AUTH/2971/8/17 - Clinical Commissioning Group v Thame Laboratories

Promotion of Thamicarb

  • Received
    17 August 2017
  • Case number
    AUTH/2971/8/17
  • Applicable Code year
    2016
  • Completed
    18 April 2018
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    No appeal
  • Review
    Published in the August 2018 Review

Case Summary

Two members of staff from a clinical commissioning group (CCG) complained about a letter sent to a clinician by Thame Laboratories. The letter was about the prescription of Sodibic Oral Solution (sodium bicarbonate) as a food supplement instead of Thamicarb Oral Solution, marketed by Thame, which was the only licensed prescribed medicine form of sodium bicarbonate. The letter stated that sodium bicarbonate solution was a medicinal product and could not be presented as a food supplement or nutritional product. The letter drew attention to the Medicines and Healthcare Products Regulatory Agency's (MHRA's) position that products approved as food supplements should be avoided when licensed prescription products were available given that the latter had been tested for quality, safety and efficacy to ensure consumer safety. The letter urged the reader to comply with this guidance and stated that Thame Laboratories would 'vigorously prosecute' any non-compliance to the MHRA risk framework. A satisfactory response was requested within 15 days otherwise 'all such steps deemed necessary' would be taken.

The complainants alleged that the letter was bullying and threatening and listed a number of concerns including that:

  • it was inappropriate for a manufacturer to directly contact a clinician in order to request that he/she justify his/her clinical decision.
  • The MHRA guidance on 'The supply of unlicensed medicinal products (“specials”)' allowed a health professional to supply an unlicensed medicine where the licensed product could not meet an individual patient's needs. This was the case with Thamicarb where its short expiry once opened (3 days for the 100ml product and 7 days for the 500ml) made it impractical for the majority of patients to use safely. It was the responsibility of the health professional caring for the patient to make that decision.
  • The letter stated that Thamicarb was 'the only licensed prescription medicinal form of Sodium Bicarbonate 1mmol/ml Oral Solution' but did not state that the licence was to treat hyperacidity, dyspepsia and symptomatic relief of heartburn and peptic ulceration in adults and children over 12 years old. The complainants alleged that the letter was misleading as it implied that Thamicarb was licensed for all of the indications that sodium bicarbonate oral solution might be used for rather than the restrictive licence it actually had.
  • The complainants noted that the letter implied that the MHRA had commissioned Thame to identify practices prescribing food supplements and that the MHRA would take action against them. The CCG, did not believe the MHRA did this, it regulated medical products and devices.
  • The CCG was not aware that the MHRA guidance was binding. A prescriber could prescribe an unlicensed product if he/she considered it was justified. The complainants alleged that Thame had misled the clinician.
  • The complainants noted that the letter urged the recipient 'to ensure that Thamicarb Oral solution, the only licensed Rx medicinal Sodium Bicarbonate 1mmol/ml Oral Solution is being prescribed in your practice and also to refrain from prescribing the food supplement (Sodibic)'. The CCG found it difficult to understand how a pharmaceutical manufacture was able to recommend this based on prescribing data only and with no knowledge of the clinical circumstances in which it was prescribed. The health professional, not a pharmaceutical manufacturer, had the responsibility to decide if a switch to Thamicarb was clinically appropriate.

The complainants noted that another practice had been sent a similar letter with regard to the prescribing of Syrsial (also a Thame product) which was a sodium chloride 1mmol/ml oral solution.

In an initial letter to the PMCPA one of the complainants stated that the cost of Thamicarb was extremely high when compared to other available products. The complainant further stated that the Specialist Pharmacy Service in October 2016 raised safety concerns about using Thamicarb due to the labelling of the product and the risk of dosing errors.

The detailed response from Thame Laboratories is given below.

The Panel disagreed with Thame's submission that the letter in question was non-promotional and that it was a communication which relayed regulatory guidance. The Panel noted that the letter to the clinician urged him/her to refrain from prescribing Sodibic and ensure that Thamicarb Oral solution was being prescribed in his/her practice. The letter in question did not state Thamicarb's licensed indication such that it qualified the otherwise misleading implication that it was licensed for all indications and could be used with all patients that sodium bicarbonate oral solutions were prescribed for. The implication was misleading and was not capable of substantiation and a breach of the Code was ruled. Such promotion was inconsistent with the terms of Thamicarb's SPC. A breach of the Code was ruled.

The Panel considered that the letter implied that all patients on sodium bicarbonate oral solution could be switched to Thamicarb without any consideration of the patient's clinical circumstances as alleged and that was not so. The letter was misleading in this regard and a breach was ruled.

The Panel did not consider that the wording in the letter in question was specifically required by the MHRA and thus a breach was ruled. The Panel also considered that the phrase 'We have been advised by the MHRA to inform them of any findings where food supplements are being dispensed against prescriptions so they can take appropriate action' implied that the MHRA had formally requested Thame to identify practices prescribing food supplements and that was not so. The letter in question was misleading in this regard and a breach was ruled.

The Panel considered that the reference to criminal jurisdiction, by using the phrase 'vigorously prosecute' and the word 'non compliance' misleadingly implied that the activity was illegal as alleged and a breach was ruled. Further, the letter queried the health professional's decision to prescribe Sodibic without any knowledge of the clinical circumstances, stating that such a decision was inconsistent with MHRA Guidance and implied that serious consequences could ensue. In the Panel's view, the content and tone of the letter was such that it disparaged the professional opinion of the health professional at issue and a breach was ruled. Thame had failed to maintain high standards and a breach was ruled.

The Panel was very concerned about the content and tone of the letter and noted its comments and rulings above. The Panel noted that the misleading implication that patients could be switched without any consideration of their clinical circumstances might potentially prejudice patient safety. The Panel was particularly concerned about the misleading impression that the MHRA had formally requested that Thame identify and report practices prescribing food supplements and in this regard, noted the particular weight that would be attached by recipients to any reference to the MHRA. The Panel was also concerned about the implication of legal consequences if the letter was not adhered to including the reference to criminal jurisdiction by use of the phrase 'vigorously prosecute'. This impression was compounded by the fact that it was signed by the company's legal advisor. In the Panel's view, a health professional who had received the letter would be very concerned by the misleading implication that his/her prescribing decision was potentially illegal. The tone of the promotional letter could be seen as threatening and, in the Panel's view, brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of Clause 2 was ruled.

Thame 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 a letter sent to a clinician by Thame about Thamicarb Oral Solution (sodium bicarbonate) was misleading and disparaged the professional opinions of the reader. The Panel had considered that the tone of the promotional letter could be seen as threatening. The Appeal Board considered that this case raised serious issues. The Appeal Board was concerned that it appeared that further similar letters had been sent as referred to by the complainant. The Appeal Board was of the view that consideration should be given to the imposition of additional sanctions under Paragraph 11.1 of the Constitution and Procedure including possible recovery of the letter at issue. Thame should respond to these concerns in writing and it was invited to attend the Appeal Board when the matter was considered. Thame was provided with a copy of the papers.

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

The Appeal Board noted that the company had apologised and agreed that the wording used in the letter at issue was totally unacceptable.

Whilst noting Thame's apology and remedial actions the Appeal Board was concerned to note that nearly 400 copies of the letter at issue had been sent. In addition, nearly 400 copies of a similar letter concerning Syrisal (sodium chloride, marketed by Thame) had also been sent.

Given the misleading content and threatening tone of the letter at issue the Appeal Board decided that in accordance with Paragraph 11.3 of the Constitution and Procedure, to require Thame to issue a corrective statement to all recipients of the letter at issue. Details of the proposed content and mode and timing of dissemination of the corrective statement must be provided to the Appeal Board for approval prior to use. The Appeal Board considered that the corrective statement should detail the Panel's comments. [The corrective statement, which was agreed by the Appeal Board prior to use, appears at the end of this report].