ＮＨＳ　重覆提供藥劑之現況

Abstract

Reasons to purchase

The UK Department of Health (DoH) has introduced a key policy concerning the reissuing of patients own pharmaceuticals on admission into hospital, determining that this will save money and improve quality of care.

This report examines and questions the introduced DoH policy to show how it may represent a significant challenge to the integrity of the Chain of Trust, which offers protection to both manufacturers and patients.

Report scope

• What is the pharmaceutical chain of trust?
• The introduced DoH policy on re-issuing medicines
• Questions regarding the introduced policy
• How does the introduced policy of selected re-issuing impact upon the basis of pharmaceutical regulation in the UK?
• Is cost-saving a valid (and ethical) basis for revising pharmaceutical regulation?
• Re-issuing in the absence of enabling legislation

This report examines and questions the introduced DoH policy on reissuing medicines in the NHS to show how it may represent a significant challenge to the integrity of the Chain of Trust, which offers protection to both manufacturers and patients.

Who should buy the report

This report is essential reading for:

• Pharmaceutical manufacturers either manufacturing in or supplying to the UK
• Product developers
• Decision makers involved in drug safety
• Policy makers
• Charities involved in donated pharmaceuticals
• Companies and institutions considering donating pharmaceuticals

Table of Contents

• 1 Introduction
  • 1.1 What is the pharmaceutical chain of trust?
• 2 The introduced policy
  • 2.1 The inspection process
• 3 Interrogating the principles and process of the introduced policy
  • 3.1 Questions regarding the introduced policy
    • 3.1.1 What are the existing regulatory policies?
    • 3.1.2 Is the DoH re-issuing policy consistent with the regulatory position(s)?
    • 3.1.3 Are there regulatory precedents to sanction the re-issuing of medicines recovered from domiciliary storage?
    • 3.1.4 Is the limited re-issuing policy logically consistent?
    • 3.1.5 How is the selective re-issuing of medicines in NHS hospitals presently justified?
  • 3.2 Questions of the relationship between the hospital trust and the patient 14
    • 3.2.1 Who is protected by the recommendation for re-issuing 'only with the agreement of the patient'?
    • 3.2.2 Is the hospital trust offering a uniform standard of care to all NHS patients?
• 4 Selected re-issuing of medicines vs the basis of pharmaceutical regulation in the UK
  • 4.1 How does the introduced policy of selected re-issuing impact upon the basis of pharmaceutical regulation in the UK?
    • 4.1.1 Allowing inspection and re-issuing
    • 4.1.2 Prohibiting re-issuing
  • 4.2 Pilot project proposal
  • 4.3 Is cost-saving a valid (and ethical) basis for revising pharmaceutical regulation?
  • 4.4 Conclusions
• 5 Re-issuing in the absence of enabling legislation
• 6 Consultation with key stakeholders prior to introducing the reissuing policy
  • 6.1 Prior consultation with patients/consumers
  • 6.2 Prior consultation with pharmacists (as represented by the RPSGB)
  • 6.3 Prior consultation with pharmaceutical manufacturers
    • 6.3.1 If the pharmaceutical industry were aware of the DoH policy
    • 6.3.2 If the industry were not aware (and consenting) of the DoH policy
      • 6.3.2.1 Regulation
      • 6.3.2.2 Liability
      • 6.3.2.3 Public perception
• 7 Concluding remarks
  • 7.1 Epilogue
• 8 Appendices
  • 8.1 References
  • 8.2 Abbreviations
  • 8.3 Glossary
  • 8.4 Biography: Dr Geoff Crumplin

List of Tables

• Figure 1.1 The pharmaceutical chain of trust
• Figure 2.1 The DoH re-issuing model
• Figure 4.1 Proposed model for re-issuing medicines recovered from domiciliary storage to charitable donation