Reissuing pharmaceuticals in the NHS: Challenging the chain of trust

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