AUTH/3309/2/20 - Complainant v Sintetica

Promotion of Ampres 20mg/ml solution for injection via LinkedIn

  • Received
    16 February 2020
  • Case number
  • Applicable Code year
  • Completed
    19 November 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional, alleged that a LinkedIn post, placed by a senior executive of Sintetica Limited, promoted Ampres 20mg/ml solution for injection (chloroprocaine hydrochloride) to the public.

The LinkedIn post stated that the company was excited to share the important announcement that Ampres 20mg/ml had been approved for peripheral nerve blocks in Europe and the UK. It was stated that peripheral nerve blocks and regional anaesthesia provided many benefits for patients and anaesthetists.

The complainant noted that Ampres 10mg/ml was only licensed for spinal anaesthesia not peripheral.

The complainant stated that there was no evidence that the item had been certified for use and he/she was concerned about Sintetica’s understanding and the robustness of its processes given that a senior executive had posted the item at issue.

The detailed response from Sintetica is given below.

The Panel noted Sintetica’s submission that the senior executive’s personal LinkedIn status update announcing the approval of Ampres 20mg/ml in perineural anaesthesia was accessible to his/her personal LinkedIn connections which inevitably comprised the public. Thus, in the Panel’s view, the executive’s LinkedIn post promoted a prescription only medicine to the public and a breach of the Code was ruled. The Panel further decided, on balance, that the post would encourage members of the public to ask their health professional to prescribe such a product and that high standards had not been maintained. Breaches of the Code were ruled.

With regard to the complainant’s concern that Ampres 10mg/ml was only licensed for spinal anaesthesia not peripheral, the Panel noted that the post referred to Ampres 20mg/ml. According to the company Ampres 10mg/ml had different indications to Ampres 20mg/ml. Ampres 20mg/ml was indicated for perineural anaesthesia (peripheral nerve block) in adults for short-duration surgeries (not exceeding 60 minutes). The Panel noted Sintetica’s submission that the marketing authorisation for Ampres 20mg/ml was granted on 12 February 2020, four days before the LinkedIn post was published; that the complainant was unable to immediately view the SPC for Ampres 20mg/ml was due to delays of up to 6 weeks with the eMC at times of high demand. The Panel did not consider that the LinkedIn post promoted Ampres 20mg/ml for an unlicensed indication as alleged. No breach of the Code was ruled.

The content of the post in question had not been certified for use, by the senior executive, on his/her LinkedIn account and a breach of the Code was ruled.

The Panel considered that junior employees were often keen to link to senior employees’ and/or corporate accounts and/or like their postings and thus all employees should be mindful of the impression given by their social media activities. In the Panel’s view, companies should give unambiguous guidance to help ensure that employees did not use social media forums in a way that was potentially within the scope of, and inconsistent with, the Code. The Panel noted Sintetica’s submission that its Communications Policy was being reviewed and rewritten with a planned implementation in December 2020.

The Panel noted its comments and rulings above and considered that a senior executive placing an uncertified post on his/her LinkedIn account, thereby promoting a prescription only medicine to the public, meant that Sintetica had brought discredit upon and reduced confidence in the pharmaceutical industry; a breach of Clause 2 was ruled.