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AUTH/2510/6/12 - Anonymous v ProStrakan

Case number:AUTH/2510/6/12
Case ref:Anonymous v ProStrakan
Description:Promotion of Abstral
No breach:No breaches Clauses 2, 3.2, 7.2, 7.4, 9.1, 15.2 and 15.9
Appeal:No appeal
Review:Published in the August 2012 Review
Case Summary:

​An anonymous physician alleged that an un-named ProStrakan representative had misled him/her with regard to the titration schedule for Abstral (fentanyl citrate). Abstral was indicated for the management of breakthrough cancer pain (BTcP) in adults using opioids for chronic cancer pain.

The complainant stated that he/she had been shown a document which looked like a prescription record card, but had not been given a copy of it. The complainant stated that the dosing looked simple. On day 1 the dose was 100mcg with a rescue dose of 100mcg. If pain relief was not obtained on day 1, the dose for day 2 should start at 200mcg with a rescue of 100mcg. This dose was used all day on day 2 and day 3 would start with a dose of 300mcg and so on until the right dose was reached.

The complainant stated that as he/she wanted to prescribe Abstral, he/she subsequently looked up the product information on-line and found that the information from the representative was totally different to the approved titration process. This sort of misinformation could affect patient care.

The detailed response from ProStrakan is given below.

The Panel noted that the complainant was anonymous and non-contactable and had provided little information and no documentation to support his/her complaint. As with any complaint, the complainant had the burden of proving his/her complaint on the balance of probabilities; the matter would be judged on the evidence provided by the parties.

The Panel noted from the Abstral summary of product characteristics (SPC) that all patients must start therapy with a single 100mcg sublingual tablet. If adequate analgesia was not obtained in 15-30 minutes a second 100mcg tablet could be given. If adequate analgesia was not obtained within 15-30 minutes of the first dose, an increase in dose to the next highest tablet strength should be considered for the next episode of BTcP. Dose escalation should continue in a stepwise manner until adequate analgesia was achieved. The maximum dose for the treatment of any episode of BTcP was 800mcg.

The Panel noted that ProStrakan had provided a copy of the Abstral Titration Chart which it assumed was the document referred to by the complainant. This chart showed that for the first episode of BTcP, patients should be given a 100mcg tablet with the option of a second tablet if the first was not effective after 15-30 minutes. If a second tablet had to be given then treatment of the second episode of BTcP should begin with a 200mcg tablet and the titrationschedule continued in this stepwise manner until adequate analgesia or the maximum dose (800mcg) was achieved, whichever came sooner. The Panel noted the layout of the titration chart and queried whether the complainant had mistaken BTcP episodes 1 to 6 with treatment days 1 to 6. In the Panel’s view the titration chart was in accordance with the titration schedule contained within the Abstral SPC.

The Panel noted that in training slides ‘Abstral:product profile and clinical value’ a slide headed ‘Titration of Abstral’ correctly referred to doses being increased, if necessary, with subsequent episodes of BTcP. Similarly a titration wheel showed that if a rescue dose had been required then the dose of the first tablet should be increased for the next episode of pain.

ProStrakan had not found evidence that any of its staff knew anything about the daily titration schedule referred to by the complainant. All of the materials provided by ProStrakan referred to the dose of Abstral being increased, if necessary, with subsequent episodes of BTcP in accordance with the SPC. On the basis of the information before it, the Panel considered that the complainant had not established, on the balance of probabilities, that a representative had advised him/her to titrate Abstral on a daily basis as alleged. No breach of the Code was ruled.