AUTH/2510/6/12: Anonymous v ProStrakan (Abstral) – alleged misleading titration advice (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2510/6/12
Complainant	Anonymous physician (pain physician; non-contactable)
Company	ProStrakan UK Ltd
Medicine	Abstral (fentanyl citrate)
Therapy area / context	Breakthrough cancer pain (BTcP) in adults using opioids for chronic cancer pain
Allegation	Representative allegedly advised a day-by-day titration schedule inconsistent with the approved titration process
Materials referenced	Abstral Titration Chart (ref M017/0476); training slides “Module Three: Abstral Product Profile and Clinical Value” (ref M017/0456); Abstral Titration Wheel (ref M017/0527)
Clauses considered	2, 3.2, 7.2, 7.4, 9.1, 15.2 and 15.9
Decision	No breach of the Code
Complaint received	7 June 2012
Case completed	2 July 2012 (HTML page lists completed 03 July 2012)
Appeal	No appeal
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth2510612-anonymous-v-prostrakan

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

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An anonymous, non-contactable pain physician alleged an un-named ProStrakan representative misled them about the titration schedule for Abstral (fentanyl citrate) at a meeting.
The complainant said they were shown a document resembling a prescription record card (said to be developed by a Scottish palliative care team in collaboration with ProStrakan) but were not given a copy.
The alleged advice described a day-by-day titration (eg day 1: 100mcg with 100mcg rescue; day 2: 200mcg with 100mcg rescue; day 3: 300mcg, etc.), which the complainant later believed conflicted with the approved titration process found online.
ProStrakan reviewed materials and interviewed relevant staff; it identified an Abstral Titration Chart (ref M017/0476) as the likely document, and also provided training slides (ref M017/0456) and an Abstral Titration Wheel (ref M017/0527).
The Panel reviewed the SPC titration approach (dose escalation by subsequent breakthrough cancer pain episodes, with timing of 15–30 minutes and a maximum dose per episode of 800mcg) and compared it with the company’s chart/wheel and training materials.

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No breach of the Code was ruled.
The Panel considered the complainant had not established, on the balance of probabilities, that a representative advised daily titration as alleged.
The Panel noted the titration chart was consistent with the SPC and queried whether the complainant may have mistaken “episodes” for “days” due to the chart layout.

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