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PMCPA Case

Cephalon supplied 30 boxes of Schedule 2 Effentora to a hospital pain team via goods-in (AUTH/2295/1/10)

📅 2010 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/2295/1/10
ComplainantHospital chief pharmacist (NHS trust)
CompanyCephalon UK Limited
MedicineEffentora (fentanyl citrate buccal tablets)
Product riskSchedule 2 controlled drug
Issue30 boxes supplied as free/titration stock; delivery bypassed pharmacy controls; inadequate request form and delivery controls
Quantity noted30 packs; Appeal Board noted 120 tablets supplied
Applicable Code year2008
Complaint received25 January 2010
Case completed8 June 2010
Breach clauses (final)2, 9.1, 15.2
Other clauses considered17.2, 17.5, 17.6, 17.8, 17.12 (no breach; 17.8 overturned on appeal)
SanctionsUndertaking received; Advertisement

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

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What happened

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  • An NHS trust chief pharmacist complained that 30 boxes of Effentora (fentanyl citrate buccal tablets) were delivered to a nurse in the pain team via the goods receiving department, rather than through the pharmacy department where controlled drug records are maintained.
  • Effentora is a Schedule 2 controlled drug indicated for breakthrough pain in adults with cancer already receiving maintenance opioid therapy.
  • The supply followed a meeting between a Cephalon representative and a local pain consultant. The consultant believed she had expressed interest, not placed an order.
  • Cephalon described the supply as “titration stock” provided free of charge, not samples.
  • The “Effentora Titration Stock Request” form was criticised as inadequate: it required the name (but not signature) of the person authorised to receive delivery and did not require the quantity requested to be specified. At appeal, Cephalon’s representatives agreed the form had not been signed.
  • Emails referenced that the supply would “assist [Cephalon] with moving forward with a formulary application” because the hospital had little experience of Effentora (suggesting it was not on formulary).
  • The Appeal Board noted a significant quantity was supplied: 120 tablets.
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Outcome

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  • Breach found: Clause 2 (upheld on appeal).
  • Breach found: Clause 9.1.
  • Breach found: Clause 15.2.
  • No breach:</strong Clause 17.8 (Panel found breach; overturned on appeal because hospital guidelines referred to “samples” but not “free stock”).
  • No breach:</strong Clauses 17.2, 17.5, 17.6, 17.12 (ruled not applicable because the supply was treated as free stock, not “samples” as defined in the Code).
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