AZ, Organon fall foul of UK's code on pharma promotion

AstraZeneca has breached the UK pharma industry's code of practice with a claim on its website for asthma drug Symbicort, while Organon overstepped the mark in its promotion of contraceptive Nexplanon.

The Prescription Medicines Code of Practice Authority (PMCPA) found that AZ breached its code after claiming on the website that, according to UK clinical guidelines, all newly diagnosed asthma patients over 12 years of age should be prescribed an inhaled corticosteroid (ICS) and beta agonist formoterol as an 'as-needed' anti-inflammatory reliever (AIR) therapy.

AZ's Symbicort Turbohaler, which was highlighted on the site, is based on ICS budesonide and formoterol fumarate dihydrate.

An investigation was launched by the PMCPA after a complaint by a healthcare professional (HCP) suggested that the wording used did not reflect the national asthma guidance, as patients in this category should also be offered low-dose maintenance and reliever therapy (MART), which relies on regular, daily dosing plus additional, as-needed doses for breakthrough asthma attacks.

The complaint also expressed concern that patients with more severe asthma symptoms could have been harmed as a result of the MART omission, a contention that was also upheld by the PMCPA, which said it could have led to inappropriate treatment in some cases.

AZ acknowledged it had made an "unintentional error" in its wording, adding that "there will be a small proportion of highly symptomatic patients who should be offered low-dose MART in the first instance, in line with the guidelines."

However, the company said it did not agree that patient safety had been jeopardised, as a patient erroneously prescribed AIR would likely self-administer enough ICS/formoterol to control symptoms or seek advice from an HCP.

Organon, meanwhile, has been taken to task for promoting long-acting reversible contraceptive (LARC) Nexplanon (etonogestrel) outside its approved indications, specifically by implying in a webinar it was a suitable option for preventing all ages of teenage pregnancy when efficacy and safety had not been established in women under 18 years of age.

Organon disputed the contention, saying that the video included a "clear statement" that Nexplanon is licensed for use in the 18-40 age group.

However, the PMCPA found that the presentation of data on pregnancies in under-18s, and the benefits of LARC in this population, amounted to off-label promotion and the "small reference" to the licensed age range "did not negate the misleading impression given that Nexplanon was a suitable option for preventing all ages of teenage pregnancy."

Image by Sammy-Sander from Pixabay