AUTH/3359/6/20 and AUTH/3360/6/20 - Anonymous NHS Employee v Glenmark and IQ Pharma

Promotion of Renocontin

  • Received
    03 June 2020
  • Case number
    AUTH/3359/6/20 and AUTH/3360/6/20 -
  • Completed
    30 November 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, non-contactable, NHS employee complained about the promotion of Renocontin (prolonged release oxycodone hydrochloride). The material (ref PP-UK-REN-0002) was issued by CactusRx which was a trading style of iQ Pharma Limited. iQ Pharma distributed Renocontin under licence from Glenmark Pharmaceuticals Limited which was the marketing authorization holder. The material stated that prescribing Renocontin by brand could halve prescribing costs for prolonged release oxycodone hydrochloride tablets. A cost comparison table compared the cost of various presentations of Renocontin (from 5mg to 80mg) with the cost of competitor products. Renocontin was indicated for severe pain which could only be managed with opioids.

The complainant explained that he/she was reviewing opioids within his/her practice; the material at issue had been received from a colleague. The complainant alleged that the information was misleading as it implied that a Renocontin 80mg tablet was available which was not so - only the 5 to 60mg strengths were. The 80mg tablet was also referred to in a claim on bioequivalence vs OxyContin. The complainant also noted that the summary of product characteristics (SPC) was updated in March 2019 but that the prescribing information included in the material had been prepared in January 2019.

The detailed responses from Glenmark and iQ Pharma are given below.

Case AUTH/3359/6/20

The Panel noted that Renocontin tablets were available in seven different strengths from 5mg to 60mg. Although a marketing authorization for an 80mg tablet had been granted, that presentation had not been made commercially available. The cost comparison table within the material provided by the complainant was arranged in a number of columns. The left-hand column was headed ‘Presentation’ and listed below were 5mg,10mg, 15mg, 20mg, 30mg, 40mg, 60mg and 80mg* presentations of prolonged release oxycodone tablets; the asterisk led the reader to a footnote which read ‘as 2 x 40mg’. The columns to the right were labelled with the various brands of prolonged release oxycodone available including ‘iQ Pharma Renocontin’. Given the construction of the table, the Panel disagreed with the implied submission that the footnote ‘as 2 x 40mg’ only applied to Renocontin, as written, the footnote applied to all of the medicines listed to the right despite the fact that all of those listed, other than Renocontin, were available as 80mg. Given the availability of 80mg tablets for other brands of prolonged release oxycodone, and the familiarity that prescribers might have with using those tablets, the Panel considered that the cost comparison table was misleading as it implied that an 80mg tablet of Renocontin was also available; in the Panel’s view, the footnote was not sufficient to negate the misleading impression. Although an 80mg dose of Renocontin could be prescribed, a health professional should know, from the outset, that unlike the competitors listed, a prescription for that dose could only be achieved with the concomitant use of at least two tablets which, in itself, might have an adverse impact on patient compliance vs the use of one 80mg tablet. Patients who were used to taking an 80mg dose with just one tablet might be confused if a repeat prescription was filled with Renocontin. The material referred to the cost savings if GP practices switched from Longtec/Abtard to Renocontin. The Panel considered that the cost comparison table was misleading and a breach of the Code was ruled.

The Panel noted its comments above and similarly considered that the claim ‘Bioequivalence to OxyContin tablets in strengths 5mg, 20mg, 40mg and 80mg in steady state has been proven’ was misleading. Although a statement of fact, it implied that, as with Oxycontin, there was an 80mg tablet of Renocontin available which was not so. A breach of the Code was ruled.

With regard to the prescribing information, the Panel noted that the Renocontin SPC had been updated in June 2019 to include a precaution about the concomitant use of serotonin agents.

The Panel noted Glenmark’s submission that it had identified clear communication internally between the regulatory and commercial functions notifying an update to the Renocontin SPC, however, this message appeared not to have been forwarded to the external commercialisation partner for Renocontin. The Panel noted that the prescribing information on the material provided by the complainant was dated January 2019; the complainant had received a copy of the material from a colleague, not from Glenmark. The complainant was non-contactable and so could not be asked for details as to when both he/she and his/her colleague had first received the material. Nonetheless, it appeared from Glenmark’s submission that the material, which should have been updated in June 2019, was not withdrawn until the company drew up corrective and preventative actions in response to this complaint almost a year later (May 2020). The Panel noted Glenmark’s admission that 23 copies of the material had been used without the update in July 2019. It was possible that the complainant’s colleague had received one of those copies which thus did not contain a succinct statement of all of the precautions likely to be needed in the prescribing of Renocontin. In the Panel’s view, prescribing information was an important component of patient safety. A breach of the Code was ruled.

The Panel noted its comments and rulings above and was extremely concerned that patient compliance and patient safety might have been compromised. A breach of the Code was ruled.

Case AUTH/3360/6/20

The Panel’s rulings in this case were the same as for Case AUTH/3359/6/20 above