AUTH/3239/8/19 - Pharmacist v Colonis

Promotion of Melatonin Oral Solution

  • Received
    13 August 2019
  • Case number
  • Applicable Code year
  • Completed
    20 December 2019
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published

Case Summary

A pharmacist in a medicines optimisation team, complained that in a letter (ref UK-CPL-121-008), Colonis Pharma Limited had blatantly promoted off-label use of Melatonin 1mg/ml Oral Solution. The medicine was only indicated for the short-term treatment of jet-lag in adults but there was hardly any reference to that in the letter.

The detailed response from Colonis is given below.

The Panel noted that the licensed indication for Melatonin 1mg/ml Oral Solution, ‘for short-term treatment of jet-lag in adults’, was stated in bold black, regular sized font in the first sentence of the letter. This was the only refence to the licensed indication in the letter which mainly otherwise discussed the use of the medicine in preference to unlicensed alternatives.

The Panel noted that it was not necessarily unacceptable to draw the attention of pharmacists, medicines optimisation teams and CCG medicines management teams to the relevant legal requirements about the use of unlicensed medicines, however such material had to comply with the Code.

The Panel noted that the Melatonin 1mg/ml Oral Solution summary of product characteristics (SPC) stated that the safety and efficacy of the medicine in children and adolescents aged 0-18 years had not been established and that Melatonin 1mg/ml Oral Solution should not be used in children and adolescents due to safety and efficacy concerns.

The Panel further noted that the letter highlighted that Melatonin 1mg/ml Oral Solution was lactose free, sugar free and strawberry flavoured. Directly beneath these statements was the question, ‘Why choose a liquid formulation?’; the answers included ‘Can be used over a wide age range’. Both the product characteristics noted above and answers were in capital letters in prominent coloured circles, in a larger font size than that used to state the licensed indication.

The Panel noted that the letter stated, in larger font than that used to set out the indication for use, that Melatonin 1mg/ml Oral Solution was now licensed and that it should be prescribed over unlicensed alternatives. A schematic which ranked options from ‘low risk’ to ‘high risk’, placed UK licensed medicines used off-label at the low risk (green) end of the spectrum, second only to a UK licensed medicine. The Panel considered that off-label use of Melatonin 1mg/ml Oral Solution might include use in many different patient types including children and adolescents and in this regard the Panel noted its comments above in relation to the statement in the letter ‘Can be used over a wide age range’. The Panel considered the immediate and overall impression to a health professional. In the Panel’s view, the letter promoted Melatonin 1mg/ml Oral Solution for off-label use and a breach of the Code was ruled.

The Panel considered that patient safety had been compromised by the promotion of off-label use, compounded by the lack of any warning to alert the reader, inter alia, that Melatonin 1mg/ml Oral Solution should not be used in children and adolescents. A breach of was ruled as high standards had not been maintained.

The Panel noted that a ruling of a breach of Clause 2 was reserved as a sign of particular censure. The supplementary information to Clause 2 gave examples of activities likely to be in breach of Clause 2 which included prejudicing patient safety. The Panel noted its comments and rulings above and considered that the letter brought discredit upon, and reduced confidence in, the pharmaceutical industry and ruled a breach of Clause 2.