BackgroundThe concept of biosimilar presents a myriad of issues such as patient safety, efficacy and financial aspects to clinicians, pharmacists and policy makers. The introduction of biosimilar infliximab, the first biosimilar on the local national health system in Malta, put clinicians at the forefront of these challenges.ObjectivesThe objective of the study was to assess the perception and awareness of Maltese clinicians working within the National Health System on the concept of biosimilars.MethodsThe questionnaire developed by the Alliance for Safe Biologics Medicines and which was previously run in 5 European countries was shortlisted to be used in the study1. Permission from the Alliance for Safe Biologics Medicines was sought to use the questionnaire. The questionnaire was sent online to prescribing clinicians working within the Maltese National Health System. The clinicians were given one month to answer the questionnaire during which time three reminders were forwarded.ResultsA total of 132 prescribers participated in the study giving a 14% response rate. Approximately 34% prescribed biologics within their practice whereas 40% treated patients prescribed biologics by another specialist. Out of the total respondents 6% consider themselves very familiar with the concept of biosimilars, 35% had a basic understanding of biosimilars whereas 59% could not define biosimilars or had never heard of them. Less than half of the respondents (36%) believe that patients can safely receive either originator or biosimilar and expect the same result. Only 27% agree that patients can safely be switched between products during the course of treatment and 46% state that is is very important or critical for them to have the sole authority to decide whether to prescribed the biosimilar or originator. Around 27% answered that they prescribe by generic name irrespective of whether the drug is a biologic or not.ConclusionsThe awareness (6%) on biosimilars in Malta is much less than that achieved in 5 European countries where an average of 22% of prescribers considered themselves very familiar with the concept of biosimilars1. Although prescribing of biologic medicines is regulated by Subsidiary Legislation 458.59 “Prescribing and Dispensing requirement rules”, Maltese prescribers are unaware that biosimilars should be prescribed by brand name. Switchability is an aspect where Maltese clinicians are not comfortable since only 27% believe that patients can be safely switched between products during treatment. This however correlates to results of the ASBM European survey where only 39% agree with switchability. Increased awareness on biosimilars together with more robust data on switchability will help Maltese clinicians adopt biosimilars in their practice without having concerns on patient safety and efficacy.ReferencesO'Dolinar M, Reilly MS. Biosimilars naming, label transparency and authority of choice - survey findings amongst European physicians. GaBI Journal. 2014;3(2):58–62.AcknowledgementMr Michael Reilly, Executive Direc...

No abstract

Purpose The purpose of this paper is to assess the patient’s perspective on a dedicated clinic set up for patients diagnosed with an inflammatory arthritis who are being treated with a biologic. It proposes that dedicated clinics offer better overall care. The aim of this quality improvement survey is to evaluate the level of patient satisfaction with this clinic and identify any unmet needs. Design/methodology/approach This study was based on a quality improvement survey, which was developed using Zineldin’s five qualities model and assessed various aspects pertaining to service quality and improvement. A structured interview approach was used and 44 consecutive patients were recruited. Findings This paper explores key aspects that influence patient satisfaction within a rheumatology outpatient setting such as education on arthritis and biologics and involvement in decision making. It provides insight on what patients value most and it also addresses organizational aspects that can have an impact on patient satisfaction. It suggests that service quality can be linked to the degree of patient satisfaction. Research limitations/implications Direct interviewing of patients could have introduced a source of bias whilst questions are being answered. On the other hand, it provided an opportunity to clarify instantly any doubts and therefore avoiding any inadvertent errors. Practical implications This paper reinforces that specialized clinics enable the caring rheumatologist to provide better care for patients on biologics. Service providers should continue developing their services around the patient’s needs and perspectives in order to continue improving the service. Social implications Dedicated biologic clinics allow more judicious monitoring of patients who are taking these highly efficacious but costly medications. Originality/value This survey has reinforced that patients highly value dedicated clinics. These results strengthen the case that healthcare services should continue investing on specialized clinics.

BackgroundBiologic disease modifying anti-rheumatic drugs (DMARDs) have been a major breakthrough in the treatment of inflammatory arthritis. In clinical practice, providing timely monitoring to ensure continued efficacy and safety remains a challenge. The availability of a dedicated clinic for patients on biologics may help meet these standards.ObjectivesThe aim of this study was to get the patients' perspective of our dedicated biologic clinic and identify any unmet needs.MethodsPatients attending the biologic clinic between April and September 2016 and who were on a biologic for more than 2 years were interviewed by a trainee following their clinic visit. The patients were asked about their level of satisfaction on various aspects including waiting times, education, involvement in decision-making and duration of consultations.Results44 patients (23 females, 21 males) participated in the survey, of whom 21 suffered from rheumatoid arthritis, 17 from ankylosing spondylitis and 6 from psoriatic arthritis. The mean age of participants was 55.1 (SD 12.62) years. The mean DAS28 was 2.26 (SD 1.03) and the mean BASDAI was 4.21 (SD 2.4). Disease duration was less than 5 years in 20%, 6 to 10 years in 30% and more than 10 years in 50%. Overall satisfaction with arthritis education before initiation of treatment was 91%, which then dropped to 76% after treatment initiation. Satisfaction with education regarding biologic therapy was more consistent at 84% and 81% before and after starting treatment, respectively. 84% of patients reported to be satisfied with their involvement in the decision to start and continue biologic therapy. 77% of patients were satisfied with a consultation lasting 15 to 20 minutes and 77% were also satisfied with 6-monthly visits. The most valued source of education was communication with the caring rheumatologist (n=32), followed by specialist nurse education (n=15), Internet resources (n=14) and use of leaflets (n=13). 95% of patients reported to have rarely or never missed an appointment. The rheumatology advice line was used by 54% of patients, whilst the rest reported that they did not need it since starting the biologic. The greater majority of advice line users were very satisfied with the service provided. Amongst the unmet needs mentioned, were better arthritis education and the introduction of telephone consultations.ConclusionsEven though most patients were clinically well-controlled, continued education delivered by the caring rheumatologist and specialist nurse is still greatly valued. Patients attending this clinic highly valued the staff dedication and had good communication with their caring clinician. They were highly satisfied with the length and frequency of consultations. Nonetheless, a significant number suggested the need to introduce telephone consultations, which could be considered for those stable patients after receiving proper education.Disclosure of InterestNone declared

BackgroundAdherence to medication depends on several factors such as medication beliefs, psychosocial factors, illness beliefs and concerns. The consequences of non-adherence are not insignificant, both from the clinical and health economic aspects.ObjectivesTo assess medication adherence of patients taking biologics who are in remission or who have low disease activity and patients' perception of disease progression.MethodsForty-four consecutive patients attending a dedicated biologic clinic and treated with TNF inhibitors were interviewed following their visit. Patients were asked about adherence to treatment, adverse effects, concerns about biologics and their perception of disease progression. Demographic and disease activity data were recorded.ResultsForty-four patients (23 females, 21 males) participated in the survey (21 suffered from rheumatoid arthritis, 17 from ankylosing spondylitis and 6 from psoriatic arthritis). The mean age was 55.1 (SD 12.62) years. The mean DAS28 was 2.26 (SD 1.03) and the mean BASDAI was 4.21 (SD 2.1). Minimal or no pain was reported by 75%, mild or no fatigue by 78% and 77% had no restriction of activities of daily living. Medication adherence was reported as high by 68% and moderate by 32%. There were no patients who had a low level of adherence. 5% of patients admitted to be unaware of the need to omit their biologic when ill and 40% when requiring surgery.One out of 4 patients reported to have experienced adverse events, most commonly infections. 19% claimed to be moderately or very concerned about the adverse effects. On further questioning about the severity of potential adverse effects, 45% were unsure as to what the severity might be. When asked about duration of therapy, 29% replied more than 10 years; whilst 71% were unsure on when, if ever, the biologic is going to be stopped. Patients were also asked whether they believed that the biologic had successfully stopped further joint damage and 68% replied yes, 9% replied no, whilst 23% were unsure. Of those who replied yes, this perception was based on the absence or reduction of symptoms.ConclusionsIn this cohort of patients with low disease activity or remission, a third of patients still reported sub-optimal adherence to TNF inhibitor use. The benefits of adherence to biologic therapies need to be reinforced at every visit and factors leading to non-adherence addressed. Adverse effects remain a major concern that needs to be addressed, even in patients who have been on biologics for many years and have sustained remission or low disease activity. A quarter of patients were unsure whether biologics have stopped joint damage. Patients' perception of joint damage progression needs to be explored to find ways of making it more understandable to patients.Disclosure of InterestNone declared