Public engagement and the role of the media in post-marketing drug safety: the case of Eltroxin® (levothyroxine) in New Zealand

Abstract

The potential for harms from adverse drug reactions (ADR) constitutes wawcritical patient safety and public health challenge, especially with increased medication usage as populations age. The research reported here explores explanations for a sudden increase in ADR reporting in New Zealand after a new formulation of a medication to treat hypothyroidism, Eltroxin ® (levothyroxine), was phased in. The formulation was adjudged to be bioequivalent to the old formulation, yet following its introduction, a sharp increase in the reporting of adverse reactions to this drug occurred. The paper analyses public engagement and the role of print media coverage, press releases and minutes of meetings of relevant agencies in order to describe the unfolding of this health controversy. Early interpretations of the sharp increase in reporting of reactions explained it as an outcome of a combination of factors, including a mistrust of state drug subsidising agencies and media attention that provoked anxiety in this vulnerable population. This paper offers an alternative explanation arguing that, as adverse drug reactions are known to be significantly underreported, the Eltroxin ® 'health scare' illustrates enhanced pharmacovigilance triggered by the interaction between patients and the media. The Eltroxin® controversy is an illustrative case example of the amplification of ADR reporting by patients following increased media attention in the context of a low consumer reporting environment. The case of Eltroxin ® indicates that drug safety can be enhanced by actively using media sources and by encouraging patient engagement and reporting of ADRs.

Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution

“…Great care must be taken to keep clinicians and patients fully informed when a reformulated branded product is introduced, and pharmacovigilance plans should be in place to monitor adverse events [21, 24, 81].…”

“…Similar problems occurred in New Zealand and Denmark a decade ago in relation to reformulated Eltroxin [21, 43, 74, 81]. A major review of the New Zealand situation also found no clear reason for the level of reported adverse events with reformulated Eltroxin [82].…”

“…A major review of the New Zealand situation also found no clear reason for the level of reported adverse events with reformulated Eltroxin [82]. Again, suggested contributing factors included poor communication and intense media interest [74, 81, 82]. Misinterpretation of the new formulation, which looked different to the old formulation may also have been a factor, i.e., a belief that the new formulation was generic leading to negative perceptions (nocebo effect) [82].…”

Nonhemorrhagic joint disorders and vitamin K antagonists: an under‐recognized adverse drug reaction?

“…Nevertheless, the creation of online pharmacovigilance reporting tools, such as the 'Portail de signalement des ev enements sanitaires ind esirables' in France in 2017, may facilitate ADRs reporting by patients themselves [20]. Those tools have already proven their value with the report of neglected and/or unknown ADRs by clinicians [21].…”

Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence

“…The opt-out default resulted in the overall generic prescribing rate to increase (in 7 months post-intervention) significantly for all drugs except levothyroxine. The opt-out rate for generic levothyroxine was 22.1% after the intervention, compared with less than 2% of other drugs; indicating the continued lack of confidence in generic levothyroxine among many physicians (23).…”