A Web-Based Survey of Patients Dispensed Viagra Connect® Behind the Counter in UK: An Evaluation of Effectiveness of Additional Risk Minimization Measures

0% found this document useful (0 votes) This document provides a checklist for pharmacists to determine if a patient is suitable for Viagra Connect or should be referred to a doctor. What is Schrödinger's cat in simple terms?Schrödinger’s cat is a famous thought experiment in quantum mechanics that illustrates how quantum uncertainties at a very small scale can lead to seemingly absurd scenarios at familiar scales. Schrödinger’s cat is a famous thought experiment in quantum mechanics that illustrates how quantum uncertainties at a very small scale can lead to seemingly absurd scenarios at familiar scales. How does gravity actually work in everyday life on Earth?Gravity is the fundamental force by which Earth and other massive bodies attract objects toward their centers. Gravity is the fundamental force by which Earth and other massive bodies attract objects toward their centers. What are the main ways different animals reproduce and have babies?Reproduction is the biological process by which animals give rise to offspring and maintain their populations. Broadly speaking, animals reproduce either sexually or asexually. Reproduction is the biological process by which animals give rise to offspring and maintain their populations. The checklist includes questions about cardiovascular health, concomitant medication use, and medical conditions. If the patient answers yes to any questions, they should not be supplied the product and should be referred to a doctor. The checklist is intended to help pharmacists supply Viagra Connect safely without a prescription to men over 18 experiencing erectile dysfunction. Background To support reclassification in the UK of sildenafil citrate (50 mg) from prescription-only medicine to a pharmacy medicine (P status) under the brand name “Viagra Connect®”, additional risk minimisation measures were implemented that included training materials and an optional checklist to assist community pharmacists in the safe supply of Viagra Connect® to suitable patients. Objective To evaluate the effectiveness of Viagra Connect® additional risk minimisation measures by assessing community pharmacists’ participation in training, their knowledge of key risk messages, and utilisation of the checklist. Setting A post-authorisation safety study implemented as a web-based survey, conducted in a representative population of UK community pharmacists. Method A random sample of community pharmacists who received at least 1 request to supply Viagra Connect® within the past 6 months completed an online questionnaire of 33 closed-ended questions/statements with multiple-choice responses. Main outcome measure Knowledge of key risk messages and dispensing practices communicated in the additional risk minimisation measures.

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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.

Assessment for Suitability for VC by Pharmacist

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).

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Results The survey was completed by 345 community pharmacists.

Respondents displayed a high level of knowledge of key risk messages, with ≥80 % selecting correct answers for 43/51 items. Nearly all respondents (90.1 %) reported that the training materials were useful/very useful, and reported using the checklist at the point of supply (91.9 %). Counselling of patients who requested Viagra Connect® was generally considered a positive exercise.

What is the difference between Viagra and Viagra Connect?

Main outcome measure Knowledge of key risk messages and dispensing practices communicated in the additional risk minimisation measures. Results The survey was completed by 345 community pharmacists. Respondents displayed a high level of knowledge of key risk messages, with ≥80 % selecting correct answers for 43/51 items. Nearly all respondents (90.1 %) reported that the training materials were useful/very useful, and reported using the checklist at the point of supply (91.9 %). Counselling of patients who requested Viagra Connect® was generally considered a positive exercise.

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Conclusions The Viagra Connect® additional risk minimisation measures were effective for education of community pharmacists and to ensure safe supply of Viagra Connect® behind-the-counter to patients. The online version contains supplementary material available at 10.1007/s11096-021-01339-7. Keywords: Additional risk minimisation measures (aRMM), Behind-the-counter (BTC), Community pharmacists, Effectiveness evaluation, Pharmacy medicine, Sildenafil citrate, Survey Reclassification in the UK of sildenafil citrate (50 mg) from a prescription-only medicine to behind-the-counter availability in pharmacies (P status) under the brand name “Viagra Connect®” has increased the role of community pharmacists in facilitating patient counselling, determining patient suitability for use of Viagra Connect®, and for directing patients to their doctor when needed. Reclassification in the UK of sildenafil citrate (50 mg) from a prescription-only medicine to behind-the-counter availability in pharmacies (P status) under the brand name “Viagra Connect®” has increased the role of community pharmacists in facilitating patient counselling, determining patient suitability for use of Viagra Connect®, and for directing patients to their doctor when needed. This study demonstrated that community pharmacists have a good working knowledge of the Viagra yellow viagra pill Connect® additional Risk Minimisation Measures, which included tailored educational materials and decision aids intended to mitigate risks around supply of Viagra Connect® without a prescription.

Statistical analysis

Community pharmacists widely utilise the Viagra Connect® Pharmacy Checklist at the point of supply and are confident in counselling patients who request Viagra Connect®. When pharmacists are uncertain of whether to supply the medicine, they tend to take a risk-averse approach and refer patients back to their doctor. Assessing the effectiveness of additional risk minimisation measures in the behind-the-counter setting is uncommon and the methodology employed may be repurposed to future medications reclassified to pharmacy medicines. Sildenafil citrate, a phosphodiesterase type-5 inhibitor (PDE5I), is first-line treatment for erectile dysfunction (ED) [1, 2] and is indicated for men ≥18 years of age [3]. In November 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved reclassification of sildenafil citrate (50 mg) from a prescription-only medicine (POM) to a pharmacy (P) medicine, for dispensing under supervision of a pharmacist (Viagra Connect®) [4]. Conclusions The Viagra Connect® additional risk minimisation measures were effective for education of community pharmacists and to ensure safe supply of Viagra Connect® behind-the-counter to patients. The online version contains supplementary material available at 10.1007/s11096-021-01339-7. Keywords: Additional risk minimisation measures (aRMM), Behind-the-counter (BTC), Community pharmacists, Effectiveness evaluation, Pharmacy medicine, Sildenafil citrate, Survey Reclassification in the UK of sildenafil citrate (50 mg) from a prescription-only medicine to behind-the-counter availability in pharmacies (P status) under the brand name “Viagra Connect®” has increased the role of community pharmacists in facilitating patient counselling, determining patient suitability for use of Viagra Connect®, and for directing patients to their doctor when needed.

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Subsequently, Ireland and Norway also permitted supply of Viagra Connect® behind-the-counter (BTC); however, sildenafil citrate remains a POM in most countries. In the EU and UK, safety concerns associated with medicinal products are typically addressed by routine risk minimisation measures (RMMs), such as product information or package inserts, to ensure benefits outweigh the risks [5]. In certain circumstances, routine RMMs may not be sufficient and additional RMMs (aRMMs) are needed to address specific safety concerns. aRMMs are used to guide appropriate patient selection, support on-treatment monitoring and/or management of adverse reactions, minimise risk of medication error, and/or ensure appropriate administration when this cannot be achieved through product information/labelling alone [6]. Pharmacists working in the community (community pharmacists) play an important role in facilitating discussions and counselling men seeking to purchase Viagra Connect® [4].

Survey participants

Community pharmacists were therefore target recipients for the UK aRMMs programme for Viagra Connect®, which, in agreement with the MHRA, aimed to minimise the risk of Viagra Connect® being supplied to patients unsuitable to take the product without consultation with their doctor [4]. The UK aRMMs for Viagra Connect® included the Essential Information for the Supply of Viagra Connect® training guide and standalone checklist, an optional tool to help pharmacists assess patient suitability (version 01/18/2018; Online Resource 1) [7]. The checklist gauges overall fitness for sex by determining if he gets out of breath or experiences chest pain during physical activity, and helps identify men with cardiovascular problems, or taking contraindicated medications that would preclude them from safely using Viagra Connect®. 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®.

What is the difference between Prescription Viagra and 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. 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. Reclassification in the UK of sildenafil citrate (50 mg) from a prescription-only medicine to behind-the-counter availability in pharmacies (P status) under the brand name “Viagra Connect®” has increased the role of community pharmacists in facilitating patient counselling, determining patient suitability for use of Viagra Connect®, and for directing patients to their doctor when needed.

This study demonstrated that community pharmacists have a good working knowledge of the Viagra yellow viagra pill Connect® additional Risk Minimisation Measures, which included tailored educational materials and decision aids intended to mitigate risks around supply of Viagra Connect® without a prescription. Community pharmacists widely utilise the Viagra Connect® Pharmacy Checklist at the point of supply and are confident in counselling patients who request Viagra Connect®. When pharmacists are uncertain of whether to supply the medicine, they tend to take a risk-averse approach and refer patients back to their doctor. Assessing the effectiveness of additional risk minimisation measures in the behind-the-counter setting is uncommon and the methodology employed may be repurposed to future medications reclassified to pharmacy medicines. Sildenafil citrate, a phosphodiesterase type-5 inhibitor (PDE5I), is first-line treatment for erectile dysfunction (ED) [1, 2] and is indicated for men ≥18 years of age [3].

• 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.

In November 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved reclassification of sildenafil citrate (50 mg) from a prescription-only medicine (POM) to a pharmacy (P) medicine, for dispensing under supervision of a pharmacist (Viagra Connect®) [4]. Subsequently, Ireland and Norway also permitted supply of Viagra Connect® behind-the-counter (BTC); however, sildenafil citrate remains a POM in most countries. In the EU and UK, safety concerns associated with medicinal products are typically addressed by routine risk minimisation measures (RMMs), such as product information or package inserts, to ensure benefits outweigh the risks [5]. In certain circumstances, routine RMMs may not be sufficient and additional RMMs (aRMMs) are needed to address specific safety concerns. aRMMs are used to guide appropriate patient selection, support on-treatment monitoring and/or management of adverse reactions, minimise risk of medication error, and/or ensure appropriate administration when this cannot be achieved through product information/labelling alone [6]. Pharmacists working in the community (community pharmacists) play an important role in facilitating discussions and counselling men seeking to purchase Viagra Connect® [4]. Community pharmacists were therefore target recipients for the UK aRMMs programme for Viagra Connect®, which, in agreement with the MHRA, aimed to minimise the risk of Viagra Connect® being supplied to patients unsuitable to take the product without consultation with their doctor [4]. The UK aRMMs for Viagra Connect® included the Essential Information for the Supply of Viagra Connect® training guide and standalone checklist, an optional tool to help pharmacists assess patient suitability (version 01/18/2018; Online Resource 1) [7]. The checklist gauges overall fitness for sex by determining if he gets out of breath or experiences chest pain during physical activity, and helps identify men with cardiovascular problems, or taking contraindicated medications that would preclude them from safely using Viagra Connect®. 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®.

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0% found this document useful (0 votes) This document provides a checklist for pharmacists to determine if a patient is suitable for Viagra Connect or should be referred to a doctor. What is Schrödinger's cat in simple terms?Schrödinger’s cat is a famous thought experiment in quantum mechanics that illustrates how quantum uncertainties at a very small scale can lead to seemingly absurd scenarios at familiar scales. Schrödinger’s cat is a famous thought experiment in quantum mechanics that illustrates how quantum uncertainties at a very small scale can lead to seemingly absurd scenarios at familiar scales. How does gravity actually work in everyday life on Earth?Gravity is the fundamental force by which Earth and other massive bodies attract objects toward their centers. Gravity is the fundamental force by which Earth and other massive bodies attract objects toward their centers.

Supplementary Information

What are the main ways different animals reproduce and have babies?Reproduction is the biological process by which animals give rise to offspring and maintain their populations. Broadly speaking, animals reproduce either sexually or asexually. Reproduction is the biological process by which animals give rise to offspring and maintain their populations. The checklist includes questions about cardiovascular health, concomitant medication use, and medical conditions. If the patient answers yes to any questions, they should not be supplied the product and should be referred to a doctor.

Who Can Use Viagra Connect?

The checklist is intended to help pharmacists supply Viagra Connect safely without a prescription to men over 18 experiencing erectile dysfunction. Background To support reclassification in the UK of sildenafil citrate (50 mg) from prescription-only medicine to a pharmacy medicine (P status) under the brand name “Viagra Connect®”, additional risk minimisation measures were implemented that included training materials and an optional checklist to assist community pharmacists in the safe supply of Viagra Connect® to suitable patients. Objective To evaluate the effectiveness of Viagra Connect® additional risk minimisation measures by assessing community pharmacists’ participation in training, their knowledge of key risk messages, and utilisation of the checklist. Setting A post-authorisation safety study implemented as a web-based survey, conducted in a representative population of UK community pharmacists. Method A random sample of community pharmacists who received at least 1 request to supply Viagra Connect® within the past 6 months completed an online questionnaire of 33 closed-ended questions/statements with multiple-choice responses. 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. 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 product is approved by health regulatory authorities.
• It can be purchased online or in-store at pharmacies.
• Not suitable for women or individuals under 18.
• Levitra and Cialis are alternative ED medications.
• Combining with certain drugs can cause serious side effects.
• Follow the recommended dosage strictly.

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.

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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).