A Web-Based Survey of Patients Dispensed Viagra Connect® Behind the Counter in UK: An Evaluation of Effectiveness of Additional Risk Minimization Measures
The checklist also instructs pharmacists to provide lifestyle advice, and advise patients to consult their doctor within 6 months for a clinical review of potential underlying conditions and risk factors associated with ED [4, 7]. A patient record tear-off slip includes follow-up advice and should be presented to a pharmacist when they next request Viagra Connect®. The training document and checklist were developed following discussions with practising pharmacists, general practice doctors, and 2 urology specialists to identify training needs of pharmacists supplying Viagra Connect®. Drafts were reviewed at a workshop of practising pharmacists and agreed with the MHRA. Findings and recommendations were incorporated into updated training materials, which were offered by the marketing authorisation holder to community pharmacists in a variety of modalities to ensure the widest opportunity for learning, including online resources, regional meetings, printed materials, and face-to-face.
| 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 |
Training materials were supplied from February 2018, before launch of Viagra Connect® on March 27, 2018. These materials (now updated) continue to be an important resource for pharmacists. Some pharmacists may have had experience supplying PDE5Is as a consequence of patient-group direction (PGD) training programmes [8]. Under UK legislation, PGD permits express healthcare professionals to supply medications to pre-defined patients without prescription [9, 10]. This post-authorisation safety study, an MHRA regulatory commitment, was a survey of pharmacists to evaluate the effectiveness of UK Viagra Connect® aRMMs in the community pharmacy setting. Effectiveness was evaluated by assessing community pharmacists’ participation in the training, knowledge of key risk messages (KRMs), and utilisation of the optional checklist when dispensing. The study was screened through the Medical Research Council and National Health Service Research Authority Research Ethics Committee algorithm ( and responses to this assessment determined that specific ethical approval was not required. Informed consent was obtained by respondents as part of the survey. The purpose of the survey, how the data would be reported, and participant confidentiality were explained in the survey invitation. KRMs were communicated in the Viagra Connect® training materials and optional checklist. Part 1 communicated KRMs when determining patient suitability for Viagra Connect®: (1) supply criteria, (2) cardiovascular health, (3) concomitant medications, and (4) enquiring about concomitant medical conditions (Table 1). Part 2 communicated KRMs to consider during consultation: (1) possible causes of ED, (2) advising patients to stop taking Viagra Connect® sildenafil viagra price 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.
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The checklist also instructs pharmacists to provide lifestyle advice, and advise patients to consult their doctor within 6 months for a clinical review of potential underlying conditions and risk factors associated with ED [4, 7]. A patient record tear-off slip includes follow-up advice and should be presented to a pharmacist when they next request Viagra Connect®. The training document and checklist were developed following discussions with practising pharmacists, general practice doctors, and 2 urology specialists to identify training needs of pharmacists supplying Viagra Connect®. Drafts were reviewed at a workshop of practising pharmacists and agreed with the MHRA. Findings and recommendations were incorporated into updated training materials, which were offered by the marketing authorisation holder to community pharmacists in a variety of modalities to ensure the widest opportunity for learning, including online resources, regional meetings, printed materials, and face-to-face.
Ethics approval
Training materials were supplied from February 2018, before launch of Viagra Connect® on March 27, 2018. These materials (now updated) continue to be an important resource for pharmacists. Some pharmacists may have had experience supplying PDE5Is as a consequence of patient-group direction (PGD) training programmes [8]. Under UK legislation, PGD permits express healthcare professionals to supply medications to pre-defined patients without prescription [9, 10]. This post-authorisation safety study, an MHRA regulatory commitment, was a survey of pharmacists to evaluate the effectiveness of UK Viagra Connect® aRMMs in the community pharmacy setting. The pilot confirmed that the invitation and respondent pool were representative of UK pharmacies and no changes were required to the protocol.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 150mg | 60 + 4 Pills | 111.25€ 105.95€ | |
| Viagra Generic | 50mg | 90 + 6 Pills | 107.37€ 102.26€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Viagra Original | 100mg | 76 + 4 Pills | 306.59€ 291.99€ | |
| Viagra Soft Tabs | 100mg | 180 + 10 Pills | 314.95€ 299.95€ | |
| Viagra Super Active | 100mg | 10 Pills | 28.76€ 27.39€ | |
| Viagra Original | 100mg | 48 + 4 Pills | 207.15€ 197.29€ | |
| Viagra Generic | 200mg | 360 + 10 Pills | 481.98€ 459.03€ | |
| Viagra Generic | 150mg | 10 Pills | 36.73€ 34.98€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ |
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®. 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.
Important information
The purpose of the survey, how data would be reported, and confidentiality were explained in the invitation. 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.
Patients’ Experience Regarding the Advice from the Pharmacist to Consult Their Doctor Within 6 Months of First Supply of VC
Data were collected via a structured, self-administered online questionnaire. 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. 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.
- Viagra Connect may interact with certain medications.
- Be aware of potential contraindications.
- Not for use with certain blood pressure medicines.
- Consult a healthcare professional before starting.
- Do not use if you have recent heart surgery.
- Regular check-ups can ensure safe use of ED medication.
Online only pharmacists who did not conduct face-to-face consultations were excluded. Data protection requirements were complied with before contacting pharmacists.
| 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 |
A random sample of pharmacists across 4000 pharmacies were sent postal invitations including a weblink to the survey.
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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. 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 %). The majority (91.3 %) always provided the tear-off slip when supplying Viagra Connect® (Table 5).
Patient and Pharmacy Characteristics
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). The purpose of the survey, how data would be reported, and confidentiality were explained in the invitation. 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. 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.
Choosing the Right Viagra Connect Pack
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®. 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).
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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. 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. Frequency distributions with 95 % CIs were calculated using the Clopper–Pearson method. 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. 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.
- 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.
At 25 mg viagra least 80 % of pharmacists selected correct responses to 24/28 items (Table 3). The majority correctly responded to questions concerning concomitant diseases which may be contributing to ED.
Key Takeaways
The majority correctly responded to questions concerning concomitant diseases which may be contributing to ED. 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.
Directions for Use
At least 80 % of respondents correctly answered 19/23 items (Table 4). 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). 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). 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).
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Frequency distributions with 95 % CIs were calculated using the Clopper–Pearson method. 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).
Study Variables
Mean completion time was ~19.6 min. 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 25 mg viagra least 80 % of pharmacists selected correct responses to 24/28 items (Table 3). 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. 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).
Product details
Effectiveness was evaluated by assessing community pharmacists’ participation in the training, knowledge of key risk messages (KRMs), and utilisation of the optional checklist when dispensing. The study was screened through the Medical Research Council and National Health Service Research Authority Research Ethics Committee algorithm ( and responses to this assessment determined that specific ethical approval was not required. Informed consent was obtained by respondents as part of the survey. The purpose of the survey, how the data would be reported, and participant confidentiality were explained in the survey invitation. KRMs were communicated in the Viagra Connect® training materials and optional checklist.
Can I take Viagra Connect with other medicines?
Part 1 communicated KRMs when determining patient suitability for Viagra Connect®: (1) supply criteria, (2) cardiovascular health, (3) concomitant medications, and (4) enquiring about concomitant medical conditions (Table 1). Part 2 communicated KRMs to consider during consultation: (1) possible causes of ED, (2) advising patients to stop taking Viagra Connect® sildenafil viagra price 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. 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 %).
| Aspect | Description | Regulation/Standard |
|---|---|---|
| Data Encryption | All personal data encrypted during transmission | GDPR, HIPAA (if applicable) |
| Data Storage | Secure storage with restricted access | Data protection laws |
| User Consent | Users must agree to terms before submitting form | Legal requirement |
| Privacy Policy | Outlines data usage and user rights | Available on the website |
The majority (91.3 %) always provided the tear-off slip when supplying Viagra Connect® (Table 5). 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).