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There was agreement that the likelihood of alcohol interaction occurring more frequently if tadalafil were available without prescription was low, as was the clinical impact with an overall score of 0.6, reflecting the evidence from clinical pharmacology studies that was reviewed by the experts during the meeting. The experts also agreed that men may be more likely to use tadalafil to enhance sexual performance (2.3), but that this would have a low clinical impact (0.7) as there was no evidence to suggest that the risks to health from use to enhance clinical performance would be clinically significant. There were mixed opinions on whether intentional use at a higher dose/frequency would increase, but consensus was that this would have a low clinical impact (0.5) according to the evidence and patient reported experiences. The overall attribute scores reflected consensus of a low likelihood or clinical impact of increased use in men with severe renal or hepatic disease (0.7), failure to read/understand safety information for men unfit to have sex due to cardiovascular disease (CVD) (1.0), use with “poppers” (1.0), use in women (0.2) or accidental ingestion by children (0.4).

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The identification of the incremental benefits and risks and collation of evidence from a diverse range of information sources including clinical trials, real-world studies and patient safety data was helpful in providing an evidence-based foundation to facilitate a comprehensive and rational assessment of the benefit-risk analysis. The Group Delphi technique provided the opportunity for divergent opinions to be frankly discussed and the experiences and expertise of the different specialists to be presented. In many cases, this led to narrowing of the range of scores where a second round of voting occurred, thereby gaining or moving towards consensus. The lack of consensus regarding the degree of likelihood and clinical impact of the majority of identified incremental benefits may in part be due to the complex number of factors involved in achieving each benefit. Importantly, the discussion about benefits is hypothetical as there is no PDE5 inhibitor available without prescription in Germany.

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Data from the UK regarding the experience with Viagra Connect was presented, but this was not felt to be directly applicable because of the differences in healthcare systems. For safety, patient safety update reports and large observational studies were able to provide strong evidence to help quantify the risks and are likely to have contributed to the high level of consensus reached. It is possible that gaps in evidence or differing opinions on whether evidence erectile dysfunction pills tadalafil from different healthcare systems would be replicable in Germany were factors in the range of scores for the benefits. For instance, some of the evidence for a reduction in barriers to treatment and improved diagnosis of underlying conditions came from the United Kingdom. Germany has substantially more urologists and therefore easier patient access to them.

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There were also differences of opinion regarding the level of health consultations that take place in pharmacies in Germany compared to the United Kingdom. However, there was general agreement that people are more likely to access services when provided locally, such as the increased take-up of flu vaccinations when provided at pharmacies. From the patient’s perspective it is more convenient to go straight to the pharmacy to get the medication rather than having to go to the doctor first for a prescription. There was some agreement that men may not want to see a doctor for ED because of embarrassment and therefore prefer to buy PDE5 inhibitors from a pharmacy. Recent TV advertising was believed to have raised awareness of ED and reduced inhibition thresholds to seek treatment. All considerations of the low clinical impact were based on evidence from published studies and 18 years of post-marketing safety data for patients exposed to Cialis worldwide that were reviewed by the experts in the meeting. Finally, there were differing views on the likelihood (1.0) and clinical impact (0.8) of delayed diagnosis of CVD and other underlying conditions. If ED were the only early symptom of CVD, it was felt to be unlikely that a man would arrange to see a cardiologist, therefore taking tadalafil would not delay a diagnosis of CVD.

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However, self-treating ED may reduce the likelihood of seeing an urologist and so could lead to a delay in diagnosis of an underlying urological condition. On balance, the overall attribute of this scenario was scored low (0.7).

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If tadalafil were to be reclassified to non-prescription status in Germany, training would be provided to pharmacists highlighting the contraindications, potential drug-drug interactions and conditions where men should first consult their physician. Messages on the carton and patient information leaflet (PIL) would include contraindications, safety information, dosage and side effects.

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These messages have been tested in men in three separate studies to ensure comprehension. The expert panel felt that these measures were appropriate and sufficient to mitigate against the identified incremental risks and that the results of the studies demonstrated that the information was sufficiently well understood and that consumers would make appropriate self-selection decisions. An additional suggested measure was to add a warning regarding the potential drug-drug interaction with veriziguat which was recently approved for chronic heart failure. The Brass decision analysis tool worked well in terms of achieving the objectives of the meeting. The identification of the incremental benefits and risks and collation of evidence from a diverse range of information sources including clinical trials, real-world studies and patient safety data was helpful in providing an evidence-based foundation to facilitate a comprehensive and rational assessment of the benefit-risk analysis. The Group Delphi technique provided the opportunity for divergent opinions to be frankly discussed and the experiences and expertise of the different specialists to be presented. In many cases, this led to narrowing of the range of scores where a second round of voting occurred, thereby gaining or moving towards consensus. The lack of consensus regarding the degree of likelihood and clinical impact of the majority of identified incremental benefits may in part be due to the complex number of factors involved in achieving each benefit. Importantly, the discussion about benefits is hypothetical as there is no PDE5 inhibitor available without prescription in Germany. Data from the UK regarding the experience with Viagra Connect was presented, but this was not felt to be directly applicable because of the differences in healthcare systems. For safety, patient safety update reports and large observational studies were able to provide strong evidence to help quantify the risks and are likely to have contributed to the high level of consensus reached. It is possible that gaps in evidence or differing opinions on whether evidence erectile dysfunction pills tadalafil from different healthcare systems would be replicable in Germany were factors in the range of scores for the benefits. For instance, some of the evidence for a reduction in barriers to treatment and improved diagnosis of underlying conditions came from the United Kingdom. Germany has substantially more urologists and therefore easier patient access to them. There were also differences of opinion regarding the level of health consultations that take place in pharmacies in Germany compared to the United Kingdom. However, there was general agreement that people are more likely to access services when provided locally, such as the increased take-up of flu vaccinations when provided at pharmacies.

Author contributions

From the patient’s perspective it is more convenient to go straight to the pharmacy to get the medication rather than having to go to the doctor first for a prescription.

• Tadalafil is used for treating pulmonary arterial hypertension under brand name Adcirca.
• The drug's sale is regulated by health authorities.
• Some countries require a prescription for quality assurance.
• Unauthorized tadalafil sales carry legal penalties.
• Online platforms sometimes offer medication without prescription.
• Be cautious of illegal vendors with unverified credentials.
• Always prioritize safety when purchasing tadalafil.

There was some agreement that men may not want to see a doctor for ED because of embarrassment and therefore prefer to buy PDE5 inhibitors from a pharmacy.

• Tadalafil’s mechanisms improve erectile function safely.
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• Tadalafil is not suitable for everyone; medical advice is essential.
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• Use caution when combining tadalafil with other medications.
• Always review potential interactions with your doctor.

Recent TV advertising was believed to have raised awareness of ED and reduced inhibition thresholds to seek treatment. If tadalafil were prescription-free, it was considered likely that the topic of ED would be more publicly discussed, and the feelings of embarrassment reduced. It was widely agreed that the consumer would be unaware if the product was counterfeited or not, but if it were available to buy in pharmacies, patients would have less reason to go to unreliable internet sources. The New Zealand example of reduced counterfeit packages following reclassification was discussed and considered to be potentially applicable in Germany. Only three risks scored above 1, the potential drug-drug interaction with riociguat which scored 2.2, potential misuse by men without ED which scored 1.6 and use with nitrates which scored 1.3. Riociguat is a relatively new drug used in the treatment of the rare condition of pulmonary arterial hypertension or more recently chronic thromboembolic pulmonary hypertension.

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There was agreement that the likelihood of alcohol interaction occurring more frequently if tadalafil were available without prescription was low, as was the clinical impact with an overall score of 0.6, reflecting the evidence from clinical pharmacology studies that was reviewed by the experts during the meeting. The experts also agreed that men may be more likely to use tadalafil to enhance sexual performance (2.3), but that this would have a low clinical impact (0.7) as there was no evidence to suggest that the risks to health from use to enhance clinical performance would be clinically significant. There were mixed opinions on whether intentional use at a higher dose/frequency would increase, but consensus was that this would have a low clinical impact (0.5) according to the evidence and patient reported experiences. The overall attribute scores reflected consensus of a low likelihood or clinical impact of increased use in men with severe renal or hepatic disease (0.7), failure to read/understand safety information for men unfit to have sex due to cardiovascular disease (CVD) (1.0), use with “poppers” (1.0), use in women (0.2) or accidental ingestion by children (0.4). All considerations of the low clinical impact were based on evidence from published studies and 18 years of post-marketing safety data for patients exposed to Cialis worldwide that were reviewed by the experts in the meeting.

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Finally, there were differing views on the likelihood (1.0) and clinical impact (0.8) of delayed diagnosis of CVD and other underlying conditions. If ED were the only early symptom of CVD, it was felt to be unlikely that a man would arrange to see a cardiologist, therefore taking tadalafil would not delay a diagnosis of CVD. However, self-treating ED may reduce the likelihood of seeing an urologist and so could lead to a delay in diagnosis of an underlying urological condition. On balance, the overall attribute of this scenario was scored low (0.7). If tadalafil were to be reclassified to non-prescription status in Germany, training would be provided to pharmacists highlighting the contraindications, potential drug-drug interactions and conditions where men should first consult their physician.

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Messages on the carton and patient information leaflet (PIL) would include contraindications, safety information, dosage and side effects. These messages have been tested in men in three separate studies to ensure comprehension. The expert panel felt that these measures were appropriate and sufficient to mitigate against the identified incremental risks and that the results of the studies demonstrated that the information was sufficiently well understood and that consumers would make appropriate self-selection decisions. An additional suggested measure was to add a warning regarding the potential drug-drug interaction with veriziguat which was recently approved for chronic heart failure. The Brass decision analysis tool worked well in terms of achieving the objectives of the meeting. The score reflected the moderate degree of clinical impact such a drug-drug reaction would have, but there was general agreement that this scenario would be unlikely because men would be under specialist clinical supervision and would also see the risk mitigation warning messages on the packaging and PIL. Potential misuse by men without ED was considered moderately likely to increase if tadalafil were to be available without prescription, but the clinical impact of this overuse was deemed to be low. The risk of drug-drug interactions with nitrates was considered of low likelihood and to have low clinical impact, largely because they are now rarely used in Germany. The warnings on the package and label were also felt to be sufficient though the panel recommended that men be directed to discuss their medication with a pharmacist or doctor if they are unsure about what they are taking. Across the domains there were no additional risk mitigation measures considered to be essential beyond the wording on the carton and in the PIL. There were suggestions to include warnings about newer medications for heart failure, such as vericiguat on the packaging and PIL. The discussion highlighted points about drug-drug interactions in general and the balance required in terms of how much information to include on the PIL, such as the trade and generic names. It was agreed that discussion with a GP or pharmacist about any potential interactions tadalafil 40mg with their other medication would be beneficial and that this could be a recommendation in the PIL. Based on this thorough and systematic assessment of the evidence for the incremental benefits and risks of making tadalafil available without prescription in Germany, the consensus amongst clinical experts was that the incremental risks would be small. They would either be unlikely to occur or, if more likely to occur, would have little clinical impact. There was high level agreement that the risks are sufficiently manageable, so even if there were differing opinions regarding the magnitude of benefits, the average risk evaluation appeared significantly lower than the potential benefits.

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There was high level agreement that the risks are sufficiently manageable, so even if there were differing opinions regarding the magnitude of benefits, the average risk evaluation appeared significantly lower than the potential benefits. With thanks to Harald Weigmann and Mohamed Amessou from Sanofi and to the team from Hamell Communications. The process was sponsored by Sanofi who provided funding to support the extensive literature review, allowed access to their post-marketing safety data, clinical trial data and clinical pharmacology data and provided funding to facilitate the meeting. However, the Group Delphi process and evaluation of the benefits/risks was independent of Sanofi. No members of Sanofi actively participated in the meeting and discussion of the evidence or interacted with the clinical experts.

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Editorial support was provided by Fiona Hammond and Alison Carr of Hamell Communications, United Kingdom, and was funded by Sanofi. Sanofi had no role in the design, execution, or interpretation of the Group Delphi process or in the writing of the paper. The authors received payment from Sanofi for their participation in the group Delphi meeting but no payment was received in relation to the writing or review of the paper. All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

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With thanks to Harald Weigmann and Mohamed Amessou from Sanofi and to the team from Hamell Communications.

Frequently Asked Questions

If tadalafil were prescription-free, it was considered likely that the topic of ED would be more publicly discussed, and the feelings of embarrassment reduced. It was widely agreed that the consumer would be unaware if the product was counterfeited or not, but if it were available to buy in pharmacies, patients would have less reason to go to unreliable internet sources. The New Zealand example of reduced counterfeit packages following reclassification was discussed and considered to be potentially applicable in Germany. Only three risks scored above 1, the potential drug-drug interaction with riociguat which scored 2.2, potential misuse by men without ED which scored 1.6 and use with nitrates which scored 1.3. Riociguat is a relatively new drug used in the treatment of the rare condition of pulmonary arterial hypertension or more recently chronic thromboembolic pulmonary hypertension.

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The score reflected the moderate degree of clinical impact such a drug-drug reaction would have, but there was general agreement that this scenario would be unlikely because men would be under specialist clinical supervision and would also see the risk mitigation warning messages on the packaging and PIL. Potential misuse by men without ED was considered moderately likely to increase if tadalafil were to be available without prescription, but the clinical impact of this overuse was deemed to be low. The risk of drug-drug interactions with nitrates was considered of low likelihood and to have low clinical impact, largely because they are now rarely used in Germany. The warnings on the package and label were also felt to be sufficient though the panel recommended that men be directed to discuss their medication with a pharmacist or doctor if they are unsure about what they are taking. Across the domains there were no additional risk mitigation measures considered to be essential beyond the wording on the carton and in the PIL.

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There were suggestions to include warnings about newer medications for heart failure, such as vericiguat on the packaging and PIL. The discussion highlighted points about drug-drug interactions in general and the balance required in terms of how much information to include on the PIL, such as the trade and generic names. It was agreed that discussion with a GP or pharmacist about any potential interactions tadalafil 40mg with their other medication would be beneficial and that this could be a recommendation in the PIL. Based on this thorough and systematic assessment of the evidence for the incremental benefits and risks of making tadalafil available without prescription in Germany, the consensus amongst clinical experts was that the incremental risks would be small. They would either be unlikely to occur or, if more likely to occur, would have little clinical impact. The process was sponsored by Sanofi who provided funding to support the extensive literature review, allowed access to their post-marketing safety data, clinical trial data and clinical pharmacology data and provided funding to facilitate the meeting. However, the Group Delphi process and evaluation of the benefits/risks was independent of Sanofi. No members of Sanofi actively participated in the meeting and discussion of the evidence or interacted with the clinical experts. Editorial support was provided by Fiona Hammond and Alison Carr of Hamell Communications, United Kingdom, and was funded by Sanofi. Sanofi had no role in the design, execution, or interpretation of the Group Delphi process or in the writing of the paper. The authors received payment from Sanofi for their participation in the group Delphi meeting but no payment was received in relation to the writing or review of the paper. All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.