AUTH/2879/10/16: Anonymous (non-contactable) v Bristol-Myers Squibb – Orencia homecare nurse visit complaint (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2879/10/16
Complainant	Anonymous, non-contactable member of the public
Company	Bristol-Myers Squibb Pharmaceuticals Limited
Product	Orencia (abatacept)
Activity	Orencia patient support/homecare service (third-party nurse training/support and cold-chain delivery)
Allegation	Third-party nurse funded by BMS attempted to call at patient’s home unannounced; concerns about consent and communication
Applicable Code year	2014
Clauses considered	2, 9.1, 18.1, 18.4
Panel decision	No breach of Clauses 18.1, 18.4, 9.1 and 2
Complaint received	11 October 2016
Case completed	4 January 2017
Appeal	No appeal
Sanctions	None stated

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

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An anonymous, non-contactable member of the public alleged their mother (with severe rheumatoid arthritis) was prescribed Orencia (abatacept) in 2014.
The complainant alleged a nurse from a third party paid for by Bristol-Myers Squibb (BMS) attempted to call at the mother’s house unannounced to show her how to use the injection.
The mother reportedly did not open the door because no visit had been pre-arranged and there had been burglaries locally.
The complainant alleged the hospital said it was part of an NHS service, and questioned why the visit had not been communicated and why permission had not been sought.
The complainant also alleged a nurse showed a blank form and said the doctor would have signed the consent form on the mother’s behalf.
BMS refuted the allegations and described multi-step consent and scheduling controls for its Orencia homecare service (registration form, installation call, information pack, nurse co-ordinator call, and written consent at the nurse visit).
The Panel noted the complainant could not be contacted for more detail and had not provided sufficient information to identify the particular circumstances.

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No breach of the Code was ruled.
No breach of Clauses 18.1, 18.4, 9.1 and 2 was ruled.
The Panel commented that the patient registration forms could have been clearer that the patient signature related to consenting to provision of the service (not just data use), but this did not lead to a breach on the evidence available.

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