Amdipharm Mercury: PV follow-up call sought patient personal data without consent (AUTH/2743/12/14)

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Key facts

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Case number	AUTH/2743/12/14
Parties	Community Pharmacist v Amdipharm Mercury Company Limited
Issue	Yellow Card / ADR follow-up call requested patient personal data (contact details, date of birth) without consent; alleged pressure/insistence
Medicine	Levothyroxine tablets
PV model	PV function outsourced to a PV provider (PV associate made the call)
Complaint received	19 December 2014
Case completed	12 February 2015
Applicable Code year	2014
Breach clauses	1.9, 9.1, 16.2
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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A community/superintendent pharmacist received a patient query (11 Dec 2014) about levothyroxine brand; the patient reported having had “issues” with product manufactured by Amdipharm Mercury and asked for alternatives including Teva.
The pharmacy contacted Teva, which said it no longer made the medicine and outsourced manufacture to Amdipharm Mercury; Teva wanted to issue a Yellow Card warning based on the patient’s account of “issues”.
An adverse event report was passed to Amdipharm Mercury (via Teva) and treated as an ADR requiring follow-up under the company’s pharmacovigilance (PV) procedures.
A PV associate from Amdipharm Mercury’s outsourced PV provider attempted follow-up twice (16 and 17 Dec 2014) and reached the pharmacist on the third attempt (18 Dec 2014).
During the call, the PV associate requested patient personal information (eg home contact details, date of birth). The pharmacist refused due to confidentiality and lack of patient consent, and alleged the caller insisted they “had to ask” for the information.
Amdipharm Mercury accepted the PV associate should not have sought patient personal details from a third party without consent and said the correct approach would have been to seek further information from the HCP and, if needed, ask the HCP to help obtain patient consent.

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Breach of Clause 9.1 ruled on the narrow point that asking for too much personal data without prior patient consent meant high standards were not maintained.
Breach of Clause 16.2 ruled because, despite training records, the PV associate’s mistake indicated they were not fully conversant with PV requirements relating to patient confidentiality relevant to their work.
Breach of Clause 1.9 ruled as a consequence of the above breaches (requirement to comply with applicable codes, laws and regulations).
No appeal.

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