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Setting A post-authorisation safety study implemented as a web-based survey, conducted in a representative population of UK community pharmacists.
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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 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.
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 ].
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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 ].
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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. 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. 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.
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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.
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Data protection requirements were complied with before contacting pharmacists. 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.
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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.
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.
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. 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.
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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 ].
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This has led to pharmacists experiencing increased responsibilities in facilitating self-care, with patients requesting medications for acute or long-term conditions [ 12 ]. 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.
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Once registered, let us know which medicines viagra connect form need, cobnect we will order these via your GP on your behalf. What to expect when ordering from the Optum Store. Genuine UK Medicines. You can tell your provider if you have a medication preference, but they'll ultimately prescribe the option they feel confident is best for you based on your symptoms and health history.
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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 ]. 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 ].
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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. 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.
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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. 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 ].
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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. Recent advances in the treatment of erectile dysfunction. Postgrad Med J. Keith A. The economics of Viagra. Health Aff. Accessed Medicines and healthcare products regulatory agency MHRA. Consultation outcome: proposal to make sildenafil 50 mg film-coated tablets available from pharmacies.
European Medicines Agency.
Viagra Connect Advice Training Module
Guideline on good pharmacovigilance practices GVP : module V — risk management systems rev 2. Guideline on good pharmacovigilance practices GVP : module XVI — risk minimisation measures: selection of tools and effectiveness indicators rev 2. Viagra Connect learning resources. Reclassifying erectile dysfunction.
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Pharm J. Patient group directions: who can use them. Patient group directions. Medicines practice guideline [MPG2]. Wertheimer AI, Serradell J. A discussion paper on self-care and its implications for pharmacists.
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Pharm World Sci. Article Google Scholar. Rutter P. Integr Pharm Res Pract.
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Are pharmacists the ultimate barrier to pharmacy practice change? Can Pharm J. How do community pharmacists make decisions?
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Results of an exploratory qualitative study in Ontario. Int J Clin Pharm.
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