Michael Kirby, visiting professor at the Centre for Research in Primary and Community Care, University of Hertfordshire
Graham Phillips, community pharmacist, Manor Pharmacy
Alison Carr, research director, Hamell
About this article
The full paper, together with references and declarations, is available online
Correspondence to: Alison Carr
Benign prostatic hyperplasia (BPH) is a common age-related condition often associated with distressing symptoms.
Estimates suggest that one in four men over the age of 40 years will experience BPH symptoms. Alpha-1 adrenoceptor antagonists are effective symptomatic treatments and have been shown to increase maximum urinary flow rate by up to 25 per cent and improve symptoms by up to 40 per cent.
To accompany the reclassification of the alpha-1 adrenoceptor antagonist tamsulosin from a prescription-only medicine to a medicine available from community pharmacies, a symptoms-check questionnaire was developed for use by pharmacists to guide them in the appropriate use of tamsulosin (Flomax Relief MR).
The questionnaire is designed to be completed by men who visit a pharmacy requesting help for symptomatic BPH or lower urinary tract symptoms (LUTS). It provides a checklist for pharmacists to structure the clinical assessments they would make of any customer requesting tamsulosin for BPH-related LUTS as part of their usual clinical practice. An interpretation guide helps pharmacists identify “red flags” and other contraindications to tamsulosin and to assess the customer’s suitability for drug treatment.
The aim of the study was to determine the role of a pharmacy tool (the questionnaire) in supporting pharmacists’ recommendations for treatment with tamsulosin and to assess its acceptability to men with LUTS who want to buy tamsulosin.
There were two parts to the study. Part 1 occurred before the launch of Flomax Relief MR to demonstrate that by following a checklist pharmacists could appropriately recommend OTC tamsulosin. Pharmacists and GPs sequentially independently assessed men with LUTS and made judgements about their suitability for OTC tamsulosin.
Pharmacists used the questionnaire to guide their assessments. GPs did not have access to the questionnaire or the pharmacists’ recommendations and based their judgements on their usual clinical assessments. A total of 181 men with LUTS, 17 pharmacists and three GPs participated in the study. Following assessment, pharmacists’ recommendations about men’s suitability for OTC tamsulosin were compared with “gold standard” recommendations.
Gold standard recommendations were based on a combination of the GP judgements and the British Association of Urological Surgeons guidelines for LUTS, the summary of product characteristics for Flomax Relief MR and International Prostate Symptom Scores.
Part 2 ran from the launch of Flomax Relief MR and was designed to capture the perceptions and experience of men with LUTS who bought tamsulosin in pharmacies. Interviews were conducted by telephone with 89 men using a standardised questionnaire that captured feedback on their interaction with the pharmacist when they had visited the pharmacy with the intention of buying tamsulosin.
A sample of 43 of these men were subsequently interviewed in depth using open-ended questions to explore their perceptions of the relative roles and responsibilities of pharmacists and GPs in managing LUTS and their feedback on use of the symptoms-check questionnaire.
Both parts of the study were reviewed and approved by an independent research ethics committee (Reading Scientific Laboratories).
Endpoints and statistical analysis
The primary endpoint for assessing the role of the symptoms-check questionnaire in recommending tamsulosin was agreement between the pharmacist and gold standard recommendations of suitability for tamsulosin (number of subjects where pharmacist and gold standard assessments of suitability or unsuitability agreed/total number of subjects).
Descriptive statistics were used to describe the demographic and clinical background of men who participated in the study. Agreement rates were estimated with 95 per cent confidence intervals. Confidence intervals were calculated using the large sample normal approximation to the binomial distribution. The in-depth interviews were transcribed and analysed using content and thematic analysis.
Agreement between pharmacist and gold standard recommendations for tamsulosin in men with LUTS was 92 per cent (agreement in 166 of 181 cases). Men took an average of 10 minutes to complete the questionnaire, depending on how much discussion was initiated with the pharmacist. The mean time taken for pharmacists to review and interpret the questionnaire was 3.79 minutes (SD 3.46).
In cases where the responses were straightforward and the pharmacist was familiar with the process, the time for interpretation was a matter of seconds. The questionnaire had high sensitivity (89 per cent) and specificity (94 per cent).
Men who had bought tamsulosin in the pharmacy viewed the symptoms-check questionnaire as an indication that they were being thoroughly assessed. This resulted in a perception that pharmacists were professional and knowledgeable about LUTS.
In this instance men were happy to receive advice from pharmacists about their urinary symptoms because they seemed knowledgeable and professional and there was a perception that they had been specially trained. This was reinforced by the use of the symptoms-check questionnaire.
There is evidence from this study that with training and guidance, pharmacists are professionally competent to advise patients on the self-management of LUTS and that consumers view them as adequately trained and qualified for this role.
The symptoms-check questionnaire acts as a checklist to enable pharmacists to identify red flag symptoms and contraindications in addition to establishing that symptoms are sufficiently severe to warrant pharmacological treatment, thus reassuring patients that tamsulosin is the right treatment for them and enhancing their perception of pharmacists’ professionalism and knowledge.
Declaration This study was funded by Boehringer Ingelheim, which holds the marketing licence for Flomax Relief MR.