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The site is secure. Setting A post-authorisation safety study implemented as a web-based survey, conducted in a representative population of UK community pharmacists. Data were summarised using descriptive statistics. Main outcome measure Knowledge of key risk messages and dispensing practices communicated in the additional risk minimisation measures.
Results The survey was completed by community pharmacists.
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Nearly all respondents The online version contains supplementary material available at 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 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 ]. 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.
These materials now updated continue to be an important resource for pharmacists. Under UK legislation, PGD permits express healthcare professionals to supply medications to pre-defined patients without prescription [ 9 , 10 ]. 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.
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This cross-sectional survey was conducted between 28 January and 31 March Before implementing the full survey, a pilot was conducted among 42 pharmacists July—August 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.
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All aspects of the survey were anonymous. The sample was generated to be representative of the UK pharmacist population, comprising Pharmacies were selected at random. 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.
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A random sample of pharmacists across 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. 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. A sample of completed surveys was planned, based on statistical and practical considerations.
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Only data from completed surveys were included. 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 invited pharmacies, were screened response rate: 9.
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In total, eligible respondents completed the survey completion rate: Respondents tended to be male Table 2. Most pharmacists were located in an urban setting Five of 28 items assessed knowledge of KRMs in Part 1.
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The majority correctly responded to questions concerning concomitant diseases which may be contributing to ED. Four questions consisting of 23 items were used to assess knowledge of KRMs in Part 2. Responses to all questions in Part 2 knowledge of key risk messages during consultation. Of the 28 8. Nearly all respondents who utilised the checklist used it all the time The majority Of eligible respondents, Of respondents who did not participate, 47 could not recall if they had taken part.
The most common reason given for not participating was lack of awareness Of respondents, Of respondents, the majority Most However, Only 5. In recent years, there has been a move towards supporting self-care, and a key element of this has been the switching from POM to P-medicine, available BTC at pharmacies. Awareness of the KRMs suggests the training materials were effective for educating community pharmacists on key aspects of its supply.
With the availability of understandable information and online resources, society is better educated than ever about health and therapy options [ 11 ]. This has led to pharmacists experiencing increased responsibilities in facilitating self-care, with patients requesting medications for acute or long-term conditions [ 12 ].
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It has been suggested that pharmacists lack confidence when supplying medications reclassified from POM to P-medicine [ 13 ], and see themselves as educators rather than decision-makers, deferring decision-making to other medical professionals in ambiguous cases [ 14 ].
Our survey suggests that when community pharmacists were unsure i.
Pharmacy Checklist
These observations are consistent with the suggestion that pharmacists see safety as the over-riding concern with supply of over-the-counter or BTC medications [ 15 ]. Although doctors and pharmacists play a critical role in encouraging self-care, they are reliant on information from consumer health sources [ 17 ].
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These educational materials are still available to pharmacists [ 7 ]. We found pharmacists were comfortable counselling patients, and the majority perceived patients open to discussing their health, whereas previous studies suggested men were embarrassed to talk about their health and hesitant to seek treatment [ 18 ].
Amongst men diagnosed with ED, few pursue treatment [ 19 ]. With patients receptive to information from providers other than their primary care physician, and the good level of knowledge demonstrated by community pharmacists in counselling patients, there is real opportunity for patients to receive education and long-term management for ED independently of their doctor. Our study should be considered in light of additional considerations. The overall response rate was 9.
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We cannot exclude the possibility that respondent characteristics, knowledge of the safety profile of sildenafil citrate, motivations, and general awareness of aRMMs differ between pharmacists who chose not to respond to the invitation.
Furthermore, we do not know if pharmacists chose to complete the survey because they were better informed about ED or had an interest in pharmacovigilance, which may be an unintentional source of selection bias.
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Possible social desirability bias of respondents may also lead to an overrepresentation of positive responses to survey questions, although healthcare professionals may be less susceptible to this bias [ 34 ]. Further studies would be needed to quantify dispensing behaviours in pharmacies. Most community pharmacists indicated that the aRMMs materials were their main source of knowledge. Medical writing support was provided by Jake Evans, Ph. The authors would also like to acknowledge the assistance of Paul Goggin, who spearheaded the effort of designing the aRMMs materials and led the discussion with the Royal Pharmaceutical Society.
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She is also a stock holder of Novartis. Terry Maguire is a community pharmacist and director of T. Rachel E. Sobel is a shareholder and was an employee of Pfizer at the time the study was conducted.
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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. As a library, NLM provides access to scientific literature.
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International Journal of Clinical Pharmacy. Int J Clin Pharm. Published online Apr 5.
Sobel 4. Joanna Lem, Email: moc.
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Corresponding author. Received Apr 6; Accepted Oct The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material.
If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. Supplementary Information The online version contains supplementary material available at 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.
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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. Open in a separate window. Methods Study design This cross-sectional survey was conducted between 28 January and 31 March Survey sample Data protection requirements were complied with before contacting pharmacists.
Sildenafil - from POM to P | Drug and Therapeutics Bulletin
Online survey Data were collected via a structured, self-administered online questionnaire. Statistical analysis A sample of completed surveys was planned, based on statistical and practical considerations. Results Survey participants From invited pharmacies, were screened response rate: 9.
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