Patient's and Consultant's Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study.

The aim of this study was to describe the opinions of patients undergoing treatment with originator biologics and medical consultants managing their conditions and identify the barriers and enablers to transitioning from originator biologics to equivalent biosimilars. This study was undertaken prior to biosimilar switching at a large teaching hospital in the United Kingdom. Five gastroenterology, rheumatology, and dermatology consultants were interviewed. Two focus groups were conducted with patients prescribed infliximab (n = 2) and etanercept originators (n = 7). Four main themes emerged, as follows: (1) 'Benefit to the NHS'; (2) 'Evidence for efficacy and safety'; (3) 'Team roles'; and (4) 'Effective communication during switching', with sub-themes such as (4a) 'What patients want to know' and (4b) 'How it should be communicated'. Recognition of the ability to save NHS money was an enabler for both patients and consultants, with patients wanting to be reassured that the money saved would be used to benefit other patients. Consultants did not always believe that biosimilars had similar efficacy as the originators or that the manufacturing standards were the same. Effective interventions to address these concerns are required. Offering patients the opportunity to revert back to their originator if necessary was seen as an enabler, as was the provision of readily available mechanisms for reporting suspected adverse events resulting from switching. The role of pharmacy in the process of switching from originator biologics to biosimilars can range from educating consultants regarding the safety and efficacy of biosimilars, explaining the rationale for switching patients, and providing a route for reporting adverse events.

Exploring what patients think when answering the Interpersonal Skills Questionnaire (ISQ): A 'think aloud' study.

BACKGROUND: The Interpersonal Skills Questionnaire (ISQ) was developed to collect patient feedback on consultation skills of practitioners. However, it has not yet been evaluated with pharmacists. OBJECTIVE: To explore the thinking process of patients as they completed the ISQ following a consultation with a pharmacist. METHODS: A qualitative think aloud (TA) methodology was used to explore patients' thinking while completing the ISQ following a consultation with a pharmacist. The study was conducted in secondary care with outpatients ≥18 years old. Interviews were carried out in rounds and were informally analysed (i.e., by writing notes while listening to recordings) to identify any associated major problem(s). Discussions were held between researchers to determine whether changes were needed based on patients' comments. RESULTS: Eight patients in total (50% females) participated in this study (mean age: 48 years). Three rounds of TA were conducted. Most items of the ISQ were interpreted similarly by all participants with no major problems necessitating refining the ISQ. CONCLUSIONS: Modification of the ISQ was unnecessary as interviews demonstrated no major problems with its use. The ISQ is thus a potentially suitable tool to collect patient feedback on pharmacists' consultations.

Women's beliefs about medication use during their pregnancy: a UK perspective.

Background Previous research has examined the number and extent of medicines taking in pregnant women but not their beliefs and risk perception surrounding their use. Objective To describe beliefs and risk perception associated with medicines use for the treatment of common acute conditions among UK women and explore whether this is related to actual medicines use. Settings Cross-sectional, web-based study in the UK. Methods Pregnant women and mothers within 1 year of giving birth were invited to participate in an online cross-sectional questionnaire-based study via a pregnancy website in the UK. Anonymous data were collected from women regarding their use of medicines (both over-the-counter and prescribed) and their beliefs regarding medicines use during pregnancy. Main outcome measures Pregnant women's beliefs about medicines and their relation to pharmacological treatment of acute conditions in pregnancy. Results Pharmacological treatment of conditions in pregnancy ranged from 65.4 % for urinary tract infections (UTIs) to 1.1 % for sleeping problems. Almost three out of ten women avoided using some medications during pregnancy. For heartburn and UTIs, women who did not treat the condition viewed medicines in general as being overused, more harmful and less beneficial, than those who treated the condition. In general, UK pregnant women perceived medicines to be beneficial and slightly overused. Conclusions Women's beliefs about medications impact on treatment of specific conditions in pregnancy such as heartburn and UTIs. Healthcare professionals should explore patient's beliefs regarding medication at the first maternity care visit to promote appropriate medication use in pregnancy.

Identification of patients with atrial fibrillation in UK community pharmacy: an evaluation of a new service.

Background Many patients with atrial fibrillation (AF) are asymptomatic and diagnosed via opportunistic screening. Community pharmacy has been advocated as a potential resource for opportunistic screening and lifestyle interventions. Objective The objective of this evaluation is to describe the outcomes from an AF service, in terms of referrals and interventions provided to patients identified as not at risk. Methods Eligibility was assessed from pharmacy records and the completion of a short questionnaire. Once consented, patients were screened for AF and their blood pressure was measured. Results Of 594 patients screened, nine were identified as at risk of having AF and were referred to their GP. The service also identified 109 patients with undiagnosed hypertension, 176 patients with a Body Mass Index >30, 131 with an Audit-C score >5 and 59 smokers. Pharmacists provided 413 interventions in 326 patients aimed at weight reduction (239), alcohol consumption (123) and smoking cessation (51). Conclusion This evaluation characterises the interventions provided to, not only those identified with the target condition-in this case AF-but also those without it. The true outcome of these additional interventions, along with appropriate follow-up, should be the focus of future studies.

One lithium level >1.0 mmol/L causes an acute decline in eGFR: findings from a retrospective analysis of a monitoring database.

OBJECTIVES: Lithium is a mainstay of bipolar disorder treatment, however, there are still differences in opinion on the effects of lithium use on renal function. The aim of this analysis was to determine if there is an association between short-term exposure to various elevated lithium levels and estimated-glomerular filtration rate (eGFR) at ≤3 months, 6 months (±3 months) and 1 year (±3 months) follow-up. SETTING: Norfolk-wide (UK) lithium register and database. PARTICIPANTS: 699 patients from the Norfolk database. PRIMARY OUTCOME MEASURES: eGFR change from baseline at ≤3 months, 6 months (±3 months) and 1 year (±3 months) after exposure to a lithium level within these ranges: 0.81-1.0 mmol/L (group 2), 1.01-1.2 mmol/L (group 3) and 1.21-2.0 mmol/L (group 4). The reference group was patients whose lithium levels never exceeded 0.8 mmol/L. RESULTS: Compared to the reference group, groups 3 and 4 showed a significant decrease in eGFR in the first 3 months after exposure (p=0.047 and p=0.040). At 6 months (±3 months) postexposure group 4 still showed a decline in eGFR, however, this result was not significant (p=0.298). CONCLUSIONS: These results show for the first time that a single incident of a lithium level >1.0 mmol/L is associated with a significant decrease in eGFR in the following 3 months when compared to patients whose lithium levels never exceeded 0.8 mmol/L. It is still not known whether the kidneys can recover this lost function and the impact that more than a single exposure to a level within these ranges can have on renal function. These results suggest that lithium level monitoring should be undertaken at least every 3 months, in line with current UK guidelines and not be reduced further until the impact of more than one exposure to these lithium levels has been fully established.

Medication use in pregnancy: a cross-sectional, multinational web-based study.

OBJECTIVES: Intercountry comparability between studies on medication use in pregnancy is difficult due to dissimilarities in study design and methodology. This study aimed to examine patterns and factors associated with medications use in pregnancy from a multinational perspective, with emphasis on type of medication utilised and indication for use. DESIGN: Cross-sectional, web-based study performed within the period from 1 October 2011 to 29 February 2012. Uniform collection of drug utilisation data was performed via an anonymous online questionnaire. SETTING: Multinational study in Europe (Western, Northern and Eastern), North and South America and Australia. PARTICIPANTS: Pregnant women and new mothers with children less than 1 year of age. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence of and factors associated with medication use for acute/short-term illnesses, chronic/long-term disorders and over-the-counter (OTC) medication use. RESULTS: The study population included 9459 women, of which 81.2% reported use of at least one medication (prescribed or OTC) during pregnancy. Overall, OTC medication use occurred in 66.9% of the pregnancies, whereas 68.4% and 17% of women reported use of at least one medication for treatment of acute/short-term illnesses and chronic/long-term disorders, respectively. The extent of self-reported medicated illnesses and types of medication used by indication varied across regions, especially in relation to urinary tract infections, depression or OTC nasal sprays. Women with higher age or lower educational level, housewives or women with an unplanned pregnancy were those most often reporting use of medication for chronic/long-term disorders. Immigrant women in Western (adjusted OR (aOR): 0.55, 95% CI 0.34 to 0.87) and Northern Europe (aOR: 0.50, 95% CI 0.31 to 0.83) were less likely to report use of medication for chronic/long-term disorders during pregnancy than non-immigrants. CONCLUSIONS: In this study, the majority of women in Europe, North America, South America and Australia used at least one medication during pregnancy. There was a substantial inter-region variability in the types of medication used.