Implementation, resource implications and audit

Local implementation

Implementation of national clinical guidelines is the responsibility of each NHS Board and is an essential part of clinical governance. It is acknowledged that every Board cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit.

Resource implications

This section is based on discussions with the guideline development group regarding current resource use in Scotland and the likely impact of implementing the recommendations made in the guideline. Where current practice will not change as a result of the recommendations it is unlikely there will be resource implications.

  • Increased numbers of people being offered testing, along with the inclusion of current injecting drug users and patients with mild chronic hepatitis C being considered for antiviral therapy, could result in more people requiring treatment.
  • There may be extra resourcing required for patients who need treatment with erythropoietin and G-CSF. Erythropoietin currently costs £350 per week, and G-CSF £130 per week. This will be in addition to the cost of HCV treatment.

The good practice point advising that clinical nurse specialists should be an integral member of the clinical team may have staffing implications.

Key points for audit

The following key clinical indicators could be used to gauge the performance of clinical services in managing people with HCV through the referral, investigation and treatment pathway:

  • the proportion of people diagnosed with chronic HCV who enter specialist care
  • the number of people with chronic HCV in specialist care who are eligible for antiviral therapy; for those considered ineligible for treatment, the reasons for their ineligibility
  • the number of people with chronic HCV who receive antiviral therapy
  • the proportion of people with chronic HCV who complete their course of antiviral therapy; for those who do not complete the course, the reasons for non-completion
  • the proportion of those administered therapy who achieve a sustained viral response (categorised into those completing the course and those who do not).

Recommendations for research

The following areas for further research were identified by the guideline development group:

  • a study into whether testing and knowledge of HCV status changes behaviour to slow down disease progression, or reduce transmission to others
  • an initiative to identify former injecting drug users should be developed, implemented and evaluated
  • a prospective study to clarify the long term prognosis of individuals with chronic HCV infection, including treated and untreated participants, ideally as part of an ongoing national clinical audit in Scotland
  • long term follow up of outcomes after the use of pegylated IFN in children
  • the effectiveness of pegylated interferon and ribavirin therapy in Caucasian patients with chronic hepatitis B and chronic hepatitis C co-infection
  • an RCT on antiviral therapy for patients with genotypes 2 and 3 with cirrhosis for 24 or 48 weeks
  • the role of coffee and its derivatives in the prevention of hepatocellular carcinoma
  • the effectiveness of long term weight reduction programmes on delayed progression in hepatitis C
  • the role of haematopoetic growth factor support in post OLT patients
  • the development of strategies to eradicate HCV post transplant
  • the effectiveness of specialist nurse intervention in the care and management of patients with HCV
  • a review of the specific palliative care needs of patients with HCV.

Further publications

The following reports have been approved by NHS Quality Improvement Scotland:

  • NICE technology appraisal guidance no.106. Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C, 2006207
  • NICE technology appraisal guidance no.75. Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C, 2004.208

The Scottish Medicines Consortium has issued advice on the use of pegylated IFN and ribavirin, for the treatment of children from three years of age, adolescents and adults with chronic hepatitis C. Further details are available from the website: www.scottishmedicines.org.uk