A complaint was received in a private capacity from a health professional who stated that he/ she worked as a consultant to a pharmaceutical company. It had previously been decided, following consideration by the then Code of Practice Committee and the ABPI Board of Management, that private complaints from pharmaceutical company employees had to be accepted. To avoid this becoming a means of circumventing the normal procedures for intercompany complaints, the employing company would be named in the report. The complainant would be advised that this would happen and be given an opportunity to withdraw the complaint.
The principles set out above were applied to this complaint. Consultancy status should not be used to circumvent the normal rules for inter-company complaints.
The complainant was advised that if he/she wished to proceed with the complaint in a private capacity Novartis would be named in the case report; and the respondent company would be informed of his/ her professional status and the connection with pharmaceutical companies. The complainant so agreed.
The complaint concerned an online advertisement for Fostair (beclomethasone and formoterol) issued by Chiesi. The advertisement included the claim ‘Effcacy with only 3 steps per inhalation’ and ‘See the features of the Fostair NEXThaler device’. The advertisement also claimed ‘Effcacy with only 3 steps per inhalation, ‘open – inhale – close’. The claim was referenced to the Fostair NEXThaler 100/6 summary of product characteristics (SPC) and Kanniess et al 2015.
Fostair was indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The complainant compared the claim that there were three steps per inhalation – open, inhale, close to the fve steps listed in the patient information leaﬂet (PIL). Those fve steps had additional points beneath each including crucially the requirement to hold one’s breath for 5-10 seconds to receive a therapeutic dose. The complainant alleged that the prescribing information was also out-of-date and omitted the special warning regarding pneumonia.
The complainant stated that the prescribing information on the website was similarly out-of date.
The detailed response from Chiesi is given below.
The Panel noted Chiesi’s submission about the timing of the update to the prescribing information. The update to the prescribing information had been prepared in July 2016 ahead of the formal approval of the summary of product characteristics (SPC) variation on 5 September 2016. The Panel considered that the prescribing information for the online advertisement and on the website was up-to date and therefore ruled no breach of the Code.
The Panel noted that the Fostair NEXThaler 100/6 SPC dated 7 September 2016 stated that correct use was essential in order for the treatment to be successful. The PIL stated that optimal lung delivery was obtained if the patient inhaled by breathing in quickly and deeply through the inhaler. A breath holding period of 5-10 seconds, or as long as comfortable for the patient was suggested before breathing out. The PIL instructions which were also in the SPC referred to four steps, visual check, open, inhale, close. Each of these steps had a number of instructions. The ‘open’ section included an instruction ‘before inhaling breathe out as far as is comfortable’.
The advertisement in question referred to ‘Effcacy with only 3 steps per inhalation. See the features of the Fostair NEXThaler device. The Panel accepted that as far as the device was concerned it had to be opened by the patient, used for an inhalation and closed by the patient. However to take the medicine correctly in order for the dose to be effcacious there were more than three steps. These were set out in full in the PIL. In addition as far as the device was concerned the PIL referred to four steps. The Panel decided that the advertisement was misleading as it was inconsistent with the SPC and the PIL. A breach the Code was ruled.
The Panel did not consider that the advertisement failed to meet high standards and nor did the circumstances warrant a ruling of a breach of Clause 2 and ruled accordingly.