GSK reprimanded over medicines-review nurse
GlaxoSmithKline has been reprimanded over the actions of an asthma-audit nurse, sponsored by the company, who made unauthorised changes to a GP repeat prescription database.
The Prescription Medicines Code of Practice Authority ruled that GSK
had failed to uphold the high standards expected under its code of practice
and ruled that the company had brought discredit upon and reduced confidence
in the pharmaceutical industry. The case is reported in the PMCPA’s
quarterly report.
The case involved a complaint from the partners of a general practice
who alleged that a nurse, sponsored by GSK to conduct asthma patient
reviews, had made changes to patients’ therapy on the practice
database (adding Seretide to all but two patients’ treatment regimens)
without authorisation. This was highly inappropriate and unethical, according
to the complainants.
A similar complaint was made against Novartis after a company employee
made changes to patients’ statin prescriptions without authorisation
(PJ, 29 September 2001, p418).
The PMCPA noted that GSK’s instructions for carrying out the audit
had not been followed. The agreed procedure was that nurses were allowed
to enter data onto the computer database only after all the GPs had signed
a therapy change register.
GSK submitted that the audit nurses believed they had been given permission
to make treatment recommendations on the computer and that the practice
nurse would obtain approval. However, GSK did not provide documentation
to show they had been given permission.
The panel also considered that the asthma patient review was in effect
linked to the prescription of Seretide, which was also a breach of the
code.
DTB complaints Complaints made to PMCPA by the Drug
and Therapeutics Bulletin over the promotion of Cerazette (desogestrel) and Ebixa
(memantine) have resulted in reprimands for the products’ manufacturers.
The PMCPA ruled that a claim made by Organon about Cerazette’s
efficacy was misleading and that a claim made by Lundbeck about Ebixa’s
effects on patients’ independence was misleading and could
not be substantiated.
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Pharmaceutical Journal