Clinical Commissioning Group v Thame

Promotion of Thamicarb

Between March and August 2017 Syri Ltd trading as Thame Laboratories sent a letter headed 'RE: Thamicarb, Sodium bicarbonate 1mmol/ml oral solution [PL 39307/0005]' about the prescription of Sodibic oral solution (sodium bicarbonate) as a food supplement instead of Thamicarb oral solution, marketed by Thame

You are being sent this corrective statement because you received this letter or a similar letter.

Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel considered that the letter in question misleadingly stated that it was specifically required by the MHRA and that the MHRA had formally requested Thame to identify practices prescribing food supplements. The Panel noted the particular weight that would be attached by recipients to any reference to the MHRA.

The Panel considered that the letter implied that all patients on sodium bicarbonate oral solution could be switched to Thamicarb which was not so. The misleading implication that patients could be switched without any consideration of their clinical circumstances might potentially prejudice patient safety.

The letter did not state Thamicarb's licensed indication and that it could not be used with all patients that sodium bicarbonate oral solutions were prescribed for. The implication was misleading and was not capable of substantiation which also meant that the promotion of Thamicarb was inconsistent with the terms of its summary of product characteristics.

Use of the phrase 'vigorously prosecute' and the word 'non compliance' misleadingly implied that the use of a food supplement in preference to the unlicensed use of a licenced medicine was illegal. In addition the content of the letter disparaged the professional opinion of the health professionals who would be very concerned by the misleading implication that his/her prescribing decision was potentially illegal. The tone of the letter could be seen as threatening. Thame had failed to maintain high standards and it had brought discredit upon, and reduced confidence in, the pharmaceutical industry.

The Code of Practice Appeal Board required Thame Laboratories to issue this corrective statement and to circulate a copy of the published report for the case (Case AUTH/2971/8/17) which contains full details. This is enclosed.

On 11 June 2018, Thame laboratories sent the following corrective statement to recipients of the letter at issue.