Novartis compromised patient safety by switching drugs without permission


LONDON (Reuters Health) – Swiss drugs group Novartis put patients at risk and brought the pharmaceutical industry into disrepute when its representatives switched patients to the company's own drugs without informing physicians, a UK industry watchdog has ruled.

The Prescription Medicines Code of Practice Authority said patients on cholesterol-lowering and anti-hypertensive medications had been switched without permission to Novartis' fluvastatin (Lescol) and its angiotensin drug valsartan (Diovan) by reps visiting a GP surgery.

This could have "compromised patient safety," the authority's appeal board ruled. The board was also concerned by financial incentives given to reps to switch patients onto Novartis products, contrary to industry guidelines.

"Overall, the appeal board considered that Novartis had brought discredit upon and reduced confidence in the pharmaceutical industry."

The reps had been called in by one of the GPs at the practice in Leeds in the north of England to audit its use of statins for patients with ischaemic heart disease.

"The practice manager signed a form to give permission. Then, without any express permission from any of the partners, indeed without any discussion between the partners, all of the patients were switched from any other statin to fluvastatin."

"Also, and without discussion with the practice manager or the doctor, all of the patients on any of the sartan medicines were switched to valsartan."

The appeal board found that the reps had not followed their own company guidelines, which stated that no therapy changes would be carried out unless an authorisation form was signed by two practice partners.

The Novartis reps said they believed verbal authorisation had been given, even though they admitted they ought not to have made the switches without permission from the GPs.

In a statement to Reuters Health, Novartis said it accepted the rulings in relation to the "unfortunate events" in Leeds. It had "acted in a responsible and reputable manner to implement remedial action immediately upon hearing of the complaint.

"The representatives who had failed to follow company procedures in relation to the audit were reprimanded and retrained in the light of these events. In addition, the process documentation was enhanced with the assistance of the Leeds practice to avoid any possible repetition.

"The company is confident that this was an isolated incident which should not detract from the quality and value of this audit process which has been repeatedly demonstrated in clinical practice," the statement added.

Dr. John Chisholm, chairman of the BMA's General Practitioners Committee said that Novartis had clearly been judged by the industry's own watchdog as having behaved outside the company's own guidelines and in a way that discredited the pharmaceutical industry.

In a statement, he added that the report showed that the drug switch had caused alarm and despondency to some patients. "It is important that doctors check prescriptions that they issue to ensure that patients receive the medicines that it is intended they should receive. Doctors are ultimately responsible for prescribing decisions."

The appeal board ruling was made in August but nobody heard about it until the case was publicised in BMA News on Friday (Sept 14).

The Prescription Medicines Code of Practice Authority was established by the Association of the British Pharmaceutical Industry (ABPI) in 1993 to operate the ABPI code of practice independently of the ABPI.

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