Pharma Sponsored Patient Review: Ethics, Outcomes and Issues

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Pharma Sponsored Patient ReviewEthics, Outcomes
and Issues

• Dr David Leather Director of Medical Affairs GSK
• Irene Bowie Managing Director APMS
• Amy Whitelaw Clinical Operations Director

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Partnership document - views from AWPAG

• ..section on confidentiality needs to be
  strengthened to reflect the caldicott principles
  which in my view would exclude many of the pseudo
  independent review services that the industry
  provide to primary care
• Our LHB is tackling the problem of drug company
  sponsored auditGPs need direction from AWMSG on
  how to respond to these offers from drug
  companies
• many examples of increased cost to the NHS from
  accepting sponsorship e.g. Audits which result
  in increased use of a particular manufacturer's
  drug

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Pharma sponsored review

• Whats in it for Pharma?
• Pseudo Independent?
• Who decides on treatment?
• ABPI issues with review?
• Ethical standards?
• Whats in it for the practice?
• Whats in it for the patients?
• What are the outcomes?

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Whats in it for pharma

• Our medicines bring true benefits for patients
  and Drs
• Patient review (in real life) is not always
  effective
• Our medicines have a place in the treatment of
  patients
• By improving patient review and quality of care
  more of our medicines get used

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Pseudo Independent?

• APMS are not affiliated to, or part of any
  pharmaceutical company.
• All protocols are generic and do not state a
  preferred drug
• APMS nurses do not seek to influence GP
  prescribing choice
• All nurses and managers are RGN qualified
• APMS abides by the NMC code of conduct

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Who decides on treatment?

• GP instructs the nurse as to the practice
  treatment preferences via Practice Guidance Form
• Nurses make recommendations in line with Practice
  Guidance Forms
• GP authorises ALL medication changes via Therapy
  Recommendation Register
• Practice staff make changes to patient medication
• GP retains full prescribing authority

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Ethical Standards

• High ethical standards are vital to us
• GSK Code of Practice
• We know that we operate (quite reasonably) under
  intense scrutiny
• Our services have to be acceptable to HCPs and
  patients
• If we intend to use data to publish it has to go
  through ethical approval processes

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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 rep- rimands
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.
(adding Seretide to all but two patients'
treatment regimens) without authorisation. This
was highly inappropriate and unethical, a
ccording to the complainants. A similar complaint
was made against Novartis after a company
employee made changes to patients' statin
prescriptions with out authorisation (PJ, 29
September 2001, p41 8). 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
GlaxoSmithKIine 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
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ABPI issues with review

• GSK asthma patient review, examined by the ABPI
  in Nov 2003
• Protocols were reviewed and found to be
  satisfactory
• Behaviour of a nurse involved was unacceptable
  and fell outside of the protocols
• Nurse was dealt with through appropriate
  disciplinary action prior to the ABPI ruling

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Whats in it for the practice

• GMS Contract deliverables and measurables
• Can bring expertise and time to practices
• Brings logistic and IT resource to help practices
  establish and review disease registers
• Helps practices audit
• Brings benefit to patients
• Manages projects

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Whats in it for the patients?

• Opportunity for expert appropriate review
• Optimisation of therapy according to accurate
  assessment
• Treatment according to Protocol (evidence based)
• Improvement in QOL/Life expectancy?

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Cohort study of UK asthma patients

• 1078 practices returned data for 59,972 patients
• 83 of these patients had symptomatic asthma on
  first review
• Asthma control in the UK is poor regardless of
  severity

Dundee University submitted ERS 2004
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A UK population perspective - Active intervention
and evidence based advice can improve symptom
control in asthma

• 19,148 patients underwent gt1 asthma review
• Patient activity, daytime and night-time symptoms
  were assessed
• All symptom categories significantly improved
• Structured review can encourage the use of
  evidence based guidelines and improve patient care

Dundee University submitted ERS 2004
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Summary

• There are ethical concerns which can be addressed
• Pharma sponsored review brings resources to the
  NHS
• Appropriately organised sponsored review brings
  benefits to practices, patients and pharma
  companies
• Self regulation and review is a rigorous process
• Dialogue may be the way to a more satisfactory
  situation