The calls to the MCC demonstrate that consumers have many unanswered questions and considerable uncertainty regarding their DMARDs. Uncertainty is acknowledged as an integral component of health and illness (22). It manifests when situations are ambiguous, complex or unpredictable; when information is inadequate or inconsistent; and when people feel insecure in their own state of knowledge or the state of knowledge in general (23). A key strategy to cope or manage uncertainty is information seeking (22, 24, 25). This is consistent with our study findings where DMARD information seeking was motivated by callers needing a second opinion, being concerned about a worrying symptom and/or having inadequate or conflicting information. This often occurs in chronic disease where more information sources may be accessed and there is a greater opportunity to encounter inconsistent information (26). This may potentially cause increased patient anxiety (27) and altered risk perception (28). Conflicting information can also impact negatively on adherence and cause patients to alter their medication regimen without consulting their physician (29).
In addition to information seeking, callers requested immediate therapeutic strategies from a trusted source to manage various situations including dosing of DMARDs and concomitant medicines, withdrawal, management of an adverse event, and the interruption of medication for surgical procedures. This suggests that it can be a challenge for consumers to access reliable DMARD information; this poor access may be perceived as a barrier to meeting their health information needs and achieving their therapeutic goals (30).
In Australia, patients with a chronic disease often need to travel large distances to visit a doctor. In our study, DMARD-related callers emanated from every state and territory, including rural and remote areas. The MCC provided an accessible alternative for people who were seeking anonymity but required timely medicines information from a trusted source (31).
Most enquiries were generated by female callers. This is consistent with health information seeking literature, where women generally seek medicines information more often than males (32, 33). The majority of patients were also female which reflects the general nature of autoimmune diseases treated by DMARDs (34). There were more calls from the patients themselves regarding DMARDs than in ROC, which potentially reflects ownership of their condition and higher involvement in management, a trait consistent across many chronic diseases such as RA (35, 36).
Most consumers were motivated to proactively information-seek due to perceived risks of DMARDs, with many seeking assistance from the MCC pharmacist to assess the risks and benefits of their DMARD. Callers sought clarification about potential side effects and a therapeutic strategy to manage DMARD use. Patients with inflammatory arthropathies in various populations often overestimate the risk of side effects, particularly with long-term treatment (6, 8, 37, 38). Safety as a goal of medicines information seeking is supported by consumer medicines information needs literature (39). High fear scores can reduce adherence and potentially impede clinical outcomes (40-42). In our cohort, most of the callers expressing their fear of taking the medicine resulted from reading the consumer package insert. Since 1993, Australian legislation requires all new prescription and pharmacist-only medicines to be accompanied by a package insert, Consumer Medicines Information (CMI), prepared by the sponsor. These aim to provide consumers with accurate, unbiased, and easy to understand medicines information for informed decision-making (43). While CMI layout is guided by legislation, it does not mandate quality and consistency of content (44). There is no requirement for the sponsor to routinely update CMI to reflect information currency or adequately address risk in special populations. These factors may contribute to consumer confusion and in some cases cause fear (45). Current CMI for various bDMARDs in Australia, also available to the public on the Australian Therapeutic Goods Administration website, report on the frequency of serious undesirable effects, particularly serious infections and malignancies, based on their original clinical trials (46). However, over the last 20 years evidence from larger registry populations using bDMARDs have demonstrated the safety of these medicines (5). This relatively high safety profile is not reflected in the official material that patients may read. The situation is similar for the Summary of Product Characteristics used in Europe and the Package Label used in the United States and may contribute to the public’s overestimation of risk with this medicines class.
A key concern raised by consumers was DMARD drug interactions where the major medicines were another DMARD, NSAIDs, cardiovascular and central nervous system agents, vaccines, and complementary medicines. The concomitant use of these medicines in inflammatory arthropathies is common. Studies have not previously identified this consumer concern (47-50).
In addition to caller focus on potential DMARD side-effects and interactions, we observed the impact of the media during the emergence of bDMARD availability in Australia. These calls indicated consumer overestimation of effectiveness. Hoffman and Del Mar conducted a comprehensive systematic review of studies that quantitatively assessed patients’ expectations of the benefits and/or harms of any treatment, test, or screening test (51). They found participants rarely had accurate expectations of benefits and harms, and for many interventions, they had a tendency to overestimate benefits and underestimate harms. For the two studies that measured medicine expectations for the bDMARD infliximab in inflammatory bowel disease (51,52), at least half of participants overestimated benefit in eight of ten outcomes. The authors suggested that there appeared to be overly optimistic expectations by the public for novel medications, particularly in chronic diseases with no cure. These authors and others suggest that this overestimation of efficacy may enable patients to meet their psychological needs such as hope, safety, a sense of control, action, and reassurance (52).
Callers to the MCC in our study were concerned about the potential effect of DMARDs on reproductive health; not only maternal but also paternal exposure to DMARDs before conceiving and during pregnancy. This is an area of concern for patients that is under-investigated in the literature. Many women of childbearing age with a chronic disease necessitating the use of DMARDs have difficulties finding adequate information related to pregnancy planning, pregnancy, and early parenting (53). The effects of DMARDs on male reproduction is an even more neglected area, with sparse data on spermatogenesis and the effects on offspring (54). Callers were worried about being in contact with other persons and animals, demonstrating patients’ perceptions of their medicines as potent and potentially toxic. This suggests that a greater effort to deliver targeted information in this domain is required.
Callers sought assistance to assess the benefit-risk balance of their DMARDs. This may, in part, be explained by the considerable mismatch between physicians’ and patients’ perspectives and preferences in the management of inflammatory arthropathies (55-58). Others were interested in the availability, cost, and subsidised access to DMARDs - crucial information for patients with chronic conditions on relatively expensive medicines. The restrictions to limit access to subsidised treatments may add a layer of complexity to patients through their disease journey.
Strengths and weaknesses
This is the first study to analyse real-life consumers’ information needs and concerns about DMARDs via a caller helpline. These enquiries were initiated proactively, predominately by the patients themselves or a significant other (family, friend, carer), for a genuine medicines information gap or concern related to a conventional or biologic DMARDs. Unlike other observational studies, where patients are invited to identify areas of concern or information needs through a questionnaire, interview or focus group, this study is a real-time capture of a population of DMARDs users. These callers had a genuine medicines information need unanswered in their usual physician-patient encounters or through other traditional sources where their uncertainty was sufficient to motivate them to actively help-seek. The longitudinal nature of the data captured over eight years, including the timeframe when the use of bDMARDs became available, provide an understanding of how consumers might manage uncertainty associated with novel and expensive medicines.
This study has limitations, including that the MCC repository contains data collected as part of a health service which was not developed for research purposes. As such, variables of interest to future researchers may not be held in the database. DMARDs were extracted from the database using ATC codes; therefore, cases could not be consistently assessed by a specific DMARD indication, such as RA. Secondly, MCC callers represent only a part of the total group of DMARDs users in Australia. However, the representation of calls was comparable to ROCs, originating from all states and territories and across metropolitan, rural and remote areas. Following on from data completion in 2010, further DMARDs particularly bDMARDs and the targeted synthetic DMARDs have become available for use in Australia and data on these newer agents are therefore lacking (59, 60).