also adjusted for male population estimates for each year.13 All data were extracted, independently checked for accuracy, and analysed using Microsoft Excel and IBM SPSS Statistics (version 21). Prescription patterns in the 10 most and the 10 least deprived CCGs as per the ONS Index of Multiple Deprivation (IMD) in 2015 (Table 2) were also extracted and analysed to explore the link between prescribing pattern and deprivation.

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This study only included NHS prescription data and private prescriptions were not accounted for. Only two PDE-5Is were included, sildenafil and tadalafil, as the authors' observations suggested that the rest of the PED-5Is accounted for negligible volume of prescribing and, hence, did not impact on the trend analysis. Similarly, community and online pharmacy sales of over-the-counter sildenafil were not included in the trend analysis. Some patients may avoid perceived embarrassment and confidentiality issues in face-to-face clinical consultations in primary care and community pharmacy16 by accessing medicines through online sources. Other available treatments for ED, including vacuum-pump treatment and psychosexual therapies, were not included in the study.

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In addition, prevalence data of ED over time were considered for this study. The segmented regression for different policy changes (for example, sildenafil patent expiry in June 2013, tadalafil patent expiry in November 2017, and reclassification of sildenafil from prescription medicine to pharmacy medicine in March 2018) could not be performed owing to: a) absence of monthly prescribing and spending data (access was restricted to annual level for historical data prior to 2015); and b) inadequate time-points before and after different policy changes needed to conduct segmented regression analysis.17 There is a lack of literature on the prescribing and management of ED in primary care. Previous studies have reported that many men do not seek help with sexual problems to avoid perceived embarrassment for themselves and their doctors.18,19 The observed increasing trend in the rate of prescriptions may have been contributed by various factors. These include inclusion of ED assessment for men with diabetes in the Quality and Outcomes Framework (QOF) since 2013–2014.20 The QOF required opportunistic screening, advice and assessment of contributory factors, and treatment options for ED in patients with diabetes in primary care. In addition, media, including social media, may have contributed to increased knowledge and awareness of the condition among members of the general public given the licensing of newer PDE-5Is in recent years. The CCGs are clinically-led autonomous NHS bodies involved in planning and commissioning healthcare services for their locality.

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A cardiovascular risk assessment by a pharmacist in the community pharmacy is a prerequisite to pharmacy supply of sildenafil.9 Such risk assessment is undertaken using a series of questions asked to the patients before a supply can be made. Sildenafil is still available on NHS prescription along with tadalafil, vardenafil, and avanafil. There is a lack of research in relation to presentation and management of ED in primary care, particularly in the UK. To date, no longitudinal research has looked into the prescribing patterns and costs of PDE-5Is in English primary care settings. Given the association of ED with CVDs, including diabetes, vascular disorders, and mental health conditions,2,3,10 understanding any link that exists between deprivation and ED drugs prescribing trend will enable targeted interventions to manage comorbidities and reduce health inequality.

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The primary aim of this study was to investigate the trend in quantity and cost of prescribing of sildenafil and tadalafil in primary care settings in England between 2009 and 2019. Specific objectives related to the investigation of: a) whether a prescribing trend of ED drugs is associated with deprivation and demography of various English geographical regions; and b) whether the legal reclassification of sildenafil to ‘pharmacy-only’ medicine has impacted on the trend in quantity and cost of prescribing of ED drugs in England. A secondary analysis of routinely collected data on the prescribing and dispensing of two ED drugs, sildenafil and tadalafil, within the NHS England primary care settings between January 2009 and November 2019, was conducted. This time period includes switches from patented medicines to generic drugs for both tadalafil and sildenafil, as well as the reclassification of sildenafil to ‘pharmacy-only’ medicine in March 2018. Prescribing datasets were extracted from NHS Digital sources including OpenPrescribing.net and Prescription Cost Analysis (PCA).11 These included data on the number of items prescribed, cost of prescribing, and prescribing patterns within specific clinical commissioning groups (CCGs) for both drugs. The 10 most deprived and the 10 least deprived CCGs covered a population of 1.38 million and 1.30 million, respectively. Number of items prescribed for ED increased by 110% between 2009 and 2019 (Figure 1).

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The increase in the number of items prescribed was mostly accounted for by sildenafil prescriptions, which increased by 165%. There were 2 145 393 items for ED prescribed in 2009 and 4 505 623 in 2019. The biggest year-on-year increase in the number of prescriptions was seen in 2014–2015, where an increase of 24% was observed.

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The total items prescribed for sildenafil was relatively steady from 2009–2013, at around 48 items prescribed a year per sildenafil film tablet 1000 men. The prescribing increased rapidly from 2013–2017. The highest yearly increase occurred from 2014–2015, which showed a 42.1% increase. A 5.8% yearly increase in the rate of prescription was observed between 2017 and 2018. A 0.5% increase in the rate of prescribing between 2018 and 2019 was observed, suggesting modest impact of reclassification on the prescribing practices. The number of items prescribed per 1000 men were 124.2 and 125.8 in 2018 and 2019, respectively. The spending on primary care prescriptions for ED decreased by 71.0% from £77.4 million in 2009 to £22.4 million in 2019. The spending on sildenafil decreased by 90% and tadalafil decreased by 75%. The biggest decreases were seen after 2014 for sildenafil and 2018 for tadalafil (Figure 1). The most deprived regions consistently showed higher rates of prescriptions for ED drugs. In 2019 there were 190.4 items prescribed per 1000 men of all ED drugs in the most deprived region. This figure was approximately 21.0% higher compared with the data from the least deprived regions, where a total of 150.5 items were prescribed per 1000 men. In the most deprived regions, the yearly increases in prescription items were 9.0% in 2016, 4.5% in 2017, and 4.4% and 5.0% in 2018 and 2019, respectively. An overall 24.9% increase in prescription items was observed from 2015–2019.

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Data were adjusted for inflation using the Bank of England inflation calculator based on Office for National Statistics (ONS) composite price index.12 Data were also adjusted for male population estimates for each year.13 All data were extracted, independently checked for accuracy, and analysed using Microsoft Excel and IBM SPSS Statistics (version 21). Prescription patterns in the 10 most and the 10 least deprived CCGs as per the ONS Index of Multiple Deprivation (IMD) in 2015 (Table 2) were also extracted and analysed to explore the link between prescribing pattern and deprivation. The CCGs are clinically-led autonomous NHS bodies involved in planning and commissioning healthcare services for their locality. The 10 most deprived and the 10 least deprived CCGs covered a population of 1.38 million and 1.30 million, respectively. Number of items prescribed for ED increased by 110% between 2009 and 2019 (Figure 1).

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The increase in the number of items prescribed was mostly accounted for by sildenafil prescriptions, which increased by 165%. There were 2 145 393 items for ED prescribed in 2009 and 4 505 623 in 2019. The biggest year-on-year increase in the number of prescriptions was seen in 2014–2015, where an increase of 24% was observed. The total items prescribed for sildenafil was relatively steady from 2009–2013, at around 48 items prescribed a year per sildenafil film tablet 1000 men. The prescribing increased rapidly from 2013–2017. In the least deprived region, the rate of increase in the number of prescriptions was 38.9% during the same period (Figure 2). A wide variation in the rate of sildenafil 5mg for sale prescribing across the six English regions were observed. The North East and the North West regions had approximately 50% higher rates of prescribing compared with London. Rates of prescribing were 15.9, 15.3, and 10.3 items per 1000 men each month, respectively, in these regions (Figure 3). The aim of this study was to investigate the trend in prescribing of drugs for ED in primary care settings in England and to assess the impact of deprivation, regional demography, and legal reclassification of sildenafil on prescribing practices of ED drugs.

Pharmacy Name Location Price per Tablet (€) Available Pack Sizes
Dublin Meds Dublin 14-16 10, 20, 30
Cork Pharmacy Cork 12-15 10, 20
Galway Health Galway 13 20
Limerick Drugs Limerick 11-14 10, 30

There was a persistent increase in the rate of prescribing for treatment of ED in men between 2009 and 2019 in English primary care.

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In the most deprived regions, the yearly increases in prescription items were 9.0% in 2016, 4.5% in 2017, and 4.4% and 5.0% in 2018 and 2019, respectively. An overall 24.9% increase in prescription items was observed from 2015–2019. In the least deprived region, the rate of increase in the number of prescriptions was 38.9% during the same period (Figure 2). A wide variation in the rate of sildenafil 5mg for sale prescribing across the six English regions were observed. The North East and the North West regions had approximately 50% higher rates of prescribing compared with London.

Primary Research Interviews

Rates of prescribing were 15.9, 15.3, and 10.3 items per 1000 men each month, respectively, in these regions (Figure 3). The aim of this study was to investigate the trend in prescribing of drugs for ED in primary care settings in England and to assess the impact of deprivation, regional demography, and legal reclassification of sildenafil on prescribing practices of ED drugs. There was a persistent increase in the rate of prescribing for treatment of ED in men between 2009 and 2019 in English primary care. Sildenafil remained the most frequently prescribed medication out of the two drugs of choice. A strong link between deprivation and prescribing trends were observed across all data points. Sildenafil remained the most frequently prescribed medication out of the two drugs of choice. A strong link between deprivation and prescribing trends were observed across all data points.

Legislation / Regulation Effect on Prices Remarks
Price Capping Policies Stabilized prices Limits maximum markup
Import Regulations Slight increase Adds compliance costs
Patent Laws Maintains higher prices Longer patent protection for brand-name drugs

These can be linked to higher prevalence of risk factors of ED, such as cardiovascular and mental health conditions, with deprivation.14 A north–south divide was observed in the rate of prescriptions, with higher prescribing rates observed in the northern regions of England compared with London and the southern regions. While some of the regional variations are explained by the differences in deprivation level, London’s younger population compared with the rest of the country15 could explain low ED prevalence and the observed low prescribing for ED. In addition, patient behaviours around use of online sources for access to sildenafil may be different across various geographical regions. Data showed that reclassification of sildenafil to a pharmacy medicine from ‘prescription-only' medicine had modest impact on the trend of prescribing. It could be assumed that the reclassification of sildenafil would lead to a decrease in the number of items prescribed as people would be able to get their medicine directly from the pharmacy instead of needing to go to the doctors and wait for an appointment.

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These can be linked to higher prevalence of risk factors of ED, such as cardiovascular and mental health conditions, with deprivation.14 A north–south divide was observed in the rate of prescriptions, with higher prescribing rates observed in the northern regions of England compared with London and the southern regions. While some of the regional variations are explained by the differences in deprivation level, London’s younger population compared with the rest of the country15 could explain low ED prevalence and the observed low prescribing for ED. In addition, patient behaviours around use of online sources for access to sildenafil may be different across various geographical regions. Data showed that reclassification of sildenafil to a pharmacy medicine from ‘prescription-only' medicine had modest impact on the trend of prescribing. It could be assumed that the reclassification of sildenafil would lead to a decrease in the number of items prescribed as people would be able to get their medicine directly from the pharmacy instead of needing to go to the doctors and wait for an appointment.

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It is important to note, however, that the pharmacy version of sildenafil costs approximately £20 for a pack of four tablets (as of April 2020) whereas the generic sildenafil prescriptions from a GP only costs £9 for the same number of tablets. The higher cost of the pharmacy version of the medicine compared with the prescription cost may dissuade patients from using pharmacy for accessing sildenafil. In addition, confidentiality and privacy have been cited as barriers to utilisation of sexual health services from pharmacy.16 The sildenafil pfizer 100g lack of long-term monitoring and follow-up in pharmacy settings may also discourage many patients from accessing the pharmacy version of sildenafil. This project included data from very large routinely collected datasets covering all primary care prescriptions in England. Deprivation data were based on CCG level and individual practice level variations were not accounted for. It is important to note, however, that the pharmacy version of sildenafil costs approximately £20 for a pack of four tablets (as of April 2020) whereas the generic sildenafil prescriptions from a GP only costs £9 for the same number of tablets. The higher cost of the pharmacy version of the medicine compared with the prescription cost may dissuade patients from using pharmacy for accessing sildenafil. In addition, confidentiality and privacy have been cited as barriers to utilisation of sexual health services from pharmacy.16 The sildenafil pfizer 100g lack of long-term monitoring and follow-up in pharmacy settings may also discourage many patients from accessing the pharmacy version of sildenafil. This project included data from very large routinely collected datasets covering all primary care prescriptions in England. Deprivation data were based on CCG level and individual practice level variations were not accounted for. This study only included NHS prescription data and private prescriptions were not accounted for. Only two PDE-5Is were included, sildenafil and tadalafil, as the authors' observations suggested that the rest of the PED-5Is accounted for negligible volume of prescribing and, hence, did not impact on the trend analysis. Similarly, community and online pharmacy sales of over-the-counter sildenafil were not included in the trend analysis.

  • Legal regulations in Ireland restrict sildenafil sales without prescription.
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Some patients may avoid perceived embarrassment and confidentiality issues in face-to-face clinical consultations in primary care and community pharmacy16 by accessing medicines through online sources. Other available treatments for ED, including vacuum-pump treatment and psychosexual therapies, were not included in the study. In addition, prevalence data of ED over time were considered for this study. The segmented regression for different policy changes (for example, sildenafil patent expiry in June 2013, tadalafil patent expiry in November 2017, and reclassification of sildenafil from prescription medicine to pharmacy medicine in March 2018) could not be performed owing to: a) absence of monthly prescribing and spending data (access was restricted to annual level for historical data prior to 2015); and b) inadequate time-points before and after different policy changes needed to conduct segmented regression analysis.17 There is a lack of literature on the prescribing and management of ED in primary care. Previous studies have reported that many men do not seek help with sexual problems to avoid perceived embarrassment for themselves and their doctors.18,19 The observed increasing trend in the rate of prescriptions may have been contributed by various factors. These include inclusion of ED assessment for men with diabetes in the Quality and Outcomes Framework (QOF) since 2013–2014.20 The QOF required opportunistic screening, advice and assessment of contributory factors, and treatment options for ED in patients with diabetes in primary care. In addition, media, including social media, may have contributed to increased knowledge and awareness of the condition among members of the general public given the licensing of newer PDE-5Is in recent years.

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