Tadalafil (International)

Sildenafil remained the most frequently prescribed medication out of the two drugs of choice.

• Generic Cialis offers similar effectiveness as the brand in treating ED.
• The active ingredient, tadalafil, is the same in generic and brand-name Cialis.
• Cost savings make generic Cialis popular in the UK and worldwide.
• Insurance coverage for generic Cialis varies by provider.
• Patients should compare prices at various licensed pharmacies.
• Generic Cialis is available without a prescription in some countries.
• Always verify that the medication is genuine before purchase.
• Generic options are produced by reputable pharmaceutical companies.
• Pharmacists can provide guidance on dosage and side effects.

A strong link between deprivation and prescribing trends were observed across all data points. 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.

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There is an opportunity in primary care for assessment of linked risk factors in men who present with symptoms. ED, ‘the persistent inability to achieve or maintain an erection that is sufficient to permit satisfactory sexual performance’, can affect the physical, emotional, and psychosocial health of the sufferer.1 ED can have both an organic and psychogenic origin, and can be a risk marker for underlying cardiovascular diseases (CVDs) and mental health conditions, which may warrant further evaluation and treatment.2,3 Medications, such as antihypertensives, antidepressants, and antipsychotics, can also lead to ED through their mechanisms of action.2 A systematic review reported that men with ED have an increased risk of all-cause mortality (odds ratio [OR] = 1.26; 95% confidence interval [CI] = 1.01 to 1.57) and CVD mortality (OR = 1.43; 95% CI = 1.00 to 2.05).4 The global prevalence of ED has been estimated to range from 3%–76.5%.4 A significant number of patients are known to suffer in isolation and do not seek help. Therefore, prevalence data are likely to be an underestimate.5 It is common for men with ED to experience anxiety, depression, relationship difficulties, and a lack of sexual confidence.2,3 These factors often lead to poorer quality of life for the sufferer, their partner, and family. Both pharmacological and non-pharmacological treatment options are available for the treatment of ED. The National Institute for Health and Care Excellence (NICE) in England recommends using phosphodiesterase type-five inhibitors (PDE-5I) as a firstline pharmacological treatment option for men with ED.

How Medication Helps

Four PDE-5Is are currently licensed in the UK and include sildenafil, tadalafil, vardenafil, and avanafil.5 However, only sildenafil and tadalafil remain the drugs of choice. Sildenafil was reclassified in March 2018 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to ‘pharmacy-only’ medicine, which allowed community and online pharmacies to supply the drug to the patients without the need of a prescription.6 MHRA make decisions to alter the legal status of medicines in the UK from ‘prescription-only’ to ‘pharmacy’ or ‘general sales list’ categories (Table 1).7,8 The decision to reclassify such medicines are primarily based on safety data.7 Such reclassifications are often expected to reduce the volume of prescribing and costs from the perspective of the NHS as patients are required to pay the price of the medicines at the point of purchase. 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.

Study design

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. 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. 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.

Regulatory bodies and their roles

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. The CCGs are clinically-led autonomous NHS bodies involved in planning and commissioning generic brand cialis healthcare services for their locality.

Prescription Trends and Adoption

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). 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 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. Data showed that reclassification of sildenafil to a pharmacy medicine from ‘prescription-only' medicine had modest impact on the trend of prescribing.

• Generic Cialis is the common name for tadalafil, used to treat erectile dysfunction.
• It is produced by multiple pharmaceutical companies worldwide.
• The drug works by increasing blood flow to the penis.
• Generic Cialis costs significantly less than the brand-name version.
• It typically comes in 2.5mg, 5mg, 10mg, and 20mg doses.
• Cialis has a long-lasting effect, up to 36 hours.
• It should be taken at least 30 minutes before sexual activity.
• Possible side effects include headache, flushing, and muscle pain.
• Consult a doctor before using Cialis, especially with other medications.

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

Bottom line

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.

Stimulation increases blood flow

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 cialis 10mg tablet 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). 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 lack of long-term monitoring and follow-up in pharmacy settings may also discourage many patients from accessing the pharmacy version of sildenafil.