Pfizer gabapentin pharmacy “patient alert” on PMR systems: no breach (AUTH/2774/6/15)

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/2774/6/15
PartiesHead of medicines management v Pfizer Limited
MaterialGabapentin patient alert on community pharmacy electronic dispensing/PMR systems
Alert text (complained about)“Remind your patient that they may experience side effects whilst taking gabapentin. If this is the case they should return to their doctor as alternative treatments are available. Supported by Pfizer.”
Products referenced in caseGabapentin (Neurontin), pregabalin (Lyrica), amitriptyline; NICE options also noted duloxetine
Complaint themesDisguised promotion; misleading implication about likely alternative and safety/side effects; high standards; industry disrepute; lack of Yellow Card prompt
Clauses considered2, 7.2, 7.9, 9.1, 12.1
DecisionNo breach of the Code
Complaint received11 June 2015
Case completed14 August 2015
AppealNo appeal
Applicable Code year2015

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

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What happened

  • A head of medicines management (CCG) complained about a Pfizer-supported “patient alert” that appeared on some community pharmacy electronic dispensing/PMR systems when gabapentin was entered/dispensed.
  • The alert text stated: “Remind your patient that they may experience side effects whilst taking gabapentin. If this is the case they should return to their doctor as alternative treatments are available. Supported by Pfizer.”
  • Gabapentin was available generically (Pfizer brand: Neurontin); Pfizer also marketed Lyrica (pregabalin). Both had indications in neuropathic pain and epilepsy.
  • The complainant alleged the alert was disguised promotion intended to drive switching from gabapentin to pregabalin, and implied pregabalin had fewer side effects/safer profile, particularly in light of Public Health England warnings about dependence/misuse potential for both medicines.
  • The complainant also raised that the alert did not encourage adverse event reporting via the MHRA Yellow Card scheme.
  • Pfizer responded that the alerts were non-promotional, designed to support pharmacist counselling at the point of dispensing, did not name any alternative, and “alternative treatments” included pharmacological and non-pharmacological options. Pfizer noted character limits (254) in the alert system and that alerts were rotated monthly across seven messages (gabapentin and amitriptyline).
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Outcome

  • No breach of the Code was found.
  • The Panel ruled no breach of Clause 12.1 (disguised promotion), Clause 7.2 (misleading), Clause 7.9 (claims about side effects/safety profile), Clause 9.1 (high standards), and Clause 2 (bringing the industry into disrepute).
  • The Panel noted it would have been helpful to include a reference to the MHRA Yellow Card scheme, but this omission did not amount to a breach in the circumstances.
  • No appeal.
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