Address
Dr. med. dent. R. Gautschi
Gotthardstrasse 29
8800 Thalwil ZH
Contact
[email protected]
+41 (0) 44 720 29 00
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 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®.
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® 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®. 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. 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. 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 50mg | 20 Pills | 40.52€ 38.59€ | |
| Viagra Original | 100mg | 76 + 4 Pills | 306.59€ 291.99€ | |
| Viagra Super Active | 100mg | 10 Pills | 28.76€ 27.39€ | |
| Viagra Super Active | 100mg | 60 + 8 Pills | 116.84€ 111.28€ | |
| Viagra Oral Jelly | 100mg | 63 + 7 Sachets | 190.54€ 181.47€ | |
| Viagra Super Active | 100mg | 270 + 30 Pills | 390.61€ 372.01€ | |
| Viagra Original | 100mg | 8 Pills | 59.84€ 56.99€ | |
| Viagra Oral Jelly | 100mg | 21 Sachets | 78.66€ 74.91€ | |
| Viagra Super Active | 100mg | 360 + 30 Pills | 470.93€ 448.50€ | |
| Viagra Generic | 25mg | 360 + 10 Pills | 213.68€ 203.50€ | |
| Viagra Generic | 200mg | 60 + 4 Pills | 125.19€ 119.23€ | |
| Viagra Soft Tabs | 100mg | 60 + 6 Pills | 152.94€ 145.66€ | |
| Viagra Generic | 200mg | 30 + 2 Pills | 83.07€ 79.11€ | |
| Viagra Oral Jelly | 100mg | 30 + 5 Sachets | 115.76€ 110.25€ |
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]. Subsequently, Ireland and Norway also permitted supply of Viagra Connect® behind-the-counter (BTC); however, sildenafil citrate remains a POM in most countries.
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. 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.
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].
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®. 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 viagra alternative uk 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. In certain circumstances, routine RMMs may not be sufficient and additional RMMs (aRMMs) are needed to address specific safety concerns.
| 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 |
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].
| Step Number | Action | Required Information | Duration | Notes |
|---|---|---|---|---|
| 1 | Visit the Website | None | 2 minutes | Access via desktop or mobile browser |
| 2 | Fill Personal Details | Name, Date of Birth, Address | 3 minutes | Ensure accurate data entry |
| 3 | Medical Questionnaire | Medical history questions | 4 minutes | Privacy is maintained |
| 4 | Confirm Identity | Photo ID upload (if needed) | 5 minutes | May vary based on verification needs |
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®. 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 viagra alternative uk 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® 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®. 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. 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. Email reminders were sent after 1 week and 1 month of initial invitation.
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 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]. 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]. 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.
Dr. med. dent. R. Gautschi
Gotthardstrasse 29
8800 Thalwil ZH
[email protected]
+41 (0) 44 720 29 00