Completing the Health Declaration for Viagra Connect

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 %).

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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.

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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. In total, 345 eligible respondents completed the survey (completion rate: 96.6 %) (Online Resource 2).

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Mean completion time was ~19.6 min.

• 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.

Respondents tended to be male (69.9 %), 41–60 years of age (40.3 %), and had been dispensing medications for ≥ 11 years (63.2 %).

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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, viagra alternative uk 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.

Patient and Pharmacy Characteristics

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. Most pharmacists were located in an urban setting (73.9 %), and nearly half worked for a large pharmacy chain.

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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. Five of 28 items assessed knowledge of KRMs in Part 1.

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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. At least 80 % of pharmacists selected correct responses to 24/28 items (Table 3).

• The drug improves quality of life for many men with ED.
• It is part of a broader treatment approach, including counseling.
• Mental health can impact erectile function.
• Lifestyle changes can enhance medication effectiveness.
• Support groups may provide additional help.
• Consult your doctor if ED persists despite treatment.

The majority correctly responded to questions concerning concomitant diseases which may be contributing to ED.

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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).

Patients’ Reported Experience with Visiting or Planning to Visit Their Doctor

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®. 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”.

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

At least 80 % of respondents correctly answered questions concerning concomitant medications not recommended with Viagra Connect® (Table 3).

• Viagra Connect requires a brief health assessment at purchase.
• Patients should disclose any health issues or medications.
• Alcohol consumption may reduce effectiveness.
• It does not cause an instant erection; arousal needed.
• Side effects are usually mild and temporary.
• Seek medical advice if experiencing persistent problems.

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.

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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].

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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].