Case Summary
An ex-employee of AstraZeneca queried whether the prescribing information in advertisements for Seroquel XL (quetiapine), Zoladex (goserelin) and Crestor (rosuvastatin), all placed by AstraZeneca in the BMJ, 20 February, was clear and legible as defined in the Code.
The detailed response from AstraZeneca is given below.
The Panel noted that in the Seroquel advertisement the headings of the various sections did not start on a new line and nor were they emboldened. The only way in which the headings had been distinguished from other text was by underlining but this was so faint as to be almost non-existent. The Panel considered that the line length and spacing between the lines meant that, although on the limits of acceptability, overall the prescribing information was legible even if a lower case 'x' was only approximately 1mm in height. However given the difficulty in identifying the various sections of the prescribing information the Panel considered that the prescribing information was not clear and a breach of the Code was ruled.
The Panel noted that in the advertisements for Zoladex and Crestor the section headings were emboldened and underlined and thus readily distinguished from the rest of the text. The Panel considered that in both advertisements the line length and spacing between the lines meant that, although on the limits of acceptability, overall the prescribing information was clear and legible even if a lower case 'x' was only approximately 1mm in height. No breaches of the Code were ruled.
CASE AUTH/2300/2/10 EX-EMPLOYEE v ASTRAZENECA
Legibility of prescribing information
An ex-employee of AstraZeneca queried whether the prescribing information in advertisements for Seroquel XL (quetiapine), Zoladex (goserelin) and Crestor (rosuvastatin), all placed by AstraZeneca in the BMJ, 20 February, was clear and legible as defined in the Code.
The detailed response from AstraZeneca is given below.
The Panel noted that in the Seroquel advertisement the headings of the various sections did not start on a new line and nor were they emboldened. The only way in which the headings had been distinguished from other text was by underlining but this was so faint as to be almost non-existent. The Panel considered that the line length and spacing between the lines meant that, although on the limits of acceptability, overall the prescribing information was legible even if a lower case 'x' was only approximately 1mm in height. However given the difficulty in identifying the various sections of the prescribing information the Panel considered that the prescribing information was not clear and a breach of the Code was ruled.
The Panel noted that in the advertisements for Zoladex and Crestor the section headings were emboldened and underlined and thus readily distinguished from the rest of the text. The Panel considered that in both advertisements the line length and spacing between the lines meant that, although on the limits of acceptability, overall the prescribing information was clear and legible even if a lower case 'x' was only approximately 1mm in height. No breaches of the Code were ruled.
COMPLAINT
An ex-employee of AstraZeneca UK Ltd queried whether the prescribing information in three advertisements placed by AstraZeneca in the BMJ, 20 February, was clear and legible as defined in the Code.
At issue were a double-page Seroquel XL (quetiapine) advertisement (CZ001847f-SERO), a one-page Zoladex (goserelin) advertisement (CZ001970m-ZOLA) and a one-page Crestor (rosuvastatin) advertisement (CZ002029-CRES).
When writing to AstraZeneca, the Authority asked it to respond in relation to Clause 4.1 of the Code.
RESPONSE
AstraZeneca submitted that it recognized that the prescribing information was essential information and therefore this had been provided in a clear and legible manner for all three advertisements. AstraZeneca did not understand how the prescribing information for these advertisements was not clear and legible.
Seroquel XL advertisement
AstraZeneca stated that the prescribing information was an integral part of the advertisement and was positioned across the bottom of both pages for ease of reference. It was clear, legible and readable. Legibility had been achieved with a lower case ‘x’ approximately 1 mm in height, a line size of 80 characters including spaces, and an appropriate choice of font style (Helvetica Roman). Readability was enhanced by the choice of colour contrast with white type on a black background for maximum contrast, clear spacing of columns and clear spacing between lines. Therefore, AstraZeneca did not agree that the prescribing information in this advertisement was not clear and legible as alleged and therefore was not in breach of Clause 4.1. Zoladex advertisement
Similarly, the prescribing information was an integral part of this advertisement and was positioned at the bottom of the page for ease of reference. It was clear, legible and readable. Legibility had been achieved with a lower case ‘x’ approximately 1 mm in height, a line size of 92 characters including spaces, and an appropriate choice of font style (Avant Garde Gothic). Readability was enhanced by the choice of colour contrast with black type on a yellow background, clear spacing of columns, clear spacing between lines and by use of emboldened headings. Therefore, AstraZeneca did not agree that the prescribing information in this advertisement was not clear and legible.
Crestor advertisement
Similarly, the prescribing information was an integral part of this advertisement and this time was positioned at the top of the page for ease of reference. It was clear, legible and readable. Legibility had been achieved with a lower case ‘x’ approximately 1 mm in height, a line size of 87 characters including spaces, and an appropriate choice of font style (Arial). Readability was enhanced by the choice of colour contrast with dark green type on a pale background, clear spacing of columns, clear spacing between lines and by use of emboldened headings. Therefore, AstraZeneca did not agree that the prescribing information in this advertisement was not clear and legible as implied by the complainant.
PANEL RULING
The Panel noted that Clause 4.1 required the prescribing information to be clear and legible. The supplementary information to Clause 4.1 gave recommendations to help achieve clarity stating that legibility was not simply a question of type size; it recommended that type size should be such that a lower case letter 'x' was not less than 1mm in height and lines should be no more than 100 characters in length. Other factors mentioned were spacing, type style, contrast and emboldening headings and starting each section on a new line.
The Panel considered each advertisement separately.
The Panel noted that in the Seroquel advertisement the headings of the various sections did not start on a new line and nor were they emboldened. The only way in which the headings had been distinguished from other text was by underlining but this was so faint as to be almost non-existent and so it was extremely difficult to find the start of any of the sections. The Panel considered that the line length and spacing between the lines meant that, although on the limits of acceptability, overall the prescribing information was legible even if a lower case 'x' was only approximately 1mm in height. However given the difficulty in identifying the various sections of the prescribing information the Panel considered that the prescribing information was not clear and a breach of Clause 4.1 was ruled.
The Panel noted that in the Zoladex advertisement the section headings were emboldened and underlined and thus readily distinguished from the rest of the text such that it was easy to find the start of any of the sections. The Panel considered that the line length and spacing between the lines meant that, although on the limits of acceptability, overall the prescribing information was clear and legible even if a lower case 'x' was only approximately 1mm in height. No breach of Clause 4.1 was ruled.
The Panel noted that in the Crestor advertisement the section headings were emboldened and thus readily distinguished from the rest of the text such that it was easy to find the start of any of the sections. The Panel considered that the line length and spacing between the lines meant that, although on the limits of acceptability, overall the prescribing information was clear and legible even if a lower case 'x' was only approximately 1mm in height. No breach of Clause 4.1 was ruled.
Complaint received 24 February 2010
Case completed 26 March 2010
