AUTH/2525/7/12: Clinical Lead Pharmacist v ProStrakan (Abstral) – post-operative use discussion (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2525/7/12
Complainant	Clinical lead pharmacist (hospital NHS foundation trust)
Company	ProStrakan Ltd
Product	Abstral (fentanyl)
Therapy area	Breakthrough cancer pain
Main issue	Alleged off-label promotion: discussion of post-operative use following urological surgery
Clauses considered	2, 3.2, 15.2, 15.9
Decision	No breach of the Code
Complaint received	16 July 2012
Case completed	5 October 2012
Applicable Code year	2012
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A clinical lead pharmacist at an NHS foundation trust complained about ProStrakan representatives’ promotion of Abstral (fentanyl), indicated for breakthrough pain in adults using opioid therapy for chronic cancer pain.
The complainant described a urology department meeting to discuss Abstral in oncology patients with urological cancers (understood to be within licence).
The discussion allegedly moved to using Abstral post-operatively in patients who had undergone urological surgery; the complainant believed this was outside the licence.
The complainant was not sure who initiated the post-operative discussion, but alleged the representative did not withdraw from the discussion or state it should not be discussed as unlicensed.
After the meeting, a specialist nurse contacted the acute pain team to discuss using Abstral in this post-operative way; the complainant confirmed with ProStrakan that it had no data to support that indication.
ProStrakan said the relevant meeting was in early May (not late June) and that discussion related to post-operative breakthrough cancer pain in patients who still had cancer (eg debulking/obstruction relief surgery), which it considered within licence.
ProStrakan described follow-up calls with a surgical recovery nurse (late May and late June), supervised/recorded as being within the licensed indication.
The complainant did not attend the meeting(s) and did not provide comments on the company’s response when invited by the Panel.

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No breach of the Code was ruled.
The Panel considered the complainant had not proven the case on the balance of probabilities; there was no evidence Abstral had been promoted for patients who did not have cancer.
No breach of Clause 3.2 (promotion must be within the terms of the marketing authorisation) was ruled.
No breach of Clause 15.2 (high standards) was ruled.
No breach of Clause 15.9 (briefing material must not advocate a course of action likely to lead to a breach) was ruled.
Given the above, no breach of Clause 2 was ruled.
The Panel noted the presentation did not give the full indication (it referenced breakthrough cancer pain but not that patients needed to be using opioid therapy for chronic cancer pain), but in the circumstances this did not amount to a breach.

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