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Tayside Centre for General Practice Division of Community Health Sciences

Tayside Centre for General Practice Division of Community Health Sciences. Compliance: A permanent concern. Dr Peter T. Donnan. Background. Management of diabetes tends to involve polypharmacy (typically up to 9 pills or more)* Control of: Blood pressure Glycaemia CHD risk

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Tayside Centre for General Practice Division of Community Health Sciences

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  1. Tayside Centre for General Practice Division of Community Health Sciences Compliance: A permanent concern Dr Peter T. Donnan

  2. Background Management of diabetes tends to involve polypharmacy (typically up to 9 pills or more)* Control of: Blood pressure Glycaemia CHD risk In addition, co-morbidity is common *Turner RC, Cull CA, Frighi V, Holman RR. UKPDS 49. Glycaemic control with diet, sulphonylurea, metformin and insulin therapy in patients with type 2 diabetes JAMA 1999; 281: 2005-12.

  3. Gliclazide Metformin Simvastatin Atenolol Ramipril Felodipine Aspirin Mononitrate Amitriptyline Thyroxine a.m. noon p.m. night

  4. Background RCTs demonstrate efficacy of these treatments Blood pressure control reduces the risk of microvascular complications1 (UKPDS 38) Tight BP control reduces the risk of retinopathy2 Poor glycaemic control increases risk of hospitalisation3 (OR = 2.5, 95% CI 1.38 to 4.64) • UKPDS 38. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes. BMJ 1998; 317: 703-13. • UKPDS Group. Risks of progression of retinopathy and vision loss related to tight blood pressure control in type 2 diabetes mellitus. Arch Ophthalmology 2004; 122: 1631-40 • Lau DT, Nau DP. Oral antihyperglycaemic medication nonadherence and subsequent hospitalisation among individuals with type 2 diabetes. Diabetes Care 2004; 27: 2149-53.

  5. So what is the problem? Patients do not take their prescribed medication as directed! Terminology reveals different philosophies: Compliance – obeying instructions from physician Adherence – slightly less paternalistic Concordance – agreement between equals

  6. Measurement of adherence Measurement of adherence follows Heisenberg’s principle Invariably good using: electronic pillbox, medicine event monitoring systems (MEMS) but unrealistic Prescription databases – more realistic but not direct measure of adherence Morisky adherence score* correlated with HbA1c *Krapek K, King K, Warren SS et al. Medication adherence and associated hemoglobin A1c in type 2 diabetes. Annals of Pharmacotherapy 2004; 38: 1357-62

  7. Tayside Study Aims* Describe patterns of adherence to oral hypoglycaemic drugs in type 2 diabetes Assess predictors of adherence Test hypothesis that once daily administration is associated with better adherence *Donnan PT, MacDonald TM, Morris AD. Adherence to prescribed oral hypoglycaemic medication in a population of patients with type 2 diabetes: a retrospective cohort study. Diabetic Med 2002; 19: 279-284.

  8. Health Informatics Centre, Scotland Tayside, Scotland

  9. Study population All subjects with type 2 diabetes resident in Tayside, Scotland (~420,000) First prescription for oral hypoglycaemic drug on or after 1st Jan 1993 Follow-up to 31 Dec 1995 with at least 12 months of prescriptions

  10. GP Lab Data Screening Purpose Built Hospital SMR Investigations PAMS Social Services Pharmacy Data, Data everywhere But usually not accessible

  11. Record Linkage of all NHS encounters via Community Health Number 05 03 54 0250 Sex Check Date of Birth

  12. Purpose Built Lab Data PAMS GP Pharmacy Hospital Social Services Screening Investigations Linking the Data Vital for Seamless Care and Research

  13. Prevalence of diabetes in Tayside, Scotland Type 2 Diabetes in TaysidePrevalence 2.05% Morris et al, BMJ, 1997

  14. FP10 Rx Trimethoprim FP10 Rx Trimethoprim Encashed Prescriptions Medicines Monitoring Unit Pharmacy Prescription Services Division MEMO

  15. Drug exposure (MEMO) • Sulphonylurea, metformin, other • Date of encashment • Duration • Dose, amount tablets, instructions

  16. Outcome Adherence index: Total time drug prescribed Total time of follow-up Expressed as percentage or drug coverage per annum

  17. Adherence index calculated separately for: • Sulphonylurea monotherapy • Sulphonylurea polytherapy • Metformin monotherapy • Metformin polytherapy

  18. Statistical methods •  90% defined as “adequate” adherence • 53% hospitalised during study - adjusted • Multiple logistic regression • Adjusted age, sex, duration diabetes, number of tablets per day, number of co-medications, social deprivation

  19. Study population 3494 1/1/93-31/12/95 2920 >12 months 1039 Sulphonylurea & metformin 1329 sulphonylurea alone 528 metformin alone

  20. Characteristics for sulphonylurea index Monotherapy 71 yrs 53% 3.7 yrs Polytherapy 65 yrs 48% 5.6 yrs Factor Mean Age % Male Duration of diabetes

  21. Distribution of sulphonylurea index (days of drug coverage per annum) in those receiving sulphonylurea monotherapy (Adherence = 31%)

  22. Adherence index by type of therapy  90% Monotherapy Sulphonylurea 31% Metformin 34% Polytherapy Sulphonylurea 19% Metformin 13%

  23. Adherence defined as  90% or 329 days per year Better adherence associated with: • Lower number of tablets per day • Lower number of co-medications • Less social deprivation • Younger age

  24. Adherence by number of tablets per day 3.0 Adjusted OR and 95% CI 2.0   1.0  0.0 1 per day 2 per day 3 per day Number of tablets relative to 4 per day

  25. Summary • Adherence generally low ( 31%) • Adherence lower in type 2 diabetes on polytherapy • Better adherence in monotherapy associated with lower number of tablets per day and lower number of co-medications

  26. Other adherence studies • Adherence was found to be not a factor in switching to insulin in a further study in Tayside1 • Recent administrative claims database study2: 37% discontinued medication after 12 months, 46% nonadherent with medication possession ratio < 80%, 31% who started on insulin persistent at 12 months • Evans JMM, Donnan PT, Morris AD. Adherence to oral hypoglycaemic agents prior to insulin therapy in type 2 diabetes. Diabetic Med 2002; 19: 685-688. • Adherence with antihyperglycaemic pharmacotherapy among working-aged adults. Clinical Therapeutics (in press)

  27. How are we responding to this challenge?

  28. Improving Adherence • Negotiated telephone support found to be successful in young people with type 1 diabetes1 • Complex educational interventions have been suggested but expensive and difficult • DAFNE study demonstrated that patients require skills as well as knowledge2 • Howells L, Wilson AC, Skinner TC, Newton R, Morris AD, Greene SA. A randomised control trial of the effect of negotiated telephone support on glycaemic control in young people with type 1 diabetes. Diab Med 2002; 19: 643-8. • DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ 2002; 325: 746-49

  29. The future of diabetes care?

  30. Clinical Management: Proven ability to link clinical data with outcomes in Tayside • NHSTayside IT for managed clinical networks • DARTS

  31. Conclusions • Evidence suggests compliance is poor • Perhaps increasing patient self-management skills is a useful approach • Adherence is a critical issue for medication benefits to be realised in the community • Given human nature compliance with medication in diabetes will remain a concern

  32. …. “I hope these are easier to flush away than the last lot” ….

  33. p.t.donnan@chs.dundee.ac.uk

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