Differences Between Prescription and Pharmacy Supply

a95 % exact two-sided CIs are calculated using the Clopper–Pearson method Nearly all respondents were aware of the optional Viagra Connect® Pharmacy Checklist, and the majority used this at point-of-supply (91.9 %; Table 5). Of the 28 (8.1 %) who did not/did not recall using the checklist, only 6 were unaware it existed. Nearly all respondents who utilised the checklist used it all the time (97.2 %).

• Viagra Connect offers a discreet way to manage ED.
• It works best when taken on an empty stomach.
• Full effect may take up to an hour to manifest.
• Avoid heavy meals immediately before taking.
• Regular use does not lead to dependency.
• An active lifestyle may improve results.

The majority (91.3 %) always provided the tear-off slip when supplying Viagra Connect® (Table 5).

What does Viagra Connect F/C 50mg Tablets contain

Part 2 communicated KRMs to consider during consultation: (1) possible causes of ED, (2) advising patients to stop taking Viagra Connect® and seek medical attention if they experience serious side effects, (3) advising patients to consult their doctor within 6 months of first purchase, and (4) advising patients who have not been supplied Viagra Connect® by a pharmacist to consult their doctor (Table 1). ED erectile dysfunction, KRMs key risk messages This cross-sectional survey was conducted between 28 January and 31 March 2019. Before implementing the full survey, a pilot was conducted among 42 pharmacists (July–August 2018) to ensure implementation was optimal, that questions performed as intended, and to gain insight into recruitment. The pilot confirmed that the invitation and respondent pool were representative of UK pharmacies and no changes were required to the protocol. The full survey was launched ~ 9 months after distribution of the aRMMs materials to allow time for pharmacists to complete the training, and gain experience counselling patients and dispensing Viagra Connect®.

Subgroup Analyses

All aspects of the survey were anonymous. Effectiveness of the aRMMs was evaluated by assessing pharmacists’ knowledge of KRMs contained in the Viagra Connect® training materials, participation in training, and utilisation of the optional checklist and tear-off slip when dispensing (Online Appendix). Community pharmacists were recruited via the National Pharmacy Database, which contains > 14,000 pharmacy records and is representative of the UK pharmacy population. The sample was generated to be representative of the UK pharmacist population, comprising 49.2 % large multiple-pharmacy chains (≥ 100 outlets), 12.4 % small multiple-pharmacy chains (6–99 outlets), and 38.4 % independent pharmacies (1–5 outlets). Practising community pharmacists who reported ≥ 1 face-to-face request for Viagra Connect® in the past 6 months, and consented to participate, regardless of prior training, were eligible.

Awareness and utilisation ofViagra Connect®Pharmacy Checklist

Pharmacists who indicated that they or an immediate family member currently worked for a pharmaceutical company, contract research organisation, the marketing authorisation holder, European Medicines Agency, or MHRA were not eligible. Online only pharmacists who did not conduct face-to-face consultations were excluded. Data protection requirements were complied with before contacting pharmacists. A random sample of pharmacists across 4000 pharmacies were sent postal invitations including a weblink to the survey. The purpose of the survey, how data would be reported, and confidentiality were explained in the invitation. PDE-5i phosphodiesterase type-5 inhibitor, PGD patient-group direction aPercentages calculated based on the sample presented with this question because of skip logic bPercentages may not total 100 % as > 1 response could be selected Of eligible respondents, 69.0 % (n=238) participated in the Viagra Connect® training, with the most popular format being printed materials received in the mail, followed by online training supplied by their pharmacy (Online Resource 3).

Question	Answer	Notes
Is Viagra Connect available over the counter?	Yes, in select pharmacies and online	Age restriction applies
How quickly does it work?	Typically within 30-60 minutes	Varies by individual
Are there any side effects?	Yes, includes headache, flushing, nasal congestion	Consult a healthcare provider before use
Can I take it with other medications?	Not advised without doctor approval	Possible drug interactions

Of 107 respondents who did not participate, 47 could not recall if they had taken part.

Data Type	Description	Usage
Personal Details	Name, DOB, Address	Confirm identity
Medical History	Past health conditions, current medications	Assess suitability
Payment Details	Credit/debit card information	Process payment
Contact Info	Phone number, email address	Order updates, notifications

The most common reason given for not participating was lack of awareness (32.7 %), and 21 pharmacists (19.6 %) were already PGD-trained for PDE5Is. At least 80 % of respondents confirmed the Essential Information for the Supply of Viagra Connect® training guide, Viagra Connect® Pharmacy Checklist, and tear-off slip were extremely useful/very useful (90.1 %, 96.8 %, 82.9 %, respectively). Of 345 respondents, 161 (46.7 %) reported the training guide being their main reference source, and one-third referred primarily to the checklist for safe dispensing practices of Viagra Connect® (Online Resource 4).

Requirement	Details	Importance
Age Verification	Must be over 18 years old	Legal requirement
Medical History	No contraindications for erectile dysfunction drugs	Safety reasons
Prescription Status	Not required if purchased as OTC in some regions	But sometimes verified online
Contact Information	Valid phone number and email address	For order confirmation and support

Of 345 respondents, the majority (91.3 %) were comfortable counselling patients. Most (72.2 %) agreed patients were interested in learning and open to discussing their health.

Product	Dosage	Quantity + Bonus	Price
Viagra Super Active	100mg	180 + 20 Pills	280.97€ 267.59€	Buy
Viagra Generic	100mg	90 + 6 Pills	129.02€ 122.88€	Buy
Viagra Generic	25mg	10 Pills	25.19€ 23.99€	Buy
Viagra Generic	100mg	10 Pills	28.91€ 27.53€	Buy
Viagra Super Active	100mg	90 + 10 Pills	165.61€ 157.72€	Buy
Viagra Original	100mg	8 Pills	59.84€ 56.99€	Buy
Viagra Generic	25mg	90 + 6 Pills	105.03€ 100.03€	Buy
Viagra Generic	25mg	60 + 4 Pills	71.99€ 68.56€	Buy
Viagra Original	100mg	76 + 4 Pills	306.59€ 291.99€	Buy
Viagra Soft Tabs	100mg	90 + 6 Pills	205.31€ 195.53€	Buy
Viagra Generic	25mg	180 + 6 Pills	154.93€ 147.55€	Buy
Viagra Generic	50mg	180 + 8 Pills	158.82€ 151.26€	Buy
Viagra Generic	100mg	180 + 8 Pills	199.37€ 189.88€	Buy

However, 53.0 % reported that discussing Viagra Connect® made some patients uncomfortable and unwilling to divulge information (Fig.

PCI DSS Compliant

Email reminders were sent after 1 week and 1 month of initial invitation. Each pharmacy received a single-use code to exclude duplicate entries by multiple respondents. If > 1 pharmacist per pharmacy wanted to participate, an additional code was requested. Respondents were offered a single financial remuneration for a completed survey, based on fair-market-value of expected completion time. Data were collected via a structured, self-administered online questionnaire.

Pharmacists’ Advice to Patients About the Appropriate/Safe Use of VC

The questionnaire comprised 33 closed-ended questions with multiple-choice responses that covered the study objectives and screening, demographics, experience with Viagra Connect®, utilisation of the checklist and tear-off slip, attitudes towards patient counselling and towards Viagra Connect® training. A sample of 200 completed surveys was planned, based on statistical and practical considerations. A completed survey was defined when all questions relevant to participant’s responses (following skip logic) were answered. Only data from completed surveys were included. Frequency distributions with 95 % CIs were calculated using the Clopper–Pearson method.

Survey sample

aRMMs were considered effective if ≥ 80 % of pharmacists provided correct answers to questions pertaining to KRMs. This level was agreed upon as a reasonable threshold, as there are no established criteria or published literature to provide valid thresholds for measuring effectiveness of aRMMs. From 4000 invited pharmacies, 387 were screened (response rate: 9.7 %), and 357 were eligible (eligibility: 92.2 %). In total, 345 eligible respondents completed the survey (completion rate: 96.6 %) (Online Resource 2). Mean completion time was ~19.6 min. Only 5.2 % of respondents felt uncomfortable counselling about Viagra Connect®. In recent years, there has been a move towards supporting self-care, and a key element of this has been the switching from POM to P-medicine, available BTC at pharmacies. We found that community pharmacists had a good level of knowledge and awareness of KRMs for Viagra Connect®, and, when unsure, acted in a risk-averse manner and did not supply Viagra Connect®. Awareness of the KRMs suggests the training materials were effective for educating community pharmacists on key aspects of its supply. To our knowledge, this was the first assessment of the effectiveness of aRMMs for a BTC-available product.

• Viagra Connect is an over-the-counter treatment for erectile dysfunction.
• It contains sildenafil, which improves blood flow to the penis.
• Available in pharmacies without a prescription.
• Patients should consult a pharmacist before use.
• Suitable for men aged 18 and over.
• Must be taken at least 30 minutes before activity.

Overall, a good level of uptake, engagement, and awareness of the Viagra Connect® aRMMs programme was seen within the UK pharmacy setting. These results may be important for informing policy regulators in other countries considering reclassification of Viagra® to non-prescription status. With the availability of understandable information and online resources, society is better educated than ever about health and therapy options [11].

Is Viagra Connect right for me?

Respondents tended to be male (69.9 %), 41–60 years of age (40.3 %), and had been dispensing medications for ≥ 11 years (63.2 %). Most pharmacists were located in an urban setting (73.9 %), and nearly half worked for a large pharmacy chain. Five of 28 items assessed knowledge of KRMs in Part 1. At least 80 % of pharmacists selected correct responses to dapoxetine viagra 24/28 items (Table 3). The majority correctly responded to questions concerning concomitant diseases which may be contributing to ED.

Survey participants

The lowest correct response rate was observed for “Men who had a heart attack or stroke > 6-months ago should not be supplied Viagra Connect® but should be referred to their doctor”, with 41.4 % correctly answering “False”. At least 80 % of respondents correctly answered questions concerning concomitant medications not recommended with Viagra Connect® (Table 3). Questions regarding suitability of patients to use Viagra Connect® when on a different dose of sildenafil or other ED treatment(s), when taking riociguat for lung problems, or beta-blockers (correct answers: “false”, “no”, “yes”, respectively) did not reach ≥ 80 % correct response rate. CI confidence interval, ED erectile dysfunction, PPI proton pump inhibitor a95 % exact two-sided CIs are calculated using the Clopper–Pearson method Four questions consisting of 23 items were used to assess knowledge of KRMs in Part 2. At least 80 % of respondents correctly answered 19/23 items (Table 4). This has led to pharmacists experiencing increased responsibilities in facilitating self-care, with patients requesting medications for acute or long-term conditions [12].

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At least 80 % correctly identified that patients should be advised to stop taking Viagra Connect® and seek immediate medical help if they experience chest pains, persistent/painful erections (> 4 h), loss of vision, or an allergic reaction. Below 80 % correctly identified that patients who experience headache or nausea do not need to stop taking Viagra Connect® and seek medical attention (correct answers were “false”, Table 4). At least 80 % correctly identified conditions that may cause ED, and that patients with evidence of undiagnosed depression, anxiety, or excessive alcohol use should receive lifestyle advice and follow-up with their doctor. Below 80 % correctly identified hypertension and hypercholesterolemia as possible causes of ED (Table 4). Most respondents understood that all patients supplied Viagra Connect® should be offered lifestyle advice, and advised to consult their doctor within 6 months of first supply, and that patients whose request for Viagra Connect® was refused should be advised to contact their doctor.