Case Summary
An anonymous complainant, who described him/herself as a concerned UK health professional, complained that the prescribing information in a journal advertisement (ref UK/NI/19-14927a) for Nicorette (nicotine), placed by McNeil Products Ltd, was out of date which could lead to adverse effects on patient safety. The prescribing information in the advertisement was dated June 2016; the advertisement was approved in November 2019. The complainant noted that the Nicorette summary of product characteristics (SPC) had been updated to include significant changes to Section 4.4 (Special warnings and precautions for use).
Nicorette was a brand of nicotine replacement therapy (NRT) indicated for use in adults and children over 12 years of age.
The detailed response from Johnson & Johnson, which owned McNeil Products Ltd, is given below.
The Panel noted that the changes implemented in Section 4.4 of the SPC in December 2019 were minor.
In the Panel’s view, the complainant had not established that the Section 4.4 SPC changes were such that consequential changes needed to be made to the prescribing information which had been approved in June 2016 and appeared in the advertisement at issue. No breach of the Code was ruled. The Panel noted Johnson & Johnson’s submission that when notification of the update was received, an assessment was made and no change was deemed necessary. There was no evidence that high standards had not been maintained and the Panel ruled no breaches of the Code including of Clause 2.
CASE AUTH/3312/2/20 NO BREACH OF THE CODE
COMPLAINANT v JOHNSON & JOHNSON
Prescribing information for Nicorette
An anonymous complainant, who described him/herself as a concerned UK health professional, complained that the prescribing information in a journal advertisement (ref UK/NI/19-14927a) for Nicorette (nicotine), placed by McNeil Products Ltd, was out of date which could lead to adverse effects on patient safety. The prescribing information in the advertisement was dated June 2016; the advertisement was approved in November 2019. The complainant noted that the Nicorette summary of product characteristics (SPC) had been updated to include significant changes to Section 4.4 (Special warnings and precautions for use).
Nicorette was a brand of nicotine replacement therapy (NRT) indicated for use in adults and children over 12 years of age.
The detailed response from Johnson & Johnson, which owned McNeil Products Ltd, is given below.
The Panel noted that the changes implemented in Section 4.4 of the SPC in December 2019 were minor.
In the Panel’s view, the complainant had not established that the Section 4.4 SPC changes were such that consequential changes needed to be made to the prescribing information which had been approved in June 2016 and appeared in the advertisement at issue. No breach of the Code was ruled. The Panel noted Johnson & Johnson’s submission that when notification of the update was received, an assessment was made and no change was deemed necessary. There was no evidence that high standards had not been maintained and the Panel ruled no breaches of the Code including of Clause 2.
A complainant, who described him/herself as a concerned UK health professional, complained about a journal advertisement (ref UK/NI/19-14927a) for Nicorette (nicotine), placed by McNeil Products Ltd in the January 2020 edition of Guidelines in Practice. Nicorette, available in several different pharmaceutical formulations, was a brand of nicotine replacement therapy (NRT) indicated to relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence in adults and children over 12 years of age. The prescribing information given in the advertisement was that for the 15mg inhalator and was dated June 2016; the advertisement was approved in November 2019.
McNeil Products was owned by Johnson & Johnson Limited and so the complaint was taken up with that company.
COMPLAINT
The complainant alleged that the prescribing information on the advertisement was out of date given that the summary of product characteristics (SPC) had been updated twice on the electronic medicines compendium (eMC) to include significant changes to Section 4.4 (Special warnings and precautions for use). The complainant submitted that that could lead to adverse effects on patient safety.
When writing to Johnson & Johnson, the Authority asked it to consider the requirements of Clauses 2, 4.1, and 9.1.
RESPONSE
Johnson & Johnson explained that the advertisement was first printed in Guidelines in Practice on 16 December 2019. When the advertisement was certified in November 2019, the prescribing information dated 27 June 2016 was based on the current Nicorette Inhalator SPC, dated June 2016 (copy provided). On 30 December 2019, subsequent to the advertisement being certified, the MHRA approved an update to the Nicorette Inhalator SPC (copy provided). Johnson & Johnson submitted that the complainant’s allegation that the prescribing information was out of date, given that the SPC had been updated twice on the eMC website was wrong as there was just one update to the SPC during that time. A screenshot from the eMC website was provided which Johnson & Johnson submitted illustrated that there were no other changes to the Nicorette Inhalator SPC between June 2016 and the December 2019 update. The SPC dated 30 December 2019 was uploaded to the eMC website on 14 January 2020.
Johnson & Johnson stated that notification of changes to the June 2016 SPC was received on 7 January 2020. In accordance with company procedures, when notification of the update was received, an assessment was made to consider if changes were required to existing prescribing information and promotional material. As per the standard operating procedure which covered general sales list (GSL) medicines, if the changes were deemed to be critical, new prescribing information would have been drawn up immediately and materials containing the old, non-compliant prescribing information would have been formally withdrawn. As this was not the case, although new prescribing information was drawn up so that all new promotional materials issued after the date of the new SPC would use the updated prescribing information, immediate withdrawal of existing material was not considered necessary.
Johnson and Johnson considered that the prescribing information drawn up in June 2016 still met the requirement of Clause 4.1 of the Code. The company noted that Clause 4.2 of the Code detailed the required component of prescribing information. In particular the company noted that, in consideration of the update to the SPC in December 2019, the only component potentially impacted was that specified in part (v) which required a succinct statement of common adverse reactions likely to be encountered in clinical practice, serious adverse reactions and precautions and contra-indications relevant to the indications in the advertisement, giving, in an abbreviated form, the substance of the relevant information in the SPC, together with a statement that prescribers should consult the SPC in relation to other adverse reactions. In that regard, Johnson & Johnson noted that Section 4.4, Special warnings and precautions for use, of the SPC was updated with minor changes which did not impact the prescribing information. All special warnings and precautions were already included in the June 2016 prescribing information. As the prescribing information also included a statement referring prescribers to the SPC for more detailed information, Johnson & Johnson considered that the relevant information was already included and no immediate update regarding that section was required and it was not necessary to withdraw existing material.
In addition to Section 4.4, Section 4.6, Fertility, pregnancy and lactation, of the SPC was also updated with additional information. As the prescribing information already stated ‘Pregnancy & lactation: Smoking cessation during pregnancy should be achieved without NRT. However, for women unable to quit on their own, NRT may be recommended to assist a quit attempt after consulting a healthcare professional’, Johnson & Johnson considered that sufficient information was already included in the prescribing information and so no immediate update regarding that section was required. Changes did not necessitate withdrawal of existing material.
Section 4.8, Undesirable effects, of the SPC was also updated with the addition of the nicotine withdrawal symptoms of dizziness, presyncopal symptoms, cough, constipation, gingival bleeding or nasopharyngitis in the section labelled ‘Effects of smoking cessation’. As these were not listed as drug related reactions or listed as common reactions likely to be encountered in clinical practice or considered to be serious adverse reactions, the company did not consider that an urgent update to the prescribing information was warranted. The update to the SPC did not involve the addition of any new adverse reactions related to Nicorette. Although cough was changed from very common to common, as the change was a reduction in incidence rather than an increase, Johnson & Johnson did not consider it likely to impact clinical decision making or patient safety and therefore it did not consider it necessary to trigger an urgent update to prescribing information.
Johnson & Johnson stated that its assessment overall was that the December 2019 SPC update did not render, as non-compliant, promotional material which incorporated the approved prescribing information from June 2016. Therefore, there was no requirement to recall and reprint/re-issue existing material which used the June 2016 prescribing information. Changes did not necessitate withdrawal of existing material.
Johnson & Johnson stated that in accordance with its procedures, the prescribing information was routinely updated in its internal system within 10 working days of the notification of the update to the SPC so that new material produced would use the updated, December 2019 prescribing information.
In summary, Johnson & Johnson submitted that the Nicorette Inhalator prescribing information used in the advertisement at issue complied with Clause 4 of the Code. As changes to the SPC in December 2019 were quickly assessed for impact on prescribing information, neither Clause 9.1 nor Clause 2 had been breached and high standards had been maintained.
PANEL RULING
The Panel noted that the complainant had referred generally to changes which had been made to Section 4.4 of the Nicorette SPC which in his/her view should have been reflected in the prescribing information. The complainant implied that, as such changes had not been made, there was a negative impact on patient safety. The complainant had not provided details of the specific changes and why in his/her view they impacted patient safety.
The Panel noted that Johnson & Johnson had provided a copy of the SPC for the Nicorette 15mg Inhalator showing the changes to Section 4.4 of the SPC which had been implemented in December 2019. The Panel noted that the changes were minor eg the statement ‘A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:’ had been introduced prior to the list of conditions. With specific reference to patients with diabetes, the SPC statement had changed from ‘Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.’ to ‘Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated as reductions in nicotine induced catecholamine release can affect carbohydrate metabolism.’. Further, Section 4.4 of the SPC now referred to danger in children rather than danger in small children when referring to the fact that doses of nicotine tolerated by adult and adolescent smokers could produce severe toxicity in children that might be fatal and therefore products containing nicotine should not be left where they may be misused, handled or ingested by children. With regard to the above changes, however, the prescribing information approved in June 2016 included children under 12 years as a contraindication and stated that the medicine should be kept out of sight and reach of children. It also listed diabetes mellitus under ‘Precautions’.
In the Panel’s view, the complainant had not established that the changes which had been made to Section 4.4 of the Nicorette 15mg Inhalator SPC in December 2019 were such that consequential changes needed to be made to the prescribing information which had been approved in June 2016 and appeared in the advertisement at issue. No breach of Clause 4.1 was thus ruled. The Panel noted Johnson & Johnson’s submission that when notification of the update was received, an assessment was made to consider if changes were required to existing prescribing information and promotional material and no change was deemed necessary. The Panel considered that there was no evidence that high standards had not been maintained and no breach of Clause 9.1 was ruled. The Panel thus also ruled no breach of Clause 2.
Complaint received 19 February 2020
Case Completed 29 May 2020
