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An increase in drug-drug interactions were deemed unlikely for tadalafil with nitrates due to their low and decreasing usage in Germany (0.8); in 2020, there were 53

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Overall attribute scores ranged from 2.8 to 5.4, with the highest scores for a decrease in barriers to treatment (5.4), less use of counterfeit medicines (5.0), improved psychological wellbeing and increased quality of life (4.0), and increased public awareness and reduced stigmatisation (4.0). There was consensus amongst experts that the risks were low/unlikely to occur and would not have a significant clinical impact. The information on the outer carton was considered to sufficiently manage the risks. Consensus was reached on how likely 12 out of 14 incremental risks were to occur and of a low clinical impact for 11 of them (Table 4, shaded boxes). The overall attribute scores were much lower than for the benefits, ranging from 0.2 to 2.2, with 11 risks scoring 1.0 or less. million defined daily doses (DDD) of long-acting nitrates prescribed (reduced from 233 million DDDs in 2011), 52 million DDDs of molsidomine and 31 million DDDs of glyceryl trinitrate.

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	10mg	180 + 8 Pills	236.88€ 225.60€	Buy
Cialis Generic	2.5mg	20 Pills	40.73€ 38.79€	Buy
Cialis Generic	2.5mg	60 + 4 Pills	83.43€ 79.46€	Buy
Cialis Generic	2.5mg	30 + 4 Pills	51.95€ 49.48€	Buy
Cialis Generic	2.5mg	10 Pills	28.51€ 27.15€	Buy
Cialis Generic	5mg	30 + 4 Pills	53.56€ 51.01€	Buy
Cialis Generic	20mg	180 + 10 Pills	254.09€ 241.99€	Buy
Cialis Generic	2.5mg	270 + 10 Pills	199.64€ 190.13€	Buy
Cialis Generic	2.5mg	120 + 6 Pills	128.93€ 122.79€	Buy
Cialis Generic	20mg	120 + 8 Pills	188.15€ 179.19€	Buy
Cialis Generic	60mg	360 + 10 Pills	570.52€ 543.35€	Buy
Cialis Generic	40mg	60 + 6 Pills	130.98€ 124.74€	Buy
Tadalista Super Active	20mg	10 Pills	55.64€ 52.99€	Buy
Cialis Generic	40mg	10 Pills	37.79€ 35.99€	Buy
Cialis Generic	5mg	20 Pills	41.99€ 39.99€	Buy

In the context of this reducing use, the warning on the package (see below) was considered sufficient mitigation for this risk.

• Tadalafil often shows up in online ads promoting sale discounts.
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IMPORTANT: Do not use if you are taking either of the following two medicines: • Nitrate medicine for chest

• Illegal tadalafil sales can pose health risks.
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pain (angina pectoris) or heart failure • Nitrate medicine for chest pain (angina pectoris) or heart failure • Riociguat for

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To ensure a systematic, transparent methodology was followed, a Brass analysis was undertaken (Brass et al., 2013). This structured process has been developed to help in complex decision-making for reclassification of prescription medications and is endorsed by regulatory authorities such as the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Federal agency, the Food and Drug Administration (FDA) (Brass et al., 2011; Medicines and Healthcare products Regulatory Agency, 2021). The Brass analysis began with the development of a Brass value tree, which was informed by a comprehensive evidence review with clinical expert input (Figure 1) (Brass et al., 2011). The Brass value tree is a framework for identifying incremental benefits and risks that might arise in addition to the established efficacy and safety of the product as a prescription medicine according to the European Medicines Agency Article 71 (1) of Directive 2001/83/EC (EMA, 2006). Within each pre-defined major benefit and risk domain that should be considered for any non-prescription drug, specific attributes were identified for tadalafil.

Table of Contents

The Brass value tree and evidence for each incremental benefit and risk were circulated to an expert clinical panel prior to the consensus meeting. The expert panel comprised four urologists, one of whom chaired the meeting, a cardiologist, a pharmacist, and the speaker was a clinical pharmacologist. This mix of specialties ensured that different important perspectives could be captured with the necessary clinical expertise to critically review the evidence, identify any additional benefits and risks, and understand the clinical impact of making a PDE5 inhibitor for the treatment of ED available without prescription. The objective of the meeting was to achieve an expert consensus on the benefits and risks; hence a Group Delphi technique was utilised. The speaker presented the evidence, it was discussed, and then the panel gave independent ratings on the likelihood and clinical impact of each incremental benefit and risk (Okoli and Pawlowski, 2004; Brass et al., 2013).

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Both the likelihood and clinical impact were scored from tadalafil online 0 (none) to 3 (high) or a “do not know” option. Results were fed back to the panel. Where consensus was not achieved, defined as scores more than 1 point apart, further open discussion was initiated. Overall scores were calculated from multiplying the mean likelihood of behaviour or event and the mean clinical impact providing an overall benefit or risk score between 0 and 9. A Public Health consultant provided expertise in relation to the health economic and public health benefits but not for the clinical benefits and risks. high blood pressure in the lungs • Riociguat for high blood pressure in the lungs The warning messages in the PIL are: What you need to know before you take *TM* (*TM* is a placeholder for the approved brand name). Take any medicines called nitrates or nitric oxide donors (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate for the

Demographic	Average Age	Usage Purpose	Frequency of Use	Typical Dosage	Common Side Effects
Men with ED	45-65	Erectile dysfunction	2-3 times/month	10-20 mg	Headache, flushing
Younger Men	30-44	Recreational purposes	Occasional	5-10 mg	Dizziness, nausea
Older Adults	65+	Chronic ED management	As prescribed	5-20 mg	Muscle pain, insomnia

relief of chest pain or heart failure, or amyl nitrite also known as “poppers”, nicorandil, molsidomine or sodium nitroprusside).

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These are often used for the relief of chest pain (angina pectoris), or heart failure.

Platform	Type	Content Focus	Regulatory Status	Audience Reach
Google Ads	Paid Ads	Erectile Dysfunction Relief	Approved with restrictions	High (global)
Facebook	Social Media	Health Benefits, Discounts	Restricted, regulated by policy	Wide (adults)
Medical Journals	Scientific Papers	Pharmacology and Efficacy	Fully approved	Medical community
E-commerce Sites	Sale Platforms	Discounts, Fast Delivery	Varies by country	Global

Using *TM* with any of these medicines may lead to a dangerous fall in blood pressure.

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2USP procures materials worldwide and most foreign materials do not undergo a fundamental change during the packaging process at USP that would substantially transform the item resulting in a country of origin change from the foreign origin to the United States. Under the Rules of Origin the original foreign country of origin would remain. Animal, Plant, Fish) may require special country importation requirements.USP recommends you contact your country competent authorities to determine if any certifications, permits or licenses may be required prior to ordering.Material Origins are found within the Product under Origin Information. An evidence-based consensus meeting was held with urologists, a pharmacist and a cardiologist to perform a structured benefit-risk analysis of reclassifying tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor for treatment of erectile dysfunction (ED), to be available without prescription in Germany. As per the Brass process endorsed by regulatory authorities, an evidence-based Brass value tree was developed, which identified the incremental benefits and risks that should be considered above the safety and efficacy evidence required for prescription medicines.

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During the Group Delphi consensus meeting, the expert panel rated the likelihood and clinical impact of each benefit and risk on a scale of 0 (none) to 3 (high). Overall attribute scores were calculated from the product of the mean likelihood and mean clinical impact scores giving a possible score of 0–9. The overall benefit attribute scores ranged from 2.8 to 5.4. The overall risk attribute scores ranged from 0.2 to 2.2 though most were 1.0 or less (3 or more is generally considered to be of concern). On balance, the independent meeting scored the benefits of reclassification of tadalafil higher than the risks and considered the risk mitigation strategies of the packaging label and patient information leaflet (PIL) sufficient.

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Keywords: erectile dysfunction, non-prescription, phosphodiesterase type 5 inhibitor (PDE5 inhibitor), reclassification, tadalafil There is a high prevalence of erectile dysfunction (ED) in Europe, with 42% (53.9 million) of men self-reporting difficulty achieving or maintaining an erection in the previous 5 months (Goldstein et al., 2020). In Germany, the figure is between 33% and 45%, which includes 5% of younger men aged 18 to 39 (Jannini et al., 2014; Briken et al., 2020; Goldstein et al., 2020). Despite the high prevalence, up to 81% of men do not seek treatment, so ED remains under-recognised, underdiagnosed and undertreated (Shabsigh et al., 2004; de Boer et al., 2005; Moreira et al., 2005; Nicolosi and et a l., 2006; Frederick et al., 2014; Jannini et al., 2014). The phosphodiesterase type 5 (PDE5) inhibitor, tadalafil, is currently only available in Germany via a prescription. The aim of this study was to convene an expert panel to quantify the likelihood of occurrence and the potential clinical impact of each incremental benefit and risk identified for reclassification of tadalafil as a non-prescription medicine. If it were to occur, the mean clinical impact score was rated low to moderate (1.7).

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The speaker and Public Health consultant participated in discussions but did not rate the risks and benefits. The meeting was thus chaired and run by the independent group of experts with no input or participation from pharmaceutical companies. The evidence for each incremental benefit and risk domain identified in the literature review for tadalafil is summarised below in Tables 1, 2. Post-marketing safety data are reported using periodic safety update reports (PSUR) and periodic benefit-risk evaluation reports (PBRER) for tadalafil that have been submitted to regulatory authorities by Lilly as required by regulations since the first marketing authorisation for tadalafil on 15 October 2002 up to 15 October 2020. Post-marketing adverse event reports from 84,674,000 patients exposed to Cialis worldwide from 2002 to 2020 (EMTEX, 2021).

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Each incremental benefit was scored in two rounds of ratings, Table 3. Shaded boxes indicate where consensus was reached (all scores within 1 point of each other). According to the second round of scoring, the expert panel considered that all incremental benefits were likely, with the exception of one expert who did not think there would be an increased likelihood of diagnosis of underlying health conditions. Individual scores ranged from low to high with mean likelihood scores of 1.7–2.3 but there was no consensus. D = do not know; Shaded boxes = consensus reached.

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Likelihood mean score: 0, the behaviour will almost never occur; 3, the behaviour is likely to be frequent. Clinical impact mean score: 0, there would be no clinical impact; 3, the clinical impact would be high. There was consensus of a moderate to high clinical impact if there were less use of counterfeit medicines (2.5). There was also agreement of a moderate clinical impact from empowering men to self-manage their condition (1.8) and for the economic benefits (1.7). For the other incremental benefits, consensus was not reached but the mean clinical impact ranged from 1.7 to 2.3.

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Fabienne Heyne
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Jonas Bünter
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Angelika Annen
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