Real-world questions and concerns about disease-modifying antirheumatic drugs (DMARDs): a retrospective analysis of questions to a medicine call center

Abstract

Background: Disease-modifying antirheumatic drugs (DMARDs) have transformed the treatment of numerous autoimmune and inflammatory diseases but their perceived risk of harm may be a barrier to use. Methods: In a retrospective mixed-methods study, we analysed conventional (c) and biologic (b) DMARDs-related calls and compared them with rest of calls (ROC) from consumers to an Australian national medicine call center operated by clinical pharmacists from September 2002 to June 2010. This includes the period where bDMARDs became available on the Pharmaceutical Benefits Scheme, the government-subsidized prescription medicines formulary. We compared caller and patient demographics, enquiry types and motivation to information-seek for both cDMARDs and bDMARDs with ROC, using a t-test for continuous data and a chi-square test for categorical data. We explored call narratives to identify common themes. Results: There were 1547 calls involving at least one DMARD. The top three cDMARD enquiry types were side effects (27.2%), interactions (21.9%), and risk versus benefit (11.7%). For bDMARDs, the most common queries involved availability and subsidized access (18%), mechanism and profile (15.8%), and side effects (15.1%). The main consumer motivations to information-seek were largely independent of medicines type and included: inadequate information (44%), wanting a second opinion (23.6%), concern about a worrying symptom (18.8%), conflicting information (6.9%), or information overload (2.3%). Question themes common to conventional and biological DMARDs were caller overemphasis on medication risk and the need for reassurance. Callers seeking information about bDMARDs generally overestimated effectiveness and focused their attention on availability, cost, storage, and medicine handling. Conclusion: Consumers have considerable uncertainty regarding DMARDs and may overemphasise risk. Patients cautiously assess the benefits and risks of their DMARDs but when new treatments emerge, they tend to overestimate their effectiveness.

The temporal association between adverse drug reactions and antirheumatic drugs utilisation in Western Australia: a retrospective study from real-world data (1995–2015)

“…Over 20 years, the recorded number of ADRs related to DMARDs indicates a generally well-tolerated and manageable toxicity profile, although evidence of under-reporting [ 17 ]. In Australia, a retrospective analysis examined 1547 calls with an Australian medical call center involving both conventional and biologic DMARDs from September 2002 to June 2010 [ 18 ]. The study revealed that most patients' enquiries and concerns regarding DMARDs focused on their effectiveness and appropriate dosage rather than safety considerations [ 18 ].…”

“…In Australia, a retrospective analysis examined 1547 calls with an Australian medical call center involving both conventional and biologic DMARDs from September 2002 to June 2010 [ 18 ]. The study revealed that most patients' enquiries and concerns regarding DMARDs focused on their effectiveness and appropriate dosage rather than safety considerations [ 18 ]. Some studies suggest that DMARDs rarely cause ADRs [ 11 , 19 , 20 ].…”

Dynamics of Patient-Based Benefit-Risk Assessment of Medicines in Chronic Diseases: A Systematic Review

“…They may overemphasize risk and overestimate the severity of potential side effects. 111 For example, patients with multiple myeloma who had previously experienced severe or life-threatening side effects put more importance on low toxicity than on progression-free survival. 107 …”

“…They may overemphasize risk and overestimate the severity of potential side effects. 111 For example, patients with multiple myeloma who had previously experienced severe or life-threatening side effects put more importance on low toxicity than on progression-free survival. 107 Another salient result is the increased acceptance of injectable treatments, notably self-administration, among patients who had already used this mode of administration.…”

Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies

“…In fact, there is growing evidence that the trade-offs between benefits and risks made by patients differ significantly from clinical experts [ 5 ]. Furthermore, patients with chronic conditions cautiously and deliberately reassess the benefits and risks of their treatments at multiple milestones in their disease journey and may overemphasize the potential risks of their current medicines or overestimate the benefits of new treatments [ 6 ]. The concept of a patient-based BRA of medicines has recently emerged and is attracting the attention of regulatory authorities who acknowledge the importance of incorporating patients' perspectives into their decision-making processes [ 7 , 8 ].…”