AUTH/3240/8/19 - Voluntary admission from Colonis

Incorrect prescribing information

  • Received
    15 August 2019
  • Case number
  • Applicable Code year
  • Completed
    26 February 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Public reprimand
  • Appeal
    No appeal
  • Review
    To be published

Case Summary

Colonis Pharma Limited voluntarily admitted that it had included the wrong prescribing information in a promotional letter (ref UK-CPL-121-008) about Melatonin 1mg/ml Oral Solution which was indicated for the short-term treatment of jet-lag in adults.

As Paragraph 5.5 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Colonis.

The detailed response from Colonis is given below.

The Panel noted that the letter in question promoted Melatonin 1mg/ml Oral Solution but the prescribing information provided was that for Melatonin 3mg film-coated tablets. In that regard, the relevant prescribing information had not been provided as required by the Code. A breach of the Code was ruled.

The incorrect prescribing information in the letter was not identified by Colonis at either the final internal hard copy print sign-off stage or the external printer QC and dispatch stage. Colonis had failed to maintain high standards and a breach of was ruled.

The Panel noted Colonis’ submission that although the letter contained the incorrect prescribing information, the risk to patient safety was low as the main safety information was consistent for both the tablet formulation and the Oral Solution.

The Panel noted that there were differences in the summary of product characteristics (SPC) between the Oral Solution and the film-coated tablets that would impact the prescribing information.

The Panel was concerned that important safety information relating to the Oral Solution was not provided by virtue of the fact that the film-coated tablets prescribing information was supplied in error.

The Panel noted its comments and rulings above and was concerned that the error had not been picked up during two different stages of the approvals process. The approvals process underpinned self- regulation and any failure in that regard was a serious matter. Clause 2 was a sign of particular censure and was reserved for such use. The supplementary information to this clause listed activities likely to be found in breach of Clause 2 and included prejudicing patient safety. The Panel considered that the provision of incorrect prescribing information which omitted important safety information meant that Colonis had brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of Clause 2 was ruled.

Colonis provided the requisite undertaking and assurance and as the case completed at Panel level the Appeal Board received the case report as set out in Paragraph 13.4 of the Constitution and Procedure.

The Appeal Board noted the Panel’s comments regarding Colonis’ submission that it had sent a corrective letter on 23 July to the recipients of the original letter to point out and apologise for the oversight in relation to the incorrect prescribing information. There had been no mention in this case that the corrective letter had been a corrective statement required and agreed by the MHRA as advised by Colonis in its submission to Case AUTH/3239/8/19. The Panel queried why Colonis’ submission in Case AUTH/3240/8/19 did not refer to the company’s correspondence with the MHRA and it noted that self-regulation relied on complete and accurate responses from companies.

The Appeal Board was concerned about the incomplete and inaccurate responses and it was of the view that consideration should be given to the imposition of additional sanctions under Paragraph 11.1 of the Constitution and Procedure. Colonis should respond to these concerns in writing and it was invited to attend the Appeal Board when this matter was considered.

The detailed response from Colonis to the possibility of further sanctions being imposed is given below.

The Appeal Board noted the Panel’s rulings of breaches of the Code including Clause 2. The Appeal Board noted that the company had apologised and admitted that it had made errors. The company submitted that these were administrative errors due to its unfamiliarity with the complaints procedure and a lack of understanding of the importance or relevance of the information which should have been provided. The Appeal Board noted that Colonis had failed to state in its response to Case AUTH/3240/8/19 that the corrective letter on 23 July was required by the MHRA. Although the response to Case AUTH/3239/8/19 included a copy of the corrective statement in question the company’s letter should have been clearer that the MHRA required a corrective statement to be sent. The information included in Case AUTH/3239/8/19 was clearly relevant to the current case, Case AUTH/3240/8/19. Both responses had been sent to the Authority by Colonis on the same day. The Appeal Board noted that any case under the Code must stand alone and be considered on its individual merits. Case AUTH/3239/8/19 and Case AUTH/3240/8/19 had not been amalgamated under Paragraph 5.1 of the Constitution and Procedure. It was essential that companies had an in depth understanding of the Code and the Constitution and Procedure including responding to complaints. The Appeal Board noted that self-regulation relied, inter alia, upon the provision of complete and accurate information from pharmaceutical companies.

The Appeal Board noted Colonis’ submission that it was a subsidiary of Clinigen set up to develop and bring to market products that were currently used as specials. The Appeal Board noted the area in which Colonis was working in and the apparent lack of Code knowledge which was of concern. The Appeal Board noted, however, that the company was in the process of being fully integrated into Clinigen which should bring increased compliance resource and oversight.

The Appeal Board decided that, in accordance with Paragraph 11.3 of the Constitution and Procedure, Colonis should be publicly reprimanded for its failure to provide complete and accurate information to the Panel.

The Appeal Board gave consideration to the use of further sanctions but decided that, on balance, none were required.